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Human Medicines Withdrawn Products

This list was last updated on Friday, January 28, 2022


Please Note
The contents of the table are believed to be correct at the time of compilation. The HPRA makes no representations or warranties about and disclaim all liability for the content,
accuracy, completeness or suitability of the information contained in the table for any purpose whatsoever and the information is made available to the public for information purposes
only.

Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Avonex Biogen Idec Ltd EU/1/97/033/001 Powder and solvent for - Interferon beta - 1a 26/01/2022
solution for injection
Yanimo Respimat 2.5 Boehringer Ingelheim PA0775/010/001 Inhalation solution - Tiotropium 26/01/2022
microgram/2.5 microgram, International GmbH - Olodaterol
inhalation solution
Zantac 25 mg/ml Solution for GlaxoSmithKline (Ireland) PA1077/013/001 Solution for injection/infusion - Ranitidine 26/01/2022
Injection/Infusion Limited
Viramune Boehringer Ingelheim EU/1/97/055/005 Prolonged-release tablet - Nevirapine 17/01/2022
International GmbH
Nutriflex Omega plus B. Braun Melsungen AG PA0736/033/001 Emulsion for infusion - Isoleucine 14/01/2022
Emulsion for infusion - Leucine
- Lysine hydrochloride
- Methionine
- Phenylalanine
- Threonine
- Tryptophan
- Valine
- Arginine
- Histidine hydrochloride
monohydrate
- Alanine
- GLYCINE PH. EUR
- Aspartic acid
- Glutamic acid
- Proline
- Serine
- Sodium hydroxide
- Sodium chloride
- Sodium acetate trihydrate
- Potassium acetate
- Magnesium acetate
trihydrate
- Calcium chloride dihydrate
- Glucose monohydrate
- Sodium dihydrogen
phosphate dihydrate
- Zinc acetate dihydrate
- Triglycerides, medium chain
- SOYA BEAN OIL,
REFINED PH. EUR.
- Omega-3 triglycerides

Human Medicines Withdrawn Products Page 1 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Nutriflex Omega Special B. Braun Melsungen AG PA0736/032/001 Emulsion for infusion - Isoleucine 14/01/2022
Emulsion for infusion - Leucine
- Lysine hydrochloride
- Methionine
- Phenylalanine
- Threonine
- Tryptophan
- Valine
- Arginine
- Histidine hyprochloride
monohydrate
- Alanine
- GLYCINE
- Aspartic acid
- Glutamic acid
- Proline
- Serine
- Sodium hydroxide
- Sodium chloride
- Sodium acetate trihydrate
- Potassium acetate
- Magnesium Acetate
Tetrahydrate
- Calcium chloride dihydrate
- Glucose monohydrate
- Sodium dihydrogen
phosphate dihydrate
- Zinc acetate dihydrate
- Triglycerides, medium-chain
- Soya-bean oil, refined
- Omega-3 triglycerides

Flutiform K-haler 125 Mundipharma PA1688/013/005 Pressurised inhalation, - Fluticasone propionate 31/12/2021
microgram/5 microgram per Pharmaceuticals Limited suspension - Formoterol fumarate
actuation pressurised dihydrate
inhalation, suspension
Flutiform K-haler 50 Mundipharma PA1688/013/004 Pressurised inhalation, - Fluticasone propionate 31/12/2021
microgram/5 microgram per Pharmaceuticals Limited suspension - Formoterol fumarate
actuation pressurised dihydrate
inhalation, suspension
Levact 100mg Powder for Astellas Pharma GmbH PA0731/005/002 Powder for concentrate for - Bendamustine 31/12/2021
Concentrate for Solution for solution for infusion hydrochloride
Infusion
Levact 25mg Powder for Astellas Pharma GmbH PA0731/005/001 Powder for concentrate for - Bendamustine 31/12/2021
Concentrate for Solution for solution for infusion hydrochloride
Infusion
Midazolam 2mg/ml Solution Mercury Pharmaceuticals PA0073/147/002 Solution for injection/infusion - Midazolam 31/12/2021
for Injection/Infusion (Ireland) Ltd
Midazolam 5mg/ml Solution Mercury Pharmaceuticals PA0073/147/001 Solution for injection/infusion - Midazolam 31/12/2021
for Injection/Infusion (Ireland) Ltd
Atropine Sulfate 600 Mercury Pharmaceuticals PA0073/036/001 Solution for injection - ATROPINE SULFATE 29/12/2021
micrograms/ml Solution for (Ireland) Ltd
Injection
Triiodothyronine 20 Mercury Pharma Group Ltd PA0701/002/001 Powder for solution for - LIOTHYRONINE SODIUM 29/12/2021
Micrograms Powder for injection
Solution for Injection
Metastron 37 MBq/ml GE Healthcare B.V. PA22734/001/001 Solution for injection - Strontium (89 sr) chloride 24/12/2021
Solution for Injection
Mucodyne Paediatric Syrup Ipsen Pharmaceuticals PA0869/009/002 Syrup - Carbocisteine 21/12/2021
125 mg/5ml Limited
Mucodyne Syrup 250 mg/5 Ipsen Pharmaceuticals PA0869/009/003 Syrup - Carbocisteine 21/12/2021
ml Limited
Pantoloc Control Takeda GmbH EU/1/09/519/001 Gastro-resistant tablet - Pantoprazole sodium 20/12/2021
sesquihydrate
Pantoloc Control Takeda GmbH EU/1/09/519/002 Gastro-resistant tablet - Pantoprazole sodium 20/12/2021
sesquihydrate
Pantoloc Control Takeda GmbH EU/1/09/519/003 Gastro-resistant tablet - Pantoprazole sodium 20/12/2021
sesquihydrate
Pantoloc Control Takeda GmbH EU/1/09/519/004 Gastro-resistant tablet - Pantoprazole sodium 20/12/2021
sesquihydrate
Rasilez HCT Noden Pharma DAC EU/1/08/491/021-040 Film-coated tablet - Aliskiren hemifumarate 20/12/2021
- Hydrochlorothiazide
Rasilez HCT Noden Pharma DAC EU/1/08/491/041-060 Film-coated tablet - Aliskiren hemifumarate 20/12/2021
- Hydrochlorothiazide
Rasilez HCT Noden Pharma DAC EU/1/08/491/061-080 Film-coated tablet - Aliskiren hemifumarate 20/12/2021
- Hydrochlorothiazide
YTRACIS CIS bio International EU/1/03/250/001 Not assigned - Yttrium (90 y) 20/12/2021

Human Medicines Withdrawn Products Page 2 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Aspirin EC 300mg, gastro- PCO Manufacturing Ltd. PA0465/057/001 Gastro-resistant tablet - Acetylsalicylic acid 18/12/2021
resistant tablets
Esomeprazole 20 mg gastro- Accord Healthcare Ireland PA2315/127/001 Gastro-resistant capsule, - Esomeprazole magnesium 17/12/2021
resistant capsules, hard Ltd. hard dihydrate
Interchangeable List Code:
IC0004-003-016
Esomeprazole 40 mg gastro- Accord Healthcare Ireland PA2315/127/002 Gastro-resistant capsule, - Esomeprazole magnesium 17/12/2021
resistant capsules, hard Ltd. hard dihydrate
Interchangeable List Code:
IC0004-004-016
Prozac 20 mg per 5 ml oral Eli Lilly Nederland B.V. PA2276/004/001 Oral solution - FLUOXETINE 17/12/2021
solution HYDROCHLORIDE
Interchangeable List Code:
IC0075-055-019
Raloxifene Hydrochloride Accord Healthcare Ireland PA2315/095/001 Film-coated tablet - Raloxifene 17/12/2021
60mg Film-coated Tablets Ltd.
Risedronate Sodium Accord Accord Healthcare Ireland PA2315/140/002 Film-coated tablet - Risedronate sodium 17/12/2021
30 mg film-coated tablets Ltd.
Interchangeable List Code:
IC0068-033-003
Tizaflex 2 mg tablets Accord Healthcare Ireland PA2315/051/001 Tablet - Tizanidine hydrochloride 17/12/2021
Ltd.
Tizaflex 4 mg tablets Accord Healthcare Ireland PA2315/051/002 Tablet - Tizanidine hydrochloride 17/12/2021
Ltd.
Budesonide Teva Pharma Teva Pharma B.V. PA0749/207/001 Nebuliser suspension - Budesonide 14/12/2021
0.25 mg/2 ml Nebuliser
Suspension
Epilim Chronosphere Sanofi-Aventis Ireland PA0540/150/008 Prolonged-release granules - SODIUM VALPROATE 14/12/2021
Limited T/A SANOFI - Valproic acid
Epilim Chronosphere Sanofi-Aventis Ireland PA0540/150/009 Prolonged-release granules - Valproic acid 14/12/2021
Limited T/A SANOFI - SODIUM VALPROATE
Epilim Chronosphere 50mg Sanofi-Aventis Ireland PA0540/150/004 Prolonged-release granules - Valproic acid 14/12/2021
prolonged-release granule Limited T/A SANOFI - SODIUM VALPROATE
Humalog Cartridges Eli Lilly Nederland B.V. EU/1/96/007/003 Solution for injection - Insulin lispro 14/12/2021
Humalog NPL Eli Lilly Nederland B.V. EU/1/96/007/007 Suspension for injection - Insulin lispro 14/12/2021
HUMALOG VIALS Eli Lilly and Company Limite EU/1/96/007/001 Solution for injection - Insulin lispro 14/12/2021

Novolizer Budesonide 400 Mylan IRE Healthcare PA2010/032/002 Inhalation powder - Budesonide 14/12/2021
micrograms inhalation Limited
powder
Novolizer® Budesonide 200 Mylan IRE Healthcare PA2010/032/001 Inhalation powder - Budesonide 14/12/2021
micrograms Inhalation Limited
Powder
Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/001-009 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/010-018 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/019-027 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/028-036 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/037-046 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/046-054 Transdermal patch - Rotigotine 13/12/2021

Leganto Schwarz Pharma Ireland Ltd EU/1/11/695/055 Transdermal patch 13/12/2021

Venex XL 225 mg Prolonged- Clonmel Healthcare Ltd PA0126/285/004 Prolonged-release capsule, - Venlafaxine 13/12/2021
release Capsules, hard hard

Blistex Cold Sore Cream D.D.D. Limited PA0302/012/001 Cream - Docosanol 10/12/2021
100mg/g cream
Captor-HCT 25 mg/12.5 mg Rowex Ltd PA0711/025/001 Tablet - Captopril 10/12/2021
Tablets - Hydrochlorothiazide
Captor-HCT 50mg/25mg Rowex Ltd PA0711/025/003 Tablet - Captopril 10/12/2021
Tablets - Hydrochlorothiazide
Ramipril/amlodipine Krka KRKA, d.d., Novo mesto PA1347/072/004 Capsule, hard - Ramipril 10/12/2021
10mg/10mg hard capsules - Amlodipine
Ramipril/amlodipine Krka KRKA, d.d., Novo mesto PA1347/072/003 Capsule, hard - Ramipril 10/12/2021
10mg/5mg hard capsules - Amlodipine
Ramipril/amlodipine Krka KRKA, d.d., Novo mesto PA1347/072/002 Capsule, hard - Ramipril 10/12/2021
5mg/10mg hard capsules - Amlodipine
Ramipril/amlodipine Krka KRKA, d.d., Novo mesto PA1347/072/001 Capsule, hard - Ramipril 10/12/2021
5mg/5mg hard capsules - Amlodipine

Human Medicines Withdrawn Products Page 3 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Lotanos 100mg Film-coated Rowex Ltd PA0711/123/005 Film-coated tablet - Losartan potassium 08/12/2021
tablets
Interchangeable List Code:
IC0003-024-003
Lotanos 50mg Film-coated Rowex Ltd PA0711/123/003 Film-coated tablet - Losartan potassium 08/12/2021
tablets
Interchangeable List Code:
IC0003-023-003
Skysona bluebird bio (Netherlands) EU/1/21/1563/001 Dispersion for infusion - Elivaldogene autotemcel 08/12/2021
B.V.
Cibacen 5 mg Film Coated Mylan IRE Healthcare PA2010/029/001 Film-coated tablet - Benazepril hydrochloride 06/12/2021
Tablet Limited
Risedronate Sodium Actavis Accord Healthcare Ireland PA2315/031/001 Film-coated tablet - Risedronate sodium 03/12/2021
once weekly 35mg Film- Ltd.
Coated Tablets Interchangeable List Code:
IC0068-124-003
Voriconazole Accordpharma Accord Healthcare Ireland PA2315/027/001 Powder for solution for - Voriconazole 03/12/2021
200 mg Powder for solution Ltd. infusion
for infusion
Mucodyne 375 mg Capsules, Ipsen Pharmaceuticals PA0869/009/001 Capsule, hard - Carbocisteine 02/12/2021
Hard Limited
Pemetrexed Teva 25 mg/ml Teva B.V. PA1986/005/003 Concentrate for solution for - Pemetrexed 02/12/2021
Concentrate for Solution for infusion
Infusion
Vascace 0.5 mg Film-coated Roche Products Limited PA0050/083/001 Film-coated tablet - Cilazapril 02/12/2021
Tablets
Antiseptic Throat Lozenges The Boots Company Plc PA0004/055/001 Lozenge - Amylmetacresol 01/12/2021
Orange & Menthol
Boots Day Cold & Flu Relief The Boots Company Plc PA0004/061/002 Oral solution - Paracetamol 01/12/2021
Oral Solution Paracetamol - Pseudoephedrine
1000mg/30mg Pholcodine hydrochloride
10mg/30ml Pseudoephedrine - Pholcodine
Hydrochloride 60mg/30ml

Boots Pharmaceuticals The Boots Company Plc PA0004/054/001 Oral solution - PSEUDOEPHEDRINE 01/12/2021
Chesty Cough & Congestion HYDROCHLORIDE
Relief Oral Solution - Guaiphenesin
Guaifenesin 100 mg/5
mlPseudoephedrine
Hydrochloride 30 mg/5 ml
Boots Pharmaceuticals Day The Boots Company Plc PA0004/061/001 Capsule, hard - Paracetamol 01/12/2021
Cold & Flu Relief Hard - Pseudoephedrine
Capsules Paracetamol 500 hydrochloride
mg Pholcodine 5 mg - Pholcodine
Pseudoephedrine
Hydrochloride 30 mg
Boots Pharmaceuticals Dry The Boots Company Plc PA0004/053/001 Oral solution - Dextromethorphan 01/12/2021
Cough & Congestion Relief hydrobromide
Oral Solution - Pseudoephedrine
Dextromethorphan hydrochloride
Hydrobromide 10 mg/5
mlPseudoephedrine
Hydrochloride 30 mg/5 ml
Boots Pharmaceuticals Sore The Boots Company Plc PA0004/057/001 Lozenge - Amylmetacresol 01/12/2021
Throat Relief Lemon Flavour
0.6 mg Lozenges
IntronA Merck Sharp & Dohme BV EU/1/99/127/002 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/003 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/004 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/005 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/006 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/007 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/008 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/009 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/010 Powder and solvent for - Interferon alfa-2b 30/11/2021
solution for injection
IntronA Merck Sharp & Dohme BV EU/1/99/127/011 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/012 Solution for injection - Interferon alfa-2b 30/11/2021

Human Medicines Withdrawn Products Page 4 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IntronA Merck Sharp & Dohme BV EU/1/99/127/013 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/014 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/015 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/016 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/017 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/018 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/019 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/020 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/021 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/022 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/023 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/024 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/025 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/026 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/027 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/028 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/029 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/030 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/031 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/032 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/033 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/034 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/035 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/037 Solution for injection - Interferon alfa-2b 30/11/2021
IntronA Merck Sharp & Dohme BV EU/1/99/127/039 Solution for injection - Interferon alfa-2b 30/11/2021
Trazodone Hydrochloride Zista Pharma Ltd PA2223/001/002 Capsule, hard - TRAZADONE 25/11/2021
100 mg Hard Capsules HYDROCHLORIDE
Trazodone Hydrochloride 50 Zista Pharma Ltd PA2223/001/001 Capsule, hard - TRAZADONE 25/11/2021
mg Hard Capsules HYDROCHLORIDE
Imatinib Krka d.d. 100 mg KRKA, d.d., Novo mesto PA1347/054/003 Dispersible tablet - Imatinib 23/11/2021
Dispersible tablets
Imatinib Krka d.d. 400 mg KRKA, d.d., Novo mesto PA1347/054/004 Dispersible tablet - Imatinib 23/11/2021
Dispersible tablets
Atripla Gilead Sciences Ireland UC EU/1/07/430/001 Film-coated tablet - Efavirenz 15/11/2021
- Emtricitabine
- Tenofovir disoproxil
fumarate
Caspofungin Clonmel 50 mg Clonmel Healthcare Ltd PA0126/287/001 Powder for concentrate for - Caspofungin 11/11/2021
powder for concentrate for solution for infusion
solution for infusion
Caspofungin Clonmel 70 mg Clonmel Healthcare Ltd PA0126/287/002 Powder for concentrate for - Caspofungin 11/11/2021
powder for concentrate for solution for infusion
solution for infusion
Methotrexate 10 mg tablets Pfizer Healthcare Ireland PA0822/206/005 Tablet - Methotrexate 10/11/2021

Interchangeable List Code:


IC0098-002-002
Folic Acid 400 microgram Clonmel Healthcare Ltd PA0126/057/002 Tablet - Folic Acid 09/11/2021
Tablets
Oilatum Junior Emollient Clonmel Healthcare Ltd PA0126/322/002 Bath additive - Liquid paraffin light 09/11/2021
Bath Additive
Linezolid Clonmel 2mg/ml Clonmel Healthcare Ltd PA0126/238/002 Solution for infusion - Linezolid 08/11/2021
solution for infusion
Naproxen sodium Krka 550 KRKA, d.d., Novo mesto PA1347/090/001 Film-coated tablet - NAPROXEN SODIUM 08/11/2021
mg film-coated tablets
Pregabalin Mylan Pharma Mylan S.A.S. EU/1/15/998/023-027 Capsule, hard - Pregabalin 03/11/2021
100 mg hard capsules
Interchangeable List Code:
IC0110-024-001
Pregabalin Mylan Pharma Mylan S.A.S. EU/1/15/998/028-034 Capsule, hard - Pregabalin 03/11/2021
150 mg hard capsules
Interchangeable List Code:
IC0110-062-001
Pregabalin Mylan Pharma Mylan S.A.S. EU/1/15/998/035-039 Capsule, hard - Pregabalin 03/11/2021
200 mg hard capsules
Interchangeable List Code:
IC0110-067-001
Pregabalin Mylan Pharma Mylan S.A.S. EU/1/15/998/040-044 Capsule, hard - Pregabalin 03/11/2021
225 mg hard capsules
Interchangeable List Code:
IC0110-064-001
Pregabalin Mylan Pharma 25 Mylan S.A.S. EU/1/15/998/001-008 Capsule, hard - Pregabalin 03/11/2021
mg hard capsules
Interchangeable List Code:
IC0110-022-001

Human Medicines Withdrawn Products Page 5 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Pregabalin Mylan Pharma Mylan S.A.S. EU/1/15/998/045-050 Capsule, hard - Pregabalin 03/11/2021
300 mg hard capsules
Interchangeable List Code:
IC0110-029-001
Pregabalin Mylan Pharma 50 Mylan S.A.S. EU/1/15/998/009-015 Capsule, hard - Pregabalin 03/11/2021
mg hard capsules
Interchangeable List Code:
IC0110-023-001
Pregabalin Mylan Pharma 75 Mylan S.A.S. EU/1/15/998/016-022 Capsule, hard - Pregabalin 03/11/2021
mg hard capsules
Interchangeable List Code:
IC0110-028-001
Methotrexate 10 mg tablets Orion Corporation PA1327/009/002 Tablet - Methotrexate 02/11/2021

Interchangeable List Code:


IC0098-002-002
Methotrexate 2.5mg Tablets Orion Corporation PA1327/009/001 Tablet - Methotrexate 02/11/2021

Interchangeable List Code:


IC0098-018-002
Carteolol hydrochloride Thea Laboratoires Thea PA1107/016/001 Eye drops, solution - Carteolol Hydrochloride 01/11/2021
20 mg/ml eye drops, solution

Singulair Paediatric 4 mg IMED Healthcare Ltd. PPA1463/064/001 Chewable tablet - Montelukast 01/11/2021
Chewable Tablets
Interchangeable List Code:
IC0023-008-007
Veramil 120mg Film-coated Orion Corporation PA1327/008/003 Film-coated tablet - VERAPAMIL 01/11/2021
Tablets HYDROCHLORIDE
Yaltormin SR 1000mg Pinewood Laboratories Ltd, PA0281/241/003 Prolonged-release tablet - METFORMIN 01/11/2021
Prolonged Release Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0067-119-024
Yaltormin SR 500mg Pinewood Laboratories Ltd, PA0281/241/001 Prolonged-release tablet - METFORMIN 01/11/2021
Prolonged Release Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0067-117-024
Yaltormin SR 750mg Pinewood Laboratories Ltd, PA0281/241/002 Prolonged-release tablet - METFORMIN 01/11/2021
Prolonged Release Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0067-141-024
Epethinan 10 mg/5 mg Acino AG PA2168/001/002 Prolonged-release tablet - OXYCODONE 29/10/2021
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - NALOXONE
IC0102-016-024 HYDROCHLORIDE
Epethinan 20 mg/10 mg Acino AG PA2168/001/003 Prolonged-release tablet - OXYCODONE 29/10/2021
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - NALOXONE
IC0102-061-024 HYDROCHLORIDE
Epethinan 40 mg/20 mg Acino AG PA2168/001/004 Prolonged-release tablet - OXYCODONE 29/10/2021
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - NALOXONE
IC0102-160-024 HYDROCHLORIDE
Epethinan 5 mg/2.5 mg Acino AG PA2168/001/001 Prolonged-release tablet - OXYCODONE 29/10/2021
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - NALOXONE
IC0102-159-024 HYDROCHLORIDE
Tadalafil Rowex 20 mg Film- Rowex Ltd PA0711/261/004 Film-coated tablet - Tadalafil 27/10/2021
coated Tablets
DDAVP Desmopressin 100 Ferring Ireland Ltd PA1009/001/001 Nasal drops, solution - DESMOPRESSIN 26/10/2021
micrograms/ml Nasal drops, ACETATE
solution
Isotretinoin 5 mg soft Rowex Ltd PA0711/312/001 Capsule, soft - Isotretinoin 26/10/2021
capsules
Gentamicin 40 mg/ml Pfizer Healthcare Ireland PA0822/203/001 Solution for injection - Gentamicin sulfate 22/10/2021
Injection, vials
Abacavir/Lamivudine Rowex Rowex Ltd PA0711/251/001 Film-coated tablet - Lamivudine 19/10/2021
600 mg/300 mg film-coated - Abacavir
tablets
Hydromorphone-HCl Mundipharma PA1688/022/001 Capsule, hard - HYDROMORPHONE 15/10/2021
Krugmann 1.3 mg capsules, Pharmaceuticals Limited HYDROCHLORIDE
hard
Hydromorphone-HCl Mundipharma PA1688/022/002 Capsule, hard - HYDROMORPHONE 15/10/2021
Krugmann 2.6 mg capsules, Pharmaceuticals Limited HYDROCHLORIDE
hard
Dithrocream 0.25%w/w Dermal Laboratories Ltd PA0278/001/002 Cream - Dithranol 14/10/2021

Human Medicines Withdrawn Products Page 6 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Dithrocream 0.5%w/w Dermal Laboratories Ltd PA0278/001/003 Cream - Dithranol 14/10/2021
Dithrocream 1% w/w Dermal Laboratories Ltd PA0278/001/004 Cream - Dithranol 14/10/2021
Glutarol 10% w/v Cutaneous Dermal Laboratories (Ireland) PA23128/002/001 Cutaneous solution - Glutaraldehyde 14/10/2021
Solution Limited
Oxydon 5 mg Prolonged- Rowex Ltd PA0711/115/004 Prolonged-release tablet - OXYCODONE 14/10/2021
release tablets HYDROCHLORIDE
Interchangeable List Code:
IC0066-001-024
Vascace 1 mg Film-coated Roche Products Limited PA0050/083/002 Film-coated tablet - Cilazapril 14/10/2021
Tablets
Vascace 2.5 mg Film-coated Roche Products Limited PA0050/083/003 Film-coated tablet - Cilazapril 14/10/2021
Tablets
Vascace 5 mg Film-coated Roche Products Limited PA0050/083/004 Film-coated tablet - Cilazapril 14/10/2021
Tablets
Abiraterone 250 mg film- Rowex Ltd PA0711/304/001 Film-coated tablet - Abiraterone acetate 12/10/2021
coated tablets
Alprazolam 1 mg tablets Rowex Ltd PA0711/140/003 Tablet - Alprazolam 12/10/2021

Interchangeable List Code:


IC0094-039-002
Dailiport 0.5 mg Prolonged- Rowex Ltd PA0711/294/001 Prolonged-release capsule, - Tacrolimus 12/10/2021
release hard capsules hard
Dailiport 1 mg Prolonged- Rowex Ltd PA0711/294/002 Prolonged-release capsule, - Tacrolimus 12/10/2021
release hard capsules hard
Dailiport 2 mg Prolonged- Rowex Ltd PA0711/294/003 Prolonged-release capsule, - Tacrolimus 12/10/2021
release hard capsules hard
Dailiport 3 mg Prolonged- Rowex Ltd PA0711/294/004 Prolonged-release capsule, - Tacrolimus 12/10/2021
release hard capsules hard
Dailiport 5 mg Prolonged- Rowex Ltd PA0711/294/005 Prolonged-release capsule, - Tacrolimus 12/10/2021
release hard capsules hard
Diltam 90 mg Prolonged Rowex Ltd PA0711/004/002 Prolonged-release tablet - Diltiazem hydrochloride 12/10/2021
release tablets
Duloxetine Rowex 30 mg Rowex Ltd PA0711/263/001 Gastro-resistant capsule, - Duloxetine hydrochloride 12/10/2021
Gastro-resistant capsules, hard
hard Interchangeable List Code:
IC0091-033-006
Duloxetine Rowex 60 mg Rowex Ltd PA0711/263/002 Gastro-resistant capsule, - Duloxetine hydrochloride 12/10/2021
Gastro-resistant capsules, hard
hard Interchangeable List Code:
IC0091-127-006
EquiHes 100 mg/ml solution B. Braun Melsungen AG PA0736/024/004 Solution for infusion - Poly(o-2- 12/10/2021
for infusion, Ecobag hydroxyethyl)starch
- Sodium chloride
- Potassium chloride
- Calcium chloride dihydrate
- Magnesium chloride
hexahydrate
- Sodium acetate trihydrate
- L-malic acid dab
EquiHes 100 mg/ml solution B. Braun Melsungen AG PA0736/024/002 Solution for infusion - Poly(o-2- 12/10/2021
for infusion, Ecoflac Plus hydroxyethyl)starch
- Sodium chloride
- Potassium chloride
- Calcium chloride dihydrate
- Magnesium chloride
hexahydrate
- Sodium acetate trihydrate
- L-malic acid dab
EquiHes 60 mg/ml solution B. Braun Melsungen AG PA0736/024/003 Solution for infusion - Poly(o-2- 12/10/2021
for infusion, Ecobag hydroxyethyl)starch
- Sodium chloride
- Potassium chloride
- Calcium chloride dihydrate
- Magnesium chloride
hexahydrate
- Sodium acetate trihydrate
- L-malic acid dab
EquiHes 60 mg/ml solution B. Braun Melsungen AG PA0736/024/001 Solution for infusion - Poly(o-2- 12/10/2021
for infusion, Ecoflac Plus hydroxyethyl)starch
- Sodium chloride
- Potassium chloride
- Calcium chloride dihydrate
- Magnesium chloride
hexahydrate
- Sodium acetate trihydrate
- L-malic acid dab

Human Medicines Withdrawn Products Page 7 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Paracetamol 10 mg/ml Rowex Ltd PA0711/228/001 Solution for infusion - Paracetamol 12/10/2021
solution for infusion
Piperin 2 g/0.25g Powder for Rowex Ltd PA0711/113/001 Powder for solution for - Piperacillin 12/10/2021
Solution for Infusion infusion - Tazobactam
Salbul 100 micrograms/dose Rowex Ltd PA0711/128/001 Pressurised inhalation, - Salbutamol 12/10/2021
pressurised inhalation, suspension
suspension Interchangeable List Code:
IC0078-138-053
Anhydrol Forte 20% IMED Healthcare Ltd. DPR1463/048/001 - Aluminium chloride 11/10/2021
hexahydrate
BRAVELLE 75 IU powder Ferring Ireland Ltd PA1009/019/001 Powder and solvent for - Urofollitropin 11/10/2021
and solvent for solution for solution for injection
injection
Calcichew D3 Forte IMED Healthcare Ltd. DPR1463/044/001 Chewable tablet - Cholecalciferol 11/10/2021
Chewable Tablets - Calcium carbonate
Captopril 25mg/5ml Oral JensonR+ (Ireland) Limited PA2282/001/002 Oral solution - Captopril 11/10/2021
Solution
Captopril 5mg/5ml Oral JensonR+ (Ireland) Limited PA2282/001/001 Oral solution - Captopril 11/10/2021
Solution
Cosopt IMED Healthcare Ltd. DPR1463/046/001 Eye drops, solution - Dorzolamide 11/10/2021
- Timolol
Diprobase IMED Healthcare Ltd. DPR1463/032/001 Cream 11/10/2021
Docetaxel Teva B.V. EU/1/09/611/1-2 Concentrate and solvent for - Docetaxel 11/10/2021
solution for infusion
Equidacent Centus Biotherapeutics EU/1/20/1472/001-002 Concentrate for solution for - Bevacizumab 11/10/2021
Europe Limited infusion
Exterol IMED Healthcare Ltd. DPR1463/049/001 - Urea hydrogen peroxide 11/10/2021
Ezetrol IMED Healthcare Ltd. DPR1463/042/001 Tablet - Ezetimibe 11/10/2021
Inspra IMED Healthcare Ltd. DPR1463/052/001 Film-coated tablet - Mesalazine 11/10/2021
Levothyroxine 100 JensonR+ (Ireland) Limited PA2282/002/003 Oral solution - Levothyroxine sodium 11/10/2021
micrograms/5 ml Oral
Solution
Levothyroxine 25 JensonR+ (Ireland) Limited PA2282/002/001 Oral solution - Levothyroxine sodium 11/10/2021
micrograms/5 ml Oral
Solution
Levothyroxine 50 JensonR+ (Ireland) Limited PA2282/002/002 Oral solution - Levothyroxine sodium 11/10/2021
micrograms/5 ml Oral
Solution
Melcam 15 mg Tablets Rowex Ltd PA0711/060/002 Tablet - Meloxicam 11/10/2021
Melcam 7.5 mg Tablets Rowex Ltd PA0711/060/001 Tablet - Meloxicam 11/10/2021
MOVICOL Paediatric Plain IMED Healthcare Ltd. DPR1463/034/001 Powder for oral solution - Potassium chloride 11/10/2021
sachet - Sodium hydrogen
carbonate (E500)
- Macrogol 3350
- Sodium chloride
Pentasa IMED Healthcare Ltd. DPR1463/051/001 Prolonged-release granules - Mesalazine 11/10/2021
Pentasa IMED Healthcare Ltd. DPR1463/051/002 Prolonged-release granules - Mesalazine 11/10/2021
Prozac IMED Healthcare Ltd. DPR1463/018/001 Capsule, hard - FLUOXETINE 11/10/2021
HYDROCHLORIDE
Salactol Collodion IMED Healthcare Ltd. DPR1463/050/001 - Salicylic acid 11/10/2021
- Lactic acid
Salatac IMED Healthcare Ltd. DPR1463/038/001 Gel - Salicylic acid 11/10/2021
- Lactic acid
Spiolto Respimat IMED Healthcare Ltd. DPR1463/047/001 Inhalation vapour, solution - Tiotropium bromide 11/10/2021
monohydrate
- Olodaterol hydrochloride
Spiriva Respimat IMED Healthcare Ltd. DPR1463/045/001 Inhalation solution - Tiotropium bromide 11/10/2021
Telmisartan Rowex 20 mg Rowex Ltd PA0711/186/001 Tablet - Telmisartan 11/10/2021
Tablets
Interchangeable List Code:
IC0049-003-014
Telmisartan Rowex 40 mg Rowex Ltd PA0711/186/002 Tablet - Telmisartan 11/10/2021
Tablets
Interchangeable List Code:
IC0049-004-014
Telmisartan Rowex 80 mg Rowex Ltd PA0711/186/003 Tablet - Telmisartan 11/10/2021
Tablets
Interchangeable List Code:
IC0049-005-014
Tradol Plus 37.5 mg/325 mg Rowex Ltd PA0711/256/001 Tablet - Tramadol hydrochloride 11/10/2021
Tablets - Paracetamol
Interchangeable List Code:
IC0077-133-014
Aspirin Rowex 75mg gastro- Rowex Ltd PA0711/247/001 Gastro-resistant tablet - Acetylsalicylic acid 08/10/2021
resistant tablets

Human Medicines Withdrawn Products Page 8 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Atazanavir Rowex 200 mg Rowex Ltd PA0711/287/003 Capsule, hard - Atazanavir sulfate 08/10/2021
Capsules hard
Ulipristal Acetate Gedeon Gedeon Richter Plc EU/1/18/1309/001-005 Tablet - Ulipristal acetate 08/10/2021
Richter
Emtricitabine/Tenofovir Accord Healthcare Ireland PA2315/200/001 Film-coated tablet - Emtricitabine 07/10/2021
disoproxil 200 mg/245 mg Ltd. - Tenofovir disoproxil
film-coated tablets Interchangeable List Code:
IC0107-165-003
Escitalopram 10 mg film- Accord Healthcare Ireland PA2315/131/002 Film-coated tablet - Escitalopram 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0071-002-003
Escitalopram 20 mg film- Accord Healthcare Ireland PA2315/131/004 Film-coated tablet - Escitalopram 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0071-003-003
Escitalopram 5mg film- Accord Healthcare Ireland PA2315/131/001 Film-coated tablet - Escitalopram 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0071-001-003
Gefitinib Accord 250 mg film Accord Healthcare Ireland PA2315/221/001 Film-coated tablet - Gefitinib 07/10/2021
coated tablets Ltd.
Lestace 2.5 mg tablets Accord Healthcare Ireland PA2315/008/001 Tablet - Lisinopril dihydrate 07/10/2021
Ltd.
Olanzapine 10 mg film- Accord Healthcare Ireland PA2315/216/004 Film-coated tablet - Olanzapine 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0007-002-038
Olanzapine 15 mg film- Accord Healthcare Ireland PA2315/216/005 Film-coated tablet - Olanzapine 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0007-032-038
Olanzapine 2.5 mg film- Accord Healthcare Ireland PA2315/216/001 Film-coated tablet - Olanzapine 07/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0007-018-035
Olanzapine 5 mg film-coated Accord Healthcare Ireland PA2315/216/002 Film-coated tablet - Olanzapine 07/10/2021
tablets Ltd.
Interchangeable List Code:
IC0007-001-038
Alendronic Acid Once Rowex Ltd PA0711/102/001 Tablet - Alendronic acid 06/10/2021
Weekly 70 mg Tablets
Interchangeable List Code:
IC0051-101-002
Alfuzosin hydrochloride Rowex Ltd PA0711/083/002 Prolonged-release tablet - ALFUZOSIN 06/10/2021
Rowex 10 mg prolonged- HYDROCHLORIDE
release tablets
Gabapentin 100 mg capsules Rowex Ltd PA0711/132/001 Capsule, hard - Gabapentin 06/10/2021

Interchangeable List Code:


IC0109-024-001
Gabapentin 300 mg capsules Rowex Ltd PA0711/132/002 Capsule, hard - Gabapentin 06/10/2021

Interchangeable List Code:


IC0109-029-001
Gabapentin 400 mg capsules Rowex Ltd PA0711/132/003 Capsule, hard - Gabapentin 06/10/2021

Interchangeable List Code:


IC0109-068-001
Losartan/Hydrochlorothiazide Rowex Ltd PA0711/139/002 Film-coated tablet - Losartan potassium 06/10/2021
100 mg/25 mg film-coated - Hydrochlorothiazide
tablets Interchangeable List Code:
IC0031-027-003
Losartan/Hydrochlorothiazide Rowex Ltd PA0711/139/001 Film-coated tablet - Losartan potassium 06/10/2021
50 mg/ 12.5 mg film-coated - Hydrochlorothiazide
tablets Interchangeable List Code:
IC0031-025-003
Metophage 500 mg Film- Rowex Ltd PA0711/147/001 Film-coated tablet - METFORMIN 06/10/2021
Coated Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0067-117-003
Metophage 850 mg Film- Rowex Ltd PA0711/147/002 Film-coated tablet - METFORMIN 06/10/2021
Coated Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0067-118-003

Human Medicines Withdrawn Products Page 9 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Brieka 100 mg hard capsules Accord Healthcare Ireland PA2315/217/004 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-024-001
Brieka 150 mg hard capsules Accord Healthcare Ireland PA2315/217/005 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-062-001
Brieka 200 mg hard capsules Accord Healthcare Ireland PA2315/217/006 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-067-001
Brieka 300 mg hard capsules Accord Healthcare Ireland PA2315/217/008 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-029-001
Brieka 50 mg hard capsules Accord Healthcare Ireland PA2315/217/002 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-023-001
Brieka 75 mg hard capsules Accord Healthcare Ireland PA2315/217/003 Capsule, hard - Pregabalin 05/10/2021
Ltd.
Interchangeable List Code:
IC0110-028-001
Quetiapine Rowex 200 mg Rowex Ltd PA0711/156/006 Prolonged-release tablet - Quetiapine 05/10/2021
Prolonged-Release Tablets
Interchangeable List Code:
IC0019-067-024
Quetiapine Rowex 300 mg Rowex Ltd PA0711/156/007 Prolonged-release tablet - Quetiapine 05/10/2021
Prolonged-Release Tablets
Interchangeable List Code:
IC0019-029-024
Quetiapine Rowex 400 mg Rowex Ltd PA0711/156/008 Prolonged-release tablet - Quetiapine 05/10/2021
Prolonged-Release Tablets
Interchangeable List Code:
IC0019-068-024
Cinacalcet Rowex 90 mg Rowex Ltd PA0711/311/003 Film-coated tablet - Cinacalcet 04/10/2021
film-coated tablets
Atorvastatin 10 mg film- Accord Healthcare Ireland PA2315/007/001 Film-coated tablet - Atorvastatin-calcium 01/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0001-002-003
Atorvastatin 20 mg film- Accord Healthcare Ireland PA2315/007/002 Film-coated tablet - Atorvastatin-calcium 01/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0001-003-003
Atorvastatin 40 mg film- Accord Healthcare Ireland PA2315/007/003 Film-coated tablet - Atorvastatin-calcium 01/10/2021
coated tablets Ltd.
Interchangeable List Code:
IC0001-004-003
Atorvastatin 80 mg Film- Accord Healthcare Ireland PA2315/007/004 Film-coated tablet - Atorvastatin calcium 01/10/2021
coated Tablets Ltd. trihydrate
Interchangeable List Code:
IC0001-005-003
Desloratadine 0.5 mg/ml oral Accord Healthcare Ireland PA2315/012/001 Oral solution - Desloratidine 01/10/2021
solution Ltd.
Fibro-Vein 0.5% w/v Solution STD Pharmaceutical PA22778/001/001 Solution for injection - Sodium tetradecyl sulfate 27/09/2021
for Injection (Ireland) Limited
Ponalgic 250mg Hard Mercury Pharmaceuticals PA0073/097/001 Capsule - Mefenamic acid 27/09/2021
Capsules (Ireland) Ltd
Requip-Modutab 4 mg Lexon (UK) Ltd PPA1097/080/001 Prolonged-release tablet - Ropinirole 27/09/2021
Prolonged-Release Tablets
Requip-Modutab 8 mg Lexon (UK) Ltd PPA1097/080/002 Prolonged-release tablet - Ropinirole 27/09/2021
Prolonged-Release Tablets
Dulcolax 5mg Suppositories Sanofi-Aventis Ireland PA0540/184/001 Suppository - Bisacodyl 25/09/2021
for Children Limited T/A SANOFI
Dulcolax Pico Perles 2.5 mg Sanofi-Aventis Ireland PA0540/183/001 Capsule, soft - Sodium picosulfate 25/09/2021
Capsules, soft Limited T/A SANOFI
Lysopadol 17.86 mg/ml Sanofi-Aventis Ireland PA0540/186/002 Oromucosal spray, solution - AMBROXOL 25/09/2021
oromucosal spray, solution Limited T/A SANOFI HYDROCHLORIDE
Peppermint Oil Sanofi 0.2 ml Sanofi-Aventis Ireland PA0540/196/001 Gastro-resistant capsule, soft - Peppermint oil 25/09/2021
gastro-resistant soft capsules Limited T/A SANOFI

Desmotabs 0.2mg Tablets Ferring Ireland Ltd PA1009/007/001 Tablet - DESMOPRESSIN 22/09/2021
ACETATE

Human Medicines Withdrawn Products Page 10 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Lotriderm Merck Sharp & Dohme PA1286/031/001 Cream - BETAMETHASONE 22/09/2021
Ireland (Human Health) DIPROPIONATE
Limited - Clotrimazole
Erythroped Forte SF 500 Amdipharm Limited PA1142/006/003 Granules for oral suspension - Erythromycin 20/09/2021
mg/5ml granules for oral
suspension
Fucibet 20 mg/g + 1 mg/g IMED Healthcare Ltd. PPA1463/082/001 Cream - Fusidic acid 20/09/2021
cream - Betamethasone valerate
Imuran 50 mg film-coated IMED Healthcare Ltd. PPA1463/014/001 Film-coated tablet - Azathioprine 20/09/2021
tablets
Lustral 100 mg Film-coated IMED Healthcare Ltd. PPA1463/131/001 Film-coated tablet - Sertraline 20/09/2021
Tablets
Interchangeable List Code:
IC0064-024-003
Lustral 50mg Film-coated IMED Healthcare Ltd. PPA1463/131/002 Film-coated tablet - Sertraline 20/09/2021
Tablets
Interchangeable List Code:
IC0064-023-003
Zovirax 200 mg Dispersible IMED Healthcare Ltd. PPA1463/086/001 Dispersible tablet - ACICLOVIR 20/09/2021
Tablets
Zovirax 800 mg Dispersible IMED Healthcare Ltd. PPA1463/132/003 Dispersible tablet - ACICLOVIR 20/09/2021
Tablets
NovoSeven Novo Nordisk A/S EU/1/96/006/001 Powder and solvent for - Factor viia human, 17/09/2021
solution for injection recombinant
NovoSeven Novo Nordisk A/S EU/1/96/006/002 Powder and solvent for - Factor viia human, 17/09/2021
solution for injection recombinant
Sporanox I.V. 10 mg/mL Janssen Sciences Ireland U PA22612/012/004 Concentrate and solvent for - Itraconazole 17/09/2021
concentrate and solvent for solution for infusion
solution for infusion
Latacris 50 microgram/ml eye NTC Srl PA2122/001/001 Eye drops, solution - Latanoprost 15/09/2021
drops, solution
Interchangeable List Code:
IC0096-152-045
Linezolid 2 mg/ml solution for McDermott Laboratories Ltd., PA0577/213/001 Solution for infusion - Linezolid 15/09/2021
infusion T/A Gerard Laboratories

Sporanox 100 mg Capsules Lexon (UK) Ltd PPA1097/063/001 Capsule - Itraconazole 14/09/2021
Cerumol Ear Drops Solution Thornton & Ross Limited PA0610/018/001 Ear drops, solution - Arachis oil 10/09/2021
- Chlorobutanol
Asacolon 400 mg Gastro- Lexon (UK) Ltd PPA1097/008/001 Gastro-resistant tablet - Mesalazine 09/09/2021
Resistant Tablets
Noctamid Tablets 1 mg Bayer Limited PA1410/009/001 Tablet - Lormetazepam 08/09/2021
Ixprim 37.5 mg/325 mg film- Lexon (UK) Ltd PPA1097/010/001 Film-coated tablet - Tramadol hydrochloride 03/09/2021
coated tablets - Paracetamol
Interchangeable List Code:
IC0077-133-014
Keflex 500 mg Film-Coated Lexon (UK) Ltd PPA1097/049/001 Film-coated tablet - Cefalexin 03/09/2021
Tablets
Cordarone X 100 mg Tablets Lexon (UK) Ltd PPA1097/051/001 Tablet - AMIODARONE 02/09/2021
HYDROCHLORIDE
Istin 10mg Tablets Lexon (UK) Ltd PPA1097/061/002 Tablet - Amlodipine besilate 02/09/2021

Interchangeable List Code:


IC0045-002-008
Binosto Once Weekly 70 mg Lexon (UK) Ltd PPA1097/045/001 Effervescent tablet - Sodium alendronate 01/09/2021
Effervescent Tablets trihydrate (micronised)
Interchangeable List Code:
IC0051-101-057
Exterol 5% w/w Ear Drops, Lexon (UK) Ltd PPA1097/044/001 Ear drops, solution - Urea hydrogen peroxide 01/09/2021
Solution
Half Beta-Prograne 80 mg Lexon (UK) Ltd PPA1097/018/001 Prolonged-release capsule, - PROPRANOLOL 01/09/2021
Prolonged-Release Capsules hard HYDROCHLORIDE

Monovo 1 mg/g Cutaneous Almirall Hermal GmbH PA1548/003/001 Cutaneous emulsion - Mometasone furoate 01/09/2021
Emulsion
Asacolon 800 mg Gastro- Lexon (UK) Ltd PPA1097/008/002 Gastro-resistant tablet - Mesalazine 31/08/2021
resistant Tablets
Beta-Prograne 160 mg Lexon (UK) Ltd PPA1097/018/002 Prolonged-release capsule, - PROPRANOLOL 31/08/2021
prolonged-release capsules hard HYDROCHLORIDE
Brolene 0.1% w/v Eye Drops Lexon (UK) Ltd PPA1097/046/001 Eye drops, solution - PROPAMIDINE 31/08/2021
Solution ISETIONATE
Calcichew 500mg Chewable Lexon (UK) Ltd PPA1097/027/001 Chewable tablet - Calcium 31/08/2021
Tablets
Cosentyx Novartis Europharm Limited EU/1/14/980/008-011 Solution for infusion in pre- - Secukinumab 31/08/2021
filled syringe

Human Medicines Withdrawn Products Page 11 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Istin 5mg Tablets Lexon (UK) Ltd PPA1097/061/001 Tablet - Amlodipine besilate 31/08/2021

Interchangeable List Code:


IC0045-001-008
Lercaril 20 mg/10 mg film- Lexon (UK) Ltd PPA1097/003/001 Film-coated tablet - Enalapril maleate 31/08/2021
coated tablets - Lercanidipine hydrochloride

Provigil 100 mg Tablets Lexon (UK) Ltd PPA1097/024/002 Tablet - Modafinil 31/08/2021
Ventolin Evohaler 100 Lexon (UK) Ltd PPA1097/054/001 Pressurised inhalation, - Salbutamol 31/08/2021
micrograms pressurised suspension
inhalation, suspension Interchangeable List Code:
IC0078-138-053
Adalat LA 20 mg Prolonged- IMED Healthcare Ltd. PPA1463/058/001 Prolonged-release tablet - Nifedipine 26/08/2021
Release Tablet
Adalat LA 30 mg Prolonged- IMED Healthcare Ltd. PPA1463/058/002 Prolonged-release tablet - Nifedipine 26/08/2021
Release Tablet
Adalat LA 60 mg Prolonged- IMED Healthcare Ltd. PPA1463/058/003 Prolonged-release tablet - Nifedipine 26/08/2021
Release Tablet
Canesten HC IMED Healthcare Ltd. PPA1463/049/001 Cream - Clotrimazole 26/08/2021
CreamClotrimazole - Hydrocortisone
1.0%w/wHydrocortisone
1.0%w/w
Cardicor 1.25 mg film-coated IMED Healthcare Ltd. PPA1463/085/001 Film-coated tablet - BISOPROLOL FUMARATE 26/08/2021
tablets
Interchangeable List Code:
IC0065-044-014
Cardicor 2.5 mg film-coated IMED Healthcare Ltd. PPA1463/085/002 Film-coated tablet - BISOPROLOL FUMARATE 26/08/2021
tablets
Interchangeable List Code:
IC0065-018-014
Cordarone X 100mg Tablets IMED Healthcare Ltd. PPA1463/094/001 Tablet - AMIODARONE 26/08/2021
HYDROCHLORIDE
Cordarone X 200mg Tablets IMED Healthcare Ltd. PPA1463/094/002 Tablet - AMIODARONE 26/08/2021
HYDROCHLORIDE
Diovan 160 mg film-coated IMED Healthcare Ltd. PPA1463/077/002 Film-coated tablet - Valsartan 26/08/2021
tablets
Interchangeable List Code:
IC0038-082-003
Diovan 80 mg film-coated IMED Healthcare Ltd. PPA1463/077/001 Film-coated tablet - Valsartan 26/08/2021
tablets
Interchangeable List Code:
IC0038-005-003
Konverge 20mg/5mg film- IMED Healthcare Ltd. PPA1463/104/001 Film-coated tablet - Amlodipine 26/08/2021
coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0046-092-003
Konverge 40mg/10mg film- IMED Healthcare Ltd. PPA1463/104/003 Film-coated tablet - Olmesartan medoxomil 26/08/2021
coated tablets - Amlodipine besylate
Interchangeable List Code:
IC0046-093-003
Konverge 40mg/5mg film- IMED Healthcare Ltd. PPA1463/104/002 Film-coated tablet - Amlodipine besylate 26/08/2021
coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0046-094-003
Malarone 250mg/100mg film- IMED Healthcare Ltd. PPA1463/095/001 Film-coated tablet - PROGUANIL 26/08/2021
coated tablets HYDROCHLORIDE
- Atovaquone
Minocin SA 100 mg Modified IMED Healthcare Ltd. PPA1463/097/001 Modified-release capsule, - Minocycline 26/08/2021
Release Capsules hard
Nebilet 5 mg tablets IMED Healthcare Ltd. PPA1463/113/001 Tablet - Nebivolol 26/08/2021

Interchangeable List Code:


IC0082-001-002
NORLEVO 1.5 mg tablet IMED Healthcare Ltd. PPA1463/087/001 Tablet - Levonorgestrel 26/08/2021
Omesar 10 mg film-coated IMED Healthcare Ltd. PPA1463/047/003 Film-coated tablet - Olmesartan medoxomil 26/08/2021
tablets
Interchangeable List Code:
IC0105-002-003
Omesar 20 mg film-coated IMED Healthcare Ltd. PPA1463/047/002 Film-coated tablet - Olmesartan medoxomil 26/08/2021
tablets
Interchangeable List Code:
IC0105-003-003
Omesar 40 mg film-coated IMED Healthcare Ltd. PPA1463/047/001 Film-coated tablet - Olmesartan medoxomil 26/08/2021
tablets
Interchangeable List Code:
IC0105-004-003

Human Medicines Withdrawn Products Page 12 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Osteofos D3 1200mg/800 IMED Healthcare Ltd. PPA1463/096/001 Powder for oral suspension - Colecalciferol 26/08/2021
I.U. powder for oral - Calcium phosphate
suspension
Roaccutane 20 mg soft IMED Healthcare Ltd. PPA1463/105/001 Capsule, soft - Isotretinoin 26/08/2021
capsules
Seretide 125 Evohaler 25 IMED Healthcare Ltd. PPA1463/006/004 Pressurised inhalation, - FLUTICASONE 26/08/2021
microgram/125 suspension PROPIONATE
microgram/dose pressurised - SALMETEROL
inhalation, suspension XINAFOATE

Seretide 250 Evohaler 25 IMED Healthcare Ltd. PPA1463/006/005 Pressurised inhalation, - FLUTICASONE 26/08/2021
microgram/250 suspension PROPIONATE
microgram/dose pressurised - SALMETEROL
inhalation, suspension XINAFOATE

Targocid 200mg Powder and IMED Healthcare Ltd. PPA1463/103/002 Powder and solvent for - Teicoplanin 26/08/2021
Solvent for Solution for solution for injection/infusion
Injection/infusion or oral
solution
Targocid 400mg Powder and IMED Healthcare Ltd. PPA1463/103/001 Powder and solvent for - Teicoplanin 26/08/2021
Solvent for Solution for solution for injection/infusion
Injection/infusion or oral
solution
Ventolin Evohaler 100 IMED Healthcare Ltd. PPA1463/007/001 Pressurised inhalation, - Salbutamol 26/08/2021
micrograms pressurised suspension
inhalation, suspension Interchangeable List Code:
IC0078-138-053
Xatral 10mg Prolonged IMED Healthcare Ltd. PPA1463/017/001 Prolonged-release tablet - ALFUZOSIN 26/08/2021
Release Tablets HYDROCHLORIDE
Zanidip 10mg film-coated IMED Healthcare Ltd. PPA1463/134/001 Film-coated tablet - Lercanidipine 26/08/2021
tablets
Interchangeable List Code:
IC0020-002-003
Zofran 4 mg film-coated IMED Healthcare Ltd. PPA1463/062/001 Film-coated tablet - Ondansetron 26/08/2021
tablets
Interchangeable List Code:
IC0114-008-061
Zoton FasTab 15 mg oro- IMED Healthcare Ltd. PPA1463/001/001 Orodispersible tablet - Lansoprazole 26/08/2021
dispersible tablets
Interchangeable List Code:
IC0008-032-033
Zoton Fastab 30 mg Oro- IMED Healthcare Ltd. PPA1463/001/002 Orodispersible tablet - Lansoprazole 26/08/2021
dispersible tablets
Interchangeable List Code:
IC0008-033-033
Seroxat 20 mg film-coated IMED Healthcare Ltd. PPA1463/009/001 Film-coated tablet - Paroxetine 25/08/2021
tablets
Interchangeable List Code:
IC0076-003-003
Seroxat 30 mg film-coated IMED Healthcare Ltd. PPA1463/009/002 Film-coated tablet - Paroxetine 25/08/2021
tablets
Interchangeable List Code:
IC0076-033-003
Caltrate 500 mg / 1000 IU, GlaxoSmithKline Consumer PA0678/157/001 Chewable tablet - Calcium carbonate 20/08/2021
chewable tablets Healthcare (Ireland) Limited - Cholecalciferol concentrate

Pandemrix GlaxoSmithKline Biologicals EU/1/08/452/1 Emulsion for injection - A/california/7/2009 (h1n1)v 20/08/2021
S.A. like strain (x-179a)
Tetralysal 300mg Hard IMED Healthcare Ltd. PPA1463/080/001 Capsule, hard - Lymecycline 17/08/2021
Capsules

Human Medicines Withdrawn Products Page 13 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NuTRIflex Lipid peri B. Braun Melsungen AG PA0736/013/001 Emulsion for infusion - Glucose monohydrate 12/08/2021
Emulsion for infusion - Sodium dihydrogen
phosphate dihydrate
- Zinc acetate dihydrate
- Soya bean oil
- Medium chain triglycerides
- Isoleucine
- Leucine
- Lysine hydrochloride
- Methionine
- Phenylalanine
- Threonine
- Tryptophan
- Valine
- Arginine
- Histidine hydrochloride
monohydrate
- Alanine
- Aspartic acid
- Glutamic acid
- GLYCINE
- Proline
- Serine
- Sodium hydroxide
- Sodium chloride
- Sodium acetate
- Potassium acetate
- Magnesium Acetate
Tetrahydrate
- Calcium chloride dihydrate
NuTRIflex Lipid special B. Braun Melsungen AG PA0736/017/001 Emulsion for infusion - Glucose monohydrate 12/08/2021
without Electrolytes Emulsion - Soya bean oil
for infusion - Medium chain triglycerides
- Isoleucine
- Leucine
- Lysine monohydrate
- Methionine
- Phenylalanine
- Threonine
- Tryptophan
- Valine
- Arginine
- Histidine
- Alanine
- Aspartic acid
- Glutamic acid
- GLYCINE
- Proline
- Serine
Hypovase 1mg Tablets Pfizer Healthcare Ireland PA0822/195/002 Tablet - Prazosin 09/08/2021
Heparin sodium 25,000 Pinewood Laboratories Ltd, PA0281/229/006 Solution for injection/infusion - Heparin sodium 05/08/2021
I.U./ml Solution for injection
or concentrate for solution for
infusion, 5 ml vials
Noradrenaline Pinewood Laboratories Ltd, PA0281/245/001 Concentrate for solution for - Noradrenaline tartrate 05/08/2021
(Norepinephrine) 1 mg/ml infusion
Concentrate for solution for
Infusion
Atenetic 100 mg/25 mg Film- McDermott Laboratories Ltd., PA0577/194/002 Coated tablet - Atenolol 04/08/2021
coated Tablets T/A Gerard Laboratories - Chlorthalidone

Atenetic 50 mg/12.5 mg Film- McDermott Laboratories Ltd., PA0577/194/001 Coated tablet - Chlorthalidone 04/08/2021
coated Tablets T/A Gerard Laboratories - Atenolol

Cibacen 10 mg Film Coated Mylan IRE Healthcare PA2010/029/002 Film-coated tablet - Benazepril hydrochloride 04/08/2021
Tablets Limited
Novolizer Salbutamol 100 Mylan IRE Healthcare PA2010/033/001 Inhalation powder - Salbutamol 04/08/2021
micrograms/dose inhalation Limited
powder
Odrik 0.5mg Hard Capsules Mylan IRE Healthcare PA2010/005/001 Capsule, hard - Trandolapril 04/08/2021
Limited
PARLODEL 5mg Hard Mylan IRE Healthcare PA2010/042/002 Capsule, hard - BROMOCRIPTINE 04/08/2021
Capsules Limited MESILATE
Perindopril arginine Mylan 10 McDermott Laboratories Ltd., PA0577/128/003 Film-coated tablet - Perindopril arginine 04/08/2021
mg film-coated tablets T/A Gerard Laboratories

Human Medicines Withdrawn Products Page 14 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Perindopril arginine Mylan McDermott Laboratories Ltd., PA0577/128/001 Film-coated tablet - Perindopril arginine 04/08/2021
2.5 mg film-coated tablets T/A Gerard Laboratories

Perindopril arginine Mylan 5 McDermott Laboratories Ltd., PA0577/128/002 Film-coated tablet - Perindopril arginine 04/08/2021
mg film-coated tablets T/A Gerard Laboratories

Perindopril McDermott Laboratories Ltd., PA0577/130/001 Film-coated tablet - Perindopril arginine 04/08/2021
Arginine/Indapamide Mylan T/A Gerard Laboratories - Indapamide
2.5 mg/0.625 mg film-coated
tablets
Perindopril McDermott Laboratories Ltd., PA0577/130/002 Film-coated tablet - Perindopril arginine 04/08/2021
Arginine/Indapamide Mylan 5 T/A Gerard Laboratories - Indapamide
mg/1.25mg film-coated
tablets
Twicor 10 mg/10 mg film- Mylan IRE Healthcare PA2010/019/001 Film-coated tablet - Rosuvastatin calcium 04/08/2021
coated tablets Limited - Ezetimibe
Interchangeable List Code:
IC0111-017-009
Twicor 20 mg/10 mg film- Mylan IRE Healthcare PA2010/019/002 Film-coated tablet - Rosuvastatin calcium 04/08/2021
coated tablets Limited - Ezetimibe
Interchangeable List Code:
IC0111-061-009
Nitrocine 1 mg/ml solution for Merus Labs Luxco II S.à.R.L. PA2118/001/001 Solution for infusion - Glyceryl trinitrate 30/07/2021
infusion, ampoule
Nitrocine 1 mg/ml solution for Merus Labs Luxco II S.à.R.L. PA2118/001/002 Solution for infusion - Glyceryl trinitrate 30/07/2021
infusion, vial
Tantum Verde mint taste 3 Aziende Chimiche Riunite PA0959/001/001 Lozenge - Benzydamine hydrochloride 30/07/2021
mg lozenges Angelini Francesco
Tantum verde orange-honey Aziende Chimiche Riunite PA0959/001/003 Lozenge - BENZYDAMINE 30/07/2021
taste 3 mg lozenges Angelini Francesco HYDROCHLORIDE
Lysopadol Lemon 20 mg Sanofi-Aventis Ireland PA0540/187/001 Lozenge - AMBROXOL 27/07/2021
Lozenges Limited T/A SANOFI HYDROCHLORIDE
Lysopadol Mint 20mg Sanofi-Aventis Ireland PA0540/186/001 Lozenge - AMBROXOL 27/07/2021
Lozenges Limited T/A SANOFI HYDROCHLORIDE
Metatone Tonic Chefaro Ireland DAC PA1186/004/001 Syrup - Calcium glycerophosphate 26/07/2021
- Potassium
glycerophosphate
- Sodium glycerophosphate
- Thiamine hydrochloride
- Manganese
glycerophosphate
Pentavac Diphtheria, tetanus, Sanofi Pasteur PA2131/005/001 Powder for suspension for - Purified Diphtheria Toxoid 26/07/2021
pertussis (acellular, injection Ph. Eur.
component), poliomyelitis - Purified tetanus toxoid
(inactivated) and - Adsorbed purified pertussis
Haemophilus influenzae type toxoid
b conjugate vaccine - Adsorbed purified
(adsorbed) filamentous haemagglutinin
- Inactivated Poliomyelitis
Virus Ph. Eur
- Inactivated type 1 poliovirus
- Inactivated type 2 poliovirus
- Inactivated type 3 poliovirus
- Haemophilus influenzae
type b, conjugate with
tetanus protein

Lumoxiti AstraZeneca AB EU/1/20/1522/001-002 Powder for concentrate for - Moxetumomab pasudotox 23/07/2021
solution for infusion
Gertac 150 mg Film-coated McDermott Laboratories Ltd., PA0577/023/001 Film-coated tablet - RANITIDINE 21/07/2021
Tablets T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0087-062-051
Gertac 300 mg Film-coated McDermott Laboratories Ltd., PA0577/023/002 Film-coated tablet - RANITIDINE 21/07/2021
Tablets T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0087-029-051
Darunavir Accord 600 mg Accord Healthcare Ireland PA2315/156/001 Film-coated tablet - Darunavir 19/07/2021
film-coated tablets Ltd.
Darunavir Accord 800 mg Accord Healthcare Ireland PA2315/156/002 Film-coated tablet - Darunavir 19/07/2021
film-coated tablets Ltd.
Glidipion Actavis Group PTC ehf EU/1/12/756/001-009 Tablet - Pioglitazone hydrochloride 19/07/2021
Glidipion Actavis Group PTC ehf EU/1/12/756/010-018 Tablet - Pioglitazone hydrochloride 19/07/2021
Glidipion Actavis Group PTC ehf EU/1/12/756/019-027 Tablet - Pioglitazone hydrochloride 19/07/2021

Human Medicines Withdrawn Products Page 15 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Padviram 600 mg/200 Rowex Ltd PA0711/277/001 Film-coated tablet - Efavirenz 12/07/2021
mg/245 mg film-coated - Emtricitabine
tablets - Tenofovir disoproxil
Voriconazole Rowex 200 mg Rowex Ltd PA0711/209/003 Powder for solution for - Voriconazole 12/07/2021
powder for solution for infusion
infusion
Ultravist 240mg/ml Solution Bayer Limited PA1410/011/001 Solution for injection - Iopromide 05/07/2021
for Injection (50ml)
Ultravist 300mg/ml Solution Bayer Limited PA1410/011/002 Solution for injection - Iopromide 05/07/2021
for Injection (20ml)
Ultravist 300mg/ml Solution Bayer Limited PA1410/011/003 Solution for injection - Iopromide 05/07/2021
for Injection (50ml, 75ml,
100ml, 150ml, 200ml and
500ml)
Ultravist 370mg/ml Solution Bayer Limited PA1410/011/004 Solution for injection - Iopromide 05/07/2021
for Injection (50 ml, 100ml,
150 ml, and 200 ml)
Selectol 200mg Tablets Lexon (UK) Ltd PPA1097/019/001 Tablet - CELIPROLOL 02/07/2021
HYDROCHLORIDE
Recombinate 1000 IU, Baxalta Innovations GmbH PA2004/006/003 Powder and solvent for - Factor viii, human 01/07/2021
powder and solvent for solution for injection recombinant
solution for injection
Recombinate 250 IU, powder Baxalta Innovations GmbH PA2004/006/001 Powder and solvent for - Factor viii, human 01/07/2021
and solvent for solution for solution for injection recombinant
injection
Recombinate 500 IU, powder Baxalta Innovations GmbH PA2004/006/002 Powder and solvent for - Factor viii, human 01/07/2021
and solvent for solution for solution for injection recombinant
injection
Dorzolamide 20mg/ml eye Accord Healthcare Ireland PA2315/126/001 Eye drops, solution - Dorzolamide hydrochloride 29/06/2021
drops, solution Ltd.
Dorzolamide/Timolol 20 Accord Healthcare Ireland PA2315/135/001 Eye drops, solution - Dorzolamide 29/06/2021
mg/ml + 5 mg/ml eye drops, Ltd. - Timolol
solution
Humulin I (Isophane) 100 Eli Lilly Nederland B.V. PA2276/002/002 Suspension for injection - Insulin human 28/06/2021
IU/ml Suspension for
Injection in cartridge
Humulin I (Isophane) 100 Eli Lilly Nederland B.V. PA2276/002/001 Suspension for injection - Insulin human 28/06/2021
IU/ml Suspension for
Injection in vial
Humulin M3 (Mixture 3) 100 Eli Lilly Nederland B.V. PA2276/003/001 Suspension for injection - Insulin human 28/06/2021
IU/ ml Suspension for
Injection in vial
Humulin M3 (Mixture 3) 100 Eli Lilly Nederland B.V. PA2276/003/002 Suspension for injection - Insulin human 28/06/2021
IU/ml Suspension for
Injection in cartridge
Humulin S (Soluble) 100 Eli Lilly Nederland B.V. PA2276/001/001 Solution for injection - Insulin human 28/06/2021
IU/ml Solution for Injection in
vial
Humulin S (Soluble), 100 Eli Lilly Nederland B.V. PA2276/001/002 Solution for injection - Insulin human 28/06/2021
IU/ml Solution for Injection in
cartridge
Ciprofloxacin Mylan 2mg/1ml McDermott Laboratories Ltd., PA0577/197/001 Solution for infusion - Ciprofloxacin 25/06/2021
solution for infusion T/A Gerard Laboratories

Cidomycin Paediatric Sanofi-Aventis Ireland PA0540/036/004 Solution for injection - Gentamicin sulfate 24/06/2021
20mg/2ml Solution for Limited T/A SANOFI
Injection
Dolmatil 400mg Film-Coated Sanofi-Aventis Ireland PA0540/147/002 Film-coated tablet - Sulpiride 24/06/2021
Tablets Limited T/A SANOFI
Duloxetine Rowa 30mg hard Rowa Pharmaceuticals PA0074/077/001 Gastro-resistant capsule, - Duloxetine hydrochloride 23/06/2021
gastro-resistant capsules Limited hard
Interchangeable List Code:
IC0091-033-006
Duloxetine Rowa 60mg hard Rowa Pharmaceuticals PA0074/077/002 Gastro-resistant capsule, - Duloxetine hydrochloride 23/06/2021
gastro-resistant capsules Limited hard
Interchangeable List Code:
IC0091-127-006
Elaxigol 13.7g sachet powder Galen Pharma Ireland PA22680/006/001 Powder for oral solution in - Macrogol 3350 23/06/2021
for oral solution Limited sachet - Potassium chloride
- Sodium chloride
- Sodium hydrogen
carbonate
Ribavirin Teva Teva Pharma B.V. EU/1/09/509/1-4 Capsule, hard - Ribavirin 22/06/2021
Ribavirin Teva Pharma BV Teva Pharma B.V. EU/1/09/527/1-8 Film-coated tablet - Ribavirin 22/06/2021
Ribavirin Teva Pharma BV Teva Pharma B.V. EU/1/09/527/9-16 Film-coated tablet - Ribavirin 22/06/2021

Human Medicines Withdrawn Products Page 16 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Mediam Stannous Agent 4 MEDiAM PA1229/002/001 Powder for solution for - Medronic acid 21/06/2021
milligrams/6.8 milligrams kit infusion - Stannous fluoride
for radiopharmaceutical
preparation
Pioglitazone Teva Pharma Teva B.V. EU/1/12/758/001-010 Tablet - Pioglitazone hydrochloride 21/06/2021
Pioglitazone Teva Pharma Teva B.V. EU/1/12/758/011-020 Tablet - Pioglitazone hydrochloride 21/06/2021
Pioglitazone Teva Pharma Teva B.V. EU/1/12/758/021-030 Tablet - Pioglitazone hydrochloride 21/06/2021
Ritemvia (previously Celltrion Healthcare Hungary EU/1/17/1207/001 Concentrate for solution for - Rituximab 21/06/2021
Vypanra) Kft. infusion
Syndol Film-coated Tablets Sanofi-Aventis Ireland PA0540/175/001 Film-coated tablet - Paracetamol 21/06/2021
Paracetamol 450 mg Limited T/A SANOFI - Codeine phosphate
Codeine Phosphate hemihydrate
Hemihydrate 10 mg - DOXYLAMINE
Doxylamine succinate 5 mg SUCCINATE
Caffeine 30 mg - Caffeine
Dobutamine 12.5mg/ml Baxter Holding B.V. PA2299/039/001 Concentrate for solution for - Dobutamine 19/06/2021
Concentrate for solution for infusion
infusion
Rocephin 1 g Powder for Roche Products (Ireland) Ltd PA2307/008/001 Powder for solution for - CEFTRIAXONE SODIUM 18/06/2021
solution for injection or injection/infusion
infusion
Accolate 20 mg film-coated AstraZeneca UK Limited PA0970/001/001 Tablet - Zafirlukast 17/06/2021
tablets
Thiopental Sodium 500 mg Kyowa Kirin Holdings B.V. PA2288/005/001 Powder for solution for - Thiopental sodium 17/06/2021
powder for solution for injection
injection
Emcor 10 mg Film-coated Merck Serono (Ireland) PA2286/002/002 Film-coated tablet - BISOPROLOL FUMARATE 15/06/2021
tablets Limited
Interchangeable List Code:
IC0065-002-014
Emcor 5 mg Film-coated Merck Serono (Ireland) PA2286/002/001 Film-coated tablet - Bisoprolol hemifumarate 15/06/2021
tablets Limited
Interchangeable List Code:
IC0065-001-014
Endofalk powder for oral Dr. Falk Pharma GmbH PA0573/006/001 Powder for oral solution - Macrogol 3350 15/06/2021
solution - Potassium chloride
- Sodium chloride
- Sodium bicarbonate
Entecavir Rowex 1 mg Film- Rowex Ltd PA0711/274/002 Film-coated tablet - ENTECAVIR 10/06/2021
coated tablets MONOHYDRATE
Intralipid 10% Emulsion for Fresenius Kabi Deutschland PA2059/041/002 Emulsion for infusion - Soya bean oil, refined 10/06/2021
Infusion GmbH
Intralipid 20 % Emulsion for Fresenius Kabi Deutschland PA2059/041/003 Emulsion for infusion - Soya bean oil, refined 10/06/2021
Infusion GmbH
Distaclor 500mg Hard Flynn Pharma Ltd PA1226/001/001 Capsule, hard - Cefaclor 31/05/2021
Capsules
Dovonex Psoriasis 50 Leo Laboratories Limited PA0046/064/001 Ointment - Calcipotriol, anhydrous 31/05/2021
microgram/g ointment
Telmisartan Teva 20 mg Teva B.V. EU/1/09/610/1-10 Tablet - Telmisartan 21/05/2021
tablets
Interchangeable List Code:
IC0049-003-014
Telmisartan Teva 40 mg Teva B.V. EU/1/09/610/11-20 Tablet - Telmisartan 21/05/2021
tablets
Interchangeable List Code:
IC0049-004-014
Telmisartan Teva 80 mg Teva B.V. EU/1/09/610/21-30 Tablet - Telmisartan 21/05/2021
tablets
Interchangeable List Code:
IC0049-005-014
Phenobarbital 60 mg Tablets Clonmel Healthcare Ltd PA0126/019/003 Tablet - PHENOBARBITAL 20/05/2021

Tinaderm Cream 1% w/w Bayer Limited PA1410/080/001 Cream - Tolnaftate 20/05/2021


Azacitidine Celgene Celgene Europe B.V. EU/1/19/1382/001 Powder for suspension for - Azacitidine 19/05/2021
injection
Quetiapine Rosemont Perrigo Pharma International PA22741/006/001 Oral suspension - Quetiapine fumarate 19/05/2021
20mg/ml Oral Suspension Designated Activity Compan

Erwinase 10,000 Units. Jazz Pharmaceuticals France PA1020/002/001 Powder for solution for - Cristanspase 17/05/2021
Powder for solution for SAS injection
injection
NovoMix 30 NovoLet Novo Nordisk A/S EU/1/00/142/006 Suspension for injection - Insulin aspart 17/05/2021
NOVOMIX 70 FlexPen Novo Nordisk A/S EU/1/00/142/0020-23 Suspension for injection - Insulin aspart 17/05/2021
Cosopt Multi preservative- Santen OY PA0879/005/003 Eye drops, solution - Dorzolamide hydrochloride 13/05/2021
free 20mg/ml+5mg/ml eye - TIMOLOL MALEATE
drops, solution

Human Medicines Withdrawn Products Page 17 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Paclitaxel 6 mg/ml Cipla Europe NV PA1963/010/001 Concentrate for solution for - Paclitaxel 13/05/2021
concentrate for solution for infusion
infusion
Valganciclovir Rowex 450 mg Rowex Ltd PA0711/233/001 Film-coated tablet - Valganciclovir hydrochloride 13/05/2021
film coated tablet
Zantac 150 milligram(s) Film- GlaxoSmithKline (Ireland) PA1077/013/003 Film-coated tablet - RANITIDINE 13/05/2021
coated tablet Limited HYDROCHLORIDE
Interchangeable List Code:
IC0087-062-051
Xeristar Esteve Pharmaceuticals S.A. EU/1/04/297/002-005 Gastro-resistant capsule, - Duloxetine hydrochloride 12/05/2021
hard
Interchangeable List Code:
IC0091-127-006
Xeristar Esteve Pharmaceuticals S.A. EU/1/04/297/1-4 Gastro-resistant capsule, - Duloxetine hydrochloride 12/05/2021
hard
Interchangeable List Code:
IC0091-033-006
Escivriens 10 mg film-coated Genthon B.V. PA0740/012/001 Film-coated tablet - Escitalopram 11/05/2021
tablets
Interchangeable List Code:
IC0071-002-003
Escivriens 20 mg film-coated Genthon B.V. PA0740/012/003 Film-coated tablet - Escitalopram 11/05/2021
tablets
Interchangeable List Code:
IC0071-003-003
Sildenafil Pfizer 100 mg film- Pfizer Healthcare Ireland PA0822/153/003 Film-coated tablet - Sildenafil 10/05/2021
coated tablets
Interchangeable List Code:
IC0063-024-014
Sildenafil Pfizer 25 mg film- Pfizer Healthcare Ireland PA0822/153/001 Film-coated tablet - Sildenafil 10/05/2021
coated tablets
Interchangeable List Code:
IC0063-022-014
Sildenafil Pfizer 50 mg film- Pfizer Healthcare Ireland PA0822/153/002 Film-coated tablet - Sildenafil 10/05/2021
coated tablets
Interchangeable List Code:
IC0063-023-014
Risedronate Sodium Accord Accord Healthcare Ireland PA2315/140/004 Film-coated tablet - Risedronate sodium 07/05/2021
75 mg Film Coated Tablets Ltd.
Abacavir/Lamivudine 600 Accord Healthcare Ireland PA2315/242/001 Film-coated tablet - Abacavir 06/05/2021
mg/300 mg film-coated Ltd. - Lamivudine
tablets
Percarnil Arginine 10 mg Accord Healthcare Ireland PA2315/048/003 Film-coated tablet - Perindopril arginine 06/05/2021
Film-coated Tablets Ltd.
Percarnil Arginine 2.5 mg Accord Healthcare Ireland PA2315/048/001 Film-coated tablet - Perindopril arginine 06/05/2021
Film-coated Tablets Ltd.
Percarnil Arginine 5 mg Film- Accord Healthcare Ireland PA2315/048/002 Film-coated tablet - Perindopril arginine 06/05/2021
coated Tablets Ltd.
Recivit 133 micrograms, Ethypharm PA0549/018/002 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Recivit 267 micrograms, Ethypharm PA0549/018/003 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Recivit 400 micrograms, Ethypharm PA0549/018/004 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Recivit 533 micrograms, Ethypharm PA0549/018/005 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Recivit 67 micrograms, Ethypharm PA0549/018/001 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Recivit 800 micrograms, Ethypharm PA0549/018/006 Sublingual tablet - Fentanyl 30/04/2021
sublingual tablets
Sevelamer Hydrochloride Waymade B.V. PA22879/001/001 Film-coated tablet - Sevelamer hydrochloride 29/04/2021
Waymade 400 mg film-
coated tablets
Blistex Relief Cream D.D.D. Limited PA0302/004/001 Cream - Strong ammonia solution 27/04/2021
- Phenol, liquefied
- Ammonia solution, aramatic

Irinotecan Mylan 20 mg/ml McDermott Laboratories Ltd., PA0577/234/001 Concentrate for solution for - Irinotecan hydrochloride 26/04/2021
concentrate for solution for T/A Gerard Laboratories infusion trihydrate
infusion
Adalat LA 20 mg Prolonged- Bayer Limited PA1410/025/005 Prolonged-release tablet - Nifedipine 23/04/2021
Release Tablet
Adalat LA 30 mg Prolonged- Bayer Limited PA1410/025/006 Prolonged-release tablet - Nifedipine 23/04/2021
Release Tablet
Adalat LA 60 mg Prolonged- Bayer Limited PA1410/025/007 Prolonged-release tablet - Nifedipine 23/04/2021
Release Tablet

Human Medicines Withdrawn Products Page 18 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Augmentin DUO 400 mg/57 GlaxoSmithKline (Ireland) PA1077/019/002 Powder for oral suspension - Potassium clavulanate 23/04/2021
mg /5 ml Powder for Oral Limited - Amoxicillin trihydrate
Suspension Interchangeable List Code:
IC0037-076-034
Azathioprine 50mg film- Relon Chem Limited PA1128/004/001 Film-coated tablet - Azathioprine 23/04/2021
coated Tablets
Truberzi (originally known Allergan Pharmaceuticals EU/1/16/1126/001-002 Film-coated tablet - Eluxadoline 23/04/2021
ELUXADOLINE - APTALIS) International Limited
Truberzi (Originally known Allergan Pharmaceuticals EU/1/16/1126/003-004 Film-coated tablet - Eluxadoline 23/04/2021
ELUXADOLINE - APTALIS) International Limited
PegInron Merck Sharp & Dohme BV EU/1/00/131/035 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/036 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/037 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/038 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/039 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/040 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/041 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/042 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/043 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/044 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/045 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/046 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/047 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/048 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/049 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/050 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PEGINTRON Merck Sharp & Dohme BV EU/1/00/131/001 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/002 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/003 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
suspension for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/004 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/005 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/006 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/007 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/008 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/009 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/010 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/011 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/012 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/013 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/014 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/015 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/016 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/017 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection

Human Medicines Withdrawn Products Page 19 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PegIntron Merck Sharp & Dohme BV EU/1/00/131/018 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/019 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/020 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/021 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/022 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/023 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/024 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/025 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PEGINTRON Merck Sharp & Dohme BV EU/1/00/131/031 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
suspension for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/032 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/033 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
PegIntron Merck Sharp & Dohme BV EU/1/00/131/034 Powder and solvent for - Peginterferon alfa-2b 21/04/2021
solution for injection
Deep Freeze Cold Gel 2.0 % Colep Laupheim GmbH & Co PA22761/003/001 Gel - Racementhol 19/04/2021
w/w KG
Xalatan 50 micrograms/ml LTT Pharma Limited PPA1562/160/001 Eye drops, solution - Latanoprost 16/04/2021
eye drops, solution
Interchangeable List Code:
IC0096-152-045
Flucol 2 mg/ml Solution for Rowex Ltd PA0711/057/006 Solution for infusion - Fluconazole 15/04/2021
Infusion
Linezolid Rowex 2 mg/ml Rowex Ltd PA0711/230/002 Solution for infusion - Linezolid 15/04/2021
solution for infusion
Minox 50 mg Film-Coated Rowex Ltd PA0711/013/001 Film-coated tablet - MINOCYCLINE 15/04/2021
Tablets HYDROCHLORIDE
Olmesartan Rowex Ltd PA0711/240/001 Film-coated tablet - Olmesartan medoxomil 15/04/2021
Hydrochlorothiazide Rowex - Hydrochlorothiazide
20 mg/12.5 mg film-coated Interchangeable List Code:
tablets IC0106-162-003
Olmesartan Rowex Ltd PA0711/240/002 Film-coated tablet - Olmesartan medoxomil 15/04/2021
Hydrochlorothiazide Rowex - Hydrochlorothiazide
20 mg/25 mg film-coated Interchangeable List Code:
tablets IC0106-163-003
Olmesartan Rowex Ltd PA0711/240/003 Film-coated tablet - Olmesartan medoxomil 15/04/2021
Hydrochlorothiazide Rowex - Hydrochlorothiazide
40 mg/12.5 mg film-coated Interchangeable List Code:
tablets IC0106-099-003
Olmesartan Rowex Ltd PA0711/240/004 Film-coated tablet - Olmesartan medoxomil 15/04/2021
Hydrochlorothiazide Rowex - Hydrochlorothiazide
40 mg/25 mg film-coated Interchangeable List Code:
tablets IC0106-164-003
Rowasip Cold and Flu with Rowex Ltd PA0711/227/001 Powder for oral solution - Paracetamol 15/04/2021
Decongestant 500 mg/12.2 - Phenylephrine
mg powder for oral solution hydrochloride
Rowasip Max Strength Cold Rowex Ltd PA0711/227/002 Powder for oral solution - Phenylephrine 15/04/2021
and Flu with Decongestant hydrochloride
1000 mg/12.2 mg powder for - Paracetamol
oral solution
Teicoplanin 200mg Powder Rowex Ltd PA0711/204/002 Powder and solvent for - Teicoplanin 15/04/2021
and Solvent for solution for solution for injection/infusion
injection/infusion or oral
solution
Tenofovir disoproxil Rowex Rowex Ltd PA0711/260/001 Film-coated tablet - Tenofovir disoproxil 15/04/2021
245 mg Film-coated tablets
Creon 10000 Gastro- LTT Pharma Limited PPA1562/143/002 Gastro-resistant capsule, - Pancreatin 13/04/2021
resistant Capsules hard
Imigran Ftab 100mg Film- LTT Pharma Limited PPA1562/188/002 Film-coated tablet - Sumatriptan succinate 13/04/2021
coated Tablets
Imigran Ftab 50mg Film- LTT Pharma Limited PPA1562/188/001 Film-coated tablet - Sumatriptan succinate 13/04/2021
coated Tablets
Kemadrin 5 mg Tablets LTT Pharma Limited PPA1562/196/001 Tablet - PROCYCLIDINE 13/04/2021
HYDROCHLORIDE
Megace 160 mg Tablets LTT Pharma Limited PPA1562/194/001 Tablet - Megestrol acetate 13/04/2021
Omacor 1000 mg Soft LTT Pharma Limited PPA1562/189/001 Capsule, soft - Omega-3-acid ethyl esters 13/04/2021
Capsules

Human Medicines Withdrawn Products Page 20 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Puri-Nethol 50mg Tablets LTT Pharma Limited PPA1562/193/001 Tablet - Mercaptopurine 13/04/2021
Xyzal 0.5 mg/ml Oral LTT Pharma Limited PPA1562/187/001 Oral solution - Levocetirizine 13/04/2021
Solution dihydrochloride
Interchangeable List Code:
IC0095-155-019
RabipurPowder and solvent GSK Vaccines GmbH PA0877/003/002 Not assigned - Rabies virus (flury lep) 09/04/2021
for solution for injection in inactivated
pre-filled syringe.Rabies
vaccine (inactivated)
Zovirax 200 mg/5 mL Oral LTT Pharma Limited PPA1562/183/003 Oral suspension - ACICLOVIR 09/04/2021
Suspension
Arthrotec 75 modified-release LTT Pharma Limited PPA1562/179/001 Modified-release tablet - Misoprostol 08/04/2021
tablets - DICLOFENAC SODIUM
Interchangeable List Code:
IC0058-113-021
Beta-Prograne 160mg LTT Pharma Limited PPA1562/182/001 Prolonged-release capsule, - PROPRANOLOL 08/04/2021
Prolonged-Release Capsules hard HYDROCHLORIDE

Campral EC 333mg Gastro- LTT Pharma Limited PPA1562/178/001 Gastro-resistant tablet - Acamprosate calcium 08/04/2021
resistant tablets
Cordarone X 200mg Tablets LTT Pharma Limited PPA1562/176/001 Tablet - AMIODARONE 08/04/2021
HYDROCHLORIDE
Dalacin 2% Vaginal Cream LTT Pharma Limited PPA1562/162/001 Vaginal cream - Clindamycin 08/04/2021
Ditropan 5 mg Tablets LTT Pharma Limited PPA1562/180/001 Tablet - OXYBUTYNIN 08/04/2021
HYDROCHLORIDE
FROVEX 2.5 mg film-coated LTT Pharma Limited PPA1562/153/001 Film-coated tablet - FROVATRIPTAN 08/04/2021
tablets
Keflex 250mg Hard capsules LTT Pharma Limited PPA1562/181/001 Capsule, hard - Cefalexin 08/04/2021

Mestinon 60mg Tablets LTT Pharma Limited PPA1562/166/001 Tablet - Pyridostigmine bromide 08/04/2021
Midon 2.5 mg Tablets LTT Pharma Limited PPA1562/159/001 Tablet - MIDODRINE 08/04/2021
HYDROCHLORIDE
Ursofalk 250 mg Hard LTT Pharma Limited PPA1562/167/001 Capsule, hard - Ursodeoxycholic acid 08/04/2021
Capsules
Zinnat 500 mg film-coated LTT Pharma Limited PPA1562/163/001 Film-coated tablet - Cefuroxime 08/04/2021
tablets
Zovirax 800 mg Dispersible LTT Pharma Limited PPA1562/183/002 Dispersible tablet - ACICLOVIR 08/04/2021
Tablets
DERMESTRIL-Septem 25 Rottapharm Ltd PA0868/002/004 Transdermal patch - Estradiol 01/04/2021
micrograms/24hours
Transdermal Patch
DERMESTRIL-Septem 50 Rottapharm Ltd PA0868/002/005 Transdermal patch - Estradiol 01/04/2021
micrograms/24hours
Transdermal Patch
DERMESTRIL-Septem 75 Rottapharm Ltd PA0868/002/006 Transdermal patch - Estradiol 01/04/2021
micrograms/24 hours
Transdermal Patch
Dubine 10 mg/g cream Ferrer Internacional, S.A PA1744/003/001 Cream - Ozenoxacin 01/04/2021
Emtricitabine/Tenofovir Rowex Ltd PA0711/271/001 Film-coated tablet - Emtricitabine 01/04/2021
disoproxil Rowex 200 mg/245 - Tenofovir disoproxil
mg film-coated tablets Interchangeable List Code:
IC0107-165-003
Gammaplex 10%100 mg/ml BPL Bioproducts Laboratory PA22765/001/001 Solution for infusion - Human normal 01/04/2021
solution for infusion GmbH immunoglobulin
Elantan 10 mg Tablets Merus Labs Luxco II S.à.R.L. PA2118/002/001 Tablet - ISOSORBIDE 31/03/2021
MONONITRATE
Flotros 20mg film-coated Pfleger Arzneimittel GmbH PA22747/001/001 Film-coated tablet - Trospium chloride 31/03/2021
tablets
Creon 25000 gastro-resistant LTT Pharma Limited PPA1562/143/001 Gastro-resistant capsule, - Pancreatin 30/03/2021
capsules hard
Crinone 8% w/w LTT Pharma Limited PPA1562/146/001 Vaginal gel - Progesterone 30/03/2021
progesterone vaginal gel
DiproSalic 0.05% w/w + 2% LTT Pharma Limited PPA1562/151/001 Cutaneous solution - Betamethasone 30/03/2021
w/w Scalp Application - Salicylic acid
Ondansetron 2mg/ml Noridem Enterprises Ltd PA1122/004/002 Solution for injection - Ondansetron 30/03/2021
Solution for Injection, glass
ampoules
Teicoplanin 400mg Powder Rowex Ltd PA0711/204/003 Powder and solvent for - Teicoplanin 30/03/2021
and Solvent for solution for solution for injection/infusion
injection/infusion or oral
solution
Trosyl 283 mg/ml Nail LTT Pharma Limited PPA1562/152/001 Cutaneous solution - Tioconazole 30/03/2021
Solution
Crixivan Merck Sharp & Dohme BV EU/1/96/024/001 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/002 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/003 Capsule - Indinavir sulfate 26/03/2021

Human Medicines Withdrawn Products Page 21 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Crixivan Merck Sharp & Dohme BV EU/1/96/024/004 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/005 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/007 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/008 Capsule - Indinavir sulfate 26/03/2021
Crixivan Merck Sharp & Dohme BV EU/1/96/024/010 Capsule - Indinavir 26/03/2021
Pregabalin Wockhardt 100 Wockhardt UK Limited PA1339/059/004 Capsule, hard - Pregabalin 26/03/2021
mg hard capsules
Interchangeable List Code:
IC0110-024-001
Pregabalin Wockhardt 150 Wockhardt UK Limited PA1339/059/005 Capsule, hard - Pregabalin 26/03/2021
mg hard capsules
Interchangeable List Code:
IC0110-062-001
Pregabalin Wockhardt 200 Wockhardt UK Limited PA1339/059/006 Capsule, hard - Pregabalin 26/03/2021
mg hard capsules
Interchangeable List Code:
IC0110-067-001
Pregabalin Wockhardt 225 Wockhardt UK Limited PA1339/059/007 Capsule, hard - Pregabalin 26/03/2021
mg hard capsules
Interchangeable List Code:
IC0110-064-001
Pregabalin Wockhardt 25 mg Wockhardt UK Limited PA1339/059/001 Capsule, hard - Pregabalin 26/03/2021
hard capsules
Interchangeable List Code:
IC0110-022-001
Pregabalin Wockhardt 300 Wockhardt UK Limited PA1339/059/008 Capsule, hard - Pregabalin 26/03/2021
mg hard capsules
Interchangeable List Code:
IC0110-029-001
Pregabalin Wockhardt 50 mg Wockhardt UK Limited PA1339/059/002 Capsule, hard - Pregabalin 26/03/2021
hard capsules
Interchangeable List Code:
IC0110-023-001
Pregabalin Wockhardt 75 mg Wockhardt UK Limited PA1339/059/003 Capsule, hard - Pregabalin 26/03/2021
hard capsules
Interchangeable List Code:
IC0110-028-001
Moduret 25 mg/2.5 mg Merck Sharp & Dohme PA1286/014/001 Tablet - Hydrochlorothiazide 24/03/2021
Tablets Ireland (Human Health) - AMILORIDE
Limited HYDROCHLORIDE
Agomelatine Rowex 25mg Rowex Ltd PA0711/281/001 Film-coated tablet - Agomelatine 22/03/2021
Film-coated tablets
Magnevist 0.5 mmol/ml Bayer Limited PA1410/006/001 Solution for injection - GADOPENTETATE 19/03/2021
Solution for Injection DIMEGLUMINE
Magnevist 0.5mmol/ml Bayer Limited PA1410/006/002 Solution for injection - GADOPENTETATE 19/03/2021
Solution for Injection, in pre- DIMEGLUMINE
filled syringe
Cardicor 1.25 mg film-coated LTT Pharma Limited PPA1562/142/001 Film-coated tablet - Bisoprolol hemifumarate 18/03/2021
tablets
Interchangeable List Code:
IC0065-044-014
Cardicor 2.5 mg film-coated LTT Pharma Limited PPA1562/142/002 Film-coated tablet - Bisoprolol hemifumarate 18/03/2021
tablets
Interchangeable List Code:
IC0065-018-014
Cardicor 7.5 mg film-coated LTT Pharma Limited PPA1562/142/003 Film-coated tablet - Bisoprolol hemifumarate 18/03/2021
tablets
Interchangeable List Code:
IC0065-041-003
Eplerenone 25 mg film- Morningside Healthcare PA23142/001/001 Film-coated tablet - Eplerenone 18/03/2021
coated tablets (Malta) Limited
Interchangeable List Code:
IC0115-022-003
Eplerenone 50 mg film- Morningside Healthcare PA23142/001/002 Film-coated tablet - Eplerenone 18/03/2021
coated tablets (Malta) Limited
Interchangeable List Code:
IC0115-023-003
Losec MUPS 40 mg gastro- Imbat Limited PPA1151/007/003 Gastro-resistant tablet - Omeprazole 18/03/2021
resistant Tablets
Interchangeable List Code:
IC0010-004-016
Sporanox 100mg Capsules Imbat Limited PPA1151/058/001 Capsule, hard - Itraconazole 18/03/2021
Topamax 25 mg film-coated Imbat Limited PPA1151/209/001 Film-coated tablet - Topiramate 18/03/2021
tablets
VASTAREL 35mg Modified- Les Laboratoires Servier PA0568/033/002 Modified-release tablet - TRIMETAZIDINE 18/03/2021
Release Tablets DIHYDROCHLORIDE

Human Medicines Withdrawn Products Page 22 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zanidip 20mg film-coated Imbat Limited PPA1151/057/002 Film-coated tablet - Lercanidipine hydrochloride 18/03/2021
tablets
Interchangeable List Code:
IC0020-003-003
Movicol Eurodrug Ltd DPR1392/032/001 Powder for oral solution - Potassium chloride 16/03/2021
- Macrogol 3350
- Sodium bicarbonate
- Sodium chloride
Nasacort Eurodrug Ltd DPR1392/016/001 Nasal spray, suspension - Triamcinolone acetonide 16/03/2021
Pentasa Sachet Eurodrug Ltd DPR1392/071/001 Prolonged-release granules - Mesalazine 16/03/2021
PROZAC Eurodrug Ltd DPR1392/027/001 Capsule, hard - FLUOXETINE 16/03/2021
HYDROCHLORIDE
Regurin Eurodrug Ltd DPR1392/068/001 Coated tablet - Trospium chloride 16/03/2021
Salactol Collodion Eurodrug Ltd DPR1392/039/001 Cutaneous solution - Lactic acid 16/03/2021
- Salicylic acid
Savlon Dry Antiseptic Eurodrug Ltd DPR1392/055/001 Cutaneous spray, powder - Povidone-iodine 16/03/2021
SINEMET 62.5 Eurodrug Ltd DPR1392/007/001 Prolonged-release tablet - Carbidopa 16/03/2021
- Levodopa
Sinemet CR Eurodrug Ltd DPR1392/007/004 Prolonged-release tablet - Carbidopa 16/03/2021
- Levodopa
SINEMET PLUS Eurodrug Ltd DPR1392/007/003 Prolonged-release tablet - Carbidopa 16/03/2021
- Levodopa
SINGULAIR Eurodrug Ltd DPR1392/035/001 Film-coated tablet - Montelukast sodium 16/03/2021
Spasmonal Forte Eurodrug Ltd DPR1392/050/001 Capsule, hard - ALVERINE CITRATE 16/03/2021
Trusopt Eye Drops Solution Eurodrug Ltd DPR1392/053/001 Eye drops, solution - Dorzolamide 16/03/2021
Alphagan Eye Drops Solutio Eurodrug Ltd DPR1392/044/001 Eye drops, solution - Brimonidine tartrate 12/03/2021

Arcoxia Film Coated Tablets Eurodrug Ltd DPR1392/056/001 Film-coated tablet - Etoricoxib 12/03/2021
Arcoxia Film Coated Tablets Eurodrug Ltd DPR1392/056/002 Film-coated tablet - Etoricoxib 12/03/2021
Arcoxia Film Coated Tablets Eurodrug Ltd DPR1392/056/003 Film-coated tablet - Etoricoxib 12/03/2021
Augmentin Intravenous GlaxoSmithKline (Ireland) PA1077/093/002 Powder for solution for - Amoxicillin 12/03/2021
1000mg/200mg powder for Limited injection/infusion - Clavulanic acid
solution for injection or
infusion
Augmentin Intravenous GlaxoSmithKline (Ireland) PA1077/093/001 Powder for solution for - Amoxicillin sodium 12/03/2021
500mg/100mg powder for Limited injection/infusion - Clavulanic acid
solution for injection or
infusion
Betacap Scalp Application Eurodrug Ltd DPR1392/042/001 Cutaneous solution - Betamethasone valerate 12/03/2021
Calcichew-D3 Forte Eurodrug Ltd DPR1392/074/001 Chewable tablet - Cholecalciferol 12/03/2021
- Calcium carbonate
Chlorhexidine Original 0.2% Eurodrug Ltd DPR1392/075/001 Oromucosal solution - Chlorhexidine gluconate 12/03/2021
Mouthwash
Chlorhexidine Peppermint Eurodrug Ltd DPR1392/075/002 Oromucosal solution - Chlorhexidine gluconate 12/03/2021
0.2% Mouthwash
Combigan Eurodrug Ltd DPR1392/059/001 Eye drops, solution - Brimonidine tartrate 12/03/2021
- Timolol
Cosopt Eurodrug Ltd DPR1392/072/001 Eye drops, solution - Dorzolamide 12/03/2021
- Timolol
Dulcolax Eurodrug Ltd DPR1392/066/001 Gastro-resistant tablet - Bisacodyl 12/03/2021
Exterol Eurodrug Ltd DPR1392/041/001 Ear drops, solution - Urea hydrogen peroxide 12/03/2021
Flotros Eurodrug Ltd DPR1392/064/001 Film-coated tablet - Trospium chloride 12/03/2021
Methotrexate Eurodrug Ltd DPR1392/070/001 Tablet - Methotrexate 12/03/2021
Perizam 1 mg/ml oral Perrigo Pharma International PA22741/002/001 Oral suspension - Clobazam 12/03/2021
suspension Designated Activity Compan

Perizam 2 mg/ml oral Perrigo Pharma International PA22741/002/002 Oral suspension - Clobazam 12/03/2021
suspension Designated Activity Compan

Eirfem 2.5 mg film-coated Rowa Pharmaceuticals PA0074/066/001 Film-coated tablet - Letrozole 11/03/2021
tablets Limited
Interchangeable List Code:
IC0117-018-003
Implanon NXT, 68 mg IMED Healthcare Ltd. PPA1463/108/001 Implant - Etonogestrel 09/03/2021
implant for subdermal use
Adenosine 30mg/10ml Wockhardt UK Limited PA1339/035/001 Solution for infusion - ADENOSINE 04/03/2021
solution for infusion
Adenosine 3mg/ml solution Wockhardt UK Limited PA1339/034/001 Solution for injection - ADENOSINE 04/03/2021
for injection
Bortezomib Koanaa 3.5 mg Koanaa Healthcare Limited PA2041/003/001 Powder for solution for - Bortezomib 04/03/2021
powder for solution for injection
injection
Calfovit D3 1200mg/800 I.U. Menarini International PA0865/006/001 Powder for oral suspension - Calcium phosphate 04/03/2021
powder for oral suspension Operations Luxembourg S.A. - Cholecalciferol

Human Medicines Withdrawn Products Page 23 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Donepezil Hydrochloride Wockhardt UK Limited PA1339/039/002 Film-coated tablet - Donepezil hydrochloride 04/03/2021
10mg Film-Coated Tablets
Interchangeable List Code:
IC0062-002-015
Donepezil Hydrochloride 5mg Wockhardt UK Limited PA1339/039/001 Film-coated tablet - Donepezil hydrochloride 04/03/2021
Film-Coated Tablets
Interchangeable List Code:
IC0062-001-015
Imatinib 100mg Film-Coated Wockhardt UK Limited PA1339/060/001 Film-coated tablet - Imatinib 04/03/2021
Tablets
Imatinib 400mg Film-Coated Wockhardt UK Limited PA1339/060/002 Film-coated tablet - Imatinib 04/03/2021
Tablets
Linezolid 600 mg Film- Wockhardt UK Limited PA1339/062/001 Film-coated tablet - Linezolid 04/03/2021
Coated Tablets
Timolol 0.25 % w/v Eye Wockhardt UK Limited PA1339/017/001 Eye drops, solution - TIMOLOL MALEATE 04/03/2021
Drops, Solution
Timolol 0.5% w/v eye drops, Wockhardt UK Limited PA1339/017/002 Eye drops, solution - TIMOLOL MALEATE 04/03/2021
solution
Bortezomib Teva 2.5mg Teva B.V. PA1986/032/002 Powder for solution for - Bortezomib 02/03/2021
powder for solution for injection
injection
Bortezomib Teva 3.5 mg Teva B.V. PA1986/032/001 Powder for solution for - Bortezomib (as mannitol 02/03/2021
Powder for Solution for injection boronic ester)
Injection
Merocaine Lozenges Sanofi-Aventis Ireland PA0540/178/001 Lozenge - Cetylpyridinium chloride 01/03/2021
Limited T/A SANOFI - Benzocaine
Merocets 1.4mg Lozenges Sanofi-Aventis Ireland PA0540/176/001 Lozenge - Cetylpyridinium chloride 01/03/2021
Limited T/A SANOFI
Merocets Plus Sanofi-Aventis Ireland PA0540/177/001 Lozenge - Cetylpyridinium chloride 01/03/2021
LozengesCetylpyridinium Limited T/A SANOFI - Eucalyptus oil
chloride 1.4 mgMenthol 5.0 - Menthol
mgEucalyptus oil 3.0 mg
ZYDOL 100 mg / 2 ml Grunenthal Pharma Ltd PA2242/005/002 Solution for injection - Tramadol hydrochloride 28/02/2021
Solution for Injection
Psoriderm Emulsion 40% w/v Dermal Laboratories Ltd PA0278/004/002 Bath additive - Coal tar 26/02/2021
Bath Additive
Darunavir Rowex 400 mg Rowex Ltd PA0711/269/002 Film-coated tablet - Darunavir 24/02/2021
Film-coated tablets
Darunavir Rowex 600 mg Rowex Ltd PA0711/269/003 Film-coated tablet - Darunavir 24/02/2021
Film-coated tablets
Darunavir Rowex 75 mg Rowex Ltd PA0711/269/001 Film-coated tablet - Darunavir 24/02/2021
Film-coated tablets
Tramadol 50mg Capsules Relon Chem Limited PA1128/003/001 Capsule, hard - Tramadol hydrochloride 24/02/2021

Interchangeable List Code:


IC0074-023-008
Clonazepam Rosemont 2 Perrigo Pharma International PA22741/007/002 Oral solution - Clonazepam 23/02/2021
mg/5 ml oral solution Designated Activity Compan

Sevelamer Carbonate Rowex Rowex Ltd PA0711/246/001 Film-coated tablet - Sevelamer carbonate 23/02/2021
800 mg film-coated tablets

Dalmapam 15mg Hard Pinewood Laboratories Ltd, PA0281/073/001 Capsule, hard - Flurazepam 22/02/2021
Capsules
Interchangeable List Code:
IC0093-032-001
Dalmapam 30mg Hard Pinewood Laboratories Ltd, PA0281/073/002 Capsule, hard - Flurazepam 22/02/2021
Capsules
Interchangeable List Code:
IC0093-033-001
Fruside 40 mg Tablets Pinewood Laboratories Ltd, PA0281/087/001 Tablet - Furosemide 22/02/2021
Ibandronic acid Pinewood Pinewood Laboratories Ltd, PA0281/159/001 Film-coated tablet - Ibandronic acid 22/02/2021
150 mg film-coated tablets
Lamoro 100mg Dispersible Pinewood Laboratories Ltd, PA0281/128/004 Dispersible tablet - Lamotrigine 22/02/2021
Tablets
Lamoro 200mg Dispersible Pinewood Laboratories Ltd, PA0281/128/005 Dispersible tablet - Lamotrigine 22/02/2021
Tablets
Lamoro 25mg Dispersible Pinewood Laboratories Ltd, PA0281/128/002 Dispersible tablet - Lamotrigine 22/02/2021
Tablets
Lamoro 50mg Dispersible Pinewood Laboratories Ltd, PA0281/128/003 Dispersible tablet - Lamotrigine 22/02/2021
Tablets
Lamoro 5mg Dispersible Pinewood Laboratories Ltd, PA0281/128/001 Dispersible tablet - Lamotrigine 22/02/2021
Tablets
Pinaclor Granules for Oral Pinewood Laboratories Ltd, PA0281/155/003 Granules for oral suspension - Anhydrous Cefaclor 22/02/2021
Suspension 125mg/5ml

Human Medicines Withdrawn Products Page 24 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Pinaclor Granules for Oral Pinewood Laboratories Ltd, PA0281/155/004 Granules for oral suspension - Anhydrous Cefaclor 22/02/2021
Suspension 250mg/5ml
Pinaclor Hard Capsules Pinewood Laboratories Ltd, PA0281/155/001 Capsule, hard - Anhydrous Cefaclor 22/02/2021
250mg
Pinaclor Hard Capsules 500 Pinewood Laboratories Ltd, PA0281/155/002 Capsule, hard - Anhydrous Cefaclor 22/02/2021
mg
Purinol 100mg Tablets Pinewood Laboratories Ltd, PA0281/103/001 Tablet - Allopurinol 22/02/2021
Purinol 300mg Tablets Pinewood Laboratories Ltd, PA0281/103/002 Tablet - Allopurinol 22/02/2021
Ranopine 150 mg Film- Pinewood Laboratories Ltd, PA0281/156/001 Film-coated tablet - Ranitidine 22/02/2021
coated Tablets
Interchangeable List Code:
IC0087-062-051
Ranopine 300 mg Film- Pinewood Laboratories Ltd, PA0281/156/002 Film-coated tablet - Ranitidine 22/02/2021
coated Tablets
Interchangeable List Code:
IC0087-029-051
Trantalol Atenolol 100 mg Pinewood Laboratories Ltd, PA0281/083/002 Tablet - Atenolol 22/02/2021
Tablets
Trantalol Atenolol 25 mg Pinewood Laboratories Ltd, PA0281/083/003 Tablet - Atenolol 22/02/2021
Tablet
Trantalol Atenolol 50 mg Pinewood Laboratories Ltd, PA0281/083/001 Tablet - Atenolol 22/02/2021
Tablets
Amoxil Paediatric 125 GlaxoSmithKline (Ireland) PA1077/033/005 Powder for oral suspension - Amoxicillin 19/02/2021
mg/1.25 ml Powder for Oral Limited
Suspension
Dutasteride 0.5mg Soft Accord Healthcare Ireland PA2315/029/001 Capsule, soft - Dutasteride 19/02/2021
Capsules Ltd.
Imatinib Koanaa 100 mg Koanaa Healthcare Limited PA2041/001/001 Film-coated tablet - Imatinib mesylate 19/02/2021
Film-coated Tablets
Imatinib Koanaa 400 mg Koanaa Healthcare Limited PA2041/001/002 Film-coated tablet - Imatinib mesylate 19/02/2021
Film-coated Tablets
Omnipaque 180 mg I/ml, GE Healthcare AS PA0735/006/022 Solution for injection - Iohexol 19/02/2021
solution for injection
(polypropylene)
Brufen 200 mg Effervescent Mylan IRE Healthcare PA2010/002/003 Effervescent granules - Ibuprofen 18/02/2021
Granules Limited
Brufen 400 mg effervescent Mylan IRE Healthcare PA2010/002/004 Effervescent granules - Ibuprofen 18/02/2021
Granules Limited
Dioderm 0.1% w/w Cream Dermal Laboratories Ltd PA0278/003/001 Cream - Hydrocortisone 18/02/2021
Esomeprazole Mylan 20 mg McDermott Laboratories Ltd., PA0577/123/001 Gastro-resistant capsule, - Esomeprazole magnesium 18/02/2021
Gastro-resistant Hard T/A Gerard Laboratories hard
Capsules Interchangeable List Code:
IC0004-003-016
Imatinib 100 mg film-coated McDermott Laboratories Ltd., PA0577/219/001 Film-coated tablet - Imatinib 18/02/2021
tablets T/A Gerard Laboratories

Imatinib 400 mg film-coated McDermott Laboratories Ltd., PA0577/219/002 Film-coated tablet - Imatinib 18/02/2021
tablets T/A Gerard Laboratories

Memantine Hydrochloride McDermott Laboratories Ltd., PA0577/176/001 Oral solution - MEMANTINE 18/02/2021
10mg/ml Oral Solution T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0022-107-019
MUSE 125 microgram Mylan IRE Healthcare PA2010/028/001 Urethral stick - Alprostadil 18/02/2021
urethral stick Limited
Mylite 100 micrograms / 20 McDermott Laboratories Ltd., PA0577/183/001 Coated tablet - Levonorgestrel 18/02/2021
micrograms coated tablets T/A Gerard Laboratories - Ethinylestradiol

Novolizer Formoterol 12 Mylan IRE Healthcare PA2010/051/002 Inhalation powder - Formoterol fumatrate 18/02/2021
micrograms /dose inhalation Limited dihydrate
powder
Novolizer Formoterol 6 Mylan IRE Healthcare PA2010/051/001 Inhalation powder - Formoterol fumatrate 18/02/2021
micrograms/dose inhalation Limited dihydrate
powder
Oxyargin 10 mg/5 mg McDermott Laboratories Ltd., PA0577/220/002 Prolonged-release tablet - OXYCODONE 18/02/2021
prolonged release tablets T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-016-024 dihydrate
Oxyargin 20 mg/10 mg McDermott Laboratories Ltd., PA0577/220/003 Prolonged-release tablet - Naloxone hydrochloride 18/02/2021
prolonged release tablets T/A Gerard Laboratories dihydrate
Interchangeable List Code: - OXYCODONE
IC0102-061-024 HYDROCHLORIDE
Oxyargin 30 mg/15 mg McDermott Laboratories Ltd., PA0577/220/004 Prolonged-release tablet - OXYCODONE 18/02/2021
prolonged release tablets T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-158-024 dihydrate

Human Medicines Withdrawn Products Page 25 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Oxyargin 40 mg/20 mg McDermott Laboratories Ltd., PA0577/220/005 Prolonged-release tablet - OXYCODONE 18/02/2021
prolonged release tablets T/A Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-160-024 dihydrate
Oxyargin 5 mg /2.5 mg McDermott Laboratories Ltd., PA0577/220/001 Prolonged-release tablet - Naloxone hydrochloride 18/02/2021
prolonged release tablets T/A Gerard Laboratories dihydrate
Interchangeable List Code: - OXYCODONE
IC0102-159-024 HYDROCHLORIDE
Pramipexole Mylan 0.088 mg McDermott Laboratories Ltd., PA0577/138/001 Tablet - Pramipexole 18/02/2021
tablets T/A Gerard Laboratories

Risedronate Mylan Once a McDermott Laboratories Ltd., PA0577/127/001 Film-coated tablet - Risedronate sodium 18/02/2021
Week 35mg film-coated T/A Gerard Laboratories hemipentahydrate
tablets Interchangeable List Code:
IC0068-124-003
Valganciclovir 450mg Film- McDermott Laboratories Ltd., PA0577/215/001 Film-coated tablet - Valganciclovir 18/02/2021
coated Tablets T/A Gerard Laboratories

Zesger Plus 20 mg/12.5 mg McDermott Laboratories Ltd., PA0577/055/002 Tablet - Lisinopril 18/02/2021
Tablets T/A Gerard Laboratories - Hydrochlorothiazide

Omesar 40 mg film-coated LTT Pharma Limited PPA1562/140/002 Film-coated tablet - Olmesartan medoxomil 17/02/2021
tablets
Interchangeable List Code:
IC0105-004-003
Seretide 100 Diskus 50 LTT Pharma Limited PPA1562/141/003 Inhalation powder - FLUTICASONE 17/02/2021
microgram/100 microgram / PROPIONATE
dose inhalation powder, pre- - SALMETEROL
dispensed XINAFOATE
Seretide 250 Diskus 50 LTT Pharma Limited PPA1562/141/001 Inhalation powder - SALMETEROL 17/02/2021
microgram/250 XINAFOATE
microgram/dose inhalation - FLUTICASONE
powder, pre-dispensed PROPIONATE
Seretide 500 Diskus 50 LTT Pharma Limited PPA1562/141/002 Inhalation powder - SALMETEROL 17/02/2021
microgram/500 XINAFOATE
microgram/dose inhalation - FLUTICASONE
powder, pre-dispensed PROPIONATE
Aldactone 25mg Film-coated LTT Pharma Limited PPA1562/133/001 Film-coated tablet - Spironolactone 16/02/2021
Tablets
Avodart 0.5 mg soft capsules LTT Pharma Limited PPA1562/131/001 Capsule, soft - Dutasteride 16/02/2021

Canesten Cream LTT Pharma Limited PPA1562/191/001 Cream - Clotrimazole 16/02/2021


Differin 0.1% w/w Cream LTT Pharma Limited PPA1562/136/002 Cream - Adapalene 16/02/2021
Differin 0.1% w/w Gel LTT Pharma Limited PPA1562/136/001 Gel - Adapalene 16/02/2021
Exemestane 25 mg Film- LTT Pharma Limited PPA1562/184/001 Film-coated tablet - Exemestane 16/02/2021
coated Tablets
Finasteride 5 mg Film-coated LTT Pharma Limited PPA1562/185/001 Film-coated tablet - Finasteride 16/02/2021
Tablets
One-Alpha 1 microgram soft LTT Pharma Limited PPA1562/139/001 Capsule, soft - Alfacalcidol 16/02/2021
capsules
Terazosin 5mg Tablets LTT Pharma Limited PPA1562/195/001 Tablet - Terazosin 16/02/2021
Triapin 5mg/5mg prolonged LTT Pharma Limited PPA1562/128/001 Prolonged-release tablet - Felodipine 16/02/2021
release tablet - Ramipril
Interchangeable List Code:
IC0032-012-024
Flixotide Nebules 0.5 mg/ LTT Pharma Limited PPA1562/144/003 Nebuliser suspension - FLUTICASONE 15/02/2021
2ml Nebuliser Suspension PROPIONATE
Flixotide Nebules 2 mg/ 2 ml LTT Pharma Limited PPA1562/144/004 Nebuliser suspension - FLUTICASONE 15/02/2021
Nebuliser Suspension PROPIONATE
Zovirax 200 mg Dispersible LTT Pharma Limited PPA1562/183/001 Dispersible tablet - ACICLOVIR 15/02/2021
Tablets
Kaletra AbbVie Deutschland GmbH EU/1/01/172/001 Capsule - Lopinavir 12/02/2021
& Co. KG - Ritonavir
Atovaquone/Proguanil LTT Pharma Limited PPA1562/177/001 Film-coated tablet - PROGUANIL 11/02/2021
Hydrochloride 250 mg/100 HYDROCHLORIDE
mg film-coated tablets - Atovaquone
Konverge 20mg/5mg film- LTT Pharma Limited PPA1562/175/001 Film-coated tablet - Amlodipine besylate 11/02/2021
coated tablets - Olmesartan medoxomil
Konverge 40mg/10mg film- LTT Pharma Limited PPA1562/175/003 Film-coated tablet - Amlodipine besylate 11/02/2021
coated tablets - Olmesartan medoxomil
Konverge 40mg/5mg film- LTT Pharma Limited PPA1562/175/002 Film-coated tablet - Amlodipine besylate 11/02/2021
coated tablets - Olmesartan medoxomil
Nasonex 50 LTT Pharma Limited PPA1562/173/001 Nasal spray, suspension - Mometasone furoate 11/02/2021
micrograms/actuation Nasal
Spray, Suspension

Human Medicines Withdrawn Products Page 26 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ViraferonPeg Merck Sharp and Dohme EU/1/00/132/003 Powder and solvent for - Peginterferon alfa-2b 11/02/2021
Limited solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/025 Powder and solvent for - Peginterferon alfa-2b 11/02/2021
suspension for injection
ViraferonPeg 2b 80mcg / 0.5 Merck Sharp & Dohme BV EU/1/00/132/036 Powder and solvent for - Peginterferon alfa-2b 11/02/2021
ml 80 mcg ampoule solution for injection
MOVIPREP, powder for oral LTT Pharma Limited PPA1562/168/001 Powder for oral solution - Macrogol 3350 10/02/2021
solution - Potassium chloride
- Ascorbic acid
- Sodium sulfate anhydrous
- Sodium chloride
- Sodium ascorbate
Plendil 10 mg Prolonged- LTT Pharma Limited PPA1562/157/002 Prolonged-release tablet - Felodipine 10/02/2021
Release Film-coated Tablets

Plendil 5 mg Prolonged- LTT Pharma Limited PPA1562/157/001 Prolonged-release tablet - Felodipine 10/02/2021
Release Film-coated Tablets

Scheriproct 1.5mg/g + 5mg/g LTT Pharma Limited PPA1562/164/001 Rectal ointment - Cinchocaine hydrochloride 10/02/2021
rectal ointment - PREDNISOLONE
CAPROATE
Aromasin 25 mg coated LTT Pharma Limited PPA1562/155/001 Coated tablet - Exemestane 09/02/2021
tablets
Geriflox 500mg Capsules, McDermott Laboratories Ltd., PA0577/199/001 Capsule, hard - Flucloxacillin 09/02/2021
Hard T/A Gerard Laboratories
Interchangeable List Code:
IC0089-117-001
Elocon 0.1% w/w Cream LTT Pharma Limited PPA1562/145/001 Cream - Mometasone furoate 08/02/2021
Elocon 0.1% w/w Ointment LTT Pharma Limited PPA1562/145/002 Ointment - Mometasone furoate 08/02/2021
Flixotide Evohaler 125 LTT Pharma Limited PPA1562/144/001 Pressurised inhalation, - FLUTICASONE 08/02/2021
micrograms, per metered suspension PROPIONATE
dose, Pressurised Inhalation,
Suspension
Flixotide Evohaler 250 LTT Pharma Limited PPA1562/144/002 Pressurised inhalation, - FLUTICASONE 08/02/2021
micrograms, per metered suspension PROPIONATE
dose, Pressurised Inhalation,
Suspension
Minocin SA 100 mg Modified LTT Pharma Limited PPA1562/132/001 Modified-release capsule, - MINOCYCLINE 08/02/2021
Release Capsules hard HYDROCHLORIDE
Omesar 10 mg film-coated LTT Pharma Limited PPA1562/140/001 Film-coated tablet - Olmesartan medoxomil 08/02/2021
tablets
Interchangeable List Code:
IC0105-002-003
Ranitidine 150mg/10ml Oral LTT Pharma Limited PPA1562/130/001 Oral solution - RANITIDINE 08/02/2021
Solution HYDROCHLORIDE
Interchangeable List Code:
IC0087-144-054
Rectogesic 4 mg/g Rectal LTT Pharma Limited PPA1562/147/001 Rectal ointment - Glyceryl trinitrate 08/02/2021
Ointment
Udenyca ERA Consulting GmbH EU/1/18/1303/001 Solution for injection in pre- - Pegfilgrastim 04/02/2021
filled syringe
Chanelle ivy leaf lozenges Chanelle Medical TR0688/001/003 Lozenge 03/02/2021
Chanelle ivy leaf syrup Chanelle Medical TR0688/001/002 Syrup 03/02/2021
Actiq 1200 micrograms Teva Pharma B.V. PA0749/195/005 Lozenge - FENTANYL CITRATE 02/02/2021
compressed lozenge with
integral oromucosal
applicator
Actiq 1600 micrograms Teva Pharma B.V. PA0749/195/006 Lozenge - FENTANYL CITRATE 02/02/2021
compressed lozenge with
integral oromucosal
applicator
Actiq 800 micrograms Teva Pharma B.V. PA0749/195/004 Compressed lozenge - Fentanyl 02/02/2021
compressed lozenge with
integral oromucosal
applicator
Zantac 300 milligram(s) Film- GlaxoSmithKline (Ireland) PA1077/013/004 Film-coated tablet - RANITIDINE 01/02/2021
coated tablet Limited HYDROCHLORIDE
Interchangeable List Code:
IC0087-029-051
Aripiprazole Wockhardt 10mg Wockhardt UK Limited PA1339/058/003 Tablet - Aripiprazole 31/01/2021
tablets
Interchangeable List Code:
IC0092-002-056

Human Medicines Withdrawn Products Page 27 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Aripiprazole Wockhardt 15mg Wockhardt UK Limited PA1339/058/004 Tablet - Aripiprazole 31/01/2021
tablets
Interchangeable List Code:
IC0092-032-056
Aripiprazole Wockhardt 30mg Wockhardt UK Limited PA1339/058/005 Tablet - Aripiprazole 31/01/2021
tablets
Interchangeable List Code:
IC0092-033-056
Aripiprazole Wockhardt 5mg Wockhardt UK Limited PA1339/058/002 Tablet - Aripiprazole 31/01/2021
tablets
Interchangeable List Code:
IC0092-001-002
Cefotaxime 2g Powder for Wockhardt UK Limited PA1339/002/003 Powder for solution for - Cefotaxime sodium 31/01/2021
solution for injection or injection/infusion
infusion
Disodium Pamidronate Wockhardt UK Limited PA1339/007/001 Concentrate for solution for - Pamidronic acid 31/01/2021
15mg/ml Concentrate for infusion
Solution for Infusion, 1ml
Disodium Pamidronate Wockhardt UK Limited PA1339/007/003 Concentrate for solution for - Pamidronic acid 31/01/2021
15mg/ml Concentrate for infusion
Solution for Infusion, 4ml
Domperidone 1mg/ml Oral Wockhardt UK Limited PA1339/050/001 Oral suspension - Domperidone 31/01/2021
Suspension
Interchangeable List Code:
IC0085-047-027
Duloxetine 20 mg Gastro- Wockhardt UK Limited PA1339/061/001 Gastro-resistant capsule, - Duloxetine hydrochloride 31/01/2021
resistant capsules, hard hard
Interchangeable List Code:
IC0091-003-006
Duloxetine 30 mg Gastro- Wockhardt UK Limited PA1339/061/002 Gastro-resistant capsule, - Duloxetine hydrochloride 31/01/2021
resistant capsules, hard hard
Interchangeable List Code:
IC0091-033-006
Duloxetine 40 mg Gastro- Wockhardt UK Limited PA1339/061/003 Gastro-resistant capsule, - Duloxetine hydrochloride 31/01/2021
resistant capsules, hard hard
Interchangeable List Code:
IC0091-004-006
Duloxetine 60 mg Gastro- Wockhardt UK Limited PA1339/061/004 Gastro-resistant capsule, - Duloxetine hydrochloride 31/01/2021
resistant capsules, hard hard
Interchangeable List Code:
IC0091-127-006
Levothyroxine 100 Wockhardt UK Limited PA1339/044/004 Oral solution - Levothyroxine sodium 31/01/2021
micrograms/5ml Oral
Solution
Levothyroxine 25 Wockhardt UK Limited PA1339/044/002 Oral solution - Levothyroxine sodium 31/01/2021
micrograms/5ml Oral
Solution
Levothyroxine 50 Wockhardt UK Limited PA1339/044/003 Oral solution - Levothyroxine sodium 31/01/2021
micrograms/5ml Oral
Solution
Morphine Sulfate 10mg/5ml Wockhardt UK Limited PA1339/051/002 Oral solution - Morphine sulphate 31/01/2021
Oral Solution
Nevirapine 200mg Tablets Wockhardt UK Limited PA1339/047/001 Tablet - Nevirapine anhydrous 31/01/2021
Nevirapine Wockhardt 400 Wockhardt UK Limited PA1339/071/001 Prolonged-release tablet - Nevirapine anhydrous 31/01/2021
mg Prolonged-Release
Tablets
Terbinafine 250 mg Tablets Wockhardt UK Limited PA1339/018/001 Tablet - TERBINAFINE 31/01/2021
HYDROCHLORIDE
Amlodipine 1mg/ml Oral Perrigo Pharma International PA22741/001/001 Oral solution - Amlodipine 30/01/2021
Solution Designated Activity Compan
Interchangeable List Code:
IC0045-047-019
Amlodipine 2mg/ml Oral Perrigo Pharma International PA22741/001/002 Oral solution - Amlodipine 30/01/2021
Solution Designated Activity Compan

Mypreg 100 mg hard McDermott Laboratories Ltd., PA0577/223/004 Capsule, hard - Pregabalin 29/01/2021
capsules T/A Gerard Laboratories
Interchangeable List Code:
IC0110-024-001
Mypreg 150 mg hard McDermott Laboratories Ltd., PA0577/223/005 Capsule, hard - Pregabalin 29/01/2021
capsules T/A Gerard Laboratories
Interchangeable List Code:
IC0110-062-001

Human Medicines Withdrawn Products Page 28 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Mypreg 200 mg hard McDermott Laboratories Ltd., PA0577/223/006 Capsule, hard - Pregabalin 29/01/2021
capsules T/A Gerard Laboratories
Interchangeable List Code:
IC0110-067-001
Mypreg 225 mg hard McDermott Laboratories Ltd., PA0577/223/007 Capsule, hard - Pregabalin 29/01/2021
capsules T/A Gerard Laboratories
Interchangeable List Code:
IC0110-064-001
Mypreg 25 mg hard capsules McDermott Laboratories Ltd., PA0577/223/001 Capsule, hard - Pregabalin 29/01/2021
T/A Gerard Laboratories
Interchangeable List Code:
IC0110-022-001
Mypreg 300 mg hard McDermott Laboratories Ltd., PA0577/223/008 Capsule, hard - Pregabalin 29/01/2021
capsules T/A Gerard Laboratories
Interchangeable List Code:
IC0110-029-001
Mypreg 50 mg hard capsules McDermott Laboratories Ltd., PA0577/223/002 Capsule, hard - Pregabalin 29/01/2021
T/A Gerard Laboratories
Interchangeable List Code:
IC0110-023-001
Mypreg 75 mg hard capsules McDermott Laboratories Ltd., PA0577/223/003 Capsule, hard - Pregabalin 29/01/2021
T/A Gerard Laboratories
Interchangeable List Code:
IC0110-028-001
Phenytoin 250 mg/5 ml Accord Healthcare Ireland PA2315/171/001 Solution for injection/infusion - PHENYTOIN SODIUM 29/01/2021
solution for injection or Ltd.
infusion
Silica (Sil.) Weleda (UK) Limited HOR0407/009/001 Tablet - Acidum silicicum 29/01/2021
Solian 100mg Tablets LTT Pharma Limited PPA1562/126/002 Tablet - Amisulpride 28/01/2021
Solian 200mg Tablets LTT Pharma Limited PPA1562/126/003 Tablet - Amisulpride 28/01/2021
Solian 400mg Film-coated LTT Pharma Limited PPA1562/126/004 Film-coated tablet - Amisulpride 28/01/2021
Tablets
Solian 50mg Tablets LTT Pharma Limited PPA1562/126/001 Tablet - Amisulpride 28/01/2021
Ixprim 37.5 mg/325 mg film- LTT Pharma Limited PPA1562/121/001 Film-coated tablet - Tramadol hydrochloride 27/01/2021
coated tablets - Paracetamol
Interchangeable List Code:
IC0077-133-014
Lipantil Supra 145mg film- LTT Pharma Limited PPA1562/124/001 Film-coated tablet - Fenofibrate 27/01/2021
coated tablets
Trazodone Hydrochloride 50 Alissa Healthcare Research PA1887/007/001 Oral solution - Trazodone hydrochloride 27/01/2021
mg/5 ml Oral solution Limited
Calendula Lotion 40% v/v Weleda (UK) Limited PA0407/025/001 Concentrate for cutaneous - Calendula officinalis 26/01/2021
Concentrate for Cutaneous solution
Solution
Cantharis Tablets Weleda (UK) Limited HOR0407/048/001 Tablet - Cantharis 26/01/2021
Chamomilla Tablets Weleda (UK) Limited HOR0407/018/001 Tablet - Chamomilla recutita 26/01/2021
Cocculus Tablets Weleda (UK) Limited HOR0407/050/001 Tablet - Anamirta cocculus fruct.sic. 26/01/2021

Efudix 5 % w/w Cream LTT Pharma Limited PPA1562/119/001 Cream - Fluorouracil 26/01/2021
Euphrasia Weleda (UK) Limited HOR0407/027/001 Tablet - Euphrasia officinalis 26/01/2021
Gelsemium Weleda (UK) Limited HOR0407/024/001 Tablet - Gelsemium sempervirens 26/01/2021
Graphites (Graph.) Weleda (UK) Limited HOR0407/004/001 Tablet - Graphites 26/01/2021
Hepar sulfuris calcareum Weleda (UK) Limited HOR0407/011/001 Tablet - HEPAR SULFURIS 26/01/2021
(Hepar. sulf.) CALCAREUM GHP
Hypericum Weleda (UK) Limited HOR0407/030/001 Tablet - Hypericum perforatum 26/01/2021
Ignatia Weleda (UK) Limited HOR0407/029/001 Tablet - Strychnos ignatii 26/01/2021
Kalium phosphoricum (Kali. Weleda (UK) Limited HOR0407/045/001 Tablet - Kalium phosphoricum 26/01/2021
phos.) (6C & 30C)
Lycopodium Weleda (UK) Limited HOR0407/028/001 Tablet - Lycopodium clavatum 26/01/2021
Massage Balm with Arnica Weleda (UK) Limited PA0407/021/001 Cutaneous solution - Betula pendula 26/01/2021
- Arnica montana
- BIRCH LEAF
Natrium muriaticum (Nat. Weleda (UK) Limited HOR0407/007/001 Tablet - Natrium chloratum 26/01/2021
mur.) Tablets
NorLevo 1.5 mg Tablet LTT Pharma Limited PPA1562/120/001 Tablet - Levonorgestrel 26/01/2021
Nux vomica Tablets Weleda (UK) Limited HOR0407/016/001 Tablet - Strychnos nux-vomica 26/01/2021
Phosphorous (Phos.) Weleda (UK) Limited HOR0407/008/001 Tablet - Phosphorus 26/01/2021
Pulsatilla Weleda (UK) Limited HOR0407/015/001 Tablet - Pulsatilla pratensis 26/01/2021
Rhus tox. Weleda (UK) Limited HOR0407/017/001 Tablet - Toxicodendron quercifolium 26/01/2021

Ruta graveolens Weleda (UK) Limited HOR0407/025/001 Tablet - Ruta graveolens 26/01/2021
Sulfur Weleda (UK) Limited HOR0407/010/001 Tablet - Sulfur 26/01/2021
Thuja Weleda (UK) Limited HOR0407/020/001 Tablet - Thuja occidentalis 26/01/2021

Human Medicines Withdrawn Products Page 29 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Weleda Arnica Bumps and Weleda (UK) Limited TR0407/001/001 Ointment 26/01/2021
Bruises Skin Salve Ointment

Weleda Calendula Cuts and Weleda (UK) Limited TR0407/003/001 Ointment - TINCTURE FROM 26/01/2021
Grazes Skin Salve Ointment CALENDULA OFFICINALIS
L., HERBA
Weleda HyperCal Wound Weleda (UK) Limited TR0407/002/001 Ointment - TINCTURE OF 26/01/2021
Salve Ointment HYPERICUM
PERFORATUM L., HERBA
- TINCTURE FROM
CALENDULA OFFICINALIS
L., HERBA
Aconite Weleda (UK) Limited HOR0407/013/001 Tablet - Aconitum napellus 25/01/2021
Apis mel Tablets Weleda (UK) Limited HOR0407/047/001 Tablet - Apis mellifica 25/01/2021
Argentum nitricum (Argent. Weleda (UK) Limited HOR0407/001/001 Tablet - Argentum nitricum 25/01/2021
nit.)
Arsenicum album (Arsen. Weleda (UK) Limited HOR0407/002/001 Tablet - Arsenicum album 25/01/2021
alb.)
Belladonna Tablets Weleda (UK) Limited HOR0407/019/001 Tablet - Atropa belladonna 25/01/2021
Bryonia Weleda (UK) Limited HOR0407/026/001 Tablet - Bryonia 25/01/2021
Calcium carbonicum Weleda (UK) Limited HOR0407/012/001 Tablet - Calcium carbonicum 25/01/2021
Hahnemanii (Calc carb) hahnemanni (conchae)
Calcium fluoratum (Calc. Weleda (UK) Limited HOR0407/046/001 Tablet - Calcium fluoratum 25/01/2021
fluor.)
Carbo vegetabilis (Carbo. Weleda (UK) Limited HOR0407/003/001 Tablet - Carbo vegetabilis 25/01/2021
veg.)
IDEOS 500 mg/400 IU LTT Pharma Limited PPA1562/078/001 Chewable tablet - Cholecalciferol 25/01/2021
chewable tablets - Calcium carbonate
Mezavant XL 1200mg gastro- LTT Pharma Limited PPA1562/114/001 Prolonged-release tablet - Mesalazine 25/01/2021
resistant, prolonged release
tablets
Requip-Modutab 2 mg LTT Pharma Limited PPA1562/115/001 Prolonged-release tablet - Ropinirole 25/01/2021
Prolonged-Release Tablets
Requip-Modutab 4 mg LTT Pharma Limited PPA1562/115/002 Prolonged-release tablet - Ropinirole 25/01/2021
Prolonged-Release Tablets
Requip-Modutab 8 mg LTT Pharma Limited PPA1562/115/003 Prolonged-release tablet - Ropinirole 25/01/2021
Prolonged-Release Tablets
Xymel SR Clonmel Healthcare Ltd PA0126/099/002 Prolonged-release tablet - Tramadol hydrochloride 25/01/2021
Combodart 0.5 mg/0.4 mg Imbat Limited PPA1151/171/001 Capsule, hard - Dutasteride 22/01/2021
hard capsules - Tamsulosin hydrochloride
Interchangeable List Code:
IC0036-065-001
Clarityn Rapide Allergy 10 Bayer Limited PA1410/075/003 Oral lyophilisate - Loratadine 21/01/2021
mg Tablets
Dazonay Rowex Ltd PA0711/252/003 Film-coated tablet - Levodopa 21/01/2021
100mg/25mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/004 Film-coated tablet - Levodopa 21/01/2021
125mg/31.25mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/005 Film-coated tablet - Levodopa 21/01/2021
150mg/37.5mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/006 Film-coated tablet - Levodopa 21/01/2021
175mg/43.75mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/007 Film-coated tablet - Levodopa 21/01/2021
200mg/50mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/001 Film-coated tablet - Levodopa 21/01/2021
50mg/12.5mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Dazonay Rowex Ltd PA0711/252/002 Film-coated tablet - Levodopa 21/01/2021
75mg/18.75mg/200mg Film- - Carbidopa
coated Tablets - Entacapone
Rennie Direct 680 mg/80 mg Bayer Limited PA1410/053/005 Oral powder - Magnesium carbonate 21/01/2021
oral powder heavy
- Calcium carbonate
Eletriptan Hormosan 20 mg Hormosan Pharma GmbH PA23052/001/001 Film-coated tablet - ELETRIPTAN 20/01/2021
film-coated tablets
Eletriptan Hormosan 40 mg Hormosan Pharma GmbH PA23052/001/002 Film-coated tablet - ELETRIPTAN 20/01/2021
film-coated tablets
Prucalopride STADA 1 mg Stada Arzneimittel AG PA0593/045/001 Film-coated tablet - Prucalopride 18/01/2021
film-coated tablets
Prucalopride STADA 2 mg Stada Arzneimittel AG PA0593/045/002 Film-coated tablet - Prucalopride 18/01/2021
film-coated tablets

Human Medicines Withdrawn Products Page 30 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zantac 150 mg Effervescent GlaxoSmithKline (Ireland) PA1077/013/005 Effervescent tablet - RANITIDINE 15/01/2021
Tablets Limited HYDROCHLORIDE
Interchangeable List Code:
IC0087-062-051
Zantac 150 mg/10 ml Syrup GlaxoSmithKline (Ireland) PA1077/013/002 Syrup - RANITIDINE 15/01/2021
Limited HYDROCHLORIDE
Interchangeable List Code:
IC0087-144-054
REMINYL XL 16 mg LTT Pharma Limited PPA1562/113/002 Prolonged-release capsule, - GALANTAMINE 14/01/2021
prolonged-release capsules hard HYDROBROMIDE
Reminyl XL 24 mg LTT Pharma Limited PPA1562/113/003 Prolonged-release capsule, - Galantamine 14/01/2021
prolonged-release capsules hard
Reminyl XL 8mg Prolonged- LTT Pharma Limited PPA1562/113/001 Prolonged-release capsule, - GALANTAMINE 14/01/2021
release Capsules hard HYDROBROMIDE
Calcichew-D3 Forte 500 LTT Pharma Limited PPA1562/100/001 Chewable tablet - Colecalciferol 13/01/2021
mg/400 IU Chewable Tablets - Calcium

Dithrocream 2% w/w Dermal Laboratories Ltd PA0278/001/005 Cream - Dithranol 13/01/2021


Dostinex 500 microgram LTT Pharma Limited PPA1562/108/001 Tablet - Cabergoline 13/01/2021
Tablets
Livial 2.5mg Tablets LTT Pharma Limited PPA1562/105/001 Tablet - Tibolone 13/01/2021
Singulair 10 mg film-coated LTT Pharma Limited PPA1562/104/001 Film-coated tablet - Montelukast 13/01/2021
tablets
Interchangeable List Code:
IC0023-002-003
Lipitor 10 mg film-coated LTT Pharma Limited PPA1562/099/001 Film-coated tablet - Atorvastatin calcium 12/01/2021
tablets
Interchangeable List Code:
IC0001-002-003
Lipitor 20 mg film-coated LTT Pharma Limited PPA1562/099/002 Film-coated tablet - Atorvastatin calcium 12/01/2021
tablets
Interchangeable List Code:
IC0001-003-003
Lipitor 40 mg Film-coated LTT Pharma Limited PPA1562/099/003 Film-coated tablet - Atorvastatin 12/01/2021
Tablets
Interchangeable List Code:
IC0001-004-003
Lipitor 80 mg Film-coated LTT Pharma Limited PPA1562/099/004 Film-coated tablet - Atorvastatin 12/01/2021
Tablets
Interchangeable List Code:
IC0001-005-003
Teveten 600mg film-coated Imbat Limited PPA1151/118/001 Film-coated tablet - Eprosartan 12/01/2021
tablets
TOPAMAX 200mg Film- Imbat Limited PPA1151/209/004 Film-coated tablet - Topiramate 12/01/2021
coated Tablets
Triapin 5 mg/5 mg prolonged Imbat Limited PPA1151/253/001 Prolonged-release tablet - Felodipine 12/01/2021
release tablets - Ramipril
Interchangeable List Code:
IC0032-012-024
Ventolin Evohaler 100 Imbat Limited PPA1151/035/001 Pressurised inhalation, - SALBUTAMOL SULFATE 12/01/2021
micrograms Pressurised suspension
Inhalation, suspension Interchangeable List Code:
IC0078-138-053
Vermox 100mg Tablets Imbat Limited PPA1151/145/002 Tablet - Mebendazole 12/01/2021
Vermox 100mg/5ml Oral Imbat Limited PPA1151/145/001 Oral solution - Mebendazole 12/01/2021
Suspension
Xatral 10mg Prolonged Imbat Limited PPA1151/042/001 Prolonged-release tablet - ALFUZOSIN 12/01/2021
Release Tablets HYDROCHLORIDE
Xyzal 5 mg film-coated Imbat Limited PPA1151/052/001 Film-coated tablet - Levocetirizine 12/01/2021
tablets dihydrochloride
Interchangeable List Code:
IC0095-001-003
Zantac 150mg Film Coated Imbat Limited PPA1151/009/001 Film-coated tablet - RANITIDINE 12/01/2021
Tablets HYDROCHLORIDE
Interchangeable List Code:
IC0087-062-051
Zantac 300mg Film-coated Imbat Limited PPA1151/009/003 Film-coated tablet - Ranitidine 12/01/2021
Tablets
Interchangeable List Code:
IC0087-029-051
Zantac 75mg Film-Coated Imbat Limited PPA1151/009/002 Film-coated tablet - RANITIDINE 12/01/2021
Tablets HYDROCHLORIDE
Zineryt 40mg/12mg per ml Imbat Limited PPA1151/148/001 Powder and solvent for - Zinc acetate 12/01/2021
powder and solvent for cutaneous solution - Erythromycin
cutaneous solution

Human Medicines Withdrawn Products Page 31 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zispin SolTab 15mg, Imbat Limited PPA1151/090/001 Orodispersible tablet - Mirtazapine 12/01/2021
Orodispersible Tablets
Interchangeable List Code:
IC0061-032-015
Zispin SolTab 30mg Imbat Limited PPA1151/090/002 Orodispersible tablet - Mirtazapine 12/01/2021
Orodispersible Tablets
Interchangeable List Code:
IC0061-033-015
Zispin SolTab 45mg Imbat Limited PPA1151/090/003 Orodispersible tablet - Mirtazapine 12/01/2021
Orodispersible Tablets
Interchangeable List Code:
IC0061-110-015
Zoladex LA 10.8mg Implant Imbat Limited PPA1151/133/001 Implant - Goserelin 12/01/2021
Zoton FasTab 15 mg Imbat Limited PPA1151/003/005 Orodispersible tablet - Lansoprazole 12/01/2021
orodispersible tablets
Interchangeable List Code:
IC0008-032-033
Zoton FasTab 30 mg Imbat Limited PPA1151/003/003 Orodispersible tablet - Lansoprazole 12/01/2021
orodispersible tablets
Interchangeable List Code:
IC0008-033-033
Zovirax 5% w/w Cream Imbat Limited PPA1151/028/001 Cream - ACICLOVIR 12/01/2021
Zydol 50 mg Capsules Imbat Limited PPA1151/031/001 Capsule, hard - Tramadol hydrochloride 12/01/2021

Interchangeable List Code:


IC0074-023-008
VIRAFERONPEG Merck Sharp & Dohme BV EU/1/00/132/001 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/002 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/004 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
Viraferonpeg Merck Sharp & Dohme BV EU/1/00/132/005 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
Viraferonpeg Merck Sharp & Dohme BV EU/1/00/132/006 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/007 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/008 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/009 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/010 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
suspension for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/011 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/012 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/013 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/014 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/015 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/016 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/017 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
suspension for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/018 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/019 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/020 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
suspension for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/021 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/022 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/023 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
ViraferonPeg Merck Sharp & Dohme BV EU/1/00/132/024 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
solution for injection
VIRAFERONPEG 2B Merck Sharp & Dohme BV EU/1/00/132/031 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
50MCG / 0.5 ML 50 MCG solution for injection
AMPOULE

Human Medicines Withdrawn Products Page 32 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ViraferonPeg 2b 50mcg / 0.5 Merck Sharp & Dohme BV EU/1/00/132/034 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
ml 50mcg ampoule solution for injection
ViraferonPeg 2b 50mcg / Merck Sharp & Dohme BV EU/1/00/132/033 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
0.5ml 50mcg ampoule solution for injection
ViraferonPeg 2b 50mcg/0.5 Merck Sharp & Dohme BV EU/1/00/132/032 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
ml 50mcg ampoule solution for injection
ViraferonPeg 2b 80mcg / 0.5 Merck Sharp & Dohme BV EU/1/00/132/035 Powder and solvent for - Peginterferon alfa-2b 11/01/2021
ml 80 mcg ampoule solution for injection
Piriton 4mg Tablets Imbat Limited PPA1151/266/001 Tablet - CHLORPHENIRAMINE 08/01/2021
MALEATE
Proscar 5 mg film-coated Imbat Limited PPA1151/043/001 Film-coated tablet - Finasteride 08/01/2021
tablets
Provigil 100 mg Tablets Imbat Limited PPA1151/267/001 Tablet - Modafinil 08/01/2021
Prozac 20 mg hard capsules Imbat Limited PPA1151/221/001 Capsule, hard - Fluoxetine 08/01/2021

Interchangeable List Code:


IC0075-003-001
Prozac 20mg hard capsules LTT Pharma Limited PPA1562/091/001 Capsule, hard - FLUOXETINE 08/01/2021
HYDROCHLORIDE
Interchangeable List Code:
IC0075-003-001
RISPERDAL CONSTA 25 Imbat Limited PPA1151/247/001 Powder and solvent for - Risperidone 08/01/2021
mg powder and solvent for suspension for injection
prolonged-release
suspension for intramuscular
injection
RISPERDAL CONSTA 37.5 Imbat Limited PPA1151/247/002 Powder and solvent for - Risperidone 08/01/2021
mg powder and solvent for suspension for injection
prolonged-release
suspension for intramuscular
injection
RISPERDAL CONSTA 50 Imbat Limited PPA1151/247/003 Powder and solvent for - Risperidone 08/01/2021
mg powder and solvent for suspension for injection
prolonged-release
suspension for intramuscular
injection
Salamol CFC-Free Inhaler Imbat Limited PPA1151/074/001 Pressurised inhalation, - Salbutamol 08/01/2021
100 micrograms Pressurised suspension
Inhalation, Suspension Interchangeable List Code:
IC0078-138-053
Salamol Easi-Breathe CFC- Imbat Limited PPA1151/074/002 Pressurised inhalation, - SALBUTAMOL SULFATE 08/01/2021
Free Inhaler 100 micrograms suspension
Pressurised Inhalation,
Suspension
Scheriproct 1.5 mg/g + 5 Imbat Limited PPA1151/123/001 Rectal ointment - Cinchocaine Hydrochloride 08/01/2021
mg/g rectal ointment - Prednisolone
Scheriproct 1mg + 1mg Imbat Limited PPA1151/123/002 Suppository - Cinchocaine hydrochloride 08/01/2021
suppositories - Prednisolone
Senokot 7.5mg Tablets Imbat Limited PPA1151/113/001 Tablet - Senna 08/01/2021
Serc 16 mg tablets Imbat Limited PPA1151/079/001 Tablet - Betahistine dihydrochloride 08/01/2021

Interchangeable List Code:


IC0084-038-002
Seretide 100 Diskus, 50 Imbat Limited PPA1151/006/003 Inhalation powder, pre- - FLUTICASONE 08/01/2021
microgram/100 dispensed PROPIONATE
microgram/dose inhalation - SALMETEROL
powder, pre-dispensed XINAFOATE
Seretide 250 Diskus 50 Imbat Limited PPA1151/006/002 Inhalation powder - Salmeterol 08/01/2021
microgram/250 - FLUTICASONE
microgram/dose inhalation PROPIONATE
powder, pre-dispensed
Seretide 500 Diskus 50 Imbat Limited PPA1151/006/001 Inhalation powder, pre- - SALMETEROL 08/01/2021
microgram/500 dispensed XINAFOATE
microgram/dose inhalation - FLUTICASONE
powder, pre-dispensed PROPIONATE
Serevent Evohaler 25 Imbat Limited PPA1151/151/001 Pressurised inhalation, - SALMETEROL 08/01/2021
micrograms per actuation suspension XINAFOATE
pressurised inhalation
suspension
Seroquel 100mg film-coated Imbat Limited PPA1151/036/008 Film-coated tablet - Quetiapine fumarate 08/01/2021
tablets
Interchangeable List Code:
IC0019-024-003

Human Medicines Withdrawn Products Page 33 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Seroquel 200mg Film-coated Imbat Limited PPA1151/036/001 Film-coated tablet - Quetiapine fumarate 08/01/2021
tablets
Interchangeable List Code:
IC0019-067-003
Seroquel 25 mg film-coated Imbat Limited PPA1151/036/002 Film-coated tablet - Quetiapine 08/01/2021
tablets
Interchangeable List Code:
IC0019-022-003
Seroquel XR 200mg Imbat Limited PPA1151/036/005 Prolonged-release tablet - Quetiapine fumarate 08/01/2021
prolonged-release tablets
Interchangeable List Code:
IC0019-067-024
Seroquel XR 300mg Imbat Limited PPA1151/036/006 Prolonged-release tablet - Quetiapine fumarate 08/01/2021
prolonged-release tablets
Interchangeable List Code:
IC0019-029-024
Seroquel XR 400mg Imbat Limited PPA1151/036/007 Prolonged-release tablet - Quetiapine fumarate 08/01/2021
prolonged-release tablets
Interchangeable List Code:
IC0019-068-024
Seroquel XR 50mg Imbat Limited PPA1151/036/004 Prolonged-release tablet - Quetiapine fumarate 08/01/2021
prolonged-release tablets
Interchangeable List Code:
IC0019-023-024
Seroxat 20 mg Film-coated Imbat Limited PPA1151/034/001 Film-coated tablet - Paroxetine hydrochloride 08/01/2021
Tablets hemihydrate
Interchangeable List Code:
IC0076-003-003
Seroxat 30 mg film-coated Imbat Limited PPA1151/034/003 Film-coated tablet - Paroxetine hydrochloride 08/01/2021
tablets
Interchangeable List Code:
IC0076-033-003
Sinemet CR 50mg/200mg Imbat Limited PPA1151/001/001A Prolonged-release tablet - Carbidopa 08/01/2021
Prolonged-Release Tablets - Levodopa
Sinemet Plus 25mg/100mg Imbat Limited PPA1151/001/003 Tablet - Carbidopa 08/01/2021
Tablets - Levodopa
SINGULAIR 10mg film- Imbat Limited PPA1151/203/003 Film-coated tablet - Montelukast 08/01/2021
coated tablets
Interchangeable List Code:
IC0023-002-003
Singulair Paediatric 4mg Imbat Limited PPA1151/203/001 Chewable tablet - Montelukast sodium 08/01/2021
chewable tablets
Interchangeable List Code:
IC0023-008-007
Singulair Paediatric 5 mg Imbat Limited PPA1151/203/002 Chewable tablet - Montelukast sodium 08/01/2021
chewable tablets
Interchangeable List Code:
IC0023-001-007
Solian 100mg Tablets Imbat Limited PPA1151/129/003 Tablet - Amisulpride 08/01/2021
Solian 200mg Tablets Imbat Limited PPA1151/129/001 Tablet - Amisulpride 08/01/2021
Solian 50mg Tablets Imbat Limited PPA1151/129/002 Tablet - Amisulpride 08/01/2021
Solpadol 500mg/30mg Imbat Limited PPA1151/191/002 Effervescent tablet - Codeine phosphate 08/01/2021
Effervescent Tablets hemihydrate
- Paracetamol
Solpadol Caplets Imbat Limited PPA1151/191/001 Tablet - Paracetamol 08/01/2021
500mg/30mg Tablets - Codeine phosphate
hemihydrate
Stilnoct 10mg Film-coated Imbat Limited PPA1151/030/001 Film-coated tablet - ZOLPIDEM TARTRATE 08/01/2021
Tablets
Stilnoct 5 mg Film-Coated Imbat Limited PPA1151/030/002 Tablet - ZOLPIDEM TARTRATE 08/01/2021
Tablets
Symbicort Turbohaler 200 Imbat Limited PPA1151/152/002 Inhalation powder - Formoterol fumatrate 08/01/2021
micrograms/6 dihydrate
micrograms/inhalation, - Budesonide
inhalation powder
Symbicort Turbohaler, 400 Imbat Limited PPA1151/152/003 Inhalation powder - Budesonide 08/01/2021
micrograms/12 - Formoterol fumatrate
micrograms/inhalation, dihydrate
inhalation powder
Telfast 120mg film-coated Imbat Limited PPA1151/080/001 Film-coated tablet - Fexofenadine hydrochloride 08/01/2021
tablets
Telfast 180mg film-coated Imbat Limited PPA1151/080/002 Film-coated tablet - Fexofenadine hydrochloride 08/01/2021
Tablets
Traxam 3% w/w Gel Imbat Limited PPA1151/081/001 Gel - Felbinac 08/01/2021
Versatis 5% medicated LTT Pharma Limited PPA1562/097/001 Medicated plaster - Lidocaine 08/01/2021
plaster

Human Medicines Withdrawn Products Page 34 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Voltarol 1%w/w Emulgel Imbat Limited PPA1151/069/001 Gel - Diclofenac sodium (as 08/01/2021
diclofenac diethylammonium)
Interchangeable List Code:
IC0056-115-043
Xalatan 50 micrograms/ml Imbat Limited PPA1151/075/001 Eye drops, solution - Latanoprost 08/01/2021
eye drops, solution
Interchangeable List Code:
IC0096-152-045
Zimovane 7.5mg Film-coated Imbat Limited PPA1151/008/001 Film-coated tablet - Zopiclone 08/01/2021
Tablets
Interchangeable List Code:
IC0055-041-003
Acerycal 10mg/10mg Tablets LTT Pharma Limited PPA1562/071/004 Tablet - Perindopril arginine 07/01/2021
- Amlodipine besylate
Interchangeable List Code:
IC0041-017-002
Acerycal 10mg/5mg Tablets LTT Pharma Limited PPA1562/071/003 Tablet - Perindopril arginine 07/01/2021
- Amlodipine besylate
Interchangeable List Code:
IC0041-016-002
Acerycal 5mg/10mg Tablets LTT Pharma Limited PPA1562/071/002 Tablet - Perindopril arginine 07/01/2021
- Amlodipine besylate
Interchangeable List Code:
IC0041-013-002
Acerycal 5mg/5mg Tablets LTT Pharma Limited PPA1562/071/001 Tablet - Perindopril arginine 07/01/2021
- Amlodipine besylate
Interchangeable List Code:
IC0041-012-002
Imodium Plus 2mg/125mg Imbat Limited PPA1151/112/001 Tablet - Dimethicone 07/01/2021
Tablets - Loperamide Hydrochloride
Implanon NXT 68 mg implant Imbat Limited PPA1151/094/001 Implant - Etonogestrel 07/01/2021
for subdermal use
Imuran Film-coated Tablets Imbat Limited PPA1151/039/001 Film-coated tablet - Azathioprine 07/01/2021
50 mg
innohep 10,000 IU in 0.5 ml, Imbat Limited PPA1151/265/002 Solution for injection - Tinzaparin sodium 07/01/2021
solution for injection
innohep 14,000 IU in 0.7 ml, Imbat Limited PPA1151/265/003 Solution for injection - Tinzaparin sodium 07/01/2021
solution for injection
innohep 18,000 IU in 0.9 ml, Imbat Limited PPA1151/265/004 Solution for injection - Tinzaparin sodium 07/01/2021
solution for injection
innohep 4,500 IU solution for Imbat Limited PPA1151/265/001 Solution for injection - Tinzaparin sodium 07/01/2021
injection
Inspra 25 mg film-coated Imbat Limited PPA1151/132/001 Film-coated tablet - Eplerenone 07/01/2021
tablets
Interchangeable List Code:
IC0115-022-003
Inspra 50 mg film-coated Imbat Limited PPA1151/132/002 Film-coated tablet - Eplerenone 07/01/2021
tablets
Interchangeable List Code:
IC0115-023-003
Istin 10mg Tablets Imbat Limited PPA1151/010/002 Tablet - Amlodipine besylate 07/01/2021

Interchangeable List Code:


IC0045-002-008
Istin 5mg Tablets Imbat Limited PPA1151/010/001 Tablet - Amlodipine besylate 07/01/2021

Interchangeable List Code:


IC0045-001-008
Kalcipos-D forte 500 mg/800 Imbat Limited PPA1151/162/001 Chewable tablet - Cholecalciferol 07/01/2021
IU chewable tablets - Calcium
Keflex 250 mg hard capsules Imbat Limited PPA1151/166/001 Capsule, hard - Cefalexin 07/01/2021

Keflex 500 mg film-coated Imbat Limited PPA1151/166/002 Film-coated tablet - Cefalexin 07/01/2021
tablets
Konverge 40 mg/10 mg film- Imbat Limited PPA1151/255/002 Film-coated tablet - Amlodipine besylate 07/01/2021
coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0046-093-003
Konverge 40 mg/5 mg film- Imbat Limited PPA1151/255/001 Film-coated tablet - Amlodipine besylate 07/01/2021
coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0046-094-003
Lamictal 100 mg Imbat Limited PPA1151/115/003 Dispersible tablet - Lamotrigine 07/01/2021
Dispersible/Chewable
Tablets
Lamictal 100mg tablets Imbat Limited PPA1151/115/008 Tablet - Lamotrigine 07/01/2021

Human Medicines Withdrawn Products Page 35 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Lamictal 200 mg Dispersible Imbat Limited PPA1151/115/004 Dispersible tablet - Lamotrigine 07/01/2021
Chewable Tablets
Lamictal 200mg tablets Imbat Limited PPA1151/115/009 Tablet - Lamotrigine 07/01/2021
Lamictal 25mg Imbat Limited PPA1151/115/001 Dispersible tablet - Lamotrigine 07/01/2021
dispersible/chewable tablets
Lamictal 25mg tablets Imbat Limited PPA1151/115/006 Tablet - Lamotrigine 07/01/2021
Lamictal 50mg Imbat Limited PPA1151/115/002 Dispersible tablet - Lamotrigine 07/01/2021
Dispersible/Chewable Tablet

Lamictal 50mg Tablets Imbat Limited PPA1151/115/007 Tablet - Lamotrigine 07/01/2021


Lamictal 5mg Imbat Limited PPA1151/115/005 Dispersible tablet - Lamotrigine 07/01/2021
dispersible/chewable tablets
Lamisil 1% w/w Cream Imbat Limited PPA1151/029/002 Cream - TERBINAFINE 07/01/2021
HYDROCHLORIDE
Lamisil 250mg Tablets Imbat Limited PPA1151/029/001 Tablet - TERBINAFINE 07/01/2021
HYDROCHLORIDE
Levocetirizine 5 mg Film- Imbat Limited PPA1151/149/001 Film-coated tablet - Levocetirizine 07/01/2021
Coated Tablets dihydrochloride
Interchangeable List Code:
IC0095-001-003
Lipantil Supra 145 mg film- Imbat Limited PPA1151/180/001 Film-coated tablet - Fenofibrate 07/01/2021
coated tablets
Loceryl 5% w/v Medicated Imbat Limited PPA1151/214/001 Medicated nail lacquer - Amorolfine 07/01/2021
Nail Lacquer
Logynon Tablets Imbat Limited PPA1151/218/001 Tablet - Levonorgestrel 07/01/2021
- Ethinylestradiol
- Ethinylestradiol
- Levonorgestrel
- Levonorgestrel
Mezavant XL 1200mg gastro- Imbat Limited PPA1151/153/001 Prolonged-release tablet - Mesalazine 07/01/2021
resistant, prolonged release
tablets
Minocin SA. 100 mg Modified Imbat Limited PPA1151/088/001 Capsule - Minocycline hydrochloride 07/01/2021
Release Capsules dihydrate
Minox 50 mg Film-Coated Imbat Limited PPA1151/138/001 Film-coated tablet - MINOCYCLINE 07/01/2021
Tablets HYDROCHLORIDE
Mirena 52 mg Intrauterine Imbat Limited PPA1151/262/001 Intrauterine delivery system - Levonorgestrel 07/01/2021
Delivery System
Movicol 13.8g sachet, Imbat Limited PPA1151/089/001 Powder for oral solution - Macrogol 35000 07/01/2021
powder for oral solution - Sodium bicarbonate
- Sodium chloride
- Potassium chloride
Movicol Chocolate 13.9g Imbat Limited PPA1151/089/002 Powder for oral solution - Potassium chloride 07/01/2021
sachet, powder for oral - Sodium hydrogen
solution carbonate
- Sodium chloride
- Macrogol 3350
Movicol Paediatric Plain 6.9 g Imbat Limited PPA1151/089/003 Powder for oral solution - Potassium chloride 07/01/2021
sachet, powder for oral - Sodium hydrogen
solution carbonate (E500)
- Macrogol 3350
- Sodium chloride
Mycostatin 100,000 units/ml Imbat Limited PPA1151/068/001 Oral suspension - Nystatin 07/01/2021
Oral Suspension (Ready-
Mixed)
Nasonex 50 Imbat Limited PPA1151/062/001 Nasal spray, suspension - Mometasone furoate 07/01/2021
micrograms/actuation Nasal
Spray, Suspension
NATRILIX SR 1.5mg Imbat Limited PPA1151/096/001 Prolonged-release tablet - Indapamide 07/01/2021
prolonged-release film-
coated Tablets
NEBILET 5 mg tablets Imbat Limited PPA1151/083/001 Tablet - Nebivolol hydrochloride 07/01/2021

Interchangeable List Code:


IC0082-001-002
Neurontin 100 mg hard Imbat Limited PPA1151/224/001 Capsule, hard - Gabapentin 07/01/2021
capsules
Interchangeable List Code:
IC0109-024-001
Neurontin 300 mg hard Imbat Limited PPA1151/224/002 Capsule, hard - Gabapentin 07/01/2021
capsules
Interchangeable List Code:
IC0109-029-001

Human Medicines Withdrawn Products Page 36 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Nexium 20 mg Gastro- Imbat Limited PPA1151/017/001 Gastro-resistant tablet - Esomeprazole 07/01/2021
resistant Tablets
Interchangeable List Code:
IC0004-003-016
Nexium 40 mg Gastro- Imbat Limited PPA1151/017/002 Gastro-resistant tablet - Esomeprazole magnesium 07/01/2021
resistant Tablets trihydrate
Interchangeable List Code:
IC0004-004-016
Nicorette 2mg Medicated Imbat Limited PPA1151/106/001 Medicated chewing-gum - Nicotine 07/01/2021
Chewing Gum
Nicorette 4mg Medicated Imbat Limited PPA1151/106/002 Medicated chewing-gum - Nicotine 07/01/2021
Chewing Gum
Nicorette Freshmint 2mg Imbat Limited PPA1151/106/003 Medicated chewing-gum - Nicotine 07/01/2021
Medicated Chewing Gum
Nicorette Freshmint 4mg Imbat Limited PPA1151/106/004 Medicated chewing-gum - Nicotine 07/01/2021
Medicated Chewing Gum
Nizoral 20mg/g Shampoo Imbat Limited PPA1151/093/001 Shampoo - Ketoconazole 07/01/2021
Noctamid 1mg Tablets Imbat Limited PPA1151/192/001 Tablet - Lormetazepam 07/01/2021
Non-drowsy Sinutab Imbat Limited PPA1151/114/001 Tablet - Paracetamol 07/01/2021
TabletsParacetamol - PSEUDOEPHEDRINE
500mgPseudoephedrine HYDROCHLORIDE
hydrochloride 30mg
Non-Drowsy Sudafed Imbat Limited PPA1151/131/001 Film-coated tablet - PSEUDOEPHEDRINE 07/01/2021
Decongestant 60mg Film- HYDROCHLORIDE
Coated Tablets
Noriday 350 micrograms Imbat Limited PPA1151/220/001 Tablet - Norethisterone 07/01/2021
tablet
NorLevo 1.5 mg tablet Imbat Limited PPA1151/177/001 Tablet - Levonorgestrel 07/01/2021
Nurofen 200 mg Coated Imbat Limited PPA1151/245/001 Coated tablet - Ibuprofen 07/01/2021
Tablets
Nurofen Cold & Flu Film- Imbat Limited PPA1151/261/001 Film-coated tablet - PSEUDOEPHEDRINE 07/01/2021
Coated TabletsIbuprofen HYDROCHLORIDE
200mgPseudoephedrine - Ibuprofen
hydrochloride 30mg
Nurofen Express Maximum Imbat Limited PPA1151/270/001 Tablet - Ibuprofen 07/01/2021
Strength 400 mg Tablets
Nurofen for Children Orange Imbat Limited PPA1151/196/001 Oral suspension - Ibuprofen 07/01/2021
100mg/5ml Oral Suspension

Nurofen Plus Tablets Imbat Limited PPA1151/126/001 Film-coated tablet - Codeine phosphate 07/01/2021
Ibuprofen 200mg Codeine hemihydrate
Phosphate Hemihydrate - Ibuprofen
12.8mg
Nu-Seals 75mg Gastro- Imbat Limited PPA1151/012/001 Gastro-resistant tablet - Acetylsalicylic acid 07/01/2021
resistant Tablets
Omesar 10 mg film-coated Imbat Limited PPA1151/154/002 Film-coated tablet - Olmesartan medoxomil 07/01/2021
tablets
Interchangeable List Code:
IC0105-002-003
Omesar 20 mg film-coated Imbat Limited PPA1151/154/003 Film-coated tablet - Olmesartan medoxomil 07/01/2021
tablets
Interchangeable List Code:
IC0105-003-003
Omnexel, 400 micrograms, Imbat Limited PPA1151/020/001 Prolonged-release tablet - Tamsulosin hydrochloride 07/01/2021
prolonged release tablets,
film-coated Interchangeable List Code:
IC0024-066-024
One-Alpha 0.25 micrograms Imbat Limited PPA1151/116/001 Capsule, soft - Alfacalcidol 07/01/2021
soft capsules
Osteofos D3 1200mg/800 Imbat Limited PPA1151/147/001 Powder for oral suspension - Calcium phosphate 07/01/2021
I.U. powder for oral - Cholecalciferol
suspension

Human Medicines Withdrawn Products Page 37 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Pharmaton Capsules LTT Pharma Limited PPA1562/081/001 Capsule, soft - Nicotinamide 07/01/2021
- Thiamine nitrate
- Zinc sulphate
- Pyridoxine hydrochloride
- D,1-a-tocopherol
- Cholecalciferol
- Anhydrous dibasic calcium
phosphate
- Ascorbic acid
- Folic acid
- Riboflavin
- Copper sulfate
- Biotin
- Vitamin a palmitate
- Lecithin
- Cyanocobalamin
- Sodium selenite
- Magnesium sulfate dried
- Ferrous sulphate
- Panax ginseng extract
Pharmaton Capsules Imbat Limited PPA1151/040/001 Capsule, soft - Vitamin a palmitate 07/01/2021
- Copper sulphate
- Iron sulphate
- Biotin
- Lecithin
- Sodium selenite
- Thiamine mononitrate
- Panax ginseng extract
- Magnesium sulfate
- Manganese sulphate
- Calcium phosphate
- Tocopheryl acetate-d-alpha
- Nicotinamide
- Zinc sulphate
- Pyridoxine hydrochloride
- Cholecalciferol
- Ascorbic acid
- Folic acid
- Riboflavin
- Cyanocobalamin

Prevenelle 1500 microgram Imbat Limited PPA1151/249/001 Tablet - Levonorgestrel 07/01/2021


Tablet
Vesitirim 5 mg film-coated LTT Pharma Limited PPA1562/086/001 Film-coated tablet - Solifenacin succinate 07/01/2021
tablets
Interchangeable List Code:
IC0116-001-003
Avodart 0.5mg Soft Capsules IMED Healthcare Ltd. PPA1463/038/001 Capsule, soft - Dutasteride 06/01/2021

Bactroban Nasal Ointment Imbat Limited PPA1151/169/001 Nasal ointment - Mupirocin calcium 06/01/2021
2.0% w/w
Calcichew-D3 Forte Imbat Limited PPA1151/155/001 Chewable tablet - Cholecalciferol 06/01/2021
Chewable Tablets, calcium - Calcium carbonate
carbonate / colecalciferol
equivalent to 500mg Calcium
/ 400 IU colecalciferol

Cardura XL 8mg Prolonged- Imbat Limited PPA1151/022/002 Prolonged-release tablet - DOXAZOSIN MESILATE 06/01/2021
release tablets
Interchangeable List Code:
IC0021-009-024
Casodex 50 mg Film-coated Imbat Limited PPA1151/104/001 Film-coated tablet - Bicalutamide 06/01/2021
Tablets
Celebrex 200mg Hard Imbat Limited PPA1151/070/001 Capsule - Celecoxib 06/01/2021
Capsules
Clindamycin 150 mg/ml Imbat Limited PPA1151/156/001 Solution for injection/infusion - CLINDAMYCIN 06/01/2021
solution for injection or PHOSPHATE
infusion
Colofac 135mg tablets Imbat Limited PPA1151/122/001 Coated tablet - MEBEVERINE 06/01/2021
HYDROCHLORIDE
Colpermin IBS Relief Imbat Limited PPA1151/087/001 Gastro-resistant capsule, - Peppermint oil 06/01/2021
Capsules hard
Concerta XL 18 mg Imbat Limited PPA1151/243/001 Prolonged-release tablet - Methylphenidate 06/01/2021
prolonged-release tablets hydrochloride
Concerta XL 27 mg Imbat Limited PPA1151/243/002 Prolonged-release tablet - Methylphenidate 06/01/2021
prolonged-release tablets hydrochloride

Human Medicines Withdrawn Products Page 38 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Concerta XL 36 mg Imbat Limited PPA1151/243/003 Prolonged-release tablet - Methylphenidate 06/01/2021
prolonged-release tablets hydrochloride
Cordarone X 100mg Tablets Imbat Limited PPA1151/084/001 Tablet - AMIODARONE 06/01/2021
HYDROCHLORIDE
Cordarone X 200mg Tablets Imbat Limited PPA1151/084/002 Tablet - AMIODARONE 06/01/2021
HYDROCHLORIDE
Cosopt 20 mg/ml + 5 mg/ml Imbat Limited PPA1151/159/001 Eye drops, solution - Timolol 06/01/2021
eye drops, solution - Dorzolamide
Cozaar 100mg Film-Coated Imbat Limited PPA1151/005/002 Film-coated tablet - Losartan potassium 06/01/2021
Tablets
Interchangeable List Code:
IC0003-024-003
Cozaar 50 mg Film-Coated Imbat Limited PPA1151/005/001 Film-coated tablet - Losartan potassium 06/01/2021
Tablets
Interchangeable List Code:
IC0003-023-003
Creon 10000 Gastro- IMED Healthcare Ltd. PPA1463/033/001 Gastro-resistant capsule, - Pancreatin 06/01/2021
resistant Capsules hard
Creon 25000 Gastro- Imbat Limited PPA1151/065/002 Gastro-resistant capsule, - Pancreatin 06/01/2021
resistant Capsules hard
Crestor 10 mg film-coated Imbat Limited PPA1151/044/002 Film-coated tablet - Rosuvastatin 06/01/2021
tablets
Interchangeable List Code:
IC0006-002-003
Crestor 20 mg film-coated Imbat Limited PPA1151/044/001 Film-coated tablet - Rosuvastatin 06/01/2021
tablets
Interchangeable List Code:
IC0006-003-003
Crestor 40 mg film-coated Imbat Limited PPA1151/044/004 Film-coated tablet - Rosuvastatin 06/01/2021
tablets
Interchangeable List Code:
IC0006-004-003
Crestor 5 mg film-coated Imbat Limited PPA1151/044/003 Film-coated tablet - Rosuvastatin 06/01/2021
tablets
Interchangeable List Code:
IC0006-001-003
Crinone 8% w/w Imbat Limited PPA1151/235/001 Vaginal gel - Progesterone 06/01/2021
progesterone vaginal gel
Cystopurin 3g Granules for Imbat Limited PPA1151/144/001 Granules for oral solution - Potassium citrate 06/01/2021
Oral Solution
Deltacortril Enteric 5mg Imbat Limited PPA1151/213/001 Gastro-resistant tablet - Prednisolone 06/01/2021
gastro-resistant tablets
Detrusitol 1mg Film-coated Imbat Limited PPA1151/158/001 Film-coated tablet - Tolterodine tartrate 06/01/2021
Tablets
Interchangeable List Code:
IC0025-039-003
Detrusitol 2 mg film-coated Imbat Limited PPA1151/158/002 Film-coated tablet - Tolterodine tartare 06/01/2021
tablets
Interchangeable List Code:
IC0025-006-003
Detrusitol SR 4 mg, Imbat Limited PPA1151/164/001 Capsule - Tolterodine tartrate 06/01/2021
prolonged-release capsules,
hard Interchangeable List Code:
IC0025-008-032
Diamicron 80mg Tablets Imbat Limited PPA1151/026/002 Tablet - Gliclazide 06/01/2021
Diamicron MR 30 mg tablets Imbat Limited PPA1151/026/001 Modified-release tablet - Gliclazide 06/01/2021

Interchangeable List Code:


IC0086-033-050
Dianette 2 mg/35 microgram Imbat Limited PPA1151/181/001 Film-coated tablet - CYPROTERONE 06/01/2021
coated tablets ACETATE
- Ethinylestradiol
Differin 0.1% w/w Gel Imbat Limited PPA1151/198/002 Gel - Adapalene 06/01/2021
Diovan 160mg Film-coated Imbat Limited PPA1151/067/002 Film-coated tablet - Valsartan 06/01/2021
Tablets
Interchangeable List Code:
IC0038-082-003
Diovan 40mg film-coated Imbat Limited PPA1151/067/003 Film-coated tablet - Valsartan 06/01/2021
tablets
Interchangeable List Code:
IC0038-004-003
Diovan 80mg Film-coated Imbat Limited PPA1151/067/001 Film-coated tablet - Valsartan 06/01/2021
Tablets
Interchangeable List Code:
IC0038-005-003
Dolmatil 200 mg tablets Imbat Limited PPA1151/183/001 Tablet - Sulpiride 06/01/2021

Human Medicines Withdrawn Products Page 39 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Dona 1500mg Powder for Imbat Limited PPA1151/056/001 Powder for oral solution - Glucosamine sulfate as 06/01/2021
Oral Solution crystalline glucosamine
sulfate
Dovobet 50 microgram/g + Imbat Limited PPA1151/053/001 Ointment - Calcipotriol 06/01/2021
0.5 mg/g ointment - BETAMETHASONE
DIPROPIONATE
Dulcolax 5 mg Tablets Imbat Limited PPA1151/045/001 Gastro-resistant tablet - Bisacodyl 06/01/2021
Durogesic DTrans 100 Imbat Limited PPA1151/252/004 Transdermal patch - Fentanyl 06/01/2021
micrograms/hour transdermal
patch
Durogesic DTrans 25 Imbat Limited PPA1151/252/003 Transdermal patch - Fentanyl 06/01/2021
micrograms/hour transdermal
patch
Durogesic DTrans 50 Imbat Limited PPA1151/252/001 Transdermal patch - Fentanyl 06/01/2021
micrograms/hour transdermal
patch
Durogesic DTrans 75 Imbat Limited PPA1151/252/002 Transdermal patch - Fentanyl 06/01/2021
micrograms/hour transdermal
patch
Dymista 137 micrograms / 50 IMED Healthcare Ltd. PPA1463/114/001 Nasal spray, suspension - Azelastine hydrochloride 06/01/2021
micrograms per actuation, - FLUTICASONE
Nasal Spray Suspension PROPIONATE

Efexor XL 150 mg IMED Healthcare Ltd. PPA1463/146/002 Prolonged-release capsule, - Venlafaxine 06/01/2021
prolonged-release capsules, hard
hard Interchangeable List Code:
IC0026-062-030
Efexor XL 75 mg prolonged- IMED Healthcare Ltd. PPA1463/146/001 Prolonged-release capsule, - Venlafaxine 06/01/2021
release capsules, hard hard
Interchangeable List Code:
IC0026-028-030
Elantan LA 25 mg Prolonged Imbat Limited PPA1151/078/002 Prolonged-release capsule, - ISOSORBIDE 06/01/2021
Release Capsules, hard hard MONONITRATE

Elantan LA 50mg Prolonged- Imbat Limited PPA1151/078/001 Prolonged-release capsule, - ISOSORBIDE 06/01/2021
Release Capsules, hard hard MONONITRATE

Epanutin 100mg Hard Imbat Limited PPA1151/165/001 Capsule, hard - PHENYTOIN SODIUM 06/01/2021
Capsules
Ezetrol 10 mg Tablets Imbat Limited PPA1151/256/001 Tablet - Ezetimibe 06/01/2021

Interchangeable List Code:


IC0104-002-002
Ferrograd C 325mg/500mg Imbat Limited PPA1151/141/001 Prolonged-release tablet - Dried ferrous sulphate 06/01/2021
Prolonged release Tablets - Vitamin c
Fucidin 20mg/g Cream Imbat Limited PPA1151/086/001 Cream - Fusidic acid 06/01/2021
Hay-Crom 2% w/v Aqueous Imbat Limited PPA1151/120/001 Eye drops, solution - Sodium cromoglicate 06/01/2021
Eye Drops, Solution
IDEOS 500mg/400 IU Imbat Limited PPA1151/202/001 Chewable tablet - Cholecalciferol 06/01/2021
Chewable Tablets - Calcium carbonate
Ikorel 10 mg Tablets Imbat Limited PPA1151/160/001 Tablet - Nicorandil 06/01/2021
Ikorel 20 mg Tablets Imbat Limited PPA1151/160/002 Tablet - Nicorandil 06/01/2021
Imdur 60 mg Prolonged- Imbat Limited PPA1151/027/001 Prolonged-release tablet - ISOSORBIDE 06/01/2021
release Tablets MONONITRATE
Imigran Ftab 100mg Film- Imbat Limited PPA1151/248/001 Film-coated tablet - Sumatriptan succinate 06/01/2021
coated tablets
Losec MUPS 20 mg gastro- IMED Healthcare Ltd. PPA1463/123/001 Gastro-resistant tablet - Omeprazole 06/01/2021
resistant tablets
Interchangeable List Code:
IC0010-003-016
Nexium 20 mg gastro- LTT Pharma Limited PPA1562/065/001 Gastro-resistant tablet - Esomeprazole magnesium 06/01/2021
resistant tablets trihydrate
Interchangeable List Code:
IC0004-003-016
Nexium 40 mg gastro- LTT Pharma Limited PPA1562/065/002 Gastro-resistant tablet - Esomeprazole magnesium 06/01/2021
resistant tablets trihydrate
Interchangeable List Code:
IC0004-004-016
Spiriva 18 microgram IMED Healthcare Ltd. PPA1463/044/001 Inhalation powder, hard - Tiotropium 06/01/2021
inhalation powder, hard capsule
capsule
Spiriva Respimat 2.5 IMED Healthcare Ltd. PPA1463/044/002 Inhalation solution - Tiotropium 06/01/2021
microgram, solution for
inhalation
Ursofalk 250 mg hard IMED Healthcare Ltd. PPA1463/056/001 Capsule, hard - Ursodeoxycholic acid 06/01/2021
capsules

Human Medicines Withdrawn Products Page 40 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VIMOVO 500 mg/20 mg IMED Healthcare Ltd. PPA1463/122/001 Modified-release tablet - Esomeprazole 06/01/2021
modified-release tablets - Naproxen
Interchangeable List Code:
IC0027-049-021
Zantac 150mg Film-coated IMED Healthcare Ltd. PPA1463/003/001 Film-coated tablet - Ranitidine 06/01/2021
Tablets.
Interchangeable List Code:
IC0087-062-051
Augmentin 250 mg/125 mg Imbat Limited PPA1151/050/001 Film-coated tablet - Amoxicillin 05/01/2021
Film-Coated Tablets - Clavulanic acid
Interchangeable List Code:
IC0037-074-003
Augmentin 500 mg/125 mg Imbat Limited PPA1151/050/003 Film-coated tablet - Amoxicillin trihydrate 05/01/2021
Film-coated Tablets - Potassium clavulanate
Interchangeable List Code:
IC0037-073-003
Augmentin-Duo 400 mg/57 Imbat Limited PPA1151/050/002 Powder for oral suspension - CLAVULANATE 05/01/2021
mg/5 ml Powder for Oral POTASSIUM
Suspension Interchangeable List Code: - Amoxicillin trihydrate
IC0037-076-034
Becotide Evohaler 250 Imbat Limited PPA1151/204/001 Pressurised inhalation, - Beclometasone 05/01/2021
micrograms, Pressurised solution dipropionate
Inhalation Solution
Bricanyl Turbohaler 500 Imbat Limited PPA1151/175/001 Inhalation powder - TERBUTALINE SULFATE 05/01/2021
micrograms per metered
dose, inhalation powder
Brolene 0.1% w/v Eye Drops Imbat Limited PPA1151/176/001 Eye drops, solution - PROPAMIDINE 05/01/2021
Solution ISETIONATE
BuTrans 10 micrograms/hour Imbat Limited PPA1151/194/002 Transdermal patch - Buprenorphine 05/01/2021
transdermal patch

BuTrans 20 micrograms/hour Imbat Limited PPA1151/194/003 Transdermal patch - Buprenorphine 05/01/2021


transdermal patch

BuTrans 5 micrograms/hour Imbat Limited PPA1151/194/001 Transdermal patch - Buprenorphine 05/01/2021


transdermal patch
Canesten Thrush Cream Imbat Limited PPA1151/201/004 Vaginal cream - Clotrimazole 05/01/2021
Cardicor 1.25mg Film-coated Imbat Limited PPA1151/048/001 Film-coated tablet - BISOPROLOL FUMARATE 05/01/2021
tablets
Interchangeable List Code:
IC0065-044-014
Cardicor 10mg Film-coated Imbat Limited PPA1151/048/006 Film-coated tablet - Bisoprolol hemifumarate 05/01/2021
tablets
Interchangeable List Code:
IC0065-002-014
Cardicor 2.5 mg Film-Coated Imbat Limited PPA1151/048/002 Film-coated tablet - Bisoprolol hemifumarate 05/01/2021
Tablets
Interchangeable List Code:
IC0065-018-014
Cardicor 3.75mg Film-coated Imbat Limited PPA1151/048/003 Film-coated tablet - Bisoprolol hemifumarate 05/01/2021
tablets
Interchangeable List Code:
IC0065-108-014
Cardicor 5mg Film-coated Imbat Limited PPA1151/048/004 Film-coated tablet - Bisoprolol hemifumarate 05/01/2021
tablets
Interchangeable List Code:
IC0065-001-014
Cardicor 7.5mg Film-coated Imbat Limited PPA1151/048/005 Film-coated tablet - Bisoprolol hemifumarate 05/01/2021
tablets
Interchangeable List Code:
IC0065-041-003
Ictastan 200 mg/245 mg film- Accord Healthcare Ireland PA2315/153/001 Film-coated tablet - Emtricitabine 05/01/2021
coated tablets Ltd. - Tenofovir disoproxil
Interchangeable List Code:
IC0107-165-003
Hibiscrub 4.0% w/v Regent Medical Overseas PA1218/001/001 Cutaneous solution - Chlorhexidine gluconate 01/01/2021
Cutaneous Solution Limited
Sterets Tisept Sachets Medlock Medical Ltd PA1175/014/001 Cutaneous solution - Chlorhexidine gluconate 01/01/2021
0.015% w/v and 0.15% w/v - Cetrimide
Cutaneous Solution
Sterets Unisept 0.05% w/v Medlock Medical Ltd PA1175/015/001 Cutaneous solution - Chlorhexidine gluconate 01/01/2021
Cutaneous Solution
Celluvisc Primecrown 2010 Limited DPR1633/014/001 Ear drops, solution - Carmellose sodium 31/12/2020
Ezetrol Primecrown 2010 Limited DPR1633/019/001 Tablet - Ezetimibe 31/12/2020
Mezavant XL Primecrown 2010 Limited DPR1633/016/001 Gastro-resistant prolonged- - Mesalazine 31/12/2020
release granules

Human Medicines Withdrawn Products Page 41 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Morphine Sulfate 20mg/ml Wockhardt UK Limited PA1339/051/001 Oral solution - Morphine sulphate 31/12/2020
Oral Solution
Nexium Primecrown 2010 Limited DPR1633/018/001 Gastro-resistant tablet - Esomeprazole 31/12/2020
Nexium Primecrown 2010 Limited DPR1633/018/002 Gastro-resistant tablet - Esomeprazole 31/12/2020
Prozac Primecrown 2010 Limited DPR1633/003/001 Capsule, hard - FLUOXETINE 31/12/2020
HYDROCHLORIDE
Restandol Testocaps 40 mg Merck Sharp & Dohme PA1286/054/001 Capsule, soft - TESTOSTERONE 31/12/2020
soft capsules Ireland (Human Health) UNDECANOATE
Limited
Spiriva Respimat Primecrown 2010 Limited DPR1633/008/001 Inhalation solution - Tiotropium 31/12/2020
Tenormin 100 mg Film- AstraZeneca AB PA1019/023/003 Film-coated tablet - Atenolol 31/12/2020
coated Tablets
Tenormin 25 mg Film-coated AstraZeneca AB PA1019/023/001 Film-coated tablet - Atenolol 31/12/2020
Tablets
Tenormin 50 mg Film-coated AstraZeneca AB PA1019/023/002 Film-coated tablet - Atenolol 31/12/2020
Tablets
Tetralysal Primecrown 2010 Limited DPR1633/020/001 Capsule, hard - Lymecycline 31/12/2020
Topamax Sprinkle 50 mg Janssen-Cilag Ltd PA0748/012/009 Capsule, hard - Topiramate 31/12/2020
Hard Capsules
Sterile Sodium Chloride Macarthys Laboratories PA0274/001/001 Concentrate for solution for - Sodium chloride ph.eur. 24/12/2020
Concentrate 30 %w/v, Limited infusion
Concentrate for solution for
infusion
Humulin I KwikPen Eli Lilly Nederland B.V. PA2276/005/001 Suspension for injection - Insulin human 23/12/2020
(Isophane) 100 IU/ml
suspension for injection
Humulin M3 KwikPen Eli Lilly Nederland B.V. PA2276/006/001 Suspension for injection - Insulin human 23/12/2020
(Mixture 3) 100 IU/ml
suspension for injection
Priorix-Tetra powder and GlaxoSmithKline (Ireland) PA1077/117/003 Powder and solvent for - Live attenuated measles 23/12/2020
solvent for solution for Limited solution for injection virus (schwarz strain)
injection Measles, mumps, - Live attenuated mumps
rubella and varicella vaccine virus (rit 4385 strain)
(live) - Live attenuated rubella virus
(wistar ra 27/3 strain)
- Live attenuated varicella
virus (oka strain)
Arcoxia 120 mg film-coated LTT Pharma Limited PPA1562/080/004 Film-coated tablet - Etoricoxib 22/12/2020
tablets
Interchangeable List Code:
IC0108-167-003
Arcoxia 30 mg film-coated LTT Pharma Limited PPA1562/080/003 Film-coated tablet - Etoricoxib 22/12/2020
tablets
Interchangeable List Code:
IC0108-033-003
Arcoxia 60 mg film-coated LTT Pharma Limited PPA1562/080/001 Film-coated tablet - Etoricoxib 22/12/2020
tablets
Interchangeable List Code:
IC0108-127-003
Arcoxia 90 mg film-coated LTT Pharma Limited PPA1562/080/002 Film-coated tablet - Etoricoxib 22/12/2020
tablets
Interchangeable List Code:
IC0108-166-003
Escitotab 10 mg film-coated Genthon B.V. PA0740/011/001 Film-coated tablet - Escitalopram oxalate 22/12/2020
tablets
Interchangeable List Code:
IC0071-002-003
Escitotab 15 mg film-coated Genthon B.V. PA0740/011/002 Film-coated tablet - Escitalopram 22/12/2020
tablets
Interchangeable List Code:
IC0071-032-003
Escitotab 20 mg film-coated Genthon B.V. PA0740/011/003 Film-coated tablet - Escitalopram oxalate 22/12/2020
tablets
Interchangeable List Code:
IC0071-003-003
Proscar 5mg Film-coated LTT Pharma Limited PPA1562/072/001 Film-coated tablet - Finasteride 21/12/2020
tablets
Halimatoz Sandoz GmbH EU/1/18/1288/001-003 Solution for infusion in pre- - Adalimumab 18/12/2020
filled syringe
Halimatoz Sandoz GmbH EU/1/18/1288/004-006 Solution for injection in pre- - Adalimumab 18/12/2020
filled pen
Halimatoz Sandoz GmbH EU/1/18/1288/007 Solution for injection in pre- - Adalimumab 18/12/2020
filled syringe
Atazanavir Teva 150 mg Teva B.V. PA1986/028/001 Capsule, hard - Atazanavir sulfate 17/12/2020
Capsules, hard

Human Medicines Withdrawn Products Page 42 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Atazanavir Teva 200 mg Teva B.V. PA1986/028/002 Capsule, hard - Atazanavir sulfate 17/12/2020
Capsules, hard
Atazanavir Teva 300 mg Teva B.V. PA1986/028/003 Capsule, hard - Atazanavir sulfate 17/12/2020
Capsules, hard
Eprosartan Teva 300 mg Teva B.V. PA1986/018/001 Film-coated tablet - Eprosartan mesylate 17/12/2020
Film-coated Tablets
Eprosartan Teva 400 mg Teva B.V. PA1986/018/002 Film-coated tablet - Eprosartan mesylate 17/12/2020
Film-coated Tablets
Eprosartan Teva 600 mg Teva B.V. PA1986/018/003 Film-coated tablet - Eprosartan mesylate 17/12/2020
Film-coated Tablets
Pemetrexed Teva 100 mg Teva B.V. PA1986/005/001 Powder for concentrate for - Pemetrexed diacid 17/12/2020
Powder for Concentrate for solution for infusion
Solution for Infusion
Pemetrexed Teva 500 mg Teva B.V. PA1986/005/002 Powder for concentrate for - Pemetrexed diacid 17/12/2020
Powder for Concentrate for solution for infusion
Solution for Infusion
Prepandrix GlaxoSmithKline Biologicals EU/1/08/453/002 Emulsion for injection - Purified antigen fractions of 17/12/2020
S.A. inactivated split virions
a/indonesia/05/2005
(h5n1)/pr8-ibcdc-rg2
Prepandrix suspension and GlaxoSmithKline Biologicals EU/1/08/453/1 Emulsion for injection - Purified antigen fractions of 17/12/2020
emulsion for emulsion fo S.A. inactivated split virions
a/vietnam/1194/2004 nibrg-
14 (h5n1)
Prozac 20 mg hard capsules Eli Lilly Nederland B.V. PA2276/004/002 Capsule, hard - FLUOXETINE 17/12/2020
HYDROCHLORIDE
Interchangeable List Code:
IC0075-003-001
TCP Liquid Chefaro Ireland DAC PA1186/005/002 Cutaneous solution - Halogenated phenols 17/12/2020
AntisepticHalogenated - Phenol
Phenols 0.68% w/vPhenol
0.175% w/v
Ranitidine 150 mg/10 ml Oral Perrigo Pharma International PA22741/009/001 Oral solution - Ranitidine 15/12/2020
Solution Designated Activity Compan
Interchangeable List Code:
IC0087-144-054
Fibro-Vein 0.2% w/v Solution STD Pharmaceutical PA22778/001/005 Solution for injection - Sodium tetradecyl sulfate 14/12/2020
for Injection (Ireland) Limited
Fibro-Vein 1.0% w/v Solution STD Pharmaceutical PA22778/001/002 Solution for injection - Sodium tetradecyl sulfate 14/12/2020
for Injection (Ireland) Limited
Fibro-Vein 3.0% w/v Solution STD Pharmaceutical PA22778/001/003 Solution for injection - Sodium tetradecyl sulfate 14/12/2020
for Injection (2 ml ampoule) (Ireland) Limited

Fibro-Vein 3.0% w/v Solution STD Pharmaceutical PA22778/001/004 Solution for injection - Sodium tetradecyl sulfate 14/12/2020
for Injection (5ml vial) (Ireland) Limited

Nebivolol 10 mg tablets Medreich Plc PA22576/003/003 Tablet - Nebivolol 11/12/2020

Interchangeable List Code:


IC0082-002-002
Nebivolol 2.5 mg tablets Medreich Plc PA22576/003/001 Tablet - Nebivolol 11/12/2020
Nebivolol 5 mg tablets Medreich Plc PA22576/003/002 Tablet - Nebivolol 11/12/2020

Interchangeable List Code:


IC0082-001-002
Tadafil 10 mg Film-coated Medreich Plc PA22576/005/003 Film-coated tablet - Tadalafil 11/12/2020
Tablets
Tadafil 2.5 mg Film-coated Medreich Plc PA22576/005/001 Film-coated tablet - Tadalafil 11/12/2020
Tablets
Tadafil 20 mg Film-coated Medreich Plc PA22576/005/004 Film-coated tablet - Tadalafil 11/12/2020
Tablets
Tadafil 5 mg Film-coated Medreich Plc PA22576/005/002 Film-coated tablet - Tadalafil 11/12/2020
Tablets
Docetaxel 20mg/ml Accord Healthcare Ireland PA2315/125/001 Concentrate for solution for - Docetaxel 08/12/2020
concentrate for solution for Ltd. infusion
infusion
Entecavir 0.5 mg Film-coated Accord Healthcare Ireland PA2315/057/001 Film-coated tablet - ENTECAVIR 08/12/2020
Tablet Ltd. MONOHYDRATE
Entecavir 1 mg Film-coated Accord Healthcare Ireland PA2315/057/002 Film-coated tablet - ENTECAVIR 08/12/2020
Tablet Ltd. MONOHYDRATE
Letrozole 2.5 mg film-coated Accord Healthcare Ireland PA2315/053/001 Film-coated tablet - Letrozole 08/12/2020
tablets Ltd.
Interchangeable List Code:
IC0117-018-003

Human Medicines Withdrawn Products Page 43 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Quetiapine 100 mg Film- Accord Healthcare Ireland PA2315/191/002 Film-coated tablet - Quetiapine fumarate 08/12/2020
coated Tablets Ltd.
Interchangeable List Code:
IC0019-024-003
Quetiapine 200 mg Film- Accord Healthcare Ireland PA2315/191/004 Film-coated tablet - Quetiapine fumarate 08/12/2020
coated Tablets Ltd.
Interchangeable List Code:
IC0019-067-003
Quetiapine 25 mg Film- Accord Healthcare Ireland PA2315/191/001 Film-coated tablet - Quetiapine fumarate 08/12/2020
coated Tablets Ltd.
Interchangeable List Code:
IC0019-022-003
Quetiapine 300 mg Film- Accord Healthcare Ireland PA2315/191/005 Film-coated tablet - Quetiapine fumarate 08/12/2020
coated Tablets Ltd.
Interchangeable List Code:
IC0019-029-003
Risedronate Sodium Accord Accord Healthcare Ireland PA2315/140/005 Gastro-resistant tablet - Risedronate sodium 08/12/2020
Once a Week 35 mg gastro- Ltd.
resistant tablets
Rosuvastatin Actavis 10 mg Accord Healthcare Ireland PA2315/230/002 Film-coated tablet - Rosuvastatin 08/12/2020
film-coated tablets Ltd.
Interchangeable List Code:
IC0006-002-003
Rosuvastatin Actavis 20 mg Accord Healthcare Ireland PA2315/230/003 Film-coated tablet - Rosuvastatin 08/12/2020
film-coated tablets Ltd.
Interchangeable List Code:
IC0006-003-003
Rosuvastatin Actavis 40 mg Accord Healthcare Ireland PA2315/230/004 Film-coated tablet - Rosuvastatin 08/12/2020
film-coated tablets Ltd.
Interchangeable List Code:
IC0006-004-003
Rosuvastatin Actavis 5 mg Accord Healthcare Ireland PA2315/230/001 Film-coated tablet - Rosuvastatin (as calcium) 08/12/2020
Film-coated Tablets Ltd.
Interchangeable List Code:
IC0006-001-003
Sildenafil 100 mg film-coated Accord Healthcare Ireland PA2315/013/003 Film-coated tablet - Sildenafil 08/12/2020
tablets Ltd.
Interchangeable List Code:
IC0063-024-014
Sildenafil 25 mg film-coated Accord Healthcare Ireland PA2315/013/001 Film-coated tablet - Sildenafil 08/12/2020
tablets Ltd.
Interchangeable List Code:
IC0063-022-014
Sildenafil 50 mg film-coated Accord Healthcare Ireland PA2315/013/002 Film-coated tablet - Sildenafil 08/12/2020
tablets Ltd.
Interchangeable List Code:
IC0063-023-014
Tadalafil 10mg Film-coated Accord Healthcare Ireland PA2315/004/003 Film-coated tablet - Tadalafil 08/12/2020
Tablets Ltd.
Tadalafil 2.5mg Film-coated Accord Healthcare Ireland PA2315/004/001 Film-coated tablet - Tadalafil 08/12/2020
Tablets Ltd.
Tadalafil 20 mg Film-coated Accord Healthcare Ireland PA2315/004/004 Film-coated tablet - Tadalafil 08/12/2020
Tablets Ltd.
Tadalafil 5mg Film-coated Accord Healthcare Ireland PA2315/004/002 Film-coated tablet - Tadalafil 08/12/2020
Tablets Ltd.
Vardenafil 10 mg film-coated Accord Healthcare Ireland PA2315/073/002 Film-coated tablet - VARDENAFIL 08/12/2020
tablets Ltd. HYDROCHLORIDE
TRIHYDRATE
Vardenafil 20 mg film-coated Accord Healthcare Ireland PA2315/073/003 Film-coated tablet - VARDENAFIL 08/12/2020
tablets Ltd. HYDROCHLORIDE
TRIHYDRATE
Vardenafil 5 mg film-coated Accord Healthcare Ireland PA2315/073/001 Film-coated tablet - VARDENAFIL 08/12/2020
tablets Ltd. HYDROCHLORIDE
TRIHYDRATE
PROHANCE Bracco International B.V. PA0788/001/001 Solution for injection - Gadoteridol 07/12/2020
Saizen 8 mg click.easy Merck Serono (Ireland) PA2286/006/003 Powder and solvent for - Somatropin, recombinant 07/12/2020
powder and solvent for Limited solution for injection human growth hormone
solution for injection
Gyno-Daktarin 1200 mg Janssen-Cilag Ltd PA0748/020/002 Vaginal capsule, soft - Miconazole nitrate 03/12/2020
vaginal capsule
ZOMACTON 4 mg powder Ferring Ireland Ltd PA1009/008/002 Powder and solvent for - Somatropin 03/12/2020
and solvent for solution for solution for injection
injection
Pickles 50% w/w Ointment Optima Consumer Health PA1904/001/001 Ointment - Salicylic acid 02/12/2020
Limited

Human Medicines Withdrawn Products Page 44 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Soothake Toothache Tinctur Optima Consumer Health PA1904/004/001 Gingival solution - Clove oil 02/12/2020
Limited - LIDOCAINE
HYDROCHLORIDE
Verrugon Ointment Optima Consumer Health PA1904/002/001 Ointment - Salicylic acid 02/12/2020
Limited
Wartex Ointment Optima Consumer Health PA1904/003/001 Ointment - Salicylic acid 02/12/2020
Limited
Agrippal Suspension for Seqirus S.r.l. PA2032/001/001 Suspension for injection in - A/Guangdong- 01/12/2020
injection in pre-filled syringe, pre-filled syringe Maonan/SWL 1536/2019
Influenza Vaccine Surface (H1N1)pdm09-like strain
Antigen, (A/Guangdong-Maonan/SWL
Inactivated(2017/2018 1536/2019, CNIC-1909)
season) - A/Hong Kong/2671/2019
(H3N2)-like strain (A/Hong
Kong/2671/2019, IVR-208)
- B/Washington/02/2019-like
strain
(B/Washington/02/2019, wild
type)

Enzira Suspension for Seqirus GmbH PA1373/001/001 Suspension for injection - A/MICHIGAN/45/2015 01/12/2020
injection, pre-filled (H1N1) PDM09 - LIKE
syringeInfluenza vaccine STRAIN
(split virion, inactivated) (A/SINGAPORE/GP1908/20
15, IVR-180A)
- A/SINGAPORE/IMFIMH-16-
0019/2016 (H3N2)-LIKE
STRAIN
(A/SINGAPORE/INFIMH-16-
0019/2016,NIB-104)
- B/COLORADO/06/2017-
LIKE STRAIN
(B/VICTORIA/2/87
LINEAGE)(B/MARYLAND/1
5/2016,NYMC BX-69A)
- B/COLORADO/06/2017 -
LIKE STRAIN
(B/MARYLAND/15/2016,WIL
D TYPE)
Fluad, Suspension for Seqirus S.r.l. PA2032/002/001 Suspension for injection in - A/Guangdong- 01/12/2020
injection in pre-filled pre-filled syringe Maonan/SWL 1536/2019
syringeInfluenza Vaccine, (H1N1)pdm09-like strain
Surface Antigen, Inactivated, (A/Guangdong-Maonan/SWL
Adjuvanted with 1536/2019, CNIC-1909)
MF59C.1(2020/2021 - A/Hong Kong/2671/2019
SEASON) (H3N2)-like strain (A/Hong
Kong/2671/2019, IVR-208)
- B/Washington/02/2019-like
strain
(B/Washington/02/2019, wild
type)

Advil 200 mg Tablets Pfizer Healthcare Ireland PA0822/163/002 Coated tablet - Ibuprofen 30/11/2020
Anadin Extra Film-coated Pfizer Healthcare Ireland PA0822/166/001 Film-coated tablet - Acetylsalicylic acid 30/11/2020
TabletsAspirin - Caffeine
300mgParacetamol - Paracetamol
200mgCaffeine 45mg
Blugral 100 mg film-coated Niche Generics Limited PA1063/048/003 Film-coated tablet - Sildenafil citrate 30/11/2020
tablets
Interchangeable List Code:
IC0063-024-014
Blugral 25 mg film-coated Niche Generics Limited PA1063/048/001 Film-coated tablet - Sildenafil citrate 30/11/2020
tablets
Interchangeable List Code:
IC0063-022-014
Blugral 50 mg film-coated Niche Generics Limited PA1063/048/002 Film-coated tablet - Sildenafil citrate 30/11/2020
tablets
Interchangeable List Code:
IC0063-023-014
Difflam 3 % w/w Cream Mylan IRE Healthcare PA2010/030/001 Cream - BENZYDAMINE 30/11/2020
Limited HYDROCHLORIDE
MST CONTINUS suspension Mundipharma PA1688/004/008 Prolonged-release granules - Morphine sulfate 30/11/2020
20 mg Pharmaceuticals Limited for oral suspension
MST CONTINUS suspension Mundipharma PA1688/004/009 Prolonged-release granules - Morphine 30/11/2020
30 mg Pharmaceuticals Limited for oral suspension
Seclodin 400mg Soft Pfizer Healthcare Ireland PA0822/162/001 Capsule, soft - Ibuprofen 30/11/2020
Capsules

Human Medicines Withdrawn Products Page 45 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Seclodin 400mg Tablets Pfizer Healthcare Ireland PA0822/162/002 Tablet - Ibuprofen ph. eur. 30/11/2020
Tamoxifen Rosemont 10 Perrigo Pharma International PA22741/010/001 Oral solution - TAMOXIFEN CITRATE 30/11/2020
mg/5 ml Oral Solution Designated Activity Compan

EPREX 10,000 IU/mL Janssen-Cilag Ltd PA0748/025/009 Solution for injection in pre- - Epoetin alfa 29/11/2020
solution for injection in pre- filled syringe
filled syringe
EPREX 2,000 IU/mL solution Janssen-Cilag Ltd PA0748/025/005 Solution for injection in pre- - Epoetin alfa 29/11/2020
for injection in pre-filled filled syringe
syringe
EPREX 4,000 IU/mL solution Janssen-Cilag Ltd PA0748/025/006 Solution for injection - Epoetin alfa 29/11/2020
for injection in pre-filled
syringe
EPREX 40,000 IU/mL Janssen-Cilag Ltd PA0748/025/012 Solution for injection - Epoetinum alfa 29/11/2020
solution for injection in pre-
filled syringe
Dropodex 0.1% w/v Eye Rayner Pharmaceuticals PA2161/003/001 Eye drops, solution - DEXAMETHASONE 27/11/2020
Drops, solution Limited PHOSPHATE
ILUBE 5% w/v Eye Drops, Rayner Pharmaceuticals PA2161/002/001 Eye drops, solution - Acetylcysteine 27/11/2020
Solution Limited
Alpivab Biocryst UK Ltd c/o Morgan EU/1/18/1269/001 Concentrate for solution for - Peramivir 20/11/2020
Lewis & Bockius infusion
Amoxicillin DSM Sinochem Centrient Pharmaceuticals PA1832/001/001 Capsule, hard - Amoxicillin (as trihydrate) 20/11/2020
Pharmaceuticals 250 mg Netherlands B.V
hard capsules
Orlistat 120mg Capsules, Alissa Healthcare Research PA1887/004/001 Capsule, hard - Orlistat 20/11/2020
hard Limited
Pharmaton Capsules Sanofi-Aventis Ireland PA0540/188/001 Capsule, soft - Panax ginseng extract 20/11/2020
Limited T/A SANOFI - Vitamin a
- Cholecalciferol concentrate
- All-rac-alpha tocopheryl
acetate
- Ascorbic acid
- Thiamine nitrate
- Riboflavin
- Nicotinamide
- Pyridoxine hydrochloride
- Folic acid
- Cyanocobalamin
- Biotin
- Anhydrous dibasic calcium
phosphate
- Iron (as dried ferrous
sulphate)
- Magnesium sulfate dried
- Zinc (as zinc sulphate
monohydrate)
- Copper (as dried copper
sulpahte)
- Selenium (as sodium
selenate)
- Lecithin

Zileze 3.75 mg Film-Coated Chiesi Limited PA0743/007/001 Film-coated tablet - Zopiclone 20/11/2020
Tablets
Interchangeable List Code:
IC0055-108-003
COSOPT 20mg/ml + 5mg/ml LTT Pharma Limited PPA1562/043/003 Eye drops, solution - TIMOLOL MALEATE 16/11/2020
eye drops, solution - Dorzolamide hydrochloride
Creon 40000 Gastro- Mylan IRE Healthcare PA2010/008/003 Gastro-resistant capsule, - Pancreas powder 16/11/2020
resistant Capsules Limited hard
Detrusitol 1 mg film-coated LTT Pharma Limited PPA1562/060/002 Film-coated tablet - Tolterodine l-tartrate 16/11/2020
tablets
Interchangeable List Code:
IC0025-039-003
Detrusitol 2 mg film-coated LTT Pharma Limited PPA1562/060/003 Film-coated tablet - Tolterodine l-tartrate 16/11/2020
tablets
Interchangeable List Code:
IC0025-006-003
Loceryl 5% w/v Medicated LTT Pharma Limited PPA1562/053/001 Medicated nail lacquer - Amorolfine 13/11/2020
Nail Lacquer
Vermox 100mg Tablets LTT Pharma Limited PPA1562/049/001 Tablet - Mebendazole 13/11/2020
Vermox 100mg/5ml Oral LTT Pharma Limited PPA1562/049/002 Oral suspension - Mebendazole 13/11/2020
Suspension

Human Medicines Withdrawn Products Page 46 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Alendronate/Colecalciferol Rowex Ltd PA0711/259/001 Tablet - Alendronic acid 12/11/2020
Rowex 70 mg/5600 IU tablet - Vitamin D3
Interchangeable List Code:
IC0052-103-002
Bisoprolol Fumarate 10mg Accord Healthcare Ireland PA2315/097/002 Tablet - BISOPROLOL FUMARATE 12/11/2020
tablets Ltd.
Interchangeable List Code:
IC0065-002-014
Bisoprolol Fumarate 5 mg Accord Healthcare Ireland PA2315/097/001 Tablet - BISOPROLOL FUMARATE 12/11/2020
tablets Ltd.
Interchangeable List Code:
IC0065-001-014
Eplerenone Accord 25 mg Accord Healthcare Ireland PA2315/010/001 Film-coated tablet - Eplerenone 12/11/2020
film-coated tablets Ltd.
Interchangeable List Code:
IC0115-022-003
Eplerenone Accord 50 mg Accord Healthcare Ireland PA2315/010/002 Film-coated tablet - Eplerenone 12/11/2020
film-coated tablets Ltd.
Interchangeable List Code:
IC0115-023-003
Fostolin Once Weekly 70mg Accord Healthcare Ireland PA2315/096/001 Tablet - Alendronic acid 12/11/2020
tablets Ltd.
Interchangeable List Code:
IC0051-101-002
Istolde 10 mg Tablets Accord Healthcare Ireland PA2315/226/002 Tablet - Amlodipine 12/11/2020
Ltd.
Interchangeable List Code:
IC0045-002-008
Istolde 5mg Tablets Accord Healthcare Ireland PA2315/226/001 Tablet - Amlodipine 12/11/2020
Ltd.
Interchangeable List Code:
IC0045-001-008
Lescol XL 80 mg Prolonged- LTT Pharma Limited PPA1562/039/001 Prolonged-release tablet - Fluvastatin sodium 12/11/2020
release tablets
Montelukast 10mg Film Accord Healthcare Ireland PA2315/215/001 Film-coated tablet - Montelukast 12/11/2020
Coated Tablets Ltd.
Interchangeable List Code:
IC0023-002-003
Montelukast Paediatric 4mg Accord Healthcare Ireland PA2315/215/002 Chewable tablet - Montelukast 12/11/2020
Chewable Tablets Ltd.
Interchangeable List Code:
IC0023-008-007
Montelukast Paediatric 5mg Accord Healthcare Ireland PA2315/215/003 Chewable tablet - Montelukast 12/11/2020
Chewable Tablets Ltd.
Interchangeable List Code:
IC0023-001-007
Paracetamol Rx 500 mg film- Accord Healthcare Ireland PA2315/009/001 Film-coated tablet - PARACETAMOL 12/11/2020
coated tablets Ltd.
Rolyprexa 15 mg film-coated Rowex Ltd PA0711/124/005 Film-coated tablet - Olanzapine 12/11/2020
tablets
Interchangeable List Code:
IC0007-032-038
Celevac 500mg Tablets Amdipharm Limited PA1142/010/001 Tablet - Methylcellulose 11/11/2020
Adalat LA 30 mg Prolonged- LTT Pharma Limited PPA1562/036/002 Prolonged-release tablet - Nifedipine 10/11/2020
Release Tablet
Adalat LA 60 mg Prolonged- LTT Pharma Limited PPA1562/036/003 Prolonged-release tablet - Nifedipine 10/11/2020
Release Tablet
Adalat Retard 20 mg LTT Pharma Limited PPA1562/036/005 Prolonged-release tablet - Nifedipine 10/11/2020
Prolonged-Release tablets
Lamictal 200 mg tablets LTT Pharma Limited PPA1562/011/004 Tablet - Lamotrigine 06/11/2020
Telfast 120mg film-coated LTT Pharma Limited PPA1562/019/001 Film-coated tablet - Fexofenadine hydrochloride 06/11/2020
tablets
Xatral 10mg Prolonged LTT Pharma Limited PPA1562/020/001 Prolonged-release tablet - ALFUZOSIN 06/11/2020
Release Tablets HYDROCHLORIDE
Xatral 2.5mg Film-Coated LTT Pharma Limited PPA1562/020/002 Film-coated tablet - ALFUZOSIN 06/11/2020
Tablets HYDROCHLORIDE
Sebivo Novartis Europharm Limited EU/1/07/388/003 Oral solution - Telbivudine 05/11/2020
SEBIVO Novartis Europharm Limited EU/1/07/388/01 Coated tablet - Telbivudine 05/11/2020
Zoledronic acid Sandoz Rowex Ltd PA0711/203/001 Concentrate for solution for - Zoledronic acid 05/11/2020
4mg/5ml Concentrate for infusion
Solution for Infusion
Primolut N 5 mg Tablets Bayer Limited PA1410/010/001 Tablet - Norethisterone 04/11/2020
Flursil Relief Sugar Free 8.75 Rowex Ltd PA0711/257/001 Lozenge - Flurbiprofen 03/11/2020
mg lozenges
Tadalafil Rowex 10 mg Film- Rowex Ltd PA0711/261/003 Film-coated tablet - Tadalafil 03/11/2020
coated Tablets

Human Medicines Withdrawn Products Page 47 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Tadalafil Rowex 2.5 mg Film- Rowex Ltd PA0711/261/001 Film-coated tablet - Tadalafil 03/11/2020
coated Tablets
Tadalafil Rowex 5 mg Film- Rowex Ltd PA0711/261/002 Film-coated tablet - Tadalafil 03/11/2020
coated Tablets
Voriconazole Rowex 200mg Rowex Ltd PA0711/209/002 Film-coated tablet - Voriconazole 03/11/2020
Film-coated Tablets
Fucidin 250mg/5ml Oral Leo Laboratories Limited PA0046/004/010 Oral suspension - Fusidic acid anhydrous 31/10/2020
Suspension
Ivabradine 5 mg Film-coated Accord Healthcare Ireland PA2315/224/001 Film-coated tablet - Ivabradine 30/10/2020
Tablets Ltd.
Ivabradine 7.5 mg Film- Accord Healthcare Ireland PA2315/224/002 Film-coated tablet - Ivabradine 30/10/2020
coated Tablets Ltd.
Movicol 13.8g sachet, LTT Pharma Limited PPA1562/004/001 Powder for oral solution - Sodium bicarbonate 30/10/2020
powder for oral solution - Sodium chloride
- Macrogol 3350
- Potassium chloride
TCP First Aid Antiseptic Chefaro Ireland DAC PA1186/005/001 Cream - TCP Liquid Antiseptic 30/10/2020
Cream.TCP Liquid Antiseptic - Chloroxylenol
25% w/w, Chloroxylenol - Triclosan
0.5% w/w, Triclosan 0.3%
w/w
Ciproxin Bayer Limited PA1410/028/001 Tablet - CIPROFLOXACIN 29/10/2020
HYDROCHLORIDE
Ciproxin Bayer Limited PA1410/028/005 Solution for infusion - Ciprofloxacin lactate 29/10/2020
Ciproxin IV Flexibag Bayer Limited PA1410/028/010 Solution for infusion - Ciprofloxacin lactate 29/10/2020
Ciproxin Oral Suspension Bayer Limited PA1410/028/008 - Ciprofloxacin 29/10/2020
250mg/5ml
Ciproxin Oral Suspension Bayer Limited PA1410/028/009 - Ciprofloxacin 29/10/2020
Forte 500 mg/5ml
Ribavirin Mylan Mylan S.A.S. EU/1/10/634/1-4 Capsule, hard - Ribavirin 29/10/2020
Alverine citrate 120mg Incepta Euro Limited PA22965/001/002 Capsule, hard - ALVERINE CITRATE 21/10/2020
capsules, hard
Alverine citrate 60mg Incepta Euro Limited PA22965/001/001 Capsule, hard - ALVERINE CITRATE 21/10/2020
capsules, hard
Kolbam Retrophin Europe Limited EU/1/13/895/001 Capsule, hard - Cholic acid 21/10/2020
Kolbam Retrophin Europe Limited EU/1/13/895/002 Capsule, hard - Cholic acid 21/10/2020
Dostinex 500 microgram Lexon (UK) Ltd PPA1097/029/001 Tablet - Cabergoline 16/10/2020
Tablets
Stelazine 1mg/5ml Syrup Amdipharm Limited PA1142/037/003 Syrup - Trifluoperazine 16/10/2020
NeoRecormon Roche Registration Limited EU/1/97/031/027 Solution for injection - Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited EU/1/97/031/028 Solution for injection - Epoetin beta 12/10/2020
NeoRecormon Roche Registration Limited EU/1/97/031/039 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/040 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/001 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/002 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/003 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/004 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/005 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/007 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/008 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/010 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/011 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/012 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Roche Registration Limited EU/1/97/031/013 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon for Reco-Pen Roche Registration Limited EU/1/97/031/024 - Epoetin beta 12/10/2020

NeoRecormon for Reco-Pen Roche Registration Limited EU/1/97/031/021 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon for Reco-Pen Roche Registration Limited EU/1/97/031/022 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection
NeoRecormon Multidose Roche Registration Limited EU/1/97/031/020 Powder and solvent for - Epoetin beta 12/10/2020
solution for injection

Human Medicines Withdrawn Products Page 48 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NeoRecormon Recopen Roche Registration Limited EU/1/97/031/023 Powder for solution for - Epoetin beta 12/10/2020
injection
Oxaliplatin Hospira 5 mg/ml Hospira UK Limited PA0437/056/002 Concentrate for solution for - Oxaliplatin 12/10/2020
Concentrate for Solution for infusion
Infusion
Zyban 150 mg prolonged PCO Manufacturing Ltd. PPA0465/089/002 Prolonged-release tablet - Bupropion hydrochloride 12/10/2020
release tablets
INACTIVATED INFLUENZA Sanofi Pasteur PA2131/012/001 Suspension for injection - A/Michigan/45/2015 05/10/2020
VACCINE (SPLIT VIRION) (H1N1)pdm09 - like strain
BP, suspension for injection (A/Michigan/45/2015, NYMC
in prefilled syringe.Influenza X-275)
vaccine (split virion, - A/hong kong/4801/2014
inactivated) (h3n2) - like strain (a/hong
kong/4801/2014, nymc x-
263b)
- B/brisbane/60/2008 - like
strain (b/brisbane/60/2008)
Invirase Roche Registration GmbH EU/1/96/026/001 Capsule - Saquinavir 05/10/2020
Mircera Roche Registration Limited EU/1/07/400/001 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/002 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/003 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/004 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/005 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/006 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/007 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/14 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/15 Solution for injection - Ro0503821 05/10/2020
Mircera Roche Registration GmbH EU/1/07/400/16 Solution for injection - Ro0503821 05/10/2020
NeoRecormon Roche Registration Limited EU/1/97/031/009 Powder and solvent for - Epoetin beta 05/10/2020
solution for injection
Tamiflu Roche Registration GmbH EU/1/02/222/002 Powder for oral suspension - Oseltamivir phosphate 05/10/2020
Paracetamol 500 mg film- Accord Healthcare Ireland PA2315/030/001 Film-coated tablet - PARACETAMOL 01/10/2020
coated tablets Ltd.
Truoxin 250 mg Film-coated Fannin Limited PA1457/013/001 Film-coated tablet - Ciprofloxacin 30/09/2020
Tablets
Truoxin 500 mg Film-coated Fannin Limited PA1457/013/002 Film-coated tablet - Ciprofloxacin 30/09/2020
Tablets
Kaletra AbbVie Ltd EU/1/01/172/002 Capsule - Ritonavir 28/09/2020
- Lopinavir
Norvir AbbVie Ltd EU/1/96/016/001 Not assigned - Ritonavir 28/09/2020
Norvir Soft Capsules AbbVie Ltd EU/1/96/016/003 Capsule - Ritonavir 28/09/2020
Nicochew Fruit 2 mg Clonmel Healthcare Ltd PA0126/263/001 Medicated chewing-gum - Nicotine 24/09/2020
medicated chewing-gum
Nicochew Fruit 4 mg Clonmel Healthcare Ltd PA0126/263/002 Medicated chewing-gum - Nicotine 24/09/2020
medicated chewing-gum
Vepacel Ology Bioservices Ireland EU/1/12/752/001 Suspension for injection - Whole virion non- 24/09/2020
LTD adjuvanted influenza virus
(a/vietnam/1203/2004
(h5n1))
TechneScan LyoMAA, Mallinckrodt Medical B.V. PA0690/012/001 Powder for suspension for - Human albumin macro 21/09/2020
Powder for suspension for injection aggregated
injection/kit for
radiopharmaceutical
preparation
Prapexin 0.26 mg prolonged Rowex Ltd PA0711/242/001 Prolonged-release tablet - Pramipexole 17/09/2020
release tablets
Prapexin 0.52 mg prolonged Rowex Ltd PA0711/242/002 Prolonged-release tablet - Pramipexole 17/09/2020
release tablets
Prapexin 1.05 mg prolonged Rowex Ltd PA0711/242/003 Prolonged-release tablet - Pramipexole 17/09/2020
release tablets
Prapexin 2.1 mg prolonged Rowex Ltd PA0711/242/004 Prolonged-release tablet - Pramipexole 17/09/2020
release tablets
Prapexin 3.15 mg prolonged Rowex Ltd PA0711/242/005 Prolonged-release tablet - Pramipexole 17/09/2020
release tablets
Quedute 0.5 mg soft Rowex Ltd PA0711/276/001 Capsule, soft - Dutasteride 16/09/2020
capsules
Mannitol Intravenous Infusion Baxter Healthcare Limited PA0167/037/009 Solution for infusion - Mannitol 13/09/2020
BP 20% w/v Solution for
Infusion
Sodium Chloride (Normal Martindale Pharmaceuticals PA0361/012/001 Eye drops, solution - Sodium chloride 11/09/2020
Saline) 0.9% w/v Eye Drops Ltd
Solution
Glycerol 2g Suppositories Ethypharm PA0549/028/002 Suppository - Glycerol 10/09/2020
Hyoscine Injection BP 400 Ethypharm PA0549/031/001 Solution for injection - Hyoscine Hydrobromide 10/09/2020
micrograms/ml, Solution for
Injection

Human Medicines Withdrawn Products Page 49 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Treosulfan Powder for medac Gesellschaft für PA0623/001/002 Powder for solution for - Treosulfan 10/09/2020
Solution for Injection or klinische Spezialpräparate injection/infusion
Infusion 5 g mbH
Abacavir/Lamivudine Clonmel Healthcare Ltd PA0126/284/001 Film-coated tablet - Abacavir 09/09/2020
Clonmel 600mg/300mg Film- - Lamivudine
coated Tablets
CosmoFer 50mg/ml solution Lexon (UK) Ltd PPA1097/034/001 Solution for injection/infusion - Iron 09/09/2020
for infusion and injection
Selectol Tablets 200 mg Sanofi-Aventis Ireland PA0540/126/001 Tablet - CELIPROLOL 08/09/2020
Limited T/A SANOFI HYDROCHLORIDE
Selectol Tablets 400mg Sanofi-Aventis Ireland PA0540/126/002 Tablet - CELIPROLOL 08/09/2020
Limited T/A SANOFI HYDROCHLORIDE
Advantan 0.1% w/w Fatty LEO Pharma A/S PA1025/013/003 Ointment - Methylprednisolone 04/09/2020
Ointment aceponate
Advantan 0.1% w/w Ointmen LEO Pharma A/S PA1025/013/002 Ointment - Methylprednisolone 04/09/2020
aceponate
Advantan cream 0.1% w/w LEO Pharma A/S PA1025/013/001 Cream - Methylprednisolone 04/09/2020
aceponate
Dalacin T Topical 10 mg/ml Pfizer Healthcare Ireland PA0822/121/002 Cutaneous solution - CLINDAMYCIN 03/09/2020
Cutaneous Solution PHOSPHATE
Telfast 180mg film-coated Lexon (UK) Ltd PPA1097/057/001 Film-coated tablet - Fexofenadine hydrochloride 03/09/2020
tablets
Asasantin Retard Imbat Limited PPA1151/128/001 Modified-release capsule, - Aspirin 01/09/2020
200mg/25mg Modified hard - Dipyridamole
Release Hard Capsules
Atacand 16mg tablets Imbat Limited PPA1151/109/001 Tablet - Candesartan cilexetil 01/09/2020

Interchangeable List Code:


IC0009-038-002
Atacand 4 mg tablets Imbat Limited PPA1151/109/002 Tablet - Candesartan cilexetil 01/09/2020

Interchangeable List Code:


IC0009-008-002
Atacand 8 mg tablets Imbat Limited PPA1151/109/003 Tablet - Candesartan cilexetil 01/09/2020

Interchangeable List Code:


IC0009-009-002
Becotide Evohaler 50 Imbat Limited PPA1151/204/002 Pressurised inhalation, - Beclometasone 01/09/2020
micrograms, Pressurised solution dipropionate
Inhalation Solution
Benylin Day & Night Tablets Imbat Limited PPA1151/264/001 Tablet - Diphenhydramine 01/09/2020
hydrochloride
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- Paracetamol
Benylin Four Flu Film-Coated Imbat Limited PPA1151/130/001 Film-coated tablet - Diphenhydramine 01/09/2020
Tablets. Paracetamol 500mg - Pseudoephedrine
Diphenhydramine - Paracetamol
hydrochloride 12.5mg
Pseudoephedrine
hydrochloride 22.5mg

Coversyl Arginine Plus LTT Pharma Limited PPA1562/063/002 Film-coated tablet - Indapamide 28/08/2020
10mg/2.5mg film-coated - Perindopril arginine
tablets
Provigil 200 mg Tablets Lexon (UK) Ltd PPA1097/024/001 Tablet - Modafinil 28/08/2020
Ibuprofen/Phenylephrine Clonmel Healthcare Ltd PA0126/296/001 Film-coated tablet - Ibuprofen 27/08/2020
Clonmel 400 mg/10 mg film- - Phenylephrine
coated tablets hydrochloride
Arcoxia 30 mg film-coated Imbat Limited PPA1151/137/001 Film-coated tablet - Etoricoxib 25/08/2020
tablets
Interchangeable List Code:
IC0108-033-003
Aromasin 25 mg coated Imbat Limited PPA1151/178/001 Coated tablet - Exemestane 25/08/2020
tablets
Arthrotec 50 modified-release Imbat Limited PPA1151/199/001 Modified-release tablet - DICLOFENAC SODIUM 25/08/2020
tablets - Misoprostol
Interchangeable List Code:
IC0058-109-021
Arthrotec 75 modified-release Imbat Limited PPA1151/199/002 Modified-release tablet - Misoprostol 25/08/2020
tablets - DICLOFENAC SODIUM
Interchangeable List Code:
IC0058-113-021
Asacolon 400 mg Gastro- Imbat Limited PPA1151/107/001 Gastro-resistant tablet - Mesalazine 25/08/2020
resistant Tablets

Human Medicines Withdrawn Products Page 50 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Asacolon 800mg Gastro- Imbat Limited PPA1151/107/003 Gastro-resistant tablet - Mesalazine 25/08/2020
resistant Tablets
By-Vertin 8 mg Tablets Fannin Limited PA1457/011/001 Tablet - Betahistine dihydrochloride 25/08/2020

Interchangeable List Code:


IC0084-009-002
Eslicarbazepine acetate McDermott Laboratories Ltd., PA0577/231/001 Tablet - Eslicarbazepine acetate 25/08/2020
Mylan 800 mg Tablets T/A Gerard Laboratories

Amaryl 2mg Tablets Imbat Limited PPA1151/063/002 Tablet - Glimepiride 24/08/2020


Amaryl 4mg Tablets Imbat Limited PPA1151/063/003 Tablet - Glimepiride 24/08/2020
Arcoxia 120 mg film-coated Imbat Limited PPA1151/137/004 Film-coated tablet - Etoricoxib 24/08/2020
tablets
Interchangeable List Code:
IC0108-167-003
Arcoxia 60 mg film-coated Imbat Limited PPA1151/137/002 Film-coated tablet - Etoricoxib 24/08/2020
tablets
Interchangeable List Code:
IC0108-127-003
Arcoxia 90 mg film-coated Imbat Limited PPA1151/137/003 Film-coated tablet - Etoricoxib 24/08/2020
tablets
Interchangeable List Code:
IC0108-166-003
Arimidex 1 mg film-coated Imbat Limited PPA1151/161/001 Film-coated tablet - Anastrozole 24/08/2020
tablets
Interchangeable List Code:
IC0011-039-003
Omeprazole Teva Pharma 10 Teva Pharma B.V. PA0749/092/001 Gastro-resistant capsule, - Omeprazole 20/08/2020
mg Gastro-resistant hard
capsules, hard Interchangeable List Code:
IC0010-002-016
Omeprazole Teva Pharma 20 Teva Pharma B.V. PA0749/092/002 Gastro-resistant capsule, - Omeprazole 20/08/2020
mg Gastro-resistant hard
capsules, hard Interchangeable List Code:
IC0010-003-016
Omeprazole Teva Pharma 40 Teva Pharma B.V. PA0749/092/003 Gastro-resistant capsule, - Omeprazole 20/08/2020
mg Gastro-resistant hard
capsules, hard Interchangeable List Code:
IC0010-004-016
Actifed 60mg/2.5mg tablets Imbat Limited PPA1151/210/001 Tablet - TRIPROLIDINE 19/08/2020
HYDROCHLORIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
Acular 0.5% w/v eye drops, Imbat Limited PPA1151/142/001 Eye drops, solution - Ketorolac trometamol 19/08/2020
solution
Adalat LA 30mg Prolonged- Imbat Limited PPA1151/047/002 Prolonged-release tablet - Nifedipine 19/08/2020
Release Tablet
Adalat Retard 20 mg Imbat Limited PPA1151/047/001 Prolonged-release tablet - Nifedipine 19/08/2020
Prolonged-Release Tablets
Aldactone 25mg Film-coated Imbat Limited PPA1151/197/001 Film-coated tablet - Spironolactone 19/08/2020
Tablets
Amaryl 1mg Tablets Imbat Limited PPA1151/063/001 Tablet - Glimepiride 19/08/2020
Dilzem XL 120mg Prolonged- Teva B.V. PA1986/089/004 Prolonged-release capsule, - Diltiazem hydrochloride 17/08/2020
release hard capsules hard

Dilzem XL 180mg Prolonged- Teva B.V. PA1986/089/005 Prolonged-release capsule, - Diltiazem hydrochloride 17/08/2020
release Hard Capsules hard

Dilzem XL 240mg Prolonged- Teva B.V. PA1986/089/006 Prolonged-release capsule, - Diltiazem hydrochloride 17/08/2020
release Hard Capsules hard

Glucobay 100 mg Tablets Bayer Limited PA1410/029/002 Tablet - Acarbose 17/08/2020


Glucobay 50 mg Tablets Bayer Limited PA1410/029/001 Tablet - Acarbose 17/08/2020
By-Vertin 16 mg Tablets Fannin Limited PA1457/011/002 Tablet - Betahistine dihydrochloride 15/08/2020

Interchangeable List Code:


IC0084-038-002
Qtrilmet AstraZeneca AB EU/1/19/1401/001-014 Modified-release tablet - Saxagliptin 14/08/2020
- METFORMIN
HYDROCHLORIDE
- Dapagliflozin
Tadalafil Clonmel 10 mg Clonmel Healthcare Ltd PA0126/283/003 Film-coated tablet - Tadalafil 14/08/2020
Film-coated Tablets
Tadalafil Clonmel 2.5 mg Clonmel Healthcare Ltd PA0126/283/001 Film-coated tablet - Tadalafil 14/08/2020
Film-coated Tablets

Human Medicines Withdrawn Products Page 51 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Tadalafil Clonmel 20 mg Clonmel Healthcare Ltd PA0126/283/004 Film-coated tablet - Tadalafil 14/08/2020
Film-coated Tablets
Tadalafil Clonmel 5 mg Film- Clonmel Healthcare Ltd PA0126/283/002 Film-coated tablet - Tadalafil 14/08/2020
coated Tablets
Grisol 1% w/w Cutaneous Transdermal Limited PA0991/001/001 Cutaneous spray, solution - Griseofulvin 12/08/2020
Spray solution
MONTELUKAST Paediatric Aurobindo Pharma (Malta) PA1445/015/002 Chewable tablet - Montelukast sodium 11/08/2020
4mg Chewable Tablets Limited
Interchangeable List Code:
IC0023-008-007
Zileze 7.5 mg Film-Coated Chiesi Limited PA0743/007/003 Film-coated tablet - Zopiclone 11/08/2020
Tablets
Interchangeable List Code:
IC0055-041-003
Lidotec 700 mg medicated Grunenthal Pharma Ltd PA2242/009/001 Medicated plaster - Lidocaine 10/08/2020
plaster
Salmeterol Neolab 25 Fannin Limited PA1457/024/001 Pressurised inhalation, - Salmeterol 07/08/2020
micrograms per metered suspension
dose pressurised inhalation
suspension
Suprecur 150 micrograms/ Sanofi-Aventis Ireland PA0540/073/002 Nasal spray, solution - Buserelin 02/08/2020
metered dose Nasal Spray, Limited T/A SANOFI
solution
Suprefact 1 mg/ml Solution Sanofi-Aventis Ireland PA0540/074/001 Solution for injection - Buserelin 02/08/2020
for Injection Limited T/A SANOFI
Duzallo Grünenthal GmbH EU/1/18/1300/001-002 Film-coated tablet - Lesinurad 31/07/2020
- Allopurinol
Duzallo Grünenthal GmbH EU/1/18/1300/003-004 Film-coated tablet - Allopurinol 31/07/2020
- Lesinurad
Pilocarpine 2% w/v Eye Martindale Pharmaceuticals PA0361/010/001 Eye drops, solution - Pilocarpine hydrochloride 31/07/2020
Drops, Solution Ltd
Pilocarpine 4 % w/v Eye Martindale Pharmaceuticals PA0361/010/002 Eye drops, solution - Pilocarpine hydrochloride 31/07/2020
Drops, solution Ltd
Rythmodan Retard 250 mg Sanofi-Aventis Ireland PA0540/069/004 Prolonged-release tablet - Disopyramide 31/07/2020
Prolonged-release Tablets Limited T/A SANOFI
Tarivid IV 2 mg/ml Solution Sanofi-Aventis Ireland PA0540/076/002 Solution for infusion - Ofloxacin 31/07/2020
for Infusion Limited T/A SANOFI
Aripiprazole Accord Accord Healthcare Ireland PA2315/026/002 Tablet - Aripiprazole 30/07/2020
Healthcare 10 mg tablets Ltd.
Interchangeable List Code:
IC0092-002-056
Zemplar 5 micrograms/ml AbbVie Limited PA1824/005/005 Solution for injection - Paricalcitol 29/07/2020
Solution for Injection, glass
vial
Cardioplegia Concentrate for Martindale Pharmaceuticals PA0361/014/001 Concentrate for solution for - Potassium chloride 27/07/2020
Solution for Infusion Ltd infusion - Procaine hydrochloride
(163mg/60mg/14mg per ml) - Magnesium chloride
Chloramphenicol 0.5% w/v Martindale Pharmaceuticals PA0361/013/001 Eye drops, solution - Chloramphenicol 27/07/2020
Eye Drops Ltd
Chloramphenicol 1% w/w Ethypharm PA0549/025/002 Eye ointment - Chloramphenicol 27/07/2020
Eye Ointment
Clarithromycin Martindale Martindale Pharmaceuticals PA0361/025/001 Powder for concentrate for - Clarithromycin 27/07/2020
Pharma 500 mg Powder for Ltd solution for infusion
Concentrate for Solution for
Infusion
Cyclizine Lactate 50 mg/ml Ethypharm PA0549/033/001 Solution for injection - Cyclizine 27/07/2020
Solution for Injection
Granisetron Martindale Martindale Pharmaceuticals PA0361/029/001 Concentrate for solution for - Granisetron hydrochloride 27/07/2020
Pharma 1mg/1ml Ltd injection
Concentrate for Solution for
Injection/Infusion
Granisetron Martindale Martindale Pharmaceuticals PA0361/029/002 Concentrate for solution for - Granisetron hydrochloride 27/07/2020
Pharma 3mg/3ml Ltd injection
Concentrate for Solution for
Injection/Infusion
Midazolam 5 mg/ml Solution Martindale Pharmaceuticals PA0361/021/001 Solution for injection/infusion - MIDAZOLAM 27/07/2020
for injection or infusion Ltd HYDROCHLORIDE
Pethidine Injection BP Martindale Pharmaceuticals PA0361/008/003 Solution for injection - PETHIDINE 27/07/2020
100mg/2ml Ltd HYDROCHLORIDE
Pethidine Injection BP Martindale Pharmaceuticals PA0361/008/002 Solution for injection - PETHIDINE 27/07/2020
50mg/ml Ltd HYDROCHLORIDE
Pethidine Tablets BP 50 mg Martindale Pharmaceuticals PA0361/008/001 Tablet - PETHIDINE 27/07/2020
Ltd HYDROCHLORIDE
Phenobarbital Sodium Martindale Pharmaceuticals PA0361/005/001 Solution for injection - Phenobarbital sodium 27/07/2020
15mg/ml Solution for Ltd
Injection

Human Medicines Withdrawn Products Page 52 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Phenobarbital Sodium Martindale Pharmaceuticals PA0361/005/002 Solution for injection - Phenobarbital sodium 27/07/2020
30mg/ml Solution for Ltd
Injection
Phenobarbital Sodium Martindale Pharmaceuticals PA0361/005/003 Solution for injection - Phenobarbital sodium 27/07/2020
60mg/ml Solution for Ltd
Injection
Drytec 2.5-100 GBq GE Healthcare B.V. PA22734/002/001 Radionuclide generator - Sodium Molybdate.99 Mo 24/07/2020
radionuclide generator
Flexove 625 mg tablets Laboratoires Expanscience PA1616/001/001 Tablet - Glucosamine 22/07/2020
Ariclaim Eli Lilly Nederland B.V. EU/1/04/283/1-6 Gastro-resistant capsule, - Duloxetine hydrochloride 16/07/2020
hard
Zurampic Grünenthal GmbH EU/1/15/1080/001-005 Film-coated tablet - Lesinurad 16/07/2020
Gastrolief 20 mg gastro- Clonmel Healthcare Ltd PA0126/220/001 Gastro-resistant tablet - Pantoprazole 15/07/2020
resistant tablets
Anafranil 10mg Capsules Novartis Pharmaceuticals UK PA0013/084/002 Capsule - Clomipramine hydrochloride 10/07/2020
Ltd
Anafranil 25mg Capsules Novartis Pharmaceuticals UK PA0013/084/003 Capsule - Clomipramine hydrochloride 10/07/2020
Ltd
Anafranil 50mg Capsules Novartis Pharmaceuticals UK PA0013/084/001 Capsule - Clomipramine hydrochloride 10/07/2020
Ltd
Captor 25 mg Tablets Rowex Ltd PA0711/002/002 Tablet - Captopril 10/07/2020
Ranitic 150 mg Film-coated Rowex Ltd PA0711/024/001 Film-coated tablet - RANITIDINE 07/07/2020
tablets HYDROCHLORIDE
Interchangeable List Code:
IC0087-062-051
Ranitic 300 mg Film-coated Rowex Ltd PA0711/024/002 Film-coated tablet - RANITIDINE 07/07/2020
tablets HYDROCHLORIDE
Interchangeable List Code:
IC0087-029-051
Ranitic 75 mg Film-coated Rowex Ltd PA0711/024/004 Film-coated tablet - RANITIDINE 07/07/2020
tablets HYDROCHLORIDE
Paramax 500mg/5mg Tablet Sanofi-Aventis Ireland PA0540/154/001 Tablet - Paracetamol 02/07/2020
Limited T/A SANOFI - Metoclopramide
hydrochloride
Captor 12.5mg Tablets Rowex Ltd PA0711/002/001 Tablet - Captopril 01/07/2020
Captor 50mg Tablets Rowex Ltd PA0711/002/003 Tablet - Captopril 01/07/2020
Isotrexin 20 mg/g + 0.5 mg/g GlaxoSmithKline (Ireland) PA1077/123/001 Gel - Isotretinoin 01/07/2020
Gel Limited - Erythromycin
Dutasteride 0.5 mg soft Cipla Europe NV PA1963/005/001 Capsule, soft - Dutasteride (dmf) 30/06/2020
capsules
Stugeron 25 mg Tablets Johnson & Johnson (Ireland) PA0330/044/002 Tablet - Cinnarizine 30/06/2020
Limited
Tyrozets Lozenges Johnson & Johnson (Ireland) PA0330/043/001 Lozenge - Benzocaine 30/06/2020
Limited - Tyrothricin
Ethinylestradiol/Drospirenone Laboratorios Leon Farma, PA1474/006/001 Film-coated tablet - Drospirenone 29/06/2020
Leon Farma & Placebo 0.02 S.A. - Ethinylestradiol
mg/3 mg film-coated tablets

Ethinylestradiol/Drospirenone Laboratorios Leon Farma, PA1474/006/002 Film-coated tablet - Ethinylestradiol 29/06/2020


Leon Farma & Placebo 0.03 S.A. - Drospirenone
mg/3 mg film-coated tablets

Caspofungin 50 mg powder Ethypharm PA0549/022/001 Powder for concentrate for - Caspofungin 25/06/2020
for concentrate for solution solution for infusion
for infusion
Caspofungin 70 mg powder Ethypharm PA0549/022/002 Powder for concentrate for - Caspofungin 25/06/2020
for concentrate for solution solution for infusion
for infusion
Picato Leo Laboratories Limited EU/1/12/796/001 Gel - Ingenol mebutate 25/06/2020
Forane 99.9% w/w, AbbVie Limited PA1824/001/001 Inhalation vapour, liquid - Isoflurane 23/06/2020
Inhalation Vapour, Liquid
Zerit Bristol Myers Squibb Pharma EU/1/96/009/001 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/002 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/003 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/004 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/005 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/006 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/007 Capsule - Stavudine 22/06/2020
EEIG

Human Medicines Withdrawn Products Page 53 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zerit Bristol Myers Squibb Pharma EU/1/96/009/008 Capsule - Stavudine 22/06/2020
EEIG
Zerit Bristol Myers Squibb Pharma EU/1/96/009/009 Powder for oral solution - Stavudine 22/06/2020
EEIG
Anastrozole 1 mg film-coated Accord Healthcare Ireland PA2315/011/001 Film-coated tablet - Anastrozole 18/06/2020
tablets Ltd.
Interchangeable List Code:
IC0011-039-003
Profal 5 mg film-coated Accord Healthcare Ireland PA2315/045/001 Film-coated tablet - Finasteride 18/06/2020
tablets Ltd.
Etoricoxib 120 mg film- Accord Healthcare Ireland PA2315/043/004 Film-coated tablet - Etoricoxib 17/06/2020
coated tablets Ltd.
Interchangeable List Code:
IC0108-167-003
Etoricoxib 30 mg film-coated Accord Healthcare Ireland PA2315/043/001 Film-coated tablet - Etoricoxib 17/06/2020
tablets Ltd.
Interchangeable List Code:
IC0108-033-003
Etoricoxib 60 mg film-coated Accord Healthcare Ireland PA2315/043/002 Film-coated tablet - Etoricoxib 17/06/2020
tablets Ltd.
Interchangeable List Code:
IC0108-127-003
Etoricoxib 90 mg film-coated Accord Healthcare Ireland PA2315/043/003 Film-coated tablet - Etoricoxib 17/06/2020
tablets Ltd.
Interchangeable List Code:
IC0108-166-003
sdfgsdfgsdfg IMB Test Pharmaceutical PA1836/001/063 Not assigned - C.perfringens type b & c 10/06/2020
Company toxoid
TEST product Test MAH PA22671/001/001 - Ibuprofen 10/06/2020
Inderal 10mg Film-coated AstraZeneca AB PA1019/010/001 Film-coated tablet - PROPRANOLOL 08/06/2020
Tablets HYDROCHLORIDE
Tenoret 50mg/12.5mg Film- AstraZeneca AB PA1019/021/001 Film-coated tablet - Atenolol 08/06/2020
coated Tablets - Chlorthalidone
Tenoretic 100mg/25mg Film- AstraZeneca AB PA1019/022/001 Film-coated tablet - Atenolol 08/06/2020
coated Tablets - Chlorthalidone
Remifentanil 1mg powder for Actavis Group PTC ehf PA1380/112/001 Powder for concentrate for - Remifentanil 02/06/2020
concentrate for solution for solution for injection/infusion
injection/infusion
Remifentanil 2mg powder for Actavis Group PTC ehf PA1380/112/002 Powder for concentrate for - Remifentanil 02/06/2020
concentrate for solution for solution for injection/infusion
injection/infusion
Remifentanil 5mg powder for Actavis Group PTC ehf PA1380/112/003 Powder for concentrate for - Remifentanil 02/06/2020
concentrate for solution for solution for injection/infusion
injection/infusion
Fetanex 12.5 microgram/hour Rowex Ltd PA0711/137/001 Transdermal patch - Fentanyl 26/05/2020
Transdermal patch

Fetanex 37.5 microgram/hour Rowex Ltd PA0711/137/003 Transdermal patch - Fentanyl 26/05/2020
Transdermal patch

TOPAMAX 200mg Film- Lexon (UK) Ltd PPA1097/002/002 Film-coated tablet - Topiramate 14/05/2020
coated Tablets
TOPAMAX 50mg Film- Lexon (UK) Ltd PPA1097/002/001 Film-coated tablet - Topiramate 14/05/2020
coated Tablets
Pipexus 0.26 mg prolonged- Macarthys Laboratories PA0274/003/001 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 0.52 mg prolonged- Macarthys Laboratories PA0274/003/002 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 1.05 mg prolonged- Macarthys Laboratories PA0274/003/003 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 1.57 mg prolonged- Macarthys Laboratories PA0274/003/004 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 2.1 mg prolonged- Macarthys Laboratories PA0274/003/005 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 2.62 mg prolonged- Macarthys Laboratories PA0274/003/006 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Pipexus 3.15 mg prolonged- Macarthys Laboratories PA0274/003/007 Prolonged-release tablet - Pramipexole 12/05/2020
release tablets Limited dihydrochloride monohydrate

Human Medicines Withdrawn Products Page 54 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Anastrozole 1 mg film-coated Fresenius Kabi Deutschland PA2059/027/001 Film-coated tablet - Anastrozole 11/05/2020
tablets GmbH
Interchangeable List Code:
IC0011-039-003
Bicalutamide 150 mg film- Fresenius Kabi Deutschland PA2059/030/002 Film-coated tablet - Bicalutamide 11/05/2020
coated tablets GmbH
Bicalutamide 50mg Film- Fresenius Kabi Deutschland PA2059/030/001 Film-coated tablet - Bicalutamide 11/05/2020
coated tablets GmbH
Letrozole 2.5mg film-coated Fresenius Kabi Deutschland PA2059/047/001 Film-coated tablet - Letrozole 11/05/2020
tablets GmbH
Zalmoxis MolMed EU/1/16/1121/001 Suspension for Infusion - Allogeneic t cells mm-tk ds 07/05/2020
Panadol 500 mg Film Coated Lexon (UK) Ltd PPA1097/016/001 Film-coated tablet - PARACETAMOL 04/05/2020
Tablets
Ciprofloxacin 2mg/ml, Baxter Holding B.V. PA2299/034/001 Solution for infusion - Ciprofloxacin lactate 01/05/2020
Solution for Infusion
Paracetamol/Diphenhydrami Chanelle Medical PA0688/037/001 Film-coated tablet - PARACETAMOL 01/05/2020
ne Hydrochloride 500 mg/25 - DIPHENHYDRAMINE
mg Film-coated Tablets HYDROCHLORIDE

Prasugrel Rowex 10 mg Rowex Ltd PA0711/282/002 Film-coated tablet - Prasugrel 01/05/2020


Film-coated tablets
Prasugrel Rowex 5 mg Film- Rowex Ltd PA0711/282/001 Film-coated tablet - PRASUGREL BESILATE 01/05/2020
coated tablets
DDAVP/Desmopressin Ferring Ireland Ltd PA1009/001/003 Tablet - DESMOPRESSIN 30/04/2020
0.1mg Tablets ACETATE
Octostim 1.5 mg/ml Nasal Ferring Ireland Ltd PA1009/014/002 Nasal spray, solution - DESMOPRESSIN 30/04/2020
Spray ACETATE
Octostim 15 micrograms/ml Ferring Ireland Ltd PA1009/014/001 Solution for injection - DESMOPRESSIN 30/04/2020
Solution for injection ACETATE
Cystrin 3mg Tablets Sanofi-Aventis Ireland PA0540/143/001 Tablet - OXYBUTYNIN 24/04/2020
Limited T/A SANOFI HYDROCHLORIDE
Cystrin 5mg Tablets Sanofi-Aventis Ireland PA0540/143/002 Tablet - OXYBUTYNIN 24/04/2020
Limited T/A SANOFI HYDROCHLORIDE
Ditropan 2.5mg Tablets Sanofi-Aventis Ireland PA0540/146/002 Tablet - OXYBUTYNIN 24/04/2020
Limited T/A SANOFI HYDROCHLORIDE
Ditropan 5mg Tablets Sanofi-Aventis Ireland PA0540/146/003 Tablet - OXYBUTYNIN 24/04/2020
Limited T/A SANOFI HYDROCHLORIDE
Latanoprost / Timolol 50 Accord Healthcare Ireland PA2315/024/001 Eye drops, solution - Latanoprost 24/04/2020
microgram/5.0 mg per ml Eye Ltd. - Timolol
Drops Solution Interchangeable List Code:
IC0100-153-045
Sotacor 80 mg Tablets Bristol-Myers Squibb PA2255/003/001 Tablet - SOTALOL 24/04/2020
Pharmaceuticals uc HYDROCHLORIDE
Varuby TESARO Bio Netherlands EU/1/17/1180/001 Film-coated tablet - Rolapitant 24/04/2020
B.V.
Xatral 2.5mg Film-Coated Sanofi-Aventis Ireland PA0540/162/001 Film-coated tablet - ALFUZOSIN 24/04/2020
Tablets Limited T/A SANOFI HYDROCHLORIDE
Dassan 700 mg Medicated Grunenthal Pharma Ltd PA2242/002/001 Medicated plaster - Lidocaine 22/04/2020
Plaster
Lonqtiv 700 mg Medicated Grunenthal Pharma Ltd PA2242/011/001 Medicated plaster - Lidocaine 22/04/2020
Plaster
Topamax 100mg film-coated IMED Healthcare Ltd. PPA1463/106/002 Film-coated tablet - Topiramate 16/04/2020
tablets
Vesitirim 10mg Film-coated IMED Healthcare Ltd. PPA1463/046/002 Film-coated tablet - Solifenacin succinate 16/04/2020
Tablets
Vesitirim 5 mg Film-coated IMED Healthcare Ltd. PPA1463/046/001 Film-coated tablet - Solifenacin succinate 16/04/2020
Tablets
Zovirax 200mg Dispersible IMED Healthcare Ltd. PPA1463/132/002 Dispersible tablet - ACICLOVIR 16/04/2020
Tablets
OSSEOR Les Laboratoires Servier EU/1/04/287/001 Granules for oral suspension - Strontium ranelate 14/04/2020

PROTELOS Les Laboratoires Servier EU/1/04/288/1-6 Granules for oral suspension - Strontium ranelate 14/04/2020

Seroxat 20 mg film-coated Lexon (UK) Ltd PPA1097/040/001 Film-coated tablet - Paroxetine hydrochloride 14/04/2020
tablets hemihydrate
Interchangeable List Code:
IC0076-003-003
Seroxat 30 mg film-coated LTT Pharma Limited PPA1562/030/004 Film-coated tablet - Paroxetine hydrochloride 14/04/2020
tablets hemihydrate
Interchangeable List Code:
IC0076-033-003
Ambrisentan betapharm 10 Betapharm Arzneimittel PA22717/001/002 Film-coated tablet - Ambrisentan 07/04/2020
mg film-coated tablets. GmbH
Ambrisentan betapharm 5 Betapharm Arzneimittel PA22717/001/001 Film-coated tablet - Ambrisentan 07/04/2020
mg film-coated tablets. GmbH

Human Medicines Withdrawn Products Page 55 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Ibuprofen Chanelle Medical Chanelle Medical PA0688/053/001 Capsule, soft - Ibuprofen lysine 07/04/2020
200 mg capsules, soft
Ibuprofen Chanelle Medical Chanelle Medical PA0688/053/002 Capsule, soft - Ibuprofen lysine 07/04/2020
400 mg capsules, soft
Lemsip Cold & Flu 500 mg Reckitt Benckiser Ireland Ltd PA0979/051/001 Tablet - Paracetamol 07/04/2020
tablets
Lemsip Decongestant & Flu Reckitt Benckiser Ireland Ltd PA0979/050/001 Tablet - Paracetamol 07/04/2020
Lemon Tablets Paracetamol - Phenylephrine
500 mg Phenylephrine hydrochloride
Hydrochloride 6.1 mg
Lemsip Decongestant and Reckitt Benckiser Ireland Ltd PA0979/050/002 Tablet - Paracetamol 07/04/2020
Flu Blackcurrant tablets - Phenylephrine
Paracetamol 500mg hydrochloride
Phenylephrine hydrochloride
6.1mg
Adcortyl Intra-articular/Intra- Bristol-Myers Squibb PA0002/018/002 Suspension for injection - Triamcinolone acetonide 01/04/2020
Dermal Injection 10mg/ml Pharmaceuticals uc
suspension for injection, 1 ml

Cozaar 2.5mg/ml Powder Merck Sharp & Dohme PA1286/004/004 Powder for oral suspension - Losartan potassium 01/04/2020
and Solvent for Oral Ireland (Human Health)
Suspension Limited
Delmosart PR 18 mg Accord Healthcare Ireland PA2315/147/001 Prolonged-release tablet - Methylphenidate 01/04/2020
prolonged-release tablets Ltd. hydrochloride
Delmosart PR 27 mg Accord Healthcare Ireland PA2315/147/002 Prolonged-release tablet - Methylphenidate 01/04/2020
prolonged-release tablets Ltd. hydrochloride
Delmosart PR 36 mg Accord Healthcare Ireland PA2315/147/003 Prolonged-release tablet - Methylphenidate 01/04/2020
prolonged-release tablets Ltd. hydrochloride
Delmosart PR 54 mg Accord Healthcare Ireland PA2315/147/004 Prolonged-release tablet - Methylphenidate 01/04/2020
prolonged-release tablets Ltd. hydrochloride
Menjugate GSK Vaccines S.r.l. PA0919/004/001 Suspension for injection - Meningococcal 01/04/2020
polysaccharide group c
Bifril Plus 30 mg/12.5 mg Menarini International PA0865/013/001 Film-coated tablet - ZOFENOPRIL CALCIUM 31/03/2020
film-coated tablets Operations Luxembourg S.A. - Hydrochlorothiazide

Darunavir Teva 600mg Film- Teva B.V. PA1986/015/002 Film-coated tablet - Darunavir 31/03/2020
coated Tablets
Duloxetine Teva 30 mg Teva B.V. PA1986/004/001 Gastro-resistant capsule, - Duloxetine hydrochloride 31/03/2020
Gastro resistant capsules, hard
hard Interchangeable List Code:
IC0091-033-006
Duloxetine Teva 60 mg Teva B.V. PA1986/004/002 Gastro-resistant capsule, - Duloxetine hydrochloride 31/03/2020
Gastro resistant capsules, hard
hard Interchangeable List Code:
IC0091-127-006
Entecavir Teva 0.5 mg Film- Teva B.V. PA1986/036/001 Tablet - Entecavir 31/03/2020
coated Tablets
Hexabrix 320 Solution for Guerbet PA0686/006/001 Solution for injection - Meglumine ioxaglate 31/03/2020
Injection - Iodine
- Sodium ioxaglate
Infacol 40mg/ml Oral Tosara Pharma Limited PA0247/004/001 Oral drops, suspension - Simeticone 31/03/2020
Suspension
Latanoprost Teva Teva Pharma B.V. PA0749/173/001 Eye drops, solution - Latanoprost 31/03/2020

Interchangeable List Code:


IC0096-152-045
Teriparatide Teva 20 Teva B.V. PA1986/022/001 Solution for injection in pre- - Teriparatide 31/03/2020
micrograms/80 microlitres filled pen
Solution for Injection in pre-
filled pen
Aripiprazole Accord Accord Healthcare Ireland PA2315/026/003 Tablet - Aripiprazole 30/03/2020
Healthcare 15 mg tablets Ltd.
Interchangeable List Code:
IC0092-032-056
Aripiprazole Accord Accord Healthcare Ireland PA2315/026/004 Tablet - Aripiprazole 30/03/2020
Healthcare 30 mg tablets Ltd.
Interchangeable List Code:
IC0092-033-056
Aripiprazole Accord Accord Healthcare Ireland PA2315/026/001 Tablet - Aripiprazole 30/03/2020
Healthcare 5 mg tablets Ltd.
Interchangeable List Code:
IC0092-001-002
Concerta XL 54 mg Janssen-Cilag Ltd PA0748/049/003 Prolonged-release tablet - Methylphenidate 27/03/2020
prolonged-release tablets hydrochloride
- Methylphenidate
hydrochloride

Human Medicines Withdrawn Products Page 56 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Optinate 75mg Film-coated Accord Healthcare Ireland PA2315/238/002 Film-coated tablet - Risedronate sodium 27/03/2020
Tablets Ltd.
Interchangeable List Code:
IC0068-028-003
Optinate Once a Week 35mg Accord Healthcare Ireland PA2315/238/001 Film-coated tablet - Risedronate sodium 27/03/2020
Film-coated Tablets Ltd.
Interchangeable List Code:
IC0068-124-003
Irbesan 150mg Film-coated Rowex Ltd PA0711/155/002 Film-coated tablet - Irbesartan 26/03/2020
Tablets
Irbesan 300mg Film-coated Rowex Ltd PA0711/155/003 Film-coated tablet - Irbesartan 26/03/2020
Tablets
Irbesan 75mg Film-coated Rowex Ltd PA0711/155/001 Film-coated tablet - Irbesartan 26/03/2020
Tablets
Ternaf 250 mg Tablets Rowex Ltd PA0711/071/002 Tablet - Terbinafine 26/03/2020
SUBCUVIA 160 g/l. Solution Baxalta Innovations GmbH PA2004/007/001 Solution for injection - Human plasma protein 25/03/2020
for injection >95% immunoglobulins
Zomestine 10 mg Prolonged- Accord Healthcare Ireland PA2315/169/002 Prolonged-release tablet - OXYCODONE 19/03/2020
release Tablets Ltd. HYDROCHLORIDE
Interchangeable List Code:
IC0066-002-024
Zomestine 20 mg Prolonged- Accord Healthcare Ireland PA2315/169/003 Prolonged-release tablet - OXYCODONE 19/03/2020
release Tablets Ltd. HYDROCHLORIDE
Interchangeable List Code:
IC0066-003-024
Zomestine 40 mg Prolonged- Accord Healthcare Ireland PA2315/169/004 Prolonged-release tablet - OXYCODONE 19/03/2020
release Tablets Ltd. HYDROCHLORIDE
Interchangeable List Code:
IC0066-004-024
Zomestine 5 mg Prolonged- Accord Healthcare Ireland PA2315/169/001 Prolonged-release tablet - OXYCODONE 19/03/2020
release Tablets Ltd. HYDROCHLORIDE
Interchangeable List Code:
IC0066-001-024
Zomestine 80 mg Prolonged- Accord Healthcare Ireland PA2315/169/005 Prolonged-release tablet - OXYCODONE 19/03/2020
release Tablets Ltd. HYDROCHLORIDE
Interchangeable List Code:
IC0066-005-024
INDAPAMIDE SR Les Laboratoires Servier PA0568/010/001 Prolonged-release tablet - Indapamide 18/03/2020
Everolimus Teva 10 mg Teva B.V. PA1986/034/003 Tablet - Everolimus 17/03/2020
Tablets
Everolimus Teva 2.5 mg Teva B.V. PA1986/034/001 Tablet - Everolimus 17/03/2020
Tablets
Everolimus Teva 5 mg Teva B.V. PA1986/034/002 Tablet - Everolimus 17/03/2020
Tablets
Perlinring 0.120 mg/0.015 mg Actavis Group PTC ehf PA1380/207/001 Vaginal delivery system - Etonogestrel 17/03/2020
per 24 hours, vaginal delivery - Ethinylestradiol
system
Beclazone 50 micrograms Norton Waterford PA0436/021/013 Pressurised inhalation, - BECLOMETASONE 16/03/2020
Easi-Breathe CFC-Free solution DIPROPIONATE
Inhaler Pressurised
Inhalation Solution
Bisodol Extra Strong Mint Teva B.V. PA1986/070/001 Chewable tablet - Calcium carbonate 16/03/2020
Chewable TabletsCalcium - Magnesium carbonate light
carbonate 522mgMagnesium - Sodium hydrogen
carbonate light 68mgSodium carbonate
hydrogen carbonate 64mg

Lansoprazole Teva 15 mg Teva Pharma B.V. PA0749/024/003 Orodispersible tablet - Lansoprazole 16/03/2020
Orodispersible Tablets
Interchangeable List Code:
IC0008-032-033
Lansoprazole Teva 30 mg Teva Pharma B.V. PA0749/024/004 Orodispersible tablet - Lansoprazole 16/03/2020
Orodispersible Tablets
Interchangeable List Code:
IC0008-033-033
Nailex 5% Medicated Nail Laboratories Gerda PA2175/002/001 Medicated nail lacquer - Amorolfine hydrochloride 13/03/2020
Lacquer
Diclofenac 50 mg/Misoprostol Morningside Healthcare Ltd PA1333/014/001 Modified-release tablet - DICLOFENAC SODIUM 11/03/2020
200 micrograms modified - Misoprostol
release tablets Interchangeable List Code:
IC0058-109-021
Diclofenac 75 mg/Misoprostol Morningside Healthcare Ltd PA1333/014/002 Modified-release tablet - Diclofenac sodium 11/03/2020
200 micrograms modified - Misoprostol
release tablets Interchangeable List Code:
IC0058-113-021

Human Medicines Withdrawn Products Page 57 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Leflunomide 10 mg Film Morningside Healthcare Ltd PA1333/011/001 Tablet - Leflunomide 11/03/2020
Coated Tablets
Leflunomide 100 mg Film Morningside Healthcare Ltd PA1333/011/003 Tablet - Leflunomide 11/03/2020
Coated Tablets
Leflunomide 20 mg Film Morningside Healthcare Ltd PA1333/011/002 Tablet - Leflunomide 11/03/2020
Coated Tablets
Candesartan/Hydrochlorothi Clonmel Healthcare Ltd PA0126/251/001 Tablet - Candesartan cilexetil 10/03/2020
azide Clonmel 16mg / - Hydrochlorothiazide
12.5mg Tablets Interchangeable List Code:
IC0029-036-002
Veramil 40 mg Film-coated Orion Corporation PA1327/008/001 Film-coated tablet - VERAPAMIL 10/03/2020
Tablets HYDROCHLORIDE
Betadine 10 mg/ml Gargle Mundipharma PA1688/021/005 Mouthwash - Iodinated povidone 03/03/2020
and Mouthwash Pharmaceuticals Limited
Betadine 10% w/w Ointment Mundipharma PA1688/021/006 Ointment 03/03/2020
Pharmaceuticals Limited
Betadine 100 mg/ml Mundipharma PA1688/021/002 Cutaneous solution - Iodinated povidone 03/03/2020
Antiseptic Paint Pharmaceuticals Limited
Betadine 40mg/ml Shampoo Mundipharma PA1688/021/007 Shampoo - Povidone iodinated 03/03/2020
Pharmaceuticals Limited
Betadine Alcoholic 100 Mundipharma PA1688/021/001 Cutaneous solution - Iodinated povidone 03/03/2020
mg/ml Cutaneous Solution Pharmaceuticals Limited
Betadine Dry Powder 25 Mundipharma PA1688/021/004 Cutaneous spray, powder - Povidone-iodine 03/03/2020
mg/g cutaneous spray Pharmaceuticals Limited
Betadine Skin Cleanser Mundipharma PA1688/021/008 Cutaneous solution - Povidone-iodine 03/03/2020
40mg/ml cutaneous solution Pharmaceuticals Limited
Betadine Surgical Scrub 75 Mundipharma PA1688/021/009 Cutaneous solution - Iodinated povidone 03/03/2020
mg/ml Cutaneous Solution Pharmaceuticals Limited
BREAKYL 1200 microgram Mylan IRE Healthcare PA2010/027/005 Buccal film - FENTANYL CITRATE 03/03/2020
buccal film Limited
BREAKYL 200 microgram Mylan IRE Healthcare PA2010/027/001 Buccal film - FENTANYL CITRATE 03/03/2020
buccal film Limited
BREAKYL 400 microgram Mylan IRE Healthcare PA2010/027/002 Buccal film - FENTANYL CITRATE 03/03/2020
buccal film Limited
BREAKYL 600 microgram Mylan IRE Healthcare PA2010/027/003 Buccal film - FENTANYL CITRATE 03/03/2020
buccal film Limited
BREAKYL 800 microgram Mylan IRE Healthcare PA2010/027/004 Buccal film - FENTANYL CITRATE 03/03/2020
buccal film Limited
Standardised Betadine Mundipharma PA1688/021/010 Cutaneous solution - Iodinated povidone 03/03/2020
Antiseptic 100 mg/ml Pharmaceuticals Limited
Cutaneous Solution
Urokinase medac 10,000 IU, Medac Gesellschaft fur PA0623/017/001 Powder for solution for - Urokinase 01/03/2020
powder for solution for Klinische Spezialpraparate infusion
infusion mbH
Urokinase medac 100,000 Medac Gesellschaft fur PA0623/017/003 Powder for solution for - Urokinase 01/03/2020
IU, powder for solution for Klinische Spezialpraparate infusion
infusion mbH
Urokinase medac 250,000 IU Medac Gesellschaft fur PA0623/017/004 Powder for solution for - Urokinase 01/03/2020
powder for solution for Klinische Spezialpraparate infusion
infusion mbH
Urokinase medac 50,000 IU, Medac Gesellschaft fur PA0623/017/002 Powder for solution for - Urokinase 01/03/2020
powder for solution for Klinische Spezialpraparate infusion
infusion mbH
Urokinase medac 500,000 Medac Gesellschaft fur PA0623/017/005 Powder for solution for - Urokinase 01/03/2020
IU, powder for solution for Klinische Spezialpraparate infusion
infusion mbH
Zoledronic Acid FAIR-MED Fair-Med Healthcare GmbH PA1789/004/001 Concentrate for solution for - Zoledronic acid 01/03/2020
4mg/5ml, Concentrate for infusion monohydrate
solution for infusion
Catacrom 2% w/v eye drops, Rayner Pharmaceuticals PA2161/001/001 Eye drops, solution - Sodium cromoglicate 28/02/2020
solution Limited
Mitomycin-C Kyowa 10 mg, Kyowa Kirin Holdings B.V. PA2288/002/001 Powder for solution for - Mitomycin 28/02/2020
Powder for Solution for injection
Injection
Mitomycin-C Kyowa 40 mg, Kyowa Kirin Holdings B.V. PA2288/002/002 Powder for solution for - Mitomycin 28/02/2020
powder for intravesical infusion
solution
Lercanidipine Teva 10 mg Teva Pharma B.V. PA0749/115/001 Film-coated tablet - Lercanidipine hydrochloride 26/02/2020
Film-coated Tablets
Interchangeable List Code:
IC0020-002-003
Lercanidipine Teva 20 mg Teva Pharma B.V. PA0749/115/002 Film-coated tablet - Lercanidipine hydrochloride 26/02/2020
Film-coated Tablets
Interchangeable List Code:
IC0020-003-003

Human Medicines Withdrawn Products Page 58 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Calamine Lotion BP Pinewood Laboratories Ltd, PA0281/051/001 Cutaneous suspension - Calamine 25/02/2020
- Zinc oxide
BIFRIL 15 mg film-coated Menarini International PA0865/004/002 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

BIFRIL 30 mg film-coated Menarini International PA0865/004/003 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

BIFRIL 60 mg film-coated Menarini International PA0865/004/004 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

BIFRIL 7.5 mg film-coated Menarini International PA0865/004/001 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

ZOFENIL 15 mg film-coated Menarini International PA0865/003/002 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

ZOFENIL 60 mg film-coated Menarini International PA0865/003/004 Film-coated tablet - ZOFENOPRIL CALCIUM 21/02/2020
tablets Operations Luxembourg S.A.

Actonel Once a Week 35 mg IMED Healthcare Ltd. PPA1463/023/001 Film-coated tablet - Risedronate sodium 17/02/2020
film-coated tablets
MST CONTINUS suspension Mundipharma PA1688/004/010 Prolonged-release granules - Morphine 14/02/2020
60 mg Pharmaceuticals Limited for oral suspension
Picato Leo Laboratories Limited EU/1/12/796/002 Gel - Ingenol mebutate 13/02/2020
RabipurPowder and solvent GSK Vaccines GmbH PA0877/003/001 Powder and solvent for - INACTIVATED RABIES 05/02/2020
for solution for injection solution for injection VIRUS
Rabies vaccine (inactivated)
Paracetamol 500 mg Tablets Clonmel Healthcare Ltd PA0126/065/001 Tablet - Paracetamol 04/02/2020

Fucidin 30mg/100cm2 LEO Pharma A/S PA1025/004/001 Impregnated dressing - Sodium fusidate 31/01/2020
impregnated dressing
PREGNYL 5000 I.U., powder NV Organon PA0964/005/002 Powder and solvent for - Chorionic gonadotrophin 31/01/2020
and solvent for solution for solution for injection
injection
Oxybutynin Hydrochloride 5 Genthon B.V. PA0740/001/001 Tablet - OXYBUTYNIN 27/01/2020
mg tablets HYDROCHLORIDE
Fertavid Merck Sharp and Dohme EU/1/09/510/10-11 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/12 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/1-2 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/13 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/14 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/15 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/16 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/17 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/18 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/19 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Schering Plough Europe EU/1/09/510/3 Solution for injection - Follitropin beta 23/01/2020
Fertavid Merck Sharp and Dohme EU/1/09/510/4-5 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/6 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/7-8 Solution for injection - Follitropin beta 23/01/2020
Limited
Fertavid Merck Sharp and Dohme EU/1/09/510/9 Solution for injection - Follitropin beta 23/01/2020
Limited
Prozit 20mg Hard Capsules Unichem Laboratories Ltd PA22654/001/001 Capsule, hard - FLUOXETINE 22/01/2020
HYDROCHLORIDE
Interchangeable List Code:
IC0075-003-001
DuoPlavin Sanofi-Aventis Groupe EU/1/10/619/001 Film-coated tablet - Clopidogrel hydrogen 21/01/2020
sulphate
- Acetylsalicylic acid
Famvir 500mg film-coated Lexon (UK) Ltd PPA1097/028/001 Film-coated tablet - Famciclovir 20/01/2020
tablets

Human Medicines Withdrawn Products Page 59 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Myelle 0.02 mg/3 mg tablets McDermott Laboratories Ltd., PA0577/226/001 Tablet - Drospirenone 20/01/2020
T/A Gerard Laboratories - Ethinylestradiol

Mymin 0.03 mg/3 mg tablets McDermott Laboratories Ltd., PA0577/227/001 Tablet - Drospirenone 20/01/2020
T/A Gerard Laboratories - Ethinylestradiol

Enantyum 25 mg granules for Laboratorios Menarini S.A. PA0901/001/005 Granules for oral solution - Dexketoprofen 17/01/2020
oral solution
Enantyum 25 mg oral Laboratorios Menarini S.A. PA0901/001/006 Oral solution - Dexketoprofen 17/01/2020
solution in sachet
Enantyum 50 mg/2ml Laboratorios Menarini S.A. PA0901/001/003 Solution for injection - Dexketoprofen 17/01/2020
Solution for injection/infusion

Keral 12.5 mg film-coated Menarini International PA0865/002/001 Film-coated tablet - Dexketoprofen 17/01/2020
tablets Operations Luxembourg S.A.

Preterax 2mg/0.625mg Les Laboratoires Servier PA0568/008/001 Tablet - Perindopril tert-butylamine 15/01/2020
tablets salt
- Indapamide
Clopidogrel ratiopharm Archie Samuel s.r.o. EU/1/09/541/1-8 Film-coated tablet - Clopidogrel besilate 13/01/2020
GmbH - Macrogol 6000
Interchangeable List Code: - Carbon dioxide
IC0005-028-003
Versatis 5% medicated IMED Healthcare Ltd. PPA1463/079/001 Medicated plaster - Lidocaine 13/01/2020
plaster
Autolus GmbH 22841/001/001 Not assigned 10/01/2020
Jafral Ltd 22907/001/001 Not assigned 10/01/2020
ALMA BIO THERAPEUTICS 22908/001/001 Not assigned 10/01/2020

Not Applicable Boehringer Ingelheim 0775/002/001 Not assigned 10/01/2020


International GmbH
Escivriens 15 mg film-coated Genthon B.V. PA0740/012/002 Film-coated tablet - Escitalopram 09/01/2020
tablets
Interchangeable List Code:
IC0071-032-003
Rolyprexa DisTab 10 mg Rowex Ltd PA0711/195/002 Orodispersible tablet - Olanzapine 08/01/2020
orodispersible tablets
Interchangeable List Code:
IC0007-002-038
Rolyprexa DisTab 15 mg Rowex Ltd PA0711/195/003 Orodispersible tablet - Olanzapine 08/01/2020
orodispersible tablets
Interchangeable List Code:
IC0007-032-038
Rolyprexa DisTab 20 mg Rowex Ltd PA0711/195/004 Orodispersible tablet - Olanzapine 08/01/2020
orodispersible tablets
Interchangeable List Code:
IC0007-003-038
Rolyprexa DisTab 5 mg Rowex Ltd PA0711/195/001 Orodispersible tablet - Olanzapine 08/01/2020
orodispersible tablets
Interchangeable List Code:
IC0007-001-038
Risperidone 0.5mg film- Wockhardt UK Limited PA1339/014/001 Film-coated tablet - Risperidone 07/01/2020
coated tablets
Interchangeable List Code:
IC0012-040-003
Risperidone 1mg film-coated Wockhardt UK Limited PA1339/014/002 Film-coated tablet - Risperidone 07/01/2020
tablets
Interchangeable List Code:
IC0012-039-003
Risperidone 2mg film-coated Wockhardt UK Limited PA1339/014/003 Film-coated tablet - Risperidone 07/01/2020
tablets
Interchangeable List Code:
IC0012-006-003
Risperidone 3mg film-coated Wockhardt UK Limited PA1339/014/004 Film-coated tablet - Risperidone 07/01/2020
tablets
Interchangeable List Code:
IC0012-045-003
Risperidone 4mg film-coated Wockhardt UK Limited PA1339/014/005 Film-coated tablet - Risperidone 07/01/2020
tablets
Interchangeable List Code:
IC0012-008-003
Risperidone 6mg film-coated Wockhardt UK Limited PA1339/014/006 Film-coated tablet - Risperidone 07/01/2020
tablets
Interchangeable List Code:
IC0012-046-003

Human Medicines Withdrawn Products Page 60 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Azithromycin 250mg Film- Wockhardt UK Limited PA1339/038/002 Film-coated tablet - Azithromycin anhydrous 06/01/2020
coated Tablets
Azithromycin 500mg Film- Wockhardt UK Limited PA1339/038/003 Film-coated tablet - Azithromycin anhydrous 06/01/2020
coated Tablets
Pioglitazone Hydrochloride Wockhardt UK Limited PA1339/040/002 Tablet - Pioglitazone hydrochloride 06/01/2020
30mg Tablets
Pioglitazone Hydrochloride Wockhardt UK Limited PA1339/040/003 Tablet - Pioglitazone hydrochloride 06/01/2020
45mg Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/002 Film-coated tablet - Rosuvastatin 06/01/2020
Krka 10mg/10mg Film-coated - Amlodipine
Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/001 Film-coated tablet - Rosuvastatin 06/01/2020
Krka 10mg/5mg Film-coated - Amlodipine
Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/006 Film-coated tablet - Rosuvastatin calcium 06/01/2020
Krka 15mg/10mg Film-coated - Amlodipine besilate
Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/005 Film-coated tablet - Amlodipine besilate 06/01/2020
Krka 15mg/5mg Film-coated - Rosuvastatin calcium
Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/004 Film-coated tablet - Rosuvastatin calcium 06/01/2020
Krka 20mg/10mg Film-coated - Amlodipine besilate
Tablets
Rosuvastatin/amlodipine Krka d.d., Novo mesto PA1347/053/003 Film-coated tablet - Rosuvastatin 06/01/2020
Krka 20mg/5mg Film-coated - Amlodipine
Tablets
Eucardic 3.125mg Tablets CHEPLAPHARM Arzneimittel PA2239/001/004 Tablet - Carvedilol 01/01/2020
GmbH
Nutraplus 100mg/g Cream Galderma International PA22743/011/001 Cream - Urea 31/12/2019
S.A.S.
Epirubicin 2 mg/ml Solution Actavis Group hf PA1366/003/001 Solution for injection - Epirubicin hydrochloride 24/12/2019
for Injection
Lisa 2 mg/0.03 mg film- Laboratorios Leon Farma, PA1474/012/001 Film-coated tablet - Dienogest 23/12/2019
coated tablets S.A. - Ethinylestradiol
Diclofenac Potassium 50 mg Accord Healthcare Ireland PA2315/138/001 Film-coated tablet - Diclofenac potassium 20/12/2019
Film-coated Tablets Ltd.
Interchangeable List Code:
IC0057-023-040
Enantyum 12.5 mg film- Laboratorios Menarini S.A. PA0901/001/001 Film-coated tablet - Dexketoprofen 20/12/2019
coated tablets
Enantyum 12.5 mg granules Laboratorios Menarini S.A. PA0901/001/004 Granules for oral solution - Dexketoprofen 20/12/2019
for oral solution
Enantyum 25 mg film-coated Laboratorios Menarini S.A. PA0901/001/002 Tablet - Dexketoprofen 20/12/2019
tablets
Keral 12.5 mg granules for Menarini International PA0865/002/004 Granules for oral solution - Dexketoprofen 20/12/2019
oral solution Operations Luxembourg S.A.

MIGUAR 2.5 mg film-coated Menarini International PA0865/008/001 Film-coated tablet - FROVATRIPTAN 20/12/2019
tablets Operations Luxembourg S.A.

Mometasone Furoate 0.1% Auden Mckenzie (Pharma PA1352/018/001 Cream - Mometasone furoate 18/12/2019
w/w Cream Division) Ltd
Mometasone Furoate 0.1% Auden Mckenzie (Pharma PA1352/018/002 Ointment - Mometasone furoate 18/12/2019
w/w Ointment Division) Ltd
Rosuvastatin 10 mg Film- Actavis Group PTC ehf PA1380/202/002 Film-coated tablet - Rosuvastatin calcium 18/12/2019
coated Tablets
Interchangeable List Code:
IC0006-002-003
Rosuvastatin 20 mg Film- Actavis Group PTC ehf PA1380/202/003 Film-coated tablet - Rosuvastatin calcium 18/12/2019
coated Tablets
Interchangeable List Code:
IC0006-003-003
Rosuvastatin 40 mg Film- Actavis Group PTC ehf PA1380/202/004 Film-coated tablet - Rosuvastatin calcium 18/12/2019
coated Tablets
Interchangeable List Code:
IC0006-004-003
Rosuvastatin 5 mg Film- Actavis Group PTC ehf PA1380/202/001 Film-coated tablet - Rosuvastatin calcium 18/12/2019
coated Tablets
Interchangeable List Code:
IC0006-001-003

Human Medicines Withdrawn Products Page 61 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Anugesic HC Cream Pfizer Healthcare Ireland PA0822/009/001 Cream - Benzyl benzoate 17/12/2019
- HYDROCORTISONE
ACETATE
- Bismuth oxide
- Balsam peru
- Pramocaine hydrochloride
- Zinc oxide
HELIXATE NexGen Bayer AG EU/1/00/144/001 Powder and solvent for - Factor viii, recombinant 16/12/2019
solution for injection
Helixate NexGen Bayer Schering Pharma AG EU/1/00/144/002 Powder and solvent for - Factor viii, recombinant 16/12/2019
solution for injection
Helixate NexGen Bayer Schering Pharma AG EU/1/00/144/003 Powder and solvent for - Factor viii, recombinant 16/12/2019
solution for injection
Helixate NexGen Bayer Schering Pharma AG EU/1/00/144/004 Powder and solvent for - Octocog alfa 16/12/2019
solution for injection
Helixate NexGen Bayer Schering Pharma AG EU/1/00/144/005 Powder and solvent for - Octocog alfa 16/12/2019
solution for injection
KROMEYA Merck Serono S.p.A. (MS- EU/1/19/1357/001 Solution for injection - Adalimumab 16/12/2019
Bari)
KROMEYA Merck Serono S.p.A. (MS- EU/1/19/1357/002 Solution for injection in pre- - Adalimumab 16/12/2019
Bari) filled syringe
KROMEYA Merck Serono S.p.A. (MS- EU/1/19/1357/003 Solution for injection in pre- - Adalimumab 16/12/2019
Bari) filled pen
Spiolto Respimat 2.5 Lexon (UK) Ltd PPA1097/048/001 Inhalation solution - Olodaterol 16/12/2019
microgram/2.5 microgram, - Tiotropium
inhalation solution
Terbinafine Liconsa 250 mg Laboratorios Velvian S.L PA1067/004/001 Tablet - Terbinafine 16/12/2019
Tablets
Apresoline Ampoules 20 mg Amdipharm Limited PA1142/015/001 Powder for concentrate for - HYDRALAZINE 15/12/2019
Powder for concentrate for solution for injection/infusion HYDROCHLORIDE
solution for injection or
infusion
Ponalgic Forte 500mg Film- Mercury Pharmaceuticals PA0073/097/002 Film-coated tablet - Mefenamic acid 15/12/2019
Coated Tablets (Ireland) Ltd
Kefort 150mg Film-Coated Laboratorios LICONSA, S.A. PA1239/014/001 Film-coated tablet - Ibandronic acid 13/12/2019
Tablets
INFUKOLL N Serumwerk Bernburg AG PA1136/001/001 Solution for infusion - Poly(o-2- 12/12/2019
hydroxyethyl)starch
- Sodium chloride
Zineryt Powder and Solvent LTT Pharma Limited PPA1562/172/001 Powder and solvent for - Zinc Acetate Dihydrate 12/12/2019
for Cutaneous Solution, 30 cutaneous solution - Erythromycin
ml
Losartan Potassium 100mg Wockhardt UK Limited PA1339/029/003 Film-coated tablet - Losartan potassium 11/12/2019
Film-Coated Tablets
Interchangeable List Code:
IC0003-024-003
Losartan Potassium 25mg Wockhardt UK Limited PA1339/029/001 Film-coated tablet - Losartan potassium 11/12/2019
Film-Coated Tablets
Interchangeable List Code:
IC0003-022-003
Losartan Potassium 50mg Wockhardt UK Limited PA1339/029/002 Film-coated tablet - Losartan potassium 11/12/2019
Film-Coated Tablets
Interchangeable List Code:
IC0003-023-003
Mycophenolate Mofetil Wockhardt UK Limited PA1339/028/001 Film-coated tablet - Mycophenolate mofetil 11/12/2019
500mg Film-Coated Tablets
Pantoprazole 20 mg gastro- Wockhardt UK Limited PA1339/021/001 Gastro-resistant tablet - Pantoprazole sodium 11/12/2019
resistant tablets sesquihydrate
Interchangeable List Code:
IC0013-003-005
Pantoprazole 40 mg gastro- Wockhardt UK Limited PA1339/021/002 Gastro-resistant tablet - Pantoprazole sodium 11/12/2019
resistant tablets sesquihydrate
Interchangeable List Code:
IC0013-004-005
Tonpular XL 150 mg Wockhardt UK Limited PA1339/023/002 Prolonged-release capsule, - Venlafaxine 11/12/2019
prolonged-release hard hard
capsules Interchangeable List Code:
IC0026-062-030
Tonpular XL 75 mg Wockhardt UK Limited PA1339/023/001 Prolonged-release capsule, - Venlafaxine 11/12/2019
prolonged-release hard hard
capsules Interchangeable List Code:
IC0026-028-030
Zoledronic Acid 4mg/100ml Wockhardt UK Limited PA1339/032/002 Solution for infusion - Zoledronic acid 11/12/2019
Solution for Infusion

Human Medicines Withdrawn Products Page 62 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zoledronic Acid 4mg/5ml Wockhardt UK Limited PA1339/032/001 Concentrate for solution for - Zoledronic acid 11/12/2019
Concentrate for Solution for infusion monohydrate
Infusion
Ibandronic Acid Liconsa 150 Laboratorios LICONSA, S.A. PA1239/013/001 Film-coated tablet - Ibandronic acid 10/12/2019
mg Film-Coated Tablets
Isotrex 0.5 mg/g Gel GlaxoSmithKline (Ireland) PA1077/122/001 Gel - Isotretinoin 10/12/2019
Limited
Tramadol Amneal Pharma Europe PA1897/011/001 Film-coated tablet - Tramadol hydrochloride 09/12/2019
hydrochloride/Paracetamol Limited - Paracetamol
Amneal 37.5 mg/ 325 mg, Interchangeable List Code:
film-coated tablets IC0077-133-014
Ethambutol 100mg Film Pfizer Healthcare Ireland PA0822/180/001 Film-coated tablet - Ethambutol hydrochloride 06/12/2019
Coated Tablets
Ethambutol 400mg Film Pfizer Healthcare Ireland PA0822/180/002 Film-coated tablet - Ethambutol hydrochloride 06/12/2019
Coated Tablets
Premique 0.625mg/2.5mg Pfizer Healthcare Ireland PA0822/096/002 Coated tablet - Conjugated estrogens 06/12/2019
Coated Tablets - Medroxyprogesterone
acetate
Prempak-C 0.625mg Coated Pfizer Healthcare Ireland PA0822/097/001 Coated tablet - Conjugated estrogens 06/12/2019
Tablets - Norgestrel
Prempak-C 1.25mg Coated Pfizer Healthcare Ireland PA0822/097/002 Coated tablet - Conjugated estrogens 06/12/2019
Tablets - Norgestrel
Voluven 6% Solution for Fresenius Kabi Limited PA0566/020/001 Solution for infusion - Poly(o-2- 05/12/2019
Infusion (Glass bottle) hydroxyethyl)starch
- Sodium chloride
Xiapex Swedish Orphan Biovitrum EU/1/11/671/001 Powder and solvent for - Collagenase clostridium 05/12/2019
AB solution for injection histolyticum
Fluarix suspension for GlaxoSmithKline (Ireland) PA1077/025/001 Suspension for injection - B/brisbane/60/2008 - like 04/12/2019
injection in a prefilled Limited strain (b/brisbane/60/2008)
syringeInfluenza vaccine - A/hong kong/4801/2014
(split virion, inactivated) (h3n2) - like strain (a/hong
kong/4801/2014, nymc x-
263b)
- A/california/7/2009 (h1n1)
pdm09-like strain used nib-
74xp derived from
a/christchurch/16/2010
OptiMARK Guerbet EU/1/07/398/1-14 Solution for injection - Gadoversetamide 04/12/2019
Kiwiherb Valerian Oral Liquid Phytomed (UK) Ltd TR1734/006/001 Oral solution - Valeriana officinalis 02/12/2019

Telmisartan/Hydrochlorothia Rowex Ltd PA0711/211/001 Coated tablet - Telmisartan 02/12/2019


zide Rowex 40 mg/12.5 mg - Hydrochlorothiazide
coated tablets Interchangeable List Code:
IC0050-099-039
Telmisartan/Hydrochlorothia Rowex Ltd PA0711/211/002 Coated tablet - Telmisartan 02/12/2019
zide Rowex 80 mg/12.5 mg - Hydrochlorothiazide
coated tablets Interchangeable List Code:
IC0050-081-039
Telmisartan/Hydrochlorothia Rowex Ltd PA0711/211/003 Coated tablet - Telmisartan 02/12/2019
zide Rowex 80 mg/25 mg - Hydrochlorothiazide
coated tablets Interchangeable List Code:
IC0050-100-039
Agomelatine Teva 25 mg Teva B.V. PA1986/047/001 Film-coated tablet - AGOMELATINE UREA 27/11/2019
Film Coated Tablets
Cymalon granules for oral Actavis Group PTC ehf PA1380/051/001 Granules for oral solution - Sodium bicarbonate 22/11/2019
solution - Sodium citrate dihydrate
- Sodium carbonate
anhydrous
- Citric acid
Veno’s Honey and Lemon Teva B.V. PA1986/075/001 Oral solution - Ammonium chloride 22/11/2019
oral solution - Lemon juice
- Ipecacuanha fluid extract
- Liquid glucose
- Honey
Venos Expectorant, Oral Teva B.V. PA1986/074/001 Oral solution - Guaifenesin 22/11/2019
SolutionGuaifenesin 100 - Treacle
mg/5 mlLiquid glucose 3 g/5 - Liquid glucose
mlTreacle 1.35 g/5 ml
Lescol 20 mg Capsules, hard Novartis Ireland Limited PA0896/016/001 Capsule, hard - Fluvastatin 20/11/2019

Lescol 40 mg Capsules, hard Novartis Ireland Limited PA0896/016/002 Capsule, hard - Fluvastatin 20/11/2019

Quetiapine 150 mg Film- Accord Healthcare Ireland PA2315/191/003 Film-coated tablet - Quetiapine fumarate 20/11/2019
coated Tablets Ltd.
Interchangeable List Code:
IC0019-062-003

Human Medicines Withdrawn Products Page 63 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Rivastigmine 1.5 mg hard Accord Healthcare Ireland PA2315/052/001 Capsule, hard - Rivastigmine 20/11/2019
capsules Ltd.
Rivastigmine 3 mg hard Accord Healthcare Ireland PA2315/052/002 Capsule, hard - Rivastigmine 20/11/2019
capsules Ltd.
Rivastigmine 4.5 mg hard Accord Healthcare Ireland PA2315/052/003 Capsule, hard - Rivastigmine 20/11/2019
capsules Ltd.
Rivastigmine 6 mg hard Accord Healthcare Ireland PA2315/052/004 Capsule, hard - Rivastigmine 20/11/2019
capsules Ltd.
Zonisamide Accord 100 mg Accord Healthcare Ireland PA2315/025/003 Capsule, hard - Zonisamide 20/11/2019
hard capsules Ltd.
Zonisamide Accord 25 mg Accord Healthcare Ireland PA2315/025/001 Capsule, hard - Zonisamide 20/11/2019
hard capsules Ltd.
Zonisamide Accord 50 mg Accord Healthcare Ireland PA2315/025/002 Capsule, hard - Zonisamide 20/11/2019
hard capsules Ltd.
Setinin XL 200 mg Actavis Group PTC ehf PA1380/103/003 Prolonged-release tablet - Quetiapine fumarate 18/11/2019
Prolonged-release tablets
Interchangeable List Code:
IC0019-067-024
Setinin XL 300 mg Actavis Group PTC ehf PA1380/103/004 Prolonged-release tablet - Quetiapine fumarate 18/11/2019
Prolonged-release tablets
Interchangeable List Code:
IC0019-029-024
Setinin XL 400 mg Actavis Group PTC ehf PA1380/103/005 Prolonged-release tablet - Quetiapine fumarate 18/11/2019
Prolonged-release tablets
Interchangeable List Code:
IC0019-068-024
Setinin XL 50 mg Prolonged- Actavis Group PTC ehf PA1380/103/001 Prolonged-release tablet - Quetiapine fumarate 18/11/2019
release tablets
Interchangeable List Code:
IC0019-023-024
Atorvastatin Pfizer 10 mg film Pfizer Ireland PA1740/002/001 Film-coated tablet - Atorvastatin calcium 15/11/2019
coated tablets Pharmaceuticals
Interchangeable List Code:
IC0001-002-003
Atorvastatin Pfizer 20 mg film Pfizer Ireland PA1740/002/002 Film-coated tablet - Atorvastatin calcium 15/11/2019
coated tablets Pharmaceuticals
Interchangeable List Code:
IC0001-003-003
Atorvastatin Pfizer 40 mg film Pfizer Ireland PA1740/002/003 Film-coated tablet - Atorvastatin calcium 15/11/2019
coated tablets Pharmaceuticals
Interchangeable List Code:
IC0001-004-003
Atorvastatin Pfizer 80 mg film Pfizer Ireland PA1740/002/004 Film-coated tablet - Atorvastatin calcium 15/11/2019
coated tablets Pharmaceuticals
Interchangeable List Code:
IC0001-005-003
Qtrilmet AstraZeneca AB EU/1/19/1401/0015-028 Modified-release tablet - Dapagliflozin 11/11/2019
- Saxagliptin
- METFORMIN
HYDROCHLORIDE
Travoprost Sandoz 40 Rowex Ltd PA0711/213/001 Eye drops, solution - Travopost 11/11/2019
micrograms/ml Eye drops,
solution
SmofKabiven Electrolyte Fresenius Kabi Deutschland PA2059/059/001 Emulsion for infusion - L-alanine 01/11/2019
Free Central emulsion for GmbH - L-arginine
infusion, Excel bags - GLYCINE
- L-histidine
- L-isoleucine
- L-leucine
- L-lysine acetate
- L-methionine
- L-phenylalanine
- L-proline
- L-serine
- Taurine
- L-threonine
- L-tryptophan
- L-tyrosine
- L-valine
- Glucose monohydrate
- Soya bean oil, refined
- Triglycerides, medium chain
- Olive oil, refined
- Fish oil, rich in omega-3
acids

Human Medicines Withdrawn Products Page 64 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Armoneve 10 mg/5 mg Mundipharma PA1688/017/003 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-016-024 dihydrate
Armoneve 15 mg/7.5 mg Mundipharma PA1688/017/004 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-157-024 dihydrate
Armoneve 2.5 mg/1.25 mg Mundipharma PA1688/017/001 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
- Naloxone hydrochloride
dihydrate
Armoneve 20 mg/10 mg Mundipharma PA1688/017/005 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-061-024 dihydrate
Armoneve 30 mg/15 mg Mundipharma PA1688/017/006 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-158-024 dihydrate
Armoneve 40 mg/20 mg Mundipharma PA1688/017/007 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-160-024 dihydrate
Armoneve 5 mg/2.5 mg Mundipharma PA1688/017/002 Prolonged-release tablet - OXYCODONE 29/10/2019
prolonged-release tablets Pharmaceuticals Limited HYDROCHLORIDE
Interchangeable List Code: - Naloxone hydrochloride
IC0102-159-024 dihydrate
Fludarabine Phosphate Actavis Group PTC ehf PA1380/134/001 Concentrate for solution for - Fludarabine phosphate 25/10/2019
25mg/ml concentrate for injection/infusion
solution for injection/infusion
Irprezide 150mg/12.5mg Actavis Group PTC ehf PA1380/080/001 Film-coated tablet - Irbesartan 25/10/2019
Film-Coated Tablets - Hydrochlorothiazide
Irprezide 300mg/12.5mg Actavis Group PTC ehf PA1380/080/002 Film-coated tablet - Irbesartan 25/10/2019
Film-Coated Tablets - Hydrochlorothiazide
Irprezide 300mg/25mg Film- Actavis Group PTC ehf PA1380/080/003 Film-coated tablet - Irbesartan 25/10/2019
Coated Tablets - Hydrochlorothiazide
Cerazette 75 microgram film- IMED Healthcare Ltd. PPA1463/071/001 Film-coated tablet - Desogestrel 23/10/2019
coated tablets
Logynon Tablets IMED Healthcare Ltd. PPA1463/072/001 Tablet - Levonorgestrel 23/10/2019
- Ethinylestradiol
- Ethinylestradiol
- Levonorgestrel
- Levonorgestrel
Neurontin 100 mg Hard IMED Healthcare Ltd. PPA1463/084/001 Capsule, hard - Gabapentin 23/10/2019
Capsules
Neurontin 300 mg Hard IMED Healthcare Ltd. PPA1463/084/002 Capsule, hard - Gabapentin 23/10/2019
Capsules
Neurontin 600 mg film-coated IMED Healthcare Ltd. PPA1463/084/003 Film-coated tablet - Gabapentin 23/10/2019
tablets
Pharmaton Capsules IMED Healthcare Ltd. PPA1463/037/001 Capsule, soft - Selenium 23/10/2019
- Zinc (as zinc sulphate
monohydrate)
- Thiamine mononitrate
- Copper (as dried copper
sulpahte)
- Pyridoxine hydrochloride
- Cholecalciferol
- Riboflavin
- Biotin
- Lecithin
- Cyanocobalamin
- Panax ginseng extract
- Folic acid
- Ascorbic acid
- Nicotinamide
- Iron
- Tocopherol acetate
- Vitamin a palmitate
- Magnesium
- Anhydrous dibasic calcium
phosphate
Atacand Plus 16/12.5mg Imbat Limited PPA1151/110/001 Tablet - Candesartan cilexetil 21/10/2019
tablets - Hydrochlorothiazide
Interchangeable List Code:
IC0029-036-002

Human Medicines Withdrawn Products Page 65 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Cerazette 75 microgram film- Imbat Limited PPA1151/222/001 Film-coated tablet - Desogestrel 21/10/2019
coated tablet
Omesar Plus 20 mg/12.5 mg Lexon (UK) Ltd PPA1097/006/001 Film-coated tablet - Hydrochlorothiazide 21/10/2019
film-coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0106-162-003
Omesar Plus 20 mg/25 mg Lexon (UK) Ltd PPA1097/006/002 Film-coated tablet - Hydrochlorothiazide 21/10/2019
film-coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0106-163-003
Omesar Plus 40 mg/12.5 mg Lexon (UK) Ltd PPA1097/006/003 Film-coated tablet - Hydrochlorothiazide 21/10/2019
film-coated tablets - Olmesartan medoxomil
Interchangeable List Code:
IC0106-099-003
Omesar Plus 40 mg/25 mg Lexon (UK) Ltd PPA1097/006/004 Film-coated tablet - Olmesartan medoxomil 21/10/2019
film-coated tablets - Hydrochlorothiazide
Interchangeable List Code:
IC0106-164-003
Revia 50 mg Film-coated Bristol-Myers Squibb PA0002/074/001 Tablet - Naltrexone hydrochloride 21/10/2019
Tablets Pharmaceuticals uc
Cipramil 10mg Film-coated Imbat Limited PPA1151/049/002 Film-coated tablet - Citalopram hydrobromide 18/10/2019
Tablets
Interchangeable List Code:
IC0073-002-003
Cipramil 20 mg Film-coated Imbat Limited PPA1151/049/001 Film-coated tablet - Citalopram hydrobromide 18/10/2019
Tablets
Interchangeable List Code:
IC0073-003-003
Dianette 2mg/35 microgram LTT Pharma Limited PPA1562/154/001 Coated tablet - CYPROTERONE 18/10/2019
coated tablets ACETATE
- Ethinylestradiol
Lexapro 10mg film-coated Imbat Limited PPA1151/025/004 Film-coated tablet - Escitalopram 18/10/2019
tablets
Interchangeable List Code:
IC0071-002-003
Lexapro 15mg Film-coated Imbat Limited PPA1151/025/005 Film-coated tablet - Escitalopram oxalate 18/10/2019
Tablets
Interchangeable List Code:
IC0071-032-003
Lexapro 20mg film-coated Imbat Limited PPA1151/025/003 Film-coated tablet - Escitalopram 18/10/2019
tablets
Interchangeable List Code:
IC0071-003-003
Lexapro 5mg film-coated Imbat Limited PPA1151/025/002 Film-coated tablet - Escitalopram 18/10/2019
tablets
Interchangeable List Code:
IC0071-001-003
Logynon Tablets LTT Pharma Limited PPA1562/127/001 Tablet - Levonorgestrel 18/10/2019
- Ethinylestradiol
- Ethinylestradiol
- Levonorgestrel
- Levonorgestrel
Srivasso 18 microgram, Boehringer Ingelheim PA0775/008/001 Inhalation powder, hard - Tiotropium 18/10/2019
inhalation powder, hard International GmbH capsule
capsule
Calmurid 10%/ 5% w/w Galderma International PA22743/002/001 Cream - Lactic acid 17/10/2019
Cream S.A.S. - Urea
Konverge Plus 20 mg/5 LTT Pharma Limited PPA1562/174/001 Film-coated tablet - Olmesartan medoxomil 17/10/2019
mg/12.5 mg film-coated - Hydrochlorothiazide
tablets - Amlodipine as amlodipine
besilate
Konverge Plus 40 mg/10 LTT Pharma Limited PPA1562/174/003 Film-coated tablet - Amlodipine as amlodipine 17/10/2019
mg/12.5 mg film-coated besilate
tablets - Hydrochlorothiazide
- Olmesartan medoxomil
Konverge Plus 40 mg/10 LTT Pharma Limited PPA1562/174/004 Film-coated tablet - Amlodipine as amlodipine 17/10/2019
mg/25 mg film-coated tablets besilate
- Hydrochlorothiazide
- Olmesartan medoxomil
Konverge Plus 40 mg/5 LTT Pharma Limited PPA1562/174/002 Film-coated tablet - Hydrochlorothiazide 17/10/2019
mg/12.5 mg film-coated - Amlodipine as amlodipine
tablets besilate
- Olmesartan medoxomil
Avelox 400 mg film-coated Lexon (UK) Ltd PPA1097/025/001 Film-coated tablet - Moxifloxacin hydrochloride 16/10/2019
tablets
Implanon NXT, 68 mg LTT Pharma Limited PPA1562/125/001 Implant - Etonogestrel 15/10/2019
implant for subdermal use

Human Medicines Withdrawn Products Page 66 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Olmesartan/Hydrochlorothia Stada Arzneimittel AG PA0593/039/001 Film-coated tablet - Olmesartan medoxomil 15/10/2019
zide STADA Arzneimittel AG - Hydrochlorothiazide
20 mg/12.5 mg film-coated Interchangeable List Code:
tablets IC0106-162-003
Olmesartan/Hydrochlorothia Stada Arzneimittel AG PA0593/039/002 Film-coated tablet - Olmesartan medoxomil 15/10/2019
zide STADA Arzneimittel AG - Hydrochlorothiazide
20 mg/25 mg film-coated Interchangeable List Code:
tablets IC0106-163-003
Olmesartan/Hydrochlorothia Stada Arzneimittel AG PA0593/039/003 Film-coated tablet - Olmesartan medoxomil 15/10/2019
zide STADA Arzneimittel AG - Hydrochlorothiazide
40 mg/12.5 mg film-coated Interchangeable List Code:
tablets IC0106-099-003
Olmesartan/Hydrochlorothia Stada Arzneimittel AG PA0593/039/004 Film-coated tablet - Olmesartan medoxomil 15/10/2019
zide STADA Arzneimittel AG - Hydrochlorothiazide
40 mg/25 mg film-coated Interchangeable List Code:
tablets IC0106-164-003
Betoptic 0.5% w/v Eye Imbat Limited PPA1151/170/001 Eye drops, solution - Betaxolol hydrochloride 11/10/2019
Drops, Solution
Relifex 500mg Film-coated Imbat Limited PPA1151/121/001 Film-coated tablet - Nabumetone 11/10/2019
Tablets
Seretide 250 Evohaler 25 Imbat Limited PPA1151/006/004 Pressurised inhalation, - FLUTICASONE 11/10/2019
microgram/250 suspension PROPIONATE
microgram/dose pressurised - SALMETEROL
inhalation, suspension XINAFOATE

Yasmin 0.03mg/3mg film- Imbat Limited PPA1151/246/001 Film-coated tablet - Drospirenone 11/10/2019
coated tablets - Ethinylestradiol
CILEST 250/35 microgram Janssen-Cilag Ltd PA0748/029/001 Tablet - Norgestimate 09/10/2019
tablets - Ethinylestradiol
Ezetimibe 10 mg tablets Accord Healthcare Ireland PA2315/044/001 Tablet - Ezetimibe 07/10/2019
Ltd.
Interchangeable List Code:
IC0104-002-002
Aerivio Spiromax Teva B.V. EU/1/16/1122/001-002 Inhalation powder - FLUTICASONE 04/10/2019
PROPIONATE
- SALMETEROL
XINAFOATE
Airexar Spiromax Teva B.V. EU/1/16/1123/001-002 Inhalation powder - FLUTICASONE 03/10/2019
PROPIONATE
- SALMETEROL
XINAFOATE
Benylin Children’s Coughs McNeil Healthcare (Ireland) PA0823/001/001 Syrup - TRIPROLIDINE 03/10/2019
and Colds 5mg/0.625mg per Ltd HYDROCHLORIDE
5ml Syrup - Dextromethorphan
hydrobromide
Ebixa H. Lundbeck A/S EU/1/02/219/004 Oral drops, solution - MEMANTINE 03/10/2019
HYDROCHLORIDE
Neupogen 480 Amgen Europe B.V. PA1026/001/002 Solution for injection - Filgrastim 03/10/2019
Brupro 200 mg Soft capsules Rowex Ltd PA0711/225/002 Capsule, soft - Ibuprofen 02/10/2019

Brupro Max 400 mg, Soft Rowex Ltd PA0711/225/003 Capsule, soft - Ibuprofen 02/10/2019
capsules
Aminoven 16, solution for Fresenius Kabi Limited PA0566/002/005 Solution for infusion - Proline 25/09/2019
infusion, polypropylene - Taurine
infusion bag - Glycine
- Serine
- Tryptophan
- Threonine
- Arginine
- Lysine acetate
- Histidine
- Alanine
- Phenylalanine
- Tyrosine
- Isoleucine
- Valine
- Methionine
- Leucine

Human Medicines Withdrawn Products Page 67 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Aminoven 25, solution for Fresenius Kabi Limited PA0566/002/006 Solution for infusion - Alanine 25/09/2019
infusion, polypropylene - Valine
infusion bag - Histidine
- Arginine
- Isoleucine
- Taurine
- Methionine
- Leucine
- Threonine
- Serine
- Glycine
- Tyrosine
- Proline
- Phenylalanine
- Lysine acetate
- Tryptophan
Aminoven 8, solution for Fresenius Kabi Limited PA0566/002/004 Solution for infusion - Leucine 25/09/2019
infusion, polypropylene - Arginine
infusion bag - Glycine
- Lysine acetate
- Methionine
- Taurine
- Phenylalanine
- Isoleucine
- Histidine
- Tyrosine
- Threonine
- Valine
- Proline
- Alanine
- Serine
- Tryptophan
Macugen Pfizer Limited EU/1/05/325/001 Solution for injection - Pegaptanib sodium 25/09/2019
Miacalcic 100 IU Nasal Novartis Ireland Limited PA0896/020/001 Nasal spray, solution - Calcitonin 25/09/2019
Spray, solution
Miacalcic 200 IU Nasal Novartis Ireland Limited PA0896/020/002 Nasal spray, solution - Calcitonin 25/09/2019
Spray, solution
Miakaril 200 IU Nasal Spray, Novartis Ireland Limited PA0896/021/001 Nasal spray, solution - Calcitonin 25/09/2019
solution
Ostulex 200 IU Nasal Spray, Novartis Ireland Limited PA0896/025/001 Nasal spray, solution - CALCITONIN, SALMON 25/09/2019
solution
Antepsin 1 g Tablets Chugai Pharma France PA22641/001/002 Tablet - Sucralfate 20/09/2019
Antepsin 1 g/5 ml Oral Chugai Pharma France PA22641/001/001 Oral suspension - Sucralfate 20/09/2019
Suspension
Tavanic 500 mg film-coated LTT Pharma Limited PPA1562/190/001 Film-coated tablet - Levofloxacin 18/09/2019
tablets
Rasagiline Actavis 1mg Accord Healthcare Ireland PA2315/028/001 Tablet - Rasagiline tartrate 17/09/2019
tablets Ltd.
Venlalic XL 150 mg Macarthys Laboratories PA0274/004/003 Prolonged-release tablet - Venlafaxine 17/09/2019
prolonged-release tablets Limited
Interchangeable List Code:
IC0026-062-030
Venlalic XL 225 mg Macarthys Laboratories PA0274/004/004 Prolonged-release tablet - Venlafaxine 17/09/2019
prolonged-release tablets Limited
Interchangeable List Code:
IC0026-064-030
Venlalic XL 300 mg Ethypharm UK Ltd PA2254/001/001 Prolonged-release tablet - Venlafaxine 17/09/2019
prolonged-release tablets
Venlalic XL 37.5 mg Macarthys Laboratories PA0274/004/001 Prolonged-release tablet - Venlafaxine 17/09/2019
prolonged-release tablets Limited
Interchangeable List Code:
IC0026-063-030
Venlalic XL 75 mg prolonged- Macarthys Laboratories PA0274/004/002 Prolonged-release tablet - Venlafaxine 17/09/2019
release tablets Limited
Interchangeable List Code:
IC0026-028-030
Adalat 10 mg soft capsules Bayer Limited PA1410/025/002 Capsule, soft - Nifedipine 16/09/2019
Adalat 5 mg soft capsules Bayer Limited PA1410/025/001 Capsule, soft - Nifedipine 16/09/2019
Adalat Retard 10 mg Bayer Limited PA1410/025/003 Prolonged-release tablet - Nifedipine 16/09/2019
Prolonged-Release tablets
Adalat Retard 20 mg Bayer Limited PA1410/025/004 Prolonged-release tablet - Nifedipine 16/09/2019
Prolonged-Release tablets
Caspofungin Actavis 50 mg Accord Healthcare Ireland PA2315/146/001 Powder for concentrate for - Caspofungin 16/09/2019
Powder for Concentrate for Ltd. solution for infusion
Solution for Infusion

Human Medicines Withdrawn Products Page 68 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Caspofungin Actavis 70 mg Accord Healthcare Ireland PA2315/146/002 Powder for concentrate for - Caspofungin 16/09/2019
Powder for Concentrate for Ltd. solution for infusion
Solution for Infusion
Caspofungin Teva 50 mg Teva B.V. PA1986/009/001 Powder for concentrate for - Caspofungin acetate 12/09/2019
Powder for Concentrate for solution for infusion
Solution for Infusion
Caspofungin Teva 70 mg Teva B.V. PA1986/009/002 Powder for concentrate for - Caspofungin acetate 12/09/2019
Powder for Concentrate for solution for infusion
Solution for Infusion
Neotigason 10mg capsules Lexon (UK) Ltd PPA1097/013/001 Capsule - Acitretin 12/09/2019
Neotigason 25mg capsules Lexon (UK) Ltd PPA1097/013/002 Capsule - Acitretin 12/09/2019
Sotacor 80mg Tablets Imbat Limited PPA1151/066/001 Tablet - SOTALOL 12/09/2019
HYDROCHLORIDE
Doxorubicin 2 mg/ml solution Cell Pharm GmbH PA1070/003/001 Solution for injection - DOXORUBICIN 11/09/2019
for injection HYDROCHLORIDE
Setofilm 4 mg Orodispersible Norgine B.V. PA1336/003/001 Orodispersible film - Ondansetron 11/09/2019
Films
Setofilm 8 mg Orodispersible Norgine B.V. PA1336/003/002 Orodispersible film - Ondansetron 11/09/2019
Films
Renagel Genzyme Europe B.V. EU/1/99/123/001 Capsule - Sevelamer 05/09/2019
Renagel Genzyme Europe B.V. EU/1/99/123/002 Capsule - Sevelamer 05/09/2019
Renagel Genzyme Europe B.V. EU/1/99/123/003 Capsule - Sevelamer 05/09/2019
Renagel Genzyme Europe B.V. EU/1/99/123/004 Capsule - Sevelamer 05/09/2019
Amoxicillin/Clavulanic acid DSM Sinochem PA1832/002/001 Film-coated tablet - Amoxicillin trihydrate 04/09/2019
DSM-Sinochem 500 mg/125 Pharmaceuticals Netherlands - Clavulanic acid (as
mg film-coated tablets B.V. Interchangeable List Code: potassium clavulanate,
IC0037-073-003 diluted with microcrystalline
cellulose (1:1))
Amoxicillin/Clavulanic acid DSM Sinochem PA1832/002/002 Film-coated tablet - Amoxicillin trihydrate 04/09/2019
DSM-Sinochem 875 mg/125 Pharmaceuticals Netherlands - Clavulanic acid (as
mg film-coated tablets B.V. Interchangeable List Code: potassium clavulanate,
IC0037-072-003 diluted with microcrystalline
cellulose (1:1))
Iblias Bayer AG EU/1/15/1077/001 Powder and solvent for - Octocog alfa 03/09/2019
solution for injection
Iblisa Bayer Pharma AG EU/1/15/1077/002 Powder and solvent for - Octocog alfa 03/09/2019
solution for injection
Iblisa Bayer Pharma AG EU/1/15/1077/003 Powder and solvent for - Octocog alfa 03/09/2019
solution for injection
Iblisa Bayer Pharma AG EU/1/15/1077/004 Powder and solvent for - Octocog alfa 03/09/2019
solution for injection
Iblisa Bayer Pharma AG EU/1/15/1077/005 Powder and solvent for - Octocog alfa 03/09/2019
solution for injection
Linezolid 600 mg film-coated Accord Healthcare Ireland PA2315/002/001 Film-coated tablet - Linezolid 03/09/2019
tablets Ltd.
Monovo 1 mg/g Ointment Almirall Hermal GmbH PA1548/001/001 Ointment - Mometasone furoate 03/09/2019
Daklinza Bristol-Myers Squibb Pharma EU/1/14/939/003-004 Film-coated tablet - Daclatasvir dihydrochloride 30/08/2019
EEIG
Daklinza Bristol-Myers Squibb Pharma EU/1/14/939/005-006 Film-coated tablet - Declatasvir dihydrochloride 30/08/2019
EEIG (bms-790052-05)

Videx EC 125 mg gastro- Bristol-Myers Squibb PA0002/057/016 Gastro-resistant capsule, - Didanosine 30/08/2019
resistant hard capsules Pharmaceuticals uc hard
Videx EC 200 mg gastro- Bristol-Myers Squibb PA0002/057/017 Gastro-resistant capsule, - Didanosine 30/08/2019
resistant hard capsules Pharmaceuticals uc hard
Videx EC 250 mg gastro- Bristol-Myers Squibb PA0002/057/018 Gastro-resistant capsule, - Didanosine 30/08/2019
resistant hard capsules Pharmaceuticals uc hard
Videx EC 400 mg gastro- Bristol-Myers Squibb PA0002/057/019 Gastro-resistant capsule, - Didanosine 30/08/2019
resistant hard capsules Pharmaceuticals uc hard
Capecitabine Sandoz 150 mg Rowex Ltd PA0711/206/001 Film-coated tablet - Capecitabine 29/08/2019
Film-coated tablets
Interchangeable List Code:
IC0079-062-003
Capecitabine Sandoz 500 mg Rowex Ltd PA0711/206/002 Film-coated tablet - Capecitabine 29/08/2019
Film-coated tablets
Interchangeable List Code:
IC0079-117-003
Ezetimibe/Simvastatin Teva Teva B.V. PA1986/030/001 Tablet - Ezetimibe 29/08/2019
10 mg/20 mg Tablets - Simvastatin
Interchangeable List Code:
IC0034-051-002
Ezetimibe/Simvastatin Teva Teva B.V. PA1986/030/002 Tablet - Ezetimibe 29/08/2019
10 mg/40 mg tablets - Simvastatin
Interchangeable List Code:
IC0034-059-002

Human Medicines Withdrawn Products Page 69 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Ezetimibe/Simvastatin Teva Teva B.V. PA1986/030/003 Tablet - Ezetimibe 29/08/2019
10 mg/80 mg Tablets - Simvastatin
Interchangeable List Code:
IC0034-060-002
Latop 50 microgram/ml eye Rowex Ltd PA0711/177/001 Eye drops, solution - Latanoprost 29/08/2019
drops, solution
Interchangeable List Code:
IC0096-152-045
Latop-Comp 50 Rowex Ltd PA0711/184/001 Eye drops, solution - Latanoprost 29/08/2019
micrograms/ml + 5 mg/ml eye - TIMOLOL MALEATE
drops, solution Interchangeable List Code:
IC0100-153-045
Metidate XL 18 mg Rowex Ltd PA0711/200/001 Prolonged-release tablet - Methylphenidate 29/08/2019
Prolonged-Release Tablets hydrochloride
- Methylphenidate
hydrochloride
Metidate XL 27 mg Rowex Ltd PA0711/200/004 Prolonged-release tablet - Methylphenidate 29/08/2019
Prolonged-Release Tablets hydrochloride
- Methylphenidate
hydrochloride
Metidate XL 36 mg Rowex Ltd PA0711/200/002 Prolonged-release tablet - Methylphenidate 29/08/2019
Prolonged-Release Tablets hydrochloride
- Methylphenidate
hydrochloride
Metidate XL 54 mg Rowex Ltd PA0711/200/003 Prolonged-release tablet - Methylphenidate 29/08/2019
Prolonged-Release Tablets hydrochloride
- Methylphenidate
hydrochloride
Cisplatin 1 mg/ml Fresenius Kabi Deutschland PA2059/033/001 Concentrate for solution for - Cisplatin 28/08/2019
concentrate for solution for GmbH infusion
infusion
Irinotecan Hydrochloride 20 Fresenius Kabi Deutschland PA2059/043/001 Solution for infusion - Irinotecan hydrochloride 28/08/2019
mg/ml Concentrate for GmbH trihydrate
Solution for Infusion
Imatinib Clonmel 100 mg Clonmel Healthcare Ltd PA0126/256/001 Film-coated tablet - Imatinib 15/08/2019
Film-coated Tablets
Imatinib Clonmel 400 mg Clonmel Healthcare Ltd PA0126/256/002 Film-coated tablet - Imatinib 15/08/2019
Film-coated Tablets
ARTISS Powders and Baxter Healthcare Limited PA0167/131/002 Powder and solvent for - Calcium chloride 14/08/2019
Solvent for Sealant sealant - Aprotinin solution, bovine
- Human thrombin
- Human fibrinogen
Imatinib Actavis Group Actavis Group PTC ehf PA1380/164/001 Film-coated tablet - Imatinib mesilate 14/08/2019
100mg Film-coated tablets
Imatinib Actavis Group Actavis Group PTC ehf PA1380/164/002 Film-coated tablet - Imatinib mesylate 14/08/2019
400mg Film-coated tablets
Rowa Cold & Flu 500 mg/30 Rowex Ltd PA0711/198/001 Granules for oral suspension - Acetylsalicylic acid 14/08/2019
mg Granules for Oral - Pseudoephedrine
Suspension hydrochloride
Methotrexate 2mg/ml Oral Rosemont Pharmaceuticals PA0312/034/001 Oral solution - Methotrexate disodium 13/08/2019
Solution Ltd
Eskeriele 685 mg cutaneous FGK Representative Service PA1320/001/001 Cutaneous solution - Hydrogen peroxide 09/08/2019
solution GmbH
Paricalcitol 2 microgram/ml Medice Arzneimittel Putter PA1555/002/001 Solution for injection - Paricalcitol 09/08/2019
Solution for Injection GmbH & Co. K.G
Paricalcitol 5 microgram/ml Medice Arzneimittel Putter PA1555/002/003 Solution for injection - Paricalcitol 09/08/2019
Solution for Injection GmbH & Co. K.G
Vizioblok 2.5 mg/ml Eye Pharmathen S.A. PA1368/017/001 Eye drops, solution - TIMOLOL MALEATE 09/08/2019
Drops Solution
NiQuitin Strips Mint 2.5mg Chefaro Ireland PA1186/018/013 - Nicotine 06/08/2019
orodispersible film
Amiodarone 50 mg/ml Stragen UK Limited PA1294/005/001 Concentrate for solution for - AMIODARONE 01/08/2019
Concentrate for solution for injection HYDROCHLORIDE
injection/infusion
Arelix 6mg Tablets Sanofi-Aventis Ireland PA0540/030/003 Tablet - Piretanide 01/08/2019
Limited T/A SANOFI
TRIALIX 5mg/6mg Tablets Sanofi-Aventis Ireland PA0540/081/001 Tablet - Piretanide 01/08/2019
Limited T/A SANOFI - Ramipril
Aristiga 10 mg/5 mg Ethypharm PA0549/017/002 Prolonged-release tablet - NALOXONE 31/07/2019
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - OXYCODONE
IC0102-016-024 HYDROCHLORIDE
Aristiga 20 mg/10mg Ethypharm PA0549/017/003 Prolonged-release tablet - OXYCODONE 31/07/2019
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - NALOXONE
IC0102-061-024 HYDROCHLORIDE

Human Medicines Withdrawn Products Page 70 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Aristiga 40 mg/20 mg Ethypharm PA0549/017/004 Prolonged-release tablet - NALOXONE 31/07/2019
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - OXYCODONE
IC0102-160-024 HYDROCHLORIDE
Aristiga 5 mg/2.5 mg Ethypharm PA0549/017/001 Prolonged-release tablet - NALOXONE 31/07/2019
prolonged release tablet HYDROCHLORIDE
Interchangeable List Code: - OXYCODONE
IC0102-159-024 HYDROCHLORIDE
Pramipexole Bluefish 0.18 Bluefish Pharmaceuticals AB PA1436/012/001 Tablet - Pramipexole 31/07/2019
mg tablets dihydrochloride monohydrate

Pramipexole Bluefish 0.7 mg Bluefish Pharmaceuticals AB PA1436/012/002 Tablet - Pramipexole 31/07/2019


tablets dihydrochloride monohydrate

Brieka 225 mg Hard Accord Healthcare Ireland PA2315/217/007 Capsule, hard - Pregabalin 30/07/2019
Capsules Ltd.
Modafinil 100mg Tablets Fannin Limited PA1457/014/001 Tablet - Modafinil 30/07/2019
Modafinil 200 mg Tablets Fannin Limited PA1457/014/002 Tablet - Modafinil 30/07/2019
Ivabradine Chanelle Medical Chanelle Medical PA0688/046/001 Film-coated tablet - Ivabradine 29/07/2019
5 mg Film-coated Tablets

Ivabradine Chanelle Medical Chanelle Medical PA0688/046/002 Film-coated tablet - Ivabradine 29/07/2019
7.5 mg Film-coated Tablets

Serdolect 4 mg film-coated H. Lundbeck A/S PA0805/001/001 Film-coated tablet - Sertindole 25/07/2019


tablets
TISSEEL KIT Baxter Healthcare Limited PA0167/129/004 - Fibrinogen 24/07/2019
- Thrombin
- Factor viii, human
- Plasminogen
- Thrombin
- Plasmafibronectin
- Calcium chloride
- Protein
- Aprotinin
Percarnil 4 mg Tablets Accord Healthcare Ireland PA2315/049/001 Tablet - Perindopril tert-butylamine 23/07/2019
Ltd.
Interchangeable List Code:
IC0002-008-002
Percarnil 8 mg Tablets Accord Healthcare Ireland PA2315/049/002 Tablet - Perindopril tert-butylamine 23/07/2019
Ltd.
Interchangeable List Code:
IC0002-009-002
Flerin 700 mg medicated Grunenthal Pharma Ltd PA2242/010/001 Medicated plaster - Lidocaine 22/07/2019
plaster
Glosan 700 mg Medicated Grunenthal Pharma Ltd PA2242/003/001 Medicated plaster - Lidocaine 22/07/2019
Plaster
Lidocaine 700 mg Medicated Grunenthal Pharma Ltd PA2242/008/001 Medicated plaster - Lidocaine 22/07/2019
Plaster
Olmesartan Medoxomil 10 Glenmark Pharmaceuticals PA1462/013/001 Film-coated tablet - Olmesartan medoxomil 19/07/2019
mg Film-coated Tablets Europe Limited
Olmesartan Medoxomil 20 Glenmark Pharmaceuticals PA1462/013/002 Film-coated tablet - Olmesartan medoxomil 19/07/2019
mg Film-coated Tablets Europe Limited
Olmesartan Medoxomil 40 Glenmark Pharmaceuticals PA1462/013/003 Film-coated tablet - Olmesartan medoxomil 19/07/2019
mg Film-coated Tablets Europe Limited
Ezetimibe 10 mg tablets Glenmark Pharmaceuticals PA1462/014/001 Tablet - Ezetimibe 18/07/2019
Europe Limited
Interchangeable List Code:
IC0104-002-002
Dutasteride 0.5 mg Soft Teva B.V. PA1986/027/001 Capsule, soft - Dutasteride 16/07/2019
Capsules
Palonosetron 250 Flynn Pharma Ltd PA1226/012/001 Solution for injection - Palonosetron (as 15/07/2019
micrograms Solution for hydrochloride)
injection
Rasagiline Flynn 1 mg Flynn Pharma Ltd PA1226/011/001 Tablet - Rasagiline tartrate 15/07/2019
Tablets
Cosartal 100 mg Film-coated Accord Healthcare Ireland PA2315/047/002 Film-coated tablet - Losartan potassium 10/07/2019
tablets Ltd.
Interchangeable List Code:
IC0003-024-003
Cosartal 50 mg Film-coated Accord Healthcare Ireland PA2315/047/001 Film-coated tablet - Losartan potassium 10/07/2019
tablets Ltd.
Interchangeable List Code:
IC0003-023-003

Human Medicines Withdrawn Products Page 71 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Pravastatin sodium 10 mg Accord Healthcare Ireland PA2315/003/001 Tablet - Pravastatin sodium 10/07/2019
Tablets Ltd.
Interchangeable List Code:
IC0014-002-014
Pravastatin sodium 20 mg Accord Healthcare Ireland PA2315/003/002 Tablet - Pravastatin sodium 10/07/2019
Tablets Ltd.
Interchangeable List Code:
IC0014-003-014
Pravastatin sodium 40mg Accord Healthcare Ireland PA2315/003/003 Tablet - Pravastatin sodium 10/07/2019
Tablets Ltd.
Interchangeable List Code:
IC0014-004-014
Cinacalcet Rowex 30 mg Rowex Ltd PA0711/285/001 Film-coated tablet - Cinacalcet hydrochloride 09/07/2019
Film-coated tablets
Cinacalcet Rowex 60 mg Rowex Ltd PA0711/285/002 Film-coated tablet - Cinacalcet hydrochloride 09/07/2019
Film-coated tablets
Cinacalcet Rowex 90 mg Rowex Ltd PA0711/285/003 Film-coated tablet - Cinacalcet hydrochloride 09/07/2019
Film-coated tablets
Leuprorelin 1-month Depot GP-PHARM, S.A. PA1766/001/001 Powder and solvent for - LEUPRORELIN ACETATE 09/07/2019
3.75 mg powder and solvent prolonged-release
for prolonged-release suspension for injection
suspension for injection
Leuprorelin 3-month Depot GP-PHARM, S.A. PA1766/001/002 Powder and solvent for - LEUPRORELIN ACETATE 09/07/2019
22.5mg Powder and Solvent prolonged-release
for Prolonged-release suspension for injection
Suspension for Injection
Vedixal XL 37.5mg Milpharm Limited PA1050/014/001 Prolonged-release capsule, - Venlafaxine hydrochloride 09/07/2019
Prolonged release capsules, hard
hard
Hartmann's Maco Pharma (UK) Ltd PA0931/009/003 Solution for infusion - Sodium lactate solution 08/07/2019
SolutionCompound Sodium 60%
Lactate Intravenous Infusion - Sodium chloride
BP - Calcium chloride dihydrate
- Potassium chloride
Axympa 180 mg Gastro- Teva Pharma B.V. PA0749/213/001 Gastro-resistant tablet - Mycophenolic acid 05/07/2019
resistant Tablets
Axympa 360 mg Gastro- Teva Pharma B.V. PA0749/213/002 Gastro-resistant tablet - Mycophenolic acid 05/07/2019
resistant Tablets
Dexamethasone phosphate 1 Alissa Healthcare Research PA1887/001/001 Eye drops, solution - Dexamethasone sodium 05/07/2019
mg/ml eye drops, solution, Limited phosphate
preservative free
Voriconazole Xellia 200 mg Xellia Pharmaceuticals ApS PA1982/001/001 Powder for solution for - Voriconazole 05/07/2019
Powder for Solution for infusion
Infusion
Tranzileve 10 Alissa Healthcare Research PA1887/006/002 Transdermal patch - Buprenorphine 04/07/2019
microgram/hour Transdermal Limited
Patch
Tranzileve 20 Alissa Healthcare Research PA1887/006/003 Transdermal patch - Buprenorphine 04/07/2019
microgram/hour Transdermal Limited
Patch
Tranzileve 5 microgram/hour Alissa Healthcare Research PA1887/006/001 Transdermal patch - Buprenorphine 04/07/2019
Transdermal Patch Limited

Xylonase 0.1 % w/v Nasal Teva Pharma B.V. PA0749/150/001 Nasal spray, solution - XYLOMETAZOLINE 04/07/2019
Spray, Solution HYDROCHLORIDE
EZETROL Eurodrug Ltd DPR1392/031/001 Tablet - Ezetimibe 01/07/2019
Spiriva Respimat Eurodrug Ltd DPR1392/049/001 Inhalation solution - Tiotropium 01/07/2019
Almotriptan 12.5mg Film- Chanelle Medical PA0688/028/001 Film-coated tablet - Almotriptan 30/06/2019
coated tablets
Mobiglan 15 mg Tablets Niche Generics Limited PA1063/020/002 Tablet - Meloxicam 27/06/2019
Mobiglan 7.5 mg Tablets Niche Generics Limited PA1063/020/001 Tablet - Meloxicam 27/06/2019
Capecitabine 150 mg film- Fresenius Kabi Deutschland PA2059/031/001 Film-coated tablet - Capecitabine 26/06/2019
coated tablets GmbH
Interchangeable List Code:
IC0079-062-003
Capecitabine 500 mg film- Fresenius Kabi Deutschland PA2059/031/002 Film-coated tablet - Capecitabine 26/06/2019
coated tablets GmbH
Interchangeable List Code:
IC0079-117-003
Gemcitabine 40 mg/ml Fresenius Kabi Deutschland PA2059/039/004 Concentrate for solution for - Gemcitabine 26/06/2019
concentrate for solution for GmbH infusion
Infusion
Palonosetron Hospira Pfizer Europe MA EEIG EU/1/16/1100/001 Solution for injection - Palonosetron hydrochloride 25/06/2019

Human Medicines Withdrawn Products Page 72 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zynor Allergy 10 mg film- Teva Pharma B.V. PA0749/175/002 Film-coated tablet - Cetirizine dihydrochloride 24/06/2019
coated tablets
Interchangeable List Code:
IC0088-002-003
Rispatal 1 mg/ml Oral Chanelle Medical PA0688/007/008 Oral solution - Risperidone 20/06/2019
Solution
Interchangeable List Code:
IC0012-047-019
Zoniselle 100 mg hard Chanelle Medical PA0688/035/003 Capsule, hard - Zonisamide 20/06/2019
capsules
Zoniselle 25 mg hard Chanelle Medical PA0688/035/001 Capsule, hard - Zonisamide 20/06/2019
capsules
Zoniselle 50 mg hard Chanelle Medical PA0688/035/002 Capsule, hard - Zonisamide 20/06/2019
capsules
ACERYCAL 10mg/10mg Primecrown 2010 Limited PPA1633/035/004 Tablet - Perindopril arginine 19/06/2019
tablets - Amlodipine besylate
ACERYCAL 10mg/5mg Primecrown 2010 Limited PPA1633/035/003 Tablet - Perindopril arginine 19/06/2019
tablets - Amlodipine besylate
ACERYCAL 5mg/10mg Primecrown 2010 Limited PPA1633/035/002 Tablet - Perindopril arginine 19/06/2019
tablets - Amlodipine besylate
ACERYCAL 5mg/5mg tablet Primecrown 2010 Limited PPA1633/035/001 Tablet - Perindopril arginine 19/06/2019
- Amlodipine besylate
Actonel Once A Week 35mg Primecrown 2010 Limited PPA1633/002/001 Film-coated tablet - Risedronate sodium 19/06/2019
Film-coated Tablets
Interchangeable List Code:
IC0068-124-003
Arcoxia Primecrown 2010 Limited DPR1633/009/001 Film-coated tablet - Etoricoxib 19/06/2019
Arcoxia Primecrown 2010 Limited DPR1633/009/002 Film-coated tablet - Etoricoxib 19/06/2019
Arcoxia Primecrown 2010 Limited DPR1633/009/003 Film-coated tablet - Etoricoxib 19/06/2019
Calcichew D3 Forte 500 Primecrown 2010 Limited DPR1633/017/001 Chewable/dispersible tablet - Cholecalciferol 19/06/2019
mg/400 IU - Calcium carbonate
Chewable/Dispersible
Tablets
Casodex 50 mg Film-coated Primecrown 2010 Limited PPA1633/068/001 Tablet - Bicalutamide 19/06/2019
Tablets
Fosamax Once Weekly Primecrown 2010 Limited DPR1633/001/001 Tablet - Alendronate sodium 19/06/2019
Ixprim 37.5 mg/325 mg, film Primecrown 2010 Limited PPA1633/044/001 Film-coated tablet - Tramadol hydrochloride 19/06/2019
coated-tablets - Paracetamol
Interchangeable List Code:
IC0077-133-014
Lamictal 50 mg Tablets Primecrown 2010 Limited PPA1633/041/002 Tablet - Lamotrigine 19/06/2019
Movicol 13.8g sachet, Primecrown 2010 Limited PPA1633/007/001 Powder for oral solution - Sodium bicarbonate 19/06/2019
powder for oral solution - Sodium chloride
- Macrogol 3350
- Potassium chloride
Movicol Paediatric Plain Primecrown 2010 Limited DPR1633/005/001 Powder for oral solution - Potassium chloride 19/06/2019
- Sodium hydrogen
carbonate (E500)
- Macrogol
- Sodium chloride
Scheriproct 1.5 mg/g + 5 Primecrown 2010 Limited PPA1633/018/001 Rectal ointment - Cinchocaine hydrochloride 19/06/2019
mg/g Rectal Ointment - PREDNISOLONE
CAPROATE
Serc 16mg Tablets Primecrown 2010 Limited PPA1633/026/002 Tablet - Betahistine dihydrochloride 19/06/2019

Interchangeable List Code:


IC0084-038-002
Zithromax 250mg Capsules Primecrown 2010 Limited PPA1633/032/001 Capsule, hard - Azithromycin dihydrate 19/06/2019
Polibar 96.5 % w/w powder Bracco Imaging spa PA1826/003/001 Powder for rectal suspension - Barium sulfate 16/06/2019
for rectal suspension
Betagan 0.5% w/v Eye Allergan Pharmaceuticals PA0148/040/001 Eye drops, solution - Levobunolol hydrochloride 14/06/2019
Drops, Solution Ireland
Celecoxib Pfizer 100 mg Pfizer Healthcare Ireland PA0822/083/001 Capsule, hard - Celecoxib 12/06/2019
capsules, hard - Gelatin
Celecoxib Pfizer 200 mg Pfizer Healthcare Ireland PA0822/083/002 Capsule, hard - Celecoxib 12/06/2019
capsules, hard - Gelatin
Ezetimibe Apotex 10 mg Apotex Europe B.V. PA1513/012/001 Tablet - Ezetimibe 10/06/2019
tablets
KETOZOL 2% w/w Dandruff Rowex Ltd PA0711/076/002 Shampoo - Ketoconazole 07/06/2019
Shampoo
Clopidogrel HCS HCS bvba EU/1/10/651/001-015 Film-coated tablet - Clopidogrel hydrochloride 06/06/2019

Interchangeable List Code:


IC0005-028-003
Ketek Aventis Pharma S.A. EU/1/01/191/001 Tablet - Telithromycin 06/06/2019
Ketek Aventis Pharma S.A. EU/1/01/191/002 Tablet - Telithromycin 06/06/2019

Human Medicines Withdrawn Products Page 73 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Ketek Aventis Pharma S.A. EU/1/01/191/003 Tablet - Telithromycin 06/06/2019
Ketek Aventis Pharma S.A. EU/1/01/191/004 Tablet - Telithromycin 06/06/2019
Minims Phenylephrine Bausch & Lomb UK Limited PA0555/014/001 Eye drops, solution - Phenylephrine 06/06/2019
Hydrochloride 10% w/v Eye hydrochloride
Drops, solution
Pemetrexed 500mg Powder McDermott Laboratories Ltd PA0577/222/001 Powder for concentrate for - Pemetrexed disodium 03/06/2019
for Concentrate for Solution t/a Gerard Laboratories solution for infusion
for Infusion
ARSENICUM ALBUM Helios Homeopathy Ltd HOR1154/004/001 - Arsenicum album 01/06/2019
Macrosoft 10 g Powder for Sanofi-Aventis Ireland PA0540/192/001 Powder for oral solution - Macrogol 4000 01/06/2019
Oral Solution in Sachet Limited T/A SANOFI
MERCURIUS VIVUS Helios Homeopathy Ltd HOR1154/013/001 Not assigned - Hydrargyrum 01/06/2019
Rhinocort Turbohaler, 100 AstraZeneca UK Limited PA0970/051/001 Nasal powder - Budesonide 01/06/2019
micrograms per metered
dose, Nasal Powder
SILICA Helios Homeopathy Ltd HOR1154/018/001 - Silicia precipitated 01/06/2019
Arzerra Novartis Europharm Limited EU/1/10/625/1-2 Concentrate for solution for - Ofatumumab 29/05/2019
infusion
Soprol 10 mg Film-coated Teva Pharma B.V. PA0749/180/002 Film-coated tablet - BISOPROLOL FUMARATE 29/05/2019
Tablets
Interchangeable List Code:
IC0065-002-014
Soprol 5 mg Film-coated Teva Pharma B.V. PA0749/180/001 Film-coated tablet - BISOPROLOL FUMARATE 29/05/2019
Tablets
Interchangeable List Code:
IC0065-001-014
TEVAX 10 mg, prolonged Teva Pharma B.V. PA0749/051/001 Prolonged-release tablet - ALFUZOSIN 29/05/2019
release tablets HYDROCHLORIDE
Ventamol CFC-Free 100 Norton Waterford PA0436/008/010 Pressurised inhalation, - SALBUTAMOL SULFATE 29/05/2019
micrograms Pressurised suspension
Inhalation, Suspension Interchangeable List Code:
IC0078-138-053
Zinbryta Biogen Idec Limited EU/1/16/1107/003-004 Solution for injection in pre- - Daclizumab 29/05/2019
filled pen
Floxapen 250mg Capsules Actavis Group PTC ehf PA1380/011/001 Capsule, hard - FLUCLOXACILLIN 28/05/2019
SODIUM
Interchangeable List Code:
IC0089-130-001
Floxapen 500mg Capsules Actavis Group PTC ehf PA1380/011/002 Capsule, hard - FLUCLOXACILLIN 28/05/2019
SODIUM
Interchangeable List Code:
IC0089-117-001
Mobic 15 mg tablets Boehringer Ingelheim PA0775/001/005 Tablet - Meloxicam 28/05/2019
International GmbH
Mobic 7.5 mg tablets Boehringer Ingelheim PA0775/001/004 Tablet - Meloxicam 28/05/2019
International GmbH
Polyfax Ointment, 10,000 IU Pliva Pharma Limited PA0585/013/001 - BACITRACIN ZINC 28/05/2019
Polymyxin B Sulphate + 500 - Polymyxin b sulfate
IU Bacitracin Zinc
Diclofenac potassium NCH GlaxoSmithKline Consumer PA0678/129/001 Film-coated tablet - Diclofenac potassium 23/05/2019
12.5mg Film-coated Tablets Healthcare (Ireland) Limited
Interchangeable List Code:
IC0057-021-003
Otriflu 12.5mg Film-coated GlaxoSmithKline Consumer PA0678/137/001 Film-coated tablet - Diclofenac potassium 23/05/2019
Tablets Healthcare (Ireland) Limited
Interchangeable List Code:
IC0057-021-003
Rasilez Novartis Europharm Limited EU/1/07/405/1-10,21-30 Film-coated tablet - Aliskiren hemifumarate 17/05/2019
Rasilez HCT Novartis Europharm Limited EU/1/08/491/001-020 Film-coated tablet - Aliskiren hemifumarate 17/05/2019
- Hydrochlorothiazide
Tentin 5mg tablets Medice Arzneimittel Putter PA1555/003/001 Tablet - DEXAMPHETAMINE 17/05/2019
GmbH & Co. K.G SULFATE
Nonafact Sanquin Plasma Products EU/1/01/186/001 Powder and solvent for - Factor ix, human 13/05/2019
B.V. solution for injection
Nonafact Sanquin Plasma Products EU/1/01/186/002 Powder and solvent for - Factor ix, human 13/05/2019
B.V. solution for injection
Relifex 500 mg / 5 ml oral Meda Health Sales Ireland PA1332/006/001 Oral suspension - Nabumetone 08/05/2019
suspension Limited
Clopidogrel-Splendris 75mg Splendris Pharmaceuticals PA1772/001/001 Film-coated tablet - Clopidogrel hydrogen 01/05/2019
Film-coated Tablets GmbH sulphate
Interchangeable List Code:
IC0005-028-003
Ibuprofen/Pseudoephedrine Diapharm GmbH & Co. KG PA1958/005/001 Film-coated tablet - Ibuprofen 01/05/2019
Hydrochloride 200mg/30mg - PSEUDOEPHEDRINE
film coated tablets HYDROCHLORIDE

Human Medicines Withdrawn Products Page 74 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zesger 5 mg Tablets McDermott Laboratories Ltd PA0577/041/001 Tablet - Lisinopril 01/05/2019
t/a Gerard Laboratories
EQUASYMÒ 10 MG Shire Pharmaceuticals PA1575/001/005 Tablet - Methylphenidate 29/04/2019
TABLETS Ireland Limited hydrochloride
EQUASYMÒ 20 MG Shire Pharmaceuticals PA1575/001/006 Tablet - Methylphenidate 29/04/2019
TABLETS Ireland Limited hydrochloride
EQUASYMÒ 5 MG Shire Pharmaceuticals PA1575/001/004 Tablet - Methylphenidate 29/04/2019
TABLETS Ireland Limited hydrochloride
Imodium 2mg Capsules Imbat Limited PPA1151/060/001 Capsule, hard - LOPERAMIDE 25/04/2019
HYDROCHLORIDE
Imodium Instants 2mg Imbat Limited PPA1151/060/002 Orodispersible tablet - LOPERAMIDE 25/04/2019
Orodispersible Tablets HYDROCHLORIDE
ReoPro 2 mg/mL solution for Janssen Biologics B.V. PA0502/003/001 Solution for injection/infusion - ABCIXIMAB 25/04/2019
injection or infusion
Vantobra PARI Pharma GmbH EU/1/14/932/001 Nebuliser solution - Tobramycin 25/04/2019
Palexia 25mg film-coated Grunenthal Pharma Ltd PA2242/012/012 Film-coated tablet - Tapentadol hydrochloride 24/04/2019
tablets
Pentasa 500mg Prolonged- Imbat Limited PPA1151/092/001 Prolonged-release tablet - Mesalazine 24/04/2019
release Tablets
Linezolid Pfizer 100 mg/5 ml Pfizer Healthcare Ireland PA0822/181/003 Granules for oral suspension - Linezolid 18/04/2019
granules for oral suspension
Linezolid Pfizer 2 mg/ml Pfizer Healthcare Ireland PA0822/181/001 Solution for infusion - Linezolid 18/04/2019
solution for infusion
Linezolid Pfizer 600mg Film- Pfizer Healthcare Ireland PA0822/181/002 Film-coated tablet - Linezolid 18/04/2019
Coated Tablets
Fluconazole 150 mg Gedeon Richter Plc PA1330/014/002 Capsule, hard - Fluconazole 15/04/2019
capsules
Topotecan Teva Teva B.V. EU/1/09/552/001-4 Concentrate for solution for - Topotecan hydrochloride 11/04/2019
infusion
Rituzena (previously Tuxella) Celltrion Healthcare Hungary EU/1/17/1206/001 Concentrate for solution for - Rituximab 10/04/2019
Kft. infusion
Ambrobene 3 mg/ml Oral Teva Pharma B.V. PA0749/158/001 Oral solution - AMBROXOL 08/04/2019
Solution HYDROCHLORIDE
Ambrobene Extra Strength 6 Teva Pharma B.V. PA0749/158/002 Oral solution - AMBROXOL 08/04/2019
mg/ml Oral Solution HYDROCHLORIDE
PectoDrill sugar-free for Pierre Fabre Medicament PA0329/009/002 Oral solution - Carbocisteine 08/04/2019
chesty coughs 250mg/5ml
oral solution
Prenopatch 10 Clonmel Healthcare Ltd PA0126/304/002 Transdermal patch - Buprenorphine 05/04/2019
microgram/hour transdermal
patch
Prenopatch 20 Clonmel Healthcare Ltd PA0126/304/003 Transdermal patch - Buprenorphine 05/04/2019
microgram/hour transdermal
patch
Prenopatch 5 Clonmel Healthcare Ltd PA0126/304/001 Transdermal patch - Buprenorphine 05/04/2019
microgram/hour transdermal
patch
Daptomycin Clonmel 350 mg Clonmel Healthcare Ltd PA0126/286/001 Powder for solution for - Daptomycin 04/04/2019
powder for solution injection injection/infusion
or infusion
Daptomycin Clonmel 500 mg Clonmel Healthcare Ltd PA0126/286/002 Powder for solution for - Daptomycin 04/04/2019
powder for solution injection injection/infusion
or infusion
Numient Amneal Pharma Europe EU/1/15/1044/001-003 Modified-release capsule, - Carbidopa 02/04/2019
Limited hard - Levodopa
Numient Amneal Pharma Europe EU/1/15/1044/004-006 Modified-release capsule, - Levodopa 02/04/2019
Limited hard - Carbidopa
Numient Amneal Pharma Europe EU/1/15/1044/007-009 Modified-release capsule, - Carbidopa 02/04/2019
Limited hard - Levodopa
Numient Amneal Pharma Europe EU/1/15/1044/010-012 Modified-release capsule, - Carbidopa 02/04/2019
Limited hard - Levodopa
Dotevatrol 50 micrograms/g Teva Pharma B.V. PA0749/189/001 Ointment - Betamethasone 01/04/2019
+ 0.5 mg/g Ointment - Calcipotriol, anhydrous
Persantin Retard 200 mg Boehringer Ingelheim Limited PA0007/008/007 Modified-release capsule, - Dipyridamole 01/04/2019
Modified Release Capsules, hard
Hard
Feldene 10 mg capsules, Pfizer Limited PA0019/024/002 Capsule - Piroxicam 29/03/2019
hard
Feldene 20 mg capsules, Pfizer Limited PA0019/024/003 Capsule - Piroxicam 29/03/2019
hard
Isaniva 75 microgram film- Actavis Group PTC ehf PA1380/133/001 Film-coated tablet - Desogestrel micronized 29/03/2019
coated tablets
Linezolid 2 mg/ml Solution for Teva Pharma B.V. PA0749/113/001 Solution for infusion - Linezolid 29/03/2019
Infusion

Human Medicines Withdrawn Products Page 75 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Olbas Pastilles GR Lane Health Products Lt PA0257/015/002 Lozenge - Methyl salicylate 29/03/2019
- Juniper berry oil
- Oil of peppermint
- Oil of eucaliptus
- Clove oil
- Menthol
Preconceive 400 microgram GR Lane Health Products Lt PA0257/055/001 Tablet - Folic acid 29/03/2019
Tablets
Quiet Life Coated Tablets GR Lane Health Products Lt PA0257/001/001 Tablet - Riboflavin 29/03/2019
- Thiamine hydrochloride
- Passiflora incarnata
- Nicotinamide
- Valerian dry hydroalcoholic
extract ph.eur.
- Leonurus cardiaca
- Humulus lupulus

Ralgex Cream GR Lane Health Products Lt PA0257/057/001 Cream - Glycol monosalicylate 29/03/2019
- Capsicum oleoresin
- Methyl nicotinate
Ralgex Heat Spray GR Lane Health Products Lt PA0257/072/001 Cutaneous spray, solution - Methyl nicotinate 29/03/2019
- Glycol monosalicylate
Sea-Legs Tablets GR Lane Health Products Lt PA0257/073/001 Tablet - MECLOZINE 29/03/2019
HYDROCHLORIDE
Tacni 0.5 mg Hard Capsules Teva Pharma B.V. PA0749/138/001 Capsule, hard - Tacrolimus 29/03/2019

Tacni 1 mg Hard Capsules Teva Pharma B.V. PA0749/138/002 Capsule, hard - Tacrolimus 29/03/2019
Tacni 5 mg Hard Capsules Teva Pharma B.V. PA0749/138/003 Capsule, hard - Tacrolimus 29/03/2019
Cicatrin GlaxoSmithKline (Ireland) PA0017/019/002 Cream - Neomycin sulfate 28/03/2019
Limited - Cysteine
- Glycine
- Threonine
- BACITRACIN ZINC
Furosemide Injection Accord Healthcare Limited PA1390/049/002 Solution for injection - Furosemide 28/03/2019
Cabaser 2 mg Tablet Pfizer Healthcare Ireland PA0822/114/002 Tablet - Cabergoline 27/03/2019
Carboplatin 10mg/ml Hospira UK Limited PA0437/017/002A Concentrate for solution for - Carboplatin 27/03/2019
Concentrate for Solution for infusion
Infusion
Etoposide 20mg/ml Actavis Group PTC ehf PA1380/168/001 Concentrate for solution for - Etoposide 27/03/2019
Concentrate for Solution for infusion
Infusion
Meropenem Hospira 1 g Hospira UK Limited PA0437/064/002 Powder for solution for - Meropenem trihydrate 27/03/2019
powder for solution for injection/infusion
injection or infusion
Meropenem Hospira 500 mg Hospira UK Limited PA0437/064/001 Powder for solution for - Meropenem trihydrate 27/03/2019
powder for solution for injection/infusion
injection or infusion
Piperacillin/Tazobactam 2 Hospira UK Limited PA0437/069/001 Powder for solution for - PIPERACILLIN SODIUM 27/03/2019
g/0.25 g powder for solution injection/infusion - Tazobactam sodium
for infusion
Piperacillin/Tazobactam 4 Hospira UK Limited PA0437/069/002 Powder for solution for - PIPERACILLIN SODIUM 27/03/2019
g/0.5 g powder for solution injection/infusion - Tazobactam sodium
for infusion
Tomudex 2mg Powder for Hospira UK Limited PA0437/062/001 Powder for suspension for - Raltitrexed 27/03/2019
Solution for Infusion injection
Alcartis 30 mg tablets EGIS Pharmaceuticals PLC PA1470/005/004 Tablet - Aripiprazole 26/03/2019

Interchangeable List Code:


IC0092-033-056
Rosuvastatin DSM Sinochem DSM Sinochem PA1832/004/002 Film-coated tablet - Rosuvastatin calcium 26/03/2019
10 mg film-coated tablets Pharmaceuticals Netherlands
B.V. Interchangeable List Code:
IC0006-002-003
Rosuvastatin DSM Sinochem DSM Sinochem PA1832/004/003 Film-coated tablet - Rosuvastatin calcium 26/03/2019
20 mg film-coated tablets Pharmaceuticals Netherlands
B.V. Interchangeable List Code:
IC0006-003-003
Rosuvastatin DSM Sinochem DSM Sinochem PA1832/004/001 Film-coated tablet - Rosuvastatin calcium 26/03/2019
5 mg film-coated tablets Pharmaceuticals Netherlands
B.V. Interchangeable List Code:
IC0006-001-003
Chirocaine 0.625 mg/ml AbbVie Limited PA1824/003/004 Solution for infusion - Levobupivacaine 25/03/2019
solution for infusion hydrochloride
Docetaxel Hospira 10 mg/ml Hospira UK Limited PA0437/067/001 Concentrate for solution for - Docetaxel 22/03/2019
Concentrate for Solution for infusion
Infusion

Human Medicines Withdrawn Products Page 76 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Gemcitabine 38 mg/ml Hospira UK Limited PA0437/063/001 Concentrate for solution for - GEMCITABINE 22/03/2019
Concentrate for Solution for infusion HYDROCHLORIDE
Infusion
Isoket 0.5 mg/ml Solution for Merus Labs Luxco II S.à.R.L. PA2118/003/003 Solution for infusion - Isosorbide dinitrate 22/03/2019
Infusion or Injection
Isoket 1mg/ml Concentrate Merus Labs Luxco II S.à.R.L. PA2118/003/002 Concentrate for solution for - Isosorbide dinitrate 22/03/2019
for solution for Injection or infusion
Infusion, 50ml bottle
Rocuronium Bromide Hospira UK Limited PA0437/072/001 Solution for injection/infusion - Rocuronium bromide 22/03/2019
10mg/ml Solution for
Injection/Infusion
Vancomycin Hydrochloride 1 Hospira UK Limited PA0437/023/002 Powder for concentrate for - VANCOMYCIN 22/03/2019
g Powder for Concentrate for solution for infusion HYDROCHLORIDE
Solution for Infusion
Vancomycin Hydrochloride Hospira UK Limited PA0437/023/001 Powder for concentrate for - VANCOMYCIN 22/03/2019
500 mg Powder for solution for infusion HYDROCHLORIDE
Concentrate for Solution for
Infusion
Amlodipine 10mg Capsules Chanelle Medical PA0688/009/002 Capsule, hard - Amlodipine besilate 20/03/2019

Interchangeable List Code:


IC0045-002-008
Amlodipine 5 mg Capsules Chanelle Medical PA0688/009/001 Capsule, hard - Amlodipine besilate 20/03/2019

Interchangeable List Code:


IC0045-001-008
Cefaclor 250mg Capsules Chanelle Medical PA0688/013/001 Capsule, hard - Cefaclor 20/03/2019
Cefaclor 500 mg Capsules Chanelle Medical PA0688/013/002 Capsule, hard - Cefaclor 20/03/2019
Citalopram 10mg Film-coated Chanelle Medical PA0688/008/001 Film-coated tablet - Citalopram hydrobromide 20/03/2019
Tablets
Interchangeable List Code:
IC0073-002-003
Citalopram 20mg Film-coated Chanelle Medical PA0688/008/002 Film-coated tablet - Citalopram hydrobromide 20/03/2019
Tablets
Interchangeable List Code:
IC0073-003-003
Citalopram 40mg Film-coated Chanelle Medical PA0688/008/003 Film-coated tablet - Citalopram hydrobromide 20/03/2019
Tablets
Interchangeable List Code:
IC0073-004-003
Glibenclamide 2.5 mg Chanelle Medical PA0688/040/001 Tablet - Glibenclamide 20/03/2019
Tablets
Glibenclamide 5 mg Tablets Chanelle Medical PA0688/040/002 Tablet - Glibenclamide 20/03/2019
Losartan Potassium Pinewood Laboratories Ltd, PA0281/154/001 Film-coated tablet - Losartan potassium 20/03/2019
Pinewood 12.5 mg film-
coated tablets Interchangeable List Code:
IC0003-021-003
Irinotecan Hydrochloride 20 Hospira UK Limited PA0437/051/001 Concentrate for solution for - Irinotecan hydrochloride 18/03/2019
mg/ml Concentrate for infusion trihydrate
Solution for Infusion
Effico Tonic, Oral Solution Forest Laboratories UK Ltd PA0100/045/001 Oral solution - Thiamine hydrochloride 14/03/2019
- Nicotinamide
- Caffeine
- Gentian compound infusion

Minatev LA 500 mg Teva Pharma B.V. PA0749/147/001 Prolonged-release tablet - Clarithromycin 14/03/2019
Prolonged-release Tablets
Interchangeable List Code:
IC0072-117-050
Tramapine 50mg Capsules Pinewood Laboratories Ltd, PA0281/100/001 Capsule, hard - Tramadol hydrochloride 14/03/2019

Interchangeable List Code:


IC0074-023-008
Dobutamine 12.5 mg/ml Hospira UK Limited PA0437/036/001 Concentrate for solution for - DOBUTAMINE 13/03/2019
Concentrate for Solution for infusion HYDROCHLORIDE
Infusion
Paclitaxel 6 mg/ml Hospira UK Limited PA0437/052/001 Concentrate for solution for - Paclitaxel 13/03/2019
concentrate for solution for infusion
infusion
ClobaDerm 0.5 mg/g Teva B.V. PA1986/057/002 Ointment - CLOBETASOL 12/03/2019
Ointment PROPIONATE
ClobaDerm 0.5mg/g Cream Teva B.V. PA1986/057/001 Cream - CLOBETASOL 12/03/2019
PROPIONATE
Clonidine Hydrochloride 25 Teva B.V. PA1986/058/001 Tablet - CLONIDINE 12/03/2019
microgram Tablets HYDROCHLORIDE

Human Medicines Withdrawn Products Page 77 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Benzydamine Hydrochloride ABDI FARMA Unipessoal PA2158/001/001 Oromucosal spray, solution - BENZYDAMINE 06/03/2019
0.15% w/v Oromucosal Lda. HYDROCHLORIDE
Spray
Cyltezo Boehringer Ingelheim EU/1/17/1240/001-004 Solution for injection in pre- - Adalimumab 05/03/2019
International GmbH filled syringe
Meroponia 500mg Powder Clonmel Healthcare Ltd PA0126/225/001 Powder for solution for - Meropenem trihydrate 05/03/2019
for Solution for Injection or injection/infusion
Infusion
Moderiba 200 mg film-coated AbbVie Limited PA1824/006/001 Film-coated tablet - Ribavirin 01/03/2019
tablets
Moderiba 400 mg film-coated AbbVie Limited PA1824/006/002 Film-coated tablet - Ribavirin 01/03/2019
tablets
Moderiba 600 mg film-coated AbbVie Limited PA1824/006/003 Film-coated tablet - Ribavirin 01/03/2019
tablets
Alcartis 10 mg orodispersible EGIS Pharmaceuticals PLC PA1470/005/006 Orodispersible tablet - Aripiprazole 26/02/2019
tablets
Interchangeable List Code:
IC0092-002-056
Alcartis 10 mg tablets EGIS Pharmaceuticals PLC PA1470/005/002 Tablet - Aripiprazole 26/02/2019

Interchangeable List Code:


IC0092-002-056
Alcartis 15 mg orodispersible EGIS Pharmaceuticals PLC PA1470/005/007 Orodispersible tablet - Aripiprazole 26/02/2019
tablets
Interchangeable List Code:
IC0092-032-056
Alcartis 15 mg tablets EGIS Pharmaceuticals PLC PA1470/005/003 Tablet - Aripiprazole 26/02/2019

Interchangeable List Code:


IC0092-032-056
Alcartis 30 mg orodispersible EGIS Pharmaceuticals PLC PA1470/005/008 Orodispersible tablet - Aripiprazole 26/02/2019
tablets
Interchangeable List Code:
IC0092-033-056
Alcartis 5 mg orodispersible EGIS Pharmaceuticals PLC PA1470/005/005 Orodispersible tablet - Aripiprazole 26/02/2019
tablets
Interchangeable List Code:
IC0092-001-056
Alcartis 5 mg tablets EGIS Pharmaceuticals PLC PA1470/005/001 Tablet - Aripiprazole 26/02/2019

Interchangeable List Code:


IC0092-001-056
Escitalopram BioOrganics 10 BioOrganics BV PA1082/002/001 Film-coated tablet - Escitalopram oxalate 26/02/2019
mg film-coated tablets
Interchangeable List Code:
IC0071-002-015
Escitalopram BioOrganics 15 BioOrganics BV PA1082/002/002 Film-coated tablet - Escitalopram oxalate 26/02/2019
mg film-coated tablets
Interchangeable List Code:
IC0071-032-015
Escitalopram BioOrganics 20 BioOrganics BV PA1082/002/003 Film-coated tablet - Escitalopram oxalate 26/02/2019
mg film-coated tablets
Interchangeable List Code:
IC0071-003-015
Rosuvastatin DSM Sinochem DSM Sinochem PA1832/004/004 Film-coated tablet - Rosuvastatin calcium 26/02/2019
40 mg film-coated tablets Pharmaceuticals Netherlands
B.V. Interchangeable List Code:
IC0006-004-003
Altargo Glaxo Group Limited EU/1/07/390/1-4 Ointment - Retapamulin 25/02/2019
Nortenolol 100mg Film- Tillomed Laboratories Limite PA0644/003/003 Film-coated tablet - Atenolol 22/02/2019
coated Tablets
Nortenolol 25mg Film-coated Tillomed Laboratories Limite PA0644/003/001 Film-coated tablet - Atenolol 22/02/2019
Tablets
Nortenolol 50mg Film-coated Tillomed Laboratories Limite PA0644/003/002 Film-coated tablet - Atenolol 22/02/2019
Tablets
Efestad 5mg film-coated Clonmel Healthcare Ltd PA0126/223/001 Film-coated tablet - Desloratidine 21/02/2019
tablets
Paracetamol Adult Rosemont Pharmaceuticals PA0312/020/001 Oral suspension - Paracetamol 21/02/2019
500mg/5ml oral suspension Ltd
Ramipril 2.5mg/5ml Oral Rosemont Pharmaceuticals PA0312/026/001 Oral solution - Ramipril 21/02/2019
Solution Ltd
Simvastatin Rosemont Rosemont Pharmaceuticals PA0312/031/001 Oral suspension - Simvastatin 21/02/2019
20mg/5ml Oral Suspension Ltd
Simvastatin Rosemont Rosemont Pharmaceuticals PA0312/031/002 Oral suspension - Simvastatin 21/02/2019
40mg/5ml Oral Suspension Ltd

Human Medicines Withdrawn Products Page 78 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Warfarin Rosemont 1 mg/1 Rosemont Pharmaceuticals PA0312/018/001 Oral suspension - WARFARIN SODIUM 21/02/2019
ml Oral Suspension Ltd
ATryn Laboratoire francais du EU/1/06/355/1-3 Powder for solution for - Antithrombin alfa 20/02/2019
Fractionnement et des infusion
Biotechnolgies
Tioconazole 283mg/ml Creo Pharma Limited PA1884/002/001 Medicated nail lacquer - Tioconazole 19/02/2019
medicated nail lacquer
Zonegran Eisai GmbH EU/1/04/307/014-015 Orodispersible tablet - Zonisamide 19/02/2019
Zonegran Eisai GmbH EU/1/04/307/016-017 Orodispersible tablet - Zonisamide 19/02/2019
Zonegran Eisai GmbH EU/1/04/307/018-019 Orodispersible tablet - Zonisamide 19/02/2019
Zonegran Eisai GmbH EU/1/04/307/020-021 Orodispersible tablet - Zonisamide 19/02/2019
Silgard Merck Sharp and Dohme EU/1/06/358/01-21 Suspension for injection - Hpv type 11 l1 protein 18/02/2019
Limited - Amorphous aluminum
hydroxyphosphate sulphate
adjuvant
- Hpv type 18 l1
- Hpv type 16 l1
- Hpv type 6 l1 protein
Irbesartan Niche 150mg film- Niche Generics Limited PA1063/056/001 Film-coated tablet - Irbesartan 15/02/2019
coated tablets
Irbesartan Niche 300mg film- Niche Generics Limited PA1063/056/002 Film-coated tablet - Irbesartan 15/02/2019
coated tablets
Imatinib medac Medac Gesellschaft fur EU/1/13/876/001 Capsule, hard - Imatinib mesilate 14/02/2019
Klinische Spezialpraparate
mbH
APHTHEAL 5% w/w Mylan IRE Healthcare PA2010/054/001 Oromucosal paste - Amlexanox 11/02/2019
Oromucosal Paste Limited
Gemcitabine 1 g powder for Actavis Group PTC ehf PA1380/015/002 Powder for solution for - Gemcitabine 08/02/2019
solution for infusion infusion
Gemcitabine 2 g powder for Actavis Group PTC ehf PA1380/015/004 Powder for solution for - Gemcitabine 08/02/2019
solution for infusion infusion
Gemcitabine 200 mg powder Actavis Group PTC ehf PA1380/015/001 Powder for solution for - Gemcitabine 08/02/2019
for solution for infusion infusion

Levothyroxine Clonmel 100 Clonmel Healthcare Ltd PA0126/257/003 Tablet - Levothyroxine sodium 08/02/2019
microgram tablets
Levothyroxine Clonmel 25 Clonmel Healthcare Ltd PA0126/257/001 Tablet - Levothyroxine sodium 08/02/2019
microgram tablets
Levothyroxine Clonmel 50 Clonmel Healthcare Ltd PA0126/257/002 Tablet - Levothyroxine sodium 08/02/2019
microgram tablets
Olmesartan Medoxomil Teva Teva Pharma B.V. PA0749/108/001 Film-coated tablet - Olmesartan medoxomil 08/02/2019
10 mg film-coated tablets

Olmesartan Medoxomil Teva Teva Pharma B.V. PA0749/108/002 Film-coated tablet - Olmesartan medoxomil 08/02/2019
20 mg film-coated tablets

Olmesartan Medoxomil Teva Teva Pharma B.V. PA0749/108/003 Film-coated tablet - Olmesartan medoxomil 08/02/2019
40 mg film-coated tablets

Alomide 0.1% w/v Eye Novartis Ireland Limited PA0896/001/001 Eye drops, solution - Lodoxamide tromethamine 07/02/2019
Drops, Solution
Betoptic 0.5% w/v Eye Novartis Ireland Limited PA0896/003/001 Eye drops, solution - Betaxolol hydrochloride 07/02/2019
Drops, Solution
Betoptic Suspension Single Novartis Ireland Limited PA0896/003/002 Eye drops, suspension - Betaxolol hydrochloride 07/02/2019
Dose 0.25% w/v, Eye Drops
Maxidex 0.1% w/w Eye Novartis Ireland Limited PA0896/018/002 Eye ointment - Dexamethasone 07/02/2019
Ointment
Moxivig 0.5% w/v eye drops, Novartis Pharmaceuticals UK PA0013/132/001 Eye drops, solution - Moxifloxacin hydrochloride 07/02/2019
solution Ltd
Vancomycin 1000 mg Actavis Group PTC ehf PA1380/180/002 Powder for concentrate for - VANCOMYCIN 07/02/2019
Powder for Concentrate for solution for infusion HYDROCHLORIDE
Solution for Infusion
Vancomycin 500 mg Powder Actavis Group PTC ehf PA1380/180/001 Powder for concentrate for - VANCOMYCIN 07/02/2019
for Concentrate for Solution solution for infusion HYDROCHLORIDE
for Infusion
AT 10 250 micrograms/ml Intrapharm Laboratories PA0997/001/001 Oral drops, solution - Dihydrotachysterol 05/02/2019
Oral Drops, Solution Limited
Feospan Spansule 150 mg Intrapharm Laboratories PA0997/007/001 Modified-release capsule, - Dried ferrous sulphate 05/02/2019
Modified Release Capsules Limited hard
HRF 100 micrograms powder Intrapharm Laboratories PA0997/005/001 Powder and solvent for - Gonadorelin 05/02/2019
and solvent for solution for Limited solution for injection
Injection
Noradrenaline Laboratoire AGUETTANT PA1968/001/002 Solution for infusion - Noradrenaline tartrate 05/02/2019
(norepinephrine) 0.25
mg/mL, solution for infusion

Human Medicines Withdrawn Products Page 79 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Emerpand 13.3mg/24h Accord Healthcare Limited PA1390/192/003 Transdermal patch - Rivastigmine 04/02/2019
Transdermal Patches
Emerpand 4.6mg/24h Accord Healthcare Limited PA1390/192/001 Transdermal patch - Rivastigmine 04/02/2019
Transdermal Patches
Emerpand 9.5mg/24h Accord Healthcare Limited PA1390/192/002 Transdermal patch - Rivastigmine 04/02/2019
Transdermal Patches
Alphaderm 1% & 10% w/w Alliance Pharmaceuticals Ltd PA0943/004/001 Cream - Urea 01/02/2019
Cream - Hydrocortisone
Amisulpride Mylan 50 mg McDermott Laboratories Ltd PA0577/125/001 Tablet - Amisulpride 01/02/2019
Tablets t/a Gerard Laboratories
Hyalgan solution for intra- Fidia Farmaceutici S.p.A. PA0814/001/001 Solution for injection - Sodium hyaluronate 01/02/2019
articular injection, 20 mg/2
ml, prefilled syringe
Imatinib medac Medac Gesellschaft fur EU/1/13/876/002 Capsule, hard - Imatinib mesilate 31/01/2019
Klinische Spezialpraparate
mbH
Mysodelle 200 micrograms Ferring Ireland Ltd PA1009/025/001 Vaginal delivery system - Misoprostol 31/01/2019
vaginal delivery system
Melphalan Teva 50 mg Teva B.V. PA1986/077/001 Powder and solvent for - Melphalan 29/01/2019
Powder and solvent for solution for injection/infusion
solution for injection/infusion
Nefopam 30mg film-coated Rivopharm Limited PA2318/001/001 Film-coated tablet - NEFOPAM 25/01/2019
tablets HYDROCHLORIDE
Perindopril Les Laboratoires Servier PA0568/019/004 Tablet - Perindopril arginine 25/01/2019
Arginine/Amlodipine Servier - Amlodipine besylate
10 mg/10 mg Tablets
Perindopril Les Laboratoires Servier PA0568/019/003 Tablet - Perindopril arginine 25/01/2019
Arginine/Amlodipine Servier - Amlodipine besylate
10 mg/5 mg Tablets
Perindopril Les Laboratoires Servier PA0568/019/002 Tablet - Perindopril arginine 25/01/2019
Arginine/Amlodipine Servier - Amlodipine besylate
5mg/10mg tablets
Perindopril Les Laboratoires Servier PA0568/019/001 Tablet - Perindopril arginine 25/01/2019
Arginine/Amlodipine Servier - Amlodipine besylate
5mg/5mg tablets
Paroser 20mg film-coated Apotex Europe B.V. PA1513/007/001 Film-coated tablet - Paroxetine hydrochloride 24/01/2019
tablet
Interchangeable List Code:
IC0076-003-003
Pravat 10 mg Tablets Apotex Europe B.V. PA1513/008/001 Tablet - Pravastatin sodium 23/01/2019

Interchangeable List Code:


IC0014-002-014
Pravat 20 mg Tablets Apotex Europe B.V. PA1513/008/002 Tablet - Pravastatin sodium 23/01/2019

Interchangeable List Code:


IC0014-003-014
Pravat 40mg Tablets Apotex Europe B.V. PA1513/008/003 Tablet - Pravastatin sodium 23/01/2019

Interchangeable List Code:


IC0014-004-014
Phenoxymethylpenicillin Morningside Healthcare PA1333/005/001 Film-coated tablet - Phenoxymethylpenicillin 16/01/2019
250mg Film-coated Tablets Limited
Cyltezo Boehringer Ingelheim EU/1/17/1240/005-008 Solution for injection in pre- - Adalimumab 15/01/2019
International GmbH filled pen
Eprosartan Niche 300 mg Niche Generics Limited PA1063/052/001 Film-coated tablet - Eprosartan mesylate 11/01/2019
Film-coated Tablets
Eprosartan Niche 400 mg Niche Generics Limited PA1063/052/002 Film-coated tablet - Eprosartan mesylate 11/01/2019
Film-coated Tablets
Eprosartan Niche 600 mg Niche Generics Limited PA1063/052/003 Film-coated tablet - Eprosartan mesylate 11/01/2019
Film-coated Tablets
Topotecan Actavis Actavis Group PTC ehf EU/1/09/536/001 Powder for concentrate for - Topotecan hydrochloride 11/01/2019
solution for infusion
Topotecan Actavis Actavis Group PTC ehf EU/1/09/536/002 Powder for concentrate for - Topotecan hydrochloride 11/01/2019
solution for infusion
Proctosedyl Suppositories Sanofi-Aventis Ireland PA0540/062/002 Suppository - Hydrocortisone 07/01/2019
Limited T/A SANOFI - Framycetin sulfate
- Aesculin
- Cinchocaine hydrochloride
Clopidogrel 1A Pharma Acino Pharma GmbH EU/1/09/542/1-7 Film-coated tablet - Clopidogrel besilate 04/01/2019
- Macrogol 6000
- Carbon dioxide
Clopidogrel Acino Pharma Acino Pharma GmbH EU/1/09/549/1-7 Film-coated tablet - Clopidogrel besilate 04/01/2019
- Macrogol 6000
- Carbon dioxide

Human Medicines Withdrawn Products Page 80 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Clopidogrel Acino Pharma Acino Pharma GmbH EU/1/09/548/1-7 Film-coated tablet - Clopidogrel besilate 04/01/2019
GmbH - Macrogol 6000
- Carbon dioxide
Clopidogrel BMS 300 mg Bristol-Myers EU/1/08/464/15-17 Film-coated tablet - Clopidogrel 04/01/2019
film-coated tablets Squibb/AstraZeneca EEIG
Clopidogrel BMS 75 mg film- Bristol-Myers EU/1/08/464/1-14, 18-19 Film-coated tablet - Clopidogrel hydrogensulfate 04/01/2019
coated tablets Squibb/AstraZeneca EEIG
Clopidogrel Hexal Acino Pharma GmbH EU/1/09/534/1-7 Film-coated tablet - Clopidogrel besilate 04/01/2019
Clopidogrel Sandoz Acino Pharma GmbH EU/1/09/547/1-7 Film-coated tablet - Clopidogrel besilate 04/01/2019
- Macrogol 6000
- Carbon dioxide
Imprida HCT Novartis Europharm Limited EU/1/09/570/1-12 Film-coated tablet - Amlodipine besylate 04/01/2019
- Hydrochlorothiazide
- Valsartan
Imprida HCT Novartis Europharm Limited EU/1/09/570/13-24 Film-coated tablet - Hydrochlorothiazide 04/01/2019
- Valsartan
- Amlodipine besylate
Imprida HCT Novartis Europharm Limited EU/1/09/570/25-36 Film-coated tablet - Amlodipine besylate 04/01/2019
- Hydrochlorothiazide
- Valsartan
Imprida HCT Novartis Europharm Limited EU/1/09/570/37-48 Film-coated tablet - Hydrochlorothiazide 04/01/2019
- Valsartan
- Amlodipine besylate
Imprida HCT Novartis Europharm Limited EU/1/09/570/49-60 Film-coated tablet - Valsartan 04/01/2019
- Hydrochlorothiazide
- Amlodipine besylate
Ilaris Novartis Europharm Limited EU/1/09/564/003 Powder and solvent for - Canakinumab 01/01/2019
solution for injection
Accupro 10 mg film-coated PCO Manufacturing Ltd. PPA0465/135/002 Film-coated tablet - Quinapril 31/12/2018
tablets
Accupro 20 mg film-coated PCO Manufacturing Ltd. PPA0465/135/003 Film-coated tablet - Quinapril 31/12/2018
tablets
Accupro 5 mg film-coated PCO Manufacturing Ltd. PPA0465/135/001 Film-coated tablet - Quinapril hydrochloride 31/12/2018
tablets
Adalat LA 30 mg Prolonged- PCO Manufacturing Ltd. PPA0465/012/005 Tablet - Nifedipine 31/12/2018
Release Tablets
Adalat LA 60 mg Prolonged- PCO Manufacturing Ltd. PPA0465/012/006 Tablet - Nifedipine 31/12/2018
release Tablets
Adalat Retard 20 mg PCO Manufacturing Ltd. PPA0465/012/003 Prolonged-release tablet - Nifedipine 31/12/2018
Prolonged-Release Tablets
Alendronic Acid 70 mg WPR Healthcare Limited PPA0565/058/001 Tablet - Alendronic acid 31/12/2018
Tablets Once Weekly
Interchangeable List Code:
IC0051-101-002
Amikin Injection 100 mg/2 ml Bristol-Myers Squibb PA2255/001/001 Solution for injection - AMIKACIN SULFATE 31/12/2018
Pharmaceuticals uc
Amlodipine 10 mg tablets WPR Healthcare Limited PPA0565/059/002 Tablet - Amlodipine as amlodipine 31/12/2018
besilate
Interchangeable List Code:
IC0045-002-008
Amlodipine 5 mg tablets PCO Manufacturing Ltd. PPA0465/439/001 Tablet - Amlodipine besilate 31/12/2018
Amlodipine 5 mg tablets WPR Healthcare Limited PPA0565/059/001 Tablet - Amlodipine as amlodipine 31/12/2018
besilate
Interchangeable List Code:
IC0045-001-008
Amoxicillin/Clavulanic acid DSM Sinochem PA1832/003/001 Film-coated tablet - Clavulanic acid (as 31/12/2018
Sinochem DSM 500 mg/125 Pharmaceuticals Netherlands potassium clavulanate,
mg film-coated tablets B.V. diluted : cellulose,
microcrystalline(1:1))
- Amoxicillin trihydrate
ARICEPT 10 mg film coated PCO Manufacturing PPA0465/426/002 Film-coated tablet - Donepezil hydrochloride 31/12/2018
tablets
Interchangeable List Code:
IC0062-002-015
ARICEPT 5 mg film coated PCO Manufacturing PPA0465/426/001 Film-coated tablet - Donepezil hydrochloride 31/12/2018
tablets
Interchangeable List Code:
IC0062-001-015
Atorvastatin 10mg film- WPR Healthcare Limited PPA0565/061/001 Film-coated tablet - Atorvastatin calcium 31/12/2018
coated tablets
Interchangeable List Code:
IC0001-002-003
Atorvastatin 20mg film- WPR Healthcare Limited PPA0565/061/002 Film-coated tablet - Atorvastatin calcium 31/12/2018
coated tablets
Interchangeable List Code:
IC0001-003-003

Human Medicines Withdrawn Products Page 81 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Atorvastatin 40mg film- WPR Healthcare Limited PPA0565/061/003 Film-coated tablet - Atorvastatin calcium 31/12/2018
coated tablets
Interchangeable List Code:
IC0001-004-003
Atorvastatin 80mg film- WPR Healthcare Limited PPA0565/061/004 Film-coated tablet - Atorvastatin calcium 31/12/2018
coated tablets
Interchangeable List Code:
IC0001-005-003
Bettamousse 1mg/g (0.1% PCO Manufacturing Ltd. PPA0465/209/001 Cutaneous foam - Betamethasone 31/12/2018
w/w) Cutaneous Foam
Difflam Spray, 0.15% w/v, PCO Manufacturing Ltd. PPA0465/425/001 Oromucosal spray, solution - BENZYDAMINE 31/12/2018
Oromucosal Spray HYDROCHLORIDE
Diovan 160 mg film-coated PCO Manufacturing Ltd. PPA0465/180/002 Film-coated tablet - Valsartan 31/12/2018
tablets
Interchangeable List Code:
IC0038-082-003
Diovan 80 mg film-coated PCO Manufacturing Ltd. PPA0465/180/001 Film-coated tablet - Valsartan 31/12/2018
tablets
Interchangeable List Code:
IC0038-005-003
Ikorel 10 mg Tablets PCO Manufacturing Ltd. PPA0465/103/001 Tablet - Nicorandil 31/12/2018
Ikorel 20 mg Tablets PCO Manufacturing Ltd. PPA0465/103/002 Tablet - Nicorandil 31/12/2018
Inegy 10 mg/20 mg tablets PCO Manufacturing Ltd. PPA0465/223/001 Tablet - Ezetimibe 31/12/2018
- Simvastatin
Interchangeable List Code:
IC0034-051-002
innohep 10,000 IU in 0.5 ml, PCO Manufacturing PPA0465/322/001 Solution for injection - Tinzaparin sodium 31/12/2018
solution for injection
innohep 14,000 IU in 0.7 ml, PCO Manufacturing PPA0465/322/003 Solution for injection - Tinzaparin sodium 31/12/2018
Solution for Injection
innohep 18,000 IU in 0.9 ml, PCO Manufacturing PPA0465/322/004 Solution for injection - Tinzaparin sodium 31/12/2018
solution for injection
Lansoprazole 15mg Gastro- WPR Healthcare Limited PPA0565/063/001 Gastro-resistant capsule, - Lansoprazole 31/12/2018
resistant Capsules, hard hard
Interchangeable List Code:
IC0008-032-033
Lansoprazole 30mg Gastro- WPR Healthcare Limited PPA0565/063/002 Gastro-resistant capsule, - Lansoprazole 31/12/2018
resistant Capsules, hard hard
Interchangeable List Code:
IC0008-033-033
Locoid Ointment 0.1% w/w LEO Pharma A/S PA1025/006/003 Ointment - HYDROCORTISONE 31/12/2018
BUTYRATE
Locoid Scalp Lotion 0.1% w/v LEO Pharma A/S PA1025/006/004 Cutaneous solution - HYDROCORTISONE 31/12/2018
Cutaneous Solution BUTYRATE
Logynon Tablets PCO Manufacturing Ltd. PPA0465/311/001 Tablet - Levonorgestrel 31/12/2018
- Ethinylestradiol
- Ethinylestradiol
- Levonorgestrel
- Levonorgestrel
Minocin SA 100 mg Modified PCO Manufacturing Ltd. PPA0465/329/001 Modified-release capsule, - Minocycline hydrochloride 31/12/2018
Release Capsules hard dihydrate
Mitomycin medac 20 mg Medac Gesellschaft fur PA0623/016/001 Powder and solvent for - Mitomycin 31/12/2018
powder and solvent for Klinische Spezialpraparate intravesical solution
intravesical solution mbH
Modecate 25 mg/ml Solution Bristol-Myers Squibb PA0002/031/005 Solution for injection - FLUPHENAZINE 31/12/2018
for Injection Pharmaceuticals uc DECANOATE
Modecate Concentrate 100 Bristol-Myers Squibb PA0002/031/001 Solution for injection - FLUPHENAZINE 31/12/2018
mg/ml Solution for Injection Pharmaceuticals uc DECANOATE
Neoral 100 mg Soft Capsule PCO Manufacturing Ltd. PPA0465/136/003 Capsule, soft - Ciclosporin 31/12/2018

Neoral 25 mg Soft Capsules PCO Manufacturing Ltd. PPA0465/136/001 Capsule, soft - Ciclosporin 31/12/2018
Neoral 50 mg Soft Capsules PCO Manufacturing Ltd. PPA0465/136/002 Capsule, soft - Ciclosporin 31/12/2018
Nitrolingual Pumpspray 400 PCO Manufacturing PPA0465/300/001 Sublingual spray, solution - Glyceryl trinitrate 31/12/2018
micrograms per metered
dose, sublingual spray
Omeprazole 10 mg Gastro- WPR Healthcare Limited PPA0565/056/002 Gastro-resistant capsule, - Omeprazole 31/12/2018
resistant Capsules, hard hard
Interchangeable List Code:
IC0010-002-016
Omeprazole 20 mg Gastro- WPR Healthcare Limited PPA0565/056/001 Gastro-resistant capsule, - Omeprazole 31/12/2018
resistant Capsules, hard hard
Interchangeable List Code:
IC0010-003-016

Human Medicines Withdrawn Products Page 82 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Omeprazole 40 mg Gastro- WPR Healthcare Limited PPA0565/056/003 Gastro-resistant capsule, - Omeprazole 31/12/2018
resistant Capsules, hard hard
Interchangeable List Code:
IC0010-004-016
Ovranette 150 PCO Manufacturing Ltd. PPA0465/431/001 Coated tablet - Levonorgestrel 31/12/2018
micrograms/30 micrograms - Ethinylestradiol
coated tablets
Pantoprazole 20 mg Gastro- WPR Healthcare Limited PPA0565/064/001 Gastro-resistant tablet - Pantoprazole sodium 31/12/2018
resistant Tablets sesquihydrate
Interchangeable List Code:
IC0013-003-005
Pantoprazole 40 mg Gastro- WPR Healthcare Limited PPA0565/064/002 Gastro-resistant tablet - Pantoprazole sodium 31/12/2018
resistant Tablets sesquihydrate
Interchangeable List Code:
IC0013-004-005
Pentasa 500 mg Prolonged- PCO Manufacturing PPA0465/235/001 Prolonged-release tablet - Mesalazine 31/12/2018
release Tablets
Pentasa Sachet 2 g PCO Manufacturing PPA0465/235/002 Prolonged-release granules - Mesalazine 31/12/2018
prolonged release granules
Pharmaton Capsules PCO Manufacturing Ltd. PPA0465/178/001 Capsule - Zinc (as zinc sulphate 31/12/2018
monohydrate)
- Folic acid
- Calcium phosphate dibasic
- Riboflavine
- Colecalciferol concentrate
(oily form) [vitamin d3]
- Vitamin e acetate
- Selenium
- Copper (as dried copper
sulpahte)
- Iron (as dried ferrous
sulphate)
- Nicotinamide
- Thiamine nitrate
- Pyridoxine hydrochloride
- Ascorbic acid
- Biotin
- Vitamin a palmitate
- Lecithin
- Cyanocobalamin
- Magnesium sulfate dried
- Panax ginseng extract
RISPERDAL CONSTA 25 PCO Manufacturing Ltd. PPA0465/274/001 Powder and solvent for - Risperidone 31/12/2018
mg powder and solvent for prolonged-release
prolonged-release suspension for injection
suspension for injection
RISPERDAL CONSTA 37.5 PCO Manufacturing Ltd. PPA0465/274/002 Suspension for injection - Risperidone 31/12/2018
mg powder and solvent for
prolonged-release
suspension for injection
RISPERDAL CONSTA 50 PCO Manufacturing Ltd. PPA0465/274/003 Suspension for injection - Risperidone 31/12/2018
mg powder and solvent for
prolonged-release
suspension for injection
Rivotril 2mg Tablets Roche Products Limited PA0050/014/002 Tablet - Clonazepam 31/12/2018
Scheriproct 1.5mg/g + 5mg/g PCO Manufacturing Ltd. PPA0465/408/001 Rectal ointment - Cinchocaine hydrochloride 31/12/2018
rectal ointment - PREDNISOLONE
CAPROATE
Senokot 7.5mg Tablets PCO Manufacturing Ltd. PPA0465/414/001 Tablet - Sennoside b 31/12/2018
Seroxat 20mg Film-coated PCO Manufacturing PPA0465/055/001 Film-coated tablet - Paroxetine hydrochloride 31/12/2018
Tablets hemihydrate
Interchangeable List Code:
IC0076-003-003
Seroxat 30mg Film-coated PCO Manufacturing PPA0465/055/002 Film-coated tablet - Paroxetine hydrochloride 31/12/2018
tablets hemihydrate
Interchangeable List Code:
IC0076-033-003
Sinemet Plus 25 mg/100 mg PCO Manufacturing Ltd. PPA0465/148/003 Tablet - Carbidopa 31/12/2018
Tablets - Levodopa
Solian 100mg Tablets PCO Manufacturing Ltd. PPA0465/412/003 Tablet - Amisulpride 31/12/2018
Solian 400mg Film-coated PCO Manufacturing Ltd. PPA0465/412/004 Film-coated tablet - Amisulpride 31/12/2018
Tablets
Solian 50mg Tablets PCO Manufacturing Ltd. PPA0465/412/002 Tablet - Amisulpride 31/12/2018
Telfast 120mg film-coated PCO Manufacturing Ltd. PPA0465/253/001 Film-coated tablet - Fexofenadine hydrochloride 31/12/2018
tablets
Telfast 180mg film-coated PCO Manufacturing Ltd. PPA0465/253/002 Film-coated tablet - Fexofenadine hydrochloride 31/12/2018
tablets

Human Medicines Withdrawn Products Page 83 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Teveten 600 mg film-coated PCO Manufacturing Ltd. PPA0465/147/002 Film-coated tablet - Eprosartan 31/12/2018
tablets
Traxam Gel 3% w/w PCO Manufacturing Ltd. PPA0465/215/001 Gel - Felbinac 31/12/2018
Xyzal 5 mg film-coated PCO Manufacturing PPA0465/169/001 Film-coated tablet - Levocetirizine 31/12/2018
tablets dihydrochloride
Interchangeable List Code:
IC0095-001-003
Zanaflex 2mg Tablets PCO Manufacturing Ltd. PPA0465/168/001 Tablet - Tizanidine hydrochloride 31/12/2018
Zanaflex 4mg Tablets PCO Manufacturing Ltd. PPA0465/168/002 Tablet - Tizanidine hydrochloride 31/12/2018
Zineryt, powder and solvent PCO Manufacturing Ltd. PPA0465/206/001 Powder and solvent for - Erythromycin 31/12/2018
for cutaneous solution cutaneous solution - Zinc acetate
Zovirax 30 mg/g Eye PCO Manufacturing Ltd. PPA0465/333/001 Eye ointment - ACICLOVIR 31/12/2018
Ointment
Zyloric 300 mg Tablets PCO Manufacturing Ltd. PPA0465/017/002 Tablet - Allopurinol 31/12/2018
Itraconazole 10mg/ml Oral Focus Pharmaceuticals Ltd PA1338/009/001 Oral solution - Itraconazole 27/12/2018
Solution
Olena 20mg Dispersible Mercury Pharmaceuticals Ltd PA0899/042/001 Dispersible tablet - FLUOXETINE 27/12/2018
Tablets HYDROCHLORIDE
Paliperidone Krka 3 mg Krka d.d., Novo mesto PA1347/081/001 Prolonged-release tablet - Paliperidone 27/12/2018
prolonged-release tablets
Paliperidone Krka 6 mg Krka d.d., Novo mesto PA1347/081/002 Prolonged-release tablet - Paliperidone 27/12/2018
prolonged-release tablets
Paliperidone Krka 9 mg Krka d.d., Novo mesto PA1347/081/003 Prolonged-release tablet - Paliperidone 27/12/2018
prolonged-release tablets
Pitressin 20 PU/ml Solution Mercury Pharmaceuticals Ltd PA0899/001/001 Solution for injection - Argipressin 27/12/2018
for Injection
Tranexamic Acid 500mg/5ml Focus Pharmaceuticals Ltd PA1338/012/001 Solution for injection - Tranexamic acid 27/12/2018
Solution for Injection

Kamillosan Chamomile Chefaro Ireland DAC PA1186/007/001 Ointment - Chamomile 19/12/2018


Ointment
Solifenacin Apotex 10 mg Apotex Europe B.V. PA1513/010/002 Film-coated tablet - Solifenacin succinate 19/12/2018
film-coated tablets
Solifenacin Apotex 5 mg film- Apotex Europe B.V. PA1513/010/001 Film-coated tablet - Solifenacin succinate 19/12/2018
coated tablets
Trospium Chloride 20mg film- Teva B.V. PA1986/062/001 Film-coated tablet - Trospium chloride 19/12/2018
coated tablets
UROSTEMOL capsules Chefaro Ireland DAC TR1186/005/001 Capsule, hard - Pumpkin seed, crushed 19/12/2018
- Pumpkin seed oil
Urostemol femina capsules Chefaro Ireland DAC TR1186/006/001 Capsule, hard - Pumpkin seed oil 19/12/2018
- Dry extract of hop strobile
- Dry extract of fragrant
sumach bark
Urostemol Men capsules Chefaro Ireland DAC TR1186/007/001 Capsule, hard - Pumpkin seed, crushed 19/12/2018
- Pumpkin seed oil
- Dry extract of saw palmetto
fruit
Urostemol Prosta capsules Chefaro Ireland DAC TR1186/004/001 Capsule, hard - Pumpkin seed soft extract 19/12/2018
Zoledronic acid 4mg/5ml Intrapharm Laboratories PA0997/009/001 Concentrate for solution for - Zoledronic acid 19/12/2018
concentrate for solution for Limited infusion monohydrate
infusion
Zoledronic acid 4mg/5ml Intrapharm Laboratories PA0997/009/002 Concentrate for solution for - Zoledronic acid 19/12/2018
concentrate for solution for Limited infusion monohydrate
infusion
Voriconazole Apotex 50mg Apotex Europe B.V. PA1513/006/001 Film-coated tablet - Voriconazole 18/12/2018
Film-coated tablets
Voriconzaole Apotex 200mg Apotex Europe B.V. PA1513/006/002 Film-coated tablet - Voriconazole 18/12/2018
Film-coated tablets
Adcus 3mg/ml Solution for Focus Pharmaceuticals Ltd PA1338/007/001 Solution for infusion - ADENOSINE 17/12/2018
Infusion
Adenosine 3mg/ml Solution Focus Pharmaceuticals Ltd PA1338/008/001 Solution for injection - ADENOSINE 17/12/2018
for Injection
Alimemazine tartrate 10mg Mercury Pharmaceuticals PA0073/153/001 Film-coated tablet - ALIMEMAZINE TARTRATE 17/12/2018
Film-coated tablets (Ireland) Ltd
Alimemazine tartrate Mercury Pharmaceuticals PA0073/153/002 Syrup - Trimeprazine (alimemazine) 17/12/2018
30mg/5ml Syrup (Ireland) Ltd tartrate
Alimemazine tartrate Mercury Pharmaceuticals PA0073/153/003 Syrup - Trimeprazine (alimemazine) 17/12/2018
7.5mg/5ml Syrup (Ireland) Ltd tartrate
Amisulpride 100mg/ml oral Focus Pharmaceuticals Ltd PA1338/006/001 Oral solution - Amisulpride 17/12/2018
solution
Cilostazol 100mg Tablets Focus Pharmaceuticals Ltd PA1338/014/001 Tablet - Cilostazol 17/12/2018
Citalopram 40mg/ml Oral Focus Pharmaceuticals Ltd PA1338/003/001 Oral drops, solution - Citalopram hydrochloride 17/12/2018
Drops, solution
Interchangeable List Code:
IC0073-132-049

Human Medicines Withdrawn Products Page 84 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Clindamycin 150mg/ml Focus Pharmaceuticals Ltd PA1338/004/001 Solution for injection/infusion - Clindamycin 17/12/2018
Solution for Injection or
Infusion
Hydrocortisone 10 mg Amdipharm Limited PA1142/019/001 Tablet - Hydrocortisone 17/12/2018
Tablets
Hydrocortisone 20 mg Amdipharm Limited PA1142/019/002 Tablet - Hydrocortisone 17/12/2018
Tablets
Lomotil 2.5mg / 0.025mg Mercury Pharmaceuticals Ltd PA0899/007/001 Tablet - ATROPINE SULFATE 17/12/2018
Tablets - DIPHENOXYLATE
HYDROCHLORIDE
Ofcram SR 200mg Focus Pharmaceuticals Ltd PA1338/013/001 Prolonged-release capsule, - Dipyridamole 17/12/2018
Prolonged-release Capsules, hard
Hard
Pevanti 10mg Tablets Mercury Pharmaceuticals Ltd PA0899/043/003 Tablet - Prednisolone 17/12/2018

Pevanti 2.5mg Tablets Mercury Pharmaceuticals Ltd PA0899/043/001 Tablet - Prednisolone 17/12/2018

Pevanti 20mg Tablets Mercury Pharmaceuticals Ltd PA0899/043/004 Tablet - Prednisolone 17/12/2018

Pevanti 25mg Tablets Mercury Pharmaceuticals Ltd PA0899/043/005 Tablet - Prednisolone 17/12/2018

Pevanti 5mg Tablets Mercury Pharmaceuticals Ltd PA0899/043/002 Tablet - Prednisolone 17/12/2018

Phorpain 5% w/w Gel Mercury Pharmaceuticals Ltd PA0899/004/004 Gel - Ibuprofen 17/12/2018
Ibuprofen
Ranitidine 150mg/10ml Oral Focus Pharmaceuticals Ltd PA1338/001/001 Oral solution - RANITIDINE 17/12/2018
Solution HYDROCHLORIDE
Interchangeable List Code:
IC0087-144-054
Ropivacaine 10 mg/ml Mercury Pharmaceuticals Ltd PA0899/041/005 Solution for injection - ROPIVACAINE 17/12/2018
solution for injection HYDROCHLORIDE
Ropivacaine 2 mg/ml solution Mercury Pharmaceuticals Ltd PA0899/041/002 Solution for infusion - ROPIVACAINE 17/12/2018
for infusion HYDROCHLORIDE
Ropivacaine 2 mg/ml solution Mercury Pharmaceuticals Ltd PA0899/041/001 Solution for injection - ROPIVACAINE 17/12/2018
for injection HYDROCHLORIDE
Ropivacaine 5 mg/ml solution Mercury Pharmaceuticals Ltd PA0899/041/003 Solution for injection - ROPIVACAINE 17/12/2018
for injection HYDROCHLORIDE
Ropivacaine 7.5 mg/ml Mercury Pharmaceuticals Ltd PA0899/041/004 Solution for injection - ROPIVACAINE 17/12/2018
solution for injection HYDROCHLORIDE
Trazodone Hydrochloride 50 Mercury Pharmaceuticals PA0073/154/001 Oral solution - Trazodone hydrochloride 17/12/2018
mg / 5 ml Oral Solution (Ireland) Ltd
Arnica Ointment Weleda (UK) Limited PA0407/001/001 Ointment - Arnica montana 14/12/2018
Cinacalcet Apotex 30 mg Apotex Europe B.V. PA1513/009/001 Film-coated tablet - Cinacalcet hydrochloride 14/12/2018
Film Coated Tablets
Cinacalcet Apotex 60 mg Apotex Europe B.V. PA1513/009/002 Film-coated tablet - Cinacalcet hydrochloride 14/12/2018
Film Coated Tablets
Cinacalcet Apotex 90 mg Apotex Europe B.V. PA1513/009/003 Film-coated tablet - Cinacalcet hydrochloride 14/12/2018
Film Coated Tablets
Lysopadol Blackcurrant 20 Sanofi-Aventis Ireland PA0540/185/001 Lozenge - AMBROXOL 13/12/2018
mg Lozenges Limited T/A SANOFI HYDROCHLORIDE
- AMBROXOL
HYDROCHLORIDE
Rasagiline Apotex 1mg Apotex Europe B.V. PA1513/011/001 Tablet - Rasagiline mesilate 13/12/2018
tablets
Fungasil 10mg/g cream Clonmel Healthcare Ltd PA0126/166/001 Cream - TERBINAFINE 11/12/2018
HYDROCHLORIDE
Optrex 13% v/v Eye Drops, Optrex Limited PA0275/006/001 Eye drops, solution - Ethanol 11/12/2018
Solution - Hamamelis water
Optrex 13% v/v Eye Lotion Optrex Limited PA0275/005/001 Eye lotion - Ethanol 11/12/2018
- Hamamelis water
Ivabradine JensonR Mylan S.A.S. EU/1/16/1145/001-017 Film-coated tablet - Ivabradine hydrochloride 06/12/2018
Ivabradine JensonR Mylan S.A.S. EU/1/16/1145/018-034 Film-coated tablet - Ivabradine hydrochloride 06/12/2018
Amisulpride Mylan 200 mg McDermott Laboratories Ltd PA0577/125/003 Tablet - Amisulpride 04/12/2018
Tablets t/a Gerard Laboratories
Ateni 100mg Film-coated Generics (UK) Limited PA0405/019/002 Film-coated tablet - Atenolol 04/12/2018
Tablets
Ateni 50mg Film-coated Generics (UK) Limited PA0405/019/001 Film-coated tablet - Atenolol 04/12/2018
Tablets
Atomoxetine 10 mg hard Generics (UK) Limited PA0405/103/001 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Atomoxetine 100 mg hard Generics (UK) Limited PA0405/103/007 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Atomoxetine 18 mg hard Generics (UK) Limited PA0405/103/002 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Atomoxetine 25 mg hard Generics (UK) Limited PA0405/103/003 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules

Human Medicines Withdrawn Products Page 85 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Atomoxetine 40 mg hard Generics (UK) Limited PA0405/103/004 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Atomoxetine 60 mg hard Generics (UK) Limited PA0405/103/005 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Atomoxetine 80 mg hard Generics (UK) Limited PA0405/103/006 Capsule, hard - Atomoxetine hydrochloride 04/12/2018
capsules
Bendamustine 100mg Generics (UK) Limited PA0405/072/002 Powder for concentrate for - Bendamustine 04/12/2018
Powder for Concentrate for solution for infusion hydrochloride
Solution for Infusion
Bendamustine 25 mg Powder Generics (UK) Limited PA0405/072/001 Powder for concentrate for - Bendamustine 04/12/2018
for Concentrate for Solution solution for infusion hydrochloride
for Infusion
Candesartan Mylan 16mg McDermott Laboratories Ltd PA0577/120/003 Tablet - Candesartan cilexetil 04/12/2018
Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0009-038-002
Candesartan Mylan 4mg McDermott Laboratories Ltd PA0577/120/001 Tablet - Candesartan cilexetil 04/12/2018
Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0009-008-002
Candesartan Mylan 8mg McDermott Laboratories Ltd PA0577/120/002 Tablet - Candesartan cilexetil 04/12/2018
Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0009-009-002
Cardioplast 0.2mg/h McDermott Laboratories Ltd PA0577/174/001 Transdermal patch - Nitroglycerin (glyceryl 04/12/2018
transdermal patches t/a Gerard Laboratories trinitrate)
Cardioplast 0.4mg/h McDermott Laboratories Ltd PA0577/174/002 Transdermal patch - Nitroglycerin (glyceryl 04/12/2018
transdermal patches t/a Gerard Laboratories trinitrate)
Cardioplast 0.6mg/h McDermott Laboratories Ltd PA0577/174/003 Transdermal patch - Nitroglycerin (glyceryl 04/12/2018
transdermal patches t/a Gerard Laboratories trinitrate)
Caspofungin Mylan 50 mg McDermott Laboratories Ltd PA0577/184/001 Powder for concentrate for - Caspofungin 04/12/2018
powder for concentrate for t/a Gerard Laboratories solution for infusion
solution for infusion
Caspofungin Mylan 70 mg McDermott Laboratories Ltd PA0577/184/002 Powder for concentrate for - Caspofungin 04/12/2018
powder for concentrate for t/a Gerard Laboratories solution for infusion
solution for infusion
Efavirenz Mylan 600 mg McDermott Laboratories Ltd PA0577/156/001 Film-coated tablet - Efavirenz 04/12/2018
Film-coated Tablets t/a Gerard Laboratories
Eplerenone Mylan 50 mg McDermott Laboratories Ltd PA0577/168/002 Film-coated tablet - Eplerenone 04/12/2018
film-coated tablets t/a Gerard Laboratories
Esomeprazole Mylan 40 mg McDermott Laboratories Ltd PA0577/123/002 Gastro-resistant capsule, - Esomeprazole 04/12/2018
Gastro-resistant Hard t/a Gerard Laboratories hard
Capsules Interchangeable List Code:
IC0004-004-016
Geroquel 300 mg film-coated McDermott Laboratories Ltd PA0577/090/004 Film-coated tablet - Quetiapine fumarate 04/12/2018
tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0019-029-003
Ivabradine Mylan 5 mg film- McDermott Laboratories Ltd PA0577/186/001 Film-coated tablet - Ivabradine oxalate 04/12/2018
coated tablets t/a Gerard Laboratories
Ivabradine Mylan 7.5 mg film- McDermott Laboratories Ltd PA0577/186/002 Film-coated tablet - Ivabradine oxalate 04/12/2018
coated tablets t/a Gerard Laboratories
Lamot 200 mg Tablets McDermott Laboratories Ltd PA0577/077/004 Tablet - Lamotrigine 04/12/2018
t/a Gerard Laboratories
Lansoprazole Mylan 15 mg McDermott Laboratories Ltd PA0577/151/001 Gastro-resistant capsule, - Lansoprazole 04/12/2018
Gastro-resistant capsules t/a Gerard Laboratories hard
Interchangeable List Code:
IC0008-032-033
Lansoprazole Mylan 30 mg McDermott Laboratories Ltd PA0577/151/002 Gastro-resistant capsule, - Lansoprazole 04/12/2018
Gastro-resistant capsules t/a Gerard Laboratories hard
Interchangeable List Code:
IC0008-033-033
Latanoprost 50 Generics (UK) Limited PA0405/068/001 Eye drops, solution - Latanoprost 04/12/2018
micrograms/ml Eye Drops,
Solution Interchangeable List Code:
IC0096-152-045
Levetiracetam Mylan 1000mg McDermott Laboratories Ltd PA0577/143/003 Film-coated tablet - Levetiracetam 04/12/2018
Film-coated Tablets t/a Gerard Laboratories

Levetiracetam Mylan 250mg McDermott Laboratories Ltd PA0577/143/001 Film-coated tablet - Levetiracetam 04/12/2018
Film-coated Tablets t/a Gerard Laboratories
Levetiracetam Mylan 500mg McDermott Laboratories Ltd PA0577/143/002 Film-coated tablet - Levetiracetam 04/12/2018
Film-coated Tablets t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 86 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/003 Film-coated tablet - Carbidopa 04/12/2018
pone Mylan - Entacapone
100mg/25mg/200mg Film- - Levodopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/004 Film-coated tablet - Entacapone 04/12/2018
pone Mylan - Carbidopa
125mg/31.25mg/200mg Film- - Levodopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/005 Film-coated tablet - Carbidopa 04/12/2018
pone Mylan - Entacapone
150mg/37.5mg/200mg Film- - Levodopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/006 Film-coated tablet - Levodopa 04/12/2018
pone Mylan - Entacapone
175mg/43.75mg/200mg Film- - Carbidopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/007 Film-coated tablet - Carbidopa 04/12/2018
pone Mylan - Entacapone
200mg/50mg/200mg Film- - Levodopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/001 Film-coated tablet - Carbidopa 04/12/2018
pone Mylan - Entacapone
50mg/12.5mg/200mg Film- - Levodopa
coated Tablets
Levodopa/Carbidopa/Entaca Generics (UK) Limited PA0405/090/002 Film-coated tablet - Entacapone 04/12/2018
pone Mylan - Levodopa
75mg/18.75mg/200mg Film- - Carbidopa
coated Tablets
Lisinopril 10 mg Tablets McDermott Laboratories Ltd PA0577/161/003 Tablet - Lisinopril (as dihydrate) 04/12/2018
t/a Gerard Laboratories - Lisinopril (as dihydrate)
Lisinopril 2.5 mg Tablets McDermott Laboratories Ltd PA0577/161/001 Tablet - Lisinopril (as dihydrate) 04/12/2018
t/a Gerard Laboratories - Lisinopril (as dihydrate)
Lisinopril 20 mg Tablets McDermott Laboratories Ltd PA0577/161/004 Tablet - Lisinopril (as dihydrate) 04/12/2018
t/a Gerard Laboratories - Lisinopril (as dihydrate)
Lisinopril 5 mg Tablets McDermott Laboratories Ltd PA0577/161/002 Tablet - Lisinopril (as dihydrate) 04/12/2018
t/a Gerard Laboratories - Lisinopril (as dihydrate)
Lisinopril/Hydrochlorothiazide McDermott Laboratories Ltd PA0577/165/001 Tablet - Hydrochlorothiazide 04/12/2018
10 mg/12.5 mg Tablets t/a Gerard Laboratories - Lisinopril (as dihydrate)
Lisinopril/Hydrochlorothiazide McDermott Laboratories Ltd PA0577/165/002 Tablet - Hydrochlorothiazide 04/12/2018
20 mg/12.5 mg Tablets t/a Gerard Laboratories - Lisinopril (as dihydrate)
Losartan Mylan 100mg Film- McDermott Laboratories Ltd PA0577/160/003 Film-coated tablet - Losartan potassium 04/12/2018
Coated Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0003-024-003
Losartan Mylan 12.5mg Film- McDermott Laboratories Ltd PA0577/160/001 Film-coated tablet - Losartan potassium 04/12/2018
Coated Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0003-021-003
Losartan Mylan 50mg Film- McDermott Laboratories Ltd PA0577/160/002 Film-coated tablet - Losartan potassium 04/12/2018
Coated Tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0003-023-003
Mefenamic Acid 250mg Generics (UK) Limited PA0405/014/001 Capsule, hard - Mefenamic acid 04/12/2018
Capsules BP
Metformin Mylan 1000 mg McDermott Laboratories Ltd PA0577/132/003 Film-coated tablet - METFORMIN 04/12/2018
film-coated tablets t/a Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0067-119-003
Metformin Mylan 500 mg McDermott Laboratories Ltd PA0577/132/001 Film-coated tablet - METFORMIN 04/12/2018
film-coated tablets t/a Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0067-117-003
Metformin Mylan 850 mg McDermott Laboratories Ltd PA0577/132/002 Film-coated tablet - METFORMIN 04/12/2018
film-coated tablets t/a Gerard Laboratories HYDROCHLORIDE
Interchangeable List Code:
IC0067-118-003
Mymicyas 50 mg Powder for Generics (UK) Limited PA0405/087/001 Powder for concentrate for - Caspofungin acetate 04/12/2018
Concentrate for Solution for solution for infusion
Infusion
Mymicyas 70 mg Powder for Generics (UK) Limited PA0405/087/002 Powder for concentrate for - Caspofungin acetate 04/12/2018
Concentrate for Solution for solution for infusion
Infusion
Omeprazole 10 mg gastro- McDermott Laboratories Ltd PA0577/178/001 Gastro-resistant tablet - Omeprazole magnesium 04/12/2018
resistant tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0010-002-016

Human Medicines Withdrawn Products Page 87 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Omeprazole 20 mg gastro- McDermott Laboratories Ltd PA0577/178/002 Gastro-resistant tablet - Omeprazole magnesium 04/12/2018
resistant tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0010-003-016
Omeprazole 40 mg gastro- McDermott Laboratories Ltd PA0577/178/003 Gastro-resistant tablet - Omeprazole magnesium 04/12/2018
resistant tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0010-004-016
Risedronate Once a week 35 McDermott Laboratories Ltd PA0577/159/001 Film-coated tablet - Risedronate sodium 04/12/2018
mg film-coated tablets t/a Gerard Laboratories
Interchangeable List Code:
IC0068-124-003
Risedronate/Calcium Mylan McDermott Laboratories Ltd PA0577/167/001 Film-coated tablet - Risedronate sodium 04/12/2018
35mg/500mg Film-coated t/a Gerard Laboratories - Calcium
tablets Interchangeable List Code:
IC0068-125-003
Teicoplanin 100 mg Powder Generics (UK) Limited PA0405/076/001 Powder for solution for - Teicoplanin 04/12/2018
for Solution for injection/infusion
Injection/Infusion or Oral
Solution
Teicoplanin 200 mg Powder Generics (UK) Limited PA0405/076/002 Powder for solution for - Teicoplanin 04/12/2018
for Solution for injection/infusion
Injection/Infusion or Oral
Solution
Teicoplanin 400 mg Powder Generics (UK) Limited PA0405/076/003 Powder for solution for - Teicoplanin 04/12/2018
for Solution for injection/infusion
Injection/Infusion or Oral
Solution
Vancomycin 1000mg powder Generics (UK) Limited PA0405/092/002 Powder for concentrate for - VANCOMYCIN 04/12/2018
for concentrate for solution solution for infusion HYDROCHLORIDE
for infusion
Vancomycin 500mg powder Generics (UK) Limited PA0405/092/001 Powder for concentrate for - VANCOMYCIN 04/12/2018
for concentrate for solution solution for infusion HYDROCHLORIDE
for infusion
Vexarin XL 150 mg McDermott Laboratories Ltd PA0577/169/002 Prolonged-release capsule, - Venlafaxine hydrochloride 04/12/2018
Prolonged-release capsules, t/a Gerard Laboratories hard
hard Interchangeable List Code:
IC0026-062-030
Vexarin XL 75 mg Prolonged- McDermott Laboratories Ltd PA0577/169/001 Prolonged-release capsule, - Venlafaxine hydrochloride 04/12/2018
release capsules, hard t/a Gerard Laboratories hard
Interchangeable List Code:
IC0026-028-030
Voriconazole Mylan 200mg McDermott Laboratories Ltd PA0577/173/001 Film-coated tablet - Voriconazole 04/12/2018
film-coated tablets t/a Gerard Laboratories
Zesger 10 mg Tablets McDermott Laboratories Ltd PA0577/041/002 Tablet - Lisinopril 04/12/2018
t/a Gerard Laboratories
Zesger 20 mg Tablets McDermott Laboratories Ltd PA0577/041/003 Tablet - Lisinopril 04/12/2018
t/a Gerard Laboratories
Zoledronic acid Mylan 4 Generics (UK) Limited PA0405/064/001 Solution for infusion - Zoledronic acid 04/12/2018
mg/100 ml Solution for monohydrate
Infusion
Norprolac 150 microgram Ferring Ireland Ltd PA1009/020/003 Tablet - Quinagolide 01/12/2018
tablets
Norprolac 25 microgram + 50 Ferring Ireland Ltd PA1009/020/001 Tablet - Quinagolide 01/12/2018
microgram tablets - Quinagolide
Norprolac 75 microgram Ferring Ireland Ltd PA1009/020/002 Tablet - Quinagolide 01/12/2018
tablets

Human Medicines Withdrawn Products Page 88 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Kabiven emulsion for infusio Fresenius Kabi Limited PA0566/003/001 Emulsion for infusion - Alanine 27/11/2018
- Proline
- Potassium chloride
- Valine
- Arginine
- Lysine
- Threonine
- Histidine
- Soybean oil
- Tyrosine
- Magnesium sulfate
- Sodium glycerophosphate
anhydrous
- Phenylalanine
- Serine
- Tryptophan
- Leucine
- Aspartic acid
- Calcium chloride
- Glycine hydrochloride
- Glucose anhydrous
- Sodium acetate
- Isoleucine
- Glutamic acid
- Methionine
Kabiven Peripheral emulsion Fresenius Kabi Limited PA0566/003/002 Emulsion for infusion - Arginine 27/11/2018
for infusion - Isoleucine
- Methionine
- Valine
- Sodium acetate
- Soybean oil
- Histidine
- MAGNESIUM SULPHATE
HEPTAHYDRATE
- Leucine
- GLYCINE
- Calcium chloride
- Sodium glycerophosphate
anhydrous
- Phenylalanine
- Serine
- Threonine
- Proline
- Aspartic acid
- Lysine
- Alanine
- Potassium chloride
- Tryptophan
- Glucose anhydrous
- Glutamic acid
- Tyrosine

Human Medicines Withdrawn Products Page 89 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SmofKabiven Peripheral, Fresenius Kabi Limited PA0566/051/001 Emulsion for infusion - Soya Bean Oil, Refined 27/11/2018
emulsion for infusion, Excel Ph.Eur
bag - Medium chain triglycerides
- Refined olive oil
- Fish oil, rich in omega-3
acids
- Isoleucine
- Leucine
- Methionine
- Lysine acetate
- Phenylalanine
- Threonine
- Tryptophan
- Valine
- Arginine
- Histidine
- Alanine
- GLYCINE
- Proline
- Serine
- Tyrosine
- Taurine
- Calcium chloride dihydrate
- Sodium glycerophophate
hydrate
- MAGNESIUM SULPHATE
HEPTAHYDRATE
- Potassium chloride
- Sodium acetate trihydrate
- Zinc sulphate heptahydrate
- Glucose monohydrate

Omeprazole Mylan 10 mg McDermott Laboratories Ltd PA0577/150/001 Gastro-resistant capsule, - Omeprazole 26/11/2018
Gastro-resistant capsules, t/a Gerard Laboratories hard
hard Interchangeable List Code:
IC0010-002-016
Omeprazole Mylan 20 mg McDermott Laboratories Ltd PA0577/150/002 Gastro-resistant capsule, - Omeprazole 26/11/2018
Gastro-resistant capsules, t/a Gerard Laboratories hard
hard Interchangeable List Code:
IC0010-003-016
Omeprazole Mylan 40 mg McDermott Laboratories Ltd PA0577/150/003 Gastro-resistant capsule, - Omeprazole 26/11/2018
Gastro-resistant capsules, t/a Gerard Laboratories hard
hard Interchangeable List Code:
IC0010-004-016
Omeprazole 20 mg gastro- Laboratorios LICONSA, S.A. PA1239/019/001 Gastro-resistant capsule, - Omeprazole 23/11/2018
resistant capsules, hard hard
REMINYL 12 mg tablets Shire Pharmaceuticals PA0535/006/004 Film-coated tablet - GALANTAMINE 23/11/2018
Limited HYDROBROMIDE
REMINYL 4 mg tablets Shire Pharmaceuticals PA0535/006/002 Film-coated tablet - GALANTAMINE 23/11/2018
Limited HYDROBROMIDE
REMINYL 8 mg tablets Shire Pharmaceuticals PA0535/006/003 Film-coated tablet - GALANTAMINE 23/11/2018
Limited HYDROBROMIDE
TRIAXIS, suspension for Sanofi Pasteur PA2131/010/001 Suspension for injection - Tetanus toxoid 23/11/2018
injection. Diphtheria, - Diphtheria toxoid
Tetanus, Pertussis (acellular - Filamentous haemagglutinin
component) Vaccine - Pertussis toxoid
(adsorbed, reduced - Pertactin
antigen(s) content) - Fimbriae types 2 and 3
- Adsorbed aluminium
phosphate

Octreotide 500 Fresenius Kabi Limited PA0566/062/003 Solution for injection - OCTREOTIDE ACETATE 21/11/2018
micrograms/ml solution for
injection
Pregabalin Clonmel 100mg Clonmel Healthcare Ltd PA0126/278/004 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Pregabalin Clonmel 150mg Clonmel Healthcare Ltd PA0126/278/005 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Pregabalin Clonmel 200mg Clonmel Healthcare Ltd PA0126/278/006 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Pregabalin Clonmel 25mg Clonmel Healthcare Ltd PA0126/278/001 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Pregabalin Clonmel 300mg Clonmel Healthcare Ltd PA0126/278/008 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Pregabalin Clonmel 50mg Clonmel Healthcare Ltd PA0126/278/002 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard

Human Medicines Withdrawn Products Page 90 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Pregabalin Clonmel 75mg Clonmel Healthcare Ltd PA0126/278/003 Capsule, hard - Pregabalin 21/11/2018
Capsules, Hard
Methadone 1 mg/ml Oral Teva B.V. PA1986/060/001 Oral solution - Methadone hydrochloride 13/11/2018
Solution Sugar Free
Citalopram 40 mg/ml Oral Rosemont Pharmaceuticals PA0312/012/001 Oral drops, solution - Citalopram 12/11/2018
Drops, Solution Ltd
Eperzan GlaxoSmithKline Trading EU/1/13/908/001 Powder and solvent for - Albiglutide 12/11/2018
Services Limited solution for injection
Eperzan GlaxoSmithKline Trading EU/1/13/908/002 Powder and solvent for - Albiglutide 12/11/2018
Services Limited solution for injection
Torvacol 10 mg film-coated Clonmel Healthcare Ltd PA0126/234/001 Film-coated tablet - Atorvastatin calcium 12/11/2018
tablets - Atorvastatin
Torvacol 20 mg film-coated Clonmel Healthcare Ltd PA0126/234/002 Film-coated tablet - Atorvastatin calcium 12/11/2018
tablets - Atorvastatin
Torvacol 40 mg film-coated Clonmel Healthcare Ltd PA0126/234/003 Film-coated tablet - Atorvastatin calcium 12/11/2018
tablets - Atorvastatin
Torvacol 80 mg film-coated Clonmel Healthcare Ltd PA0126/234/004 Film-coated tablet - Atorvastatin 12/11/2018
tablets - Atorvastatin calcium
Amoxil 3g Powder for Oral GlaxoSmithKline (Ireland) PA1077/033/006 Powder for oral suspension - Amoxycillin trihydrate 05/11/2018
Suspension Sachets Limited
BREAKYL Start 200, 400, Mylan IRE Healthcare PA2010/027/006 Buccal film - FENTANYL CITRATE 05/11/2018
600, 800 microgram buccal Limited
film
Competact Takeda Pharma A/S EU/1/06/354/10-12 Film-coated tablet - Pioglitazone 01/11/2018
- METFORMIN
HYDROCHLORIDE
Doxorubicin 2mg/ml Genepharm (Europe) Trading PA1658/001/001 Concentrate for solution for - DOXORUBICIN 31/10/2018
Concentrate for Solution for Ltd infusion HYDROCHLORIDE
Infusion
Taxespira Hospira UK Limited EU/1/15/1017/001 Concentrate for solution for - Docetaxel trihydrate 30/10/2018
infusion
Venex XL 150 mg prolonged- Clonmel Healthcare Ltd PA0126/182/003 Prolonged-release capsule, - Venlafaxine hydrochloride 30/10/2018
release capsules hard
Venex XL 37.5mg prolonged Clonmel Healthcare Ltd PA0126/182/001 Prolonged-release capsule, - Venlafaxine hydrochloride 30/10/2018
release capsules, hard hard

Venex XL 75 mg prolonged- Clonmel Healthcare Ltd PA0126/182/002 Prolonged-release capsule, - Venlafaxine hydrochloride 30/10/2018
release capsules hard
Lusduna Merck Sharp & Dohme BV EU/1/16/1162/001-003 Solution for injection in pre- - Insulin glargine 29/10/2018
filled pen
Aceomel 12.5mg Tablets Clonmel Healthcare Ltd PA0126/094/001 Tablet - Captopril 25/10/2018
Aceomel 25mg Tablets Clonmel Healthcare Ltd PA0126/094/002 Tablet - Captopril 25/10/2018
Aceomel 50mg Tablets Clonmel Healthcare Ltd PA0126/094/003 Tablet - Captopril 25/10/2018
Dixarit Tablets 25 Boehringer Ingelheim Limited PA0007/032/001 Tablet - CLONIDINE 19/10/2018
micrograms HYDROCHLORIDE
Rosuvastatin Momaja 10mg Momaja s.r.o PA1827/003/002 Film-coated tablet - Rosuvastatin (as calcium) 18/10/2018
film-coated tablets
Rosuvastatin Momaja 20 mg Momaja s.r.o PA1827/003/003 Film-coated tablet - Rosuvastatin (as calcium) 18/10/2018
film-coated tablets
Rosuvastatin Momaja 40mg Momaja s.r.o PA1827/003/004 Film-coated tablet - Rosuvastatin (as calcium) 18/10/2018
film-coated tablets
Rosuvastatin Momaja 5mg Momaja s.r.o PA1827/003/001 Film-coated tablet - Rosuvastatin (as calcium) 18/10/2018
film-coated tablets
Intanza Sanofi Pasteur EU/1/08/505/001-003 Suspension for injection - Split influenza 17/10/2018
virus,inactivated containg
antigens
Co-Vatan 320 mg/12.5 mg Rowex Ltd PA0711/182/004 Film-coated tablet - Valsartan 16/10/2018
Film-coated Tablets - Hydrochlorothiazide
Co-Vatan 320 mg/25 mg Rowex Ltd PA0711/182/005 Film-coated tablet - Hydrochlorothiazide 16/10/2018
Film-coated Tablets - Valsartan
Diclac 25 mg Gastro- Rowex Ltd PA0711/009/007 Gastro-resistant tablet - DICLOFENAC SODIUM 16/10/2018
resistant Tablets
Vatan 320 mg Film-coated Rowex Ltd PA0711/183/004 Film-coated tablet - Valsartan 16/10/2018
Tablets
Voriconazole Rowex 50mg Rowex Ltd PA0711/209/001 Film-coated tablet - Voriconazole 16/10/2018
Film-coated Tablets
Valsartan/Hydrochlorothiazid Fair-Med Healthcare GmbH PA1789/003/002 Film-coated tablet - Hydrochlorothiazide 15/10/2018
e Fair-Med 160 mg/12.5 mg - Valsartan
film-coated tablets
Valsartan/Hydrochlorothiazid Fair-Med Healthcare GmbH PA1789/003/004 Film-coated tablet - Hydrochlorothiazide 15/10/2018
e Fair-Med 320 mg/12.5 mg - Valsartan
film-coated tablets
Valsartan/Hydrochlorothiazid Fair-Med Healthcare GmbH PA1789/003/005 Film-coated tablet - Hydrochlorothiazide 15/10/2018
e Fair-Med 320 mg/25 mg - Valsartan
film-coated tablets

Human Medicines Withdrawn Products Page 91 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Olysio Janssen-Cilag International EU/1/14/924/001-002 Capsule, hard - Simeprevir 11/10/2018
NV
Coversyl 2 mg Tablets Les Laboratoires Servier PA0568/002/001 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Coversyl 4 mg Tablets Les Laboratoires Servier PA0568/002/002 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Coversyl Plus 4mg/1.25mg Les Laboratoires Servier PA0568/016/001 Tablet - Perindopril tert-butylamine 09/10/2018
tablets salt
- Indapamide
Coversyl Tablets 8 mg Les Laboratoires Servier PA0568/002/003 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Esomeprazole Pensa 20mg Pensa Pharma AB PA1647/005/001 Gastro-resistant tablet - Esomeprazole sodium 09/10/2018
gastro-resistant tablets
Esomeprazole Pensa 40mg Pensa Pharma AB PA1647/005/002 Gastro-resistant tablet - Esomeprazole sodium 09/10/2018
gastro-resistant tablets
Lopinavir/Ritonavir Sandoz Rowex Ltd PA0711/239/001 Film-coated tablet - Lopinavir (amorphous) 09/10/2018
200/50mg Film-coated - Ritonavir
Tablets
Omeprazole Pensa 10 mg Pensa Pharma AB PA1647/003/001 Gastro-resistant capsule, - Omeprazole 09/10/2018
Gastro-resistant Capsules, hard
hard
Omeprazole Pensa 20 mg Pensa Pharma AB PA1647/003/002 Gastro-resistant capsule, - Omeprazole 09/10/2018
Gastro-resistant Capsules, hard
hard
Omeprazole Pensa 40 mg Pensa Pharma AB PA1647/003/003 Gastro-resistant capsule, - Omeprazole 09/10/2018
Gastro-resistant Capsules, hard
hard
Perindopril Tert-butylamine / Les Laboratoires Servier PA0568/022/001 Tablet - Perindopril tert-butylamine 09/10/2018
Indapamide Servier - Indapamide
8mg/2.5mg tablets
Prindace 2 mg Tablets Les Laboratoires Servier PA0568/011/001 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Prindace 4 mg Tablets Les Laboratoires Servier PA0568/011/002 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Prindace 8 mg Tablets Les Laboratoires Servier PA0568/011/003 Tablet - Perindopril tert-butylamine 09/10/2018
salt
Fluenz MedImmune, LLC EU/1/10/661/001-002 Nasal spray, suspension - Influenza virus, type b 08/10/2018
- Influenza virus, type a, h3n2
- Influenza virus, type a, h1n1

Ipreziv Takeda Pharma A/S EU/1/11/735/001-004 Tablet - Azilsartan medoxomil 08/10/2018


Ipreziv Takeda Pharma A/S EU/1/11/735/005-008 Tablet - Azilsartan medoxomil 08/10/2018
Ipreziv Takeda Pharma A/S EU/1/11/735/009-011 Tablet - Azilsartan medoxomil 08/10/2018
Nyracta SmithKline Beecham Plc EU/1/00/139/001 Tablet - Rosiglitazone 08/10/2018
OSIGRAFT Olympus Biotech (Ireland) EU/1/01/179/001 Implant - Eptotermin alfa 08/10/2018
Limited
Venvia SmithKline Beecham Plc EU/1/00/138/002 Tablet - Rosiglitazone 08/10/2018
Acnisal 2% w/w Cutaneous Alliance Pharmaceuticals Ltd PA0943/008/001 Cutaneous solution - Salicylic acid 03/10/2018
Solution
Artelac Preservative Free Imbat Limited PPA1151/207/001 Eye drops, solution - Hypromellose 03/10/2018
Single Dose Unit
PERFALGAN 10 mg/ml, Bristol-Myers Squibb PA0002/069/002 Solution for infusion - Paracetamol 30/09/2018
solution for infusion, Pharmaceuticals uc
polypropylene bag
Epirubicin hydrochloride 2 Fresenius Kabi Oncology Plc PA1422/002/001 Solution for injection/infusion - Epirubicin hydrochloride 28/09/2018
mg/ml Solution for injection
or infusion
Octreotide 100 Fresenius Kabi Limited PA0566/062/002 Solution for injection - OCTREOTIDE ACETATE 28/09/2018
micrograms/ml solution for
injection
Octreotide 50 micrograms/ml Fresenius Kabi Limited PA0566/062/001 Solution for injection - OCTREOTIDE ACETATE 28/09/2018
solution for injection

Volulyte 6% Solution for Fresenius Kabi Limited PA0566/037/001 Solution for infusion - Poly(o-2- 28/09/2018
Infusion hydroxyethyl)starch
- Sodium acetate trihydrate
- Sodium chloride
- Potassium chloride
- Magnesium chloride
hexahydrate

Human Medicines Withdrawn Products Page 92 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Volulyte 6% Solution for Fresenius Kabi Limited PA0566/037/002 Solution for infusion - Poly(o-2- 28/09/2018
Infusion hydroxyethyl)starch
- Sodium acetate trihydrate
- Sodium chloride
- Potassium chloride
- Magnesium chloride
hexahydrate
Voluven 10 % solution for Fresenius Kabi Limited PA0566/020/004 Solution for infusion - Poly-(0-2- 28/09/2018
infusion hydroxyethyl)starch (130/0.4)
- Sodium chloride

Voluven 10% Solution for Fresenius Kabi Limited PA0566/020/005 Solution for infusion - Poly-(0-2- 28/09/2018
Infusion hydroxyethyl)starch (130/0.4)
- Sodium chloride

Voluven 6% Solution for Fresenius Kabi Limited PA0566/020/002 Solution for infusion - Poly(o-2- 28/09/2018
Infusion (Polyolefine/Freeflex hydroxyethyl)starch
Bag) - Sodium chloride
Voluven 6% Solution for Fresenius Kabi Limited PA0566/020/003 Solution for infusion - Poly(o-2- 28/09/2018
Infusion (PVC Bag) hydroxyethyl)starch
- Sodium chloride
Ionsys Incline Therapeutics Europe EU/1/15/1050/001 - Fentanyl hydrochloride 27/09/2018
Ltd
Losartan/Hydrochlorothiazide Bluefish Pharmaceuticals AB PA1436/011/002 Film-coated tablet - Hydrochlorothiazide 27/09/2018
Bluefish 100 mg/25 mg film- - Losartan potassium
coated tablets
Losartan/Hydrochlorothiazide Bluefish Pharmaceuticals AB PA1436/011/001 Film-coated tablet - Hydrochlorothiazide 27/09/2018
Bluefish 50 mg/12.5 mg film- - Losartan potassium
coated tablets
Bortezomib Ebewe 3.5 mg Rowex Ltd PA0711/283/001 Powder for solution for - Bortezomib 19/09/2018
Powder for solution for injection
injection
Angiox The Medicines Company UK EU/1/04/289/001 Powder for solution for - Bivalirudin 14/09/2018
Limited injection/infusion
Cisplatin Teva 1 mg/ml, Teva Pharma B.V. PA0749/119/002 Concentrate for solution for - Cisplatin 06/09/2018
concentrate for solution for infusion
infusion
Atorvastatin 10mg film- Chanelle Medical PA0688/021/001 Film-coated tablet - Atorvastatin calcium 03/09/2018
coated tablets trihydrate
Atorvastatin 20mg film- Chanelle Medical PA0688/021/002 Film-coated tablet - Atorvastatin calcium 03/09/2018
coated tablets trihydrate
Atorvastatin 40mg film- Chanelle Medical PA0688/021/003 Film-coated tablet - Atorvastatin calcium 03/09/2018
coated tablets trihydrate
Atorvastatin 80mg film- Chanelle Medical PA0688/021/004 Film-coated tablet - Atorvastatin calcium 03/09/2018
coated tablets trihydrate
Daklinza Bristol-Myers Squibb Pharma EU/1/14/939/001-002 Film-coated tablet - Daclatasvir dihydrochloride 30/08/2018
EEIG
Entacapone Niche 200 mg Niche Generics Limited PA1063/055/001 Film-coated tablet - Entacapone 29/08/2018
film-coated tablets
Tizanidine 2 mg Tablets Niche Generics Limited PA1063/035/001 Tablet - Tizanidine 29/08/2018
Tizanidine 4 mg Tablets Niche Generics Limited PA1063/035/002 Tablet - Tizanidine 29/08/2018
Bendamustine Medac Medac Gesellschaft fur PA0623/015/001 Powder for concentrate for - Bendamustine 21/08/2018
Klinische Spezialpraparate solution for infusion hydrochloride
mbH
Bendamustine Medac Medac Gesellschaft fur PA0623/015/002 Powder for concentrate for - Bendamustine 21/08/2018
Klinische Spezialpraparate solution for infusion hydrochloride
mbH
Dovonex 50 micrograms/ml Leo Laboratories Limited PA0046/061/003 Cutaneous solution - Calcipotriol 13/08/2018
Scalp Solution
Intanza Sanofi Pasteur EU/1/08/505/004-006 Suspension for injection - Split influenza 03/08/2018
virus,inactivated containg
antigens
DESLORATADINE Rosemont Pharmaceuticals PA0312/037/001 Oral Solution - DESLORATIDINE 01/08/2018
Ltd
OxyContin Mundipharma PA1688/005/006 Prolonged-release tablet - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE
OxyContin Mundipharma PA1688/005/007 Prolonged-release tablet - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE
OxyContin Mundipharma PA1688/005/008 Prolonged-release tablet - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE
OxyContin Mundipharma PA1688/005/009 Prolonged-release tablet - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE
OxyContin Mundipharma PA1688/005/010 Prolonged-release tablet - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE

Human Medicines Withdrawn Products Page 93 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TARGIN Mundipharma PA1688/010/005 Tablet Prolonged Release - OXYCODONE 01/08/2018
Pharmaceuticals Limited HYDROCHLORIDE
- NALOXONE
HYDROCHLORIDE
Dovobet LTT Pharma Limited PPA1562/103/001 Gel - Calcipotriol 31/07/2018
- Betamethasone
LIPOSTAT Bristol-Myers Squibb PA0002/055/004 Tablets - PRAVASTATIN SODIUM 31/07/2018
Pharmaceuticals uc
LIPOSTAT Bristol-Myers Squibb PA0002/055/005 Tablets - PRAVASTATIN SODIUM 31/07/2018
Pharmaceuticals uc
LIPOSTAT Bristol-Myers Squibb PA0002/055/006 Tablets - PRAVASTATIN SODIUM 31/07/2018
Pharmaceuticals uc
PERFALGAN Bristol-Myers Squibb PA0002/069/001 Solution for Infusion - PARACETAMOL 31/07/2018
Pharmaceuticals uc
RISPERDAL Quicklet Janssen-Cilag Ltd PA0748/003/013 Orodispersible tablet - Risperidone 30/07/2018
RISPERDAL Quicklet Janssen-Cilag Ltd PA0748/003/014 Orodispersible tablet - Risperidone 30/07/2018
RISPERDAL Quicklet 2 mg Janssen-Cilag Ltd PA0748/003/015 Orodispersible tablet - Risperidone 30/07/2018
orodispersible tablets
RISPERDAL Quicklet 3 mg Janssen-Cilag Ltd PA0748/003/016 Orodispersible tablet - Risperidone 30/07/2018
orodispersible tablets
RISPERDAL Quicklet 4 mg Janssen-Cilag Ltd PA0748/003/017 Orodispersible tablet - Risperidone 30/07/2018
orodispersible tablets
OMACOR Imbat Limited PPA1151/134/001 Capsules, Soft - OMEGA-3-ACID ETHYL 19/07/2018
ESTERS
- EICOSAPENTAENOIC
ACID
- DOCOSAHEXANOIC ACID

Trobalt Glaxo Group Limited EU/1/11/681/001-003,13 Film-coated tablet - Retigabine 19/07/2018


Trobalt Glaxo Group Limited EU/1/11/681/004-006 Film-coated tablet - Retigabine 19/07/2018
Trobalt Glaxo Group Limited EU/1/11/681/007-008 Film-coated tablet - Retigabine 19/07/2018
Trobalt Glaxo Group Limited EU/1/11/681/009-10 Film-coated tablet - Retigabine 19/07/2018
Trobalt Glaxo Group Limited EU/1/11/681/011-012 Film-coated tablet - Retigabine 19/07/2018
ASASANTIN RETARD Boehringer Ingelheim Limited PA0007/013/002 Modified-release capsule, - DIPYRIDAMOLE 18/07/2018
hard - ACETYLSALICYLIC ACID
CALENDOLON Weleda (UK) Limited PA0407/005/001 Ointment - CALENDULA OFFICINALIS 18/07/2018

HYPERICUM/CALENDULA Weleda (UK) Limited PA0407/024/001 Ointment - HYPERICUM 18/07/2018


PERFORATUM
- CALENDULA OFFICINALIS

ACT-HIB Sanofi Pasteur PA2131/001/001 Pdr+Solv for Soln for Inj - HAEMOPHILUS 17/07/2018
INFLUENZAE TYPE B,
CONJUGATE WITH
TETANUS PROTEIN
POLIOMYELITIS VACCINE Sanofi Pasteur PA2131/003/001 Suspension for Injection - POLIO VIRUS TYPE 1 17/07/2018
(INACTIVATED) INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
BONEFOS Bayer Limited PA1410/002/001 Film Coated Tablet - CLODRONATE DISODIUM 13/07/2018
TETRAHYDRATE

NITROLINGUAL LTT Pharma Limited PPA1562/058/001 Sublingual spray, solution - GLYCERYL TRINITRATE 13/07/2018
ARICLAIM Eli Lilly Nederland B.V. EU/1/04/283/11-12 Capsules Gastro-Resistant - DULOXETINE 09/07/2018
HYDROCHLORIDE
ARICLAIM Eli Lilly Nederland B.V. EU/1/04/283/8-10 Capsules Gastro-Resistant - DULOXETINE 09/07/2018
HYDROCHLORIDE
DUTASTERIDE Generics (UK) Limited PA0405/098/001 Capsules, Soft - DUTASTERIDE 09/07/2018
DepoCyte SkyePharma PLC EU/1/01/187/001 Suspension for injection - Cytarabine 06/07/2018
Kineret Amgen Europe B.V. EU/1/02/203/003 Solution for injection - Anakinra 06/07/2018
TUBERCULIN PPD RT 23 AJ Vaccines A/S PA2160/004/002 Solution for Injection - TUBERCULIN PPD 01/07/2018
BUFAR EASYHALER Orion Corporation PA1327/018/001 Inhalation powder - BUDESONIDE 30/06/2018
- FORMOTEROL
FUMARATE DIHYDRATE
CAVERJECT Pfizer Healthcare Ireland PA0822/115/001 Pdr+Solv for Soln for Inj - ALPROSTADIL 29/06/2018
VICTRELIS Merck Sharp & Dohme Ltd EU/1/11/704/001 Capsules Hard - BOCEPREVIR 21/06/2018
Solymbic Amgen Europe B.V. EU/1/16/1163/001 Solution for injection - Adalimumab 15/06/2018
Solymbic Amgen Europe B.V. EU/1/16/1163/002-009 Solution for injection - Adalimumab 15/06/2018
FEMINAX TABLETS Bayer Limited PA1410/045/001 Tablets - PARACETAMOL 08/06/2018
- CAFFEINE
- CODEINE PHOSPHATE
- HYOSCINE
HYDROBROMIDE

Human Medicines Withdrawn Products Page 94 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PIPERACILLIN/TAZOBACT Teva Pharma B.V. PA0749/126/002 Powder for solution for - PIPERACILLIN SODIUM 05/06/2018
AM TEVA infusion - TAZOBACTAM (AS
SODIUM SALT)
Venlafaxine Teva Teva Pharma B.V. PA0749/077/001 Tablet - Venlafaxine hydrochloride 05/06/2018
Venlafaxine Teva Teva Pharma B.V. PA0749/077/002 Tablet - Venlafaxine hydrochloride 05/06/2018
PROMIXIN Zambon S.p.A. PA1441/003/001 Powder for nebuliser solution - COLISTIN MESILATE 04/06/2018
SODIUM
AROMASIN Haemato Pharm AG PPA1841/001/001 Coated Tablets - EXEMESTANE 31/05/2018
CLARELUX PIERRE FABRE PA1230/001/001 Cutaneous Foam - CLOBETASOL 31/05/2018
DERMATOLOGIE PROPIONATE
TRAMADOL/PARACETAM Teva Pharma B.V. PA0749/120/001 Film Coated Tablet - TRAMADOL 31/05/2018
OL TEVA HYDROCHLORIDE
- PARACETAMOL
DARUNAVIR CLONMEL Clonmel Healthcare Ltd PA0126/299/001 Film Coated Tablet - DARUNAVIR 29/05/2018
PREGABALIN CLONMEL Clonmel Healthcare Ltd PA0126/278/007 Capsules Hard - PREGABALIN 29/05/2018
TARGOCID Ennogen Healthcare Ltd PPA1959/001/002 Pdr+Solv for Soln for Inj - TEICOPLANIN 29/05/2018
BUPLEX JUNIOR Actavis Group PTC ehf PA1380/087/003 Oral Suspension - IBUPROFEN 28/05/2018
IMMUKIN 2 X 106 IU (0.1 Horizon Pharma Ireland PA2138/001/001 Solution for Injection - INTERFERON GAMMA 24/05/2018
MG) Limited
OXALIPLATIN Pharmachemie BV PA0937/007/001 Concentrate for Soln for Inf - OXALIPLATIN 21/05/2018
CANDESARTAN TEVA Teva Pharma B.V. PA0749/124/004 Tablets - CANDESARTAN 18/05/2018
CILEXETIL
MENJUGATE KIT GSK Vaccines S.r.l. PA0919/004/002 Pdr+Solv for Susp for Inj - NEISSERIA MENINGITIDIS 18/05/2018
C
- CORYNEBACTERIUM
DIPHTHERIAE CRM197
CARRIER PROTEIN
ZOLEDRONIC ACID Cipla (EU) Limited PA1809/008/001 Solution for Infusion - ZOLEDRONIC ACID 17/05/2018
MONOHYDRATE
Imatinib Teva B.V. Teva B.V. EU/1/17/1243/001-012 Film-coated tablet - Imatinib 08/05/2018
- Imatinib mesilate
Imatinib Teva B.V. Teva B.V. EU/1/17/1243/012-024 Capsule, hard - Imatinib 08/05/2018
- Imatinib mesilate
Imatinib Teva B.V. Teva B.V. EU/1/17/1243/025-032 Film-coated tablet - Imatinib 08/05/2018
- Imatinib mesilate
Imatinib Teva B.V. Teva B.V. EU/1/17/1243/033-040 Capsule, hard - Imatinib 08/05/2018
- Imatinib mesilate
CARDURA XL LTT Pharma Limited PPA1562/003/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 03/05/2018
CARDURA XL LTT Pharma Limited PPA1562/003/003 Tablet Prolonged Release - DOXAZOSIN MESILATE 03/05/2018
DORZOLAMIDE Blumont Pharma PA1859/001/001 Eye Drops Solution - DORZOLAMIDE 30/04/2018
HYDROCHLORIDE
SALBUTAMOL CFC FREE McDermott Laboratories Ltd PA0577/091/001 Pressurised Inhalation - SALBUTAMOL 30/04/2018
t/a Gerard Laboratories Suspension
FLOXAPEN Actavis Group PTC ehf PA1380/011/006 Powder for Oral Suspension - FLUCLOXACILLIN 27/04/2018
MAGNESIUM
FLOXAPEN SYRUP Actavis Group PTC ehf PA1380/011/005 Powder for Oral Suspension - FLUCLOXACILLIN 27/04/2018
MAGNESIUM
FLUMAZENIL TEVA Teva Pharma B.V. PA0749/069/001 Solution for injection/infusion - FLUMAZENIL 27/04/2018

GRANISETRON TEVA Teva Pharma B.V. PA0749/027/004 Concentrate for Soln for Inf - GRANISETRON 27/04/2018
HYDROCHLORIDE
LISVY Gedeon Richter Plc PA1330/019/001 Transdermal Patch - ETHINYLESTRADIOL 27/04/2018
- GESTODENE
TELMISARTAN - Teva Pharma B.V. PA0749/186/002 Tablets - TELMISARTAN 27/04/2018
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE
TEVA
TELMISARTAN - Teva Pharma B.V. PA0749/186/003 Tablets - TELMISARTAN 27/04/2018
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE
TEVA
ARYTHMOL Teva B.V. PA1986/048/001 Film Coated Tablet - PROPAFENONE 26/04/2018
HYDROCHLORIDE
ARYTHMOL Teva B.V. PA1986/048/002 Film Coated Tablet - PROPAFENONE 26/04/2018
HYDROCHLORIDE
AXID Flynn Pharma Ltd PA1226/004/001 Capsules Hard - NIZATIDINE 26/04/2018
CANDESARTAN TEVA Teva Pharma B.V. PA0749/124/003 Tablets - CANDESARTAN 26/04/2018
CILEXETIL
Candesartan Teva 4 mg Teva Pharma B.V. PA0749/124/002 Tablet - Candesartan cilexetil 26/04/2018
Tablets
Candesartan/Hydrochlorothi Teva Pharma B.V. PA0749/192/001 Tablet - Candesartan cilexetil 26/04/2018
azide Teva 16 mg/12.5 mg - Hydrochlorothiazide
Tablets
DARUNAVIR Teva B.V. PA1986/015/001 Film Coated Tablet 26/04/2018
DIFLAZOLE Teva Pharma B.V. PA0749/127/001 Capsules Hard - FLUCONAZOLE 26/04/2018
DIFLAZOLE Teva Pharma B.V. PA0749/127/002 Capsules Hard - FLUCONAZOLE 26/04/2018
DIFLAZOLE Teva Pharma B.V. PA0749/127/003 Capsules Hard - FLUCONAZOLE 26/04/2018

Human Medicines Withdrawn Products Page 95 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DILZEM SR Cephalon UK Limited PA0827/006/001 Prolonged Release Capsules - DILTIAZEM 26/04/2018
HYDROCHLORIDE
DILZEM SR Cephalon UK Limited PA0827/006/002 Prolonged Release Capsules - DILTIAZEM 26/04/2018
HYDROCHLORIDE
DILZEM SR Cephalon UK Limited PA0827/006/003 Prolonged Release Capsules - DILTIAZEM 26/04/2018
HYDROCHLORIDE
Esomeprazole Teva Pharma Teva Pharma B.V. PA0749/123/001 Gastro-resistant tablet - Esomeprazole 26/04/2018
20 mg Gastro-resistant
Tablets
Esomeprazole Teva Pharma Teva Pharma B.V. PA0749/123/002 Gastro-resistant tablet - Esomeprazole 26/04/2018
40 mg Gastro-resistant
Tablets
OLMESARTAN Teva B.V. PA1986/038/001 Film Coated Tablet - OLMESARTAN 26/04/2018
MEDOXOMIL/AMLODIPINE MEDOXOMIL
TEVA - AMLODIPINE BESILATE
OLMESARTAN Teva B.V. PA1986/038/002 Film Coated Tablet - OLMESARTAN 26/04/2018
MEDOXOMIL/AMLODIPINE MEDOXOMIL
TEVA - AMLODIPINE BESILATE
OLMESARTAN Teva B.V. PA1986/038/003 Film Coated Tablet - OLMESARTAN 26/04/2018
MEDOXOMIL/AMLODIPINE MEDOXOMIL
TEVA - AMLODIPINE BESILATE
SERENACE Norton Healthcare Limited PA0282/063/003 Capsule - HALOPERIDOL 26/04/2018
T/A IVAX Pharmaceuticals
UK
SERENACE Norton Healthcare Limited PA0282/063/005 Tablets - HALOPERIDOL 26/04/2018
T/A IVAX Pharmaceuticals
UK
SERENACE Norton Healthcare Limited PA0282/063/006 Tablets - HALOPERIDOL 26/04/2018
T/A IVAX Pharmaceuticals
UK
SERENACE Norton Healthcare Limited PA0282/063/007 Tablets - HALOPERIDOL 26/04/2018
T/A IVAX Pharmaceuticals
UK
SYMBICORT TURBOHALE Imbat Limited PPA1151/152/001 Inhalation powder - BUDESONIDE 26/04/2018
- FORMOTEROL
FUMATRATE DIHYDRATE
TADALAFIL TEVA Teva B.V. PA1986/023/001 Film Coated Tablet - TADALAFIL 26/04/2018
TADALAFIL TEVA Teva B.V. PA1986/023/002 Film Coated Tablet - TADALAFIL 26/04/2018
TIZANIDINE 2 MG TABLETS Cephalon UK Limited PA0827/009/001 Tablets - TIZANIDINE 26/04/2018
HYDROCHLORIDE
TIZANIDINE 4 MG TABLETS Cephalon UK Limited PA0827/009/002 Tablets - TIZANIDINE 26/04/2018
HYDROCHLORIDE
VARDENAFIL TEVA Teva B.V. PA1986/049/001 Orodispersible Tablet - VARDENAFIL 26/04/2018
HYDROCHLORIDE
TRIHYDRATE
VESITIRIM LTT Pharma Limited PPA1562/086/004 Film Coated Tablet - SOLIFENACIN 23/04/2018
SUCCINATE
TRANYLCYPROMINE Lime Pharma Ltd PA2005/002/001 Coated Tablets - TRANYLCYPROMINE 20/04/2018
SULPHATE
DESLORATADINE Clonmel Healthcare Ltd PA0126/241/001 Oral Solution - DESLORATIDINE 19/04/2018
CLONMEL
IVABRADINE Clonmel Healthcare Ltd PA0126/292/001 Film Coated Tablet - IVABRADINE 19/04/2018
IVABRADINE Clonmel Healthcare Ltd PA0126/292/002 Film Coated Tablet - IVABRADINE 19/04/2018
IVABRADINE Clonmel Healthcare Ltd PA0126/292/003 Film Coated Tablet - IVABRADINE 19/04/2018
MALUSONE Clonmel Healthcare Ltd PA0126/233/001 Film Coated Tablet - ATOVAQUONE 19/04/2018
- PROGUANIL
HYDROCHLORIDE
MOVILIEF Clonmel Healthcare Ltd PA0126/217/001 Powder for Oral Solution - MACROGOL 3350 19/04/2018
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- SODIUM HYDROGEN
CARBONATE
MOVILIEF PAEDIATRIC Clonmel Healthcare Ltd PA0126/217/002 Powder for Oral Solution - MACROGOL 3350 19/04/2018
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- SODIUM HYDROGEN
CARBONATE
LOSARTAN POTASSIUM / Merck Sharp & Dohme PA1286/024/001 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
HYDROCHLOROTHIAZIDE Ireland (Human Health) - HYDROCHLOROTHIAZIDE
MSD Limited
LOSARTAN POTASSIUM / Merck Sharp & Dohme PA1286/024/002 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
HYDROCHLOROTHIAZIDE Ireland (Human Health) - HYDROCHLOROTHIAZIDE
MSD Limited
LOSARTAN POTASSIUM / Merck Sharp & Dohme PA1286/024/003 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
HYDROCHLOROTHIAZIDE Ireland (Human Health) - HYDROCHLOROTHIAZIDE
MSD Limited

Human Medicines Withdrawn Products Page 96 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LOSARTAN POTASSIUM Merck Sharp & Dohme PA1286/023/001 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
MSD Ireland (Human Health)
Limited
LOSARTAN POTASSIUM Merck Sharp & Dohme PA1286/023/002 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
MSD Ireland (Human Health)
Limited
LOSARTAN POTASSIUM Merck Sharp & Dohme PA1286/023/003 Film Coated Tablet - LOSARTAN POTASSIUM 16/04/2018
MSD Ireland (Human Health)
Limited
AMITIZA Takeda UK Limited PA1547/011/001 Capsules, Soft - LUBIPROSTONE 13/04/2018
CYTARABINE TEVA Teva B.V. PA1986/041/001 Not assigned - CYTARABINE 13/04/2018
DERMOVATE SCALP LTT Pharma Limited PPA1562/093/001 Cutaneous Solution - CLOBETASOL 13/04/2018
APPLICATION PROPIONATE
FOLINIC ACID (AS Actavis Group PTC ehf PA1380/120/001 Solution for Inj/Inf - FOLINIC ACID 13/04/2018
CALCIUM FOLINATE)
ACTAVIS
MEDISIP WITH Actavis Group PTC ehf PA1380/160/001 Powder for Oral Solution - PARACETAMOL 13/04/2018
DECONGESTANT POWDER - PHENYLEPHRINE
FOR ORAL SOLUTION HYDROCHLORIDE

MORHULIN Actavis Group PTC ehf PA1380/064/001 Ointment - COD LIVER OIL 13/04/2018
- ZINC OXIDE
URSODEOXYCHOLIC ACID Teva B.V. PA1986/063/001 Tablets - URSODEOXYCHOLIC 13/04/2018
ACID
ALVERINE CITRATE 120MG Auden Mckenzie (Pharma PA1352/010/002 Capsules Hard - ALVERINE CITRATE 11/04/2018
CAPSULES Division) Ltd
ALVERINE CITRATE 60MG Auden Mckenzie (Pharma PA1352/010/001 Capsules Hard - ALVERINE CITRATE 11/04/2018
CAPSULES Division) Ltd
BEVACOMB Teva B.V. PA1986/040/001 Film Coated Tablet - VALSARTAN 11/04/2018
- AMLODIPINE BESILATE
BEVACOMB Teva B.V. PA1986/040/002 Film Coated Tablet - VALSARTAN 11/04/2018
- AMLODIPINE BESILATE
BEVACOMB Teva B.V. PA1986/040/003 Film Coated Tablet - VALSARTAN 11/04/2018
- AMLODIPINE BESILATE
DENELA Teva B.V. PA1986/059/001 Cream - LIDOCAINE 11/04/2018
- PRILOCAINE
CAPECITABINE ACTAVIS Actavis Group PTC ehf PA1380/115/001 Film Coated Tablet - CAPECITABINE 10/04/2018
CAPECITABINE ACTAVIS Actavis Group PTC ehf PA1380/115/002 Film Coated Tablet - CAPECITABINE 10/04/2018
DIANETTE IMED Healthcare Ltd. PPA1463/050/001 Coated Tablets - CYPROTERONE 06/04/2018
ACETATE
- ETHINYLESTRADIOL
ELTROXIN Imbat Limited PPA1151/064/001 Tablets - LEVOTHYROXINE 06/04/2018
SODIUM
ELTROXIN Imbat Limited PPA1151/064/002 Tablets - LEVOTHYROXINE 06/04/2018
SODIUM
ELTROXIN Imbat Limited PPA1151/064/003 Tablets - LEVOTHYROXINE 06/04/2018
SODIUM
EMIZOF Imbat Limited PPA1151/077/001 Film Coated Tablet - ONDANSETRON 06/04/2018
EMIZOF Imbat Limited PPA1151/077/002 Film Coated Tablet - ONDANSETRON 06/04/2018
HYDROCORTISYL SKIN Sanofi-Aventis Ireland PA0540/046/002 Ointment - HYDROCORTISONE 06/04/2018
OINTMENT 1% Limited T/A SANOFI
Kineret Amgen Europe B.V. EU/1/02/203/001 Solution for injection - Anakinra 06/04/2018
Kineret Amgen Europe B.V. EU/1/02/203/002 Solution for injection - Anakinra 06/04/2018
Kineret Amgen Europe B.V. EU/1/02/203/004 Solution for injection - Anakinra 06/04/2018
SUPRAX POWDER Sanofi-Aventis Ireland PA0540/016/001 Powder for Oral Suspension - CEFIXIME 06/04/2018
PAEDIATRIC Limited T/A SANOFI
SUPREFACT Sanofi-Aventis Ireland PA0540/074/004 Nasal Spray Solution - BUSERELIN ACETATE 06/04/2018
Limited T/A SANOFI
MIL-PAR ORAL Seven Seas Ltd PA0417/014/001 Oral Suspension - MAGNESIUM HYDROXIDE 01/04/2018
SUSPENSION - PARAFFIN, LIQUID

CAPOTEN Bristol-Myers Squibb PA0002/039/001 Tablets - CAPTOPRIL 31/03/2018


Pharmaceuticals uc
CAPOTEN Bristol-Myers Squibb PA0002/039/002 Tablets - CAPTOPRIL 31/03/2018
Pharmaceuticals uc
CAPOZIDE Bristol-Myers Squibb PA0002/053/002 Tablets - CAPTOPRIL 31/03/2018
Pharmaceuticals uc - HYDROCHLOROTHIAZIDE

NALOREX Bristol-Myers Squibb PA0002/070/001 Tablets - NALTREXONE 31/03/2018


Pharmaceuticals uc HYDROCHLORIDE
BORTEZOMIB MYLAN Generics (UK) Limited PA0405/073/001 Pdr for Soln for Injection 29/03/2018
Raplixa Mallinckrodt Pharmaceuticals EU/1/14/985/001-003 Not assigned - Human fibrinogen 27/03/2018
Ireland Limited - Human thrombin

MEZAVANT XL MPT Pharma Ltd PPA1825/002/001 Tablet Prolonged Release - MESALAZINE 23/03/2018

Human Medicines Withdrawn Products Page 97 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VIBATIV Theravance Biopharma EU/1/11/705/001 Powder for concentrate for - TELAVANCIN 23/03/2018
Ireland Limited solution for infusion HYDROCHLORIDE
VIBATIV Theravance Biopharma EU/1/11/705/002 Powder for concentrate for - TELAVANCIN 23/03/2018
Ireland Limited solution for infusion HYDROCHLORIDE
IDFLU Sanofi Pasteur SA EU/1/08/507/001-003 Suspension for Injection - A/NEW CALEDONIA/20/99 19/03/2018
(H1H1)-LIKE STRAIN
- A/WISCONSIN/67/2005
(H3N2) LIKE STRAIN
- B/MALAYSIA/2506/2004
LIKE STRAIN

IDFLU Sanofi Pasteur SA EU/1/08/507/004-006 Suspension for Injection - A/NEW CALEDONIA/20/99 19/03/2018
(H1H1)-LIKE STRAIN
- A/WISCONSIN/67/2005
(H3N2) LIKE STRAIN
- B/MALAYSIA/2506/2004
LIKE STRAIN

EZETROL LTT Pharma Limited PPA1562/138/001 Tablets - EZETIMIBE 16/03/2018


INNOHEP LTT Pharma Limited PPA1562/134/001 Solution for Injection - TINZAPARIN SODIUM 16/03/2018
INNOHEP LTT Pharma Limited PPA1562/134/002 Solution for Injection - TINZAPARIN SODIUM 16/03/2018
INNOHEP LTT Pharma Limited PPA1562/134/003 Solution for Injection - TINZAPARIN SODIUM 16/03/2018
TARGOCID Ennogen Healthcare Ltd PPA1959/001/001 Pdr+Solv for Soln for Inj - TEICOPLANIN 06/03/2018
PROVIN McNeil Healthcare (Ireland) PA0823/044/001 Oral Suspension - IBUPROFEN 05/03/2018
Ltd
SUDAFED BLOCKED NOSE McNeil Healthcare (Ireland) PA0823/062/001 Nasal Spray Solution - XYLOMETAZOLINE 05/03/2018
Ltd HYDROCHLORIDE
FERRUM FOL Vifor France PA0949/002/001 Tablets Chewable - IRON POLYMALTOSE 02/03/2018
- FOLIC ACID
FERRUM HAUSMANN Vifor France PA0949/003/002 Tablets Chewable - FERRIC HYDROXIDE 02/03/2018
POLYMALTOSE COMPLEX

FERRUM HAUSMANN Vifor France PA0949/003/001 Oral Drops Solution - FERRIC HYDROXIDE 02/03/2018
SYRUP POLYMALTOSE COMPLEX

ATENOLOL ACTAVIS Actavis Group PTC ehf PA1380/105/001 Film Coated Tablet - ATENOLOL 01/03/2018
ATENOLOL ACTAVIS Actavis Group PTC ehf PA1380/105/002 Film Coated Tablet - ATENOLOL 01/03/2018
ATENOLOL ACTAVIS Actavis Group PTC ehf PA1380/105/003 Film Coated Tablet - ATENOLOL 01/03/2018
ATOMOXETINE Actavis Group PTC ehf PA1380/186/001 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/002 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/003 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/004 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/005 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/006 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
ATOMOXETINE Actavis Group PTC ehf PA1380/186/007 Capsules Hard - ATOMOXETINE 01/03/2018
HYDROCHLORIDE
BICALUTAMIDE ACTAVIS Actavis Group PTC ehf PA1380/153/001 Film Coated Tablet - BICALUTAMIDE 01/03/2018
CEFUROXIME ACTAVIS Actavis Group PTC ehf PA1380/055/001 Film Coated Tablet - CEFUROXIME AXETIL 01/03/2018
CEFUROXIME ACTAVIS Actavis Group PTC ehf PA1380/055/002 Film Coated Tablet - CEFUROXIME AXETIL 01/03/2018
CLEONITA Actavis Group PTC ehf PA1380/132/001 Film Coated Tablet - DROSPIRENONE 01/03/2018
- ETHINYL ESTRADIOL
CLEOSENSA Actavis Group PTC ehf PA1380/132/002 Film Coated Tablet - DROSPIRENONE 01/03/2018
- ETHINYL ESTRADIOL
CLINDAMYCIN Actavis Group PTC ehf PA1380/188/001 Capsules Hard - CLINDAMYCIN (AS 01/03/2018
HYDROCHLORIDE)
ERLIDONA Actavis Group PTC ehf PA1380/140/001 Film Coated Tablet - LEVONORGESTREL 01/03/2018
- ETHINYLESTRADIOL
GEMCITABINE Actavis Group PTC ehf PA1380/015/003 Concentrate for Soln for Inf - GEMCITABINE 01/03/2018
HEPATYRIX GlaxoSmithKline (Ireland) PA1077/099/001 Suspension for Injection - HEPATIT A VIRUS 01/03/2018
Limited ANTIGEN
- VI POLYSACCHARIDE OF
SALMONELLA TYPHI
KEFTID Strides Shasun (UK) Ltd PA0894/004/001 Capsule - CEFACLOR 01/03/2018
MONOHYDRATE
KEFTID Strides Shasun (UK) Ltd PA0894/004/002 Capsules Hard - CEFACLOR 01/03/2018
MONOHYDRATE
KEFTID Strides Shasun (UK) Ltd PA0894/004/003 Powder for Oral Suspension - CEFACLOR 01/03/2018
MONOHYDRATE
KEFTID Strides Shasun (UK) Ltd PA0894/004/004 Powder for Oral Suspension - CEFACLOR 01/03/2018
MONOHYDRATE

Human Medicines Withdrawn Products Page 98 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OLMESARTAN ACTAVIS Actavis Group PTC ehf PA1380/203/001 Film Coated Tablet - OLMESARTAN 01/03/2018
MEDOXOMIL
OLMESARTAN ACTAVIS Actavis Group PTC ehf PA1380/203/002 Film Coated Tablet - OLMESARTAN 01/03/2018
MEDOXOMIL
OLMESARTAN ACTAVIS Actavis Group PTC ehf PA1380/203/003 Film Coated Tablet - OLMESARTAN 01/03/2018
MEDOXOMIL
OLMESARTAN ACTAVIS Actavis Group PTC ehf PA1380/203/004 Film Coated Tablet - OLMESARTAN 01/03/2018
MEDOXOMIL
OLMESARTAN Actavis Group PTC ehf PA1380/204/001 Film Coated Tablet - HYDROCHLOROTHIAZIDE 01/03/2018
HYDROCHLOROTHIAZIDE - OLMESARTAN
ACTAVIS MEDOXOMIL

OLMESARTAN Actavis Group PTC ehf PA1380/204/002 Film Coated Tablet - HYDROCHLOROTHIAZIDE 01/03/2018
HYDROCHLOROTHIAZIDE - OLMESARTAN
ACTAVIS MEDOXOMIL

OLMESARTAN Actavis Group PTC ehf PA1380/204/003 Film Coated Tablet - HYDROCHLOROTHIAZIDE 01/03/2018
HYDROCHLOROTHIAZIDE - OLMESARTAN
ACTAVIS MEDOXOMIL

OLMESARTAN Actavis Group PTC ehf PA1380/204/004 Film Coated Tablet - HYDROCHLOROTHIAZIDE 01/03/2018
HYDROCHLOROTHIAZIDE - OLMESARTAN
ACTAVIS MEDOXOMIL

PYRIDOSTIGMINE Teva B.V. PA1986/065/001 Tablets - PYRIDOSTIGMINE 01/03/2018


BROMIDE
RELTEBON Actavis Group PTC ehf PA1380/129/004 Tablet Prolonged Release - OXYCODONE 01/03/2018
HYDROCHLORIDE
RELTEBON Actavis Group PTC ehf PA1380/129/005 Tablet Prolonged Release - OXYCODONE 01/03/2018
HYDROCHLORIDE
RELTEBON Actavis Group PTC ehf PA1380/129/007 Tablet Prolonged Release - OXYCODONE 01/03/2018
HYDROCHLORIDE
RELTEBON Actavis Group PTC ehf PA1380/129/008 Tablet Prolonged Release - OXYCODONE 01/03/2018
HYDROCHLORIDE
SOMINEX NIGHT Actavis Group PTC ehf PA1380/208/001 Film Coated Tablet - PARACETAMOL 01/03/2018
- DIPHENHYDRAMINE
HYDROCHLORIDE PH.
EUR.
TYPHERIX GlaxoSmithKline (Ireland) PA1077/038/001 Solution for injection in pre- - SALMONELLA TYPHI, VI 01/03/2018
Limited filled syringe ANTIGEN
VESAGEX Strides Shasun (UK) Ltd PA0894/003/001 Cream - CETRIMONIUM BROMIDE 01/03/2018

XEFO RAPID 8 MG FILM- Takeda UK Limited PA1547/005/004 Film Coated Tablet - LORNOXICAM 01/03/2018
COATED TABLETS
CLARITHROMYCIN Milpharm Limited PA1050/023/001 Film Coated Tablet - CLARITHROMYCIN 28/02/2018
AUROBINDO
CLARITHROMYCIN Milpharm Limited PA1050/023/002 Film Coated Tablet - CLARITHROMYCIN 28/02/2018
AUROBINDO
MIRTAZAPINE AUROBIND Milpharm Limited PA1050/020/001 Film Coated Tablet - MIRTAZAPINE 28/02/2018

MIRTAZAPINE AUROBIND Milpharm Limited PA1050/020/002 Film Coated Tablet - MIRTAZAPINE 28/02/2018

MIRTAZAPINE AUROBIND Milpharm Limited PA1050/020/003 Film Coated Tablet - MIRTAZAPINE 28/02/2018

MIRTAZAPINE AUROBIND Aurobindo Pharma Limited PA1311/012/001 Orodispersible Tablet - MIRTAZAPINE 28/02/2018

MIRTAZAPINE AUROBIND Aurobindo Pharma Limited PA1311/012/002 Orodispersible Tablet - MIRTAZAPINE 28/02/2018

MIRTAZAPINE AUROBIND Aurobindo Pharma Limited PA1311/012/003 Orodispersible Tablet - MIRTAZAPINE 28/02/2018

NOCTAMID PCO Manufacturing PPA0465/402/001 Tablets - LORMETAZEPAM 28/02/2018


RISEDRONATE Milpharm Limited PA1050/008/003 Film Coated Tablet - RISEDRONATE SODIUM 28/02/2018
AUROBINDO ONCE A
WEEK
SERTRALINE AUROBINDO Aurobindo Pharma Limited PA1311/001/001 Film Coated Tablet - SERTRALINE 28/02/2018
HYDROCHLORIDE
SERTRALINE AUROBINDO Aurobindo Pharma Limited PA1311/001/002 Film Coated Tablet - SERTRALINE 28/02/2018
HYDROCHLORIDE
SIMVASTATIN AUROBINDO Aurobindo Pharma Limited PA1311/014/001 Film Coated Tablet - SIMVASTATIN 28/02/2018

SIMVASTATIN AUROBINDO Aurobindo Pharma Limited PA1311/014/002 Film Coated Tablet - SIMVASTATIN 28/02/2018

SIMVASTATIN AUROBINDO Aurobindo Pharma Limited PA1311/014/003 Film Coated Tablet - SIMVASTATIN 28/02/2018

SIMVASTATIN AUROBINDO Aurobindo Pharma Limited PA1311/014/004 Film Coated Tablet - SIMVASTATIN 28/02/2018

Human Medicines Withdrawn Products Page 99 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALCICHEW-D3 EXTRA Takeda UK Limited PA1547/007/005 Tablets Chewable - CALCIUM CARBONATE 22/02/2018
500 MG/1000 IU - CHOLECALCIFEROL
CHEWABLE TABLETS CONCENTRATE (POWDER
FORM)
- COLECALCIFEROL
- ALL-RAC ALPHA-
TOCOPHEROL
- MEDIUM CHAIN
TRIGLYCERIDES
- MODIFIED MAIZE
STARCH
- SUCROSE
- SODIUM ASCORBATE
- SILICA COLLOIDAL
ANHYDROUS
CALCICHEW-D3 FORTE Takeda UK Limited PA1547/007/003 Film Coated Tablet - CALCIUM CARBONATE 22/02/2018
500 MG / 400 IU FILM- - CHOLECALCIFEROL
COATED TABLETS CONCENTRATE (POWDER
FORM)
AUGMENTIN-DUO IMED Healthcare Ltd. PPA1463/015/002 Powder for Oral Suspension - AMOXICILLIN 20/02/2018
TRIHYDRATE
- CLAVULANATE
POTASSIUM
DIFENE DUAL RELEASE Imbat Limited PPA1151/073/001 Modified-release capsule, - DICLOFENAC SODIUM 16/02/2018
hard
VALSARTAN/HYDROCHLO Milpharm Limited PA1050/016/001 Film Coated Tablet - VALSARTAN 14/02/2018
ROTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE

VALSARTAN/HYDROCHLO Milpharm Limited PA1050/016/002 Film Coated Tablet - VALSARTAN 14/02/2018


ROTHIAZIDE AUROBINDO

VALSARTAN/HYDROCHLO Milpharm Limited PA1050/016/003 Film Coated Tablet - VALSARTAN 14/02/2018


ROTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE

MEMANTINE Rosemont Pharmaceuticals PA0312/032/001 - MEMANTINE 12/02/2018


HYDROCHLORIDE Ltd HYDROCHLORIDE
REMIFENTANIL Hospira UK Limited PA0437/068/001 Powder for concentrate for - REMIFENTANIL 12/02/2018
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL Hospira UK Limited PA0437/068/002 Powder for concentrate for - REMIFENTANIL 12/02/2018
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL Hospira UK Limited PA0437/068/003 Powder for concentrate for - REMIFENTANIL 12/02/2018
solution for injection/infusion HYDROCHLORIDE
VERTIGON Aurobindo Pharma (Malta) PA1445/013/001 Tablets - BETAHISTINE 12/02/2018
Limited DIHYDROCHLORIDE
VERTIGON Aurobindo Pharma (Malta) PA1445/013/002 Tablets - BETAHISTINE 12/02/2018
Limited DIHYDROCHLORIDE
COMBIVENT UDVS Boehringer Ingelheim Limited PA0007/052/002 Nebuliser Solution - IPRATROPIUM BROMIDE 08/02/2018
MONOHYDRATE
- SALBUTAMOL SULFATE
FREEDONEL & PLACEBO Rowex Ltd PA0711/210/001 Film Coated Tablet - DROSPIRENONE 07/02/2018
- ETHINYLESTRADIOL
LEVOFLOXACIN TEVA Teva Pharma B.V. PA0749/071/001 Solution for Infusion - LEVOFLOXACIN 02/02/2018
MOMETASONE FUROATE Teva Pharma B.V. PA0749/188/001 Nasal Spray Suspension - MOMETASONE FUROATE 02/02/2018
TEVA MONOHYDRATE

SENZIOLA Actavis Group PTC ehf PA1380/167/001 Nasal Spray Solution - XYLOMETAZOLINE 02/02/2018
HYDROCHLORIDE
SENZIOLA Actavis Group PTC ehf PA1380/167/002 Nasal Spray Solution - XYLOMETAZOLINE 02/02/2018
HYDROCHLORIDE
VANQUORAL Teva Pharma B.V. PA0749/179/001 Capsules, Soft - CICLOSPORIN 02/02/2018
VANQUORAL Teva Pharma B.V. PA0749/179/002 Capsules, Soft - CICLOSPORIN 02/02/2018
VANQUORAL Teva Pharma B.V. PA0749/179/003 Capsules, Soft - CICLOSPORIN 02/02/2018
VANQUORAL Teva Pharma B.V. PA0749/179/004 Capsules, Soft - CICLOSPORIN 02/02/2018
VORICONAZOLE PHARMA Pharma Regulatory Solutions PA1881/002/001 Powder for solution for - VORICONAZOLE 02/02/2018
REGULATORY SOLUTIONS Ltd infusion

ALZTEV Teva Pharma B.V. PA0749/203/003 Transdermal Patch - RIVASTIGMINE BASE 01/02/2018
BONDULC Actavis Group PTC ehf PA1380/169/001 Eye Drops Solution - TRAVOPROST 01/02/2018
DOXORUBICIN Hospira UK Limited PA0437/026/002 Pdr for Soln for Injection - DOXORUBICIN 01/02/2018
HYDROCHLORIDE HYDROCHLORIDE
OXYCODONE Teva Pharma B.V. PA0749/211/001 Capsules Hard - OXYCODONE 01/02/2018
HYDROCHLORIDE TEVA HYDROCHLORIDE
OXYCODONE Teva Pharma B.V. PA0749/211/002 Capsules Hard - OXYCODONE 01/02/2018
HYDROCHLORIDE TEVA HYDROCHLORIDE
OXYCODONE Teva Pharma B.V. PA0749/211/003 Capsules Hard - OXYCODONE 01/02/2018
HYDROCHLORIDE TEVA HYDROCHLORIDE

Human Medicines Withdrawn Products Page 100 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RIVASTIGMINE TEVA Teva Pharma B.V. PA0749/203/001 Transdermal Patch - RIVASTIGMINE BASE 01/02/2018
RIVASTIGMINE TEVA Teva Pharma B.V. PA0749/203/002 Transdermal Patch - RIVASTIGMINE BASE 01/02/2018
ROSUVASTATIN TEVA Teva Pharma B.V. PA0749/096/001 Film Coated Tablet - ROSUVASTATIN 01/02/2018
CALCIUM
ROSUVASTATIN TEVA Teva Pharma B.V. PA0749/096/002 Film Coated Tablet - ROSUVASTATIN 01/02/2018
CALCIUM
ROSUVASTATIN TEVA Teva Pharma B.V. PA0749/096/003 Film Coated Tablet - ROSUVASTATIN 01/02/2018
CALCIUM
ROSUVASTATIN TEVA Teva Pharma B.V. PA0749/096/004 Film Coated Tablet - ROSUVASTATIN 01/02/2018
CALCIUM
TAMSULOSIN TEVA Teva Pharma B.V. PA0749/130/001 Modified-release capsule, - TAMSULOSIN 01/02/2018
hard HYDROCHLORIDE
TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/001 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/002 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/003 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/004 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/005 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEMOZOLOMIDE ACTAVIS Actavis Group PTC ehf PA1380/151/006 Capsules Hard - TEMOZOLOMIDE 01/02/2018

TEVAQUEL Teva Pharma B.V. PA0749/060/003 Film Coated Tablet - QUETIAPINE FUMARATE 01/02/2018
ZOLMITRIPTAN TEVA Teva Pharma B.V. PA0749/068/002 Orodispersible Tablet - ZOLMITRIPTAN 01/02/2018
AMLODIPINE/VALSARTAN Teva B.V. PA1986/013/001 Film Coated Tablet - VALSARTAN 31/01/2018
TEVA - AMLODIPINE BESILATE
AMLODIPINE/VALSARTAN Teva B.V. PA1986/013/002 Film Coated Tablet - VALSARTAN 31/01/2018
TEVA - AMLODIPINE BESILATE
AMLODIPINE/VALSARTAN Teva B.V. PA1986/013/003 Film Coated Tablet - VALSARTAN 31/01/2018
TEVA - AMLODIPINE BESILATE
Busiete 10 micrograms/hour Teva B.V. PA1986/026/002 Transdermal patch - Buprenorphine 31/01/2018
transdermal patch
Busiete 20 micrograms/hour Teva B.V. PA1986/026/003 Transdermal patch - Buprenorphine 31/01/2018
transdermal patch
Busiete 5 micrograms/hour Teva B.V. PA1986/026/001 Transdermal patch - Buprenorphine 31/01/2018
transdermal patch
CARSEM XL Teva Pharma B.V. PA0749/072/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 31/01/2018
FRUCO Norton Healthcare Limited PA0282/060/001 Tablets - FUROSEMIDE 31/01/2018
T/A IVAX Pharmaceuticals - AMILORIDE
UK HYDROCHLORIDE
GINKGOFORCE MEMORY Bioforce (UK) Ltd TR0725/016/001 Tablets - EXTRACT OF GINKGO 31/01/2018
& CIRCULATION GINKGO BILOBA L. FRESH LEAF (3-
5:1). EXTRACTION
SOLVENT ETHANOL
60%M/M
HISTEK Fannin Limited PA1457/012/002 Film Coated Tablet - CETIRIZINE 31/01/2018
DIHYDROCHLORIDE
HISTEK ALLERGY 10 MG Fannin Limited PA1457/012/001 Film Coated Tablet - CETIRIZINE 31/01/2018
FILM-COATED TABLETS DIHYDROCHLORIDE
IVABRADINE TEVA Teva B.V. PA1986/029/001 Film Coated Tablet - IVABRADINE ADIPATE 31/01/2018
IVABRADINE TEVA Teva B.V. PA1986/029/002 Film Coated Tablet - IVABRADINE ADIPATE 31/01/2018
LAXATEV Teva Pharma B.V. PA0749/200/001 Powder for Oral Solution - MACROGOL 3350 31/01/2018
- SODIUM CHLORIDE
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
LAXATEV PAEDIATRIC Teva Pharma B.V. PA0749/200/002 Powder for Oral Solution - MACROGOL 3350 31/01/2018
- SODIUM CHLORIDE
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
LERCANIDIPINE TEVA Teva Pharma B.V. PA0749/183/001 Film Coated Tablet - LERCANIDIPINE 31/01/2018
PHARMA HYDROCHLORIDE
LERCANIDIPINE TEVA Teva Pharma B.V. PA0749/183/002 Film Coated Tablet - LERCANIDIPINE 31/01/2018
PHARMA HYDROCHLORIDE
LEVOCETIRIZINE TEVA Teva Pharma B.V. PA0749/046/001 Film Coated Tablet - LEVOCETIRIZINE 31/01/2018
DIHYDROCHLORIDE
LEVONORGESTREL TEVA Teva Pharma B.V. PA0749/184/001 Tablets - LEVONORGESTREL 31/01/2018
OXYCODONE ACTAVIS Actavis Group PTC ehf PA1380/129/001 Capsules Hard - OXYCODONE 31/01/2018
HYDROCHLORIDE
OXYCODONE ACTAVIS Actavis Group PTC ehf PA1380/129/002 Capsules Hard - OXYCODONE 31/01/2018
HYDROCHLORIDE
OXYCODONE ACTAVIS Actavis Group PTC ehf PA1380/129/003 Capsules Hard - OXYCODONE 31/01/2018
HYDROCHLORIDE
PACIFA Fannin Limited PA1457/008/001 Coated Tablets - DRY EXTRACT OF ST. 31/01/2018
JOHN'S WORT

Human Medicines Withdrawn Products Page 101 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SERENACE Norton Healthcare Limited PA0282/063/008 Tablets - HALOPERIDOL 31/01/2018
T/A IVAX Pharmaceuticals
UK
VIRIDAL DUO UCB (Pharma) Ireland PA0891/015/001 Pdr+Solv for Soln for Inj - ALPROSTADIL 31/01/2018
Limited
VIRIDAL DUO UCB (Pharma) Ireland PA0891/015/002 Pdr+Solv for Soln for Inj - ALPROSTADIL 31/01/2018
Limited
VIRIDAL DUO UCB (Pharma) Ireland PA0891/015/003 Pdr+Solv for Soln for Inj - ALPROSTADIL 31/01/2018
Limited
ZYNOR Teva Pharma B.V. PA0749/175/001 Film Coated Tablet - CETIRIZINE 31/01/2018
DIHYDROCHLORIDE
LEUKOSCAN Immunomedics GmbH EU/1/97/032/001 Pdr for Soln for Injection - SULESOMAB 30/01/2018
ACTONEL ONCE A WEEK Clear Pharmacy PPA1596/001/001 Film Coated Tablet - RISEDRONATE SODIUM 29/01/2018
ADALAT LA Clear Pharmacy PPA1596/035/001 Tablet Prolonged Release - NIFEDIPINE 29/01/2018
ADALAT LA Clear Pharmacy PPA1596/035/002 Tablet Prolonged Release - NIFEDIPINE 29/01/2018
ADALAT LA Clear Pharmacy PPA1596/035/003 Tablet Prolonged Release - NIFEDIPINE 29/01/2018
ARCOXIA Clear Pharmacy PPA1596/043/001 Film Coated Tablet - ETORICOXIB 29/01/2018
ARCOXIA Clear Pharmacy PPA1596/043/002 Film Coated Tablet - ETORICOXIB 29/01/2018
ARICEPT Clear Pharmacy PPA1596/047/001 Film Coated Tablet - DONEPEZIL 29/01/2018
HYDROCHLORIDE
ARICEPT Clear Pharmacy PPA1596/047/002 Film Coated Tablet - DONEPEZIL 29/01/2018
HYDROCHLORIDE
ARIMIDEX Clear Pharmacy PPA1596/050/001 Film Coated Tablet - ANASTRAZOLE 29/01/2018
AVODART Clear Pharmacy PPA1596/002/001 Capsules, Soft - DUTASTERIDE 29/01/2018
CARDURA XL Clear Pharmacy PPA1596/024/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/01/2018
CARDURA XL Clear Pharmacy PPA1596/024/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/01/2018
CASODEX Clear Pharmacy PPA1596/049/001 Film Coated Tablet - BICALUTAMIDE 29/01/2018
CELEBREX 200 MG Clear Pharmacy PPA1596/034/001 Capsules Hard - CELECOXIB 29/01/2018
CAPSULE, HARD
COSOPT Clear Pharmacy PPA1596/060/001 Eye Drops Solution - DORZOLAMIDE 29/01/2018
- TIMOLOL
COVERSYL ARGININE Clear Pharmacy PPA1596/007/001 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2018
COVERSYL ARGININE Clear Pharmacy PPA1596/007/002 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2018
COVERSYL ARGININE Clear Pharmacy PPA1596/031/001 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2018
PLUS - INDAPAMIDE
COZAAR Clear Pharmacy PPA1596/003/001 Film Coated Tablet - LOSARTAN POTASSIUM 29/01/2018
COZAAR Clear Pharmacy PPA1596/003/002 Film Coated Tablet - LOSARTAN POTASSIUM 29/01/2018
CRESTOR Clear Pharmacy PPA1596/025/001 Film Coated Tablet - ROSUVASTATIN 29/01/2018
CRESTOR Clear Pharmacy PPA1596/025/002 Film Coated Tablet - ROSUVASTATIN 29/01/2018
DETRUSITOL SR Clear Pharmacy PPA1596/014/001 Prolonged Release Capsules - TOLTERODINE 29/01/2018
TARTRATE
DIANETTE Clear Pharma Limited PPA1823/001/001 Coated Tablets - CYPROTERONE 29/01/2018
ACETATE
- ETHINYLESTRADIOL
DOVOBET Clear Pharmacy PPA1596/004/001 Ointment - CALCIPOTRIOL HYDRATE 29/01/2018
- BETAMETHASONE
DIPROPIONATE

DOVONEX Clear Pharmacy PPA1596/039/001 Cream - CALCIPOTRIOL 29/01/2018


FUCIBET Clear Pharmacy PPA1596/041/001 Cream - FUSIDIC ACID 29/01/2018
ANHYDROUS
- BETAMETHASONE
VALERATE
FUCIDIN Clear Pharmacy PPA1596/040/001 Cream - FUSIDIC ACID 29/01/2018
IMURAN Clear Pharma Limited PPA1823/010/001 Film Coated Tablet - AZATHIOPRINE 29/01/2018
INSPRA Clear Pharmacy PPA1596/048/001 Film Coated Tablet - EPLERENONE 29/01/2018
LIPITOR Clear Pharmacy PPA1596/005/001 Film Coated Tablet - ATORVASTATIN-CALCIUM 29/01/2018

LIPITOR Clear Pharmacy PPA1596/005/002 Film Coated Tablet - ATORVASTATIN-CALCIUM 29/01/2018

LIPITOR Clear Pharmacy PPA1596/005/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 29/01/2018

LIPITOR Clear Pharmacy PPA1596/005/004 Film Coated Tablet - ATORVASTATIN-CALCIUM 29/01/2018

LOGYNON Clear Pharma Limited PPA1823/006/001 Coated Tablets - LEVONORGESTREL 29/01/2018


- ETHINYLESTRADIOL
- LEVONORGESTREL
- ETHINYLESTRADIOL
- LEVONORGESTREL
- ETHINYLESTRADIOL
LOSEC MUPS Clear Pharmacy PPA1596/027/001 Tablets Gastro-Resistant - OMEPRAZOLE 29/01/2018
MEZAVANT XL Clear Pharma Limited PPA1823/002/001 Tablet Prolonged Release - MESALAZINE 29/01/2018
NEXIUM Clear Pharmacy PPA1596/008/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 29/01/2018
MAGNESIUM TRIHYDRATE

Human Medicines Withdrawn Products Page 102 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEXIUM Clear Pharmacy PPA1596/008/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 29/01/2018
MAGNESIUM TRIHYDRATE

PLAQUENIL Clear Pharmacy PPA1596/052/001 Film Coated Tablet - HYDROXYCHLOROQUINE 29/01/2018


SULPHATE

PROSTAP 3 DCS DEPOT Clear Pharma Limited PPA1823/004/001 Unknown - LEUPRORELIN ACETATE 29/01/2018
INJECTION
PROTIUM Clear Pharmacy PPA1596/032/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 29/01/2018
SESQUIHYDRATE

PROTIUM Clear Pharmacy PPA1596/032/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 29/01/2018


SESQUIHYDRATE

PULMICORT RESPULES Clear Pharmacy PPA1596/062/001 Nebuliser Suspension - BUDESONIDE 29/01/2018


PULMICORT RESPULES Clear Pharmacy PPA1596/062/002 Nebuliser Suspension - BUDESONIDE 29/01/2018
PULMICORT TURBOHALER Clear Pharmacy PPA1596/011/001 Inhalation powder - BUDESONIDE 29/01/2018
100 MICROGRAMS
INHALATION POWDER

PULMICORT TURBOHALER Clear Pharmacy PPA1596/011/002 Inhalation powder - BUDESONIDE 29/01/2018


200 MICROGRAMS
INHALATION POWDER

PULMICORT TURBOHALER Clear Pharmacy PPA1596/011/003 Inhalation powder - BUDESONIDE 29/01/2018


400 MICROGRAMS
INHALATION POWDER

RISPERDAL CONSTA Clear Pharmacy PPA1596/053/001 Pdr+Solv for Susp for Inj - RISPERIDONE 29/01/2018
RISPERDAL CONSTA Clear Pharmacy PPA1596/053/002 Pdr+Solv for Susp for Inj - RISPERIDONE 29/01/2018
RISPERDAL CONSTA Clear Pharmacy PPA1596/053/003 Pdr+Solv for Susp for Inj - RISPERIDONE 29/01/2018
SCHERIPROCT OINTMENT Clear Pharmacy PPA1596/051/001 Rectal Ointment - PREDNISOLONE 29/01/2018
CAPROATE
- CINCHOCAINE
HYDROCHLORIDE
SERETIDE Clear Pharmacy PPA1596/018/001 Pressurised Inhalation - SALMETEROL 29/01/2018
Suspension - FLUTICASONE
PROPIONATE
SERETIDE 100 DISKUS Clear Pharmacy PPA1596/018/002 Inhalation powder - SALMETEROL 29/01/2018
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE 250 DISKUS Clear Pharmacy PPA1596/018/003 Inhalation powder - SALMETEROL 29/01/2018
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE 500 DISKUS Clear Pharmacy PPA1596/018/004 Inhalation powder - SALMETEROL 29/01/2018
XINAFOATE
- FLUTICASONE
PROPIONATE
SINEMET PLUS Clear Pharmacy PPA1596/046/001 Tablets - LEVODOPA 29/01/2018
- CARBIDOPA
SINGULAIR Clear Pharmacy PPA1596/020/003 Film Coated Tablet - MONTELUKAST SODIUM 29/01/2018
SINGULAIR PAEDIATRIC Clear Pharmacy PPA1596/020/001 Tablets Chewable - MONTELUKAST SODIUM 29/01/2018
SINGULAIR PAEDIATRIC Clear Pharmacy PPA1596/020/002 Tablets Chewable - MONTELUKAST SODIUM 29/01/2018
SPIRIVA Clear Pharmacy PPA1596/036/001 Inhalation powder, hard - TIOTROPIUM BROMIDE 29/01/2018
capsule
TETRALYSAL Clear Pharma Limited PPA1823/003/001 Capsules Hard - LYMECYCLINE 29/01/2018
TOPAMAX Clear Pharmacy PPA1596/058/001 Film Coated Tablet - TOPIRAMATE 29/01/2018
TOPAMAX Clear Pharmacy PPA1596/058/002 Film Coated Tablet - TOPIRAMATE 29/01/2018
URSOFALK Clear Pharmacy PPA1596/045/001 Capsules Hard - URSODEOXYCHOLIC 29/01/2018
ACID
XYZAL Clear Pharmacy PPA1596/016/001 Film Coated Tablet - LEVOCETIRIZINE 29/01/2018
DIHYDROCHLORIDE
ZANIDIP Clear Pharmacy PPA1596/009/001 Film Coated Tablet - LERCANIDIPINE 29/01/2018
HYDROCHLORIDE
ZANIDIP Clear Pharmacy PPA1596/009/002 Film Coated Tablet - LERCANIDIPINE 29/01/2018
HYDROCHLORIDE
ZOMIG Clear Pharmacy PPA1596/037/001 Film Coated Tablet - ZOLMITRIPTAN 29/01/2018
ZOMIG RAPIMELT Clear Pharmacy PPA1596/037/002 Orodispersible Tablet - ZOLMITRIPTAN 29/01/2018
ZOTON FASTAB Clear Pharmacy PPA1596/006/001 Orodispersible Tablet - LANSOPRAZOLE 29/01/2018
ZOTON FASTAB Clear Pharmacy PPA1596/006/002 Orodispersible Tablet - LANSOPRAZOLE 29/01/2018
AVELOX Bayer Limited PA1410/027/002 Solution for Infusion - MOXIFLOXACIN 25/01/2018
HYDROCHLORIDE
VISANNE Bayer Limited PA1410/059/001 Tablets - DIENOGEST 19/01/2018

Human Medicines Withdrawn Products Page 103 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Zoledronic acid Teva Pharm Teva B.V. EU/1/12/772/001-004 Solution for infusion - Zoledronic acid 18/01/2018

METROGEL Galderma (UK) Ltd PA0590/015/001 Gel - METRONIDAZOLE 17/01/2018


ATORVASTATIN Pharmathen S.A. PA1368/013/001 Film Coated Tablet - ATORVASTATIN CALCIUM 15/01/2018
PHARMATHEN
ATORVASTATIN Pharmathen S.A. PA1368/013/002 Film Coated Tablet - ATORVASTATIN CALCIUM 15/01/2018
PHARMATHEN
ATORVASTATIN Pharmathen S.A. PA1368/013/003 Film Coated Tablet - ATORVASTATIN 15/01/2018
PHARMATHEN
DALIRESP AstraZeneca AB EU/1/11/668/001-003 Film Coated Tablet - ROFLUMILAST 11/01/2018
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/3-4 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP BASAL GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/6/368/20-28,64-69,89 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP BASAL GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/6/368/29-37,71-75,90 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 15 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/5-6 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 15 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/7-8 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 25 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/6/368/38-46,76-81,91 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 25 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/143-168 Suspension for Injection - INSULIN HUMAN HR1799 11/01/2018
WINTHROP COMB 30 GmbH
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/9-10 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 50 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/6/368/47-55,82-87,92 Suspension for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP COMB 50 GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/1-2 Solution for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP RAPID GmbH HR1799
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/6/368/11-19,58-63,88 Solution for Injection - INSULIN HUMAN GT 11/01/2018
WINTHROP RAPID GmbH HR1799
LIBERTEK AstraZeneca AB EU/1/11/666/001-003 Coated Tablets - ROFLUMILAST 11/01/2018
CALCIUM SANDOZ GlaxoSmithKline Consumer PA0678/127/001 Syrup - CALCIUM GLUBIONATE 08/01/2018
Healthcare (Ireland) Limited - CALCIUM LACTOBIONATE

CANESTEN HC PCO Manufacturing PPA0465/246/001 Cream - CLOTRIMAZOLE 31/12/2017


- HYDROCORTISONE
CARDICOR PCO Manufacturing PPA0465/204/001 Film Coated Tablet - BISOPROLOL 31/12/2017
HEMIFUMARATE
CARDICOR PCO Manufacturing PPA0465/204/002 Film Coated Tablet - BISOPROLOL 31/12/2017
HEMIFUMARATE
CERAZETTE PCO Manufacturing PPA0465/307/001 Film Coated Tablet - DESOGESTREL 31/12/2017
CLEXANE PCO Manufacturing PPA0465/251/001 Solution for Injection - ENOXAPARIN SODIUM 31/12/2017
COVERSYL ARGININE PCO Manufacturing PPA0465/067/006 Film Coated Tablet - PERINDOPRIL ARGININE 31/12/2017
PLUS - INDAPAMIDE
COVERSYL ARGININE PCO Manufacturing PPA0465/067/007 Film Coated Tablet - PERINDOPRIL ARGININE 31/12/2017
PLUS - INDAPAMIDE
CYSTOPURIN PCO Manufacturing PPA0465/280/001 Granules for oral solution - POTASSIUM CITRATE 31/12/2017
ELOCON PCO Manufacturing PPA0465/268/002 Ointment - MOMETASONE FUROATE 31/12/2017

ELUMATIC III 2-20 GBQ CIS bio International PA0677/010/001 Unknown - SODIUM 31/12/2017
RADIONUCLIDE PERTECHNETATE (99M
GENERATOR TC)
FLIXOTIDE NEBULES PCO Manufacturing PPA0465/073/003 Nebuliser Suspension - FLUTICASONE 31/12/2017
PROPIONATE
FLIXOTIDE NEBULES PCO Manufacturing PPA0465/073/004 Nebuliser Suspension - FLUTICASONE 31/12/2017
PROPIONATE
FUCITHALMIC PCO Manufacturing PPA0465/339/001 Eye Drops Suspension - FUSIDIC ACID 31/12/2017
INEGY PCO Manufacturing PPA0465/223/002 Tablets - EZETIMIBE 31/12/2017
- SIMVASTATIN
INEGY PCO Manufacturing PPA0465/223/003 Tablets - EZETIMIBE 31/12/2017
- SIMVASTATIN
INSPRA PCO Manufacturing PPA0465/297/001 Film Coated Tablet - EPLERENONE 31/12/2017
INSPRA PCO Manufacturing PPA0465/297/002 Film Coated Tablet - EPLERENONE 31/12/2017
IXPRIM PCO Manufacturing PPA0465/282/001 Film Coated Tablet - TRAMADOL 31/12/2017
HYDROCHLORIDE
- PARACETAMOL
KEFLEX PCO Manufacturing PPA0465/010/002 Capsules Hard - CEFALEXIN 31/12/2017
MONOHYDRATE
KEFLEX PCO Manufacturing PPA0465/010/003 Film Coated Tablet - CEFALEXIN 31/12/2017
MONOHYDRATE
MELOXICAM WPR Healthcare Limited PPA0565/041/001 Tablets - MELOXICAM 31/12/2017
MELOXICAM WPR Healthcare Limited PPA0565/041/002 Tablets - MELOXICAM 31/12/2017
MIRTAZAPINE TEVA WPR Healthcare Limited PPA0565/043/001 Orodispersible Tablet - MIRTAZAPINE 31/12/2017

Human Medicines Withdrawn Products Page 104 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MONTELUKAST WPR Healthcare Limited PPA0565/054/001 Tablets Chewable - MONTELUKAST SODIUM 31/12/2017
MONTELUKAST WPR Healthcare Limited PPA0565/054/002 Tablets Chewable - MONTELUKAST SODIUM 31/12/2017
OSTEOFOS D3 PCO Manufacturing PPA0465/278/001 Powder for Oral Suspension - CALCIUM PHOSPHATE 31/12/2017
- COLECALCIFEROL
PROTIUM PCO Manufacturing PPA0465/071/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2017
SESQUIHYDRATE

PROTIUM PCO Manufacturing PPA0465/071/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2017


SESQUIHYDRATE

PULMICORT TURBOHALER PCO Manufacturing PPA0465/100/006 Inhalation powder - BUDESONIDE 31/12/2017

PULMICORT TURBOHALER PCO Manufacturing PPA0465/100/001 Inhalation powder - BUDESONIDE 31/12/2017

SALOFALK PCO Manufacturing PPA0465/266/001 Rectal Suspension - MESALAZINE 31/12/2017


SEREVENT EVOHALER PCO Manufacturing PPA0465/127/003 Pressurised Inhalation - SALMETEROL 31/12/2017
Suspension XINAFOATE
SINEMET CR PCO Manufacturing PPA0465/148/005 Tablet Prolonged Release - LEVODOPA 31/12/2017
- CARBIDOPA
SOLARAZE PCO Manufacturing PPA0465/275/001 Gel - DICLOFENAC SODIUM 31/12/2017
TESTOGEL PCO Manufacturing PPA0465/306/001 Gel - TESTOSTERONE 31/12/2017
VAGIFEM PCO Manufacturing PPA0465/330/001 Vaginal Tablets - ESTRADIOL 31/12/2017
HEMIHYDRATE
VALCYTE PCO Manufacturing PPA0465/221/001 Film Coated Tablet - VALGANCICLOVIR 31/12/2017
VASTAREL 20MG FILM- PCO Manufacturing PPA0465/122/001 Film Coated Tablet - TRIMETAZIDINE 31/12/2017
COATED TABLETS DIHYDROCHLORIDE
VIDISIC PCO Manufacturing PPA0465/309/001 Eyegel - CARBOMER 31/12/2017
YASMIN PCO Manufacturing PPA0465/326/001 Film Coated Tablet - DROSPIRENONE 31/12/2017
- ETHINYLESTRADIOL
ZANTAC PCO Manufacturing PPA0465/033/001 Film Coated Tablet - RANITIDINE 31/12/2017
HYDROCHLORIDE
ZANTAC PCO Manufacturing PPA0465/033/002 Film Coated Tablet - RANITIDINE 31/12/2017
HYDROCHLORIDE
ZITHROMAX PCO Manufacturing PPA0465/139/001 Capsules Hard - AZITHROMYCIN 31/12/2017
DIHYDRATE
LOSEC MUPS Imbat Limited PPA1151/007/002 Tablets Gastro-Resistant - OMEPRAZOLE 20/12/2017
MAGNESIUM
ERYMAX Hospira UK Limited PA0437/048/001 Capsule - ERYTHROMYCIN 19/12/2017
IMIGRAN MIGRAINE GlaxoSmithKline Consumer PA0678/110/001 Film Coated Tablet - SUMATRIPTAN 19/12/2017
RELIEF Healthcare (Ireland) Limited SUCCINATE
PANADEINE GlaxoSmithKline Consumer PA0678/026/001 Tablets - PARACETAMOL 19/12/2017
Healthcare (Ireland) Limited - CODEINE PHOSPHATE
PANTOPRAZOLE ROWEX Rowex Ltd PA0711/142/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 19/12/2017
SESQUIHYDRATE

RAZOLE Rowex Ltd PA0711/169/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 19/12/2017


RAZOLE Rowex Ltd PA0711/169/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 19/12/2017
SUVALAN GlaxoSmithKline Consumer PA0678/108/001 Film Coated Tablet - SUMATRIPTAN 19/12/2017
Healthcare (Ireland) Limited SUCCINATE
SUVALAN GlaxoSmithKline Consumer PA0678/108/002 Film Coated Tablet - SUMATRIPTAN 19/12/2017
Healthcare (Ireland) Limited SUCCINATE
VENFAX XL Rowex Ltd PA0711/145/001 Prolonged Release Capsules - VENLAFAXINE 19/12/2017
HYDROCHLORIDE
VENFAX XL Rowex Ltd PA0711/145/002 Prolonged Release Capsules - VENLAFAXINE 19/12/2017
HYDROCHLORIDE
VENFAX XL Rowex Ltd PA0711/145/003 Prolonged Release Capsules - VENLAFAXINE 19/12/2017
HYDROCHLORIDE
BANDIDA Actavis Group PTC ehf PA1380/183/001 Capsules Hard - FLUCONAZOLE 15/12/2017
CANDESARTAN Actavis Group PTC ehf PA1380/126/001 Tablets - CANDESARTAN 15/12/2017
HYDROCHLOROTHIAZIDE CILEXETIL
ACTAVIS - HYDROCHLOROTHIAZIDE

ESCID CONTROL Actavis Group PTC ehf PA1380/159/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 15/12/2017
MAGNESIUM DIHYDRATE
LEMILVO Actavis Group PTC ehf PA1380/174/005 Orodispersible Tablet - ARIPIPRAZOLE 15/12/2017
LEMILVO Actavis Group PTC ehf PA1380/174/006 Orodispersible Tablet - ARIPIPRAZOLE 15/12/2017
LEMILVO Actavis Group PTC ehf PA1380/174/007 Orodispersible Tablet - ARIPIPRAZOLE 15/12/2017
CLOPIDOGREL McDermott Laboratories Ltd PA0577/157/001 Film Coated Tablet - CLOPIDOGREL 13/12/2017
t/a Gerard Laboratories HYDROBROMIDE
MONOHYDRATE
CLOROM Imbat Limited PPA1151/119/001 Film Coated Tablet - CLARITHROMYCIN 08/12/2017
KLACID Imbat Limited PPA1151/046/003 Film Coated Tablet - CLARITHROMYCIN 08/12/2017
KLACID FORTE Imbat Limited PPA1151/046/002 Film Coated Tablet - CLARITHROMYCIN 08/12/2017
KLACID LA Imbat Limited PPA1151/046/001 Modified-release Tablets - CLARITHROMYCIN 08/12/2017

Human Medicines Withdrawn Products Page 105 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZITHROMAX Imbat Limited PPA1151/237/001 Capsule - AZITHROMYCIN 08/12/2017
DIHYDRATE
TENOFOVIR DISOPROXIL Actavis Group PTC ehf PA1380/187/001 Tablets - TENOFOVIR DISOPROXIL 05/12/2017
ACTAVIS SUCCINATE
VORICONAZOLE ACTAVIS Actavis Group PTC ehf PA1380/172/001 Film Coated Tablet - VORICONAZOLE 05/12/2017
VORICONAZOLE ACTAVIS Actavis Group PTC ehf PA1380/172/002 Film Coated Tablet - VORICONAZOLE 05/12/2017
PERINDOPRIL TERT- Arrow Generics Limited PA1130/011/001 Tablets - PERINDOPRIL TERT- 04/12/2017
BUTYLAMINE BUTYLAMINE
PERINDOPRIL TERT- Arrow Generics Limited PA1130/011/002 Tablets - PERINDOPRIL TERT- 04/12/2017
BUTYLAMINE BUTYLAMINE
PREDMYCIN-P LIQUIFILM Allergan Pharmaceuticals PA0148/017/001 Eye Drops Suspension - PREDNISOLONE 29/11/2017
Ireland ACETATE
- NEOMYCIN SULFATE
- POLYMYXIN B SULFATE
FAVYND Boehringer Ingelheim PA0775/007/001 Inhalation powder, hard - TIOTROPIUM BROMIDE 28/11/2017
International GmbH capsule MONOHYDRATE
SANDOCAL GlaxoSmithKline Consumer PA0678/132/001 Tablets - CALCIUM 28/11/2017
EFFERVESCENT Healthcare (Ireland) Limited LACTOGLUCONATE
- CALCIUM CARBONATE
CISPLATIN Caduceus Pharma Ltd PA1399/005/001 Concentrate for Soln for Inf - CISPLATIN 23/11/2017
CASOMIDE Clonmel Healthcare Ltd PA0126/174/001 Film Coated Tablet - BICALUTAMIDE 22/11/2017
VANCOMYCIN Hikma Farmaceutica PA1217/013/001 Powder for concentrate for - VANCOMYCIN 22/11/2017
(Portugal) SA solution for infusion HYDROCHLORIDE
VANCOMYCIN Hikma Farmaceutica PA1217/013/002 Powder for concentrate for - VANCOMYCIN 22/11/2017
(Portugal) SA solution for infusion HYDROCHLORIDE
ZOLEDRONIC ACID Clonmel Healthcare Ltd PA0126/226/001 Concentrate for Soln for Inf - ZOLEDRONIC ACID 22/11/2017
CLONMEL MONOHYDRATE
MOMENDOL Aziende Chimiche Riunite PA0959/002/001 Film Coated Tablet - NAPROXEN SODIUM 17/11/2017
Angelini Francesco
LIFSAR PULMOJET Sanofi-Aventis Ireland PA0540/174/001 Inhalation powder - SALMETEROL 16/11/2017
Limited T/A SANOFI XINAFOATE
- FLUTICASONE
PROPIONATE
PROXAL Actavis Group PTC ehf PA1380/161/001 Eye Drops Solution - LATANOPROST 16/11/2017
EVARREST SEALANT Omrix Biopharmaceuticals EU/1/13/868/001 Sponge - HUMAN FIBRINOGEN 15/11/2017
MATRIX NV/SA - HUMAN THROMBIN
PACLITAXEL Stragen Nordic A/S PA1426/002/001 Concentrate for Soln for Inf - PACLITAXEL 15/11/2017
FREEDO & PLACEBO Rowex Ltd PA0711/219/001 Film Coated Tablet - DROSPIRENONE 14/11/2017
- ETHINYLESTRADIOL
MEMANTINE SANDOZ Rowex Ltd PA0711/214/001 Film Coated Tablet - MEMANTINE 14/11/2017
HYDROCHLORIDE
MONTUL PAEDIATRIC Rowex Ltd PA0711/172/001 Tablets Chewable - MONTELUKAST SODIUM 14/11/2017
MONTUL PAEDIATRIC Rowex Ltd PA0711/172/002 Tablets Chewable - MONTELUKAST SODIUM 14/11/2017
PANTOPRAZOLE ROWEX Rowex Ltd PA0711/142/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 14/11/2017
SESQUIHYDRATE

ROMEP Rowex Ltd PA0711/126/001 Capsules Gastro-Resistant - OMEPRAZOLE 14/11/2017


ROMEP Rowex Ltd PA0711/126/002 Capsules Gastro-Resistant - OMEPRAZOLE 14/11/2017
ROMEP Rowex Ltd PA0711/126/003 Capsules Gastro-Resistant - OMEPRAZOLE 14/11/2017
TEICOPLANIN Rowex Ltd PA0711/204/001 Pdr+Solv for soln for inf/inj - TEICOPLANIN 14/11/2017
TOPIT Rowex Ltd PA0711/111/001 Film Coated Tablet - TOPIRAMATE 14/11/2017
TOPIT Rowex Ltd PA0711/111/002 Film Coated Tablet - TOPIRAMATE 14/11/2017
TOPIT Rowex Ltd PA0711/111/003 Film Coated Tablet - TOPIRAMATE 14/11/2017
TOPIT Rowex Ltd PA0711/111/004 Film Coated Tablet - TOPIRAMATE 14/11/2017
CALCIUM-D-SANDOZ GlaxoSmithKline Consumer PA0678/128/001 Tablets Effervescent - CALCIUM CARBONATE 13/11/2017
Healthcare (Ireland) Limited - COLECALCIFEROL
RISTEMPA Amgen Europe B.V. EU/1/15/996/001-003 Solution for Injection - PEGFILGRASTIM 10/11/2017
MAALOX SACHETS Sanofi-Aventis Ireland PA0540/110/006 Oral Suspension - ALUMINIUM OXIDE 09/11/2017
Limited T/A SANOFI HYDRATED
- MAGNESIUM HYDROXIDE

MAALOX SUGAR-FREE Sanofi-Aventis Ireland PA0540/110/007 Tablets Chewable - ALUMINIUM OXIDE 09/11/2017
CHEWABLE TABLETS Limited T/A SANOFI HYDRATED
- MAGNESIUM HYDROXIDE

Somatropin Biopartners BioPartners GmbH EU/1/13/849/001 Powder and solvent for - Somatropin, recombinant 09/11/2017
suspension for injection human growth hormone
Somatropin Biopartners BioPartners GmbH EU/1/13/849/002 Powder and solvent for - Somatropin, recombinant 09/11/2017
suspension for injection human growth hormone
Somatropin Biopartners BioPartners GmbH EU/1/13/849/003 Powder and solvent for - Somatropin, recombinant 09/11/2017
suspension for injection human growth hormone
Somatropin Biopartners BioPartners GmbH EU/1/13/849/004-005 Powder and solvent for - Somatropin, recombinant 09/11/2017
suspension for injection human growth hormone
Somatropin Biopartners BioPartners GmbH EU/1/13/849/006-007 Powder and solvent for - Somatropin, recombinant 09/11/2017
suspension for injection human growth hormone

Human Medicines Withdrawn Products Page 106 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MEROPENEM MEDIPHA Medipha Sante SN PA1566/002/001 Pdr for Soln Inj/Inf - MEROPENEM 07/11/2017
SANTE TRIHYDRATE
- MEROPENEM
MEROPENEM MEDIPHA Medipha Sante SN PA1566/002/002 Pdr for Soln Inj/Inf - MEROPENEM 07/11/2017
SANTE TRIHYDRATE
- MEROPENEM
OLMESARTAN Teva Pharma B.V. PA0749/163/001 Film Coated Tablet - OLMESARTAN 04/11/2017
MEDOXOMIL/HYDROCHLO MEDOXOMIL
ROTHIAZIDE TEVA - HYDROCHLOROTHIAZIDE

OLMESARTAN Teva Pharma B.V. PA0749/163/002 Film Coated Tablet - OLMESARTAN 04/11/2017
MEDOXOMIL/HYDROCHLO MEDOXOMIL
ROTHIAZIDE TEVA - HYDROCHOLOTHIAZIDE
MOMENDOL Aziende Chimiche Riunite PA0959/002/002 Gel - NAPROXEN 03/11/2017
Angelini Francesco
KALCIPOS - D FORTE LTT Pharma Limited PPA1562/161/001 Tablets Chewable - CALCIUM 01/11/2017
- COLECALCIFEROL
AVODART B & S Healthcare PPA1328/134/001 Capsules, Soft - DUTASTERIDE 31/10/2017
CREON 10000 B & S Healthcare PPA1328/065/001 Capsule - PANCREATIN 31/10/2017
DOVONEX B & S Healthcare PPA1328/023/002 Cream - CALCIPOTRIOL 31/10/2017
IMURAN B & S Healthcare PPA1328/170/001 Film Coated Tablet - AZATHIOPRINE 31/10/2017
LAMICTAL B & S Healthcare PPA1328/128/001 Dispersable Tablet - LAMOTRIGINE 31/10/2017
LAMICTAL B & S Healthcare PPA1328/128/002 Dispersable Tablet - LAMOTRIGINE 31/10/2017
LAMICTAL B & S Healthcare PPA1328/128/003 Dispersable Tablet - LAMOTRIGINE 31/10/2017
SALAMOL CFC-FREE B & S Healthcare PPA1328/040/001 Pressurised Inhalation - SALBUTAMOL SULFATE 31/10/2017
INHALER Suspension
TEVETEN B & S Healthcare PPA1328/174/001 Film Coated Tablet - EPROSARTAN MESYLATE 31/10/2017

TOTELLE Pfizer Healthcare Ireland PA0822/073/001 Coated Tablets - ESTRADIOL 31/10/2017


HEMIHYDRATE
- TRIMEGESTONE
TOTELLE CYCLE Pfizer Healthcare Ireland PA0822/073/002 Coated Tablets - ESTRADIOL 31/10/2017
- TRIMEGESTONE
Glybera Amsterdam Molecular EU/1/12/791/001 Solution for injection - Alipogene tipravovec 29/10/2017
Therapeutics
CASPOFUNGIN XELLIA Xellia Pharmaceuticals ApS PA1982/004/001 Powder for concentrate for - CASPOFUNGIN 18/10/2017
solution for infusion
CASPOFUNGIN XELLIA Xellia Pharmaceuticals ApS PA1982/004/002 Powder for concentrate for - CASPOFUNGIN 18/10/2017
solution for infusion
ZOTON FASTAB LTT Pharma Limited PPA1562/001/001 Orodispersible Tablet - LANSOPRAZOLE 17/10/2017
ZOTON FASTAB LTT Pharma Limited PPA1562/001/002 Orodispersible Tablet - LANSOPRAZOLE 17/10/2017
LAMICTAL LTT Pharma Limited PPA1562/011/003 Tablets - LAMOTRIGINE 12/10/2017
CALCIUM PHOSPHORICUM Weleda (UK) Limited HOR0407/021/001 Tablets - CALCIUM 10/10/2017
(CALC. PHOS.)(6C & 30C) PHOSPHORICUM

CAUSTICUM (CAUST.)(6C & Weleda (UK) Limited HOR0407/022/001 Tablets - CAUSTICUM 10/10/2017
30C) HAHNEMANNI
CUPRUM METALLICUM Weleda (UK) Limited HOR0407/023/001 Tablets - CUPRUM METALLICUM 10/10/2017
(CUPRUM. MET.) (6C &
30C)
KALIUM BICHROMICUM Weleda (UK) Limited HOR0407/005/001 Tablets - KALIUM BICHROMICUM 10/10/2017
(KALI. BIC.) (6C & 30C)
MERCUIRIUS SOLUBILIS Weleda (UK) Limited HOR0407/006/001 Tablets - MERCURIUS SOLUBILIS 10/10/2017
HAHNEMANII (MERC. SOL.) HAHNEMANNI

CASPOFUNGIN ROWEX Rowex Ltd PA0711/249/001 Powder for concentrate for - CASPOFUNGIN 09/10/2017
solution for infusion
CASPOFUNGIN ROWEX Rowex Ltd PA0711/249/002 Powder for concentrate for - CASPOFUNGIN 09/10/2017
solution for infusion
DONEPEZIL Rosemont Pharmaceuticals PA0312/029/001 Oral Solution - DONEPEZIL 05/10/2017
HYDROCHLORIDE Ltd HYDROCHLORIDE
SUPPLYELT Laboratoire AGUETTANT PA1968/004/001 Concentrate for Soln for Inf - ZINC GLUCONATE 05/10/2017
- COPPER GLUCONATE
- MANGANESE
GLUCONATE
- SODIUM FLUORIDE
- POTASSIUM IODIDE
- SODIUM SELENITE
- FERROUS GLUCONATE
- SODIUM MOLYBDATE
2H2O
- CHROMIUM CHLORIDE
6H2O
AUDAVAL RD Auden Mckenzie (Pharma PA1352/020/003 Cream - BETAMETHASONE 04/10/2017
Division) Ltd VALERATE

Human Medicines Withdrawn Products Page 107 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MEROPENEM SANDOZ Sandoz B.V. PA1681/001/001 Pdr for Soln Inj/Inf - MEROPENEM 01/10/2017
TRIHYDRATE
MEROPENEM SANDOZ Sandoz B.V. PA1681/001/002 Pdr for Soln Inj/Inf - MEROPENEM 01/10/2017
TRIHYDRATE
ATORVASTATIN Pharmathen S.A. PA1368/013/004 Film Coated Tablet - ATORVASTATIN CALCIUM 29/09/2017
PHARMATHEN
ARICEPT Imbat Limited PPA1151/037/001 Film Coated Tablet - DONEPEZIL 27/09/2017
HYDROCHLORIDE
ARICEPT Imbat Limited PPA1151/037/002 Film Coated Tablet - DONEPEZIL 27/09/2017
HYDROCHLORIDE
APODESPAN PR Accord Healthcare Limited PA1390/042/002 Tablet Prolonged Release - CARBIDOPA 26/09/2017
- LEVODOPA
CARDURA XL Imbat Limited PPA1151/022/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 25/09/2017
ZANTAC LTT Pharma Limited PPA1562/051/003 Syrup - RANITIDINE 25/09/2017
HYDROCHLORIDE
DANCEX SR Rowex Ltd PA0711/143/005 Tablet Prolonged Release - OXYCODONE 23/09/2017
HYDROCHLORIDE
RABEPRAZOLE SODIUM Accord Healthcare Limited PA1390/048/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 22/09/2017
ARICEPT LTT Pharma Limited PPA1562/129/001 Film Coated Tablet - DONEPEZIL 20/09/2017
HYDROCHLORIDE
ARICEPT LTT Pharma Limited PPA1562/129/002 Film Coated Tablet - DONEPEZIL 20/09/2017
HYDROCHLORIDE
SELENIUM Laboratoire AGUETTANT PA1968/005/001 Concentrate for Soln for Inf - SELENIUM 20/09/2017
ZINC Laboratoire AGUETTANT PA1968/008/001 Concentrate for Soln for Inf - ZINC GLUCONATE 20/09/2017
BRUPRO FOR CHILDREN Rowex Ltd PA0711/225/001 Oral Suspension - IBUPROFEN 14/09/2017
ESCIPREX DISTAB Rowex Ltd PA0711/194/005 Orodispersible Tablet - ESCITALOPRAM 14/09/2017
OXALATE
ESCIPREX DISTAB Rowex Ltd PA0711/194/006 Orodispersible Tablet - ESCITALOPRAM 14/09/2017
OXALATE
ESCIPREX DISTAB Rowex Ltd PA0711/194/007 Orodispersible Tablet - ESCITALOPRAM 14/09/2017
OXALATE
ESCIPREX DISTAB Rowex Ltd PA0711/194/008 Orodispersible Tablet - ESCITALOPRAM 14/09/2017
OXALATE
IBUPROFEN FOR Rowex Ltd PA0711/205/001 Oral Suspension - IBUPROFEN 14/09/2017
CHILDREN
LINEZOLID Cipla (EU) Limited PA1809/023/001 Film Coated Tablet - LINEZOLID (FORM II) 14/09/2017
TOPOTECAN Fresenius Kabi Oncology Plc PA1422/005/001 Powder for concentrate for - TOPOTECAN 12/09/2017
solution for infusion HYDROCHLORIDE
TOPOTECAN Fresenius Kabi Oncology Plc PA1422/005/002 Concentrate for Soln for Inf - TOPOTECAN 12/09/2017
HYDROCHLORIDE
EQUIVALENT TO
TOPOTECAN
ZOLEDRONIC ACID Rowex Ltd PA0711/203/002 Solution for Infusion - ZOLEDRONIC ACID 06/09/2017
SANDOZ MONOHYDRATE
DYAZIDE 50MG/25MG Mercury Pharmaceuticals Ltd PA0899/009/001 Tablets - TRIAMTERENE 04/09/2017
TABLETS. - HYDROCHLOROTHIAZIDE

SINEMET PLUS LTT Pharma Limited PPA1562/023/001 Tablets - LEVODOPA 04/09/2017


- CARBIDOPA
SYMBICORT TURBOHALE LTT Pharma Limited PPA1562/165/001 Inhalation powder - BUDESONIDE 04/09/2017
- FORMOTEROL
FUMARATE DIHYDRATE
SYMBICORT TURBOHALE LTT Pharma Limited PPA1562/165/002 Inhalation powder - BUDESONIDE 04/09/2017
- FORMOTEROL
FUMARATE DIHYDRATE
ERYTHROMYCIN Amdipharm Limited PA1142/007/001 Tablets Gastro-Resistant - ERYTHROMYCIN 01/09/2017
LIDOCAINE Mercury Pharmaceuticals PA0073/112/001 Solution for Injection - LIDOCAINE 01/09/2017
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
LIDOCAINE Mercury Pharmaceuticals PA0073/112/002 Solution for Injection - LIDOCAINE 01/09/2017
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
LIDOCAINE Mercury Pharmaceuticals PA0073/112/006 Solution for Injection - LIDOCAINE 01/09/2017
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
ONDANSETRON Mercury Pharmaceuticals Ltd PA0899/030/001 Solution for Inj/Inf - ONDANSETRON 01/09/2017

PHENYTOIN SODIUM Mercury Pharmaceuticals PA0073/127/001 Solution for Injection - PHENYTOIN SODIUM 01/09/2017
(Ireland) Ltd
PROMETHAZINE Mercury Pharmaceuticals PA0073/053/004 Solution for Injection - PROMETHAZINE 01/09/2017
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
SEREVENT EVOHALER LTT Pharma Limited PPA1562/149/001 Pressurised Inhalation - SALMETEROL 01/09/2017
Suspension XINAFOATE
SODIUM CHLORIDE Mercury Pharmaceuticals PA0073/105/001 Solution for Injection - SODIUM CHLORIDE 01/09/2017
(Ireland) Ltd
TRAXAM Mercury Pharmaceuticals Ltd PA0899/019/002 Cutaneous Foam - FELBINAC 01/09/2017

Human Medicines Withdrawn Products Page 108 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
WATER FOR INJECTIONS Mercury Pharmaceuticals PA0073/107/001 Unknown - WATER FOR INJECTIONS 01/09/2017
(Ireland) Ltd
WATER FOR INJECTIONS Mercury Pharmaceuticals PA0073/107/007 Solvent for Parenteral Use - WATER FOR INJECTIONS 01/09/2017
(Ireland) Ltd
ZEPHOLIN S.R. Astellas Pharma Co. Ltd PA1241/015/001 Prolonged Release Capsules - THEOPHYLLINE 01/09/2017

ZEPHOLIN S.R. Astellas Pharma Co. Ltd PA1241/015/002 Prolonged Release Capsules - THEOPHYLLINE 01/09/2017

ZEPHOLIN S.R. Astellas Pharma Co. Ltd PA1241/015/003 Prolonged Release Capsules - THEOPHYLLINE 01/09/2017

METFORMIN LTT Pharma Limited PPA1562/137/001 Not assigned - METFORMIN 31/08/2017


HYDROCHLORIDE HYDROCHLORIDE
QUETIAPINE LTT Pharma Limited PPA1562/186/001 Film Coated Tablet - QUETIAPINE 31/08/2017
HEMIFUMARATE
QUETIAPINE LTT Pharma Limited PPA1562/186/002 Film Coated Tablet - QUETIAPINE 31/08/2017
HEMIFUMARATE
QUETIAPINE LTT Pharma Limited PPA1562/186/003 Film Coated Tablet - QUETIAPINE 31/08/2017
HEMIFUMARATE
CASODEX LTT Pharma Limited PPA1562/192/001 Film Coated Tablet - BICALUTAMIDE 30/08/2017
CEFTAZIDIME Hospira UK Limited PA0437/074/001 Pdr for Soln for Injection - CEFTAZIDIME 30/08/2017
PENTAHYDRATE
CEFTAZIDIME Hospira UK Limited PA0437/074/002 Pdr for Soln Inj/Inf - CEFTAZIDIME 30/08/2017
PENTAHYDRATE
CEFTAZIDIME Hospira UK Limited PA0437/074/003 Pdr for Soln Inj/Inf - CEFTAZIDIME 30/08/2017
PENTAHYDRATE
PROPOFOL HOSPIRA Hospira UK Limited PA0437/073/001 Emulsion for Inj/Inf - PROPOFOL 30/08/2017
ATENOGEN Mercury Pharmaceuticals PA0073/117/001 Film Coated Tablet - ATENOLOL 25/08/2017
(Ireland) Ltd
ATENOGEN Mercury Pharmaceuticals PA0073/117/002 Film Coated Tablet - ATENOLOL 25/08/2017
(Ireland) Ltd
ATENOGEN Mercury Pharmaceuticals PA0073/117/003 Tablets - ATENOLOL 25/08/2017
(Ireland) Ltd
CHLOROMYCETIN 1% W/W Mercury Pharmaceuticals Ltd PA0899/028/001 Eye Ointment - CHLORAMPHENICOL 25/08/2017
OPHTHALMIC OINTMENT

FUCITHALMIC Amdipharm Limited PA1142/016/002 Eye Drops Suspension - FUSIDIC ACID 25/08/2017
PROVIGIL LTT Pharma Limited PPA1562/041/002 Tablets - MODAFINIL 23/08/2017
LAMICTAL LTT Pharma Limited PPA1562/011/001 Tablets - LAMOTRIGINE 22/08/2017
LAMICTAL LTT Pharma Limited PPA1562/011/002 Tablets - LAMOTRIGINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/001 Film Coated Tablet - OLANZAPINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/002 Film Coated Tablet - OLANZAPINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/003 Film Coated Tablet - OLANZAPINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/004 Film Coated Tablet - OLANZAPINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/005 Film Coated Tablet - OLANZAPINE 22/08/2017
OLANZAPINE Chanelle Medical PA0688/023/006 Film Coated Tablet - OLANZAPINE 22/08/2017
QVAR Norton Waterford PA0436/035/001 Pressurised Inhalation Soln - BECLOMETASONE 18/08/2017
DIPROPIONATE
QVAR Norton Waterford PA0436/035/002 Pressurised Inhalation Soln - BECLOMETASONE 18/08/2017
DIPROPIONATE
QVAR AUTOHALER Norton Waterford PA0436/035/003 Pressurised Inhalation Soln - BECLOMETASONE 18/08/2017
DIPROPIONATE
QVAR AUTOHALER Norton Waterford PA0436/035/004 Pressurised Inhalation Soln - BECLOMETASONE 18/08/2017
DIPROPIONATE
RABEPRAZOLE CLONMEL Clonmel Healthcare Ltd PA0126/252/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 18/08/2017
RABEPRAZOLE CLONMEL Clonmel Healthcare Ltd PA0126/252/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 18/08/2017
TEVICON Teva Pharma B.V. PA0749/146/001 Powder for Oral Solution - MACROGOL 3350 18/08/2017
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- SODIUM HYDROGEN
CARBONATE
ZYCRON MR Clonmel Healthcare Ltd PA0126/248/001 Modified-release Tablets - GLICLAZIDE 18/08/2017
DIFFLAM SPRAY Imbat Limited PPA1151/127/001 Oromucosal spray, solution - BENZYDAMINE 15/08/2017
HYDROCHLORIDE
FENILABIAL GlaxoSmithKline Consumer PA0678/141/001 Film Coated Tablet - FAMCICLOVIR 15/08/2017
Healthcare (Ireland) Limited
IVIVERZ Actavis Group PTC ehf PA1380/192/001 Film Coated Tablet - LAMIVUDINE 15/08/2017
TOPAMAX LTT Pharma Limited PPA1562/111/001 Film Coated Tablet - TOPIRAMATE 10/08/2017
CEFTRIAXONE HOSPIRA Hospira UK Limited PA0437/070/001 Pdr for Soln for Injection - CEFTRIAXONE SODIUM 09/08/2017

Human Medicines Withdrawn Products Page 109 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMINOVEN 3.5% Fresenius Kabi Limited PA0566/014/001 Solution for Infusion - TYROSINE 08/08/2017
GLUCOSE/ELECTROLYTE - ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE, ACTIVE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- ALANINE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TAURINE
- GLUCOSE
MONOHYDRATE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- ZINC CHLORIDE
CREON McDowell Pharmaceuticals PPA1473/018/001 Capsules Gastro-Resistant - PANCREATIN 04/08/2017
CREON 10000 McDowell Pharmaceuticals PPA1473/018/002 Capsules Gastro-Resistant 04/08/2017
IMURAN McDowell Pharmaceuticals PPA1473/007/002 Film Coated Tablet - AZATHIOPRINE 04/08/2017
ISTIN McDowell Pharmaceuticals PPA1473/041/001 Tablets - AMLODIPINE BESYLATE 04/08/2017
ISTIN McDowell Pharmaceuticals PPA1473/041/002 Tablets - AMLODIPINE BESYLATE 04/08/2017
LAMICTAL McDowell Pharmaceuticals PPA1473/050/001 Tablets - LAMOTRIGINE 04/08/2017
LAMICTAL McDowell Pharmaceuticals PPA1473/050/002 Tablets - LAMOTRIGINE 04/08/2017
OXALIPLATIN HOSPIRA Hospira UK Limited PA0437/056/001 Powder for solution for - OXALIPLATIN 04/08/2017
infusion
TELFAST McDowell Pharmaceuticals PPA1473/052/001 Film Coated Tablet - FEXOFENADINE 04/08/2017
HYDROCHLORIDE
XATRAL McDowell Pharmaceuticals PPA1473/013/001 Tablet Prolonged Release - ALFUZOSIN 04/08/2017
HYDROCHLORIDE
ZANTAC McDowell Pharmaceuticals PPA1473/009/001 Film Coated Tablet - RANITIDINE 04/08/2017
HYDROCHLORIDE
ZOTON FASTAB McDowell Pharmaceuticals PPA1473/004/001 Orodispersible Tablet - LANSOPRAZOLE 04/08/2017
ZOTON FASTAB McDowell Pharmaceuticals PPA1473/004/002 Orodispersible Tablet - LANSOPRAZOLE 04/08/2017
NICOTINELL FRUITY MINT GlaxoSmithKline Consumer PA0678/142/001 Lozenges - NICOTINE BITARTRATE 03/08/2017
Healthcare (Ireland) Limited DIHYDRATE
NICOTINELL FRUITY MINT GlaxoSmithKline Consumer PA0678/142/002 Lozenges - NICOTINE BITARTRATE 03/08/2017
Healthcare (Ireland) Limited DIHYDRATE
LEVETIRACETAM CIPLA Cipla (EU) Limited PA1809/012/001 Film Coated Tablet - LEVETIRACETAM 24/07/2017
LEVETIRACETAM CIPLA Cipla (EU) Limited PA1809/012/002 Film Coated Tablet - LEVETIRACETAM 24/07/2017
LEVETIRACETAM CIPLA Cipla (EU) Limited PA1809/012/003 Film Coated Tablet - LEVETIRACETAM 24/07/2017
LEVETIRACETAM CIPLA Cipla (EU) Limited PA1809/012/004 Film Coated Tablet - LEVETIRACETAM 24/07/2017
ENZEPI Allergan Pharmaceuticals EU/1/16/1113/001-004 Capsules Gastro-Resistant - PANCREAS POWDER 19/07/2017
International Limited
ENZEPI Allergan Pharmaceuticals EU/1/16/1113/005-008 Capsules Gastro-Resistant - PANCREAS POWDER 19/07/2017
International Limited
ENZEPI Allergan Pharmaceuticals EU/1/16/1113/009-012 Capsules Gastro-Resistant - PANCREAS POWDER 19/07/2017
International Limited
ENZEPI Allergan Pharmaceuticals EU/1/16/1113/013-016 Capsules Gastro-Resistant - PANCREAS POWDER 19/07/2017
International Limited
STREPSILS COOL Reckitt Benckiser Ireland Ltd PA0979/038/001 Lozenges - AMYLMETACRESOL 18/07/2017
- DICHLOROBENZYL
ALCOHOL
STREPSILS LOZENGES Reckitt Benckiser Ireland Ltd PA0979/062/001 Lozenges - AMYLMETACRESOL 18/07/2017
FOR ADULTS AND - 2, 4-DICHLOROBENZYL
CHILDREN OVER SIX ALCOHOL
STREPSILS WITH VITAMIN Reckitt Benckiser Ireland Ltd PA0979/039/002 Lozenges - AMYLMETACRESOL 18/07/2017
C - 2, 4-DICHLOROBENZYL
ALCOHOL
- ASCORBIC ACID
REPSO Teva B.V. EU/1/11/674/001-005 Film Coated Tablet - LEFLUNOMIDE 17/07/2017
LATANOPROST/TIMOLOL Actavis Group PTC ehf PA1380/149/001 Eye Drops Solution - LATANOPROST 12/07/2017
- TIMOLOL MALEATE
PARACETAMOL Teva Pharma B.V. PA0749/145/001 Solution for Infusion - PARACETAMOL 12/07/2017
STERILLIUM Bode Chemie GmbH PA0808/001/001 Cutaneous Solution - PROPAN-2-OL 10/07/2017
- PROPANOL
- MECETRONIUM
ETILSULFATE

Human Medicines Withdrawn Products Page 110 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GLAUCOTIMA PharmaSwiss Ceska PA1696/003/001 Eye Drops Solution - LATANOPROST 07/07/2017
republika s.r.o. - TIMOLOL MALEATE
IMODEX PLUS Rowex Ltd PA0711/238/001 Tablets - LOPERAMIDE 06/07/2017
HYDROCHLORIDE
- DIMETICONE, ACTIVATED

LEVETIRACETAM Milpharm Limited PA1050/003/001 Film Coated Tablet - LEVETIRACETAM 05/07/2017


AUROBINDO
LEVETIRACETAM Milpharm Limited PA1050/003/002 Film Coated Tablet - LEVETIRACETAM 05/07/2017
AUROBINDO
LEVETIRACETAM Milpharm Limited PA1050/003/004 Film Coated Tablet - LEVETIRACETAM 05/07/2017
AUROBINDO
AMLODIPINE AUROBINDO Milpharm Limited PA1050/005/001 Tablets - AMLODIPINE BESILATE 03/07/2017
AMLODIPINE AUROBINDO Milpharm Limited PA1050/005/002 Tablets - AMLODIPINE BESILATE 03/07/2017
ARIPIPRAZOLE MILPHARM Milpharm Limited PA1050/026/001 Tablets - ARIPIPRAZOLE 03/07/2017

ARIPIPRAZOLE MILPHARM Milpharm Limited PA1050/026/002 Tablets - ARIPIPRAZOLE 03/07/2017

ARIPIPRAZOLE MILPHARM Milpharm Limited PA1050/026/003 Tablets - ARIPIPRAZOLE 03/07/2017

ARIPIPRAZOLE MILPHARM Milpharm Limited PA1050/026/004 Tablets - ARIPIPRAZOLE 03/07/2017

CO-AMOXICLAV Aurobindo Pharma Limited PA1311/016/001 Film Coated Tablet - AMOXICILLIN 03/07/2017
AUROBINDO TRIHYDRATE
- POTASSIUM
CLAVULANATE, DILUTED
(WITH
MICROCRYSTALLINE
CELLULOSE IN A RATIO OF
1:1)
Co-Amoxiclav Aurobindo Aurobindo Pharma Limited PA1311/016/002 Film-coated tablet - Amoxicillin trihydrate 03/07/2017
- Potassium clavulanate,
diluted (with microcrystalline
cellulose in a ratio of 1:1)
LAMOTRIGINE Milpharm Limited PA1050/009/001 Dispersable Tablet - LAMOTRIGINE 03/07/2017
AUROBINDO
LAMOTRIGINE Milpharm Limited PA1050/009/002 Dispersable Tablet - LAMOTRIGINE 03/07/2017
AUROBINDO
LAMOTRIGINE Milpharm Limited PA1050/009/003 Dispersable Tablet - LAMOTRIGINE 03/07/2017
AUROBINDO
LAMOTRIGINE Milpharm Limited PA1050/009/004 Dispersable Tablet - LAMOTRIGINE 03/07/2017
AUROBINDO
LAMOTRIGINE Milpharm Limited PA1050/009/005 Dispersable Tablet - LAMOTRIGINE 03/07/2017
AUROBINDO
LEVETIRACETAM Milpharm Limited PA1050/003/003 Film Coated Tablet - LEVETIRACETAM 03/07/2017
AUROBINDO
LOSARTAN POTASSIUM Milpharm Limited PA1050/025/001 Film Coated Tablet - LOSARTAN POTASSIUM 03/07/2017
MILPHARM
LOSARTAN POTASSIUM Milpharm Limited PA1050/025/002 Film Coated Tablet - LOSARTAN POTASSIUM 03/07/2017
MILPHARM
OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/007 Orodispersible Tablet - OLANZAPINE 03/07/2017

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/008 Orodispersible Tablet - OLANZAPINE 03/07/2017

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/009 Orodispersible Tablet - OLANZAPINE 03/07/2017

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/010 Orodispersible Tablet - OLANZAPINE 03/07/2017

PAROXETINE AUROBINDO Aurobindo Pharma Limited PA1311/002/001 Film Coated Tablet - PAROXETINE 03/07/2017

Paroxetine Aurobindo Aurobindo Pharma Limited PA1311/002/002 Film-coated tablet - Paroxetine 03/07/2017
PRAMIPEXOLE Milpharm Limited PA1050/011/001 Tablets - PRAMIPEXOLE 03/07/2017
AUROBINDO DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE Milpharm Limited PA1050/011/002 Tablets - PRAMIPEXOLE 03/07/2017
AUROBINDO DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE Milpharm Limited PA1050/011/003 Tablets - PRAMIPEXOLE 03/07/2017
AUROBINDO DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE Milpharm Limited PA1050/011/004 Tablets - PRAMIPEXOLE 03/07/2017
AUROBINDO DIHYDROCHLORIDE
MONOHYDRATE
RABEPRAZOLE Milpharm Limited PA1050/010/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 03/07/2017
AUROBINDO

Human Medicines Withdrawn Products Page 111 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RABEPRAZOLE Milpharm Limited PA1050/010/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 03/07/2017
AUROBINDO
RISEDRONATE Milpharm Limited PA1050/008/001 Film Coated Tablet - RISEDRONATE SODIUM 03/07/2017
AUROBINDO
RISEDRONATE Milpharm Limited PA1050/008/002 Film Coated Tablet - RISEDRONATE SODIUM 03/07/2017
AUROBINDO
ROMEP Milpharm Limited PA1050/015/001 Capsules Gastro-Resistant - OMEPRAZOLE 03/07/2017
ROMEP Milpharm Limited PA1050/015/002 Capsules Gastro-Resistant - OMEPRAZOLE 03/07/2017
ROMEP Milpharm Limited PA1050/015/003 Capsules Gastro-Resistant - OMEPRAZOLE 03/07/2017
VALSARTAN AUROBINDO Milpharm Limited PA1050/018/001 Film Coated Tablet - VALSARTAN 03/07/2017
VALSARTAN AUROBINDO Milpharm Limited PA1050/018/002 Film Coated Tablet - VALSARTAN 03/07/2017
VALSARTAN AUROBINDO Milpharm Limited PA1050/018/003 Film Coated Tablet - VALSARTAN 03/07/2017
VALSARTAN AUROBINDO Milpharm Limited PA1050/018/004 Film Coated Tablet - VALSARTAN 03/07/2017
VALSARTAN/HYDROCHLO Milpharm Limited PA1050/016/004 Film Coated Tablet - VALSARTAN 03/07/2017
ROTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE

VALSARTAN/HYDROCHLO Milpharm Limited PA1050/016/005 Film Coated Tablet - VALSARTAN 03/07/2017


ROTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE

CARMEN Clonmel Healthcare Ltd PA0126/254/001 Film Coated Tablet - DROSPIRENONE 29/06/2017
- ETHINYL ESTRADIOL
CARMENELLE Clonmel Healthcare Ltd PA0126/253/001 Film Coated Tablet - DROSPIRENONE 29/06/2017
- ETHINYLESTRADIOL
Invega ((Note - this EU # to Janssen-Cilag International EU/1/07/395/077-95 Prolonged-release tablet - Paliperidone 29/06/2017
be deleted as result of NV
variation at EOP KH
29.06.2017))
ZANIDIP LTT Pharma Limited PPA1562/021/001 Film Coated Tablet - LERCANIDIPINE 26/06/2017
ZANIDIP LTT Pharma Limited PPA1562/021/002 Film Coated Tablet - LERCANIDIPINE 26/06/2017
ARCOXIA IMED Healthcare Ltd. DPR1463/020/001 Film Coated Tablet - ETORICOXIB 23/06/2017
ARCOXIA IMED Healthcare Ltd. DPR1463/020/002 Film Coated Tablet - ETORICOXIB 23/06/2017
ARCOXIA IMED Healthcare Ltd. DPR1463/020/003 Film Coated Tablet - ETORICOXIB 23/06/2017
AVELOX LTT Pharma Limited PPA1562/158/001 Film Coated Tablet - MOXIFLOXACIN 23/06/2017
HYDROCHLORIDE
COLOMYCIN IMED Healthcare Ltd. DPR1463/043/001 Pdr for Soln Inj/Inf - COLISTIN MESILATE 23/06/2017
SODIUM
ACERYCAL IMED Healthcare Ltd. PPA1463/065/001 Tablets - PERINDOPRIL ARGININE 20/06/2017
- AMLODIPINE
ACERYCAL IMED Healthcare Ltd. PPA1463/065/002 Tablets - PERINDOPRIL ARGININE 20/06/2017
- AMLODIPINE
ACERYCAL IMED Healthcare Ltd. PPA1463/065/003 Tablets - PERINDOPRIL ARGININE 20/06/2017
- AMLODIPINE
ACERYCAL IMED Healthcare Ltd. PPA1463/065/004 Tablets - PERINDOPRIL ARGININE 20/06/2017
- AMLODIPINE
COVERSYL ARGININE IMED Healthcare Ltd. PPA1463/024/001 Film Coated Tablet - PERINDOPRIL ARGININE 20/06/2017
COVERSYL ARGININE IMED Healthcare Ltd. PPA1463/024/002 Film Coated Tablet - PERINDOPRIL ARGININE 20/06/2017
COVERSYL ARGININE IMED Healthcare Ltd. PPA1463/039/002 Film Coated Tablet - PERINDOPRIL ARGININE 20/06/2017
PLUS - INDAPAMIDE
DETRUSITOL SR IMED Healthcare Ltd. PPA1463/040/001 Prolonged Release Capsules - TOLTERODINE 20/06/2017
TARTRATE
DETRUSITOL SR IMED Healthcare Ltd. PPA1463/078/001 Prolonged Release Capsules - TOLTERODINE TARTARE 20/06/2017

DOVOBET OINTMENT IMED Healthcare Ltd. PPA1463/022/001 Ointment - CALCIPOTRIOL 20/06/2017


- BETAMETHASONE
DOVONEX IMED Healthcare Ltd. PPA1463/020/001 Cream - CALCIPOTRIOL 20/06/2017
ISTIN IMED Healthcare Ltd. PPA1463/010/001 Tablets - AMLODIPINE BESYLATE 20/06/2017
IXPRIM IMED Healthcare Ltd. PPA1463/052/001 Film Coated Tablet - TRAMADOL 20/06/2017
HYDROCHLORIDE
- PARACETAMOL
KERAL IMED Healthcare Ltd. PPA1463/089/001 Film Coated Tablet - DEXKETOPROFEN 20/06/2017
LUSTRAL IMED Healthcare Ltd. PPA1463/026/001 Film Coated Tablet - SERTRALINE 20/06/2017
HYDROCHLORIDE
LUSTRAL IMED Healthcare Ltd. PPA1463/026/002 Film Coated Tablet - SERTRALINE 20/06/2017
HYDROCHLORIDE
NORIDAY IMED Healthcare Ltd. PPA1463/073/001 Tablets - NORETHISTERONE 20/06/2017
PROTIUM IMED Healthcare Ltd. PPA1463/008/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 20/06/2017
SESQUIHYDRATE

PROTIUM IMED Healthcare Ltd. PPA1463/008/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 20/06/2017
SESQUIHYDRATE

PULMICORT TURBOHALER IMED Healthcare Ltd. PPA1463/061/001 Inhalation powder - BUDESONIDE 20/06/2017

SEROQUEL IMED Healthcare Ltd. PPA1463/048/001 Film Coated Tablet - QUETIAPINE FUMARATE 20/06/2017
SEROQUEL IMED Healthcare Ltd. PPA1463/048/002 Film Coated Tablet - QUETIAPINE FUMARATE 20/06/2017

Human Medicines Withdrawn Products Page 112 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SEROQUEL IMED Healthcare Ltd. PPA1463/048/003 Film Coated Tablet - QUETIAPINE FUMARATE 20/06/2017
ZANIDIP IMED Healthcare Ltd. PPA1463/016/001 Film Coated Tablet - LERCANIDIPINE 20/06/2017
HYDROCHLORIDE
ZANIDIP IMED Healthcare Ltd. PPA1463/016/002 Film Coated Tablet - LERCANIDIPINE HCI 20/06/2017
BIVALIRUDIN CIPLA Cipla (EU) Limited PA1809/024/001 Powder for concentrate for - BIVALIRUDIN 19/06/2017
solution for injection/infusion
IMATINIB Cipla (EU) Limited PA1809/017/001 Capsules Hard - IMATINIB MESILATE 19/06/2017
IMATINIB Cipla (EU) Limited PA1809/017/002 Capsules Hard - IMATINIB MESILATE 19/06/2017
CLOPIDOGREL TEVA HCS bvba EU/1/09/561/001-9 Film Coated Tablet - CLOPIDOGREL 15/06/2017
PHARMA HYDROCHLORIDE
OMEPRAZOLE Accord Healthcare Limited PA1390/058/001 Capsules Gastro-Resistant - OMEPRAZOLE 09/06/2017
OMEPRAZOLE Accord Healthcare Limited PA1390/058/002 Capsules Gastro-Resistant - OMEPRAZOLE 09/06/2017
REMOVAB Fresenius Biotech GmbH EU/1/09/512/001 Concentrate for Soln for Inf - CATUMAXOMAB 02/06/2017
REMOVAB Fresenius Biotech GmbH EU/1/09/512/002 Concentrate for Soln for Inf - CATUMAXOMAB 02/06/2017
EMCOLOL McDermott Laboratories Ltd PA0577/038/001 Film Coated Tablet - BISOPROLOL FUMARATE 28/05/2017
t/a Gerard Laboratories
MEDICAL OXYGEN Air Products Ireland Limited PA1075/001/001 Inhalation vapour, liquid - OXYGEN 26/05/2017
Rosuvastatin Aurobindo 40 Milpharm Limited PA1050/012/004 Film-coated tablet - Rosuvastatin (as calcium) 24/05/2017
mg film-coated tablets
PRAVASTATIN SODIUM Milpharm Limited PA1050/013/001 Tablets - PRAVASTATIN SODIUM 20/05/2017
AUROBINDO
PRAVASTATIN SODIUM Milpharm Limited PA1050/013/002 Tablets - PRAVASTATIN SODIUM 20/05/2017
AUROBINDO
PRAVASTATIN SODIUM Milpharm Limited PA1050/013/003 Tablets - PRAVASTATIN SODIUM 20/05/2017
AUROBINDO
PREGABALIN MILPHARM Milpharm Limited PA1050/027/001 Capsules Hard - PREGABALIN 20/05/2017
PREGABALIN MILPHARM Milpharm Limited PA1050/027/002 Capsules Hard - PREGABALIN 20/05/2017
PREGABALIN MILPHARM Milpharm Limited PA1050/027/003 Capsules Hard - PREGABALIN 20/05/2017
PREGABALIN MILPHARM Milpharm Limited PA1050/027/004 Capsules Hard - PREGABALIN 20/05/2017
PREGABALIN MILPHARM Milpharm Limited PA1050/027/005 Capsules Hard - PREGABALIN 20/05/2017
PREGABALIN MILPHARM Milpharm Limited PA1050/027/006 Capsules Hard - PREGABALIN 20/05/2017
RAMIPRIL AUROBINDO Aurobindo Pharma (Malta) PA1445/009/001 Tablets - RAMIPRIL 20/05/2017
Limited
RAMIPRIL AUROBINDO Aurobindo Pharma (Malta) PA1445/009/002 Tablets - RAMIPRIL 20/05/2017
Limited
ROSUVASTATIN Milpharm Limited PA1050/012/001 Film Coated Tablet - ROSUVASTATIN (AS 20/05/2017
AUROBINDO CALCIUM)
ROSUVASTATIN Milpharm Limited PA1050/012/002 Film Coated Tablet - ROSUVASTATIN (AS 20/05/2017
AUROBINDO CALCIUM)
ROSUVASTATIN Milpharm Limited PA1050/012/003 Film Coated Tablet - ROSUVASTATIN (AS 20/05/2017
AUROBINDO CALCIUM)
BETAHECON BGP Products Ltd PA2007/001/001 Tablets - BETAHISTINE 16/05/2017
DIHYDROCHLORIDE
BETAHECON BGP Products Ltd PA2007/001/002 Tablets - BETAHISTINE 16/05/2017
DIHYDROCHLORIDE
FEMUREST-CONTI BGP Products Ltd PA2007/009/001 Film Coated Tablet - ESTRADIOL 16/05/2017
HEMIHYDRATE
- DYDROGESTERONE
Imprida Novartis Europharm Limited EU/1/06/373/001-008 Film-coated tablet - Amlodipine besylate 16/05/2017
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/009-016 Film-coated tablet - Amlodipine besylate 16/05/2017
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/017-024 Film-coated tablet - Amlodipine besylate 16/05/2017
- Valsartan
EXTRANEAL CLEAR-FLEX Baxter Healthcare Limited PA0167/088/002 Soln for Peritoneal Dialysis - ICODEXTRIN 05/05/2017
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM (S)-LACTATE
SOLUTION

Human Medicines Withdrawn Products Page 113 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NUTRINEAL PD4 1.1% Baxter Healthcare Limited PA0167/086/009 Soln for Peritoneal Dialysis - TYROSINE 05/05/2017
AMINO ACIDS CLEAR-FLE - TRYPTOPHAN, L-
- PHENYLALANINE
- THREONINE
- SERINE
- PROLINE
- AMINOACETIC ACID
- ALANINE
- VALINE
- DL-METHIONINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- HISTIDINE
- ARGININE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
- SODIUM CHLORIDE
CLONAMOX Clonmel Healthcare Ltd PA0126/031/001 Capsule - AMOXICILLIN 04/05/2017
TRIHYDRATE
CLONAMOX Clonmel Healthcare Ltd PA0126/031/002 Capsule - AMOXICILLIN 04/05/2017
TRIHYDRATE
CLONAMOX Clonmel Healthcare Ltd PA0126/031/003 Powder for Oral Suspension - AMOXICILLIN 04/05/2017
TRIHYDRATE
CLONAMOX Clonmel Healthcare Ltd PA0126/031/004 Powder for Oral Suspension - AMOXICILLIN 04/05/2017
TRIHYDRATE
ZANTAC LTT Pharma Limited PPA1562/051/001 Film Coated Tablet - RANITIDINE 02/05/2017
HYDROCHLORIDE
ZANTAC LTT Pharma Limited PPA1562/051/002 Film Coated Tablet - RANITIDINE 02/05/2017
HYDROCHLORIDE
ARIPIL OROTAB McDermott Laboratories Ltd PA0577/099/003 Orodispersible Tablet - DONEPEZIL 28/04/2017
t/a Gerard Laboratories HYDROCHLORIDE
ARIPIL OROTAB McDermott Laboratories Ltd PA0577/099/004 Orodispersible Tablet - DONEPEZIL 28/04/2017
t/a Gerard Laboratories HYDROCHLORIDE
BENIFEMA Actavis Group PTC ehf PA1380/137/001 Film Coated Tablet - DESOGESTREL 28/04/2017
- ETHINYLESTRADIOL
BISOPROLOL McDermott Laboratories Ltd PA0577/154/001 Film Coated Tablet - BISOPROLOL FUMARATE 28/04/2017
t/a Gerard Laboratories
BISOPROLOL McDermott Laboratories Ltd PA0577/154/002 Film Coated Tablet - BISOPROLOL FUMARATE 28/04/2017
t/a Gerard Laboratories
CEFOTAXIME Teva Pharma B.V. PA0749/012/001 Pdr for Soln for Injection - CEFOTAXIME SODIUM 28/04/2017
CEFOTAXIME Teva Pharma B.V. PA0749/012/002 Pdr for Soln for Injection - CEFOTAXIME SODIUM 28/04/2017
CELECOXIB Generics (UK) Limited PA0405/071/001 Capsules Hard - CELECOXIB 28/04/2017
CELECOXIB Generics (UK) Limited PA0405/071/002 Capsules Hard - CELECOXIB 28/04/2017
CLOBAVATE Auden Mckenzie (Pharma PA1352/019/002 Ointment - CLOBETASONE 28/04/2017
Division) Ltd BUTYRATE
DESOGESTREL/ETHINYLE Actavis Group PTC ehf PA1380/136/001 Film Coated Tablet - DESOGESTREL 28/04/2017
STRADIOL ACTAVIS MICRONIZED
- ETHINYLESTRADIOL
MICRONIZED
EMCOLOL 10 MG McDermott Laboratories Ltd PA0577/038/002 Film Coated Tablet - BISOPROLOL FUMARATE 28/04/2017
t/a Gerard Laboratories
EPTIFIBATIDE STRIDES Generics (UK) Limited PA0405/086/001 Solution for Infusion - EPTIFIBATIDE 28/04/2017
EPTIFIBATIDE STRIDES Generics (UK) Limited PA0405/086/002 Solution for Injection - EPTIFIBATIDE 28/04/2017
FLUCLOXACILLIN Norton Healthcare Limited PA0282/041/001 Capsule - FLUCLOXACILLIN 28/04/2017
T/A IVAX Pharmaceuticals SODIUM
UK
FLUCLOXACILLIN Norton Healthcare Limited PA0282/041/002 Capsule - FLUCLOXACILLIN 28/04/2017
T/A IVAX Pharmaceuticals SODIUM
UK
FLUDARABINE Pharmachemie BV PA0937/006/001 Concentrate for Soln for Inj - FLUDARABINE 28/04/2017
PHOSPHATE PHOSPHATE
FLYNISE Actavis Group PTC ehf PA1380/162/001 Orodispersible Tablet - DESLORATIDINE 28/04/2017
GERICARB Generics (UK) Limited PA0405/016/001 Tablets - CARBAMAZEPINE 28/04/2017
GERICARB Generics (UK) Limited PA0405/016/002 Tablets - CARBAMAZEPINE 28/04/2017
GERIFLOX Generics (UK) Limited PA0405/010/001 Capsule - FLUCLOXACILLIN 28/04/2017
SODIUM
IBUPROFEN McDermott Laboratories Ltd PA0577/177/001 Film Coated Tablet - IBUPROFEN LYSINE 28/04/2017
t/a Gerard Laboratories
IBUPROFEN McDermott Laboratories Ltd PA0577/177/002 Film Coated Tablet - IBUPROFEN LYSINE 28/04/2017
t/a Gerard Laboratories
KLARIGER McDermott Laboratories Ltd PA0577/093/001 Film Coated Tablet - CLARITHROMYCIN 28/04/2017
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 114 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LAMOT McDermott Laboratories Ltd PA0577/077/001 Tablets - LAMOTRIGINE 28/04/2017
t/a Gerard Laboratories
LAMOT McDermott Laboratories Ltd PA0577/077/002 Tablets - LAMOTRIGINE 28/04/2017
t/a Gerard Laboratories
LAMOT McDermott Laboratories Ltd PA0577/077/003 Tablets - LAMOTRIGINE 28/04/2017
t/a Gerard Laboratories
LATANOPROST/TIMOLOL Generics (UK) Limited PA0405/070/001 Eye Drops Solution - LATANOPROST 28/04/2017
- TIMOLOL
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/001 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/002 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/003 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/004 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/005 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/006 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVODOPA/CARBIDOPA/E Teva Pharma B.V. PA0749/206/007 Film Coated Tablet - LEVODOPA 28/04/2017
NTACAPONE TEVA - CARBIDOPA
- ENTACAPONE
LEVOFLOXACIN Generics (UK) Limited PA0405/056/001 Solution for Infusion - LEVOFLOXACIN 28/04/2017
LEVOFLOXACIN Generics (UK) Limited PA0405/056/002 Solution for Infusion - LEVOFLOXACIN 28/04/2017
METOP Generics (UK) Limited PA0405/024/001 Tablets - METOPROLOL TARTRATE 28/04/2017

METOP Generics (UK) Limited PA0405/024/002 Tablets - METOPROLOL TARTRATE 28/04/2017

MIRTAZAPIN TEVA Teva Pharma B.V. PA0749/017/001 Orodispersible Tablet - MIRTAZAPINE 28/04/2017
MIRTAZAPIN TEVA Teva Pharma B.V. PA0749/017/002 Orodispersible Tablet - MIRTAZAPINE 28/04/2017
MIRTAZAPIN TEVA Teva Pharma B.V. PA0749/017/003 Orodispersible Tablet - MIRTAZAPINE 28/04/2017
MYLAFENT Generics (UK) Limited PA0405/061/001 Transdermal Patch - FENTANYL 28/04/2017
MYLAFENT Generics (UK) Limited PA0405/061/002 Transdermal Patch - FENTANYL 28/04/2017
MYLAFENT Generics (UK) Limited PA0405/061/003 Transdermal Patch - FENTANYL 28/04/2017
MYLAFENT Generics (UK) Limited PA0405/061/004 Transdermal Patch - FENTANYL 28/04/2017
MYLAFENT Generics (UK) Limited PA0405/061/005 Transdermal Patch - FENTANYL 28/04/2017
OLANZAPINE MYLAN McDermott Laboratories Ltd PA0577/166/001 Orodispersible Tablet - OLANZAPINE 28/04/2017
t/a Gerard Laboratories
OLANZAPINE MYLAN McDermott Laboratories Ltd PA0577/166/002 Orodispersible Tablet - OLANZAPINE 28/04/2017
t/a Gerard Laboratories
OLANZAPINE MYLAN McDermott Laboratories Ltd PA0577/166/003 Orodispersible Tablet - OLANZAPINE 28/04/2017
t/a Gerard Laboratories
OLANZAPINE MYLAN McDermott Laboratories Ltd PA0577/166/004 Orodispersible Tablet - OLANZAPINE 28/04/2017
t/a Gerard Laboratories
OLMESARTAN McDermott Laboratories Ltd PA0577/175/001 Film Coated Tablet - OLMESARTAN 28/04/2017
MEDOXOMIL/HYDROCHLO t/a Gerard Laboratories MEDOXOMIL
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

OLMESARTAN McDermott Laboratories Ltd PA0577/175/002 Film Coated Tablet - OLMESARTAN 28/04/2017
MEDOXOMIL/HYDROCHLO t/a Gerard Laboratories MEDOXOMIL
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

OLMESARTAN McDermott Laboratories Ltd PA0577/175/003 Film Coated Tablet - OLMESARTAN 28/04/2017
MEDOXOMIL/HYDROCHLO t/a Gerard Laboratories MEDOXOMIL
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

OLMESARTAN McDermott Laboratories Ltd PA0577/175/004 Film Coated Tablet - OLMESARTAN 28/04/2017
MEDOXOMIL/HYDROCHLO t/a Gerard Laboratories MEDOXOMIL
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

OXALIPLATIN Generics (UK) Limited PA0405/078/001 Concentrate for Soln for Inf - OXALIPLATIN 28/04/2017
OXALIPLATIN Actavis Group PTC ehf PA1380/095/001 Concentrate for Soln for Inf - OXALIPLATIN 28/04/2017
PREGABALIN TEVA Teva B.V. PA1986/001/007 Capsules Hard - PREGABALIN 28/04/2017
RABEPRAZOLE McDermott Laboratories Ltd PA0577/179/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/04/2017
t/a Gerard Laboratories
RABEPRAZOLE McDermott Laboratories Ltd PA0577/179/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/04/2017
t/a Gerard Laboratories
RABEPRAZOLE McDermott Laboratories Ltd PA0577/158/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/04/2017
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 115 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RABEPRAZOLE McDermott Laboratories Ltd PA0577/158/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/04/2017
t/a Gerard Laboratories
TELMISARTAN/HYDROCH McDermott Laboratories Ltd PA0577/170/001 Tablets - TELMISARTAN 28/04/2017
LOROTHIAZIDE MYLAN t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

TELMISARTAN/HYDROCH McDermott Laboratories Ltd PA0577/170/002 Tablets - TELMISARTAN 28/04/2017


LOROTHIAZIDE MYLAN t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

TELMISARTAN/HYDROCH McDermott Laboratories Ltd PA0577/170/003 Tablets - TELMISARTAN 28/04/2017


LOROTHIAZIDE MYLAN t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

VORINA Pharmachemie BV PA0937/005/001 Solution for Injection - FOLINIC ACID 28/04/2017


NIQUITIN MINIS CHERRY Chefaro Ireland DAC PA1186/018/014 Lozenges - NICOTINE RESINATE 21/04/2017
FLAVOUR
NIQUITIN MINIS CHERRY Chefaro Ireland DAC PA1186/018/015 Lozenges - NICOTINE RESINATE 21/04/2017
FLAVOUR
EXIMINE XL Clonmel Healthcare Ltd PA0126/250/001 Transdermal Patch - RIVASTIGMINE BASE 19/04/2017
EXIMINE XL Clonmel Healthcare Ltd PA0126/250/002 Transdermal Patch - RIVASTIGMINE BASE 19/04/2017
FLUCLON Clonmel Healthcare Ltd PA0126/063/001 Capsules Hard - FLUCLOXACILLIN 19/04/2017
SODIUM
FLUCLON Clonmel Healthcare Ltd PA0126/063/002 Capsules Hard - FLUCLOXACILLIN 19/04/2017
SODIUM
CEFUROXIME AUROBINDO Milpharm Limited PA1050/021/001 Tablets - CEFUROXIME AXETIL 13/04/2017

CEFUROXIME AUROBINDO Milpharm Limited PA1050/021/002 Tablets - CEFUROXIME AXETIL 13/04/2017

CEFUROXIME AUROBINDO Milpharm Limited PA1050/021/003 Tablets - CEFUROXIME AXETIL 13/04/2017

ZISPIN NV Organon PA0964/007/003 Film Coated Tablet - MIRTAZAPINE 11/04/2017


ZISPIN Merck Sharp & Dohme PA1286/047/004 Not assigned - MIRTAZAPINE 11/04/2017
Ireland (Human Health)
Limited
OPTIVATE Bio Products Laboratory PA0763/002/001 Pdr+Solv for Soln for Inj - FACTOR VIII 10/04/2017
Limited (ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
OPTIVATE Bio Products Laboratory PA0763/002/002 Pdr+Solv for Soln for Inj - FACTOR VIII 10/04/2017
Limited (ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
OPTIVATE Bio Products Laboratory PA0763/002/003 Pdr+Solv for Soln for Inj - FACTOR VIII 10/04/2017
Limited (ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
TRITACE LTT Pharma Limited PPA1562/118/001 Tablets - RAMIPRIL 07/04/2017
TRITACE LTT Pharma Limited PPA1562/118/002 Tablets - RAMIPRIL 07/04/2017
TRITACE LTT Pharma Limited PPA1562/118/003 Tablets - RAMIPRIL 07/04/2017
TRITACE LTT Pharma Limited PPA1562/118/004 Tablets - RAMIPRIL 07/04/2017
FINASTERIDE Merck Sharp & Dohme PA1286/044/001 Film Coated Tablet - FINASTERIDE 04/04/2017
Ireland (Human Health)
Limited
LANSOPRAZOLE Teva Pharma B.V. PA0749/135/001 Capsules Gastro-Resistant - LANSOPRAZOLE 03/04/2017
LANSOPRAZOLE Teva Pharma B.V. PA0749/135/002 Capsules Gastro-Resistant - LANSOPRAZOLE 03/04/2017
DYPRACET Auden Mckenzie (Pharma PA1352/012/001 Tablets - PARACETAMOL 29/03/2017
Division) Ltd - DIHYDROCODEINE
BITARTRATE
DYPRACET Auden Mckenzie (Pharma PA1352/012/002 Tablets - PARACETAMOL 29/03/2017
Division) Ltd - DIHYDROCODEINE
BITARTRATE
MOMETASONE FUROATE Cipla (EU) Limited PA1809/007/001 Nasal Spray Suspension - MOMETASONE FUROATE 24/03/2017
MONOHYDRATE

ARIMIDEX Primecrown 2010 Ltd PPA1633/031/001 Film Coated Tablet - ANASTRAZOLE 22/03/2017
ASASANTIN RETARD Primecrown 2010 Ltd PPA1633/019/001 Modified-release capsule, - DIPYRIDAMOLE 22/03/2017
hard - ACETYLSALICYLIC ACID
AUGMENTIN DUO Primecrown 2010 Ltd PPA1633/017/001 Powder for Oral Suspension - AMOXICILLIN 22/03/2017
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CARDURA XL Primecrown 2010 Ltd PPA1633/012/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 22/03/2017
CARDURA XL Primecrown 2010 Ltd PPA1633/012/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 22/03/2017
COZAAR Primecrown 2010 Ltd PPA1633/013/001 Film Coated Tablet - LOSARTAN POTASSIUM 22/03/2017
COZAAR Primecrown 2010 Ltd PPA1633/013/002 Film Coated Tablet - LOSARTAN POTASSIUM 22/03/2017

Human Medicines Withdrawn Products Page 116 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CRESTOR Primecrown 2010 Ltd PPA1633/005/001 Film Coated Tablet - ROSUVASTATIN (AS 22/03/2017
CALCIUM)
CRESTOR Primecrown 2010 Ltd PPA1633/005/002 Film Coated Tablet - ROSUVASTATIN (AS 22/03/2017
CALCIUM)
CRESTOR Primecrown 2010 Ltd PPA1633/005/003 Film Coated Tablet - ROSUVASTATIN (AS 22/03/2017
CALCIUM)
DIAZEPAM Wockhardt UK Limited PA1339/006/001 Solution for Injection - DIAZEPAM 22/03/2017
DIAZEPAM Wockhardt UK Limited PA1339/006/002 Solution for Injection - DIAZEPAM 22/03/2017
DIAZEPAM RECTUBES Wockhardt UK Limited PA1339/006/003 Rectal Solution - DIAZEPAM 22/03/2017
DIAZEPAM RECTUBES Wockhardt UK Limited PA1339/006/004 Rectal Solution - DIAZEPAM 22/03/2017
DIAZEPAM RECTUBES Wockhardt UK Limited PA1339/006/005 Rectal Solution - DIAZEPAM 22/03/2017
DOVOBET Primecrown 2010 Ltd PPA1633/003/001 Ointment - CALCIPOTRIOL HYDRATE 22/03/2017
- BETAMETASONE
DIPROPIONATE

LEXAPRO Primecrown 2010 Ltd PPA1633/014/001 Film Coated Tablet - ESCITALOPRAM 22/03/2017
LEXAPRO Primecrown 2010 Ltd PPA1633/014/002 Film Coated Tablet - ESCITALOPRAM 22/03/2017
LIPITOR Primecrown 2010 Ltd PPA1633/006/001 Film Coated Tablet - ATORVASTATIN 22/03/2017
LIPITOR Primecrown 2010 Ltd PPA1633/006/002 Film Coated Tablet - ATORVASTATIN 22/03/2017
LIPITOR Primecrown 2010 Ltd PPA1633/006/003 Film Coated Tablet - ATORVASTATIN 22/03/2017
LIPITOR Primecrown 2010 Ltd PPA1633/006/004 Film Coated Tablet - ATORVASTATIN 22/03/2017
MALARONE Primecrown 2010 Ltd PPA1633/038/001 Film Coated Tablet - ATOVAQUONE 22/03/2017
- PROGUANIL
HYDROCHLORIDE
NUROFEN ADVANCE Reckitt Benckiser Ireland Ltd PA0979/032/014 Oral Powder - IBUPROFEN 22/03/2017
MAXIMUM STRENGTH
OMNEXEL Primecrown 2010 Ltd PPA1633/021/001 Tablet Prolonged Release - TAMSULOSIN 22/03/2017
HYDROCHLORIDE
SAFLUTAN Primecrown 2010 Ltd PPA1633/039/001 Eye Drops Solution - TAFLUPROST 22/03/2017
SINGULAIR Primecrown 2010 Ltd PPA1633/024/002 Film Coated Tablet - MONTELUKAST SODIUM 22/03/2017
SINGULAIR PAEDIATRIC Primecrown 2010 Ltd PPA1633/024/003 Tablets Chewable - MONTELUKAST SODIUM 22/03/2017
SINGULAIR PAEDIATRIC Primecrown 2010 Ltd PPA1633/024/001 Tablets Chewable - MONTELUKAST SODIUM 22/03/2017
XYZAL Primecrown 2010 Ltd PPA1633/009/001 Film Coated Tablet - LEVOCETIRIZINE 22/03/2017
DIHYDROCHLORIDE
ZANIDIP Primecrown 2010 Ltd PPA1633/008/001 Film Coated Tablet - LERCANIDIPINE 22/03/2017
HYDROCHLORIDE
ZANIDIP Primecrown 2010 Ltd PPA1633/008/002 Film Coated Tablet - LERCANIDIPINE 22/03/2017
HYDROCHLORIDE
UNITUXIN United Therapeutics Europe EU/1/15/1022/001 Concentrate for Soln for Inf - DINUTUXIMAB 20/03/2017
Ltd
MEROPENEM Ranbaxy Ireland Limited PA0408/086/001 Pdr for Soln Inj/Inf - MEROPENEM 15/03/2017
TRIHYDRATE (STERILE)
MEROPENEM Ranbaxy Ireland Limited PA0408/086/002 Pdr for Soln Inj/Inf - MEROPENEM 15/03/2017
TRIHYDRATE (STERILE)
ARKOVOX Laboratoires ARKOPHARMA PA1450/001/001 Syrup - IVY LEAF DRY EXTRACT 09/03/2017
(HEDERA HELIX L.) (4-6:1)
EXTRACTION SOLVENT:
ETHANOL 30% V/V
APFEN PLUS GlaxoSmithKline Consumer PA0678/109/001 Film Coated Tablet - IBUPROFEN 08/03/2017
Healthcare (Ireland) Limited - CODEINE PHOSPHATE
HEMIHYDRATE
PREFLUCEL Nanotherapeutics Bohumil PA2077/001/001 Suspension for Injection - A/CALIFORNIA/07/2009 08/03/2017
S.R.O (H1N1)
- A/VICTORIA/361/2011
(A/H3N2)
- B/HUBEI-
WUJIAGANG/158/2009 (B)
HYDROCORTISONE Bristol Laboratories Limited PA1240/013/001 Tablets - HYDROCORTISONE 28/02/2017
HYDROCORTISONE Bristol Laboratories Limited PA1240/013/002 Tablets - HYDROCORTISONE 28/02/2017
TROSPIUM Glenmark Pharmaceuticals PA1462/009/001 Film Coated Tablet - TROSPIUM CHLORIDE 28/02/2017
Europe Limited
ATACAND B & S Healthcare PPA1328/018/001 Tablets - CANDESARTAN 24/02/2017
CILEXETIL
CASODEX B & S Healthcare PPA1328/146/001 Film Coated Tablet - BICALUTAMIDE 24/02/2017
EMCOR B & S Healthcare PPA1328/135/002 Film Coated Tablet - BISOPROLOL FUMARATE 24/02/2017

IPRAGARD Cipla (EU) Limited PA1809/001/001 Pressurised Inhalation Soln - IPRATROPIUM BROMIDE 24/02/2017
MONOHYDRATE
SPIRIVA B & S Healthcare PPA1328/142/001 Inhalation powder, hard - TIOTROPIUM 24/02/2017
capsule
COVERSYL ARGININE Les Laboratoires Servier PA0568/002/007 Orodispersible Tablet - PERINDOPRIL ARGININE 15/02/2017
FLUORETS Chauvin Pharmaceuticals PA0118/026/001 Unknown - FLUORESCEIN SODIUM 13/02/2017
Limited
PHENYTOIN SODIUM Lime Pharma Ltd PA2005/001/001 Capsules Hard - PHENYTOIN SODIUM 09/02/2017
100MG CAPSULES

Human Medicines Withdrawn Products Page 117 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COVERDINE Les Laboratoires Servier PA0568/024/001 Film Coated Tablet - PERINDOPRIL ARGININE 01/02/2017
- INDAPAMIDE
- AMLODIPINE BESILATE
DACEPTON EVER Valinject GmbH PA1774/001/001 Solution for Inj/Inf - APOMORPHINE 01/02/2017
HYDROCHLORIDE
HEMIHYDRATE
ROZEX Galderma (UK) Ltd PA0590/010/003 Cutaneous Emulsion - METRONIDAZOLE 27/01/2017
CANDESARTAN/HYDROC McDermott Laboratories Ltd PA0577/121/001 Tablets - CANDESARTAN 26/01/2017
HLOROTHIAZIDE MYLAN t/a Gerard Laboratories CILEXETIL
- HYDROCHLOROTHIAZIDE

NICORETTE MINT 2MG McNeil Healthcare (Ireland) PA0823/049/005 Medicated Chewing Gum - NICOTINE RESIN 24/01/2017
MEDICATED CHEWING- Ltd
GUM
NICORETTE MINT 4MG McNeil Healthcare (Ireland) PA0823/049/006 Medicated Chewing Gum - NICOTINE RESIN 24/01/2017
MEDICATED CHEWING- Ltd
GUM
VEXOL Alcon Laboratories (UK) Ltd PA0290/073/001 Eye Drops Suspension - RIMEXOLONE 23/01/2017
LAMISIL Novartis Pharmaceuticals UK PA0013/045/004 Cutaneous Solution - TERBINAFINE 20/01/2017
Ltd HYDROCHLORIDE
LAMISIL Novartis Pharmaceuticals UK PA0013/045/005 Cutaneous Spray Solution - TERBINAFINE 20/01/2017
Ltd HYDROCHLORIDE
LAMISIL Novartis Pharmaceuticals UK PA0013/045/006 Gel - TERBINAFINE 20/01/2017
Ltd
CLOPIDOGREL ACINO Luye Pharma AG EU/1/09/532/1-7 Film Coated Tablet - CLOPIDOGREL BESILATE 18/01/2017
- MACROGOL 6000
- CARBON DIOXIDE

CIPROFLOXACIN TEVA Teva Pharma B.V. PA0749/031/005 Solution for Infusion - CIPROFLOXACIN 12/01/2017
VYLAER SPIROMAX Teva Pharma B.V. EU/1/14/949/001 Inhalation powder - BUDESONIDE 11/01/2017
- FORMOTEROL
FUMARATE DIHYDRATE
VYLAER SPIROMAX Teva Pharma B.V. EU/1/14/949/002 Inhalation powder - BUDESONIDE 11/01/2017
- FORMOTEROL
FUMARATE DIHYDRATE
HYTRIN B & S Healthcare PPA1328/095/003 Tablets - TERAZOSIN 10/01/2017
HYDROCHLORIDE
ZINERYT B & S Healthcare PPA1328/200/001 Powder and solvent for - ERYTHROMYCIN 10/01/2017
cutaneous solution - ZINC ACETATE
ACCOLATE PCO Manufacturing PPA0465/198/001 Film Coated Tablet - ZAFIRLUKAST 31/12/2016
ATORVASTATIN WPR Healthcare Limited PPA0565/051/001 Film Coated Tablet - ATORVASTATIN CALCIUM 31/12/2016

ATORVASTATIN WPR Healthcare Limited PPA0565/051/002 Film Coated Tablet - ATORVASTATIN CALCIUM 31/12/2016

ATORVASTATIN WPR Healthcare Limited PPA0565/051/003 Film Coated Tablet - ATORVASTATIN CALCIUM 31/12/2016

ATORVASTATIN WPR Healthcare Limited PPA0565/051/004 Film Coated Tablet - ATORVASTATIN CALCIUM 31/12/2016

AUGMENTIN-DUO PCO Manufacturing PPA0465/284/001 Powder for Oral Suspension - AMOXICILLIN 31/12/2016
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

BENYLIN FOUR FLU PCO Manufacturing PPA0465/411/001 Film Coated Tablet - DIPHENHYDRAMINE 31/12/2016
HYDROCHLORIDE
- PARACETAMOL
- PSEUDOEPHEDRINE
HYDROCHLORIDE
CAPOTEN PCO Manufacturing PPA0465/002/001 Tablets - CAPTOPRIL 31/12/2016
CAPOTEN PCO Manufacturing PPA0465/002/002 Tablets - CAPTOPRIL 31/12/2016
CARDURA XL PCO Manufacturing PPA0465/095/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 31/12/2016
CARDURA XL PCO Manufacturing PPA0465/095/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 31/12/2016
CITALOPRAM WPR Healthcare Limited PPA0565/031/001 Film Coated Tablet - CITALOPRAM 31/12/2016
HYDROBROMIDE
CONCERTA XL PCO Manufacturing PPA0465/417/001 Tablet Prolonged Release - METHYLPHENIDATE 31/12/2016
HYDROCHLORIDE
CONCERTA XL PCO Manufacturing PPA0465/417/002 Tablet Prolonged Release - METHYLPHENIDATE 31/12/2016
HYDROCHLORIDE
DUAC ONCE DAILY GlaxoSmithKline (Ireland) PA1077/120/002 Gel - BENZOYL PEROXIDE 31/12/2016
Limited HYDROUS
- CLINDAMYCIN
PHOSPHATE
ESCITALPRO WPR Healthcare Limited PPA0565/055/001 Film Coated Tablet - ESCITALOPRAM 31/12/2016
OXALATE

Human Medicines Withdrawn Products Page 118 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ESCITALPRO WPR Healthcare Limited PPA0565/055/002 Film Coated Tablet - ESCITALOPRAM 31/12/2016
OXALATE
ESCITALPRO WPR Healthcare Limited PPA0565/055/003 Film Coated Tablet - ESCITALOPRAM 31/12/2016
OXALATE
ESOMEPRAZOLE WPR Healthcare Limited PPA0565/053/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 31/12/2016
MAGNESIUM
(AMORPHOUS)
ESOMEPRAZOLE WPR Healthcare Limited PPA0565/053/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 31/12/2016
MAGNESIUM
(AMORPHOUS)
FAMVIR WPR Healthcare Limited PPA0565/038/001 Film Coated Tablet - FAMCICLOVIR 31/12/2016
FAMVIR WPR Healthcare Limited PPA0565/038/002 Film Coated Tablet - FAMCICLOVIR 31/12/2016
FOSAMAX ONCE WEEKLY PCO Manufacturing PPA0465/115/001 Tablets - SODIUM ALENDRONATE 31/12/2016
KERAL PCO Manufacturing PPA0465/277/001 Film Coated Tablet - DEXKETOPROFEN 31/12/2016
KLARAM WPR Healthcare Limited PPA0565/033/001 Film Coated Tablet - CLARITHROMYCIN 31/12/2016
KLARAM WPR Healthcare Limited PPA0565/033/002 Film Coated Tablet - CLARITHROMYCIN 31/12/2016
LANSOPRAZOLE WPR Healthcare Limited PPA0565/057/001 Capsules Gastro-Resistant - LANSOPRAZOLE 31/12/2016
LANSOPRAZOLE WPR Healthcare Limited PPA0565/057/002 Capsules Gastro-Resistant - LANSOPRAZOLE 31/12/2016
LEXAPRO PCO Manufacturing PPA0465/129/003 Film Coated Tablet - ESCITALOPRAM 31/12/2016
OXALATE
LISINOPRIL WPR Healthcare Limited PPA0565/046/001 Tablets - LISINOPRIL DIHYDRATE 31/12/2016
LISINOPRIL WPR Healthcare Limited PPA0565/046/002 Tablets - LISINOPRIL DIHYDRATE 31/12/2016
MACO PHARMA Maco Pharma (UK) Ltd PA0931/003/001 Solution for Infusion - METRONIDAZOLE 31/12/2016
METRONIDAZOLE
MOTILIUM PCO Manufacturing PPA0465/272/001 Film Coated Tablet - DOMPERIDONE 31/12/2016
MOXICLAV WPR Healthcare Limited PPA0565/030/001 Film Coated Tablet - AMOXICILLIN 31/12/2016
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

ORAP 4 MG TABLETS Janssen-Cilag Ltd PA0748/024/002 Tablets - PIMOZIDE 31/12/2016


PANTOPRAZOLE PCO Manufacturing PPA0465/403/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2016
SESQUIHYDRATE

PANTOPRAZOLE PCO Manufacturing PPA0465/403/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2016


SESQUIHYDRATE

PANTOPRAZOLE TEVA WPR Healthcare Limited PPA0565/034/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2016
SESQUIHYDRATE

PANTOPRAZOLE TEVA WPR Healthcare Limited PPA0565/034/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 31/12/2016
SESQUIHYDRATE

PROVIGIL PCO Manufacturing PPA0465/415/002 Tablets - MODAFINIL 31/12/2016


RISPATAL WPR Healthcare Limited PPA0565/048/001 Film Coated Tablet - RISPERIDONE 31/12/2016
RISPATAL WPR Healthcare Limited PPA0565/048/002 Film Coated Tablet - RISPERIDONE 31/12/2016
VENLOFEX WPR Healthcare Limited PPA0565/042/001 Prolonged Release Capsules - VENLAFAXINE 31/12/2016

VENLOFEX WPR Healthcare Limited PPA0565/042/002 Prolonged Release Capsules - VENLAFAXINE 31/12/2016

VOLTAROL Novartis Pharmaceuticals UK PA0013/087/003 Suppositories - DICLOFENAC SODIUM 31/12/2016


Ltd
ZANIDIP PCO Manufacturing PPA0465/193/001 Film Coated Tablet - LERCANIDIPINE 31/12/2016
HYDROCHLORIDE
ZANIDIP PCO Manufacturing PPA0465/193/002 Film Coated Tablet - LERCANIDIPINE 31/12/2016
HYDROCHLORIDE
ZISMIRT OROTAB WPR Healthcare Limited PPA0565/044/001 Orodispersible Tablet - MIRTAZAPINE 31/12/2016
KOZYLEX IWA Consulting ApS PA1367/002/001 Orodispersible Tablet - OLANZAPINE 19/12/2016
KOZYLEX IWA Consulting ApS PA1367/002/002 Orodispersible Tablet - OLANZAPINE 19/12/2016
KOZYLEX IWA Consulting ApS PA1367/002/003 Orodispersible Tablet - OLANZAPINE 19/12/2016
KOZYLEX IWA Consulting ApS PA1367/002/004 Orodispersible Tablet - OLANZAPINE 19/12/2016
ACCUPRO B & S Healthcare PPA1328/045/003 Film Coated Tablet - QUINAPRIL 16/12/2016
HYDROCHLORIDE
ACTIVELLE B & S Healthcare PPA1328/046/001 Film Coated Tablet - ESTRADIOL 16/12/2016
HEMIHYDRATE
- NORETHISTERONE
ACETATE
ACTONEL ONCE A WEEK B & S Healthcare PPA1328/017/002 Film Coated Tablet - RISEDRONATE SODIUM 16/12/2016
ADALAT RETARD B & S Healthcare PPA1328/047/004 Tablet Prolonged Release - NIFEDIPINE 16/12/2016
AMARYL B & S Healthcare PPA1328/048/003 Tablets - GLIMEPIRIDE 16/12/2016
AUGMENTIN B & S Healthcare PPA1328/050/001 Film Coated Tablet - AMOXICILLIN 16/12/2016
TRIHYDRATE
- CLAVULANIC ACID

Human Medicines Withdrawn Products Page 119 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BENETOR B & S Healthcare PPA1328/151/001 Film Coated Tablet - OLMESARTAN 16/12/2016
MEDOXOMIL
BENETOR B & S Healthcare PPA1328/151/002 Film Coated Tablet - OLMESARTAN 16/12/2016
MEDOXOMIL
BICALUTAMIDE HIKMA Hikma Farmaceutica PA1217/003/001 Film Coated Tablet - BICALUTAMIDE 16/12/2016
(Portugal) SA
BIRESP SPIROMAX TEVA Teva Pharma B.V. EU/1/14/948/002 Inhalation powder - BUDESONIDE 16/12/2016
- FORMOTEROL
FUMARATE DIHYDRATE
BUDESONIDE/FORMOTER Teva Pharma B.V. EU/1/14/948/001 Inhalation powder - BUDESONIDE 16/12/2016
OL TEVA - FORMOTEROL
FUMARATE DIHYDRATE
BUDESONIDE/FORMOTER Teva Pharma B.V. EU/1/14/950/001 Inhalation powder - BUDESONIDE 16/12/2016
OL TEVA PHARMA B.V. - FORMOTEROL
FUMARATE DIHYDRATE
BUDESONIDE/FORMOTER Teva Pharma B.V. EU/1/14/950/002 Inhalation powder - BUDESONIDE 16/12/2016
OL TEVA PHARMA B.V. - FORMOTEROL
FUMARATE DIHYDRATE
CO-DIOVAN B & S Healthcare PPA1328/178/001 Film Coated Tablet - VALSARTAN 16/12/2016
- HYDROCHLOROTHIAZIDE

DOVOBET B & S Healthcare PPA1328/066/002 Gel - CALCIPOTRIOL 16/12/2016


- BETAMETHASONE
DIPROPIONATE
EMCOR B & S Healthcare PPA1328/135/001 Film Coated Tablet - BISOPROLOL FUMARATE 16/12/2016

NOCTAMID B & S Healthcare PPA1328/158/001 Tablets - LORMETAZEPAM 16/12/2016


DIPROBATH Merck Sharp & Dohme PA1286/036/001 Bath Additive - LIQUID PARAFFIN LIGHT 08/12/2016
Ireland (Human Health) - ISOPROPYL MYRISTATE
Limited
DIPROSALIC 0.05% W/W + Merck Sharp & Dohme PA1286/029/002 Ointment - BETAMETHASONE 08/12/2016
Ireland (Human Health) DIPROPIONATE
Limited - SALICYLIC ACID
DIPROSON Merck Sharp & Dohme PA1286/027/003 Cutaneous Solution - BETAMETHASONE 08/12/2016
Ireland (Human Health) DIPROPIONATE
Limited
DIPROSONE Merck Sharp & Dohme PA1286/027/001 Cream - BETAMETHASONE 08/12/2016
Ireland (Human Health) DIPROPIONATE
Limited
DIPROSONE Merck Sharp & Dohme PA1286/027/002 Ointment - BETAMETHASONE 08/12/2016
Ireland (Human Health) DIPROPIONATE
Limited
DROGENIL Merck Sharp & Dohme PA1286/026/001 Tablets - FLUTAMIDE 08/12/2016
Ireland (Human Health)
Limited
OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/001 Tablets - OLANZAPINE 08/12/2016

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/002 Tablets - OLANZAPINE 08/12/2016

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/003 Tablets - OLANZAPINE 08/12/2016

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/004 Tablets - OLANZAPINE 08/12/2016

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/005 Tablets - OLANZAPINE 08/12/2016

OLANZAPINE AUROBINDO Milpharm Limited PA1050/004/006 Tablets - OLANZAPINE 08/12/2016

POTASSIUM CHLORIDE & Maco Pharma (UK) Ltd PA0931/007/002 Solution for Infusion - POTASSIUM CHLORIDE 08/12/2016
SODIUM CHLORIDE - SODIUM CHLORIDE
PREGNYL 1500 I.U. NV Organon PA0964/005/001 Pdr+Solv for Soln for Inj - CHORIONIC 08/12/2016
POWDER AND SOLVENT GONADOTROPHIN
FOR SOLUTION
AVENA SATIVA COMP. Weleda (UK) Limited PA0407/003/001 Oral Drops Solution - HUMULUS LUPULUS 07/12/2016
- AVENA SATIVA
- PASSIFLORA INCARNATA
- VALERIANA OFFICINALIS
- COFFEE PREPARED

AMARYL B & S Healthcare PPA1328/048/001 Tablets - GLIMEPIRIDE 05/12/2016


ATACAND PLUS B & S Healthcare PPA1328/052/001 Tablets - HYDROCHLOROTHIAZIDE 05/12/2016
- CANDESARTAN
CILEXETIL

BENETOR B & S Healthcare PPA1328/151/003 Film Coated Tablet - OLMESARTAN 05/12/2016


MEDOXOMIL

Human Medicines Withdrawn Products Page 120 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ELOCON B & S Healthcare PPA1328/127/001 Cream - MOMETASONE FUROATE 05/12/2016

CLINDAMYCIN Fannin (UK) Ltd PA1585/001/001 Solution for Inj/Inf - CLINDAMYCIN 04/12/2016
REFAZ Pharmathen S.A. PA1368/007/001 Film Coated Tablet - LEVOFLOXACIN 04/12/2016
HEMIHYDRATE
REFAZ Pharmathen S.A. PA1368/007/002 Film Coated Tablet - LEVOFLOXACIN 04/12/2016
HEMIHYDRATE
ADALAT LA B & S Healthcare PPA1328/047/002 Tablet Prolonged Release - NIFEDIPINE 02/12/2016
ESOMEPRAZOLE Imbat Limited PPA1151/146/001 Capsules Gastro-Resistant - ESOMEPRAZOLE 02/12/2016
MAGNESIUM DIHYDRATE
ESOMEPRAZOLE Imbat Limited PPA1151/146/002 Capsules Gastro-Resistant - ESOMEPRAZOLE 02/12/2016
MAGNESIUM DIHYDRATE
INEGY B & S Healthcare PPA1328/203/001 Tablets - EZETIMIBE 02/12/2016
- SIMVASTATIN
ISTIN B & S Healthcare PPA1328/082/002 Tablets - AMLODIPINE BESYLATE 02/12/2016
IXPRIM B & S Healthcare PPA1328/210/001 Film Coated Tablet - TRAMADOL 02/12/2016
HYDROCHLORIDE
- PARACETAMOL
LANSOPRAZOLE Imbat Limited PPA1151/206/001 Capsules Gastro-Resistant - LANSOPRAZOLE 02/12/2016
LANSOPRAZOLE Imbat Limited PPA1151/206/002 Capsules Gastro-Resistant - LANSOPRAZOLE 02/12/2016
LANSOPRAZOLE Imbat Limited PPA1151/206/003 Orodispersible Tablet - LANSOPRAZOLE 02/12/2016
LANSOPRAZOLE Imbat Limited PPA1151/206/004 Orodispersible Tablet - LANSOPRAZOLE 02/12/2016
NEURONTIN B & S Healthcare PPA1328/028/001 Capsules Hard - GABAPENTIN 02/12/2016
NEURONTIN B & S Healthcare PPA1328/028/004 Film Coated Tablet - GABAPENTIN 02/12/2016
PARIET Imbat Limited PPA1151/033/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 02/12/2016
PARIET Imbat Limited PPA1151/033/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 02/12/2016
PREDSOL RETENTION RPH Pharmaceuticals AB PA1638/008/001 Rectal Solution - PREDNISOLONE SODIUM 02/12/2016
ENEMA PHOSPHATE
PREMARIN 0.625 MG B & S Healthcare PPA1328/111/001 Tablet Prolonged Release - ESTROGENS 02/12/2016
PROLONGED-RELEASE CONJUGATED
TABLETS
PREMARIN 1.25 MG B & S Healthcare PPA1328/111/002 Tablet Prolonged Release - ESTROGENS 02/12/2016
PROLONGED-RELEASE CONJUGATED
TABLETS
PROSCAR 5MG FILM- B & S Healthcare PPA1328/119/001 Film Coated Tablet - FINASTERIDE 02/12/2016
COATED TABLETS
PROTIUM Imbat Limited PPA1151/016/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 02/12/2016
SESQUIHYDRATE

PROTIUM Imbat Limited PPA1151/016/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 02/12/2016


SESQUIHYDRATE

REGURIN B & S Healthcare PPA1328/207/001 Coated Tablets - TROSPIUM CHLORIDE 02/12/2016


RISPERDAL B & S Healthcare PPA1328/126/001 Film Coated Tablet - RISPERIDONE 02/12/2016
RISPERDAL B & S Healthcare PPA1328/126/002 Film Coated Tablet - RISPERIDONE 02/12/2016
RISPERDAL B & S Healthcare PPA1328/126/003 Film Coated Tablet - RISPERIDONE 02/12/2016
ZOFRAN B & S Healthcare PPA1328/148/001 Film Coated Tablet - ONDANSETRON 02/12/2016
HYDROCHLORIDE
DIHYDRATE
ZOFRAN B & S Healthcare PPA1328/148/002 Film Coated Tablet - ONDANSETRON 02/12/2016
HYDROCHLORIDE
DIHYDRATE
ZOLADEX B & S Healthcare PPA1328/136/001 Implant - GOSERELIN ACETATE 02/12/2016
ACTONEL ONCE A WEEK Imbat Limited PPA1151/021/001 Film Coated Tablet - RISEDRONATE SODIUM 01/12/2016
FOSAMAX ONCE WEEKLY Imbat Limited PPA1151/015/001 Tablets - ALENDRONATE SODIUM 01/12/2016
TRIHYDRATE
SEROXAT Imbat Limited PPA1151/034/004 Film Coated Tablet - PAROXETINE 01/12/2016
HYDROCHLORIDE
HEMIHYDRATE
CHONDROCELECT TiGenix nv EU/1/09/563/001 Implantation suspension - CHARACTERIZED 30/11/2016
AUTOLOGOUS CARTILAGE

Human Medicines Withdrawn Products Page 121 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VIASPAN Bristol-Myers Squibb PA0002/075/001 Solution for Organ - POLY(O-2- 30/11/2016
Pharmaceuticals uc Preservation HYDROXYETHYL)STARCH
- LACTOBIONIC ACID
- POTASSIUM HYDROXIDE
- SODIUM HYDROXIDE
(40%)
- ADENOSINE
- ALLOPURINOL
- POTASSIUM PHOSPHATE
MONOBASIC
- MAGNESIUM SULFATE
- RAFFINOSE
- GLUTATHIONE

CLOPIDOGREL CLONMEL Clonmel Healthcare Ltd PA0126/204/001 Film Coated Tablet - CLOPIDOGREL BESILATE 25/11/2016

OXIMEL Clonmel Healthcare Ltd PA0126/264/001 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/002 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/003 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/004 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/005 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/006 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/007 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
OXIMEL Clonmel Healthcare Ltd PA0126/264/008 Tablet Prolonged Release - OXYCODONE 25/11/2016
HYDROCHLORIDE
ETOPOSIDE Cipla (EU) Limited PA1809/020/001 Concentrate for Soln for Inf - ETOPOSIDE 24/11/2016
FLUOROURACIL Generics (UK) Limited PA0405/096/001 Solution for Inj/Inf - FLUOROURACIL 24/11/2016
MONTELUKAST Cipla (EU) Limited PA1809/004/003 Film Coated Tablet - MONTELUKAST SODIUM 23/11/2016
MONTELUKAST Cipla (EU) Limited PA1809/004/001 Tablets Chewable - MONTELUKAST SODIUM 23/11/2016
PAEDIATRIC - MONTELUKAST
MONTELUKAST Cipla (EU) Limited PA1809/004/002 Tablets Chewable - MONTELUKAST SODIUM 23/11/2016
PAEDIATRIC - MONTELUKAST
TETRALYSAL B & S Healthcare PPA1328/208/001 Capsules Hard - LYMECYCLINE 22/11/2016
TILDIEM RETARD 90MG B & S Healthcare PPA1328/101/001 Tablet Prolonged Release - DILTIAZEM 22/11/2016
PROLONGED RELEASE HYDROCHLORIDE
TABLETS
TRIAPIN B & S Healthcare PPA1328/184/001 Tablet Prolonged Release - FELODIPINE 22/11/2016
- RAMIPRIL
VENTOLIN EVOHALER B & S Healthcare PPA1328/041/001 Pressurised Inhalation - SALBUTAMOL SULFATE 22/11/2016
Suspension
XATRAL 10MG B & S Healthcare PPA1328/104/001 Tablet Prolonged Release - ALFUZOSIN 22/11/2016
PROLONGED RELEASE HYDROCHLORIDE
TABLETS
CELVAPAN Nanotherapeutics Bohumil EU/1/08/506/001 Suspension for Injection - A/CALIFORNIA/07/2009 21/11/2016
S.R.O (H1N1)V
LAMISIL B & S Healthcare PPA1328/120/002 Tablets - TERBINAFINE 21/11/2016
HYDROCHLORIDE
LIVIAL B & S Healthcare PPA1328/185/001 Tablets - TIBOLONE 21/11/2016
LUSTRAL B & S Healthcare PPA1328/085/002 Film Coated Tablet - SERTRALINE 21/11/2016
HYDROCHLORIDE
MEZAVANT XL B & S Healthcare PPA1328/198/001 Tablet Prolonged Release - MESALAZINE 21/11/2016
NASONEX B & S Healthcare PPA1328/011/001 Nasal Spray Suspension - MOMETASONE FUROATE 21/11/2016

OMNEXEL B & S Healthcare PPA1328/096/001 Tablet Prolonged Release - TAMSULOSIN 21/11/2016


HYDROCHLORIDE
PROZAC B & S Healthcare PPA1328/032/001 Capsules Hard - FLUOXETINE 21/11/2016
HYDROCHLORIDE
ROZEX B & S Healthcare PPA1328/138/001 Gel - METRONIDAZOLE 21/11/2016
SCHERIPROCT B & S Healthcare PPA1328/033/001 Rectal Ointment - PREDNISOLONE 21/11/2016
CAPROATE
- CINCHOCAINE
HYDROCHLORIDE
SERETIDE 500 DISKUS B & S Healthcare PPA1328/035/001 Inhalation powder - SALMETEROL 21/11/2016
XINAFOATE
- FLUTICASONE
PROPIONATE
YASMIN B & S Healthcare PPA1328/206/001 Film Coated Tablet - DROSPIRENONE 19/11/2016
- ETHINYLESTRADIOL

Human Medicines Withdrawn Products Page 122 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PERFAN Carinopharm GmbH PA1682/001/001 Concentrate for Soln for Inf - ENOXIMONE 15/11/2016
NORLEVO Laboratoire HRA Pharma PA1166/001/001 Tablets - LEVONORGESTREL 10/11/2016
RUBEX ORANGE 1000 MG Ricesteele Manufacturing Ltd PA0095/008/002 Tablets Effervescent - ASCORBIC ACID 10/11/2016
EFFERVESCENT TABLETS

ARPLEXAM Les Laboratoires Servier PA0568/025/001 Film Coated Tablet - PERINDOPRIL ARGININE 09/11/2016
- INDAPAMIDE
- AMLODIPINE BESILATE
ARPLEXAM Les Laboratoires Servier PA0568/025/002 Film Coated Tablet - PERINDOPRIL ARGININE 09/11/2016
- INDAPAMIDE
- AMLODIPINE BESILATE
ARPLEXAM Les Laboratoires Servier PA0568/025/003 Film Coated Tablet - PERINDOPRIL ARGININE 09/11/2016
- INDAPAMIDE
- AMLODIPINE BESILATE
ARPLEXAM Les Laboratoires Servier PA0568/025/004 Film Coated Tablet - PERINDOPRIL ARGININE 09/11/2016
- INDAPAMIDE
- AMLODIPINE BESILATE
ARPLEXAM Les Laboratoires Servier PA0568/025/005 Film Coated Tablet - PERINDOPRIL ARGININE 09/11/2016
- INDAPAMIDE
- AMLODIPINE BESILATE
IXPRIM Imbat Limited PPA1151/139/001 Film Coated Tablet - TRAMADOL 04/11/2016
HYDROCHLORIDE
- PARACETAMOL
REGURIN LTT Pharma Limited PPA1562/096/001 Coated Tablets - TROSPIUM CHLORIDE 04/11/2016
SIMVASTATIN Rosemont Pharmaceuticals PA0312/014/001 Oral Suspension - SIMVASTATIN 04/11/2016
Ltd
SIMVASTATIN Rosemont Pharmaceuticals PA0312/014/002 Oral Suspension - SIMVASTATIN 04/11/2016
Ltd
VITEKTA Gilead Sciences International EU/1/13/883/001 Film Coated Tablet - ELVITEGRAVIR 03/11/2016

VITEKTA Gilead Sciences International EU/1/13/883/002 Film Coated Tablet - ELVITEGRAVIR 03/11/2016

RENLAUCOL MG Pharma PA1811/002/001 Tablets Effervescent - PARACETAMOL 30/10/2016


- CODEINE PHOSPHATE
HEMIHYDRATE
CAPOZIDE B & S Healthcare PPA1328/088/001 Tablets - CAPTOPRIL 28/10/2016
- HYDROCHLOROTHIAZIDE

CO-DIOVAN B & S Healthcare PPA1328/178/002 Film Coated Tablet - VALSARTAN 28/10/2016


- HYDROCHLOROTHIAZIDE

COZAAR B & S Healthcare PPA1328/081/001 Film Coated Tablet - LOSARTAN POTASSIUM 28/10/2016
COZAAR B & S Healthcare PPA1328/081/002 Film Coated Tablet - LOSARTAN POTASSIUM 28/10/2016
ELANTAN LA B & S Healthcare PPA1328/103/002 Prolonged Release Capsules - ISOSORBIDE 28/10/2016
MONONITRATE
EPANUTIN B & S Healthcare PPA1328/147/001 Capsules Hard - PHENYTOIN SODIUM 28/10/2016
LEXAPRO B & S Healthcare PPA1328/084/002 Film Coated Tablet - ESCITALOPRAM 28/10/2016
TILDIEM LA B & S Healthcare PPA1328/101/003 Prolonged Release Capsules - DILTIAZEM 28/10/2016
HYDROCHLORIDE
TILDIEM LA 300 MG B & S Healthcare PPA1328/101/004 Prolonged Release Capsules - DILTIAZEM 28/10/2016
PROLONGED-RELEASE HYDROCHLORIDE
HARD CAPSULES
ESCITALOPRAM Cipla (EU) Limited PA1809/002/001 Film Coated Tablet - ESCITALOPRAM 21/10/2016
OXALATE
ESCITALOPRAM Cipla (EU) Limited PA1809/002/002 Film Coated Tablet - ESCITALOPRAM 21/10/2016
OXALATE
ESCITALOPRAM Cipla (EU) Limited PA1809/002/003 Film Coated Tablet - ESCITALOPRAM 21/10/2016
OXALATE
METOJECT Medac Gesellschaft fur PA0623/007/001 Solution for Injection - METHOTREXATE 21/10/2016
Klinische Spezialpraparate
mbH
SEREVENT EVOHALER B & S Healthcare PPA1328/169/001 Pressurised Inhalation - SALMETEROL 19/10/2016
Suspension
SOLIAN B & S Healthcare PPA1328/176/001 Tablets - AMISULPRIDE 19/10/2016
TEGRETOL B & S Healthcare PPA1328/007/001 Oral Suspension - CARBAMAZEPINE 19/10/2016
VERMOX B & S Healthcare PPA1328/180/001 Tablets - MEBENDAZOLE 19/10/2016
VERMOX B & S Healthcare PPA1328/180/002 Oral Suspension - MEBENDAZOLE 19/10/2016
XYZAL B & S Healthcare PPA1328/114/001 Film Coated Tablet - LEVOCETIRIZINE 19/10/2016
DIHYDROCHLORIDE
ZANTAC B & S Healthcare PPA1328/105/001 Film Coated Tablet - RANITIDINE 19/10/2016
HYDROCHLORIDE
ZANTAC B & S Healthcare PPA1328/105/002 Film Coated Tablet - RANITIDINE 19/10/2016
HYDROCHLORIDE
ELTROXIN B & S Healthcare PPA1328/162/001 Tablets - LEVOTHYROXINE 18/10/2016
SODIUM

Human Medicines Withdrawn Products Page 123 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NICOTINELL CLASSIC Novartis Consumer Health PA0030/054/001 Medicated Chewing Gum - NICOTINE 18/10/2016
UK Limited
NICOTINELL CLASSIC Novartis Consumer Health PA0030/054/002 Medicated Chewing Gum - NICOTINE 18/10/2016
UK Limited
NIQERO FRUIT Stasisport Pharma N.V. PA1750/001/001 Medicated Chewing Gum - NICOTINE RESINATE 17/10/2016
NIQERO FRUIT Stasisport Pharma N.V. PA1750/001/002 Medicated Chewing Gum - NICOTINE RESINATE 17/10/2016
NIQERO MINT Stasisport Pharma N.V. PA1750/001/003 Medicated Chewing Gum - NICOTINE RESINATE 17/10/2016
NIQERO MINT Stasisport Pharma N.V. PA1750/001/004 Medicated Chewing Gum - NICOTINE RESINATE 17/10/2016
ALVESCO Takeda GmbH PA1421/002/001 Pressurised Inhalation Soln - CICLESONIDE 14/10/2016
CYTARABINE EBEWE Fannin Limited PA1457/007/001 Solution for Inj/Inf - CYTARABINE 14/10/2016
CYTARABINE EBEWE Fannin Limited PA1457/007/002 Solution for Inj/Inf - CYTARABINE 14/10/2016
CYTARABINE EBEWE Fannin Limited PA1457/007/003 Solution for Inj/Inf - CYTARABINE 14/10/2016
EPIRUBICIN "EBEWE" Fannin Limited PA1457/005/001 Solution for Inj/Inf - EPIRUBICIN 14/10/2016
LAMISIL B & S Healthcare PPA1328/120/001 Cream - TERBINAFINE 14/10/2016
HYDROCHLORIDE
LOPID B & S Healthcare PPA1328/165/001 Film Coated Tablet - GEMFIBROZIL 14/10/2016
NEURONTIN B & S Healthcare PPA1328/028/002 Capsules Hard - GABAPENTIN 14/10/2016
OSTEOFOS D3 B & S Healthcare PPA1328/201/001 Powder for Oral Solution - CALCIUM PHOSPHATE 14/10/2016
- COLECALCIFEROL
PACLITAXEL "EBEWE" Fannin Limited PA1457/006/001 Concentrate for Soln for Inf - PACLITAXEL 14/10/2016
PULMICORT TURBOHALER B & S Healthcare PPA1328/113/002 Inhalation powder - BUDESONIDE 14/10/2016

RELESTAT B & S Healthcare PPA1328/196/001 Eye Drops Solution - EPINASTINE 14/10/2016


HYDROCHLORIDE
RELIFEX B & S Healthcare PPA1328/121/001 Film Coated Tablet - NABUMETONE 14/10/2016
REQUIP-MODUTAB B & S Healthcare PPA1328/199/001 Tablet Prolonged Release - ROPINIROLE (AS 14/10/2016
HYDROCHLORIDE)
REQUIP-MODUTAB B & S Healthcare PPA1328/199/002 Tablet Prolonged Release - ROPINIROLE (AS 14/10/2016
HYDROCHLORIDE)
VINORELBINE EBEWE Fannin Limited PA1457/004/001 Concentrate for Soln for Inf - VINORELBINE 14/10/2016
DOLMATIL B & S Healthcare PPA1328/167/001 Tablets - SULPIRIDE 13/10/2016
ELOCON B & S Healthcare PPA1328/127/002 Ointment - MOMETASONE FUROATE 13/10/2016

FLIXOTIDE EVOHALER B & S Healthcare PPA1328/124/001 Pressurised Inhalation - FLUTICASONE 13/10/2016


Suspension PROPIONATE
FLIXOTIDE EVOHALER B & S Healthcare PPA1328/124/002 Pressurised Inhalation - FLUTICASONE 13/10/2016
Suspension PROPIONATE
FUCIDIN B & S Healthcare PPA1328/024/001 Cream - FUSIDIC ACID 13/10/2016
HYTRIN B & S Healthcare PPA1328/095/001 Tablets - TERAZOSIN 13/10/2016
HYDROCHLORIDE
HYTRIN B & S Healthcare PPA1328/095/002 Tablets - TERAZOSIN 13/10/2016
HYDROCHLORIDE
ISTIN B & S Healthcare PPA1328/082/001 Tablets - AMLODIPINE BESILATE 13/10/2016
NUASA Uniphar plc PA1455/003/001 Tablets Gastro-Resistant - ACETYLSALICYLIC ACID 13/10/2016
CREON B & S Healthcare PPA1328/065/002 Capsules Hard - PANCREATIN 12/10/2016
DIPROSALIC B & S Healthcare PPA1328/075/001 Ointment - BETAMETHASONE 12/10/2016
DIPROPIONATE
- SALICYLIC ACID
ACTONEL B & S Healthcare PPA1328/017/001 Film Coated Tablet - RISEDRONATE SODIUM 10/10/2016
BECOTIDE EVOHALER B & S Healthcare PPA1328/077/001 Pressurised Inhalation Soln - BECLOMETASONE 10/10/2016
DIPROPIONATE
BENETOR PLUS B & S Healthcare PPA1328/152/001 Film Coated Tablet - OLMESARTAN 10/10/2016
MEDOXOMIL
- HYDROCHLOROTHIAZIDE

BETTAMOUSSE B & S Healthcare PPA1328/072/001 Cutaneous Foam - BETAMETHASONE 10/10/2016


VALERATE
CANESTEN HC B & S Healthcare PPA1328/150/001 Cream - CLOTRIMAZOLE 10/10/2016
- HYDROCORTISONE
CELEBREX B & S Healthcare PPA1328/057/002 Capsules Hard - CELECOXIB 10/10/2016
COSOPT B & S Healthcare PPA1328/145/001 Eye Drops Solution - DORZOLAMIDE 10/10/2016
HYDROCHLORIDE
- TIMOLOL MALEATE
COZAAR COMP B & S Healthcare PPA1328/091/001 Film Coated Tablet - LOSARTAN POTASSIUM 10/10/2016
- HYDROCHLOROTHIAZIDE

COZAAR COMP B & S Healthcare PPA1328/091/002 Film Coated Tablet - LOSARTAN POTASSIUM 10/10/2016
- HYDROCHLOROTHIAZIDE

ADALAT LA B & S Healthcare PPA1328/047/003 Tablet Prolonged Release - NIFEDIPINE 07/10/2016


FLUCONAZOLE MILPHARM Milpharm Limited PA1050/017/002 Capsules Hard - FLUCONAZOLE 06/10/2016
150 MG CAPSULES, HARD

Human Medicines Withdrawn Products Page 124 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FLUCONAZOLE MILPHARM Milpharm Limited PA1050/017/003 Capsules Hard - FLUCONAZOLE 06/10/2016
200 MG CAPSULES, HARD

FLUCONAZOLE MILPHARM Milpharm Limited PA1050/017/001 Capsules Hard - FLUCONAZOLE 06/10/2016


50 MG CAPSULES, HARD

INCIVO Janssen-Cilag International EU/1/11/720/001 Film Coated Tablet - TELAPREVIR 06/10/2016


NV
CARBOPLATIN CIPLA Cipla Europe NV PA1963/008/001 Concentrate for Soln for Inf - CARBOPLATIN 03/10/2016
DESLORATADINE CIPLA Cipla Europe NV PA1963/006/001 Film Coated Tablet - DESLORATIDINE 30/09/2016
FINASTERIDE Cipla (EU) Limited PA1809/019/001 Film Coated Tablet - FINASTERIDE 30/09/2016
MEGGEZONES 16MG Bayer Limited PA1410/079/001 Pastilles - LEVOMENTHOL 29/09/2016
PASTILLES.
PYLERA Allergan Pharmaceuticals PA2103/002/001 Capsule - BISMUTH SUBCITRATE 29/09/2016
International Limited POTASSIUM
- METRONIDAZOLE
- TETRACYCLINE
HYDROCHLORIDE
RINSTEAD ADULT GEL Bayer Limited PA1410/078/001 Oromucosal Gel - BENZOCAINE 29/09/2016
WITH BENZOCAINE - CHLOROXYLENOL
OMEGA-3-ACID-ETHYL- Epax AS PA1849/001/001 Capsules, Soft - OMEGA-3-ACID ETHYL 28/09/2016
ESTERS EPAX ESTERS 90
COVERSYL ARGININE LTT Pharma Limited PPA1562/063/001 Film Coated Tablet - PERINDOPRIL ARGININE 26/09/2016
PLUS - INDAPAMIDE
DOLMATIL LTT Pharma Limited PPA1562/122/001 Tablets - SULPIRIDE 26/09/2016
DOLMATIL LTT Pharma Limited PPA1562/122/002 Film Coated Tablet - SULPIRIDE 26/09/2016
ESOMEPRAZOLE Cipla (EU) Limited PA1809/006/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 22/09/2016
MAGNESIUM DIHYDRATE
- ESOMEPRAZOLE
ESOMEPRAZOLE Cipla (EU) Limited PA1809/006/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 22/09/2016
MAGNESIUM DIHYDRATE
- ESOMEPRAZOLE
PANTECTA CONTROL Takeda GmbH EU/1/09/518/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 19/09/2016
SESQUIHYDRATE

PANTECTA CONTROL Takeda GmbH EU/1/09/518/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 19/09/2016
SESQUIHYDRATE

PANTECTA CONTROL Takeda GmbH EU/1/09/518/003 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 19/09/2016
SESQUIHYDRATE

PANTECTA CONTROL Takeda GmbH EU/1/09/518/004 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 19/09/2016
SESQUIHYDRATE

RINSTEAD SUGAR FREE Bayer Limited PA1410/077/001 Pastilles - CETYLPYRIDINIUM 13/09/2016


CHLORIDE
- LEVOMENTHOL
LACTULOSE RESOLUTION Resolution Chemicals PA1569/001/001 Oral Solution - LACTULOSE 12/09/2016
Limited
ISTIN Sam McCauley Chemists PPA1488/002/001 Tablets - AMLODIPINE AS 09/09/2016
Limited AMLODIPINE BESILATE
ISTIN Sam McCauley Chemists PPA1488/002/002 Tablets - AMLODIPINE AS 09/09/2016
Limited AMLODIPINE BESILATE
ZOTON FASTAB Sam McCauley Chemists PPA1488/001/001 Orodispersible Tablet - LANSOPRAZOLE 09/09/2016
Limited
ZOTON FASTAB Sam McCauley Chemists PPA1488/001/002 Orodispersible Tablet - LANSOPRAZOLE 09/09/2016
Limited
FAMCICLOVIR Fannin (UK) Ltd PA1585/005/001 Film Coated Tablet - FAMCICLOVIR 08/09/2016
FAMCICLOVIR Fannin (UK) Ltd PA1585/005/002 Film Coated Tablet - FAMCICLOVIR 08/09/2016
PRAPEXIN Rowex Ltd PA0711/163/001 Tablets - PRAMIPEXOLE 05/09/2016
PRAPEXIN Rowex Ltd PA0711/163/002 Tablets - PRAMIPEXOLE 05/09/2016
PRAPEXIN Rowex Ltd PA0711/163/003 Tablets - PRAMIPEXOLE 05/09/2016
CLARITHYROMYCIN Rowex Ltd PA0711/197/001 Granules for Oral - CLARITHROMYCIN 02/09/2016
Suspension
CLARITHYROMYCIN Rowex Ltd PA0711/197/002 Granules for Oral - CLARITHROMYCIN 02/09/2016
Suspension
DITROPAN B & S Healthcare PPA1328/092/001 Tablets - OXYBUTYNIN 01/09/2016
HYDROCHLORIDE
DITROPAN B & S Healthcare PPA1328/092/002 Tablets - OXYBUTYNIN 01/09/2016
HYDROCHLORIDE
NIVADIL Astellas Pharma Co. Ltd PA1241/013/001 Prolonged Release Capsules - NILVADIPINE 30/08/2016

NIVADIL Astellas Pharma Co. Ltd PA1241/013/002 Prolonged Release Capsules - NILVADIPINE 30/08/2016

Human Medicines Withdrawn Products Page 125 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OSVAREN Fresenius Medical Care PA1350/004/001 Film Coated Tablet - CALCIUM ACETATE 25/08/2016
Nephrologica Deutschland - MAGNESIUM
GmbH CARBONATE HEAVY
METHOTREXATE Cipla (EU) Limited PA1809/014/001 Tablets 24/08/2016
METHOTREXATE Cipla (EU) Limited PA1809/014/002 Tablets 24/08/2016
DUTASTERIDE Rowex Ltd PA0711/220/001 Capsules, Soft - DUTASTERIDE 19/08/2016
XEFO 8 MG FILM-COATED Takeda UK Limited PA1547/005/002 Film Coated Tablet - LORNOXICAM 19/08/2016
TABLETS
METHADONE TEVA Teva Pharma B.V. PA0749/116/001 Oral Solution - METHADONE 18/08/2016
HYDROCHLORIDE
OLANZAPINE CLONMEL Clonmel Healthcare Ltd PA0126/213/001 Orodispersible Tablet - OLANZAPINE 18/08/2016
OLANZAPINE CLONMEL Clonmel Healthcare Ltd PA0126/213/002 Orodispersible Tablet - OLANZAPINE 18/08/2016
OLANZAPINE CLONMEL Clonmel Healthcare Ltd PA0126/213/003 Orodispersible Tablet - OLANZAPINE 18/08/2016
OLANZAPINE CLONMEL Clonmel Healthcare Ltd PA0126/213/004 Orodispersible Tablet - OLANZAPINE 18/08/2016
PREMIQUE Pfizer Healthcare Ireland PA0822/096/001 Coated Tablets - ESTROGENS 06/08/2016
CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
PREMIQUE 5 SEPARATE Pfizer Healthcare Ireland PA0822/096/004 Tablets - ESTROGENS 06/08/2016
CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
PREMIQUE CYCLE 5 Pfizer Healthcare Ireland PA0822/096/005 Tablets - ESTROGENS 06/08/2016
SEPARATE CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
ZINATAN Clonmel Healthcare Ltd PA0126/191/001 Film Coated Tablet - CEFUROXIME 05/08/2016
ZINATAN Clonmel Healthcare Ltd PA0126/191/002 Film Coated Tablet - CEFUROXIME 05/08/2016
TAZOCIN Pfizer Healthcare Ireland PA0822/098/001 Powder for solution for - TAZOBACTAM SODIUM 03/08/2016
infusion - PIPERACILLIN SODIUM
TAZOCIN Pfizer Healthcare Ireland PA0822/098/002 Powder for solution for - PIPERACILLIN SODIUM 03/08/2016
infusion - TAZOBACTAM SODIUM
ASPIRIN Accord-UK Ltd PA0176/015/003 Dispersable Tablet - ACETYLSALICYLIC ACID 02/08/2016
CAPECITABINE CIPLA Cipla Europe NV PA1963/004/001 Film Coated Tablet - CAPECITABINE 01/08/2016
CAPECITABINE CIPLA Cipla Europe NV PA1963/004/002 Film Coated Tablet - CAPECITABINE 01/08/2016
ERTRACER M2i Limited PA1125/001/001 Solution for Injection - FLUDEOXYGLUCOSE 01/08/2016
(18F)
LEVOCETIRIZINE Cipla (EU) Limited PA1809/009/001 Film Coated Tablet - LEVOCETIRIZINE 01/08/2016
DIHYDROCHLORIDE DIHYDROCHLORIDE
LARIAM Roche Products Limited PA0050/073/001 Tablets - MEFLOQUINE 31/07/2016
HYDROCHLORIDE
ROFERON A Roche Products Limited PA0050/068/020 Solution for Injection - INTERFERON ALFA-2A 31/07/2016
ROFERON A Roche Products Limited PA0050/068/021 Solution for Injection - INTERFERON ALFA-2A 31/07/2016
ROFERON A Roche Products Limited PA0050/068/022 Solution for Injection - INTERFERON ALFA-2A 31/07/2016
ROFERON A Roche Products Limited PA0050/068/023 Solution for Injection - INTERFERON ALFA-2A 31/07/2016
ROSUVASTATIN Ranbaxy Ireland Limited PA0408/088/001 Film Coated Tablet - ROSUVASTATIN 31/07/2016
CALCIUM
ROSUVASTATIN Ranbaxy Ireland Limited PA0408/088/002 Film Coated Tablet - ROSUVASTATIN 31/07/2016
CALCIUM
ROSUVASTATIN Ranbaxy Ireland Limited PA0408/088/003 Film Coated Tablet - ROSUVASTATIN 31/07/2016
CALCIUM
ROSUVASTATIN Ranbaxy Ireland Limited PA0408/088/004 Film Coated Tablet - ROSUVASTATIN 31/07/2016
CALCIUM
- ROSUVASTATIN
GLUCOPHAGE Merck Serono Limited PA0654/019/004 Powder for Oral Solution - METFORMIN 22/07/2016
HYDROCHLORIDE
GLUCOPHAGE Merck Serono Limited PA0654/019/005 Powder for Oral Solution - METFORMIN 22/07/2016
HYDROCHLORIDE
GLUCOPHAGE Merck Serono Limited PA0654/019/006 Powder for Oral Solution - METFORMIN 22/07/2016
HYDROCHLORIDE
HEPAR SULPH A. Nelson & Company HOR1149/014/001 Not assigned - HEPAR SULPHURIS 21/07/2016
Limited CALCAREUM
PIPERACILLIN/TAZOBACT Pfizer Healthcare Ireland PA0822/179/001 Powder for solution for - PIPERACILLIN SODIUM 21/07/2016
AM infusion - TAZOBACTAM (AS
SODIUM SALT)
PIPERACILLIN/TAZOBACT Pfizer Healthcare Ireland PA0822/179/002 Powder for solution for - PIPERACILLIN SODIUM 21/07/2016
AM infusion - TAZOBACTAM (AS
SODIUM SALT)
SEPIA A. Nelson & Company HOR1149/027/001 Not assigned - SEPIA OFFICINALIS 21/07/2016
Limited

Human Medicines Withdrawn Products Page 126 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METHYLPREDNISOLONE Beacon Pharmaceuticals Ltd PA1312/010/001 Pdr+Solv for soln for inf/inj - METHYLPREDNISOLONE 07/07/2016
SODIUM SUCCINATE

METHYLPREDNISOLONE Beacon Pharmaceuticals Ltd PA1312/010/002 Pdr+Solv for soln for inf/inj - METHYLPREDNISOLONE 07/07/2016
SODIUM SUCCINATE

ZESTRIL PCO Manufacturing PPA0465/066/001 Tablets - LISINOPRIL 06/07/2016


FERROLOGIC Fresenius Medical Care PA1350/001/001 Solution for Injection - IRON SUCROSE 30/06/2016
Nephrologica Deutschland
GmbH
KRYSTEXXA Savient Pharma Ireland EU/1/12/810/001 Concentrate for Soln for Inf - PEGLOTICASE 30/06/2016
Limited
MEMANTINE Ranbaxy Ireland Limited PA0408/093/001 Film Coated Tablet - MEMANTINE 30/06/2016
HYDROCHLORIDE
MOBICAM Ranbaxy Ireland Limited PA0408/062/001 Tablets - MELOXICAM 30/06/2016
MOBICAM Ranbaxy Ireland Limited PA0408/062/002 Tablets - MELOXICAM 30/06/2016
OPGENRA Howmedica International IRL EU/1/08/489/1 Powder for implantation - EPTOTERMIN ALFA 30/06/2016
suspension
PARICALCITOL Fresenius Medical Care PA1350/005/001 Solution for Injection - PARICALCITOL 30/06/2016
FRESENIUS Nephrologica Deutschland
GmbH
PARICALCITOL Fresenius Medical Care PA1350/005/002 Solution for Injection - PARICALCITOL 30/06/2016
FRESENIUS Nephrologica Deutschland
GmbH
ESCITOMAR Genthon BV PA0740/013/001 Film Coated Tablet - ESCITALOPRAM 28/06/2016
OXALATE
ESCITOMAR Genthon BV PA0740/013/002 Film Coated Tablet - ESCITALOPRAM 28/06/2016
OXALATE
ESCITOMAR Genthon BV PA0740/013/003 Film Coated Tablet - ESCITALOPRAM 28/06/2016
OXALATE
NAT. MUR. A. Nelson & Company HOR1149/022/001 Not assigned - NATRUM CHLORATUM 28/06/2016
Limited
COVERSYL ARGININE IMED Healthcare Ltd. PPA1463/039/001 Film Coated Tablet - PERINDOPRIL ARGININE 24/06/2016
PLUS - INDAPAMIDE
ACARBOSE McDermott Laboratories Ltd PA0577/171/001 Tablets - ACARBOSE 23/06/2016
t/a Gerard Laboratories
ACARBOSE McDermott Laboratories Ltd PA0577/171/002 Tablets - ACARBOSE 23/06/2016
t/a Gerard Laboratories
CANDESARTAN MYLAN McDermott Laboratories Ltd PA0577/120/004 Tablets - CANDESARTAN 23/06/2016
t/a Gerard Laboratories CILEXETIL
DETERODINE SR McDermott Laboratories Ltd PA0577/144/001 Prolonged Release Capsules - TOLTERODINE 23/06/2016
t/a Gerard Laboratories TARTRATE
DORZOLAMIDE/TIMOLOL McDermott Laboratories Ltd PA0577/124/001 Eye Drops Solution - DORZOLAMIDE 23/06/2016
MYLAN t/a Gerard Laboratories HYDROCHLORIDE
- TIMOLOL MALEATE
ESOMEPRAZOLE MYLAN McDermott Laboratories Ltd PA0577/147/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 23/06/2016
t/a Gerard Laboratories MAGNESIUM
(AMORPHOUS)
ESOMEPRAZOLE MYLAN McDermott Laboratories Ltd PA0577/147/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 23/06/2016
t/a Gerard Laboratories MAGNESIUM
(AMORPHOUS)
GERAMOX Generics (UK) Limited PA0405/005/003 Powder for Oral Suspension - AMOXICILLIN 23/06/2016
TRIHYDRATE
GERAMOX Generics (UK) Limited PA0405/005/004 Powder for Oral Suspension - AMOXICILLIN 23/06/2016
TRIHYDRATE
GERICARB SR McDermott Laboratories Ltd PA0577/037/001 Tablets - CARBAMAZEPINE 23/06/2016
t/a Gerard Laboratories
GERICARB SR McDermott Laboratories Ltd PA0577/037/002 Tablets - CARBAMAZEPINE 23/06/2016
t/a Gerard Laboratories
GERIVENT CFC FREE McDermott Laboratories Ltd PA0577/056/001 Pressurised Inhalation - SALBUTAMOL SULFATE 23/06/2016
t/a Gerard Laboratories Suspension
LIPAPRAV McDermott Laboratories Ltd PA0577/095/001 Film Coated Tablet - PRAVASTATIN SODIUM 23/06/2016
t/a Gerard Laboratories
LIPAPRAV McDermott Laboratories Ltd PA0577/095/002 Film Coated Tablet - PRAVASTATIN SODIUM 23/06/2016
t/a Gerard Laboratories
LIPAPRAV McDermott Laboratories Ltd PA0577/095/003 Film Coated Tablet - PRAVASTATIN SODIUM 23/06/2016
t/a Gerard Laboratories
MYVAL McDermott Laboratories Ltd PA0577/102/001 Film Coated Tablet - VALACICLOVIR 23/06/2016
t/a Gerard Laboratories HYDROCHLORIDE
PRAMIPEXOLE MYLAN McDermott Laboratories Ltd PA0577/138/002 Tablets - PRAMIPEXOLE 23/06/2016
t/a Gerard Laboratories DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE MYLAN McDermott Laboratories Ltd PA0577/138/003 Tablets - PRAMIPEXOLE 23/06/2016
t/a Gerard Laboratories DIHYDROCHLORIDE
MONOHYDRATE

Human Medicines Withdrawn Products Page 127 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/001 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/002 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/003 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/004 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/005 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RISPERIDONE MYLAN McDermott Laboratories Ltd PA0577/145/006 Film Coated Tablet - RISPERIDONE 23/06/2016
t/a Gerard Laboratories
RIVASTIGMINE MYLAN McDermott Laboratories Ltd PA0577/110/001 Capsules Hard - RIVASTIGMINE 23/06/2016
t/a Gerard Laboratories HYDROGEN TARTRATE
RIVASTIGMINE MYLAN McDermott Laboratories Ltd PA0577/110/002 Capsules Hard - RIVASTIGMINE 23/06/2016
t/a Gerard Laboratories HYDROGEN TARTRATE
RIVASTIGMINE MYLAN McDermott Laboratories Ltd PA0577/110/003 Capsules Hard - RIVASTIGMINE 23/06/2016
t/a Gerard Laboratories HYDROGEN TARTRATE
RIVASTIGMINE MYLAN McDermott Laboratories Ltd PA0577/110/004 Capsules Hard - RIVASTIGMINE 23/06/2016
t/a Gerard Laboratories HYDROGEN TARTRATE
SOTOGER McDermott Laboratories Ltd PA0577/021/002 Tablets - SOTALOL 23/06/2016
t/a Gerard Laboratories HYDROCHLORIDE
STATEASE XL McDermott Laboratories Ltd PA0577/098/001 Tablet Prolonged Release - FLUVASTATIN SODIUM 23/06/2016
t/a Gerard Laboratories
TAMOXIFEN Generics (UK) Limited PA0405/001/001 Tablets - TAMOXIFEN CITRATE 23/06/2016
TAVAGER McDermott Laboratories Ltd PA0577/104/001 Film Coated Tablet - LEVOFLOXACIN 23/06/2016
t/a Gerard Laboratories
VERISOP Generics (UK) Limited PA0405/020/001 Tablets - VERAPAMIL 23/06/2016
HYDROCHLORIDE
VERISOP Generics (UK) Limited PA0405/020/002 Tablets - VERAPAMIL 23/06/2016
HYDROCHLORIDE
VERISOP Generics (UK) Limited PA0405/020/003 Tablets - VERAPAMIL 23/06/2016
HYDROCHLORIDE
CAPECITABINE SUN Sun Phamaceutical EU/1/13/831/001 Film Coated Tablet - CAPECITABINE 21/06/2016
Industries Europe B.V.
CAPECITABINE SUN Sun Phamaceutical EU/1/13/831/002 Film Coated Tablet - CAPECITABINE 21/06/2016
Industries Europe B.V.
MERC. SOL. A. Nelson & Company HOR1149/021/001 Not assigned - MERCURIUS SOLUBILIS 20/06/2016
Limited HAHNEMANNI
KALI. BICH. A. Nelson & Company HOR1149/018/001 Not assigned - KALIUM BICHROMICUM 19/06/2016
Limited
MERAPEM Ranbaxy Ireland Limited PA0408/087/001 Pdr for Soln Inj/Inf - MEROPENEM 16/06/2016
TRIHYDRATE (STERILE)
MERAPEM Ranbaxy Ireland Limited PA0408/087/002 Pdr for Soln Inj/Inf - MEROPENEM 16/06/2016
TRIHYDRATE (STERILE)
TACROLIMUS MYLAN McDermott Laboratories Ltd PA0577/148/001 Capsules Hard - TACROLIMUS 16/06/2016
t/a Gerard Laboratories
TACROLIMUS MYLAN McDermott Laboratories Ltd PA0577/148/002 Capsules Hard - TACROLIMUS 16/06/2016
t/a Gerard Laboratories
TACROLIMUS MYLAN McDermott Laboratories Ltd PA0577/148/003 Capsules Hard - TACROLIMUS 16/06/2016
t/a Gerard Laboratories
LATANOPROST Cipla (EU) Limited PA1809/013/001 Eye Drops Solution - LATANOPROST 15/06/2016
ARSEN. ALB. A. Nelson & Company HOR1149/005/001 Not assigned - ACIDUM ARSENICOSUM 13/06/2016
Limited
IMODIUM 1MG/5ML McNeil Healthcare (Ireland) PA0823/056/004 Not assigned - LOPERAMIDE 10/06/2016
Ltd HYDROCHLORIDE
SCHOLL ATHLETE’S FOOT Scholl Consumer Products PA0455/001/004 Cutaneous Spray Solution - TOLNAFTATE 10/06/2016
SPRAY LIQUID Limited
KALI. PHOS. A. Nelson & Company HOR1149/019/001 Not assigned - KALIUM PHOSPHORICUM 09/06/2016
Limited
SILICEA A. Nelson & Company HOR1149/028/001 Not assigned - SILICEA 09/06/2016
Limited
PANTOPRAZOLE Fannin (UK) Ltd PA1585/004/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 02/06/2016
SESQUIHYDRATE

AMLODIPINE Cipla (EU) Limited PA1809/018/001 Tablets - AMLODIPINE BESILATE 01/06/2016


- AMLODIPINE
AMLODIPINE Cipla (EU) Limited PA1809/018/002 Tablets - AMLODIPINE BESILATE 01/06/2016
- AMLODIPINE
CLOPIDOGREL / Teva Pharma B.V. EU/1/14/942/001-005 Film Coated Tablet - CLOPIDOGREL 01/06/2016
ACETYLSALICYLIC ACID HYDROGEN SULPHATE
TEVA - ACETYLSALICYLIC ACID
CLOPIDOGREL / Teva Pharma B.V. EU/1/14/942/006-014 Film Coated Tablet - CLOPIDOGREL 01/06/2016
ACETYLSALICYLIC ACID HYDROGEN SULPHATE
TEVA - ACETYLSALICYLIC ACID
ZESTRIL AstraZeneca UK Limited PA0970/023/001 Tablets - LISINOPRIL 01/06/2016

Human Medicines Withdrawn Products Page 128 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DESLORATADINE ACTAVIS Actavis Group PTC ehf PA1380/122/001 Orodispersible Tablet - DESLORATIDINE 30/05/2016

LOCABIOTAL Servier Laboratories (Ireland) PA0068/004/001 Nasal/Oromucosal spray - FUSAFUNGINE 28/05/2016


Ltd solution
CORDARONE X LTT Pharma Limited PPA1562/112/001 Tablets - AMIODARONE 26/05/2016
HYDROCHLORIDE
CORDARONE X LTT Pharma Limited PPA1562/112/002 Tablets - AMIODARONE 26/05/2016
HYDROCHLORIDE
DOCETAXEL MYLAN Generics (UK) Limited PA0405/077/001 Concentrate and solvent for - DOCETAXEL 25/05/2016
solution for infusion (ANHYDROUS)
DOCETAXEL MYLAN Generics (UK) Limited PA0405/077/002 Concentrate and solvent for - DOCETAXEL 25/05/2016
solution for infusion (ANHYDROUS)
DOXORUBICIN Generics (UK) Limited PA0405/097/001 Concentrate for Soln for Inf - DOXORUBICIN 25/05/2016
HYDROCHLORIDE
DOXORUBICIN Generics (UK) Limited PA0405/097/002 Powder for concentrate for - DOXORUBICIN 25/05/2016
solution for infusion HYDROCHLORIDE
DOXORUBICIN Generics (UK) Limited PA0405/097/003 Powder for concentrate for - DOXORUBICIN 25/05/2016
solution for infusion HYDROCHLORIDE
EPIRUBICIN Generics (UK) Limited PA0405/081/001 Solution for Inj/Inf - EPIRUBICIN 25/05/2016
HYDROCHLORIDE
METHOTREXATE Generics (UK) Limited PA0405/085/001 Solution for Inj/Inf - METHOTREXATE 25/05/2016
CLAVAMEL Rowex Ltd PA0711/229/001 Film Coated Tablet - AMOXICILLIN 18/05/2016
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CYCLIZINE Cipla (EU) Limited PA1809/011/001 Tablets - CYCLIZINE 13/05/2016
HYDROCHLORIDE HYDROCHLORIDE
PRIORIX-TETRA GlaxoSmithKline (Ireland) PA1077/117/002 Pdr+Solv for Soln for Inj - LIVE ATTENUATED 07/05/2016
Limited MEASLES VIRUS
(SCHWARZ STRAIN)
- LIVE ATTENUATED
MUMPS VIRUS (RIT 4385
STRAIN)
- LIVE ATTENUATED
RUBELLA VIRUS (WISTAR
RA 27/3 STRAIN)
- LIVE ATTENUATED
VARICELLA VIRUS (OKA
STRAIN)
CISPLATIN Generics (UK) Limited PA0405/082/001 Concentrate for Soln for Inf - CISPLATIN 05/05/2016
IRINOTECAN Generics (UK) Limited PA0405/079/001 Concentrate for Soln for Inf - IRINOTECAN 05/05/2016
HYDROCHLORIDE HYDROCHLORIDE
TRIHYDRATE TRIHYDRATE
PARALINK 10MG/ML Ricesteele Manufacturing Ltd PA0095/007/011 Solution for Infusion - PARACETAMOL 05/05/2016

KALILACTASOL Gambro Lundia AB PA0785/004/001 Unknown - SODIUM CHLORIDE 30/04/2016


- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- POTASSIUM CHLORIDE
- SODIUM LACTATE
- GLUCOSE
TIMOPTOL LA Santen OY PA0879/007/005 Eye Drops Solution - TIMOLOL 30/04/2016
TIMOPTOL LA Santen OY PA0879/007/006 Eye Drops Solution - TIMOLOL MALEATE 30/04/2016
TIMOPTOL UNIT DOSE Santen OY PA0879/007/003 Eye Drops Solution - TIMOLOL MALEATE 30/04/2016
TIMOPTOL UNIT DOSE Santen OY PA0879/007/004 Eye Drops Solution - TIMOLOL MALEATE 30/04/2016
BIOZAC Niche Generics Limited PA1063/011/001 Capsules Hard - FLUOXETINE 27/04/2016
HYDROCHLORIDE
BISOPROLOL FUMARATE Niche Generics Limited PA1063/044/002 Tablets - BISOPROLOL FUMARATE 27/04/2016

BISOPROLOL FUMARATE Niche Generics Limited PA1063/044/003 Tablets - BISOPROLOL FUMARATE 27/04/2016

UCERAX UCB (Pharma) Ireland PA0891/005/001 Film Coated Tablet - HYDROXYZINE 27/04/2016
Limited HYDROCHLORIDE
UCERAX UCB (Pharma) Ireland PA0891/005/002 Syrup - HYDROXYZINE 27/04/2016
Limited HYDROCHLORIDE
AERRANE (ISOFLURANE), Baxter Healthcare Limited PA0167/106/001 Inhalation Vapour Liquid - ISOFLURANE 25/04/2016
INHALATION VAPOUR,
LIQUID
CALC CARB A. Nelson & Company HOR1149/008/001 Not assigned - CALCIUM CARBONICUM 20/04/2016
Limited HAHNEMANNI (CONCHAE)

CALC. FLUOR. A. Nelson & Company HOR1149/009/001 Not assigned - CALCIUM FLUORATUM 20/04/2016
Limited

Human Medicines Withdrawn Products Page 129 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARBO VEG A. Nelson & Company HOR1149/010/001 Not assigned - CARBO VEGETABILIS 20/04/2016
Limited
BENYLIN FOUR FLU McNeil Healthcare (Ireland) PA0823/034/001 Oral Solution - DIPHENHYDRAMINE 12/04/2016
Ltd HYDROCHLORIDE
- PARACETAMOL
- PSEUDOEPHEDRINE
HYDROCHLORIDE
MOTILIUM McNeil Healthcare (Ireland) PA0823/051/004 Suppositories - DOMPERIDONE 12/04/2016
Ltd
Vinorelbine 10 mg/ml Generics (UK) Limited PA0405/083/001 Concentrate for solution for - Vinorelbine tartrate 08/04/2016
concentrate for solution for infusion
infusion
CELLUVISC EYE DROPS McDowell Pharmaceuticals DPR1473/052/002 Eye Drops Solution - CARMELLOSE SODIUM 05/04/2016
SOLUTION
COLOMYCIN INJECTION McDowell Pharmaceuticals DPR1473/059/001 Pdr for Soln Inj/Inf - COLISTIN MESILATE 05/04/2016
SODIUM
COSOPT McDowell Pharmaceuticals DPR1473/041/001 Eye Drops Solution - DORZOLAMIDE 05/04/2016
- TIMOLOL
DIPROBASE McDowell Pharmaceuticals DPR1473/051/001 Cream 05/04/2016
INEGY McDowell Pharmaceuticals DPR1473/042/002 Tablets - EZETIMIBE 05/04/2016
- SIMVASTATIN
INEGY McDowell Pharmaceuticals DPR1473/042/003 Tablets - EZETIMIBE 05/04/2016
- SIMVASTATIN
INSPRA McDowell Pharmaceuticals DPR1473/047/002 Tablets - EPLERENONE 05/04/2016
NASONEX McDowell Pharmaceuticals DPR1473/016/001 Nasal Spray Suspension - MOMETASONE FUROATE 05/04/2016

QUESTRAN McDowell Pharmaceuticals DPR1473/056/001 Powder for Oral Suspension - COLESTYRAMINE 05/04/2016
STRATTERA CAPSULES McDowell Pharmaceuticals DPR1473/054/001 Capsules Hard - ATOMOXETINE 05/04/2016
HYDROCHLORIDE
STRATTERA CAPSULES McDowell Pharmaceuticals DPR1473/054/002 Capsules Hard - ATOMOXETINE 05/04/2016
HYDROCHLORIDE
STRATTERA CAPSULES McDowell Pharmaceuticals DPR1473/054/003 Capsules Hard - ATOMOXETINE 05/04/2016
HYDROCHLORIDE
IGNATIA A. Nelson & Company HOR1149/016/001 Not assigned - STRYCHNOS IGNATII 04/04/2016
Limited
IPECAC A. Nelson & Company HOR1149/017/001 Not assigned - URAGOGA 04/04/2016
Limited IPECACUANHA
LYCOPODIUM A. Nelson & Company HOR1149/020/001 Not assigned - LYCOPODIUM CLAVATUM 04/04/2016
Limited
THUJA A. Nelson & Company HOR1149/030/001 Not assigned - THUJA OCCIDENTALIS 04/04/2016
Limited
VESITIRIM Clear Pharmacy PPA1596/023/001 Film Coated Tablet - SOLIFENACIN 29/03/2016
SUCCINATE
VESITIRIM Clear Pharmacy PPA1596/023/002 Film Coated Tablet - SOLIFENACIN 29/03/2016
SUCCINATE
MOXELLE Relon Chem Limited PA1128/008/001 Tablets - TAMOXIFEN CITRATE 24/03/2016
TAMOXIFEN Relon Chem Limited PA1128/007/001 Tablets - TAMOXIFEN CITRATE 24/03/2016
GEODON Pfizer Limited PA0019/052/006 Oral Suspension - ZIPRASIDONE 22/03/2016
HYDROCHLORIDE
MONOHYDRATE
ACERYCAL Imbat Limited PPA1151/167/001 Tablets - PERINDOPRIL ARGININE 17/03/2016
- AMLODIPINE
ACERYCAL Imbat Limited PPA1151/167/002 Tablets - PERINDOPRIL ARGININE 17/03/2016
- AMLODIPINE
ACERYCAL Imbat Limited PPA1151/167/003 Tablets - PERINDOPRIL ARGININE 17/03/2016
- AMLODIPINE
ACERYCAL Imbat Limited PPA1151/167/004 Tablets - PERINDOPRIL ARGININE 17/03/2016
- AMLODIPINE BESYLATE
COVERSYL ARGININE Imbat Limited PPA1151/014/003 Film Coated Tablet - PERINDOPRIL ARGININE 17/03/2016
COVERSYL ARGININE Imbat Limited PPA1151/014/004 Film Coated Tablet - PERINDOPRIL ARGININE 17/03/2016
COVERSYL ARGININE Imbat Limited PPA1151/085/001 Film Coated Tablet - PERINDOPRIL ARGININE 17/03/2016
PLUS - INDAPAMIDE
COZAAR COMP Imbat Limited PPA1151/095/001 Film Coated Tablet - LOSARTAN POTASSIUM 17/03/2016
- HYDROCHLOROTHIAZIDE

COZAAR COMP Imbat Limited PPA1151/095/002 Film Coated Tablet - LOSARTAN POTASSIUM 17/03/2016
- HYDROCHLOROTHIAZIDE

OMESAR Imbat Limited PPA1151/154/001 Film Coated Tablet - OLMESARTAN 17/03/2016


MEDOXOMIL
PRAVITIN Imbat Limited PPA1151/054/001 Tablets - PRAVASTATIN SODIUM 17/03/2016
INNOVACE Imbat Limited PPA1151/072/001 Tablets - ENALAPRIL MALEATE 16/03/2016
INNOVACE Imbat Limited PPA1151/072/002 Tablets - ENALAPRIL MALEATE 16/03/2016
CIFOX Rowex Ltd PA0711/168/001 Solution for Infusion - CIPROFLOXACIN 15/03/2016
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 130 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LIPITOR Imbat Limited PPA1151/011/001 Film Coated Tablet - ATORVASTATIN CALCIUM 15/03/2016
TRIHYDRATE
LIPITOR Imbat Limited PPA1151/011/002 Film Coated Tablet - ATORVASTATIN CALCIUM 15/03/2016
TRIHYDRATE
LIPITOR Imbat Limited PPA1151/011/003 Film Coated Tablet - ATORVASTATIN CALCIUM 15/03/2016
TRIHYDRATE
LIPITOR Imbat Limited PPA1151/011/004 Film Coated Tablet - ATORVASTATIN CALCIUM 15/03/2016

LIPOSTAT Imbat Limited PPA1151/004/001 Tablets - PRAVASTATIN SODIUM 15/03/2016


LIPOSTAT Imbat Limited PPA1151/004/002 Tablets - PRAVASTATIN SODIUM 15/03/2016
LIPOSTAT Imbat Limited PPA1151/004/003 Tablets - PRAVASTATIN SODIUM 15/03/2016
ZOCOR Imbat Limited PPA1151/061/001 Film Coated Tablet - SIMVASTATIN 15/03/2016
ZOCOR Imbat Limited PPA1151/061/002 Film Coated Tablet - SIMVASTATIN 15/03/2016
ZOCOR Imbat Limited PPA1151/061/003 Film Coated Tablet - SIMVASTATIN 15/03/2016
CO-DIOVAN Imbat Limited PPA1151/173/001 Film Coated Tablet - VALSARTAN 14/03/2016
- HYDROCHLOROTHIAZIDE

CO-DIOVAN Imbat Limited PPA1151/173/002 Film Coated Tablet - VALSARTAN 14/03/2016


- HYDROCHLOROTHIAZIDE

LODOTRA Mundipharma PA1688/015/001 Modified-release Tablets - PREDNISONE 14/03/2016


Pharmaceuticals Limited
LODOTRA Mundipharma PA1688/015/002 Modified-release Tablets - PREDNISONE 14/03/2016
Pharmaceuticals Limited
LODOTRA Mundipharma PA1688/015/003 Modified-release Tablets - PREDNISONE 14/03/2016
Pharmaceuticals Limited
RAMIPRIL Imbat Limited PPA1151/051/001 Tablets - RAMIPRIL 14/03/2016
RAMIPRIL Imbat Limited PPA1151/051/002 Tablets - RAMIPRIL 14/03/2016
RAMIPRIL Imbat Limited PPA1151/051/003 Tablets - RAMIPRIL 14/03/2016
SIMVASTATIN SY Genthon BV PA0740/004/002 Film Coated Tablet - SIMVASTATIN 14/03/2016
SIMVASTATIN SY Genthon BV PA0740/004/003 Film Coated Tablet - SIMVASTATIN 14/03/2016
SIMVASTATIN SY Genthon BV PA0740/004/004 Film Coated Tablet - SIMVASTATIN 14/03/2016
TRITACE Imbat Limited PPA1151/051/004 Tablets - RAMIPRIL 14/03/2016
CO-DIOVAN Imbat Limited PPA1151/173/003 Film Coated Tablet - VALSARTAN 10/03/2016
- HYDROCHLOROTHIAZIDE

DOXAZOSIN AUROBINDO Aurobindo Pharma (Malta) PA1445/006/001 Tablets - DOXAZOSIN 10/03/2016


Limited
DOXAZOSIN AUROBINDO Aurobindo Pharma (Malta) PA1445/006/002 Tablets - DOXAZOSIN 10/03/2016
Limited
DOXAZOSIN AUROBINDO Aurobindo Pharma (Malta) PA1445/006/003 Tablets - DOXAZOSIN 10/03/2016
Limited
NASACORT LTT Pharma Limited PPA1562/148/001 Nasal Spray Suspension - TRIAMCINOLONE 08/03/2016
ACETONIDE
PINACLAV Pinewood Laboratories Ltd, PA0281/145/002 Powder for Oral Suspension - AMOXICILLIN 08/03/2016
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

PINACLAV Pinewood Laboratories Ltd, PA0281/145/003 Film Coated Tablet - AMOXICILLIN 08/03/2016
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

ACERYCAL Clear Pharmacy PPA1596/033/001 Tablets - PERINDOPRIL ARGININE 07/03/2016


- AMLODIPINE BESILATE
ACERYCAL Clear Pharmacy PPA1596/033/002 Tablets - PERINDOPRIL ARGININE 07/03/2016
- AMLODIPINE BESILATE
ACERYCAL Clear Pharmacy PPA1596/033/003 Tablets - PERINDOPRIL ARGININE 07/03/2016
- AMLODIPINE BESILATE
ACERYCAL Clear Pharmacy PPA1596/033/004 Tablets - PERINDOPRIL ARGININE 07/03/2016
- AMLODIPINE BESILATE
CO-DIOVAN Clear Pharmacy PPA1596/029/001 Film Coated Tablet - VALSARTAN 07/03/2016
- HYDROCHLOROTHIAZIDE

CO-DIOVAN Clear Pharmacy PPA1596/029/002 Film Coated Tablet - VALSARTAN 07/03/2016


- HYDROCHLOROTHIAZIDE

CO-DIOVAN Clear Pharmacy PPA1596/029/003 Film Coated Tablet - VALSARTAN 07/03/2016


- HYDROCHLOROTHIAZIDE

COZAAR COMP Clear Pharmacy PPA1596/038/001 Film Coated Tablet - LOSARTAN POTASSIUM 07/03/2016
- HYDROCHLOROTHIAZIDE

Human Medicines Withdrawn Products Page 131 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COZAAR COMP Clear Pharmacy PPA1596/038/002 Film Coated Tablet - LOSARTAN POTASSIUM 07/03/2016
- HYDROCHLOROTHIAZIDE

FOSAMAX ONCE WEEKLY Clear Pharmacy PPA1596/019/001 Tablets - ALENDRONATE SODIUM 07/03/2016
TRIHYDRATE
HEXOPAL Clonmel Healthcare Ltd PA0126/144/001 Tablets - INOSITOL NICOTINATE 07/03/2016
LEXAPRO Clear Pharmacy PPA1596/013/001 Film Coated Tablet - ESCITALOPRAM 07/03/2016
LEXAPRO Clear Pharmacy PPA1596/013/002 Film Coated Tablet - ESCITALOPRAM 07/03/2016
LEXAPRO Clear Pharmacy PPA1596/013/003 Film Coated Tablet - ESCITALOPRAM 07/03/2016
OXALATE
NEBILET Clear Pharmacy PPA1596/017/001 Tablets - NEBIVOLOL 07/03/2016
HYDROCHLORIDE
OMNEXEL Clear Pharmacy PPA1596/021/001 Tablet Prolonged Release - TAMSULOSIN 07/03/2016
HYDROCHLORIDE
PARIET Clear Pharmacy PPA1596/015/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 07/03/2016
PARIET Clear Pharmacy PPA1596/015/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 07/03/2016
PAXT WPR Healthcare Limited PPA0565/037/001 Film Coated Tablet - PAROXETINE (AS 07/03/2016
PAROXETINE
HYDROCHLORIDE
ANHYDRATE)
REQUIP-MODUTAB Clear Pharmacy PPA1596/022/001 Tablet Prolonged Release - ROPINIROLE 07/03/2016
HYDROCHLORIDE
REQUIP-MODUTAB Clear Pharmacy PPA1596/022/002 Tablet Prolonged Release - ROPINIROLE 07/03/2016
HYDROCHLORIDE
REQUIP-MODUTAB Clear Pharmacy PPA1596/022/003 Tablet Prolonged Release - ROPINIROLE 07/03/2016
HYDROCHLORIDE
SEROQUEL Clear Pharmacy PPA1596/010/005 Film Coated Tablet - QUETIAPINE FUMARATE 07/03/2016
SEROQUEL XR Clear Pharmacy PPA1596/010/001 Tablet Prolonged Release - QUETIAPINE 07/03/2016
SEROQUEL XR Clear Pharmacy PPA1596/010/002 Tablet Prolonged Release - QUETIAPINE 07/03/2016
SEROQUEL XR Clear Pharmacy PPA1596/010/003 Tablet Prolonged Release - QUETIAPINE 07/03/2016
SEROQUEL XR Clear Pharmacy PPA1596/010/004 Tablet Prolonged Release - QUETIAPINE 07/03/2016
TOBI Clear Pharmacy PPA1596/056/001 Nebuliser Solution - TOBRAMYCIN 07/03/2016
VALCYTE Clear Pharmacy PPA1596/055/001 Film Coated Tablet - VALGANCICLOVIR 07/03/2016
XATRAL Clear Pharmacy PPA1596/028/001 Tablet Prolonged Release - ALFUZOSIN 07/03/2016
HYDROCHLORIDE
FOSAMAX ONCE WEEKLY Profind Wholesale Ltd PPA1500/075/001 Tablets - ALENDRONIC ACID 02/03/2016
NUEDEXTA Jenson Pharmaceutical EU/1/13/833/001-002 Capsules Hard - DEXTROMETHORPHAN 02/03/2016
Services Ltd HYDROBROMIDE
- QUINIDINE SULFATE
NUEDEXTA Jenson Pharmaceutical EU/1/13/833/003 Capsules Hard - DEXTROMETHORPHAN 02/03/2016
Services Ltd HYDROBROMIDE
- QUINIDINE SULFATE
AMLID Pinewood Laboratories Ltd, PA0281/122/001 Tablets - AMLODIPINE MALEATE 01/03/2016
AMLID Pinewood Laboratories Ltd, PA0281/122/002 Tablets - AMLODIPINE MALEATE 01/03/2016
DF 118 Galen Limited PA1329/007/001 Tablets - DIHYDROCODEINE 01/03/2016
BITARTRATE
DOPACIS CIS bio International PA0677/019/001 Solution for Injection - FLUORODOPA (18 F) 01/03/2016
PARAMOL Galen Limited PA1329/006/001 Tablets - PARACETAMOL 01/03/2016
- DIHYDROCODEINE
BITARTRATE
ANUGESIC HC Pfizer Healthcare Ireland PA0822/009/002 Suppositories - PRAMOCAINE 29/02/2016
HYDROCHLORIDE
- HYDROCORTISONE
ACETATE
- BENZYL BENZOATE
- BISMUTH OXIDE
- BALSAM PERU
- ZINC OXIDE
- BISMUTH SUBGALLATE
PRO-BANTHINE Archimedes Pharma UK PA0757/009/001 Coated Tablets - PROPANTHELINE 29/02/2016
Limited BROMIDE
ZOLEDRONIC ACID Pfizer Healthcare Ireland PA0822/154/001 Concentrate for Soln for Inf - ZOLEDRONIC ACID 29/02/2016
MONOHYDRATE
IMOGAS McNeil Healthcare (Ireland) PA0823/065/001 Capsules, Soft - DIMETICONE, ACTIVATED 28/02/2016
Ltd
OXALIPLATIN Accord Healthcare Limited PA1390/034/001 Powder for solution for - OXALIPLATIN 26/02/2016
infusion
Kepivance Amgen Europe B.V. EU/1/05/314/001 Powder for solution for - Palifermin 24/02/2016
injection
CIRCLET Merck Sharp & Dohme PA1286/049/001 Unknown - ETONOGESTREL 23/02/2016
Ireland (Human Health) - ETHINYLESTRADIOL
Limited
ZITHROMAX Pfizer Limited PA0019/047/008 Film Coated Tablet - AZITHROMYCIN 19/02/2016
DIHYDRATE

Human Medicines Withdrawn Products Page 132 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZITHROMAX Pfizer Limited PA0019/047/009 Film Coated Tablet - AZITHROMYCIN 19/02/2016
DIHYDRATE
ZITHROMAX Pfizer Limited PA0019/047/010 Film Coated Tablet - AZITHROMYCIN 19/02/2016
DIHYDRATE
EPILIM Imbat Limited PPA1151/117/002 Tablets Gastro-Resistant - VALPROATE SODIUM 18/02/2016
EPILIM ENTERIC Imbat Limited PPA1151/117/001 Tablets Gastro-Resistant - VALPROATE SODIUM 18/02/2016
AZITHROMYCIN PFIZER Pfizer Limited PA0019/093/001 Capsules Hard - AZITHROMYCIN 16/02/2016
DIHYDRATE
AZITHROMYCIN PFIZER Pfizer Limited PA0019/093/002 Powder for Oral Suspension - AZITHROMYCIN 16/02/2016
DIHYDRATE
GEODON Pfizer Limited PA0019/052/005 Pdr+Solv for Soln for Inj - ZIPRASIDONE MESILATE 16/02/2016
TRIHYDRATE
HALF-INDERAL LA Imbat Limited PPA1151/157/001 Prolonged Release Capsules - PROPRANOLOL 09/02/2016
HYDROCHLORIDE
ESOMEPRAZOLE Hospira UK Limited PA0437/071/001 Pdr for Soln Inj/Inf - ESOMEPRAZOLE 08/02/2016
SODIUM
CLOPIDOGREL Wockhardt UK Limited PA1339/026/001 Film Coated Tablet - CLOPIDOGREL 03/02/2016
HYDROCHLORIDE
MICROVAL Pfizer Healthcare Ireland PA0822/067/001 Tablets - LEVONORGESTREL 02/02/2016
ALENDRONIC ACID CEFT Milpharm Limited PA1050/019/001 Tablets - SODIUM ALENDRONATE 01/02/2016
DAUNOXOME Galen Limited PA1329/009/001 Concentrate for Soln for Inf - DAUNORUBICIN CITRATE 31/01/2016

ROCALTROL Roche Products Limited PA0050/047/001 Capsules, Soft - CALCITRIOL 31/01/2016


MIDAZOLAM INJECTION B Accord Healthcare Limited PA1390/010/003 Solution for Inj/Inf - MIDAZOLAM 29/01/2016

MIDAZOLAM INJECTION B Accord Healthcare Limited PA1390/010/004 Solution for Inj/Inf - MIDAZOLAM 29/01/2016

PARACETAMOL MAX Aziende Chimiche Riunite PA0959/004/001 Tablets - PARACETAMOL 29/01/2016


Angelini Francesco
GEMCITABINE Generics (UK) Limited PA0405/080/001 Powder for solution for - GEMCITABINE 22/01/2016
infusion HYDROCHLORIDE
GEMCITABINE Generics (UK) Limited PA0405/080/002 Powder for solution for - GEMCITABINE 22/01/2016
infusion HYDROCHLORIDE
OXALIPLATIN Generics (UK) Limited PA0405/078/002 Powder for solution for - OXALIPLATIN 22/01/2016
infusion
TEVETEN LTT Pharma Limited PPA1562/085/001 Film Coated Tablet - EPROSARTAN MESYLATE 22/01/2016

LUSERT Pinewood Laboratories Ltd, PA0281/121/001 Film Coated Tablet - SERTRALINE 20/01/2016
HYDROCHLORIDE
LUSERT Pinewood Laboratories Ltd, PA0281/121/002 Film Coated Tablet - SERTRALINE 20/01/2016
HYDROCHLORIDE
DONEPEZIL NICHE Niche Generics Limited PA1063/046/001 Orodispersible Tablet - DONEPEZIL 19/01/2016
HYDROCHLORIDE
DONEPEZIL NICHE Niche Generics Limited PA1063/046/002 Orodispersible Tablet - DONEPEZIL 19/01/2016
HYDROCHLORIDE
SILDENAFIL PFIZER LTT Pharma Limited PPA1562/117/001 Film Coated Tablet - SILDENAFIL CITRATE 12/01/2016
SILDENAFIL PFIZER LTT Pharma Limited PPA1562/117/002 Film Coated Tablet - SILDENAFIL CITRATE 12/01/2016
CANESTEN HC CREAM LTT Pharma Limited PPA1562/095/001 Cream - CLOTRIMAZOLE 08/01/2016
- HYDROCORTISONE
SEROQUEL XR LTT Pharma Limited PPA1562/116/001 Tablet Prolonged Release - QUETIAPINE FUMARATE 08/01/2016
SEROQUEL XR LTT Pharma Limited PPA1562/116/002 Tablet Prolonged Release - QUETIAPINE FUMARATE 08/01/2016
SEROQUEL XR LTT Pharma Limited PPA1562/116/003 Tablet Prolonged Release - QUETIAPINE FUMARATE 08/01/2016
SEROQUEL XR LTT Pharma Limited PPA1562/116/004 Tablet Prolonged Release - QUETIAPINE FUMARATE 08/01/2016
ALPHAGAN LTT Pharma Limited PPA1562/090/001 Ear Drops Solution - BRIMONIDINE TARTRATE 07/01/2016

LUSTRAL LTT Pharma Limited PPA1562/094/001 Film Coated Tablet - SERTRALINE 07/01/2016
HYDROCHLORIDE
LUSTRAL LTT Pharma Limited PPA1562/094/002 Film Coated Tablet - SERTRALINE 07/01/2016
HYDROCHLORIDE
COVERSYL ARGININE LTT Pharma Limited PPA1562/079/001 Film Coated Tablet - PERINDOPRIL ARGININE 06/01/2016
COVERSYL ARGININE LTT Pharma Limited PPA1562/079/002 Film Coated Tablet - PERINDOPRIL ARGININE 06/01/2016
NATRIXAM Les Laboratoires Servier PA0568/026/001 Modified-release Tablets - INDAPAMIDE 06/01/2016
- AMLODIPINE AS
AMLODIPINE BESILATE
NATRIXAM Les Laboratoires Servier PA0568/026/002 Modified-release Tablets - INDAPAMIDE 06/01/2016
- AMLODIPINE AS
AMLODIPINE BESILATE
OSTEOLE Pinewood Laboratories Ltd, PA0281/135/001 Powder for Oral Solution - GLUCOSAMINE SULFATE 06/01/2016
SODIUM CHLORIDE

ACULAR LTT Pharma Limited PPA1562/037/001 Eye Drops Solution - KETOROLAC 05/01/2016
TROMETAMOL
BETOPTIC LTT Pharma Limited PPA1562/047/001 Eye Drops Solution - BETAXOLOL 05/01/2016
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 133 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SELECTOL LTT Pharma Limited PPA1562/048/001 Film Coated Tablet - CELIPROLOL 05/01/2016
HYDROCHLORIDE
SELECTOL LTT Pharma Limited PPA1562/048/002 Tablets - CELIPROLOL 05/01/2016
HYDROCHLORIDE
AMARYL 2 MG TABLET Sanofi-Aventis Ireland PA0540/028/002 Tablets - GLIMEPIRIDE 04/01/2016
Limited T/A SANOFI
AMARYL 4 MG TABLET Sanofi-Aventis Ireland PA0540/028/004 Tablets - GLIMEPIRIDE 04/01/2016
Limited T/A SANOFI
CEFODOX Sanofi-Aventis Ireland PA0540/033/002 Film Coated Tablet - CEFPODOXIME 04/01/2016
Limited T/A SANOFI PROXETIL
DAONIL Sanofi-Aventis Ireland PA0540/039/001 Tablets - GLIBENCLAMIDE 04/01/2016
Limited T/A SANOFI
IKOREL LTT Pharma Limited PPA1562/033/001 Tablets - NICORANDIL 04/01/2016
IKOREL LTT Pharma Limited PPA1562/033/002 Tablets - NICORANDIL 04/01/2016
LASIX Sanofi-Aventis Ireland PA0540/052/004 Tablets - FUROSEMIDE 04/01/2016
Limited T/A SANOFI
LASIX Sanofi-Aventis Ireland PA0540/052/005 Tablets - FUROSEMIDE 04/01/2016
Limited T/A SANOFI
PHENERGAN Sanofi-Aventis Ireland PA0540/121/004 Solution for Injection - PROMETHAZINE 04/01/2016
Limited T/A SANOFI HYDROCHLORIDE
TILDIEM 60MG Sanofi-Aventis Ireland PA0540/161/003 Tablet Prolonged Release - DILTIAZEM 04/01/2016
PROLONGED RELEASE Limited T/A SANOFI HYDROCHLORIDE
TABLETS
TILDIEM LA Sanofi-Aventis Ireland PA0540/161/001 Prolonged Release Capsules - DILTIAZEM 04/01/2016
Limited T/A SANOFI HYDROCHLORIDE
TILDIEM LA Sanofi-Aventis Ireland PA0540/161/002 Prolonged Release Capsules - DILTIAZEM 04/01/2016
Limited T/A SANOFI HYDROCHLORIDE
TILDIEM RETARD 120 MG Sanofi-Aventis Ireland PA0540/161/005 Tablets - DILTIAZEM 04/01/2016
PROLONGED RELEASE Limited T/A SANOFI HYDROCHLORIDE
TABLETS
TILDIEM RETARD 90 MG Sanofi-Aventis Ireland PA0540/161/004 Tablets - DILTIAZEM 04/01/2016
PROLONGED RELEASE Limited T/A SANOFI HYDROCHLORIDE
TABLETS
NANOGAM Sanquin PA1656/001/001 Solution for Infusion - HUMAN NORMAL 01/01/2016
IMMUNOGLOBULIN
ALESSE Pfizer Healthcare Ireland PA0822/065/001 Film Coated Tablet - LEVONORGESTREL 31/12/2015
- ETHINYLESTRADIOL
ARICEPT PCO Manufacturing PPA0465/108/001 Film Coated Tablet - DONEPEZIL 31/12/2015
HYDROCHLORIDE
ARICEPT PCO Manufacturing PPA0465/108/002 Film Coated Tablet - DONEPEZIL 31/12/2015
HYDROCHLORIDE
BELLISIN WPR Healthcare Limited PPA0565/047/001 Tablets - LISINOPRIL DIHYDRATE 31/12/2015
EMCOR PCO Manufacturing PPA0465/087/001 Film Coated Tablet - BISOPROLOL FUMARATE 31/12/2015

FLIXONASE AQUEOUS PCO Manufacturing PPA0465/285/001 Nasal Spray Suspension - FLUTICASONE 31/12/2015
PROPIONATE
GABAPENTIN TEVA WPR Healthcare Limited PPA0565/032/001 Capsules Hard - GABAPENTIN 31/12/2015
GABAPENTIN TEVA WPR Healthcare Limited PPA0565/032/002 Capsules Hard - GABAPENTIN 31/12/2015
GABAPENTIN TEVA WPR Healthcare Limited PPA0565/032/003 Capsules Hard - GABAPENTIN 31/12/2015
GYNO-DAKTARIN PCO Manufacturing PPA0465/291/001 Vaginal Cream - MICONAZOLE NITRATE 31/12/2015
HARMONET Pfizer Healthcare Ireland PA0822/066/001 Coated Tablets - GESTODENE 31/12/2015
- ETHINYLESTRADIOL
LYRINEL XL PCO Manufacturing PPA0465/295/001 Tablet Prolonged Release - OXYBUTYNIN 31/12/2015
HYDROCHLORIDE
NORCURON 10 MG, NV Organon PA0964/002/002 Pdr+Solv for Soln for Inj - VECURONIUM BROMIDE 31/12/2015
POWDER FOR SOLUTION
FOR INJECTION
OVRAN 250MCG/50MCG Pfizer Healthcare Ireland PA0822/068/001 Coated Tablets - LEVONORGESTREL 31/12/2015
COATED TABLETS. - ETHINYLESTRADIOL
PRAVASTATIN SODIUM WPR Healthcare Limited PPA0565/028/001 Tablets - PRAVASTATIN SODIUM 31/12/2015
PRAVASTATIN SODIUM WPR Healthcare Limited PPA0565/028/002 Tablets - PRAVASTATIN SODIUM 31/12/2015
PRAVASTATIN SODIUM WPR Healthcare Limited PPA0565/028/003 Tablets - PRAVASTATIN SODIUM 31/12/2015
RISPEVA WPR Healthcare Limited PPA0565/049/001 Film Coated Tablet - RISPERIDONE 31/12/2015
RISPEVA WPR Healthcare Limited PPA0565/049/002 Film Coated Tablet - RISPERIDONE 31/12/2015
RISPEVA WPR Healthcare Limited PPA0565/049/003 Film Coated Tablet - RISPERIDONE 31/12/2015
SEROQUEL XR PCO Manufacturing PPA0465/153/006 Tablet Prolonged Release - QUETIAPINE FUMARATE 31/12/2015
SEROQUEL XR PCO Manufacturing PPA0465/153/007 Tablet Prolonged Release - QUETIAPINE FUMARATE 31/12/2015
SEROQUEL XR PCO Manufacturing PPA0465/153/008 Tablet Prolonged Release - QUETIAPINE FUMARATE 31/12/2015
SEROQUEL XR PCO Manufacturing PPA0465/153/009 Tablet Prolonged Release - QUETIAPINE FUMARATE 31/12/2015
LANTANOPROST PFIZER Pfizer Healthcare Ireland PA0822/064/001 Eye Drops Solution - LATANOPROST 24/12/2015
LANTANOPROST/TIMOLOL Pfizer Healthcare Ireland PA0822/092/001 Eye Drops Solution - LANTANOPROST 24/12/2015
- TIMOLOL MALEATE
CALLOUS REMOVAL PADS Scholl Consumer Products PA0455/006/003 Impregnated Dressing - SALICYLIC ACID 22/12/2015
Limited

Human Medicines Withdrawn Products Page 134 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CORN REMOVAL PADS Scholl Consumer Products PA0455/006/001 Medicated Plaster - SALICYLIC ACID 22/12/2015
Limited
SCHOLL CORN REMOVAL Scholl Consumer Products PA0455/007/001 Medicated Plaster - SALICYLIC ACID 22/12/2015
Limited
ATECOR Imbat Limited PPA1151/055/001 Film Coated Tablet - ATENOLOL 21/12/2015
ATECOR Imbat Limited PPA1151/055/002 Film Coated Tablet - ATENOLOL 21/12/2015
ATECOR Imbat Limited PPA1151/055/003 Film Coated Tablet - ATENOLOL 21/12/2015
ZIPRASIDONE PFIZER Pfizer Limited PA0019/094/001 Capsules Hard - ZIPRASIDONE 21/12/2015
HYDROCHLORIDE
MONOHYDRATE
ZIPRASIDONE PFIZER Pfizer Limited PA0019/094/002 Capsules Hard - ZIPRASIDONE 21/12/2015
HYDROCHLORIDE
MONOHYDRATE
ZIPRASIDONE PFIZER Pfizer Limited PA0019/094/003 Capsules Hard - ZIPRASIDONE 21/12/2015
HYDROCHLORIDE
MONOHYDRATE
ZIPRASIDONE PFIZER Pfizer Limited PA0019/094/004 Capsules Hard - ZIPRASIDONE 21/12/2015
HYDROCHLORIDE
MONOHYDRATE
ZIPRASIDONE PFIZER Pfizer Limited PA0019/094/005 Oral Suspension - ZIPRASIDONE 21/12/2015
HYDROCHLORIDE
MONOHYDRATE
LIQUIFILM TEARS OCULAR Allergan Pharmaceuticals PA0148/026/001 Eye Drops Solution - POLYVINYL ALCOHOL 20/12/2015
LUBRICANT Ireland
OXALIPLATIN Accord Healthcare Limited PA1390/023/002 Powder for solution for - OXALIPLATIN 18/12/2015
infusion
SKINOREN 20% W/W Bayer Limited PA1410/072/001 Cream - AZELAIC ACID 18/12/2015
CREAM
REPEVAX Sanofi Pasteur MSD Ltd PA0544/036/002 Suspension for Injection - TETANUS TOXOID 17/12/2015
- DIPHTHERIA TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
- ADSORBED FIMBRIAE
TYPES 2 + 3
BETAGAN LTT Pharma Limited PPA1562/056/001 Eye Drops Solution - LEVOBUNOLOL 16/12/2015
HYDROCHLORIDE
Donesyn 10mg Clonmel Healthcare Ltd PA0126/214/002 Orodispersible tablet - Donepezil hydrochloride 16/12/2015
Orodispersible Tablets
Donesyn 5mg Orodispersible Clonmel Healthcare Ltd PA0126/214/001 Orodispersible tablet - Donepezil hydrochloride 16/12/2015
Tablets
DULOXETINE CLONMEL Clonmel Healthcare Ltd PA0126/269/001 Capsules Gastro-Resistant - DULOXETINE 16/12/2015
HYDROCHLORIDE
DULOXETINE CLONMEL Clonmel Healthcare Ltd PA0126/269/003 Capsules Gastro-Resistant - DULOXETINE 16/12/2015
HYDROCHLORIDE
ETALOPRO MELTS Clonmel Healthcare Ltd PA0126/212/005 Orodispersible Tablet - ESCITALOPRAM 16/12/2015
OXALATE
ETALOPRO MELTS Clonmel Healthcare Ltd PA0126/212/006 Orodispersible Tablet - ESCITALOPRAM 16/12/2015
OXALATE
ETALOPRO MELTS Clonmel Healthcare Ltd PA0126/212/007 Orodispersible Tablet - ESCITALOPRAM 16/12/2015
OXALATE
ETALOPRO MELTS Clonmel Healthcare Ltd PA0126/212/008 Orodispersible Tablet - ESCITALOPRAM 16/12/2015
OXALATE
GALANTAX XL Clonmel Healthcare Ltd PA0126/222/001 Prolonged Release Capsules - GALANTAMINE 16/12/2015
HYDROBROMIDE
GALANTAX XL Clonmel Healthcare Ltd PA0126/222/002 Prolonged Release Capsules - GALANTAMINE 16/12/2015
HYDROBROMIDE
GALANTAX XL Clonmel Healthcare Ltd PA0126/222/003 Prolonged Release Capsules - GALANTAMINE 16/12/2015
HYDROBROMIDE
LANAFINE Niche Generics Limited PA1063/018/001 Cream - TERBINAFINE 16/12/2015
HYDROCHLORIDE
LANAFINE AFR Niche Generics Limited PA1063/018/002 Cream - TERBINAFINE 16/12/2015
HYDROCHLORIDE
METHOTREXATE Clonmel Healthcare Ltd PA0126/262/001 Solution for injection in pre- - METHOTREXATE 16/12/2015
CLONMEL filled syringe
IKOREL IMED Healthcare Ltd. PPA1463/088/001 Tablets - NICORANDIL 15/12/2015
IKOREL IMED Healthcare Ltd. PPA1463/088/002 Tablets - NICORANDIL 15/12/2015
SEROQUEL XR IMED Healthcare Ltd. PPA1463/048/004 Tablet Prolonged Release - QUETIAPINE FUMARATE 15/12/2015

Human Medicines Withdrawn Products Page 135 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FREESTOM Sanofi-Aventis Ireland PA0540/167/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 14/12/2015
Limited T/A SANOFI SESQUIHYDRATE

SERTRALINE PFIZER Pfizer Healthcare Ireland PA0822/025/001 Film Coated Tablet - SERTRALINE 14/12/2015
HYDROCHLORIDE
SERTRALINE PFIZER Pfizer Healthcare Ireland PA0822/025/002 Film Coated Tablet - SERTRALINE 14/12/2015
HYDROCHLORIDE
SILDENAFIL ZENTIVA Sanofi-Aventis Ireland PA0540/171/001 Film Coated Tablet - SILDENAFIL BASE (AS 14/12/2015
Limited T/A SANOFI CITRATE)
SILDENAFIL ZENTIVA Sanofi-Aventis Ireland PA0540/171/002 Film Coated Tablet - SILDENAFIL BASE (AS 14/12/2015
Limited T/A SANOFI CITRATE)
SILDENAFIL ZENTIVA Sanofi-Aventis Ireland PA0540/171/003 Film Coated Tablet - SILDENAFIL BASE (AS 14/12/2015
Limited T/A SANOFI CITRATE)
ZOLMITRIPTAN SANOFI Sanofi-Aventis Ireland PA0540/172/001 Film Coated Tablet - ZOLMITRIPTAN 14/12/2015
Limited T/A SANOFI
ZOLMITRIPTAN SANOFI Sanofi-Aventis Ireland PA0540/172/002 Orodispersible Tablet - ZOLMITRIPTAN 14/12/2015
Limited T/A SANOFI
COMPOUND SODIUM Baxter Healthcare Limited PA0167/055/001 Solution for Infusion - SODIUM CHLORIDE 03/12/2015
LACTATE INTRAVENOUS - SODIUM LACTATE
INFUSION BP, - POTASSIUM CHLORIDE
(HARTMANN’S SOLUTION) - CALCIUM CHLORIDE
DIHYDRATE
APIS MEL A. Nelson & Company HOR1149/002/001 Not assigned - APIS MELLIFICA 02/12/2015
Limited
ROPIRADE XL Clonmel Healthcare Ltd PA0126/221/001 Tablet Prolonged Release - ROPINIROLE (AS 02/12/2015
HYDROCHLORIDE)
ROPIRADE XL Clonmel Healthcare Ltd PA0126/221/002 Tablet Prolonged Release - ROPINIROLE (AS 02/12/2015
HYDROCHLORIDE)
ROPIRADE XL Clonmel Healthcare Ltd PA0126/221/003 Tablet Prolonged Release - ROPINIROLE (AS 02/12/2015
HYDROCHLORIDE)
LATANOPROST/TIMOLOL Portfarma ehf PA1625/001/001 Eye Drops Solution - LATANOPROST 01/12/2015
PORTFARMA - TIMOLOL MALEATE
CEFUROXIME ACTAVIS Actavis Group PTC ehf PA1380/066/001 Pdr for Soln for Injection - CEFUROXIME SODIUM 25/11/2015
CEFUROXIME ACTAVIS Actavis Group PTC ehf PA1380/066/002 Pdr for Soln for Injection - CEFUROXIME SODIUM 25/11/2015
CEFUROXIME ACTAVIS Actavis Group PTC ehf PA1380/066/003 Pdr for Soln Inj/Inf - CEFUROXIME SODIUM 25/11/2015
(STERILE)
EXEMESTANE PFIZER Pfizer Healthcare Ireland PA0822/071/001 Coated Tablets - EXEMESTANE 23/11/2015
NIVOLUMAB BMS Bristol-Myers Squibb Pharma EU/1/15/1026/001-002 Concentrate for Soln for Inf - NIVOLUMAB (BMS- 23/11/2015
EEIG 936558)
- NIVOLUMAB (BMS-
936558)
SODIUM CHLORIDE AND Baxter Healthcare Limited PA0167/050/005 Solution for Infusion - SODIUM CHLORIDE 20/11/2015
GLUCOSE - GLUCOSE
DONEPEZIL NICHE Niche Generics Limited PA1063/043/001 Film Coated Tablet - DONEPEZIL 18/11/2015
HYDROCHLORIDE
DONEPEZIL NICHE Niche Generics Limited PA1063/043/002 Film Coated Tablet - DONEPEZIL 18/11/2015
HYDROCHLORIDE
NARAMIG GlaxoSmithKline (Ireland) PA1077/009/001 Coated Tablets - NARATRIPTAN 13/11/2015
Limited HYDROCHLORIDE
REQUIP GlaxoSmithKline (Ireland) PA1077/037/002 Film Coated Tablet - ROPINIROLE 13/11/2015
Limited HYDROCHLORIDE
VENLAFAXINE Rowex Ltd PA0711/160/001 Tablets - VENLAFAXINE 12/11/2015
HYDROCHLORIDE
VENLAFAXINE Rowex Ltd PA0711/160/002 Tablets - VENLAFAXINE 12/11/2015
HYDROCHLORIDE
ACTONEL PLUS B & S Healthcare PPA1328/090/001 Film Coated Tablet - RISEDRONATE SODIUM 09/11/2015
- CALCIUM CARBONATE
- COLECALCIFEROL
ADALAT LA B & S Healthcare PPA1328/047/001 Tablet Prolonged Release - NIFEDIPINE 09/11/2015
ATACAND B & S Healthcare PPA1328/018/002 Tablets - CANDESARTAN 09/11/2015
CILEXETIL
BRICANYL TURBOHALER B & S Healthcare PPA1328/055/001 Inhalation powder - TERBUTALINE SULFATE 09/11/2015
CELLUVISC B & S Healthcare DPR1328/027/001 Eye Drops Solution - CARMELLOSE SODIUM 09/11/2015
CO-DIOVAN B & S Healthcare PPA1328/178/003 Film Coated Tablet - VALSARTAN 09/11/2015
- HYDROCHLOROTHIAZIDE

CRESTOR B & S Healthcare PPA1328/059/002 Film Coated Tablet - ROSUVASTATIN 09/11/2015


CALCIUM
DALACIN C B & S Healthcare PPA1328/132/001 Capsules Hard - CLINDAMYCIN 09/11/2015
HYDROCHLORIDE
EFEXOR XL B & S Healthcare PPA1328/118/003 Prolonged Release Capsules - VENLAFAXINE 09/11/2015
HYDROCHLORIDE
ELANTAN LA B & S Healthcare PPA1328/103/001 Prolonged Release Capsules - ISOSORBIDE 09/11/2015
MONONITRATE
EPANUTIN B & S Healthcare PPA1328/147/002 Capsules Hard - PHENYTOIN SODIUM 09/11/2015

Human Medicines Withdrawn Products Page 136 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FOSAMAX ONCE WEEKLY B & S Healthcare PPA1328/205/001 Tablets - ALENDRONATE SODIUM 09/11/2015
TRIHYDRATE
INEGY B & S Healthcare DPR1328/012/003 Tablets - EZETIMIBE 09/11/2015
- SIMVASTATIN
LEXAPRO B & S Healthcare PPA1328/084/001 Film Coated Tablet - ESCITALOPRAM 09/11/2015
LOSEC MUPS B & S Healthcare PPA1328/015/003 Tablets Gastro-Resistant - OMEPRAZOLE 09/11/2015
LUSTRAL B & S Healthcare PPA1328/085/001 Film Coated Tablet - SERTRALINE 09/11/2015
HYDROCHLORIDE
LYRINEL XL B & S Healthcare DPR1328/018/002 Tablet Prolonged Release - OXYBUTYNIN 09/11/2015
HYDROCHLORIDE
MYCOSTATIN B & S Healthcare PPA1328/171/001 Oral Suspension - NYSTATIN 09/11/2015
NAPROSYN EC B & S Healthcare PPA1328/097/001 Tablets Gastro-Resistant - NAPROXEN 09/11/2015
NAPROSYN EC B & S Healthcare PPA1328/097/002 Tablets Gastro-Resistant - NAPROXEN 09/11/2015
NITROLINGUAL B & S Healthcare PPA1328/149/001 Sublingual spray, solution - GLYCERYL TRINITRATE 09/11/2015
PUMPSPRAY
OXIS TURBOHALER B & S Healthcare PPA1328/130/001 Inhalation powder - FORMOTEROL 09/11/2015
FUMATRATE DIHYDRATE
PHYLLOCONTIN B & S Healthcare PPA1328/031/001 Tablet Prolonged Release - AMINOPHYLLINE 09/11/2015
CONTINUS HYDRATE
PLAQUENIL B & S Healthcare PPA1328/177/001 Film Coated Tablet - HYDROXYCHLOROQUINE 09/11/2015
SULFATE

PULMICORT RESPULES B & S Healthcare PPA1328/113/003 Nebuliser Suspension - BUDESONIDE 09/11/2015


SINEMET PLUS B & S Healthcare PPA1328/037/001 Tablets - LEVODOPA 09/11/2015
- CARBIDOPA
TROSYL NAIL SOLUTION B & S Healthcare PPA1328/156/001 Cutaneous Solution - TIOCONAZOLE 09/11/2015
VENTOLIN NEBULES B & S Healthcare PPA1328/041/002 Nebuliser Solution - SALBUTAMOL SULFATE 09/11/2015
ZANAFLEX B & S Healthcare PPA1328/153/001 Tablets - TIZANIDINE 09/11/2015
HYDROCHLORIDE
ZOMIG B & S Healthcare PPA1328/005/001 Tablets - ZOLMITRIPTAN 09/11/2015
PINACLAV Pinewood Laboratories Ltd, PA0281/093/001 Powder for Oral Suspension - AMOXICILLIN 06/11/2015
- CLAVULANIC ACID
PINACLAV Pinewood Laboratories Ltd, PA0281/093/002 Tablets - AMOXICILLIN 06/11/2015
- CLAVULANIC ACID
PINACLAV Pinewood Laboratories Ltd, PA0281/093/003 Tablets - AMOXICILLIN 06/11/2015
- CLAVULANIC ACID
ACCUPRO B & S Healthcare PPA1328/045/002 Film Coated Tablet - QUINAPRIL 05/11/2015
HYDROCHLORIDE
ARICEPT B & S Healthcare PPA1328/087/001 Film Coated Tablet - DONEPEZIL 05/11/2015
HYDROCHLORIDE
ARYTHMOL B & S Healthcare PPA1328/049/001 Film Coated Tablet - PROPAFENONE 05/11/2015
HYDROCHLORIDE
ATACAND B & S Healthcare PPA1328/018/003 Tablets - CANDESARTAN 05/11/2015
CILEXETIL
BENETOR PLUS B & S Healthcare PPA1328/152/002 Film Coated Tablet - OLMESARTAN 05/11/2015
MEDOXOMIL
- HYDROCHLOROTHIAZIDE

BETAGAN B & S Healthcare PPA1328/137/001 Eye Drops Solution - LEVOBUNOLOL 05/11/2015


HYDROCHLORIDE
BICALUTAMIDE Farmaprojects S.A. PA1391/001/001 Film Coated Tablet - BICALUTAMIDE 05/11/2015
FARMAPROJECTS
CAPOTEN B & S Healthcare PPA1328/056/002 Tablets - CAPTOPRIL 05/11/2015
CLEXANE B & S Healthcare PPA1328/064/001 Solution for Injection - ENOXAPARIN SODIUM 05/11/2015
COMBIGAN B & S Healthcare DPR1328/028/001 Eye Drops Solution - BRIMONIDINE TARTRATE 05/11/2015
- TIMOLOL

DETRUSITOL SR B & S Healthcare PPA1328/061/003 Prolonged Release Capsules - TOLTERODINE L- 05/11/2015


TARTRATE
DIPROBASE B & S Healthcare PPA1328/182/001 Cream 05/11/2015
EPANUTIN B & S Healthcare PPA1328/147/003 Capsules Hard - PHENYTOIN SODIUM 05/11/2015
FAVERIN B & S Healthcare DPR1328/030/001 Film Coated Tablet - FLUVOXAMINE MALEATE 05/11/2015

FAVERIN B & S Healthcare DPR1328/030/002 Film Coated Tablet - FLUVOXAMINE MALEATE 05/11/2015

INDERAL LA B & S Healthcare PPA1328/106/001 Prolonged Release Capsules - PROPRANOLOL 05/11/2015


HYDROCHLORIDE
INEGY B & S Healthcare DPR1328/012/001 Tablets - EZETIMIBE 05/11/2015
- SIMVASTATIN
INEGY B & S Healthcare DPR1328/012/002 Tablets - EZETIMIBE 05/11/2015
- SIMVASTATIN
NARAMIG B & S Healthcare PPA1328/175/001 Film Coated Tablet - NARATRIPTAN 05/11/2015
HYDROCHLORIDE
PARIET B & S Healthcare PPA1328/098/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 05/11/2015

Human Medicines Withdrawn Products Page 137 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SINEMET 62.5 B & S Healthcare DPR1328/006/001 Tablets - CARBIDOPA 05/11/2015
- LEVODOPA
TENORMIN B & S Healthcare PPA1328/110/001 Film Coated Tablet - ATENOLOL 05/11/2015
TILDIEM RETARD 120MG B & S Healthcare PPA1328/101/002 Tablet Prolonged Release - DILTIAZEM 05/11/2015
PROLONGED RELEASE HYDROCHLORIDE
TABLETS
TRUSOPT B & S Healthcare PPA1328/143/001 Eye Drops Solution - DORZOLAMIDE 05/11/2015
HYDROCHLORIDE
VAGIFEM B & S Healthcare PPA1328/161/001 Vaginal Tablets - ESTRADIOL 05/11/2015
HEMIHYDRATE
ARICEPT B & S Healthcare PPA1328/087/002 Film Coated Tablet - DONEPEZIL 04/11/2015
HYDROCHLORIDE
COVERSYL ARGININE B & S Healthcare PPA1328/080/002 Film Coated Tablet - PERINDOPRIL ARGININE 04/11/2015
EFEXOR XL B & S Healthcare PPA1328/118/002 Prolonged Release Capsules - VENLAFAXINE 04/11/2015
HYDROCHLORIDE
LOSEC MUPS B & S Healthcare PPA1328/015/001 Tablets Gastro-Resistant - OMEPRAZOLE 04/11/2015
MAGNESIUM
PARIET B & S Healthcare PPA1328/098/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 04/11/2015
SPIRIVA RESPIMAT B & S Healthcare DPR1328/007/001 Inhalation solution - TIOTROPIUM 04/11/2015
TELFAST B & S Healthcare DPR1328/002/001 Film Coated Tablet - FEXOFENADINE 04/11/2015
HYDROCHLORIDE
TELFAST B & S Healthcare DPR1328/002/002 Film Coated Tablet - FEXOFENADINE 04/11/2015
HYDROCHLORIDE
VASTAREL B & S Healthcare PPA1328/212/001 Film Coated Tablet - TRIMETAZIDINE 04/11/2015
DIHYDROCHLORIDE
ARIMIDEX B & S Healthcare PPA1328/155/001 Film Coated Tablet - ANASTRAZOLE 01/11/2015
AUGMENTIN-DUO B & S Healthcare PPA1328/050/002 Powder for Oral Suspension - AMOXICILLIN 01/11/2015
TRIHYDRATE
- CLAVULANIC ACID
BICALUTAMIDE AVANSOR Avansor Pharma Oy PA1375/001/001 Film Coated Tablet - BICALUTAMIDE 01/11/2015
50MG FILM-COATED
TABLETS
CALCICHEW-D3 FORTE B & S Healthcare PPA1328/209/001 Tablets Chewable - CALCIUM CARBONATE 01/11/2015
- COLECALCIFEROL
CARDURA XL B & S Healthcare PPA1328/079/001 Tablet Prolonged Release - DOXAZOSIN 01/11/2015
CARDURA XL B & S Healthcare PPA1328/079/002 Tablet Prolonged Release - DOXAZOSIN 01/11/2015
CRESTOR B & S Healthcare PPA1328/059/001 Film Coated Tablet - ROSUVASTATIN 01/11/2015
EZETROL B & S Healthcare PPA1328/166/001 Tablets - EZETIMIBE 01/11/2015
FUCIBET CREAM B & S Healthcare PPA1328/183/001 Cream - FUSIDIC ACID 01/11/2015
- BETAMETHASONE
IDEOS B & S Healthcare PPA1328/202/001 Tablets Chewable - CALCIUM CARBONATE 01/11/2015
- COLECALCIFEROL
LEXAPRO B & S Healthcare PPA1328/084/003 Film Coated Tablet - ESCITALOPRAM 01/11/2015
LIPITOR B & S Healthcare PPA1328/083/001 Film Coated Tablet - ATORVASTATIN CALCIUM 01/11/2015

LIPITOR B & S Healthcare PPA1328/083/002 Film Coated Tablet - ATORVASTATIN CALCIUM 01/11/2015

LIPITOR B & S Healthcare PPA1328/083/004 Film Coated Tablet - ATORVASTATIN-CALCIUM 01/11/2015

MOVICOL B & S Healthcare PPA1328/027/001 Powder for Oral Solution - MACROGOL 3350 01/11/2015
- SODIUM BICARBONATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
MOVICOL B & S Healthcare PPA1328/027/002 Powder for Oral Solution - MACROGOL 3350 01/11/2015
- SODIUM CHLORIDE
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
NEXIUM B & S Healthcare PPA1328/029/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 01/11/2015
NORLEVO B & S Healthcare PPA1328/160/001 Tablets - LEVONORGESTREL 01/11/2015
SERETIDE 250 DISKUS B & S Healthcare PPA1328/035/002 Inhalation powder - SALMETEROL 01/11/2015
XINAFOATE
- FLUTICASONE
PROPIONATE
VERSATIS B & S Healthcare PPA1328/211/001 Medicated Plaster - LIDOCAINE 01/11/2015
VESITIRIM B & S Healthcare PPA1328/179/001 Film Coated Tablet - SOLIFENACIN 01/11/2015
SUCCINATE
VESITIRIM B & S Healthcare PPA1328/179/002 Film Coated Tablet - SOLIFENACIN 01/11/2015
SUCCINATE
ZANIDIP B & S Healthcare PPA1328/042/001 Film Coated Tablet - LERCANIDIPINE 01/11/2015
HYDROCHLORIDE
ZITHROMAX B & S Healthcare PPA1328/168/001 Film Coated Tablet - AZITHROMYCIN 01/11/2015
DIHYDRATE
ZOTON FASTAB B & S Healthcare PPA1328/078/002 Orodispersible Tablet - LANSOPRAZOLE 01/11/2015

Human Medicines Withdrawn Products Page 138 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFLEXAL V Crucell Italy S.r.l. PA0941/002/001 Suspension for Injection - A/CALIFORNIA/7/2009 31/10/2015
(H1N1)PDM09-DERIVED
STRAIN USED (NYMC X-
181)
- A/VICTORIA/361/2011
(H3N2)-LIKE STRAIN USED
(NYMC X-223A) DERIVED
FROM A/TEXAS/50/2012
-
B/MASSACHUSETTS/02/20
12 DERIVED STRAIN USED
(NYMC BX-51B)

SALAZOPYRIN Pharmacia Laboratories PA0187/051/002 Suppositories - SULFASALAZINE 31/10/2015


Limited
ACCUPRO B & S Healthcare PPA1328/045/001 Film Coated Tablet - QUINAPRIL 30/10/2015
ARTHROTEC B & S Healthcare PPA1328/163/001 Modified-release Tablets - DICLOFENAC SODIUM 30/10/2015
- MISOPROSTOL
CARDURA B & S Healthcare PPA1328/079/003 Tablets - DOXAZOSIN MESILATE 30/10/2015
CATHATE Pfizer Healthcare Ireland PA0822/091/001 Coated Tablets - ESTROGENS 30/10/2015
CONJUGATED
COVERSYL ARGININE B & S Healthcare PPA1328/080/001 Film Coated Tablet - PERINDOPRIL ARGININE 30/10/2015
LIPOSTAT B & S Healthcare PPA1328/026/001 Tablets - PRAVASTATIN SODIUM 30/10/2015
LIPOSTAT B & S Healthcare PPA1328/026/002 Tablets - PRAVASTATIN SODIUM 30/10/2015
TAMBOCOR B & S Healthcare PPA1328/164/001 Tablets - FLECAINIDE ACETATE 30/10/2015
VOLTAROL EMULGEL B & S Healthcare PPA1328/204/001 Gel - DICLOFENAC 30/10/2015
DIETHYLAMMONIUM
ZOTON FASTAB B & S Healthcare PPA1328/078/001 Orodispersible Tablet - LANSOPRAZOLE 30/10/2015
CEPTON MEDICATED Eastern Pharmaceuticals PA0739/003/001 Gel - CHLORHEXIDINE 29/10/2015
CLEAR GEL Limited GLUCONATE
CEPTON MEDICATED Eastern Pharmaceuticals PA0739/003/002 Cutaneous Solution - CHLORHEXIDINE 29/10/2015
LOTION Limited GLUCONATE
CEPTON MEDICATED SKIN Eastern Pharmaceuticals PA0739/003/003 Cutaneous Solution - CHLORHEXIDINE 29/10/2015
WASH Limited GLUCONATE
DONEPEZIL SYNTHON Synthon BV PA0840/007/001 Film Coated Tablet - DONEPEZIL 29/10/2015
HYDROCHLORIDE
MONOHYDRATE
DONEPEZIL SYNTHON Synthon BV PA0840/007/002 Film Coated Tablet - DONEPEZIL 29/10/2015
HYDROCHLORIDE
MONOHYDRATE
HEMOCANE Eastern Pharmaceuticals PA0739/002/001 Cream - LIDOCAINE 29/10/2015
Limited HYDROCHLORIDE
- ZINC OXIDE
- BISMUTH OXIDE
- BENZOIC ACID
- CINNAMIC ACID
NEXIUM B & S Healthcare PPA1328/029/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 29/10/2015
ARGENT. NIT. A. Nelson & Company HOR1149/003/001 Not assigned - ARGENTUM NITRICUM 28/10/2015
Limited
FLEBOGAMMA Instituto Grifols S.A. PA0849/004/001 Solution for Infusion - HUMAN 28/10/2015
IMMUMOGLOBULINS
MODAFINIL McDermott Laboratories Ltd PA0577/142/001 Tablets - MODAFINIL 28/10/2015
t/a Gerard Laboratories
PULSATILLA A. Nelson & Company HOR1149/024/001 Not assigned - PULSATILLA PRATENSIS 28/10/2015
Limited
EZETROL B & S Healthcare DPR1328/032/001 Tablets - EZETIMIBE 26/10/2015
HAEMACCEL SOLUTION Piramal Healthcare UK PA1603/001/001 Solution for Infusion - POLYGELINE 23/10/2015
FOR INFUSION Limited
ALZMERAN XL Ranbaxy Ireland Limited PA0408/070/001 Tablet Prolonged Release - ALFUZOSIN 22/10/2015
HYDROCHLORIDE
- LACTOSE ANHYDROUS
- SILICA COLLOIDALIS
ANHYDRICA
- POVIDONE (PVP K-30)
- TALC
- MAGNESIUM STEARATE
BELLSERT Ranbaxy Ireland Limited PA0408/091/001 Film Coated Tablet - SERTRALINE 22/10/2015
HYDROCHLORIDE
BELLSERT Ranbaxy Ireland Limited PA0408/091/002 Film Coated Tablet - SERTRALINE 22/10/2015
HYDROCHLORIDE
ESCITALOPRAM Ranbaxy Ireland Limited PA0408/083/001 Film Coated Tablet - ESCITALOPRAM 22/10/2015
OXALATE
ESCITALOPRAM Ranbaxy Ireland Limited PA0408/083/002 Film Coated Tablet - ESCITALOPRAM 22/10/2015
OXALATE
RISEDRONATE SODIUM Ranbaxy Ireland Limited PA0408/079/001 Film Coated Tablet - RISEDRONATE SODIUM 22/10/2015
ONCE A WEEK

Human Medicines Withdrawn Products Page 139 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LEVETIRACETAM Rosemont Pharmaceuticals PA0312/027/001 Oral Solution - LEVETIRACETAM 19/10/2015
Ltd
TRAMAPINE Pinewood Laboratories Ltd, PA0281/100/003 Tablet Prolonged Release - TRAMADOL 19/10/2015
HYDROCHLORIDE
TRAMAPINE Pinewood Laboratories Ltd, PA0281/100/004 Tablet Prolonged Release - TRAMADOL 19/10/2015
HYDROCHLORIDE
STERILISED WATER Organon Laboratories PA0261/035/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 16/10/2015
Limited
ATORVASTATIN Rowex Ltd PA0711/192/001 Film Coated Tablet - ATORVASTATIN CALCIUM 15/10/2015
TRIHYDRATE
ATORVASTATIN Rowex Ltd PA0711/192/002 Film Coated Tablet - ATORVASTATIN CALCIUM 15/10/2015
TRIHYDRATE
ATORVASTATIN Rowex Ltd PA0711/192/003 Film Coated Tablet - ATORVASTATIN CALCIUM 15/10/2015
TRIHYDRATE
CATASART Rowex Ltd PA0711/134/004 Tablets - CANDESARTAN 15/10/2015
CILEXETIL
DEXKETOPROFEN ROWEX Rowex Ltd PA0711/216/001 Film Coated Tablet - DEXKETOPROFEN 15/10/2015
TROMETAMOL
LEVOFLOXACIN Rowex Ltd PA0711/144/001 Film Coated Tablet - LEVOFLOXACIN 15/10/2015
LEVOFLOXACIN Rowex Ltd PA0711/144/002 Film Coated Tablet - LEVOFLOXACIN 15/10/2015
NIFED RETARD Rowex Ltd PA0711/011/011 Modified-release Tablets - NIFEDIPINE 15/10/2015
PIOGLITAZONE ROWEX Rowex Ltd PA0711/199/001 Tablets - PIOGLITAZONE 15/10/2015
HYDROCHLORIDE
PIOGLITAZONE ROWEX Rowex Ltd PA0711/199/002 Tablets - PIOGLITAZONE 15/10/2015
HYDROCHLORIDE
PIOGLITAZONE ROWEX Rowex Ltd PA0711/199/003 Tablets - PIOGLITAZONE 15/10/2015
HYDROCHLORIDE
TACAP Synthon BV PA0840/014/001 Modified-release capsule, - TAMSULOSIN 13/10/2015
hard HYDROCHLORIDE
ATRACURIUM BESILATE Hospira UK Limited PA0437/042/001 Solution for Injection - ATRACURIUM BESILATE 09/10/2015
ATRACURIUM BESILATE, Hospira UK Limited PA0437/042/002 Solution for Injection - ATRACURIUM BESILATE 09/10/2015
VIAL
FLUDARABINE Hospira UK Limited PA0437/061/001 Pdr for Soln Inj/Inf - FLUDARABINE 09/10/2015
PHOSPHATE PHOSPHATE
NALOXONE Hospira UK Limited PA0437/024/002 Solution for Injection - NALOXONE 09/10/2015
HYDROCHLORIDE HYDROCHLORIDE
FLEXYESS Bayer Limited PA1410/065/001 Film Coated Tablet - DROSPIRENONE 08/10/2015
MICRONIZED
- ETHINYLESTRADIOL (AS
BETADEX CLATHRATE
MICRONIZED)
LIOFORA Bayer Limited PA1410/019/001 Film Coated Tablet - DROSPIRENONE 08/10/2015
- ETHINYLESTRADIOL (AS
BETADEX-CLATHRATE)
CEFOTAXIME Sandoz GmbH PA0111/005/001 Solution for Injection - CEFOTAXIME 07/10/2015
CEFOTAXIME Sandoz GmbH PA0111/005/002 Solution for Inj/Inf - CEFOTAXIME 07/10/2015
CEFOTAXIME Sandoz GmbH PA0111/005/003 Solution for Inj/Inf - CEFOTAXIME 07/10/2015
GAVISCON SACHETS Reckitt Benckiser Ireland Ltd PA0979/015/008 Oral Powder - SODIUM ALGINATE 06/10/2015
ORAL POWDER COOLMINT - SODIUM HYDROGEN
FLAVOUR CARBONATE
- CALCIUM CARBONATE
PALANDRA Bayer Limited PA1410/060/001 Film Coated Tablet - ETHINYLESTRADIOL 06/10/2015
- DROSPIRENONE
CALCIUM FLUORIDE Seven Seas Ltd HOR0417/001/001 Tablets - CALCIUM FLUORIDE 04/10/2015
CALCIUM PHOSPHATE Seven Seas Ltd HOR0417/002/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
CALCIUM SULPHATE Seven Seas Ltd HOR0417/003/001 Tablets - CALCIUM SULFATE 04/10/2015
FERRUM PHOSPHORICUM Seven Seas Ltd HOR0417/004/001 Tablets - FERRUM 04/10/2015
PHOSPHORICUM
KALIUM SULPHURICUM Seven Seas Ltd HOR0417/007/001 Tablets - POTASSIUM SULFATE 04/10/2015
MAGNESIUM Seven Seas Ltd HOR0417/008/001 Tablets - MAGNESIUM 04/10/2015
PHOSPHORICUM PHOSPHATE
NEW ERA COMBINATION A Seven Seas Ltd HOR0417/034/001 Tablets - FERRUM 04/10/2015
BIOCHEMIC TISSUE SALTS PHOSPHORICUM
- POTASSIUM PHOSPHATE
MONOBASIC
- MAGNESIUM
PHOSPHORICUM
NEW ERA COMBINATION B Seven Seas Ltd HOR0417/035/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
BIOCHEMIC TISSUE SALT - FERRUM
PHOSPHORICUM
- POTASSIUM PHOSPHATE
MONOBASIC

Human Medicines Withdrawn Products Page 140 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEW ERA COMBINATION C Seven Seas Ltd HOR0417/036/001 Tablets - MAGNESIUM 04/10/2015
BIOCHEMIC TISSUE SALT PHOSPHORICUM
- SODIUM PHOSPHATE
- SODIUM SULPHATE
- SILICON DIOXIDE,
COLLOIDAL
NEW ERA COMBINATION D Seven Seas Ltd HOR0417/037/001 Tablets - CALCIUM SULFATE 04/10/2015
BIOCHEMIC TISSUE SALTS - POTASSIUM CHLORIDE
- KALI SULPHURICUM
- SILICON DIOXIDE,
COLLOIDAL
NEW ERA COMBINATION E Seven Seas Ltd HOR0417/038/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
BIOCHEMIC TISSUE SALT - MAGNESIUM
PHOSPHATE
- SODIUM PHOSPHATE
- SODIUM SULPHATE
NEW ERA COMBINATION F Seven Seas Ltd HOR0417/039/001 Tablets - SILICON DIOXIDE, 04/10/2015
BIOCHEMIC TISSUE SALT COLLOIDAL
- POTASSIUM PHOSPHATE
MONOBASIC
- MAGNESIUM
PHOSPHORICUM
- SODIUM CHLORIDE
PH.EUR.
NEW ERA COMBINATION G Seven Seas Ltd HOR0417/040/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
BIOCHEMIC TISSUE SALT - POTASSIUM PHOSPHATE
MONOBASIC
- CALCIUM FLUORIDE
- SODIUM CHLORIDE
PH.EUR.
NEW ERA COMBINATION H Seven Seas Ltd HOR0417/041/001 Tablets - MAGNESIUM 04/10/2015
BIOCHEMIC TISSUE SALT PHOSPHORICUM
- SODIUM CHLORIDE
PH.EUR.
- SILICON DIOXIDE,
COLLOIDAL
NEW ERA COMBINATION I Seven Seas Ltd HOR0417/042/001 Tablets - FERRUM 04/10/2015
BIOCHEMIC TISSUE SALT PHOSPHORICUM
- KALI SULPHURICUM
- MAGNESIUM
PHOSPHORICUM
NEW ERA COMBINATION J Seven Seas Ltd HOR0417/043/001 Tablets - FERRUM 04/10/2015
BIOCHEMIC TISSUE SALT PHOSPHORICUM
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
PH.EUR.
NEW ERA COMBINATION K Seven Seas Ltd HOR0417/044/001 Tablets - KALI SULPHURICUM 04/10/2015
BIOCHEMIC TISSUE SALT - SODIUM CHLORIDE
PH.EUR.
- SILICON DIOXIDE,
COLLOIDAL
NEW ERA COMBINATION L Seven Seas Ltd HOR0417/045/001 Tablets - CALCIUM FLUORIDE 04/10/2015
BIOCHEMIC TISSUE SALT - FERRUM
PHOSPHORICUM
- SODIUM CHLORIDE
PH.EUR.
NEW ERA COMBINATION M Seven Seas Ltd HOR0417/046/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
BIOCHEMIC TISSUE SALT - POTASSIUM CHLORIDE
- SODIUM PHOSPHATE
- SODIUM SULPHATE
NEW ERA COMBINATION N Seven Seas Ltd HOR0417/047/001 Tablets - CALCIUM PHOSPHATE 04/10/2015
BIOCHEMIC TISSUE SALT - POTASSIUM CHLORIDE
- POTASSIUM PHOSPHATE
MONOBASIC
- MAGNESIUM
PHOSPHORICUM
NEW ERA COMBINATION P Seven Seas Ltd HOR0417/048/001 Tablets - CALCIUM FLUORIDE 04/10/2015
BIOCHEMIC TISSUE SALT - CALCIUM PHOSPHATE
- POTASSIUM PHOSPHATE
MONOBASIC
- MAGNESIUM
PHOSPHORICUM

Human Medicines Withdrawn Products Page 141 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEW ERA COMBINATION Q Seven Seas Ltd HOR0417/049/001 Tablets - FERRUM 04/10/2015
BIOCHEMIC TISSUE SALT PHOSPHORICUM
- POTASSIUM CHLORIDE
- KALI SULPHURICUM
- SODIUM CHLORIDE
PH.EUR.
NEW ERA COMBINATION R Seven Seas Ltd HOR0417/050/001 Tablets - CALCIUM FLUORIDE 04/10/2015
BIOCHEMIC TISSUE SALT - CALCIUM PHOSPHATE
- FERRUM
PHOSPHORICUM
- MAGNESIUM
PHOSPHORICUM
- SILICON DIOXIDE,
COLLOIDAL
NEW ERA COMBINATION S Seven Seas Ltd HOR0417/051/001 Tablets - POTASSIUM CHLORIDE 04/10/2015
BIOCHEMIC TISSUE SALT - SODIUM PHOSPHATE
- SODIUM SULPHATE
POTASSIUM CHLORIDE Seven Seas Ltd HOR0417/005/001 Tablets - POTASSIUM CHLORIDE 04/10/2015
POTASSIUM DIHYDROGEN Seven Seas Ltd HOR0417/006/001 Tablets - POTASSIUM PHOSPHATE 04/10/2015
PHOSPHATE MONOBASIC

SILICON DIOXIDE Seven Seas Ltd HOR0417/012/001 Tablets - SILICON DIOXIDE, 04/10/2015
COLLOIDAL
SODIUM CHLORIDE Seven Seas Ltd HOR0417/009/001 Tablets - SODIUM CHLORIDE 04/10/2015
SODIUM PHOSPHATE Seven Seas Ltd HOR0417/010/001 Tablets - SODIUM PHOSPHATE 04/10/2015
SODIUM SULPHATE Seven Seas Ltd HOR0417/011/001 Tablets - SODIUM SULFATE 04/10/2015
DOCETAXEL Seacross Pharmaceuticals PA1840/003/002 Concentrate for Soln for Inf - DOCETAXEL 01/10/2015
Limited ANHYDROUS
DOLFLASH Ethypharm PA0549/011/001 Orodispersible Tablet - PARACETAMOL 01/10/2015
FLUANXOL Lundbeck Limited PA0115/002/001 Film Coated Tablet - FLUPENTIXOL 01/10/2015
DIHYDROCHLORIDE
FLUANXOL Lundbeck Limited PA0115/002/002 Film Coated Tablet - FLUPENTIXOL 01/10/2015
DIHYDROCHLORIDE
PINACLAV Pinewood Laboratories Ltd, PA0281/145/001 Film Coated Tablet - AMOXICILLIN 30/09/2015
TRIHYDRATE
- CLAVULANATE
POTASSIUM
PUGRITEX Laboratorios Davur S.L.U. PA1271/003/001 Capsules Gastro-Resistant - OMEPRAZOLE 30/09/2015
PUGRITEX Laboratorios Davur S.L.U. PA1271/003/002 Capsules Gastro-Resistant - OMEPRAZOLE 30/09/2015
SAYANA 104 MG/0.65 ML Pfizer Limited PA0019/054/001 Suspension for Injection - 30/09/2015
SUSPENSION FOR MEDROXYPROGESTERO
INJECTION NE ACETATE
SAYANA PRESS Pfizer Limited PA0019/054/002 Suspension for Injection - 30/09/2015
MEDROXYPROGESTERO
NE ACETATE
SODIUM PICOSULFATE Ferring Ireland Ltd PA1009/024/001 Tablets - SODIUM PICOSULFATE 30/09/2015
FERRING
SODIUM PICOSULFATE Ferring Ireland Ltd PA1009/024/002 Tablets - SODIUM PICOSULFATE 30/09/2015
FERRING
VANCOCIN MATRIGEL Flynn Pharma Ltd PA1226/005/002 Capsule - VANCOMYCIN 30/09/2015
HYDROCHLORIDE
VITAROS Recordati Ireland Limited PA1404/004/001 Cream - ALPROSTADIL 25/09/2015
VITAROS Recordati Ireland Limited PA1404/004/002 Cream - ALPROSTADIL 25/09/2015
BIOGRASTIM Ratiopharm GmbH EU/1/08/450/1-4 Solution for Inj/Inf - FILGRASTIM 23/09/2015
BIOGRASTIM Ratiopharm GmbH EU/1/08/450/5-8 Solution for Injection - FILGRASTIM 23/09/2015
STREPSILS ORIGINAL Reckitt Benckiser Ireland Ltd PA0979/057/001 Lozenges - AMYLMETACRESOL 22/09/2015
- 2, 4-DICHLOROBENZYL
ALCOHOL
POLYTAR EMOLLIENT GlaxoSmithKline Consumer PA0678/116/002 Bath Additive - COAL TAR 21/09/2015
Healthcare (Ireland) Limited - CADE OIL
- COAL TAR SOLUTION
- COAL TAR EXTRACT
POLYTAR LIQUID GlaxoSmithKline Consumer PA0678/116/001 Shampoo - COAL TAR 21/09/2015
Healthcare (Ireland) Limited - CADE OIL
- COAL TAR SOLUTION
- ARACHIS OIL
DEQUADIN 0.25 MG Reckitt Benckiser Ireland Ltd PA0979/036/001 Lozenges - DEQUALINIUM CHLORIDE 15/09/2015
LOZENGES
IBUPROFEN Reckitt Benckiser Ireland Ltd PA0979/064/001 Capsules, Soft - IBUPROFEN 15/09/2015

NUROFEN 200MG Reckitt Benckiser Ireland Ltd PA0979/059/001 Tablets Effervescent - IBUPROFEN 15/09/2015
EFFERVESCENT TABLETS.

VOLTAROL Novartis Pharmaceuticals UK PA0013/087/004 Suppositories - DICLOFENAC SODIUM 15/09/2015


Ltd

Human Medicines Withdrawn Products Page 142 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFANRIX IPV & HIB GlaxoSmithKline (Ireland) PA1077/029/002 Not assigned - DIPHTHERIA TOXOID 11/09/2015
Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
- HAEMOPHILUS
INFLUENZAE TYPE B
CAPSULAR
POLYSACCHARIDE (PRP)
AND TETANUS TOXOID
- TETANUS VACCINE
ADSORBED
Dorzolamide Mylan 20 mg/ml Generics (UK) Limited PA0405/052/001 Eye drops, solution - Dorzolamide 09/09/2015
Eye Drops Solution
NEBILET B & S Healthcare PPA1328/076/002 Tablets - NEBIVOLOL 09/09/2015
HYDROCHLORIDE
URSOFALK LTT Pharma Limited PPA1562/031/001 Capsules Hard - URSODEOXYCHOLIC 04/09/2015
ACID
GLUSAMIN FMC Pharma Ltd PA1521/002/001 Film Coated Tablet - GLUCOSAMINE 02/09/2015
SULPHATE SODIUM
CHLORIDE
GLUSAMIN FMC Pharma Ltd PA1521/002/002 Film Coated Tablet - GLUCOSAMINE SULFATE 02/09/2015
SODIUM CHLORIDE

GRACIAL 25/40 AND 125/30 Aspen Pharma Trading PA1691/015/001 Tablets - DESOGESTREL 31/08/2015
MICROGRAM TABLETS. Limited - ETHINYLESTRADIOL
- DESOGESTREL
- ETHINYLESTRADIOL
VALIUM Roche Products Limited PA0050/017/002 Tablets - DIAZEPAM 31/08/2015
LAMOTRIGINE Aurobindo Pharma Limited PA1311/013/001 Tablets - LAMOTRIGINE 26/08/2015
AUROBINDO
LAMOTRIGINE Aurobindo Pharma Limited PA1311/013/002 Tablets - LAMOTRIGINE 26/08/2015
AUROBINDO
LAMOTRIGINE Aurobindo Pharma Limited PA1311/013/003 Tablets - LAMOTRIGINE 26/08/2015
AUROBINDO
LAMOTRIGINE Aurobindo Pharma Limited PA1311/013/004 Tablets - LAMOTRIGINE 26/08/2015
AUROBINDO
LEVOFLOXACIN Farmaprojects S.A. PA1391/002/001 Solution for Infusion - LEVOFLOXACIN 26/08/2015
HEMIHYDRATE
IMODIUM PLUS McNeil Healthcare (Ireland) PA0823/060/001 Tablets Chewable - LOPERAMIDE 17/08/2015
2MG/125MG CHEWABLE Ltd HYDROCHLORIDE
TABLETS - DIMETICONE
CLAVAMEL Clonmel Healthcare Ltd PA0126/103/001 Film Coated Tablet - AMOXICILLIN 11/08/2015
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CLAVAMEL PEDIATRIC Clonmel Healthcare Ltd PA0126/103/002 Powder for Oral Suspension - AMOXICILLIN 11/08/2015
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CO-AMOXICLAV Clonmel Healthcare Ltd PA0126/103/006 Film Coated Tablet - AMOXICILLIN 11/08/2015
TRIHYDRATE
- CLAVULANATE
POTASSIUM
MELOXAT Genthon BV PA0740/002/001 Film Coated Tablet - PAROXETINE MESYLATE 11/08/2015

BETNOVATE-N 0.1% / 0.5% GlaxoSmithKline (Ireland) PA1077/003/001 Cream - BETAMETHASONE 10/08/2015


W/W CREAM Limited VALERATE
- NEOMYCIN SULFATE
CODALAX Mundipharma PA1688/003/001 Capsules Hard - DANTRON 07/08/2015
Pharmaceuticals Limited - POLOXALCOL
CODALAX FORTE Mundipharma PA1688/003/002 Capsules Hard - DANTRON 07/08/2015
Pharmaceuticals Limited - POLOXALCOL
IFFEZA Mundipharma PA1688/014/001 Pressurised Inhalation - FLUTICASONE 07/08/2015
Pharmaceuticals Limited Suspension PROPIONATE
- FORMOTEROL
FUMARATE

Human Medicines Withdrawn Products Page 143 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IFFEZA Mundipharma PA1688/014/002 Pressurised Inhalation - FLUTICASONE 07/08/2015
Pharmaceuticals Limited Suspension PROPIONATE
- FORMOTEROL
FUMARATE
IFFEZA Mundipharma PA1688/014/003 Pressurised Inhalation - FLUTICASONE 07/08/2015
Pharmaceuticals Limited Suspension PROPIONATE
- FORMOTEROL
FUMARATE
SERENACE Norton Healthcare Limited PA0282/063/004 Oral Solution - HALOPERIDOL 07/08/2015
T/A IVAX Pharmaceuticals
UK
ANASTROZOL Welding GmbH & Co. KG PA1487/001/001 Film Coated Tablet - ANASTROZOLE 05/08/2015
TEVA COLD RELIEF Procter & Gamble (Health & PA0441/045/001 Film Coated Tablet - IBUPROFEN 04/08/2015
Beauty Care) Limited - PSEUDOEPHEDRINE
HYDROCHLORIDE
KUDEQ Pfizer Healthcare Ireland PA0822/084/001 Capsules Hard - CELECOXIB 03/08/2015
KUDEQ Pfizer Healthcare Ireland PA0822/084/002 Capsules Hard - CELECOXIB 03/08/2015
DEXLANSOPRAZOLE Takeda Pharma A/S PA1864/002/001 Modified-release capsule, - DEXLANSOPRAZOLE 01/08/2015
TAKEDA hard
DEXLANSOPRAZOLE Takeda Pharma A/S PA1864/002/002 Modified-release capsule, - DEXLANSOPRAZOLE 01/08/2015
TAKEDA hard
GLADEXA Takeda Pharma A/S PA1864/001/001 Modified-release capsule, - DEXLANSOPRAZOLE 01/08/2015
hard
GLADEXA Takeda Pharma A/S PA1864/001/002 Modified-release capsule, - DEXLANSOPRAZOLE 01/08/2015
hard
LIPOVAS Ranbaxy (UK) Limited PA0967/008/001 Tablets - PRAVASTATIN SODIUM 31/07/2015
LIPOVAS Ranbaxy (UK) Limited PA0967/008/002 Tablets - PRAVASTATIN SODIUM 31/07/2015
LIPOVAS Ranbaxy (UK) Limited PA0967/008/003 Tablets - PRAVASTATIN SODIUM 31/07/2015
RASILAMLO Novartis Europharm Limited EU/1/11/686/043-056 Film Coated Tablet - ALISKIREN 25/07/2015
HEMIFUMARATE
- AMLODIPINE BESYLATE
BUDESONIDE TEVA Teva Pharma B.V. PA0749/141/001 Nebuliser Suspension - BUDESONIDE 24/07/2015
FLUCONAZOLE TEVA Teva Pharma B.V. PA0749/041/001 Solution for Infusion - FLUCONAZOLE 24/07/2015
NEBRIS STERI-NEB Teva Pharma B.V. PA0749/153/001 Nebuliser Solution - TOBRAMYCIN 24/07/2015
OMEPRAZOLE TEVA Teva Pharma B.V. PA0749/042/001 Powder for solution for - OMEPRAZOLE 24/07/2015
infusion
BELLISIN Ranbaxy Ireland Limited PA0408/057/001 Tablets - LISINOPRIL DIHYDRATE 22/07/2015
BELLISIN Ranbaxy Ireland Limited PA0408/057/002 Tablets - LISINOPRIL DIHYDRATE 22/07/2015
BELLISIN Ranbaxy Ireland Limited PA0408/057/003 Tablets - LISINOPRIL DIHYDRATE 22/07/2015
BELLISIN Ranbaxy Ireland Limited PA0408/057/004 Tablets - LISINOPRIL DIHYDRATE 22/07/2015
IRBESARTAN RANBAXY Ranbaxy Ireland Limited PA0408/067/001 Film Coated Tablet - IRBESARTAN 22/07/2015
IRBESARTAN RANBAXY Ranbaxy Ireland Limited PA0408/067/002 Film Coated Tablet - IRBESARTAN 22/07/2015
IRBESARTAN RANBAXY Ranbaxy Ireland Limited PA0408/067/003 Film Coated Tablet - IRBESARTAN 22/07/2015
DETRUSITOL SR LTT Pharma Limited PPA1562/060/001 Prolonged Release Capsules - TOLTERODINE 21/07/2015
TARTRATE
HEPARIN SODIUM CP Pharmaceuticals Ltd PA0409/006/001 Solution for Injection - HEPARIN SODIUM 20/07/2015
trading as Wockhardt UK
HEPARIN SODIUM CP Pharmaceuticals Ltd PA0409/006/002 Solution for Injection - HEPARIN SODIUM 20/07/2015
trading as Wockhardt UK
ARKOLAMYL McDermott Laboratories Ltd PA0577/114/001 Orodispersible Tablet - OLANZAPINE 15/07/2015
t/a Gerard Laboratories
ARKOLAMYL McDermott Laboratories Ltd PA0577/114/002 Orodispersible Tablet - OLANZAPINE 15/07/2015
t/a Gerard Laboratories
ARKOLAMYL McDermott Laboratories Ltd PA0577/114/003 Orodispersible Tablet - OLANZAPINE 15/07/2015
t/a Gerard Laboratories
ARKOLAMYL McDermott Laboratories Ltd PA0577/114/004 Orodispersible Tablet - OLANZAPINE 15/07/2015
t/a Gerard Laboratories
CANAZOLE Pinewood Laboratories Ltd, PA0281/076/001 Cream - CLOTRIMAZOLE 14/07/2015
CLOTRIMAZOLE
DONEPEZIL PFIZER Pfizer Healthcare Ireland PA0822/076/001 Film Coated Tablet - DONEPEZIL 14/07/2015
HYDROCHLORIDE
DONEPEZIL PFIZER Pfizer Healthcare Ireland PA0822/076/002 Film Coated Tablet - DONEPEZIL 14/07/2015
HYDROCHLORIDE
ZOLEDRONIC ACID TEVA Teva Generics B.V. EU/1/14/912/001-005 Solution for Infusion - ZOLEDRONIC ACID 13/07/2015
GENERICS MONOHYDRATE
HUMULIN S KWIKPEN Eli Lilly and Company Limite PA0047/089/001 Solution for Injection - INSULIN HUMAN 12/07/2015
(SOLUBLE)
ETOPOSID "EBEWE" Ebewe Pharma Ges.m.b.H PA0789/013/001 Concentrate for Soln for Inf - ETOPOSIDE 10/07/2015
Nfg. KG
GEMZAR 1 G POWDER Eli Lilly and Company Limite PA0047/079/002 Powder for solution for - GEMCITABINE 10/07/2015
FOR SOLUTION FOR infusion HYDROCHLORIDE
INFUSION.
GEMZAR 200 MG POWDER Eli Lilly and Company Limite PA0047/079/001 Powder for solution for - GEMCITABINE 10/07/2015
FOR SOLUTION FOR infusion HYDROCHLORIDE
INFUSION.

Human Medicines Withdrawn Products Page 144 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RALOXIEP Synthon BV PA0840/010/001 Film Coated Tablet - RALOXIFENE 05/07/2015
HYDROCHLORIDE
SONATA Meda AB EU/1/99/102/001 Capsule - ZALEPLON 03/07/2015
SONATA Meda AB EU/1/99/102/002 Capsule - ZALEPLON 03/07/2015
SONATA Meda AB EU/1/99/102/003 Capsule - ZALEPLON 03/07/2015
SONATA Meda AB EU/1/99/102/004 Capsule - ZALEPLON 03/07/2015
SONATA Meda AB EU/1/99/102/005 Capsule - ZALEPLON 03/07/2015
SONATA Meda AB EU/1/99/102/006 Capsule - ZALEPLON 03/07/2015
DOCETAXEL EBEWE Ebewe Pharma Ges.m.b.H PA0789/017/001 Concentrate for Soln for Inf - DOCETAXEL 01/07/2015
Nfg. KG
POSIJECT Primex Pharmaceuticals Oy PA1719/001/001 Concentrate for Soln for Inf - DOBUTAMINE 01/07/2015
HYDROCHLORIDE
FLUCONAZOLE REDIBAG Baxter Healthcare Limited PA0167/127/001 Solution for Infusion - FLUCONAZOLE 30/06/2015
LOSEPINE Pinewood Laboratories Ltd, PA0281/118/001 Tablets Gastro-Resistant - OMEPRAZOLE PH. EUR. 30/06/2015
LOSEPINE Pinewood Laboratories Ltd, PA0281/118/002 Tablets Gastro-Resistant - OMEPRAZOLE PH. EUR. 30/06/2015
TORVAN Pinewood Laboratories Ltd, PA0281/150/002 Film Coated Tablet - ATORVASTATIN 30/06/2015
TORVAN Pinewood Laboratories Ltd, PA0281/150/003 Film Coated Tablet - ATORVASTATIN 30/06/2015
RASILAMLO Novartis Europharm Limited EU/1/11/686/015-028 Film Coated Tablet - ALISKIREN 25/06/2015
HEMIFUMARATE
- AMLODIPINE BESYLATE
RASILAMLO Novartis Europharm Limited EU/1/11/686/029-042 Film Coated Tablet - ALISKIREN 25/06/2015
HEMIFUMARATE
- AMLODIPINE BESYLATE
MINADEX TONIC Seven Seas Ltd PA0417/007/002 Oral Emulsion - RETINOL PALMITATE 23/06/2015
- COLECALCIFEROL
- FERRIC AMMONIUM
CITRATE
- POTASSIUM
GLYCEROPHOSPHATE
- CALCIUM
GLYCEROPHOSPHATE
- MANGANESE SULFATE
- COPPER SULFATE
PENTAHYDRATE
ASCAL Meda Health Sales Ireland PA1332/011/001 Tablets Effervescent - CARBASALATE CALCIUM 19/06/2015
Limited
FOSAMAX ONCE WEEKLY IMED Healthcare Ltd. PPA1463/036/001 Tablets - ALENDRONIC ACID 17/06/2015
GLUCOSAMINE SULFATE FMC Pharma Ltd PA1521/003/001 Film Coated Tablet - GLUCOSAMINE 12/06/2015
SULPHATE SODIUM
CHLORIDE
LOZITAR COMP Pinewood Laboratories Ltd, PA0281/144/001 Film Coated Tablet - LOSARTAN POTASSIUM 12/06/2015
- HYDROCHLOROTHIAZIDE

LOZITAR COMP Pinewood Laboratories Ltd, PA0281/144/002 Film Coated Tablet - LOSARTAN POTASSIUM 12/06/2015
- HYDROCHLOROTHIAZIDE

LOZITAR COMP Pinewood Laboratories Ltd, PA0281/144/003 Film Coated Tablet - LOSARTAN POTASSIUM 12/06/2015
- HYDROCHLOROTHIAZIDE

VIANI 125 EVOHALER GlaxoSmithKline (Ireland) PA1077/050/005 Pressurised Inhalation - SALMETEROL 12/06/2015
Limited Suspension XINAFOATE
- FLUTICASONE
PROPIONATE
VIANI 250 EVOHALER GlaxoSmithKline (Ireland) PA1077/050/006 Pressurised Inhalation - SALMETEROL 12/06/2015
Limited Suspension XINAFOATE
- FLUTICASONE
PROPIONATE
VIANI 50 EVOHALER GlaxoSmithKline (Ireland) PA1077/050/004 Pressurised Inhalation - SALMETEROL 12/06/2015
Limited Suspension XINAFOATE
- FLUTICASONE
PROPIONATE
VIANI DISKUS GlaxoSmithKline (Ireland) PA1077/050/001 Inhalation powder - SALMETEROL 12/06/2015
Limited XINAFOATE
- FLUTICASONE
PROPIONATE
VIANI DISKUS GlaxoSmithKline (Ireland) PA1077/050/002 Inhalation powder - SALMETEROL 12/06/2015
Limited XINAFOATE
- FLUTICASONE
PROPIONATE
VIANI DISKUS GlaxoSmithKline (Ireland) PA1077/050/003 Inhalation powder - SALMETEROL 12/06/2015
Limited XINAFOATE
- FLUTICASONE
PROPIONATE
CARBOPLATIN "EBEWE" Ebewe Pharma Ges.m.b.H PA0789/003/001 Concentrate for Soln for Inf - CARBOPLATIN 10/06/2015
Nfg. KG

Human Medicines Withdrawn Products Page 145 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CISPLATIN "EBEWE" Ebewe Pharma Ges.m.b.H PA0789/002/005 Concentrate for Soln for Inf - CISPLATIN 10/06/2015
Nfg. KG
CISPLATIN 'EBEWE' Ebewe Pharma Ges.m.b.H PA0789/002/001 Concentrate for Soln for Inf - CISPLATIN 10/06/2015
Nfg. KG
DOXORUBICIN EBEWE Ebewe Pharma Ges.m.b.H PA0789/001/001 Concentrate for Soln for Inf - DOXORUBICIN 10/06/2015
Nfg. KG HYDROCHLORIDE
EBETAXEL Ebewe Pharma Ges.m.b.H PA0789/014/001 Concentrate for Soln for Inf - PACLITAXEL 10/06/2015
Nfg. KG
FLUOROURACIL "EBEWE" Ebewe Pharma Ges.m.b.H PA0789/005/001 Concentrate for Soln for Inf - FLUOROURACIL 10/06/2015
Nfg. KG
FOLINIC ACID Ebewe Pharma Ges.m.b.H PA0789/011/001 Solution for Inj/Inf - CALCIUM FOLINATE 10/06/2015
Nfg. KG
FOLINIC ACID Ebewe Pharma Ges.m.b.H PA0789/011/002 Solution for Inj/Inf - CALCIUM FOLINATE 10/06/2015
Nfg. KG
GEMCITABINE EBEWE Ebewe Pharma Ges.m.b.H PA0789/022/001 Concentrate for Soln for Inf - GEMCITABINE 10/06/2015
Nfg. KG HYDROCHLORIDE
LEVOFOLINIC ACID Ebewe Pharma Ges.m.b.H PA0789/024/001 Solution for Inj/Inf - CALCIUM LEVOFOLINATE 10/06/2015
EBEWE Nfg. KG PENTAHYDRATE

METHOTREXATE EBEWE Ebewe Pharma Ges.m.b.H PA0789/020/001 Concentrate for Soln for Inf - METHOTREXATE 10/06/2015
Nfg. KG
OXALIPLATIN EBEWE Ebewe Pharma Ges.m.b.H PA0789/016/001 Powder for solution for - OXALIPLATIN 10/06/2015
Nfg. KG infusion
OXALIPLATIN EBEWE Ebewe Pharma Ges.m.b.H PA0789/016/002 Concentrate for Soln for Inf - OXALIPLATIN 10/06/2015
Nfg. KG
PALAT Ebewe Pharma Ges.m.b.H PA0789/023/001 Concentrate for Soln for Inf - PACLITAXEL 10/06/2015
Nfg. KG
TOPOTECAN EBEWE Ebewe Pharma Ges.m.b.H PA0789/021/001 Concentrate for Soln for Inf - TOPOTECAN 10/06/2015
Nfg. KG HYDROCHLORIDE
IRINOTECAN EBEWE Ebewe Pharma Ges.m.b.H PA0789/018/001 Concentrate for Soln for Inf - IRINOTECAN 03/06/2015
Nfg. KG HYDROCHLORIDE
TRIHYDRATE
ARTHRIAID FMC Pharma Ltd PA1521/001/001 Film Coated Tablet - GLUCOSAMINE SULFATE 31/05/2015

ARTHRIAID FMC Pharma Ltd PA1521/001/002 Film Coated Tablet - GLUCOSAMINE SULFATE 31/05/2015

ARTHRIAID FMC Pharma Ltd PA1521/001/003 Film Coated Tablet - GLUCOSAMINE SULFATE 31/05/2015

VANTAS Orion Corporation PA1327/014/001 Implant - HISTRELIN ACETATE 29/05/2015


CANDIST PLUS Clonmel Healthcare Ltd PA0126/207/001 Tablets - CANDESARTAN 15/05/2015
CILEXETIL
- HYDROCHLOROTHIAZIDE

DETTOL MED Reckitt Benckiser Ireland Ltd PA0979/004/003 Concentrate for solution for - CHLOROXYLENOL 14/05/2015
infusion
MEDINOL OVER 6 Cupal Limited PA0258/045/001 Oral Suspension - PARACETAMOL 14/05/2015
MEDINOL UNDER 6 Cupal Limited PA0258/015/001 Oral Suspension - PARACETAMOL 14/05/2015
PARACETAMOL ORAL
SUSPENSION
PROLOSIN Niche Generics Limited PA1063/021/001 Prolonged Release Capsules - TAMSULOSIN 12/05/2015
HYDROCHLORIDE
Azelastine Hydrochloride Brown & Burk UK LTD PA1648/003/001 Eye drops, solution - Azelastine hydrochloride 10/05/2015
0.5mg/ml Eye Drops,
Solution
Dexdomitor Orion Corporation EU/2/02/033/001 Solution for injection 08/05/2015
EURIFEL RCP - FELV Merial Animal Health Limited EU/2/02/031/001 Emulsion for Injection 08/05/2015

KARVOL DECONGESTANT Reckitt Benckiser Ireland Ltd PA0979/061/001 Capsule - CHLOROBUTANOL 06/05/2015
CAPSULES - LEVOMENTHOL
- PINE OIL SYLVESTRIS
BLEND
- TERPINEOL
- THYMOL
- PUMILIO PINE OIL BLEND

CLOPIDOGREL DURA Mylan dura GmbH EU/1/09/560/001-9 Film Coated Tablet - CLOPIDOGREL 05/05/2015
HYDROCHLORIDE
PROVENGE Dendreon UK Ltd EU/1/13/867/001 Suspension for Infusion - AUTOLOGOUS 05/05/2015
PERIPHERAL BLOOD
MONONUCLEAR CELLS
RISPERGER McDermott Laboratories Ltd PA0577/096/001 Film Coated Tablet - RISPERIDONE 05/05/2015
t/a Gerard Laboratories
RISPERGER McDermott Laboratories Ltd PA0577/096/002 Film Coated Tablet - RISPERIDONE 05/05/2015
t/a Gerard Laboratories
RISPERGER McDermott Laboratories Ltd PA0577/096/003 Film Coated Tablet - RISPERIDONE 05/05/2015
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 146 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RISPERGER McDermott Laboratories Ltd PA0577/096/004 Film Coated Tablet - RISPERIDONE 05/05/2015
t/a Gerard Laboratories
NICORETTE INHALER McNeil Healthcare (Ireland) PA0823/049/009 Inhalation Vapour, Cartridge - NICOTINE 27/04/2015
10MG Ltd
NICORETTE MICROTAB McNeil Healthcare (Ireland) PA0823/049/010 Tablet Sublingual - NICOTINE B- 27/04/2015
Ltd CYCLODEXTRIN COMPLEX

VOLTAROL OPHTHA Laboratoires Thea PA1107/009/001 Eye Drops Solution - DICLOFENAC SODIUM 24/04/2015
ZADITEN Laboratoires Thea PA1107/010/002 Eye Drops Solution - KETOTIFEN FUMARATE 24/04/2015
GEMCITABINE EBEWE Ebewe Pharma Ges.m.b.H PA0789/019/003 Concentrate for Soln for Inf - GEMCITABIN HCL 22/04/2015
Nfg. KG - GEMCITABIN HCL
- GEMCITABIN HCL
ARCOXIA McDowell Pharmaceuticals DPR1473/033/001 Film Coated Tablet - ETORICOXIB 20/04/2015
ARCOXIA McDowell Pharmaceuticals DPR1473/033/002 Film Coated Tablet - ETORICOXIB 20/04/2015
ARCOXIA McDowell Pharmaceuticals DPR1473/033/003 Film Coated Tablet - ETORICOXIB 20/04/2015
STREPSILS INTENSIVE Reckitt Benckiser Ireland Ltd PA0979/041/002 Granules - FLURBIPROFEN 17/04/2015

STREPSILS INTENSIVE Reckitt Benckiser Ireland Ltd PA0979/041/003 Granules - FLURBIPROFEN 17/04/2015
MINT
SIMZOR McDermott Laboratories Ltd PA0577/115/001 Film Coated Tablet - SIMVASTATIN 08/04/2015
t/a Gerard Laboratories
SIMZOR McDermott Laboratories Ltd PA0577/115/002 Film Coated Tablet - SIMVASTATIN 08/04/2015
t/a Gerard Laboratories
SIMZOR McDermott Laboratories Ltd PA0577/115/003 Film Coated Tablet - SIMVASTATIN 08/04/2015
t/a Gerard Laboratories
SIMZOR McDermott Laboratories Ltd PA0577/115/004 Film Coated Tablet - SIMVASTATIN 08/04/2015
t/a Gerard Laboratories
PRAVASTATIN SODIUM Rowex Ltd PA0711/150/001 Tablets - PRAVASTATIN SODIUM 07/04/2015
PRAVASTATIN SODIUM Rowex Ltd PA0711/150/002 Tablets - PRAVASTATIN SODIUM 07/04/2015
PRAVASTATIN SODIUM Rowex Ltd PA0711/150/003 Tablets - PRAVASTATIN SODIUM 07/04/2015
YOSQIERO Rowex Ltd PA0711/201/002 Oral Solution - DESLORATIDINE 07/04/2015
STIEMYCIN GlaxoSmithKline (Ireland) PA1077/129/001 Cutaneous Solution - ERYTHROMYCIN 05/04/2015
Limited
AMOCLAV DUO Rowex Ltd PA0711/095/002 Film Coated Tablet - AMOXICILLIN 02/04/2015
TRIHYDRATE
- CLAVULANIC ACID
IODOFLEX Smith & Nephew PA0710/005/001 Cutaneous Paste - CADEXOMER IODINE 02/04/2015
Pharmaceuticals
LOTANOS Rowex Ltd PA0711/123/001 Film Coated Tablet - LOSARTAN POTASSIUM 02/04/2015
Romep MUT 10 mg Gastro- Rowex Ltd PA0711/126/004 Gastro-resistant tablet - Omeprazole magnesium 02/04/2015
resistant
tablets<?xml:namespace
prefix = o /&gt;
Romep MUT 20 mg Gastro- Rowex Ltd PA0711/126/005 Gastro-resistant tablet - Omeprazole magnesium 02/04/2015
resistant
tablets<?xml:namespace
prefix = o /&gt;
Romep MUT 40 mg Gastro- Rowex Ltd PA0711/126/006 Gastro-resistant tablet - Omeprazole magnesium 02/04/2015
resistant
tablets<?xml:namespace
prefix = o /&gt;
REMIFENTANIL Generics (UK) Limited PA0405/057/001 Powder for concentrate for - REMIFENTANIL 01/04/2015
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL Generics (UK) Limited PA0405/057/002 Powder for concentrate for - REMIFENTANIL 01/04/2015
solution for injection/infusion HYDROCHLORIDE
Xefo 4 mg film-coated tablets Takeda UK Limited PA1547/005/001 Film-coated tablet - Lornoxicam 01/04/2015

XEFO 8MG POWDER AND Takeda UK Limited PA1547/005/003 Pdr+Solv for soln for Inf - LORNOXICAM 01/04/2015
SOLVENT FOR SOLUTION
FOR INJEC
AMISULPRIDE MYLAN McDermott Laboratories Ltd PA0577/125/004 Film Coated Tablet - AMISULPRIDE 31/03/2015
t/a Gerard Laboratories
AMLIST McDermott Laboratories Ltd PA0577/062/001 Tablets - AMLODIPINE MALEATE 31/03/2015
t/a Gerard Laboratories
AMLIST McDermott Laboratories Ltd PA0577/062/002 Tablets - AMLODIPINE MALEATE 31/03/2015
t/a Gerard Laboratories
ARIPEZ Teva Pharma B.V. PA0749/034/001 Film Coated Tablet - DONEPEZIL 31/03/2015
HYDROCHLORIDE
ARIPEZ Teva Pharma B.V. PA0749/034/002 Film Coated Tablet - DONEPEZIL 31/03/2015
HYDROCHLORIDE
DOTHEP McDermott Laboratories Ltd PA0577/020/001 Film Coated Tablet - DOSULEPIN 31/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
DOTHEP McDermott Laboratories Ltd PA0577/020/002 Capsules Hard - DOSULEPIN 31/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
ENTACAPONE MYLAN McDermott Laboratories Ltd PA0577/137/001 Film Coated Tablet - ENTACAPONE 31/03/2015
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 147 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GABAPENTIN TEVA Teva Pharma B.V. PA0749/055/001 Film Coated Tablet - GABAPENTIN 31/03/2015
GABAPENTIN TEVA Teva Pharma B.V. PA0749/055/002 Film Coated Tablet - GABAPENTIN 31/03/2015
GERINAP E.C. McDermott Laboratories Ltd PA0577/008/001 Tablets Gastro-Resistant - NAPROXEN 31/03/2015
t/a Gerard Laboratories
GERINAP E.C. McDermott Laboratories Ltd PA0577/008/002 Tablets Gastro-Resistant - NAPROXEN 31/03/2015
t/a Gerard Laboratories
HISTACLAR ALLERGY McDermott Laboratories Ltd PA0577/046/002 Tablets - LORATADINE 31/03/2015
t/a Gerard Laboratories
LOSARTAN / McDermott Laboratories Ltd PA0577/152/003 Film Coated Tablet - LOSARTAN POTASSIUM 31/03/2015
HYDROCHLOROTHIAZIDE t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE
MYLAN
LOSARTAN / McDermott Laboratories Ltd PA0577/152/001 Film Coated Tablet - LOSARTAN POTASSIUM 31/03/2015
HYDROCHLOROTHIAZIDE t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE
MYLAN
Losartan/Hydrochlorothiazide McDermott Laboratories Ltd PA0577/152/002 Film-coated tablet - Hydrochlorothiazide 31/03/2015
Mylan 100 mg/12.5 mg Film- t/a Gerard Laboratories - Losartan potassium
coated Tablets
LOSARTAN/HYDROCHLOR Teva Pharma B.V. PA0749/026/003 Film Coated Tablet - LOSARTAN POTASSIUM 31/03/2015
OTHIAZIDE TEVA - HYDROCHOLOTHIAZIDE
MIANSERIN Generics (UK) Limited PA0405/022/001 Film Coated Tablet - MIANSERIN 31/03/2015
HYDROCHLORIDE
MIANSERIN Generics (UK) Limited PA0405/022/003 Film Coated Tablet - MIANSERIN 31/03/2015
HYDROCHLORIDE
MIGRASTAT McDermott Laboratories Ltd PA0577/078/001 Tablets - SUMATRIPTAN 31/03/2015
t/a Gerard Laboratories SUCCINATE
MIGRASTAT McDermott Laboratories Ltd PA0577/078/002 Tablets - SUMATRIPTAN 31/03/2015
t/a Gerard Laboratories SUCCINATE
MYCOPHENOLATE McDermott Laboratories Ltd PA0577/126/001 Film Coated Tablet - MYCOPHENOLATE 31/03/2015
MOFETIL MYLAN t/a Gerard Laboratories MOFETIL
ROPINIROLE McDermott Laboratories Ltd PA0577/094/001 Film Coated Tablet - ROPINIROLE 31/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
ROPINIROLE McDermott Laboratories Ltd PA0577/094/002 Film Coated Tablet - ROPINIROLE 31/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
ROPINIROLE McDermott Laboratories Ltd PA0577/094/004 Film Coated Tablet - ROPINIROLE 31/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
VALSARTAN TEVA Teva Pharma B.V. PA0749/084/004 Film Coated Tablet - VALSARTAN 31/03/2015
ZIRTENE ALLERGY 10MG McDermott Laboratories Ltd PA0577/084/002 Film Coated Tablet - CETIRIZINE 31/03/2015
FILM-COATED TABLETS t/a Gerard Laboratories DIHYDROCHLORIDE
GEMCITABINE MYLAN Generics (UK) Limited PA0405/055/003 Powder for solution for - GEMCITABINE 30/03/2015
infusion
BINDREN Mitsubishi Pharma Europe EU/1/12/804/001-010 Film Coated Tablet - COLESTILAN 26/03/2015
Ltd
BINDREN Mitsubishi Pharma Europe EU/1/12/804/011-013 Granules - COLESTILAN 26/03/2015
Ltd
BINDREN Mitsubishi Pharma Europe EU/1/12/804/014-016 Granules - COLESTILAN 26/03/2015
Ltd
Irinotecan medac 20 mg/ml, Medac Gesellschaft fur PA0623/013/001 Concentrate for solution for - Irinotecan hydrochloride 25/03/2015
concentrate for solution for Klinische Spezialpraparate infusion trihydrate
infusion mbH
RANITIDINE Accord Healthcare Limited PA1390/017/003 Film Coated Tablet - RANITIDINE 25/03/2015
HYDROCHLORIDE (FORM
II)
GERFORMIN McDermott Laboratories Ltd PA0577/039/001 Film Coated Tablet - METFORMIN 20/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
GERFORMIN McDermott Laboratories Ltd PA0577/039/002 Film Coated Tablet - METFORMIN 20/03/2015
t/a Gerard Laboratories HYDROCHLORIDE
MAGNEGITA Agfa Healthcare Imaging PA1504/001/001 Solution for Injection - GADOPENTETATE 18/03/2015
Agents GmbH DIMEGLUMINE
DETERODINE SR McDermott Laboratories Ltd PA0577/144/002 Prolonged Release Capsules - TOLTERODINE 15/03/2015
t/a Gerard Laboratories TARTRATE
BARICAT Bracco UK Limited PA1022/016/001 Cachet - BARIUM SULFATE 13/03/2015
DEQUACAINE LOZENGES, Reckitt Benckiser Ireland Ltd PA0979/035/001 Lozenges - DEQUALINIUM CHLORIDE 11/03/2015
BENZOCAINE 10 MG, - BENZOCAINE
DEQUALINIUM
DR. SCHEFFLER VITAMIN Dr. B. Scheffler Nachf GmbH PA0998/001/001 Tablets Effervescent - ASCORBIC ACID 11/03/2015
C & Co. KG
ATORVASTATIN BILLEV Billev Pharma ApS PA0995/010/001 Film Coated Tablet - ATORVASTATIN CALCIUM 03/03/2015
PHARMA
ATORVASTATIN BILLEV Billev Pharma ApS PA0995/010/002 Film Coated Tablet - ATORVASTATIN CALCIUM 03/03/2015
PHARMA
ATORVASTATIN BILLEV Billev Pharma ApS PA0995/010/003 Film Coated Tablet - ATORVASTATIN CALCIUM 03/03/2015
PHARMA
LEVETIRACETAM PENSA Pensa Pharma AB PA1647/009/001 Film Coated Tablet - LEVETIRACETAM 23/02/2015
LEVETIRACETAM PENSA Pensa Pharma AB PA1647/009/002 Film Coated Tablet - LEVETIRACETAM 23/02/2015
LEVETIRACETAM PENSA Pensa Pharma AB PA1647/009/003 Film Coated Tablet - LEVETIRACETAM 23/02/2015

Human Medicines Withdrawn Products Page 148 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METFORMIN PENSA Pensa Pharma AB PA1647/008/001 Film Coated Tablet - METFORMIN 23/02/2015
HYDROCHLORIDE
METFORMIN PENSA Pensa Pharma AB PA1647/008/002 Film Coated Tablet - METFORMIN 23/02/2015
HYDROCHLORIDE
METFORMIN PENSA Pensa Pharma AB PA1647/008/003 Film Coated Tablet - METFORMIN 23/02/2015
HYDROCHLORIDE
MONTELUKAST PENSA Pensa Pharma AB PA1647/007/001 Tablets Chewable - MONTELUKAST SODIUM 23/02/2015
MONTELUKAST PENSA Pensa Pharma AB PA1647/007/002 Tablets Chewable - MONTELUKAST SODIUM 23/02/2015
MONTELUKAST PENSA Pensa Pharma AB PA1647/007/003 Film Coated Tablet - MONTELUKAST SODIUM 23/02/2015
OLANZAPINE PENSA Pensa Pharma AB PA1647/006/001 Orodispersible Tablet - OLANZAPINE 23/02/2015
OLANZAPINE PENSA Pensa Pharma AB PA1647/006/002 Orodispersible Tablet - OLANZAPINE 23/02/2015
OLANZAPINE PENSA Pensa Pharma AB PA1647/006/003 Orodispersible Tablet - OLANZAPINE 23/02/2015
OLANZAPINE PENSA Pensa Pharma AB PA1647/006/004 Orodispersible Tablet - OLANZAPINE 23/02/2015
PARACETAMOL Pensa Pharma AB PA1647/001/001 Tablets - PARACETAMOL 23/02/2015
PARACETAMOL MAX Pensa Pharma AB PA1647/001/002 Tablets - PARACETAMOL 23/02/2015
ZOLEDRONIC ACID MCM MCM Pharma GmbH PA1718/001/001 Concentrate for Soln for Inf - ZOLEDRONIC ACID 19/02/2015
PHARMA MONOHYDRATE
LOCHOL XL Clonmel Healthcare Ltd PA0126/171/001 Tablet Prolonged Release - FLUVASTATIN SODIUM 18/02/2015
SIMVASTATIN GENTHON Genthon BV PA0740/006/001 Film Coated Tablet - SIMVASTATIN 14/02/2015
SIMVASTATIN GENTHON Genthon BV PA0740/006/002 Film Coated Tablet - SIMVASTATIN 14/02/2015
SIMVASTATIN GENTHON Genthon BV PA0740/006/003 Film Coated Tablet - SIMVASTATIN 14/02/2015
SIMVASTATIN GENTHON Genthon BV PA0740/006/004 Film Coated Tablet - SIMVASTATIN 14/02/2015
PUMARIX GlaxoSmithKline Biologicals EU/1/10/664/001 Emulsion and suspension for - PURIFIED ANTIGEN 11/02/2015
S.A. emulsion for injection FRACTIONS OF
INACTIVATED SPLIT
VIRIONS
A/CALIFORNIA/7/2009
(H1N1) V-LIKE STRAIN
ROPIRADE Clonmel Healthcare Ltd PA0126/176/001 Film Coated Tablet - ROPINIROLE (AS 05/02/2015
HYDROCHLORIDE)
ROPIRADE Clonmel Healthcare Ltd PA0126/176/002 Film Coated Tablet - ROPINIROLE (AS 05/02/2015
HYDROCHLORIDE)
ROPIRADE Clonmel Healthcare Ltd PA0126/176/003 Film Coated Tablet - ROPINIROLE (AS 05/02/2015
HYDROCHLORIDE)
ROPIRADE Clonmel Healthcare Ltd PA0126/176/004 Film Coated Tablet - ROPINIROLE (AS 05/02/2015
HYDROCHLORIDE)
CLAROPT Clonmel Healthcare Ltd PA0126/227/001 Eye Drops Solution - DORZOLAMIDE 03/02/2015
HYDROCHLORIDE
- TIMOLOL MALEATE
VALTAN Clonmel Healthcare Ltd PA0126/211/004 Film Coated Tablet - VALSARTAN 03/02/2015
CARDURA XL IMED Healthcare Ltd. PPA1463/005/001 Tablet Prolonged Release - DOXAZOSIN 01/02/2015
CARDURA XL IMED Healthcare Ltd. PPA1463/005/002 Tablet Prolonged Release - DOXAZOSIN 01/02/2015
CONRAY 280 Mallinckrodt UK Commercial PA1850/001/001 Solution for Injection - IOTALAMATE 01/02/2015
Ltd MEGLUMINE
OCTANATE 1000 IU Octapharma Limited PA0521/012/003 Pdr for Soln for Injection - HUMAN 01/02/2015
PLASMAFRAKTION
(FACTOR VIII)
OCTANATE 500 IU Octapharma Limited PA0521/012/002 Pdr for Soln for Injection - HUMAN 01/02/2015
PLASMAFRAKTION
(FACTOR VIII)
ROPINIROLE Accord Healthcare Limited PA1390/052/001 Film Coated Tablet - ROPINIROLE 01/02/2015
HYDROCHLORIDE
ROPINIROLE Accord Healthcare Limited PA1390/052/002 Film Coated Tablet - ROPINIROLE 01/02/2015
HYDROCHLORIDE
ROPINIROLE Accord Healthcare Limited PA1390/052/003 Film Coated Tablet - ROPINIROLE 01/02/2015
HYDROCHLORIDE
ROPINIROLE Accord Healthcare Limited PA1390/052/004 Film Coated Tablet - ROPINIROLE 01/02/2015
HYDROCHLORIDE
ROPINIROLE Accord Healthcare Limited PA1390/052/005 Film Coated Tablet - ROPINIROLE 01/02/2015
HYDROCHLORIDE
TOPOTECAN Accord Healthcare Limited PA1390/036/001 Powder for concentrate for - TOPOTECAN (AS 01/02/2015
solution for infusion HYDROCHLORIDE)
TORVAN Pinewood Laboratories Ltd, PA0281/150/004 Film Coated Tablet - ATORVASTATIN 31/01/2015
TRAMAPINE Pinewood Laboratories Ltd, PA0281/100/002 Tablet Prolonged Release - TRAMADOL 31/01/2015
HYDROCHLORIDE
FOSALEN ONCE WEEKLY Teva Pharma B.V. PA0749/129/002 Tablets - ALENDRONIC ACID 30/01/2015
EPROSARTAN MYLAN McDermott Laboratories Ltd PA0577/139/001 Film Coated Tablet - EPROSARTAN MESYLATE 27/01/2015
t/a Gerard Laboratories
EPROSARTAN MYLAN McDermott Laboratories Ltd PA0577/139/002 Film Coated Tablet - EPROSARTAN MESYLATE 27/01/2015
t/a Gerard Laboratories
RETIN-A CREAM Janssen-Cilag Ltd PA0748/033/004 Cream - TRETINOIN 27/01/2015
BUDESITAN 0.5MG/2ML Breath Limited PA1831/001/001 Nebuliser Suspension - BUDESONIDE 23/01/2015
NEBULISER SUSPENSION
BUDESITAN 1.0MG/2ML Breath Limited PA1831/001/002 Nebuliser Suspension - BUDESONIDE 23/01/2015
NEBULISER SUSPENSION

Human Medicines Withdrawn Products Page 149 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COMBINEB Breath Limited PA1831/003/001 Nebuliser Solution - IPRATROPIUM BROMIDE 23/01/2015
- SALBUTAMOL
IPRAVENT Breath Limited PA1831/002/001 Nebuliser Solution - IPRATROPIUM BROMIDE 23/01/2015
IPRAVENT Breath Limited PA1831/002/002 Nebuliser Solution - IPRATROPIUM BROMIDE 23/01/2015
SALBUVENT Breath Limited PA1831/004/001 Nebuliser Solution - SALBUTAMOL SULFATE 23/01/2015
SALBUVENT Breath Limited PA1831/004/002 Nebuliser Solution - SALBUTAMOL SULFATE 23/01/2015
TAVANIC B & S Healthcare PPA1328/173/001 Film Coated Tablet - LEVOFLOXACIN 22/01/2015
HEMIHYDRATE
ARCOXIA PCO Manufacturing DPR0465/012/001 Film Coated Tablet - ETORICOXIB 14/01/2015
ARCOXIA PCO Manufacturing DPR0465/012/002 Film Coated Tablet - ETORICOXIB 14/01/2015
ARCOXIA PCO Manufacturing DPR0465/012/003 Film Coated Tablet - ETORICOXIB 14/01/2015
ARCOXIA PCO Manufacturing DPR0465/012/004 Film Coated Tablet - ETORICOXIB 14/01/2015
CELLUVISC PCO Manufacturing DPR0465/031/001 Eye Drops Solution - CARMELLOSE SODIUM 14/01/2015
CELLUVISC PCO Manufacturing DPR0465/031/002 Eye Drops Solution - CARMELLOSE SODIUM 14/01/2015
COSOPT PCO Manufacturing DPR0465/013/001 Eye Drops Solution - DORZOLAMIDE 14/01/2015
- TIMOLOL
HALF SINEMET CR PCO Manufacturing DPR0465/009/003 Tablet Prolonged Release - LEVODOPA 14/01/2015
- CARBIDOPA
INEGY PCO Manufacturing DPR0465/025/001 Tablets - EZETIMIBE 14/01/2015
- SIMVASTATIN
INEGY PCO Manufacturing DPR0465/025/002 Tablets - EZETIMIBE 14/01/2015
- SIMVASTATIN
INSPRA PCO Manufacturing DPR0465/030/001 Tablets - EPLERENONE 14/01/2015
INSPRA PCO Manufacturing DPR0465/030/002 Tablets - EPLERENONE 14/01/2015
REMINYL XL PCO Manufacturing DPR0465/028/001 Prolonged Release Capsules - GALANTAMINE 14/01/2015

REMINYL XL PCO Manufacturing DPR0465/028/002 Prolonged Release Capsules - GALANTAMINE 14/01/2015

REMINYL XL PCO Manufacturing DPR0465/028/003 Prolonged Release Capsules - GALANTAMINE 14/01/2015

RISPERDAL CONSTA PCO Manufacturing DPR0465/039/001 Pdr+Solv for Susp for Inj - RISPERIDONE 14/01/2015
RISPERDAL CONSTA PCO Manufacturing DPR0465/039/002 Pdr+Solv for Soln for Inj 14/01/2015
RISPERDAL CONSTA PCO Manufacturing DPR0465/039/003 Pdr+Solv for Soln for Inj 14/01/2015
SINEMET CR PCO Manufacturing DPR0465/009/002 Prolonged Release Capsules - LEVODOPA 14/01/2015
- CARBIDOPA
SINEMET PLUS PCO Manufacturing DPR0465/009/001 Tablets - LEVODOPA 14/01/2015
- CARBIDOPA
SINGULAIR PCO Manufacturing DPR0465/019/002 Film Coated Tablet - MONTELUKAST SODIUM 14/01/2015
SINGULAIR PAEDIATRIC PCO Manufacturing DPR0465/019/001 Tablets Chewable - MONTELUKAST SODIUM 14/01/2015
SINGULAIR PAEDIATRIC PCO Manufacturing DPR0465/019/004 Tablets Chewable - MONTELUKAST SODIUM 14/01/2015
SINGULAIR PAEDIATRIC PCO Manufacturing DPR0465/019/003 Granules - MONTELUKAST SODIUM 14/01/2015
GRANULES
TELFAST PCO Manufacturing DPR0465/011/001 Film Coated Tablet - FEXOFENADINE 14/01/2015
HYDROCHLORIDE
TELFAST PCO Manufacturing DPR0465/003/001 Film Coated Tablet - FEXOFENADINE 14/01/2015
HYDROCHLORIDE
VALCYTE PCO Manufacturing DPR0465/040/001 Film Coated Tablet - VALGANCICLOVIR 14/01/2015
ZANAFLEX PCO Manufacturing DPR0465/023/001 Tablets - TIZANIDINE 14/01/2015
HYDROCHLORIDE
ZANAFLEX PCO Manufacturing DPR0465/023/002 Tablets - TIZANIDINE 14/01/2015
HYDROCHLORIDE
COMBIVENT UDVS B & S Healthcare PPA1328/123/001 Nebuliser Solution - IPRATROPIUM BROMIDE 07/01/2015
MONOHYDRATE
- SALBUTAMOL SULFATE
EPAXAL Crucell Italy S.r.l. PA0941/001/001 Suspension for Injection - HEPATITIS A VIRUS 01/01/2015
(STRAIN RG-SB)
AREDIA Novartis Pharmaceuticals UK PA0013/090/004 Powder for concentrate for - PAMIDRONATE 31/12/2014
Ltd solution for infusion DISODIUM PENTAHYDRAT

AREDIA Novartis Pharmaceuticals UK PA0013/090/002 Powder for concentrate for - PAMIDRONATE 31/12/2014
Ltd solution for infusion DISODIUM PENTAHYDRAT

AUGMENTIN DUO PCO Manufacturing PPA0465/047/002 Film Coated Tablet - AMOXICILLIN 31/12/2014
TRIHYDRATE
- CLAVULANATE
POTASSIUM
BRICANYL TURBOHALER PCO Manufacturing PPA0465/088/001 Inhalation powder, hard - TERBUTALINE SULFATE 31/12/2014
capsule
CATAFLAM Novartis Pharmaceuticals UK PA0013/088/001 Coated Tablets - DICLOFENAC 31/12/2014
Ltd POTASSIUM
DETRUSITOL SR PCO Manufacturing PPA0465/080/003 Prolonged Release Capsules - TOLTERODINE L- 31/12/2014
TARTRATE
DETRUSITOL SR PCO Manufacturing PPA0465/080/004 Prolonged Release Capsules - TOLTERODINE TARTARE 31/12/2014

Human Medicines Withdrawn Products Page 150 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOVOBET PCO Manufacturing PPA0465/213/001 Ointment - CALCIPOTRIOL 31/12/2014
- BETAMETHASONE
FAVERIN PCO Manufacturing PPA0465/319/001 Film Coated Tablet - FLUVOXAMINE MALEATE 31/12/2014

FAVERIN PCO Manufacturing PPA0465/319/002 Film Coated Tablet - FLUVOXAMINE MALEATE 31/12/2014

LEXAPRO H. Lundbeck A/S PA0805/002/006 Oral Drops Solution - ESCITALOPRAM 31/12/2014


OXALATE
LEXAPRO MELTZ H. Lundbeck A/S PA0805/002/008 Orodispersible Tablet - ESCITALOPRAM 31/12/2014
LEXAPRO MELTZ H. Lundbeck A/S PA0805/002/009 Orodispersible Tablet - ESCITALOPRAM 31/12/2014
LIPOSTAT PCO Manufacturing PPA0465/059/002 Tablets - PRAVASTATIN SODIUM 31/12/2014
LIPOSTAT PCO Manufacturing PPA0465/059/003 Tablets - PRAVASTATIN SODIUM 31/12/2014
OMNIC PCO Manufacturing PPA0465/086/001 Modified-release capsule, - TAMSULOSIN 31/12/2014
hard HYDROCHLORIDE
PULMICORT TURBOHALER PCO Manufacturing PPA0465/100/002 Inhalation powder - BUDESONIDE 31/12/2014
200 MICROGRAMS
INHALATION POW

QUESTRAN PCO Manufacturing PPA0465/290/001 Powder for Oral Suspension - COLESTYRAMINE RESIN 31/12/2014
SEROQUEL PCO Manufacturing PPA0465/153/002 Film Coated Tablet - QUETIAPINE FUMARATE 31/12/2014
SPASMONAL PCO Manufacturing PPA0465/264/001 Capsules Hard - ALVERINE CITRATE 31/12/2014
STRATTERA PCO Manufacturing PPA0465/325/001 Capsules Hard - ATOMOXETINE 31/12/2014
HYDROCHLORIDE
STRATTERA PCO Manufacturing PPA0465/325/002 Capsules Hard - ATOMOXETINE 31/12/2014
HYDROCHLORIDE
STRATTERA PCO Manufacturing PPA0465/325/003 Capsules Hard - ATOMOXETINE 31/12/2014
HYDROCHLORIDE
TAMBOCOR PCO Manufacturing PPA0465/224/001 Tablets - FLECAINIDE ACETATE 31/12/2014
VAGIFEM PCO Manufacturing PPA0465/294/001 Vaginal Tablets - ESTRADIOL 31/12/2014
VOLTAROL Novartis Pharmaceuticals UK PA0013/087/001 Tablets Gastro-Resistant - DICLOFENAC SODIUM 31/12/2014
Ltd
VOLTAROL AMPOULES Novartis Pharmaceuticals UK PA0013/087/005 Solution for Injection - DICLOFENAC SODIUM 31/12/2014
Ltd
WILATE 450 Octapharma Limited PA0521/017/001 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 31/12/2014
- VON WILLEBRAND
FACTOR HUMAN
WILATE 900 Octapharma Limited PA0521/017/002 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 31/12/2014
- VON WILLEBRAND
FACTOR HUMAN
COSOPT LTT Pharma Limited PPA1562/043/001 Eye Drops Solution - DORZOLAMIDE 22/12/2014
- TIMOLOL
DURAPHAT LTT Pharma Limited PPA1562/123/001 Toothpaste - SODIUM FLUORIDE 22/12/2014
ISOPTIN SR LTT Pharma Limited PPA1562/092/001 Tablet Prolonged Release - VERAPAMIL 22/12/2014
HYDROCHLORIDE
LEXAPRO LTT Pharma Limited PPA1562/109/001 Film Coated Tablet - ESCITALOPRAM 22/12/2014
OXALATE
VESITIRIM LTT Pharma Limited PPA1562/086/003 Film Coated Tablet - SOLIFENACIN 22/12/2014
SUCCINATE
CRESTOR B & S Healthcare PPA1328/059/003 Film Coated Tablet - ROSUVASTATIN 21/12/2014
CALCIUM
DICYNENE 250MG/2ML OM PHARMA SA PA1108/001/001 Solution for Injection - ETAMSILATE 19/12/2014
SOLUTION FOR INJECTIO

LAXAGOL Auden Mckenzie (Pharma PA1352/005/001 Powder for Oral Solution - MACROGOL 3350 17/12/2014
Division) Ltd - SODIUM CHLORIDE
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
UNICOUGH CHESTY Pinewood Laboratories Ltd, PA0281/142/001 Oral Solution - CARBOCISTEINE 17/12/2014
DIACARDYNE SR Ethypharm PA0549/001/010 Prolonged Release Capsules - DILTIAZEM 15/12/2014
HYDROCHLORIDE
DIACARDYNE SR Ethypharm PA0549/001/001 Prolonged Release Capsules - DILTIAZEM 15/12/2014
HYDROCHLORIDE
DIACARDYNE SR Ethypharm PA0549/001/002 Prolonged Release Capsules - DILTIAZEM 15/12/2014
HYDROCHLORIDE
DIACARDYNE SR Ethypharm PA0549/001/003 Prolonged Release Capsules - DILTIAZEM 15/12/2014
HYDROCHLORIDE
DIACARDYNE SR Ethypharm PA0549/001/004 Prolonged Release Capsules - DILTIAZEM 15/12/2014
HYDROCHLORIDE
METHOTREXATE Actavis Group PTC ehf PA1380/116/001 Solution for Inj/Inf 12/12/2014
TERBINAFINE Actavis Group PTC ehf PA1380/079/001 Cream - TERBINAFINE 12/12/2014
HYDROCHLORIDE
VANCOMYCIN Actavis Group PTC ehf PA1380/099/001 Powder for concentrate for - VANCOMYCIN 10/12/2014
solution for infusion HYDROCHLORIDE
VANCOMYCIN Actavis Group PTC ehf PA1380/099/002 Powder for concentrate for - VANCOMYCIN 10/12/2014
solution for infusion HYDROCHLORIDE

Human Medicines Withdrawn Products Page 151 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VALACICLOVIR CLONMEL Clonmel Healthcare Ltd PA0126/219/001 Film Coated Tablet - VALACICLOVIR 09/12/2014
HYDROCHLORIDE
MONOHYDRATE
ZESGER 2.5 MG TABLETS. McDermott Laboratories Ltd PA0577/041/004 Tablets - LISINOPRIL 08/12/2014
t/a Gerard Laboratories
CLAVAMEL Clonmel Healthcare Ltd PA0126/103/005 Tablets - AMOXICILLIN 05/12/2014
- CLAVULANIC ACID
PARACETAMOL Accord Healthcare Limited PA1390/016/002 Tablets Effervescent - PARACETAMOL 04/12/2014
LOSEC MUPS B & S Healthcare PPA1328/015/002 Tablets Gastro-Resistant - OMEPRAZOLE 03/12/2014
PIPERACILLIN / Actavis Group PTC ehf PA1380/048/001 Pdr+Solv for soln for Inf - PIPERACILLIN 03/12/2014
TAZOBACTAM ACTAVIS - TAZOBACTAM
2G/0.25G POWDER
PIPERACILLIN / Actavis Group PTC ehf PA1380/048/002 Powder for solution for - PIPERACILLIN 03/12/2014
TAZOBACTAM ACTAVIS infusion - TAZOBACTAM
4G/0.5G POWDER F
ADALAT LA LTT Pharma Limited PPA1562/036/001 Tablet Prolonged Release - NIFEDIPINE 01/12/2014
ADALAT RETARD LTT Pharma Limited PPA1562/036/004 Tablet Prolonged Release - NIFEDIPINE 01/12/2014
AGGRASTAT Correvio (UK) Ltd PA1720/001/001 Concentrate for Soln for Inf - TIROFIBAN 01/12/2014
HYDROCHLORIDE
MONOHYDRATE
AGGRASTAT Correvio (UK) Ltd PA1720/001/002 Concentrate for Soln for Inf - TIROFIBAN 01/12/2014
HYDROCHLORIDE
MONOHYDRATE
ESTELLE Clonmel Healthcare Ltd PA0126/170/002 Coated Tablets - ETHINYLESTRADIOL 01/12/2014
- GESTODENE
CODALAX Mundipharma PA1688/003/003 Oral Suspension - DANTRON 30/11/2014
Pharmaceuticals Limited - POLOXALCOL
CODALAX FORTE Mundipharma PA1688/003/004 Oral Suspension - DANTRON 30/11/2014
1000MG/75MG PER 5ML Pharmaceuticals Limited - POLOXALCOL
SUSPENSION
LOZITAR Pinewood Laboratories Ltd, PA0281/141/003 Film Coated Tablet - LOSARTAN POTASSIUM 30/11/2014
TORVAN Pinewood Laboratories Ltd, PA0281/150/001 Film Coated Tablet - ATORVASTATIN 30/11/2014
CYPROTERONE Generics (UK) Limited PA0405/032/002 Tablets - CYPROTERONE 28/11/2014
ACETATE/ETHINYLESTRA ACETATE
DIOL - ETHINYLESTRADIOL
LERCANIDIPINE Arrow Generics Limited PA1130/028/001 Film Coated Tablet - LERCANIDIPINE 26/11/2014
HYDROCHLORIDE HYDROCHLORIDE
LERCANIDIPINE Arrow Generics Limited PA1130/028/002 Film Coated Tablet - LERCANIDIPINE 26/11/2014
HYDROCHLORIDE HYDROCHLORIDE
MAGREZOL Arrow Generics Limited PA1130/031/001 Film Coated Tablet - ZOLMITRIPTAN 26/11/2014
MAGREZOL Arrow Generics Limited PA1130/031/002 Orodispersible Tablet - ZOLMITRIPTAN 26/11/2014
CREON LTT Pharma Limited PPA1562/008/001 Capsules Gastro-Resistant - PANCREATIN 21/11/2014
CREON LTT Pharma Limited PPA1562/008/002 Capsules Gastro-Resistant - PANCREATIN 21/11/2014
LOZITAR Pinewood Laboratories Ltd, PA0281/141/004 Film Coated Tablet - LOSARTAN POTASSIUM 21/11/2014
TILDIEM LA LTT Pharma Limited PPA1562/107/001 Prolonged Release Capsules - DILTIAZEM 21/11/2014
HYDROCHLORIDE
SKINMAN Ecolab Limited PA1110/012/001 Cutaneous Solution - DENATURED ALCOHOL 20/11/2014
(DENATURED ETHANOL)
- PURIFIED WATER
- METHYL ETHYL KETONE
KLARIGER LA McDermott Laboratories Ltd PA0577/093/003 Modified-release Tablets - CLARITHROMYCIN 18/11/2014
t/a Gerard Laboratories CITRATE
AXID Flynn Pharma Ltd PA1226/004/002 Capsules Hard - NIZATIDINE 17/11/2014
DUROGESIC DTRANS Imbat Limited PPA1151/187/001 Transdermal Patch - FENTANYL 17/11/2014
DUROGESIC DTRANS Imbat Limited PPA1151/187/002 Transdermal Patch - FENTANYL 17/11/2014
DUROGESIC DTRANS Imbat Limited PPA1151/187/003 Transdermal Patch - FENTANYL 17/11/2014
DUROGESIC DTRANS Imbat Limited PPA1151/187/004 Transdermal Patch - FENTANYL 17/11/2014
INFANRIX IN A PREFILLED GlaxoSmithKline (Ireland) PA1077/030/002 Suspension for Injection - DIPHTHERIA TOXOID 17/11/2014
SYRINGE Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
INFANRIX-HIB GlaxoSmithKline (Ireland) PA1077/028/002 Powder for suspension for - PERTUSSIS TOXOID 17/11/2014
Limited injection - FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- DIPHTHERIA TOXOID
- TETANUS TOXOID
- HAEMOPHILUS
INFLUENZAE TYPE B
POLYSACCHARIDE
- TETANUS TOXOID
RAMIPRIL TEVA Teva Pharma B.V. PA0749/107/003 Tablets - RAMIPRIL 12/11/2014
RAMIPRIL TEVA Teva Pharma B.V. PA0749/107/004 Tablets - RAMIPRIL 12/11/2014

Human Medicines Withdrawn Products Page 152 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LIPIDEM B. Braun Melsungen AG PA0736/021/001 Emulsion for Infusion - TRIGLYCERIDES, 06/11/2014
MEDIUM CHAIN
- SOYA OIL
- OMEGA-3-ACID
TRIGLYCERIDES
LIPIDEM B. Braun Melsungen AG PA0736/021/002 Emulsion for Infusion - TRIGLYCERIDES, 06/11/2014
MEDIUM CHAIN
- SOYA OIL
- OMEGA-3-ACID
TRIGLYCERIDES
TETAGAM P CSL Behring GmbH PA0800/009/001 Solution for Injection - HUMAN PLASMA 06/11/2014
PROTEIN
- HUMAN TETANUS
IMMUNOGLOBULIN PH.
EUR.
- IMMUNOGLOBULINS
- TETANUS ANTIBODIES
TACROLIMUS Accord Healthcare Limited PA1390/019/001 Capsules Hard - TACROLIMUS 05/11/2014
TACROLIMUS Accord Healthcare Limited PA1390/019/002 Capsules Hard - TACROLIMUS 05/11/2014
TACROLIMUS Accord Healthcare Limited PA1390/019/004 Capsules Hard - TACROLIMUS 05/11/2014
MONOHYDRATE
AULIN Helsinn Birex PA0294/018/003 Gel - NIMESULIDE 04/11/2014
Pharmaceuticals Limited
CIPROFLOXACIN AMNEAL Amneal Pharma Europe PA1897/003/001 Solution for Infusion - CIPROFLOXACIN 01/11/2014
Limited LACTATE
Clasteon 800mg Film-coated Beacon Pharmaceuticals Ltd PA1312/012/001 Film-coated tablet - Sodium clodronate 01/11/2014
Tablets
NIFED RETARD Rowex Ltd PA0711/011/006 Modified-release Tablets - NIFEDIPINE 30/10/2014
PENTRAX Alliance Pharmaceuticals Ltd PA0943/010/001 Shampoo - COAL TAR 30/10/2014

ESOMEPRAZOLE Ranbaxy Ireland Limited PA0408/081/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 29/10/2014


MAGNESIUM
(AMORPHOUS)
ESOMEPRAZOLE Ranbaxy Ireland Limited PA0408/081/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 29/10/2014
MAGNESIUM
(AMORPHOUS)
LEVOFLOXACIN Amneal Pharma Europe PA1897/004/001 Solution for Infusion - LEVOFLOXACIN 29/10/2014
Limited HEMIHYDRATE
LEVOFLOXACIN Amneal Pharma Europe PA1897/004/002 Solution for Infusion - LEVOFLOXACIN 29/10/2014
Limited HEMIHYDRATE
METED Alliance Pharmaceuticals Ltd PA0943/011/001 Shampoo - COLLOIDAL SULPHUR 29/10/2014
- SALICYLIC ACID
ONDANSETRON PFIZER Amneal Pharma Europe PA1897/005/001 Solution for Inj/Inf - ONDANSETRON 29/10/2014
Limited HYDROCHLORIDE
DIHYDRATE
VALSARTAN RANBAXY Ranbaxy Ireland Limited PA0408/069/001 Film Coated Tablet - VALSARTAN 29/10/2014
VALSARTAN RANBAXY Ranbaxy Ireland Limited PA0408/069/002 Film Coated Tablet - VALSARTAN 29/10/2014
VALSARTAN RANBAXY Ranbaxy Ireland Limited PA0408/069/003 Film Coated Tablet - VALSARTAN 29/10/2014
VALSARTAN/HYDROCHLO Ranbaxy Ireland Limited PA0408/082/001 Film Coated Tablet - VALSARTAN 29/10/2014
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

VALSARTAN/HYDROCHLO Ranbaxy Ireland Limited PA0408/082/002 Film Coated Tablet - VALSARTAN 29/10/2014
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

VALSARTAN/HYDROCHLO Ranbaxy Ireland Limited PA0408/082/003 Film Coated Tablet - VALSARTAN 29/10/2014
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

FOLICID STADApharm GmbH PA1070/001/001 Solution for Injection - CALCIUM FOLINATE 27/10/2014
CO-AMOXICLAV Rowa Pharmaceuticals PPA0074/001/001 Film Coated Tablet - AMOXICILLIN 24/10/2014
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
BUPIVACAINE AMNEAL Amneal Pharma Europe PA1897/001/001 Solution for Injection - BUPIVACAINE 21/10/2014
Limited HYDROCHLORIDE
BUPIVACAINE AMNEAL Amneal Pharma Europe PA1897/001/002 Solution for Injection - BUPIVACAINE 21/10/2014
Limited HYDROCHLORIDE
CLOPIDOGREL TEVA Teva Pharma B.V. EU/1/10/649/001-016 Film Coated Tablet - CLOPIDOGREL 21/10/2014
PHARMA B.V. HYDROCHLORIDE
PAROX Rowex Ltd PA0711/040/001 Film Coated Tablet - PAROXETINE 21/10/2014
HYDROCHLORIDE
HEMIHYDRATE
PAROX Rowex Ltd PA0711/040/002 Film Coated Tablet - PAROXETINE 21/10/2014
HYDROCHLORIDE
HEMIHYDRATE
LOZITAR Pinewood Laboratories Ltd, PA0281/141/001 Film Coated Tablet - LOSARTAN POTASSIUM 20/10/2014
LOZITAR Pinewood Laboratories Ltd, PA0281/141/002 Film Coated Tablet - LOSARTAN POTASSIUM 20/10/2014

Human Medicines Withdrawn Products Page 153 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SIMATOR Arrow Generics Limited PA1130/001/001 Film Coated Tablet - SIMVASTATIN 20/10/2014
SIMATOR Arrow Generics Limited PA1130/001/002 Film Coated Tablet - SIMVASTATIN 20/10/2014
SIMATOR Arrow Generics Limited PA1130/001/003 Film Coated Tablet - SIMVASTATIN 20/10/2014
SIMATOR Arrow Generics Limited PA1130/001/004 Film Coated Tablet - SIMVASTATIN 20/10/2014
MIDAZOLAM Auden Mckenzie (Pharma PA1352/014/001 Solution for Injection - MIDAZOLAM 15/10/2014
Division) Ltd
MIDAZOLAM Auden Mckenzie (Pharma PA1352/014/002 Solution for Injection - MIDAZOLAM 15/10/2014
Division) Ltd
MORPHINE SULPHATE Auden Mckenzie (Pharma PA1352/008/001 Solution for Injection - MORPHINE SULPHATE 15/10/2014
Division) Ltd
MORPHINE SULPHATE Auden Mckenzie (Pharma PA1352/008/002 Solution for Injection - MORPHINE SULPHATE 15/10/2014
Division) Ltd
MORPHINE SULPHATE Auden Mckenzie (Pharma PA1352/008/003 Solution for Injection - MORPHINE SULPHATE 15/10/2014
Division) Ltd
MORPHINE SULPHATE Auden Mckenzie (Pharma PA1352/008/004 Solution for Injection - MORPHINE SULPHATE 15/10/2014
Division) Ltd
PRINDEX Glenmark Pharmaceuticals PA1462/002/001 Tablets - PERINDOPRIL TERT- 15/10/2014
Europe Limited BUTYLAMINE
PRINDEX Glenmark Pharmaceuticals PA1462/002/002 Tablets - PERINDOPRIL TERT- 15/10/2014
Europe Limited BUTYLAMINE
PRINDEX Glenmark Pharmaceuticals PA1462/002/003 Tablets - PERINDOPRIL TERT- 15/10/2014
Europe Limited BUTYLAMINE
MADOPAR B & S Healthcare PPA1328/139/001 Capsules Hard - LEVODOPA 14/10/2014
- BENSERAZIDE
IRBESARTAN MYLAN McDermott Laboratories Ltd PA0577/164/001 Tablets - IRBESARTAN 06/10/2014
t/a Gerard Laboratories
IRBESARTAN MYLAN McDermott Laboratories Ltd PA0577/164/002 Tablets - IRBESARTAN 06/10/2014
t/a Gerard Laboratories
IRBESARTAN MYLAN McDermott Laboratories Ltd PA0577/164/003 Tablets - IRBESARTAN 06/10/2014
t/a Gerard Laboratories
ZESGER PLUS McDermott Laboratories Ltd PA0577/055/001 Tablets - LISINOPRIL 06/10/2014
t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

FUNGAFINE Norton Waterford PA0436/038/001 Tablets - TERBINAFINE 02/10/2014


HYDROCHLORIDE
ANASTROZOLE HIKMA Hikma Farmaceutica PA1217/004/001 Film Coated Tablet - ANASTRAZOLE 01/10/2014
(Portugal) SA
RABICLON Clonmel Healthcare Ltd PA0126/229/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 01/10/2014
RABICLON Clonmel Healthcare Ltd PA0126/229/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 01/10/2014
SILDENAFIL AJANTA Ajanta Pharma UK Limited PA1747/001/001 Film Coated Tablet - SILDENAFIL CITRATE 01/10/2014
PHARMA
SILDENAFIL AJANTA Ajanta Pharma UK Limited PA1747/001/002 Film Coated Tablet - SILDENAFIL CITRATE 01/10/2014
PHARMA
TOPOTECAN EAGLE Eagle Laboratories Limited EU/1/11/744/001-002 Concentrate for Soln for Inf - TOPOTECAN HCL 01/10/2014
c/o
CLOPIDOGREL QUALIMED Qualimed EU/1/09/557/1-9 Film Coated Tablet - CLOPIDOGREL 30/09/2014
HYDROCHLORIDE
EPOPROSTENOL DREHM Drehm Pharma GmbH PA1533/001/001 Pdr+Solv for soln for Inf - EPOPROSTENOL 30/09/2014
EPOPROSTENOL DREHM Drehm Pharma GmbH PA1533/001/002 Pdr+Solv for soln for Inf - EPOPROSTENOL 30/09/2014
PIOGLITAZONE KRKA Krka d.d., Novo mesto EU/1/11/723/001-007 Tablets - PIOGLITAZONE 30/09/2014
HYDROCHLORIDE
PIOGLITAZONE KRKA Krka d.d., Novo mesto EU/1/11/723/008-014 Tablets - PIOGLITAZONE 30/09/2014
HYDROCHLORIDE
PIOGLITAZONE KRKA Krka d.d., Novo mesto EU/1/11/723/015-045 Tablets - PIOGLITAZONE 30/09/2014
HYDROCHLORIDE
REVASC Canyon Pharmaceuticals Ltd EU/1/97/043/001 Pdr+Solv for Soln for Inj - DESIRUDIN 30/09/2014

REVASC Canyon Pharmaceuticals Ltd EU/1/97/043/002 Pdr+Solv for Soln for Inj - DESIRUDIN 30/09/2014

LOCABIOTAL Servier Laboratories (Ireland) PA0068/015/001 Nasal Spray Solution - FUSAFUNGINE 24/09/2014
Ltd
RIVASTIGMINE 3M 3M Health Care Limited EU/1/14/911/001-004 Transdermal Patch - RIVASTIGMINE 24/09/2014
RIVASTIGMINE 3M 3M Health Care Limited EU/1/14/911/005-008 Transdermal Patch - RIVASTIGMINE 24/09/2014
BABYLAX 1.8 G RECTAL Bausch & Lomb UK Limited PA0555/009/001 Rectal Solution - GLYCEROL 85% 23/09/2014
SOLUTION
BI PRETERAX Les Laboratoires Servier PA0568/008/002 Tablets - PERINDOPRIL TERT- 23/09/2014
BUTYLAMINE SALT
- INDAPAMIDE
TRIMETAZIDINE Servier Laboratories (Ireland) PA0068/016/001 Tablet Prolonged Release - TRIMETAZIDINE 23/09/2014
Ltd DIHYDROCHLORIDE
VIVIDRIN Bausch & Lomb UK Limited PA0555/005/001 Nasal Spray Solution - CROMOGLICATE SODIUM 23/09/2014

CLOPIDOGREL PENSA Pensa Pharma AB PA1647/004/001 Film Coated Tablet - CLOPIDOGREL BESILATE 19/09/2014

CRESTOR Pharma First Limited PPA1592/002/003 Film Coated Tablet - ROSUVASTATIN 19/09/2014

Human Medicines Withdrawn Products Page 154 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZOTON FASTAB Pharma First Limited PPA1592/003/002 Orodispersible Tablet - LANSOPRAZOLE 19/09/2014
PERINDOPRIL TERT- Glenmark Pharmaceuticals PA1462/005/001 Tablets - PERINDOPRIL TERT- 10/09/2014
BUTYLAMINE/INDAPAMIDE Europe Limited BUTYLAMINE
GLENMARK - INDAPAMIDE
PERINDOPRIL TERT- Glenmark Pharmaceuticals PA1462/005/002 Tablets - PERINDOPRIL TERT- 10/09/2014
BUTYLAMINE/INDAPAMIDE Europe Limited BUTYLAMINE
GLENMARK - INDAPAMIDE
ACTONEL ONCE A WEEK Pharma First Limited PPA1592/001/001 Film Coated Tablet - RISEDRONATE SODIUM 05/09/2014
CRESTOR Pharma First Limited PPA1592/002/001 Film Coated Tablet - ROSUVASTATIN 05/09/2014
CRESTOR Pharma First Limited PPA1592/002/002 Film Coated Tablet - ROSUVASTATIN 05/09/2014
INACTIVATED INFLUENZA Sanofi Pasteur MSD Ltd PA0544/034/002 Suspension for Injection - A/CALIFORNIA/7/2009 05/09/2014
VACCINE (SPLIT VIRON) (H1N1)PDM09 - DERIVED
STRAIN USED NYMC X-
179A
- A/VICTORIA/361/2011
(H3N2) - DERIVED STRAIN
USED IVR-165
-
B/MASSACHUSETTS/2/201
2
NEXIUM Pharma First Limited PPA1592/004/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 05/09/2014
NEXIUM Pharma First Limited PPA1592/004/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 05/09/2014
ZOTON FASTAB Pharma First Limited PPA1592/003/001 Orodispersible Tablet - LANSOPRAZOLE 05/09/2014
DECAN Baxter Healthcare Limited PA0167/102/001 Concentrate for Soln for Inf - FERROUS GLUCONATE 29/08/2014
- COPPER GLUCONATE
- MANGANESE
GLUCONATE
- ZINC GLUCONATE
- SODIUM FLUORIDE
- COBALT GLUCONATE
- SODIUM IODIDE
- SODIUM SELENITE
- AMMONIUM MOLYBDATE
- CHROMIUM CHLORIDE

GEMCITABINE MYLAN Generics (UK) Limited PA0405/055/001 Powder for solution for - GEMCITABINE 27/08/2014
infusion
GEMCITABINE MYLAN Generics (UK) Limited PA0405/055/002 Solution for Infusion - GEMCITABINE 27/08/2014
CILEST Imbat Limited PPA1151/108/001 Tablets - NORGESTIMATE 26/08/2014
- ETHINYLESTRADIOL
NIFED Rowex Ltd PA0711/011/009 Capsules, Soft - NIFEDIPINE 26/08/2014
CEFTAZIDIME Clonmel Healthcare Ltd PA0126/178/001 Pdr for Soln for Injection - CEFTAZIDIME 21/08/2014
CEFTAZIDIME Clonmel Healthcare Ltd PA0126/178/002 Pdr for Soln for Injection - CEFTAZIDIME 21/08/2014
CEFTAZIDIME Clonmel Healthcare Ltd PA0126/178/003 Pdr for Soln Inj/Inf - CEFTAZIDIME 21/08/2014
CEFTAZIDIME Clonmel Healthcare Ltd PA0126/178/004 Pdr for Soln Inj/Inf - CEFTAZIDIME 21/08/2014
ACOXXEL Merck Sharp & Dohme PA1286/042/001 Film Coated Tablet - ETORICOXIB 15/08/2014
Ireland (Human Health)
Limited
ACOXXEL Merck Sharp & Dohme PA1286/042/002 Film Coated Tablet - ETORICOXIB 15/08/2014
Ireland (Human Health)
Limited
ACOXXEL Merck Sharp & Dohme PA1286/042/003 Film Coated Tablet - ETORICOXIB 15/08/2014
Ireland (Human Health)
Limited
ACOXXEL Merck Sharp & Dohme PA1286/042/004 Film Coated Tablet - ETORICOXIB 15/08/2014
Ireland (Human Health)
Limited
AMOLIN Stada Arzneimittel AG PA0593/004/001 Tablets - ATENOLOL 15/08/2014
AMOLIN Stada Arzneimittel AG PA0593/004/002 Tablets - ATENOLOL 15/08/2014
AMOLIN Stada Arzneimittel AG PA0593/004/003 Tablets - ATENOLOL 15/08/2014
KAPAKE Imbat Limited PPA1151/135/001 Tablets - PARACETAMOL 15/08/2014
- CODEINE PHOSPHATE
SYNDOL Imbat Limited PPA1151/111/001 Tablets - PARACETAMOL BP 15/08/2014
- CODEINE PHOSPHATE
BP
- DOXYLAMINE
SUCCINATE NF
- CAFFEINE BP
TERAXANS Les Laboratoires Servier PA0568/023/002 Film Coated Tablet - PERINDOPRIL ARGININE 13/08/2014
- INDAPAMIDE
VAGIFEM Novo Nordisk A/S PA0218/030/001 Vaginal tablet - ESTRADIOL 06/08/2014
HEMIHYDRATE
DORIBAX Janssen-Cilag International EU/1/08/467/002 Powder for solution for - DORIPENEM 05/08/2014
NV infusion MONOHYDRATE

Human Medicines Withdrawn Products Page 155 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DORIBAX 500 MG POWDER Janssen-Cilag International EU/1/08/467/1 Powder for solution for - DORIPENEM 05/08/2014
FOR SOLUTION FOR NV infusion MONOHYDRATE
INFUSION
OLANZAPINE CIPLA Cipla (EU) Limited EU/1/07/426/10-11 Coated Tablets - OLANZAPINE 05/08/2014
OLANZAPINE CIPLA Cipla (EU) Limited EU/1/07/426/1-2 Coated Tablets - OLANZAPINE 05/08/2014
OLANZAPINE CIPLA Cipla (EU) Limited EU/1/07/426/3-4 Coated Tablets - OLANZAPINE 05/08/2014
OLANZAPINE CIPLA Cipla (EU) Limited EU/1/07/426/5-6 Coated Tablets - OLANZAPINE 05/08/2014
OLANZAPINE CIPLA Cipla (EU) Limited EU/1/07/426/7-9 Coated Tablets - OLANZAPINE 05/08/2014
Vistide Gilead Sciences International EU/1/97/037/001 Concentrate for solution for - Cidofovir 02/08/2014
infusion
COLOMYCIN UNITS/5ML Forest Laboratories UK Ltd PA0100/001/003 Syrup - COLISTIN SULFATE 31/07/2014
IOA NV Organon EU/1/11/689/001-002 Film-coated tablet - NOMEGESTROL 31/07/2014
ACETATE
- Estradiol hemihydrate
EFEXOR B & S Healthcare PPA1328/118/001 Tablets - VENLAFAXINE 30/07/2014
HYDROCHLORIDE
PULMICORT TURBOHALER B & S Healthcare PPA1328/113/001 Inhalation powder - BUDESONIDE 30/07/2014

BICALUTAMIDE SYNTHON Synthon BV PA0840/006/001 Film Coated Tablet - BICALUTAMIDE 28/07/2014


50MG FILM-COATED
TABLETS
SIMVASTATIN SY Genthon BV PA0740/004/001 Film Coated Tablet - SIMVASTATIN 28/07/2014
MYCOPHENOLATE Actavis Group PTC ehf PA1380/039/001 Capsules Hard - MYCOPHENOLATE 23/07/2014
MOFETIL MOFETIL
CELECOXIB Actavis Group PTC ehf PA1380/143/001 Capsules Hard - CELECOXIB 18/07/2014
CELECOXIB Actavis Group PTC ehf PA1380/143/002 Capsules Hard - CELECOXIB 18/07/2014
Cozaar Comp 100 mg/12.5 IMB- Test Agent Company PA013639/048/478 Not assigned 16/07/2014
mg film-coated tablets
CIPROFLOXACIN Teva UK Limited PA0237/063/001 Solution for Infusion - CIPROFLOXACIN 11/07/2014
PERINDOPRIL SERVIER Les Laboratoires Servier PA0568/012/003 Tablets - PERINDOPRIL TERT- 11/07/2014
BUTYLAMINE SALT
PERINDOPRIL TERT- Les Laboratoires Servier PA0568/012/001 Tablets - PERINDOPRIL TERT- 11/07/2014
BUTYLAMINE SERVIER BUTYLAMINE SALT
ZORCLONE Synthon BV PA0840/001/001 Film Coated Tablet - ZOPICLONE 10/07/2014
TENORET B & S Healthcare PPA1328/107/001 Film Coated Tablet - ATENOLOL 09/07/2014
- CHLORTALIDONE
LIQUI-CHAR Oxford Pharmaceuticals Ltd PA0961/001/001 Oral Suspension - CHARCOAL, ACTIVATED 03/07/2014
AKNEMIN Surtech International Ltd PA0557/002/001 Capsule - MINOCYCLINE 02/07/2014
HYDROCHLORIDE
AKNEMIN Surtech International Ltd PA0557/002/002 Capsule - MINOCYCLINE 02/07/2014
HYDROCHLORIDE
AMPICILLIN Regent Laboratories Limited PA0493/003/001 Syrup - AMPICILLIN TRIHYDRATE 02/07/2014

AMPICILLIN Regent Laboratories Limited PA0493/003/002 Syrup - AMPICILLIN TRIHYDRATE 02/07/2014

NICOZONE Helm AG PA1466/002/001 Tablets - NICORANDIL 02/07/2014


NICOZONE Helm AG PA1466/002/002 Tablets - NICORANDIL 02/07/2014
SIMVASTATIN Genthon BV PA0740/003/001 Film Coated Tablet - SIMVASTATIN 02/07/2014
SIMVASTATIN Genthon BV PA0740/003/002 Film Coated Tablet - SIMVASTATIN 02/07/2014
ZISPIN SOLTAB B & S Healthcare PPA1328/115/001 Orodispersible Tablet - MIRTAZAPINE 02/07/2014
CLOPIXOL ACUPHASE Lundbeck Limited PA0115/005/009 Solution for Injection - ZUCLOPENTHIXOL 01/07/2014
ACETATE
DEPIXOL 200 MG/ML Lundbeck Limited PA0115/001/010 Solution for Injection - FLUPENTIXOL 01/07/2014
SOLUTION FOR INJECTIO DECANOATE

MAGNETOLUX 500 Sanochemia Pharmazeutika PA1153/002/001 Solution for Injection - GADOPENTETATE 01/07/2014
MICROMOL/ML SOLUTION AG DIMEGLUMINE
FOR INJECTION
SERDOLECT H. Lundbeck A/S PA0805/001/004 Film Coated Tablet - SERTINDOLE 01/07/2014
SERDOLECT H. Lundbeck A/S PA0805/001/005 Film Coated Tablet - SERTINDOLE 01/07/2014
COLGATE TOTAL FRESH Colgate-Palmolive (U.K.) Ltd PA0320/005/002 Toothpaste - SODIUM FLUORIDE 27/06/2014
STRIPE TOOTHPASTE (EQUIVALENT TO 1450
PPM FLUORIDE)
- TRICLOSAN
- TRICLOSAN
- SODIUM FLUORIDE
(EQUIVALENT TO 1450
PPM FLUORIDE)
GEMCITABINE TEVA Teva Pharma B.V. PA0749/097/004 Concentrate for Soln for Inf - GEMCITABINE 27/06/2014
PACLITAXEL 6 MG/ML Pharmachemie BV PA0937/004/001 Concentrate for Soln for Inf - PACLITAXEL 27/06/2014
CONCENTRATE FOR
SOLUTION FOR IN
PANTOPRAZOLE TEVA Teva Pharma B.V. PA0749/087/001 Pdr for Soln Inj/Inf - PANTOPRAZOLE SODIUM 27/06/2014
SESQUIHYDRATE

Human Medicines Withdrawn Products Page 156 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PIPERACILLIN/TAZOBACT Teva Pharma B.V. PA0749/126/001 Powder for solution for - PIPERACILLIN SODIUM 27/06/2014
AM TEVA infusion - TAZOBACTAM SODIUM
ZEMPLAR Abbott Laboratories Ireland PA0038/090/004 Capsules, Soft - PARICALCITOL 27/06/2014
Ltd
CANDESARTAN TEVA Teva Pharma B.V. PA0749/171/001 Tablets - CANDESARTAN 26/06/2014
PHARMA CILEXETIL
CANDESARTAN TEVA Teva Pharma B.V. PA0749/171/002 Tablets - CANDESARTAN 26/06/2014
PHARMA CILEXETIL
CANDESARTAN TEVA Teva Pharma B.V. PA0749/171/003 Tablets - CANDESARTAN 26/06/2014
PHARMA CILEXETIL
CANDESARTAN TEVA Teva Pharma B.V. PA0749/171/004 Tablets - CANDESARTAN 26/06/2014
PHARMA CILEXETIL
CANDESARTAN/HYDROC Teva Pharma B.V. PA0749/172/001 Tablets - CANDESARTAN 26/06/2014
HLOROTHIAZIDE TEVA CILEXETIL
- HYDROCHLOROTHIAZIDE

CANDESARTAN/HYDROC Teva Pharma B.V. PA0749/172/002 Tablets - CANDESARTAN 26/06/2014


HLOROTHIAZIDE TEVA CILEXETIL
- HYDROCHLOROTHIAZIDE

BISOPROLOL FUMARATE Pinewood Laboratories Ltd, PA0281/095/001 Tablets - BISOPROLOL FUMARATE 24/06/2014

BISOPROLOL FUMARATE Pinewood Laboratories Ltd, PA0281/095/002 Tablets - BISOPROLOL FUMARATE 24/06/2014

LOCHOL Clonmel Healthcare Ltd PA0126/171/002 Capsules Hard - FLUVASTATIN SODIUM 24/06/2014
LOCHOL Clonmel Healthcare Ltd PA0126/171/003 Capsules Hard - FLUVASTATIN SODIUM 24/06/2014
MINODENE Clonmel Healthcare Ltd PA0126/177/001 Film Coated Tablet - MINOCYCLINE 24/06/2014
HYDROCHLORIDE
DIHYDRATE
PANTOPRAZOLE TEVA Teva Pharma B.V. PA0749/089/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 24/06/2014
SESQUIHYDRATE

PANTOPRAZOLE TEVA Teva Pharma B.V. PA0749/089/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 24/06/2014
SESQUIHYDRATE

TENORMIN B & S Healthcare PPA1328/110/002 Film Coated Tablet - ATENOLOL 24/06/2014


ZOCOR B & S Healthcare PPA1328/125/001 Film Coated Tablet - SIMVASTATIN 20/06/2014
ZOCOR B & S Healthcare PPA1328/125/002 Film Coated Tablet - SIMVASTATIN 20/06/2014
ZOCOR B & S Healthcare PPA1328/125/003 Film Coated Tablet - SIMVASTATIN 20/06/2014
TAMBOCOR LTT Pharma Limited PPA1562/016/001 Tablets - FLECAINIDE ACETATE 19/06/2014
IRBESARTAN DEXCEL Dexcel-Pharma Limited PA0895/011/001 Film Coated Tablet - IRBESARTAN 18/06/2014
IRBESARTAN DEXCEL Dexcel-Pharma Limited PA0895/011/002 Film Coated Tablet - IRBESARTAN 18/06/2014
IRBESARTAN DEXCEL Dexcel-Pharma Limited PA0895/011/003 Film Coated Tablet - IRBESARTAN 18/06/2014
DINORTES Laboratorios LICONSA, S.A. PA1239/016/001 Tablets - TELMISARTAN 13/06/2014

DINORTES Laboratorios LICONSA, S.A. PA1239/016/002 Tablets - TELMISARTAN 13/06/2014

DINORTES Laboratorios LICONSA, S.A. PA1239/016/003 Tablets - TELMISARTAN 13/06/2014

ZANACODAR Laboratorios LICONSA, S.A. PA1239/015/001 Tablets - TELMISARTAN 13/06/2014

ZANACODAR Laboratorios LICONSA, S.A. PA1239/015/002 Tablets - TELMISARTAN 13/06/2014

ZANACODAR Laboratorios LICONSA, S.A. PA1239/015/003 Tablets - TELMISARTAN 13/06/2014

NORZAC Norton Healthcare Limited PA0282/072/001 Capsules Hard - FLUOXETINE 11/06/2014


T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
NASONEX Primecrown 2010 Ltd DPR1633/015/001 Nasal Spray Suspension - MOMETASONE FUROATE 05/06/2014

CILEST B & S Healthcare PPA1328/102/001 Tablets - NORGESTIMATE 04/06/2014


- ETHINYLESTRADIOL
PREOTACT NPS Pharma Holdings EU/1/06/339/1-2 Pdr+Solv for Soln for Inj - PARATHYROID 04/06/2014
Limited HORMONE
ZANOPRO Clonmel Healthcare Ltd PA0126/194/001 Eye Drops Solution - LATANOPROST 04/06/2014
CARBOCISTEINE TEVA Teva UK Limited PA0237/066/001 Capsules Hard - CARBOCISTEINE 03/06/2014
MEFENAMIC ACID Norton Healthcare Limited PA0282/048/002 Film Coated Tablet - MEFENAMIC ACID 03/06/2014
T/A IVAX Pharmaceuticals
UK
TOPIRAMATE Pharmathen S.A. PA1368/010/001 Film Coated Tablet - TOPIRAMATE 03/06/2014
PHARMATHEN
TOPIRAMATE Pharmathen S.A. PA1368/010/002 Film Coated Tablet - TOPIRAMATE 03/06/2014
PHARMATHEN
TOPIRAMATE Pharmathen S.A. PA1368/010/003 Film Coated Tablet - TOPIRAMATE 03/06/2014
PHARMATHEN

Human Medicines Withdrawn Products Page 157 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TOPIRAMATE Pharmathen S.A. PA1368/010/004 Film Coated Tablet - TOPIRAMATE 03/06/2014
PHARMATHEN
MITHEGAN XL Pharmathen S.A. PA1368/012/001 Prolonged Release Capsules - GALANTAMINE 30/05/2014
HYDROBROMIDE
MITHEGAN XL Pharmathen S.A. PA1368/012/002 Prolonged Release Capsules - GALANTAMINE 30/05/2014
HYDROBROMIDE
MITHEGAN XL Pharmathen S.A. PA1368/012/003 Prolonged Release Capsules - GALANTAMINE 30/05/2014
HYDROBROMIDE
OXALIPLATIN Fresenius Kabi Oncology Plc PA1422/004/002 Powder for solution for - OXALIPLATIN 30/05/2014
infusion
sgsdfg IMB Test Pharmaceutical PA11836/025/085 Tablet - Dextrorphan 29/05/2014
Company
ALPHAGAN IMED Healthcare Ltd. DPR1463/007/001 Eye Drops Solution - BRIMONIDINE TARTRATE 28/05/2014

AMOXICILLIN/CLAVULANIC Rowex Ltd PA0711/187/001 Film Coated Tablet - AMOXICILLIN 28/05/2014


ACID TRIHYDRATE
- CLAVULANATE
POTASSIUM
AUGMENTIN IMED Healthcare Ltd. PPA1463/015/001 Tablets - AMOXICILLIN 28/05/2014
TRIHYDRATE
- CLAVULANATE
POTASSIUM
BRICANYL TURBOHALER IMED Healthcare Ltd. PPA1463/032/001 Inhalation powder - TERBUTALINE SULFATE 28/05/2014
COZAAR COMP IMED Healthcare Ltd. PPA1463/092/001 Film Coated Tablet - LOSARTAN POTASSIUM 28/05/2014
- HYDROCHLOROTHIAZIDE

COZAAR COMP IMED Healthcare Ltd. PPA1463/092/002 Film Coated Tablet - LOSARTAN POTASSIUM 28/05/2014
- HYDROCHLOROTHIAZIDE

CRESTOR IMED Healthcare Ltd. PPA1463/030/001 Film Coated Tablet - ROSUVASTATIN 28/05/2014
CALCIUM
CRESTOR IMED Healthcare Ltd. PPA1463/030/002 Film Coated Tablet - ROSUVASTATIN (AS 28/05/2014
CALCIUM)
CRESTOR IMED Healthcare Ltd. PPA1463/030/003 Film Coated Tablet - ROSUVASTATIN 28/05/2014
HALF SINEMET CR IMED Healthcare Ltd. DPR1463/029/006 Tablet Prolonged Release - LEVODOPA 28/05/2014
- CARBIDOPA
KLACID LA IMED Healthcare Ltd. PPA1463/028/001 Modified-release Tablets - CLARITHROMYCIN 28/05/2014
LEXAPRO IMED Healthcare Ltd. PPA1463/012/001 Film Coated Tablet - ESCITALOPRAM 28/05/2014
OXALATE
LEXAPRO IMED Healthcare Ltd. PPA1463/012/002 Film Coated Tablet - ESCITALOPRAM 28/05/2014
OXALATE
LEXAPRO IMED Healthcare Ltd. PPA1463/012/003 Film Coated Tablet - ESCITALOPRAM 28/05/2014
OXALATE
LEXAPRO 15 MG FILM- IMED Healthcare Ltd. PPA1463/012/004 Film Coated Tablet - ESCITALOPRAM 28/05/2014
COATED TABLETS
LIPITOR IMED Healthcare Ltd. PPA1463/004/001 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/05/2014

LIPITOR IMED Healthcare Ltd. PPA1463/004/002 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/05/2014

LIPITOR IMED Healthcare Ltd. PPA1463/004/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/05/2014

LIPITOR IMED Healthcare Ltd. PPA1463/004/004 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/05/2014

LIPOSTAT IMED Healthcare Ltd. PPA1463/076/001 Tablets - PRAVASTATIN SODIUM 28/05/2014


LIPOSTAT IMED Healthcare Ltd. PPA1463/076/002 Tablets - PRAVASTATIN SODIUM 28/05/2014
LOSEC MUPS IMED Healthcare Ltd. PPA1463/021/002 Tablets Gastro-Resistant - OMEPRAZOLE 28/05/2014
MAGNESIUM
LOSEC MUPS IMED Healthcare Ltd. PPA1463/021/003 Tablets Gastro-Resistant - OMEPRAZOLE 28/05/2014
MAGNESIUM
PARIET IMED Healthcare Ltd. PPA1463/027/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/05/2014
PARIET IMED Healthcare Ltd. PPA1463/027/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/05/2014
PLAQUENIL IMED Healthcare Ltd. PPA1463/055/001 Film Coated Tablet - HYDROXYCHLOROQUINE 28/05/2014
SULFATE

PULMICORT TURBOHALER IMED Healthcare Ltd. PPA1463/061/002 Inhalation powder - BUDESONIDE 28/05/2014

SEROQUEL XR IMED Healthcare Ltd. PPA1463/048/005 Tablet Prolonged Release - QUETIAPINE FUMARATE 28/05/2014
SPORANOX 100MG HARD IMED Healthcare Ltd. PPA1463/018/001 Capsules Hard - ITRACONAZOLE 28/05/2014
CAPSULES
TOPAMAX Profind Wholesale Ltd PPA1500/050/002 Film Coated Tablet - TOPIRAMATE 28/05/2014
XYZAL IMED Healthcare Ltd. PPA1463/019/001 Tablets - LEVOCETIRIZINE 28/05/2014
DIHYDROCHLORIDE
ZESTORETIC LTT Pharma Limited PPA1562/057/001 Tablets - LISINOPRIL DIHYDRATE 28/05/2014
- HYDROCHLOROTHIAZIDE

Human Medicines Withdrawn Products Page 158 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZESTORETIC LTT Pharma Limited PPA1562/057/002 Tablets - LISINOPRIL DIHYDRATE 28/05/2014
- HYDROCHLOROTHIAZIDE

ZISPIN SOLTAB IMED Healthcare Ltd. PPA1463/034/002 Orodispersible Tablet - MIRTAZAPINE 28/05/2014
ZISPIN SOLTAB IMED Healthcare Ltd. PPA1463/034/003 Orodispersible Tablet - MIRTAZAPINE 28/05/2014
ZITHROMAX IMED Healthcare Ltd. PPA1463/054/001 Capsule - AZITHROMYCIN 28/05/2014
DIHYDRATE
ZOMIG RAPIMELT IMED Healthcare Ltd. PPA1463/057/001 Orodispersible Tablet - ZOLMITRIPTAN 28/05/2014
PHARMORUBICIN 2 MG/ML Pfizer Healthcare Ireland PA0822/132/002 Solution for Inj/Inf - EPIRUBICIN 27/05/2014
SOLUTION FOR INJECTION HYDROCHLORIDE
OR IN
PHARMORUBICIN 2 MG/ML Pfizer Healthcare Ireland PA0822/132/005 Solution for Inj/Inf - EPIRUBICIN 27/05/2014
SOLUTION FOR INJECTION HYDROCHLORIDE
OR IN
SEREVENT EVOHALER LTT Pharma Limited PPA1562/022/001 Pressurised Inhalation - SALMETEROL 27/05/2014
Suspension XINAFOATE
ZESTRIL B & S Healthcare PPA1328/112/001 Tablets - LISINOPRIL 27/05/2014
ZESTRIL B & S Healthcare PPA1328/112/002 Tablets - LISINOPRIL 27/05/2014
ZESTRIL B & S Healthcare PPA1328/112/003 Tablets - LISINOPRIL 27/05/2014
ZESTRIL B & S Healthcare PPA1328/112/004 Tablets - LISINOPRIL 27/05/2014
IKOREL 20MG TABLETS B & S Healthcare PPA1328/025/002 Tablets - NICORANDIL 21/05/2014
TENORETIC B & S Healthcare PPA1328/108/001 Film Coated Tablet - ATENOLOL 21/05/2014
- CHLORTALIDONE
LIPITOR B & S Healthcare PPA1328/083/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 07/05/2014

ZANIDIP B & S Healthcare PPA1328/042/002 Film Coated Tablet - LERCANIDIPINE 07/05/2014


FLUVAT Rowex Ltd PA0711/117/001 Capsules Hard - FLUVASTATIN SODIUM 01/05/2014
FLUVAT Rowex Ltd PA0711/117/002 Capsules Hard - FLUVASTATIN SODIUM 01/05/2014
FLUVAT Rowex Ltd PA0711/117/003 Tablet Prolonged Release - FLUVASTATIN SODIUM 01/05/2014
RIVOTRIL Roche Products Limited PA0050/014/003 Concentrate for Soln for Inj - CLONAZEPAM 01/05/2014
PERINDOPRIL TERT- Les Laboratoires Servier PA0568/012/002 Tablets - PERINDOPRIL TERT- 30/04/2014
BUTYLAMINE SERVIER BUTYLAMINE SALT
SPORANOX B & S Healthcare PPA1328/100/001 Capsules Hard - ITRACONAZOLE 30/04/2014
ALLOPURINOL TEVA Teva Pharma B.V. PA0749/099/002 Tablets - ALLOPURINOL 29/04/2014
CANDESARTAN TEVA Teva Pharma B.V. PA0749/124/005 Tablets - CANDESARTAN 29/04/2014
CILEXETIL
CANDESARTAN TEVA Teva Pharma B.V. PA0749/124/001 Tablets - CANDESARTAN 29/04/2014
CILEXETIL
CEFOTAXIME Teva Pharma B.V. PA0749/012/003 Pdr for Soln Inj/Inf - CEFOTAXIME SODIUM 29/04/2014
CEFUROXIME TEVA Teva Pharma B.V. PA0749/082/001 Film Coated Tablet - CEFUROXIME AXETIL 29/04/2014
CIPROFLOXACIN TEVA Teva Pharma B.V. PA0749/031/004 Film Coated Tablet - CIPROFLOXACIN 29/04/2014
BILENI Meda Health Sales Ireland PA1332/048/001 Nasal Spray Suspension - AZELASTINE 28/04/2014
Limited HYDROCHLORIDE
- FLUTICASONE
PROPIONATE
DYVISTANIL Meda Health Sales Ireland PA1332/047/001 Nasal Spray Suspension - AZELASTINE 28/04/2014
Limited HYDROCHLORIDE
- FLUTICASONE
PROPIONATE
SILDENAFIL TEVA Teva Pharma B.V. PA0749/187/001 Tablets Chewable - SILDENAFIL CITRATE 25/04/2014
SILDENAFIL TEVA Teva Pharma B.V. PA0749/187/002 Tablets Chewable - SILDENAFIL CITRATE 25/04/2014
SIMVASTATIN Teva Pharma B.V. PA0749/121/001 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN Teva Pharma B.V. PA0749/121/002 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN Teva Pharma B.V. PA0749/121/003 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN Teva Pharma B.V. PA0749/121/004 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN Teva Pharma B.V. PA0749/121/005 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN TEVA Teva Pharma B.V. PA0749/052/001 Film Coated Tablet - SIMVASTATIN 25/04/2014
SIMVASTATIN TEVA Teva Pharma B.V. PA0749/052/005 Film Coated Tablet - SIMVASTATIN 25/04/2014
EPLERENONE TEVA Teva Pharma B.V. PA0749/169/001 Film Coated Tablet - EPLERENONE 24/04/2014
EPLERENONE TEVA Teva Pharma B.V. PA0749/169/002 Film Coated Tablet - EPLERENONE 24/04/2014
LANSOPRAZOLE TEVA Teva Pharma B.V. PA0749/024/001 Capsules Gastro-Resistant - LANSOPRAZOLE 24/04/2014
LANSOPRAZOLE TEVA Teva Pharma B.V. PA0749/024/002 Capsules Gastro-Resistant - LANSOPRAZOLE 24/04/2014
LEVOFLOXACIN TEVA Teva Pharma B.V. PA0749/081/001 Film Coated Tablet - LEVOFLOXACIN 24/04/2014
HEMIHYDRATE
LEVOFLOXACIN TEVA Teva Pharma B.V. PA0749/081/002 Film Coated Tablet - LEVOFLOXACIN 24/04/2014
HEMIHYDRATE
OMEGA 3 Teva Pharma B.V. PA0749/149/001 Capsules, Soft - OMEGA-3-ACID ETHYL 24/04/2014
ESTERS 90
PERINDOPRIL TOSILATE Teva Pharma B.V. PA0749/168/001 Film Coated Tablet - PERINDOPRIL TOSILATE 24/04/2014
TEVA
REMIFENTANIL TEVA Teva Pharma B.V. PA0749/098/001 Powder for concentrate for - REMIFENTANIL 24/04/2014
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL TEVA Teva Pharma B.V. PA0749/098/002 Powder for concentrate for - REMIFENTANIL 24/04/2014
solution for injection/infusion HYDROCHLORIDE

Human Medicines Withdrawn Products Page 159 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
REMIFENTANIL TEVA Teva Pharma B.V. PA0749/098/003 Powder for concentrate for - REMIFENTANIL 24/04/2014
solution for injection/infusion HYDROCHLORIDE
DONEPEZIL KRKA Krka d.d., Novo mesto PA1347/014/001 Orodispersible Tablet - DONEPEZIL 22/04/2014
HYDROCHLORIDE
DONEPEZIL KRKA Krka d.d., Novo mesto PA1347/014/002 Orodispersible Tablet - DONEPEZIL 22/04/2014
HYDROCHLORIDE
SINGULAIR Primecrown 2010 Ltd DPR1633/004/002 Film Coated Tablet - MONTELUKAST SODIUM 19/04/2014
SINGULAIR PAEDIATRIC Primecrown 2010 Ltd DPR1633/004/001 Tablets Chewable - MONTELUKAST SODIUM 19/04/2014
SINGULAIR PAEDIATRIC Primecrown 2010 Ltd DPR1633/004/003 Granules - MONTELUKAST SODIUM 19/04/2014
LANACANE 3 % W/W Reckitt Benckiser Ireland Ltd PA0979/063/001 Cream - BENZOCAINE 17/04/2014
CREAM
MYCIL Reckitt Benckiser Ireland Ltd PA0979/048/001 Cutaneous Powder - TOLNAFTATE 17/04/2014
- CHLORHEXIDINE
HYDROCHLORIDE
MYCIL Reckitt Benckiser Ireland Ltd PA0979/046/001 Ointment - TOLNAFTATE 17/04/2014
- BENZALKONIUM
CHLORIDE
MYCIL ATHLETE'S FOOT Reckitt Benckiser Ireland Ltd PA0979/047/001 Cutaneous Spray Solution - TOLNAFTATE 17/04/2014
SPRAY
DONEPEZIL EGIS Pharmaceuticals PLC PA1470/001/001 Film Coated Tablet - DONEPEZIL 16/04/2014
HYDROCHLORIDE HYDROCHLORIDE
DONEPEZIL EGIS Pharmaceuticals PLC PA1470/001/002 Film Coated Tablet - DONEPEZIL 16/04/2014
HYDROCHLORIDE HYDROCHLORIDE
PARACETAMOL 1000MG, Procter & Gamble (Health & PA0441/041/001 Powder for Oral Solution - PARACETAMOL 08/04/2014
PHENYLEPHRINE Beauty Care) Limited - PHENYLEPHRINE
HYDROCHLORIDE 12 HYDROCHLORIDE
VITILE MR Actavis Group PTC ehf PA1380/068/001 Modified-release Tablets - GLICLAZIDE 07/04/2014
DOCETAXEL TEVA Teva Pharma B.V. EU/1/10/662/001 Concentrate and solvent for - DOCETAXEL 02/04/2014
PHARMA solution for infusion
DOCETAXEL TEVA Teva Pharma B.V. EU/1/10/662/002 Concentrate and solvent for - DOCETAXEL 02/04/2014
PHARMA solution for infusion
GEMCITABINE EBEWE Ebewe Pharma Ges.m.b.H PA0789/019/001 Powder for solution for - GEMCITABINE 02/04/2014
Nfg. KG infusion
GEMCITABINE EBEWE Ebewe Pharma Ges.m.b.H PA0789/019/002 Powder for solution for - GEMCITABINE 02/04/2014
Nfg. KG infusion
LANSOPRAZOLE Laboratorios Davur S.L.U. PA1271/004/001 Capsules Gastro-Resistant - LANSOPRAZOLE 01/04/2014
LANSOPRAZOLE Laboratorios Davur S.L.U. PA1271/004/002 Capsules Gastro-Resistant - LANSOPRAZOLE 01/04/2014
OTOSPORIN EAR DROPS GlaxoSmithKline (Ireland) PA1077/073/001 Ear Drops Suspension - POLYMYXIN B SULFATE 31/03/2014
Limited - NEOMYCIN SULFATE
- HYDROCORTISONE
TIZANIDINE DR REDDY'S Dr. Reddy's Laboratories PA1364/002/001 Tablets - TIZANIDINE 31/03/2014
(UK) Ltd
TIZANIDINE DR REDDY'S Dr. Reddy's Laboratories PA1364/002/002 Tablets - TIZANIDINE 31/03/2014
(UK) Ltd
CREVASTIN Clonmel Healthcare Ltd PA0126/239/001 Film Coated Tablet - ROSUVASTATIN (AS 27/03/2014
CALCIUM)
CREVASTIN Clonmel Healthcare Ltd PA0126/239/002 Film Coated Tablet - ROSUVASTATIN (AS 27/03/2014
CALCIUM)
CREVASTIN Clonmel Healthcare Ltd PA0126/239/003 Film Coated Tablet - ROSUVASTATIN (AS 27/03/2014
CALCIUM)
CREVASTIN Clonmel Healthcare Ltd PA0126/239/004 Film Coated Tablet - ROSUVASTATIN (AS 27/03/2014
CALCIUM)
CREVASTIN Clonmel Healthcare Ltd PA0126/239/005 Film Coated Tablet - ROSUVASTATIN (AS 27/03/2014
CALCIUM)
FLUMAZENIL B. Braun Melsungen AG PA0736/025/001 Solution for Injection - FLUMAZENIL 26/03/2014
ADALAT LA McDowell Pharmaceuticals PPA1473/005/001 Tablet Prolonged Release - NIFEDIPINE 25/03/2014
ADALAT LA McDowell Pharmaceuticals PPA1473/005/002 Tablet Prolonged Release - NIFEDIPINE 25/03/2014
BRICANYL TURBOHALER McDowell Pharmaceuticals PPA1473/029/001 Inhalation powder - TERBUTALINE SULFATE 25/03/2014
CARDURA XL McDowell Pharmaceuticals PPA1473/006/002 Tablets - DOXAZOSIN MESILATE 25/03/2014
CLOPIDOGREL McDowell Pharmaceuticals PPA1473/053/001 Film Coated Tablet - CLOPIDOGREL BESILATE 25/03/2014

DETRUSITOL SR McDowell Pharmaceuticals PPA1473/030/001 Prolonged Release Capsules - TOLTERODINE 25/03/2014


TARTRATE
DOVOBET McDowell Pharmaceuticals PPA1473/047/001 Ointment - CALCIPOTRIOL HYDRATE 25/03/2014
- BETAMETHASONE
DIPROPIONATE

DOVONEX McDowell Pharmaceuticals PPA1473/049/001 Cream - CALCIPOTRIOL HYDRATE 25/03/2014

IKOREL 10MG TABLETS McDowell Pharmaceuticals PPA1473/012/001 Tablets - NICORANDIL 25/03/2014


IKOREL 20MG TABLETS McDowell Pharmaceuticals PPA1473/012/002 Tablets - NICORANDIL 25/03/2014
LEXAPRO McDowell Pharmaceuticals PPA1473/034/001 Film Coated Tablet - ESCITALOPRAM 25/03/2014
LEXAPRO McDowell Pharmaceuticals PPA1473/034/002 Film Coated Tablet - ESCITALOPRAM 25/03/2014
LIVIAL McDowell Pharmaceuticals PPA1473/033/001 Tablets - TIBOLONE 25/03/2014

Human Medicines Withdrawn Products Page 160 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VENTOLIN EVOHALER McDowell Pharmaceuticals PPA1473/022/001 Pressurised Inhalation - SALBUTAMOL 25/03/2014
Suspension
VESITIRIM McDowell Pharmaceuticals PPA1473/048/001 Film Coated Tablet - SOLIFENACIN 25/03/2014
SUCCINATE
VESITIRIM McDowell Pharmaceuticals PPA1473/048/002 Film Coated Tablet - SOLIFENACIN 25/03/2014
SUCCINATE
XYZAL McDowell Pharmaceuticals PPA1473/023/001 Tablets - LEVOCETIRIZINE 25/03/2014
DIHYDROCHLORIDE
ZANIDIP McDowell Pharmaceuticals PPA1473/024/001 Film Coated Tablet - LERCANIDIPINE 25/03/2014
HYDROCHLORIDE
ANAPEN Lincoln Medical Ltd PA1072/001/003 Solution for Injection - ADRENALINE 24/03/2014
(EPINEPHRINE)
COEPRATENZ PLUS Abbott Healthcare Products PA0108/029/001 Film Coated Tablet - EPROSARTAN MESYLATE 24/03/2014
Ltd - HYDROCHLOROTHIAZIDE

TARKA Abbott Laboratories Ireland PA0038/089/002 Modified-release Tablets - VERAPAMIL 24/03/2014


Ltd HYDROCHLORIDE
- TRANDOLAPRIL
COSOPT LTT Pharma Limited PPA1562/043/002 Eye Drops Solution - DORZOLAMIDE 20/03/2014
HYDROCHLORIDE
- TIMOLOL MALEATE
PANTOSEC CONTROL Ranbaxy (UK) Limited PA0967/013/001 Tablets Gastro-Resistant - PANTOPRAZOLE 12/03/2014
POTASSIUM IODATE Alliance Pharmaceuticals Ltd PA0943/019/001 Tablets - POTASSIUM IODATE 12/03/2014

FARMADURA XL Pfizer Healthcare Ireland PA0822/023/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 11/03/2014
FARMADURA XL Pfizer Healthcare Ireland PA0822/023/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 11/03/2014
ANASTROZOLE NICHE Niche Generics Limited PA1063/030/001 Film Coated Tablet - ANASTROZOLE 10/03/2014
LEFLUNOMIDE TEVA Teva Pharma B.V. EU/1/11/675/001-005 Film Coated Tablet - LEFLUNOMIDE 10/03/2014
LEFLUNOMIDE TEVA Teva Pharma B.V. EU/1/11/675/006-10 Film Coated Tablet - LEFLUNOMIDE 10/03/2014
VINORELBINE Flynn Pharma Ltd PA1226/010/001 Concentrate for Soln for Inf - VINORELBINE TARTRATE 06/03/2014

ANASTROZOLE ARROW Arrow Generics Limited PA1130/015/001 Film Coated Tablet - ANASTRAZOLE 05/03/2014
ACTONEL ONCE A WEEK LTT Pharma Limited PPA1562/015/001 Film Coated Tablet - RISEDRONATE SODIUM 04/03/2014
RETROVIR ViiV Healthcare UK Ltd PA1716/001/004 Tablets - ZIDOVUDINE 01/03/2014
XALOPTIC COMBI Pharmaceutical Works PA1624/001/001 Eye Drops Solution - LATANOPROST 01/03/2014
POLPHARMA SA - TIMOLOL MALEATE
HALF-INDERAL LA AstraZeneca UK Limited PA0970/011/001 Prolonged Release Capsules - PROPRANOLOL 28/02/2014
HYDROCHLORIDE
INDERAL LA AstraZeneca UK Limited PA0970/011/002 Prolonged Release Capsules - PROPRANOLOL 28/02/2014
HYDROCHLORIDE
TEVETEN LTT Pharma Limited PPA1562/085/002 Film Coated Tablet - EPROSARTAN MESYLATE 27/02/2014

DONEPEZIL PFIZER Pfizer Healthcare Ireland PA0822/076/003 Orodispersible Tablet - DONEPEZIL 25/02/2014
HYDROCHLORIDE
DONEPEZIL PFIZER Pfizer Healthcare Ireland PA0822/076/004 Orodispersible Tablet - DONEPEZIL 25/02/2014
HYDROCHLORIDE
BUCCASTEM Alliance Pharmaceuticals Ltd PA0943/016/001 Buccal Tablet - PROCHLORPERAZINE 19/02/2014
MALEATE
TIMODINE Alliance Pharmaceuticals Ltd PA0943/017/001 Cream - NYSTATIN 19/02/2014
- DIMETHICONE 350
- HYDROCORTISONE
- BENZALKONIUM
CHLORIDE (AS 50% W/V
SOLUTION)
ZESTRIL LTT Pharma Limited PPA1562/013/002 Tablets - LISINOPRIL 19/02/2014
ZESTRIL LTT Pharma Limited PPA1562/013/004 Tablets - LISINOPRIL 19/02/2014
Onduarp Boehringer Ingelheim EU/1/11/729/001 Tablet - Telmisartan 17/02/2014
International GmbH - Amlodipine besilate
Onduarp Boehringer Ingelheim EU/1/11/729/003-004 Tablet - Telmisartan 17/02/2014
International GmbH - Amlodipine besilate
Onduarp Boehringer Ingelheim EU/1/11/729/005-006 Tablet - Telmisartan 17/02/2014
International GmbH - Amlodipine besilate
BRIMON Rowex Ltd PA0711/119/001 Eye Drops Solution - BRIMONIDINE TARTRATE 13/02/2014

ONDANSETRON 4MG FILM- Rowex Ltd PA0711/086/001 Tablets - ONDANSETRON 13/02/2014


COATED TABLETS
ONDANSETRON 8MG FILM- Rowex Ltd PA0711/086/002 Tablets - ONDANSETRON 13/02/2014
COATED TABLETS HYDROCHLORIDE
DIHYDRATE
CANTAXEL Clonmel Healthcare Ltd PA0126/162/001 Concentrate for Soln for Inf - PACLITAXEL 11/02/2014
CIPROTAN 40MG FILM- Clonmel Healthcare Ltd PA0126/131/003 Film Coated Tablet - CITALOPRAM 11/02/2014
COATED TABLETS HYDROBROMIDE’
LEVETIRACETAM Clonmel Healthcare Ltd PA0126/218/003 Film Coated Tablet - LEVETIRACETAM 11/02/2014
CLONMEL

Human Medicines Withdrawn Products Page 161 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LIPVASTIN Clonmel Healthcare Ltd PA0126/193/001 Film Coated Tablet - ATORVASTATIN CALCIUM 11/02/2014

LIPVASTIN Clonmel Healthcare Ltd PA0126/193/002 Film Coated Tablet - ATORVASTATIN CALCIUM 11/02/2014

LIPVASTIN Clonmel Healthcare Ltd PA0126/193/003 Film Coated Tablet - ATORVASTATIN CALCIUM 11/02/2014

ABIDEC MULTIVITAMIN LTT Pharma Limited PPA1562/050/001 Oral Drops Solution - RETINOL PALMITATE 10/02/2014
- ERGOCALCIFEROL
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- ASCORBIC ACID
SPASMONAL LTT Pharma Limited PPA1562/045/001 Capsules Hard - ALVERINE CITRATE 10/02/2014
SPASMONAL FORTE LTT Pharma Limited PPA1562/045/002 Capsules Hard - ALVERINE CITRATE 10/02/2014
XYZAL LTT Pharma Limited PPA1562/062/001 Film Coated Tablet - LEVOCETIRIZINE 06/02/2014
DIHYDROCHLORIDE
ZOLMITRIPTAN TEVA Teva Pharma B.V. PA0749/068/001 Film Coated Tablet - ZOLMITRIPTAN 05/02/2014
SIMVASTATIN SYNTHON Genthon BV PA0740/009/001 Film Coated Tablet - SIMVASTATIN 04/02/2014
SIMVASTATIN SYNTHON Genthon BV PA0740/009/002 Film Coated Tablet - SIMVASTATIN 04/02/2014
SIMVASTATIN SYNTHON Genthon BV PA0740/009/003 Film Coated Tablet - SIMVASTATIN 04/02/2014
SIMVASTATIN SYNTHON Genthon BV PA0740/009/004 Film Coated Tablet - SIMVASTATIN 04/02/2014
ENTRYDIL 60MG MODIFIED Orion Corporation PA1327/004/001 Coated Tablets - DILTIAZEM 01/02/2014
RELEASE TABLETS. HYDROCHLORIDE

ENTRYDIL S.R. 120MG Orion Corporation PA1327/004/003 Coated Tablets - DILTIAZEM 01/02/2014
PROLONGED RELEASE HYDROCHLORIDE
FILM-COATED
ENTRYDIL S.R. 90 MG Orion Corporation PA1327/004/002 Tablets - DILTIAZEM 01/02/2014
PROLONGED-RELEASE, HYDROCHLORIDE
FILM-COATED
PEPCID Merck Sharp and Dohme PA0035/069/001 Film Coated Tablet - FAMOTIDINE 01/02/2014
Limited
PEPCID Merck Sharp and Dohme PA0035/069/002 Film Coated Tablet - FAMOTIDINE 01/02/2014
Limited
TENOX Orion Corporation PA1327/006/001 Tablets - TEMAZEPAM 01/02/2014
TENOX Orion Corporation PA1327/006/002 Tablets - TEMAZEPAM 01/02/2014
ACARBOSE TECNIMEDE Multigeneris GmbH PA1773/001/001 Tablets - ACARBOSE 31/01/2014
ACARBOSE TECNIMEDE Multigeneris GmbH PA1773/001/002 Tablets - ACARBOSE 31/01/2014
DOCIRENA Fresenius Kabi Limited PA0566/059/001 Concentrate for Soln for Inf - DOCETAXEL 30/01/2014
ANHYDROUS
DOCIRENA Fresenius Kabi Limited PA0566/059/002 Concentrate for Soln for Inf - DOCETAXEL 30/01/2014
ANHYDROUS
BYLANS Teva Pharma B.V. PA0749/131/001 Capsules Gastro-Resistant - LANSOPRAZOLE 20/01/2014
BYLANS Teva Pharma B.V. PA0749/131/002 Capsules Gastro-Resistant - LANSOPRAZOLE 20/01/2014
GLENTEK Glenmark Pharmaceuticals PA1462/008/001 Film Coated Tablet - RILUZOLE 17/01/2014
Europe Limited
GLEPARK Glenmark Pharmaceuticals PA1462/001/001 Tablets - PRAMIPEXOLE 17/01/2014
Europe Limited DIHYDROCHLORIDE
MONOHYDRATE
GLEPARK Glenmark Pharmaceuticals PA1462/001/002 Tablets - PRAMIPEXOLE 17/01/2014
Europe Limited DIHYDROCHLORIDE
MONOHYDRATE
GLEPARK Glenmark Pharmaceuticals PA1462/001/003 Tablets - PRAMIPEXOLE 17/01/2014
Europe Limited DIHYDROCHLORIDE
MONOHYDRATE
GLEPARK Glenmark Pharmaceuticals PA1462/001/004 Tablets - PRAMIPEXOLE 17/01/2014
Europe Limited DIHYDROCHLORIDE
MONOHYDRATE
Onduarp Boehringer Ingelheim EU/1/11/729/002 Tablet - Telmisartan 17/01/2014
International GmbH
Ropinirole Glenmark 0.25mg Glenmark Pharmaceuticals PA1462/003/001 Film-coated tablet - Ropinirole hydrochloride 17/01/2014
film coated tablets Europe Limited
Ropinirole Glenmark 0.5mg Glenmark Pharmaceuticals PA1462/003/002 Film-coated tablet - Ropinirole hydrochloride 17/01/2014
film coated tablets Europe Limited
Ropinirole Glenmark 1mg Glenmark Pharmaceuticals PA1462/003/003 Film-coated tablet - Ropinirole hydrochloride 17/01/2014
film coated tablets Europe Limited
Ropinirole Glenmark 2mg Glenmark Pharmaceuticals PA1462/003/004 Film-coated tablet - Ropinirole hydrochloride 17/01/2014
film coated tablets Europe Limited
Ropinirole Glenmark 5mg Glenmark Pharmaceuticals PA1462/003/005 Film-coated tablet - Ropinirole 17/01/2014
film-coated tablets Europe Limited

Human Medicines Withdrawn Products Page 162 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PERCARNIL PLUS Arrow Generics Limited PA1130/018/001 Tablets - PERINDOPRIL TERT- 08/01/2014
BUTYLAMINE
- INDAPAMIDE
VINORELBINE TEVA Teva Pharma B.V. PA0749/086/001 Concentrate for Soln for Inf - VINORELBINE TARTRATE 08/01/2014

AFFEX Astellas Pharma Co. Ltd PA1241/011/001 Capsules Hard - FLUOXETINE 01/01/2014
HYDROCHLORIDE
DIFENE AMPOULES Astellas Pharma Co. Ltd PA1241/012/006 Solution for injection/infusion - DICLOFENAC SODIUM 01/01/2014

TRITANRIX HB Smith & Nephew Healthcare EU/1/96/014/001 Suspension for Injection - DIPHTHERIA TOXOID 01/01/2014
Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
TRITANRIX HB Smith & Nephew Healthcare EU/1/96/014/002 Suspension for Injection - DIPHTHERIA TOXOID 01/01/2014
Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
ULCID Astellas Pharma Co. Ltd PA1241/001/001 Capsules Gastro-Resistant - OMEPRAZOLE 01/01/2014
DIFLUCAN 2 MG/ML Pfizer Limited PA0019/044/006 Solution for Infusion - FLUCONAZOLE 31/12/2013
SOLUTION FOR INFUSION
SOLIAN PCO Manufacturing PPA0465/192/001 Tablets - AMISULPRIDE 31/12/2013
SPASMONAL FORTE PCO Manufacturing PPA0465/264/002 Capsules Hard - ALVERINE CITRATE 31/12/2013
TEVETEN PCO Manufacturing PPA0465/147/001 Film Coated Tablet - EPROSARTAN MESYLATE 31/12/2013

TRITACE PCO Manufacturing PPA0465/163/004 Tablets - RAMIPRIL 31/12/2013


TRITACE PCO Manufacturing PPA0465/163/005 Tablets - RAMIPRIL 31/12/2013
VERMOX PCO Manufacturing PPA0465/076/001 Tablets - MEBENDAZOLE 31/12/2013
XALACOM PCO Manufacturing PPA0465/269/001 Eye Drops Solution - LATANOPROST 31/12/2013
- TIMOLOL MALEATE
ZIMOVANE PCO Manufacturing PPA0465/053/001 Film Coated Tablet - ZOPICLONE 31/12/2013
ZIRTEK PCO Manufacturing PPA0465/061/001 Film Coated Tablet - CETIRIZINE 31/12/2013
HYDROCHLORIDE
ZOCOR PCO Manufacturing PPA0465/056/001 Film Coated Tablet - SIMVASTATIN 31/12/2013
ZOCOR PCO Manufacturing PPA0465/056/002 Film Coated Tablet - SIMVASTATIN 31/12/2013
ZOCOR PCO Manufacturing PPA0465/056/003 Film Coated Tablet - SIMVASTATIN 31/12/2013
ZOVIRAX PCO Manufacturing PPA0465/038/006 Dispersable Tablet - ACICLOVIR 31/12/2013
ACTONEL PCO Manufacturing PPA0465/165/002 Film Coated Tablet - RISEDRONATE SODIUM 30/12/2013
BETAGAN PCO Manufacturing PPA0465/210/001 Ear Drops Solution - LEVOBUNOLOL 30/12/2013
HYDROCHLORIDE
BETNOVATE SCALP PCO Manufacturing PPA0465/142/001 Cutaneous Solution - BETAMETHASONE 30/12/2013
APPLICATION VALERATE
CLARITYN PCO Manufacturing PPA0465/049/001 Tablets - LORATADINE 30/12/2013
COPEGUS PCO Manufacturing PPA0465/194/001 Film Coated Tablet - RIBAVIRIN 30/12/2013
CRESTOR PCO Manufacturing PPA0465/140/001 Film Coated Tablet - ROSUVASTATIN (AS 30/12/2013
CALCIUM)
CRESTOR PCO Manufacturing PPA0465/140/002 Film Coated Tablet - ROSUVASTATIN (AS 30/12/2013
CALCIUM)
DAONIL PCO Manufacturing PPA0465/149/001 Tablets - GLIBENCLAMIDE 30/12/2013
DETRUSITOL PCO Manufacturing PPA0465/080/001 Tablets - TOLTERODINE L- 30/12/2013
TARTRATE
DETRUSITOL PCO Manufacturing PPA0465/080/002 Tablets - TOLTERODINE L- 30/12/2013
TARTRATE
DIFFLAM SPRAY PCO Manufacturing PPA0465/228/001 Oromucosal spray, solution - BENZYDAMINE 30/12/2013
HYDROCHLORIDE
DOVONEX 50 PCO Manufacturing PPA0465/132/001 Cream - CALCIPOTRIOL 30/12/2013
MICROGRAMS/G CREAM
DOVONEX 50 PCO Manufacturing PPA0465/132/003 Cutaneous Solution - CALCIPOTRIOL 30/12/2013
MICROGRAMS/ML SCALP
SOLUTION
ELANTAN LA PCO Manufacturing PPA0465/241/001 Prolonged Release Capsules - ISOSORBIDE 30/12/2013
MONONITRATE
ELANTAN LA PCO Manufacturing PPA0465/241/002 Prolonged Release Capsules - ISOSORBIDE 30/12/2013
MONONITRATE
ELTROXIN PCO Manufacturing PPA0465/120/001 Tablets - LEVOTHYROXINE 30/12/2013
SODIUM
ELTROXIN PCO Manufacturing PPA0465/120/002 Tablets - LEVOTHYROXINE 30/12/2013
SODIUM
EMCOR PCO Manufacturing PPA0465/087/002 Film Coated Tablet - BISOPROLOL FUMARATE 30/12/2013

HALF INDERAL LA 80MG PCO Manufacturing PPA0465/220/001 Prolonged Release Capsules - PROPRANOLOL 30/12/2013
PROLONGED-RELEASE HYDROCHLORIDE
CAPSULES

Human Medicines Withdrawn Products Page 163 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IMDUR PCO Manufacturing PPA0465/060/001 Tablet Prolonged Release - ISOSORBIDE 30/12/2013
MONONITRATE
INDERAL LA 160MG PCO Manufacturing PPA0465/220/002 Prolonged Release Capsules - PROPRANOLOL 30/12/2013
PROLONGED-RELEASE HYDROCHLORIDE
CAPSULES
KLACID LA MODIFIED- PCO Manufacturing PPA0465/051/003 Modified-release Tablets - CLARITHROMYCIN 30/12/2013
RELEASE 500MG TABLETS

LIPOSTAT PCO Manufacturing PPA0465/059/001 Tablets - PRAVASTATIN SODIUM 30/12/2013


LOSEC MUPS PCO Manufacturing PPA0465/039/004 Tablets Gastro-Resistant - OMEPRAZOLE 30/12/2013
MAGNESIUM
LOSEC MUPS PCO Manufacturing PPA0465/039/005 Tablets Gastro-Resistant - OMEPRAZOLE 30/12/2013
MAGNESIUM
NU-SEALS PCO Manufacturing PPA0465/074/002 Tablets Gastro-Resistant - ACETYLSALICYLIC ACID 30/12/2013
PANADOL PCO Manufacturing PPA0465/158/001 Film Coated Tablet - PARACETAMOL 30/12/2013
PARIET PCO Manufacturing PPA0465/107/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 30/12/2013
PARIET PCO Manufacturing PPA0465/107/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 30/12/2013
PHYLLOCONTIN PCO Manufacturing PPA0465/298/001 Tablet Prolonged Release - AMINOPHYLLINE 30/12/2013
CONTINUS HYDRATE
PULMICORT RESPULES PCO Manufacturing PPA0465/100/004 Nebuliser Suspension - BUDESONIDE 30/12/2013
PULMICORT RESPULES PCO Manufacturing PPA0465/100/005 Nebuliser Suspension - BUDESONIDE 30/12/2013
SEROQUEL PCO Manufacturing PPA0465/153/001 Film Coated Tablet - QUETIAPINE FUMARATE 30/12/2013
SEROQUEL PCO Manufacturing PPA0465/153/003 Film Coated Tablet - QUETIAPINE FUMARATE 30/12/2013
SEROQUEL PCO Manufacturing PPA0465/153/004 Film Coated Tablet - QUETIAPINE FUMARATE 30/12/2013
SEROQUEL XR PCO Manufacturing PPA0465/153/005 Tablet Prolonged Release - QUETIAPINE FUMARATE 30/12/2013
OMEPRAZOLE Laboratorios Davur S.L.U. PA1271/002/001 Capsules Gastro-Resistant - OMEPRAZOLE 20/12/2013
OMEPRAZOLE Laboratorios Davur S.L.U. PA1271/002/002 Capsules Gastro-Resistant - OMEPRAZOLE 20/12/2013
OMEPRAZOLE Laboratorios Davur S.L.U. PA1271/002/003 Capsules Gastro-Resistant - OMEPRAZOLE 20/12/2013
COMBODART PCO Manufacturing PPA0465/293/001 Capsules Hard - DUTASTERIDE 16/12/2013
- TAMSULOSIN
HYDROCHLORIDE
BIODOL Niche Generics Limited PA1063/001/001 Capsules Hard - TRAMADOL 12/12/2013
HYDROCHLORIDE
AVODART LTT Pharma Limited PPA1562/082/001 Capsules, Soft - DUTASTERIDE 11/12/2013
HARTMANN'S SOLUTION - Maco Pharma (UK) Ltd PA0931/009/004 Solution for Infusion - SODIUM CHLORIDE 11/12/2013
COMPOUND SODIUM - CALCIUM CHLORIDE
LACTATE INTR DIHYDRATE
- POTASSIUM CHLORIDE
- SODIUM LACTATE
SOLUTION 60%
HARTMANN'S SOLUTION - Maco Pharma (UK) Ltd PA0931/009/002 Solution for Infusion - SODIUM CHLORIDE 11/12/2013
COMPOUND SODIUM - CALCIUM CHLORIDE
LACTATE INTR DIHYDRATE
- POTASSIUM CHLORIDE
- SODIUM LACTATE
SOLUTION 60%
PERIOSTAT Alliance Pharmaceuticals Ltd PA0943/012/001 Tablets - DOXYCYCLINE HYCLATE 11/12/2013

GEMCITABINE Flynn Pharma Ltd PA1226/008/001 Powder for solution for - GEMCITABINE 09/12/2013
infusion
GEMCITABINE Flynn Pharma Ltd PA1226/008/002 Powder for solution for - GEMCITABINE 09/12/2013
infusion
IRINOTECAN Flynn Pharma Ltd PA1226/007/001 Concentrate for Soln for Inf - IRINOTECAN 09/12/2013
HYDROCHLORIDE HYDROCHLORIDE
TRIHYDRATE TRIHYDRATE
ACTONEL PLUS CA & D IPS Healthcare Limited PPA1659/041/001 Film Coated Tablet - RISEDRONATE SODIUM 02/12/2013
- CALCIUM CARBONATE
- COLECALCIFEROL
ADALAT LA IPS Healthcare Limited PPA1659/039/001 Tablet Prolonged Release - NIFEDIPINE 02/12/2013
ADALAT LA IPS Healthcare Limited PPA1659/039/002 Tablet Prolonged Release - NIFEDIPINE 02/12/2013
ADALAT LA IPS Healthcare Limited PPA1659/039/003 Tablet Prolonged Release - NIFEDIPINE 02/12/2013
EPANUTIN IPS Healthcare Limited PPA1659/051/001 Capsules Hard - PHENYTOIN SODIUM 02/12/2013
EPANUTIN IPS Healthcare Limited PPA1659/051/002 Capsules Hard - PHENYTOIN SODIUM 02/12/2013
EPANUTIN IPS Healthcare Limited PPA1659/051/003 Oral Suspension - PHENYTOIN 02/12/2013
IMPLANON NXT IPS Healthcare Limited PPA1659/033/001 Implant - ETONOGESTREL 02/12/2013
IMURAN IPS Healthcare Limited PPA1659/046/001 Film Coated Tablet - AZATHIOPRINE 02/12/2013
IMURAN IPS Healthcare Limited PPA1659/046/002 Film Coated Tablet - AZATHIOPRINE 02/12/2013
TAMBOCOR IPS Healthcare Limited PPA1659/035/002 Tablets - FLECAINIDE ACETATE 02/12/2013
TEGRETOL IPS Healthcare Limited PPA1659/036/001 Tablets - CARBAMAZEPINE 02/12/2013
TEGRETOL IPS Healthcare Limited PPA1659/036/002 Tablets - CARBAMAZEPINE 02/12/2013
ZESTRIL IPS Healthcare Limited PPA1659/034/001 Tablets - LISINOPRIL 02/12/2013
ZESTRIL IPS Healthcare Limited PPA1659/034/002 Tablets - LISINOPRIL 02/12/2013
ZESTRIL IPS Healthcare Limited PPA1659/034/003 Tablets - LISINOPRIL 02/12/2013
PANTOPRAZOLE Martindale Pharmaceuticals PA0361/031/001 Pdr for Soln for Injection - PANTOPRAZOLE 01/12/2013
MARTINDALE PHARMA Ltd

Human Medicines Withdrawn Products Page 164 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AXANUM AstraZeneca UK Limited PA0970/063/001 Capsules Hard - ACETYLSALICYLIC ACID 30/11/2013
- ESOMEPRAZOLE
MAGNESIUM TRIHYDRATE

CARDIOXANE 500MG Novartis Pharmaceuticals UK PA0013/121/001 Powder for concentrate for - DEXRAZOXANE 30/11/2013
POWDER FOR Ltd solution for infusion
CONCENTRATE FOR
SOLUTI
FLUDARABINE Ebewe Pharma Ges.m.b.H PA0789/015/001 Concentrate for Soln for Inf - FLUDARABINE 27/11/2013
PHOSPHATE "EBEWE" Nfg. KG PHOSPHATE
FLUCONAZOLE 200 MG Gedeon Richter Plc PA1330/014/003 Capsules Hard - FLUCONAZOLE 25/11/2013
CAPSULES
FLUCONAZOLE 50 MG Gedeon Richter Plc PA1330/014/001 Capsules Hard - FLUCONAZOLE 25/11/2013
CAPSULES
DIFENE PCO Manufacturing PPA0465/185/001 Modified-release capsule, - DICLOFENAC SODIUM 18/11/2013
hard
MYCOSTATIN 100,000 PCO Manufacturing PPA0465/216/001 Oral Suspension - NYSTATIN 15/11/2013
UNITS/ML ORAL
SUSPENSION (READY
PLAQUENIL PCO Manufacturing PPA0465/254/001 Film Coated Tablet - HYDROXYCHLOROQUINE 15/11/2013
SULFATE

TYLEX PCO Manufacturing PPA0465/257/001 Capsules Hard - CODEINE PHOSPHATE 15/11/2013


HEMIHYDRATE
- PARACETAMOL
DEBDOX Teva Pharma B.V. PA0749/083/002 Powder for concentrate for - DOXORUBICIN 14/11/2013
solution for infusion HYDROCHLORIDE
VANCOMYCIN NRIM Limited PA1423/009/001 Powder for concentrate for - VANCOMYCIN 14/11/2013
solution for infusion HYDROCHLORIDE
VANCOMYCIN NRIM Limited PA1423/009/002 Powder for concentrate for - VANCOMYCIN 14/11/2013
solution for infusion HYDROCHLORIDE
CLOPIDOGREL Archie Samuel s.r.o. EU/1/09/554/002 Film Coated Tablet - CLOPIDOGREL BESILATE 13/11/2013
RATIOPHARM - MACROGOL 6000
- CARBON DIOXIDE

CLOPIDOGREL Archie Samuel s.r.o. EU/1/09/554/007 Film Coated Tablet - CLOPIDOGREL BESILATE 13/11/2013
RATIOPHARM - MACROGOL 6000
- CARBON DIOXIDE

CLOPIDOGREL Archie Samuel s.r.o. EU/1/09/554/1-6 Film Coated Tablet - CLOPIDOGREL BESILATE 13/11/2013
RATIOPHARM - MACROGOL 6000
- CARBON DIOXIDE

DACARBAZINE MEDAC Medac Gesellschaft fur PA0623/003/001 Pdr for Soln Inj/Inf - DACARBAZINE CITRATE 13/11/2013
Klinische Spezialpraparate
mbH
FLUOXETINE Pinewood Laboratories Ltd, PA0281/114/001 Oral Solution - FLUOXETINE 12/11/2013
HYDROCHLORIDE
ATORVASTATIN BIOKANO Biokanol Pharma GmbH PA1304/004/001 Film Coated Tablet - ATORVASTATIN CALCIUM 11/11/2013

ATORVASTATIN BIOKANO Biokanol Pharma GmbH PA1304/004/002 Film Coated Tablet - ATORVASTATIN CALCIUM 11/11/2013

ATORVASTATIN BIOKANO Biokanol Pharma GmbH PA1304/004/003 Film Coated Tablet - ATORVASTATIN CALCIUM 11/11/2013

ATORVASTATIN BIOKANO Biokanol Pharma GmbH PA1304/004/004 Film Coated Tablet - ATORVASTATIN CALCIUM 11/11/2013

OSTEOEZE Galen Limited PA1329/005/001 Film Coated Tablet - GLUCOSAMINE 11/11/2013


HYDROCHLORIDE
DIANETTE McDowell Pharmaceuticals PPA1473/032/001 Coated Tablets - CYPROTERONE 09/11/2013
ACETATE
- ETHINYLESTRADIOL
OMNEXEL McDowell Pharmaceuticals PPA1473/037/001 Tablet Prolonged Release - TAMSULOSIN 09/11/2013
HYDROCHLORIDE
RISEDRONATE SODIUM McDowell Pharmaceuticals PPA1473/051/001 Film Coated Tablet - RISEDRONATE SODIUM 09/11/2013
ONCE A WEEK
SERETIDE McDowell Pharmaceuticals PPA1473/042/001 Inhalation powder - SALMETEROL 09/11/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SPIRIVA McDowell Pharmaceuticals PPA1473/026/001 Inhalation powder, hard - TIOTROPIUM BROMIDE 09/11/2013
capsule
SYMBICORT TURBOHALE McDowell Pharmaceuticals PPA1473/028/001 Inhalation powder - BUDESONIDE 09/11/2013
- FORMOTEROL
FUMARATE

Human Medicines Withdrawn Products Page 165 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LEVOFOLINIC ACID Medac Gesellschaft fur PA0623/010/001 Solution for Inj/Inf - LEVOFOLINIC ACID 08/11/2013
MEDAC Klinische Spezialpraparate - SODIUM HYDROXIDE
mbH
SERETIDE 100 DISKUS LTT Pharma Limited PPA1562/098/001 Inhalation powder - SALMETEROL 08/11/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE 250 DISKUS LTT Pharma Limited PPA1562/098/002 Inhalation powder - SALMETEROL 08/11/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
ARTHRIMEL ONCE DAILY Clonmel Healthcare Ltd PA0126/149/004 Powder for Oral Solution - GLUCOSAMINE 06/11/2013
SULPHATE SODIUM
CHLORIDE
CIMELDINE Clonmel Healthcare Ltd PA0126/077/001 Tablets - CIMETIDINE 06/11/2013
DOCETAXEL TEVA Teva Generics B.V. PA1557/001/001 Powder and solvent for - DOCETAXEL 06/11/2013
GENERICS concentrate for solution for ANHYDROUS
infusion
DOCETAXEL TEVA Teva Generics B.V. PA1557/001/002 Powder and solvent for - DOCETAXEL 06/11/2013
GENERICS concentrate for solution for ANHYDROUS
infusion
CLOPIDOGREL TEVA Teva Generics B.V. EU/1/10/650/001-015 Film Coated Tablet - CLOPIDOGREL 05/11/2013
GENERICS B.V. HYDROCHLORIDE
GLYDIUM Les Laboratoires Servier PA0568/021/001 Modified-release Tablets - GLICLAZIDE 04/11/2013
GLYDIUM Les Laboratoires Servier PA0568/021/002 Modified-release Tablets - GLICLAZIDE 04/11/2013
OLANZAPINE RENANTOS Renantos PA1695/002/001 Not assigned - OLANZAPINE 04/11/2013
Pharmavertriebsges. mbH
OLANZAPINE RENANTOS Renantos PA1695/002/002 Not assigned - OLANZAPINE 04/11/2013
Pharmavertriebsges. mbH
OLANZAPINE RENANTOS Renantos PA1695/002/003 Not assigned - OLANZAPINE 04/11/2013
Pharmavertriebsges. mbH
CEFUROXIME Amneal Pharma Europe PA1897/002/001 Pdr for Soln Inj/Inf - CEFUROXIME SODIUM 01/11/2013
Limited
CEFUROXIME Amneal Pharma Europe PA1897/002/002 Pdr for Soln Inj/Inf - CEFUROXIME SODIUM 01/11/2013
Limited
CEFUROXIME Amneal Pharma Europe PA1897/002/003 Pdr for Soln Inj/Inf - CEFUROXIME SODIUM 01/11/2013
Limited
CARBOPLATIN Amneal Pharma Europe PA1897/008/001 Concentrate for Soln for Inf - CARBOPLATIN 31/10/2013
Limited
PANOXYL ACNEGEL GlaxoSmithKline (Ireland) PA1077/127/001 Gel - BENZOYL PEROXIDE 31/10/2013
Limited
PANOXYL ACNEGEL GlaxoSmithKline (Ireland) PA1077/127/002 Gel - BENZOYL PEROXIDE 31/10/2013
Limited
PLASMA VOLUME Baxter Healthcare Limited PA0167/133/001 Solution for Infusion - HYDROXYETHYL 31/10/2013
REDIBAG 6 % SOLUTION STARCH
FOR INFUSION - SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
DIHYDRATE
- SODIUM ACETATE
TRIHYDRATE
CLEXANE MULTI DOSE Sanofi-Aventis Ireland PA0540/097/003 Solution for Injection - ENOXAPARIN SODIUM 29/10/2013
Limited T/A SANOFI
INTAL SPINCAPS 20MG Sanofi-Aventis Ireland PA0540/104/001 Inhalation powder, hard - CROMOGLICATE SODIUM 29/10/2013
INHALATION POWDER Limited T/A SANOFI capsule
CAPSULES
MYZAAR COMP McDermott Laboratories Ltd PA0577/101/001 Film Coated Tablet - LOSARTAN POTASSIUM 23/10/2013
t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

MYZAAR COMP McDermott Laboratories Ltd PA0577/101/002 Film Coated Tablet - LOSARTAN POTASSIUM 23/10/2013
t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

PANTOPRAZOLE Takeda GmbH PA1421/003/001 Tablets Gastro-Resistant - PANTOPRAZOLE 21/10/2013


NYCOMED
PANTOPRAZOLE Takeda GmbH PA1421/003/002 Tablets Gastro-Resistant - PANTOPRAZOLE 21/10/2013
NYCOMED
PANTOPRAZOLE Takeda GmbH PA1421/003/003 Pdr for Soln for Injection - PANTOPRAZOLE 21/10/2013
NYCOMED I.V.
QUETIAPINE Accord Healthcare Limited PA1390/027/003 Film Coated Tablet - QUETIAPINE 21/10/2013
HEMIFUMARATE
PIPERACILLIN/TAZOBACT Milpharm Limited PA1050/002/001 Pdr for Soln Inj/Inf - PIPERACILLIN 17/10/2013
AM MILPHARM 2 G/0.25 G - TAZOBACTAM
POWDER

Human Medicines Withdrawn Products Page 166 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PIPERACILLIN/TAZOBACT Milpharm Limited PA1050/002/002 Pdr for Soln Inj/Inf - PIPERACILLIN 17/10/2013
AM MILPHARM 4 G/0.5 G - TAZOBACTAM
POWDER
CIPRAPINE Pinewood Laboratories Ltd, PA0281/117/001 Film Coated Tablet - CITALOPRAM 07/10/2013
HYDROBROMIDE
CIPRAPINE Pinewood Laboratories Ltd, PA0281/117/002 Film Coated Tablet - CITALOPRAM 07/10/2013
HYDROBROMIDE
CIPRAPINE Pinewood Laboratories Ltd, PA0281/117/003 Film Coated Tablet - CITALOPRAM 07/10/2013
HYDROBROMIDE
BENPH McDermott Laboratories Ltd PA0577/049/001 Tablets - TERAZOSIN 03/10/2013
t/a Gerard Laboratories HYDROCHLORIDE
BENPH McDermott Laboratories Ltd PA0577/049/002 Tablets - TERAZOSIN 03/10/2013
t/a Gerard Laboratories HYDROCHLORIDE
BENPH McDermott Laboratories Ltd PA0577/049/003 Tablets - TERAZOSIN 03/10/2013
t/a Gerard Laboratories HYDROCHLORIDE
BENPH McDermott Laboratories Ltd PA0577/049/004 Tablets - TERAZOSIN 03/10/2013
t/a Gerard Laboratories HYDROCHLORIDE
FLUOXETINE Dr. Reddy's Laboratories PA1364/001/001 Capsules Hard - FLUOXETINE 02/10/2013
(UK) Ltd
GABTURE Milpharm Limited PA1050/001/001 Capsule - GABAPENTIN 30/09/2013
GABTURE Milpharm Limited PA1050/001/002 Capsule - GABAPENTIN 30/09/2013
GABTURE Milpharm Limited PA1050/001/003 Capsule - GABAPENTIN 30/09/2013
ESMOCARD Orpha-Devel Handels und PA1353/001/002 Concentrate for Soln for Inf - ESMOLOL 27/09/2013
Vertriebs GmbH HYDROCHLORIDE
TRAMADOL/PARACETAM Paladin Labs Europe Limited PA1246/002/001 Tablet Prolonged Release - TRAMADOL 26/09/2013
OL HYDROCHLORIDE
- PARACETAMOL
- PARACETAMOL
CODALUX Aziende Chimiche Riunite PA0959/003/001 Eye Drops Solution - LATANOPROST 25/09/2013
Angelini Francesco - TIMOLOL MALEATE
MALARONE PCO Manufacturing PPA0465/255/001 Film Coated Tablet - ATOVAQUONE 25/09/2013
- PROGUANIL
HYDROCHLORIDE
ALENDRONIC ACID 10 MG Accord Healthcare Limited PA1390/035/001 Tablets - ALENDRONIC ACID 16/09/2013
TABLETS
OLANZAPINE ACCORD Accord Healthcare Limited PA1390/045/006 Film Coated Tablet - OLANZAPINE (FORM-1) 16/09/2013
PARACETAMOL Millmount Healthcare Limited PA0767/001/001 Tablets - PARACETAMOL 04/09/2013

RIVASTIGMINE ACINO Luye Pharma AG PA1649/002/001 Transdermal Patch - RIVASTIGMINE 01/09/2013


RIVASTIGMINE ACINO Luye Pharma AG PA1649/002/002 Transdermal Patch - RIVASTIGMINE 01/09/2013
ROFERON A Roche Products Limited PA0050/068/024 Solution for Injection - INTERFERON ALFA-2A 01/09/2013
SERDOLECT H. Lundbeck A/S PA0805/001/003 Film Coated Tablet - SERTINDOLE 01/09/2013
ADVIL Pfizer Healthcare Ireland PA0822/163/003 Tablets Effervescent - IBUPROFEN 30/08/2013
ADVIL MAXIMUM Pfizer Healthcare Ireland PA0822/163/004 Tablets Effervescent - IBUPROFEN 30/08/2013
STRENGTH
LANAFINE Niche Generics Limited PA1063/018/003 Tablets - TERBINAFINE 28/08/2013
PERINDOPRIL TERT- Les Laboratoires Servier PA0568/017/001 Tablets - PERINDOPRIL TERT- 27/08/2013
BUTYLAMINE BUTYLAMINE SALT
PERINDOPRIL TERT- Les Laboratoires Servier PA0568/017/002 Tablets - PERINDOPRIL TERT- 27/08/2013
BUTYLAMINE BUTYLAMINE SALT
Perindopril tert-butylamine Les Laboratoires Servier PA0568/023/001 Tablet - Perindopril tert-butylamine 27/08/2013
/Indapamide Servier - Indapamide
8mg/2.5mg tablets
DOXEL Clarendon Pharma Limited PA1124/001/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 19/08/2013
LETROZOLE Flynn Pharma Ltd PA1226/006/001 Film Coated Tablet - LETROZOLE 19/08/2013
RISEDRONATE 30MG FILM- Aspire Pharma Limited PA1619/003/002 Film Coated Tablet - RISEDRONATE SODIUM 09/08/2013
COATED TABLETS
RISEDRONATE 5MG FILM- Aspire Pharma Limited PA1619/003/001 Film Coated Tablet - RISEDRONATE SODIUM 09/08/2013
COATED TABLETS
RISEDRONATE ONCE A Aspire Pharma Limited PA1619/003/003 Film Coated Tablet - RISEDRONATE SODIUM 09/08/2013
WEEK 35MG FILM-COATED HEMIPENTAHYDRATE
TABLET
REDUCTIL LTT Pharma Limited PPA1562/006/001 Capsule - SIBUTRAMINE 08/08/2013
HYDROCHLORIDE
MONOHYDRATE
REDUCTIL LTT Pharma Limited PPA1562/006/002 Capsule - SIBUTRAMINE 08/08/2013
HYDROCHLORIDE
MONOHYDRATE
CYTAMEN RPH Pharmaceuticals AB PA1638/003/001 Solution for Injection - CYANOCOBALAMIN 07/08/2013
PERDAMEL Clonmel Healthcare Ltd PA0126/169/007 Film Coated Tablet - RISPERIDONE 06/08/2013
IRBESARTAN Arrow ApS PA1522/006/001 Film Coated Tablet - IRBESARTAN 02/08/2013
IRBESARTAN Arrow ApS PA1522/006/002 Film Coated Tablet - IRBESARTAN 02/08/2013
IRBESARTAN Arrow ApS PA1522/006/003 Film Coated Tablet - IRBESARTAN 02/08/2013

Human Medicines Withdrawn Products Page 167 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IRBESARTAN/HYDROCHL Arrow ApS PA1522/007/002 Film Coated Tablet - IRBESARTAN 02/08/2013
OROTHIAZIDE - HYDROCHLOROTHIAZIDE

IRBESARTAN/HYDROCHL Arrow ApS PA1522/007/003 Film Coated Tablet - IRBESARTAN 02/08/2013


OROTHIAZIDE - HYDROCHLOROTHIAZIDE

LAMOTRIGINE 100 MG Arrow Generics Limited PA1130/006/005 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
LAMOTRIGINE 2 MG Arrow Generics Limited PA1130/006/001 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
LAMOTRIGINE 200 MG Arrow Generics Limited PA1130/006/006 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
LAMOTRIGINE 25 MG Arrow Generics Limited PA1130/006/003 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
LAMOTRIGINE 5 MG Arrow Generics Limited PA1130/006/002 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
LAMOTRIGINE 50 MG Arrow Generics Limited PA1130/006/004 Dispersable Tablet - LAMOTRIGINE 02/08/2013
DISPERSIBLE TABLETS
NIQUITIN CQ GlaxoSmithKline Consumer PA0678/099/001 Medicated Chewing Gum - NICOTINE 02/08/2013
Healthcare (Ireland) Limited
NIQUITIN CQ GlaxoSmithKline Consumer PA0678/099/002 Medicated Chewing Gum - NICOTINE 02/08/2013
Healthcare (Ireland) Limited
SOLPADEINE COLD & FLU GlaxoSmithKline Consumer PA0678/101/001 Capsules Hard - PARACETAMOL 02/08/2013
Healthcare (Ireland) Limited - PSEUDOEPHEDRINE
HYDROCHLORIDE
- PHOLCODINE
TELMISARTAN ARROW Arrow Generics Limited PA1130/033/001 Tablets - TELMISARTAN 02/08/2013
TELMISARTAN ARROW Arrow Generics Limited PA1130/033/002 Tablets - TELMISARTAN 02/08/2013
TELMISARTAN ARROW Arrow Generics Limited PA1130/033/003 Tablets - TELMISARTAN 02/08/2013
TOPIRAMA Arrow Generics Limited PA1130/009/001 Film Coated Tablet - TOPIRAMATE 02/08/2013
TOPIRAMA Arrow Generics Limited PA1130/009/002 Film Coated Tablet - TOPIRAMATE 02/08/2013
TOPIRAMA Arrow Generics Limited PA1130/009/003 Film Coated Tablet - TOPIRAMATE 02/08/2013
TOPIRAMA Arrow Generics Limited PA1130/009/004 Film Coated Tablet - TOPIRAMATE 02/08/2013
VALSARTAN Arrow Generics Limited PA1130/029/001 Film Coated Tablet - VALSARTAN 02/08/2013
VALSARTAN Arrow Generics Limited PA1130/029/002 Film Coated Tablet - VALSARTAN 02/08/2013
VALSARTAN Arrow Generics Limited PA1130/029/003 Film Coated Tablet - VALSARTAN 02/08/2013
VALSARTAN Arrow Generics Limited PA1130/029/004 Film Coated Tablet - VALSARTAN 02/08/2013
FAMVIR Novartis Pharmaceuticals UK PA0013/106/004 Coated Tablets - FAMCICLOVIR 01/08/2013
Ltd
Imprida Novartis Europharm Limited EU/1/06/373/025-027 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/028-030 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/031-033 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/034 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/035 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
Imprida Novartis Europharm Limited EU/1/06/373/036 Film-coated tablet - Amlodipine besylate 01/08/2013
- Valsartan
CITALOPRAM Niche Generics Limited PA1063/017/001 Film Coated Tablet - CITALOPRAM 31/07/2013
HYDROBROMIDE
- CITALOPRAM
CITALOPRAM Niche Generics Limited PA1063/017/002 Film Coated Tablet - CITALOPRAM 31/07/2013
HYDROBROMIDE
- CITALOPRAM
ERYTHROMYCIN 1G Hospira UK Limited PA0437/025/001 Powder for solution for - ERYTHROMYCIN 31/07/2013
POWDER FOR infusion - LACTOBIONIC ACID
CONCENTRATE FOR
SOLUTIO
NIZORAL SHAMPOO B & S Healthcare PPA1328/030/001 Shampoo - KETOCONAZOLE 31/07/2013
PROPOFOL Hospira Enterprises B.V. PA1250/002/001 Emulsion for Inj/Inf - PROPOFOL 31/07/2013
BETNESOL RPH Pharmaceuticals AB PA1638/001/002 Eye Ointment - BETAMETHASONE 30/07/2013
SODIUM PHOSPHATE
HIBICET HOSPITAL Regent Medical Overseas PA1218/004/001 Cutaneous Solution - CHLORHEXIDINE 23/07/2013
CONCENTRATE Limited Concentrate GLUCONATE
- CETRIMONIUM BROMIDE

SOOTHELIP Bayer PLC PA0021/087/001 Cream - ACICLOVIR 22/07/2013


SCHOLL CORN AND Scholl Consumer Products PA0455/003/001 Cutaneous Solution - SALICYLIC ACID 19/07/2013
CALLOUS REMOVAL Limited - CAMPHOR
LIQUID
NEURONTIN B & S Healthcare PPA1328/028/003 Capsules Hard - GABAPENTIN 18/07/2013
CELLUVISC IMED Healthcare Ltd. DPR1463/039/001 Eye Drops Solution - CARMELLOSE SODIUM 17/07/2013

Human Medicines Withdrawn Products Page 168 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CELLUVISC IMED Healthcare Ltd. DPR1463/039/002 Eye Drops Solution - CARMELLOSE SODIUM 17/07/2013
TOLTERODINE TARTRATE Specifar S.A. PA1653/001/001 Film Coated Tablet - TOLTERODINE 16/07/2013
SPECIFAR TARTRATE
TOLTERODINE TARTRATE Specifar S.A. PA1653/001/002 Film Coated Tablet - TOLTERODINE 16/07/2013
SPECIFAR TARTRATE
IBANDRONIC ACID VAIA Vaia S.A. PA1668/001/001 Film Coated Tablet - IBANDRONATE SODIUM 15/07/2013
MONOHYDRATE
IBANDRONIC ACID VAIA Vaia S.A. PA1668/001/002 Film Coated Tablet - IBANDRONATE SODIUM 15/07/2013
MONOHYDRATE
ESOMEPRAZOLE ARROW Arrow Generics Limited PA1130/035/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 10/07/2013
MAGNESIUM DIHYDRATE
ESOMEPRAZOLE ARROW Arrow Generics Limited PA1130/035/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 10/07/2013
MAGNESIUM DIHYDRATE
CANDIST Clonmel Healthcare Ltd PA0126/206/004 Tablets - CANDESARTAN 04/07/2013
CILEXETIL
REAPTAN Les Laboratoires Servier PA0568/020/001 Tablets - PERINDOPRIL ARGININE 03/07/2013
- AMLODIPINE BESYLATE
REAPTAN Les Laboratoires Servier PA0568/020/002 Tablets - PERINDOPRIL ARGININE 03/07/2013
- AMLODIPINE BESYLATE
REAPTAN Les Laboratoires Servier PA0568/020/003 Tablets - PERINDOPRIL ARGININE 03/07/2013
- AMLODIPINE BESYLATE
REAPTAN Les Laboratoires Servier PA0568/020/004 Tablets - PERINDOPRIL ARGININE 03/07/2013
- AMLODIPINE BESYLATE
DARONRIX GlaxoSmithKline Biologicals EU/1/06/381/1-8 Suspension for Injection - WHOLE VIRON, 02/07/2013
S.A. INACTIVATED, OF
PANDEMIC STRAIN
(PROPAGATED IN EGGS)
A/HONG
KONG/1073/99(H9N2)
DOMPERIDONE PIERRE FABRE Ltd PA1287/002/001 Orodispersible Tablet - DOMPERIDONE 01/07/2013
IOPAMIGITA Agfa Healthcare Imaging PA1504/002/001 Solution for Inj/Inf - IOPAMIDOL 01/07/2013
Agents GmbH - IODINE
IOPAMIGITA Agfa Healthcare Imaging PA1504/002/002 Solution for Inj/Inf - IOPAMIDOL 01/07/2013
Agents GmbH - IODINE
VALSARTAN KRKA Krka d.d., Novo mesto PA1347/010/005 Film Coated Tablet - VALSARTAN 28/06/2013
OLICLINOMEL Baxter Healthcare Limited PA0167/109/002 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE, ACTIVE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE
- SODIUM ACETATE
- SODIUM
GLYCEROPHOSPHATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE

Human Medicines Withdrawn Products Page 169 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OLICLINOMEL Baxter Healthcare Limited PA0167/109/004 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE, ACTIVE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE
- SODIUM ACETATE
- SODIUM
GLYCEROPHOSPHATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
OLICLINOMEL Baxter Healthcare Limited PA0167/109/006 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE, ACTIVE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE
- SODIUM ACETATE
- SODIUM
GLYCEROPHOSPHATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
OLICLINOMEL Baxter Healthcare Limited PA0167/109/007 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE

Human Medicines Withdrawn Products Page 170 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OLICLINOMEL Baxter Healthcare Limited PA0167/109/008 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE, ACTIVE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE
- SODIUM ACETATE
- SODIUM
GLYCEROPHOSPHATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
OLICLINOMEL Baxter Healthcare Limited PA0167/109/009 Emulsion for Infusion - OLIVE OIL 27/06/2013
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
- SODIUM
GLYCEROPHOSPHATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
- CALCIUM CHLORIDE
DIHYDRATE
SUMATRIPTAN ARROW Arrow Generics Limited PA1130/022/001 Tablets - SUMATRIPTAN 25/06/2013
SUCCINATE
SUMATRIPTAN ARROW Arrow Generics Limited PA1130/022/002 Tablets - SUMATRIPTAN 25/06/2013
SUCCINATE
LOSARTAN TEVA Teva Pharma B.V. PA0749/090/001 Film Coated Tablet - LOSARTAN POTASSIUM 19/06/2013
LOSARTAN TEVA Teva Pharma B.V. PA0749/090/002 Film Coated Tablet - LOSARTAN POTASSIUM 19/06/2013
MONTELUKAST Arrow Generics Limited PA1130/036/001 Tablets Chewable - MONTELUKAST SODIUM 17/06/2013
MONTELUKAST Arrow Generics Limited PA1130/036/002 Tablets Chewable - MONTELUKAST SODIUM 17/06/2013
MONTELUKAST Arrow Generics Limited PA1130/036/003 Film Coated Tablet - MONTELUKAST SODIUM 17/06/2013
QUETIAPINE ARROW Arrow Generics Limited PA1130/023/001 Film Coated Tablet - QUETIAPINE 17/06/2013
QUETIAPINE ARROW Arrow Generics Limited PA1130/023/002 Film Coated Tablet - QUETIAPINE 17/06/2013
QUETIAPINE ARROW Arrow Generics Limited PA1130/023/003 Film Coated Tablet - QUETIAPINE 17/06/2013
QUETIAPINE ARROW Arrow Generics Limited PA1130/023/004 Film Coated Tablet - QUETIAPINE 17/06/2013
QUETIAPINE ARROW Arrow Generics Limited PA1130/023/005 Film Coated Tablet - QUETIAPINE 17/06/2013
BENEPRAV Daiichi Sankyo Ireland Ltd PA1595/004/001 Tablets - PRAVASTATIN SODIUM 12/06/2013
BENEPRAV Daiichi Sankyo Ireland Ltd PA1595/004/002 Tablets - PRAVASTATIN SODIUM 12/06/2013
BENEPRAV Daiichi Sankyo Ireland Ltd PA1595/004/003 Tablets - PRAVASTATIN SODIUM 12/06/2013
SODIOFOLIN Medac Gesellschaft fur PA0623/005/001 Solution for Injection - FOLINIC ACID 07/06/2013
Klinische Spezialpraparate
mbH
RIVASTIGMINE Beacon Pharmaceuticals Ltd PA1312/013/001 Oral Solution - RIVASTIGMINE 06/06/2013
HYDROGEN TARTRATE
Sepioglin Vaia S.A. EU/1/12/754/001-007 Tablet - Pioglitazone hydrochloride 06/06/2013
Sepioglin Vaia S.A. EU/1/12/754/008-014 Tablet - Pioglitazone hydrochloride 06/06/2013
Sepioglin Vaia S.A. EU/1/12/754/015-021 Tablet - Pioglitazone hydrochloride 06/06/2013

Human Medicines Withdrawn Products Page 171 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLOPIXOL 25MG FILM- Lundbeck Limited PA0115/005/004 Film Coated Tablet - ZUCLOPENTHIXOL 05/06/2013
COATED TABLETS DIHYDROCHLORIDE
PARACETAMOL 500MG, Procter & Gamble (Health & PA0441/043/001 Powder for Oral Solution - PARACETAMOL 04/06/2013
GUAIFENESIN 200MG, Beauty Care) Limited - GUAIFENESIN
PHENYLEPHRIN - PHENYLEPHRINE
HYDROCHLORIDE
PROPOFOL PFIZER Pfizer Healthcare Ireland PA0822/029/001 Emulsion for Inj/Inf - PROPOFOL 04/06/2013
PROPOFOL PFIZER Pfizer Healthcare Ireland PA0822/029/002 Emulsion for Inj/Inf - PROPOFOL 04/06/2013
SAUREV Pfizer Healthcare Ireland PA0822/030/001 Emulsion for Inj/Inf - PROPOFOL 04/06/2013
SAUREV Pfizer Healthcare Ireland PA0822/030/002 Emulsion for Inj/Inf - PROPOFOL 04/06/2013
ZOLMITRIPTAN Renantos PA1695/001/001 - ZOLMITRIPTAN 04/06/2013
RENANTOS Pharmavertriebsges. mbH
ZOLMITRIPTAN Renantos PA1695/001/002 - ZOLMITRIPTAN 04/06/2013
RENANTOS Pharmavertriebsges. mbH
LISATIN Chanelle Medical PA0688/022/001 Film Coated Tablet - ATORVASTATIN CALCIUM 31/05/2013

LISATIN Chanelle Medical PA0688/022/002 Film Coated Tablet - ATORVASTATIN CALCIUM 31/05/2013

LISATIN Chanelle Medical PA0688/022/003 Film Coated Tablet - ATORVASTATIN CALCIUM 31/05/2013

LISATIN Chanelle Medical PA0688/022/004 Film Coated Tablet - ATORVASTATIN CALCIUM 31/05/2013

PAROXETINE Chanelle Medical PA0688/016/001 Film Coated Tablet - PAROXETINE 31/05/2013


HYDROCHLORIDE
HEMIHYDRATE
PAROXETINE Chanelle Medical PA0688/016/002 Film Coated Tablet - PAROXETINE 31/05/2013
HYDROCHLORIDE
HEMIHYDRATE
PARACETAMOL Beacon Pharmaceuticals Ltd PA1312/014/001 Solution for Infusion - PARACETAMOL 30/05/2013

GRANISETRON TEVA 1 Teva Pharma B.V. PA0749/027/003 Concentrate for Soln for Inf - GRANISETRON 29/05/2013
MG/1 ML CONCENTRATE
FOR SOLUTIO
GRANISETRON TEVA 3 Teva Pharma B.V. PA0749/027/005 Concentrate for Soln for Inf - GRANISETRON 29/05/2013
MG/3 ML CONCENTRATE HYDROCHLORIDE
FOR SOLUTIO
GRANISETRON TEVA 3 Teva Pharma B.V. PA0749/027/006 Concentrate for Soln for Inf - GRANISETRON 29/05/2013
MG/3 ML CONCENTRATE HYDROCHLORIDE
FOR SOLUTIO
RISPERDAL PCO Manufacturing PPA0465/078/006 Film Coated Tablet - RISPERIDONE 27/05/2013
PANTOPRAZOLE Laboratorios Davur S.L.U. PA1271/007/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 24/05/2013
SESQUIHYDRATE

PANTOPRAZOLE Laboratorios Davur S.L.U. PA1271/007/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 24/05/2013
SESQUIHYDRATE

ARICEPT Profind Wholesale Ltd PPA1500/039/001 Film Coated Tablet - DONEPEZIL 23/05/2013
HYDROCHLORIDE
ASASANTIN RETARD Profind Wholesale Ltd PPA1500/045/001 Modified-release capsule, - DIPYRIDAMOLE 23/05/2013
hard - ACETYLSALICYLIC ACID
BECOTIDE EVOHALER Profind Wholesale Ltd PPA1500/040/001 Pressurised Inhalation Soln - BECLOMETASONE 23/05/2013
DIPROPIONATE
CARDICOR Profind Wholesale Ltd PPA1500/036/001 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd PPA1500/036/002 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd PPA1500/036/003 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd PPA1500/036/004 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd PPA1500/036/005 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd PPA1500/036/006 Film Coated Tablet - BISOPROLOL 23/05/2013
HEMIFUMARATE
CELEBREX Profind Wholesale Ltd PPA1500/038/001 Capsules Hard - CELECOXIB 23/05/2013
CIPRAMIL Profind Wholesale Ltd PPA1500/051/001 Film Coated Tablet - CITALOPRAM 23/05/2013
CORDARONE X Profind Wholesale Ltd PPA1500/044/001 Tablets - AMIODARONE 23/05/2013
HYDROCHLORIDE
ELANTAN LA Profind Wholesale Ltd PPA1500/027/001 Prolonged Release Capsules - ISOSORBIDE 23/05/2013
MONONITRATE
ELANTAN LA Profind Wholesale Ltd PPA1500/027/002 Prolonged Release Capsules - ISOSORBIDE 23/05/2013
MONONITRATE
IMDUR Profind Wholesale Ltd PPA1500/028/001 Film Coated Tablet - ISOSORBIDE 23/05/2013
MONONITRATE
LIPOSTAT Profind Wholesale Ltd PPA1500/031/001 Tablets - PRAVASTATIN SODIUM 23/05/2013
LOSEC MUPS Profind Wholesale Ltd PPA1500/013/001 Tablets Gastro-Resistant - OMEPRAZOLE 23/05/2013

Human Medicines Withdrawn Products Page 172 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEBILET Profind Wholesale Ltd PPA1500/041/001 Tablets - NEBIVOLOL 23/05/2013
HYDROCHLORIDE
NEURONTIN Profind Wholesale Ltd PPA1500/029/001 Capsules Hard - GABAPENTIN 23/05/2013
NEURONTIN Profind Wholesale Ltd PPA1500/029/002 Capsules Hard - GABAPENTIN 23/05/2013
PENTASA Profind Wholesale Ltd PPA1500/049/001 Tablet Prolonged Release - MESALAZINE 23/05/2013
SERETIDE 250 EVOHALER Profind Wholesale Ltd PPA1500/009/002 Pressurised Inhalation - SALMETEROL 23/05/2013
Suspension - FLUTICASONE
PROPIONATE
SERETIDE EVOHALER Profind Wholesale Ltd PPA1500/009/004 Pressurised Inhalation - SALMETEROL 23/05/2013
Suspension XINAFOATE
- FLUTICASONE
PROPIONATE
SEROXAT Profind Wholesale Ltd PPA1500/022/002 Tablets - PAROXETINE 23/05/2013
HYDROCHLORIDE
TENORET Profind Wholesale Ltd PPA1500/016/001 Film Coated Tablet - ATENOLOL 23/05/2013
- CHLORTALIDONE
TENORETIC Profind Wholesale Ltd PPA1500/017/001 Film Coated Tablet - ATENOLOL 23/05/2013
- CHLORTALIDONE
TOPAMAX Profind Wholesale Ltd PPA1500/050/001 Film Coated Tablet - TOPIRAMATE 23/05/2013
ZANTAC Profind Wholesale Ltd PPA1500/023/002 Film Coated Tablet - RANITIDINE 23/05/2013
HYDROCHLORIDE
ZESTRIL Profind Wholesale Ltd PPA1500/018/001 Tablets - LISINOPRIL DIHYDRATE 23/05/2013
ZESTRIL Profind Wholesale Ltd PPA1500/018/002 Tablets - LISINOPRIL DIHYDRATE 23/05/2013
ZESTRIL Profind Wholesale Ltd PPA1500/018/003 Tablets - LISINOPRIL DIHYDRATE 23/05/2013
ZOCOR Profind Wholesale Ltd PPA1500/030/001 Film Coated Tablet - SIMVASTATIN 23/05/2013
ZOCOR Profind Wholesale Ltd PPA1500/030/002 Film Coated Tablet - SIMVASTATIN 23/05/2013
ZOCOR Profind Wholesale Ltd PPA1500/030/003 Film Coated Tablet - SIMVASTATIN 23/05/2013
ZOMIG Profind Wholesale Ltd PPA1500/014/001 Film Coated Tablet - ZOLMITRIPTAN 23/05/2013
BONDENZA Roche Registration Limited EU/1/03/266/3-4 Coated Tablets - IBANDRONIC ACID 20/05/2013
BONDENZA Roche Registration Limited EU/1/03/266/5-6 Solution for Injection - IBANDRONIC ACID 20/05/2013
SUMAGRAN Chanelle Medical PA0688/011/001 Film Coated Tablet - SUMATRIPTAN 16/05/2013
SUMAGRAN Chanelle Medical PA0688/011/002 Film Coated Tablet - SUMATRIPTAN 16/05/2013
CLOPIDOGREL NICHE Niche Generics Limited PA1063/039/001 Film Coated Tablet - CLOPIDOGREL BESILATE 15/05/2013

IBANDRONIC ACID ROCHE Roche Registration Limited EU/1/03/266/01-2 Tablet - Ibandronic acid 13/05/2013
2.5mg FILM-COATED tablet

ARYTHMOL SR Abbott Laboratories Ireland PA0038/079/004 Prolonged Release Capsules - PROPAFENONE 08/05/2013
Ltd HYDROCHLORIDE
ARYTHMOL SR Abbott Laboratories Ireland PA0038/079/005 Prolonged Release Capsules - PROPAFENONE 08/05/2013
Ltd HYDROCHLORIDE
ARYTHMOL SR Abbott Laboratories Ireland PA0038/079/006 Prolonged Release Capsules - PROPAFENONE 08/05/2013
Ltd HYDROCHLORIDE
PARACETAMOL MACOSOL Maco Pharma (UK) Ltd PA0931/011/001 Solution for Infusion - PARACETAMOL 06/05/2013

CLOPIDOGREL Pfizer Healthcare Ireland PA0822/060/001 Film Coated Tablet - CLOPIDOGREL 03/05/2013
REMIFENTANIL Pfizer Healthcare Ireland PA0822/156/001 Powder for concentrate for - REMIFENTANIL 03/05/2013
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL Pfizer Healthcare Ireland PA0822/156/002 Powder for concentrate for - REMIFENTANIL 03/05/2013
solution for injection/infusion HYDROCHLORIDE
REMIFENTANIL Pfizer Healthcare Ireland PA0822/156/003 Powder for concentrate for - REMIFENTANIL 03/05/2013
solution for injection/infusion HYDROCHLORIDE
AMARYL Profind Wholesale Ltd PPA1500/063/001 Tablets - GLIMEPIRIDE 02/05/2013
AMARYL Profind Wholesale Ltd PPA1500/063/002 Tablets - GLIMEPIRIDE 02/05/2013
ARTHROTEC Profind Wholesale Ltd PPA1500/074/001 Modified-release Tablets - DICLOFENAC SODIUM 02/05/2013
- MISOPROSTOL
CASODEX Profind Wholesale Ltd PPA1500/073/001 Film Coated Tablet - BICALUTAMIDE 02/05/2013
IKOREL Profind Wholesale Ltd PPA1500/078/001 Tablets - NICORANDIL 02/05/2013
IKOREL Profind Wholesale Ltd PPA1500/078/002 Tablets - NICORANDIL 02/05/2013
KYTRIL Profind Wholesale Ltd PPA1500/076/001 Film Coated Tablet - GRANISETRON 02/05/2013
HYDROCHLORIDE
LIVIAL Profind Wholesale Ltd PPA1500/056/001 Tablets - TIBOLONE 02/05/2013
OMESAR Profind Wholesale Ltd PPA1500/052/002 Film Coated Tablet - OLMESARTAN 02/05/2013
MEDOXOMIL
PROSCAR Profind Wholesale Ltd PPA1500/077/001 Film Coated Tablet - FINASTERIDE 02/05/2013
SEREVENT EVOHALER Profind Wholesale Ltd PPA1500/084/001 Pressurised Inhalation - SALMETEROL 02/05/2013
Suspension XINAFOATE
SYMBICORT TURBOHALE Profind Wholesale Ltd PPA1500/065/003 Inhalation powder - BUDESONIDE 02/05/2013
- FORMOTEROL
FUMATRATE DIHYDRATE
TELFAST Profind Wholesale Ltd PPA1500/072/001 Film Coated Tablet - FEXOFENADINE 02/05/2013
HYDROCHLORIDE
TELFAST Profind Wholesale Ltd PPA1500/072/002 Film Coated Tablet - FEXOFENADINE 02/05/2013
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 173 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VALTREX Profind Wholesale Ltd PPA1500/079/001 Film Coated Tablet - VALACICLOVIR 02/05/2013
HYDROCHLORIDE
Yantil SR Grünenthal Ltd PA1189/008/008 Prolonged-release tablet - Tapentadol hydrochloride 02/05/2013
- Equivalent to free base
ZOLADEX LA Profind Wholesale Ltd PPA1500/061/001 Implant - GOSERELIN ACETATE 02/05/2013
ASMABEC CLICKHALER RPH Pharmaceuticals AB PA1638/010/002 Inhalation powder - BECLOMETASONE 01/05/2013
100 MICROGRAMS. DIPROPIONATE
INHALATION POW
ASMABEC CLICKHALER RPH Pharmaceuticals AB PA1638/010/003 Inhalation powder - BECLOMETASONE 01/05/2013
250 MICROGRAMS. DIPROPIONATE
INHALATION POW
ASMASAL CLICKHALER RPH Pharmaceuticals AB PA1638/011/001 Inhalation powder - SALBUTAMOL SULFATE 01/05/2013
TOPAAL CHEWABLE Pierre Fabre Medicament PA0329/002/001 Tablets Chewable - ALUMINIUM HYDROXIDE 01/05/2013
TABLETS GEL, DRIED
- MAGNESIUM
CARBONATE LIGHT
- ALGINIC ACID
- SILICA COLLOIDAL
HYDRATED
CETIRIZINE 10MG FILM- McDermott Laboratories Ltd PA0577/085/001 Film Coated Tablet - CETIRIZINE 30/04/2013
COATED TABLETS. t/a Gerard Laboratories DIHYDROCHLORIDE
CETIRIZINE MYLAN 10MG McDermott Laboratories Ltd PA0577/085/002 Film Coated Tablet - CETIRIZINE 30/04/2013
FILM-COATED TABLETS. t/a Gerard Laboratories DIHYDROCHLORIDE
DIACLIDE 80MG TABLETS McDermott Laboratories Ltd PA0577/030/001 Tablets - GLICLAZIDE 30/04/2013
t/a Gerard Laboratories
LIPANTIL MICRO Abbott Healthcare Products PA0108/030/004 Capsules Hard - FENOFIBRATE 30/04/2013
Ltd
MEBECON Abbott Healthcare Products PA0108/033/001 Coated Tablets - MEBEVERINE 30/04/2013
Ltd HYDROCHLORIDE
SALBUTAMOL HFA McDermott Laboratories Ltd PA0577/092/001 Pressurised Inhalation - SALBUTAMOL 30/04/2013
t/a Gerard Laboratories Suspension
SELIPROL McDermott Laboratories Ltd PA0577/052/001 Coated Tablets - CELIPROLOL 30/04/2013
t/a Gerard Laboratories HYDROCHLORIDE
SELIPROL McDermott Laboratories Ltd PA0577/052/002 Coated Tablets - CELIPROLOL 30/04/2013
t/a Gerard Laboratories HYDROCHLORIDE
STATEASE McDermott Laboratories Ltd PA0577/098/002 Capsules Hard - FLUVASTATIN 30/04/2013
t/a Gerard Laboratories
STATEASE McDermott Laboratories Ltd PA0577/098/003 Capsules Hard - FLUVASTATIN 30/04/2013
t/a Gerard Laboratories
TRILAM Generics (UK) Limited PA0405/023/002 Tablets - TRIAZOLAM 30/04/2013
YANTIL Grünenthal Ltd PA1189/008/010 Oral Solution - TAPENTADOL 30/04/2013
HYDROCHLORIDE
YANTIL Grünenthal Ltd PA1189/008/011 Oral Solution - TAPENTADOL 30/04/2013
HYDROCHLORIDE
YANTIL Grünenthal Ltd PA1189/008/001 Film Coated Tablet - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL Grünenthal Ltd PA1189/008/002 Film Coated Tablet - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL Grünenthal Ltd PA1189/008/003 Film Coated Tablet - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL SR Grünenthal Ltd PA1189/008/004 Tablet Prolonged Release - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL SR Grünenthal Ltd PA1189/008/005 Tablet Prolonged Release - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL SR Grünenthal Ltd PA1189/008/006 Tablet Prolonged Release - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL SR Grünenthal Ltd PA1189/008/007 Tablet Prolonged Release - TAPENTADOL 30/04/2013
HYDROCHLORIDE
- EQUIVALENT TO FREE
BASE
YANTIL SR Grünenthal Ltd PA1189/008/009 Tablet Prolonged Release - TAPENTADOL 30/04/2013
HYDROCHLORIDE
ZESTRIL PCO Manufacturing PPA0465/066/002 Tablets - LISINOPRIL 30/04/2013

Human Medicines Withdrawn Products Page 174 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZISTAP McDermott Laboratories Ltd PA0577/058/001 Film Coated Tablet - MIRTAZAPINE 30/04/2013
t/a Gerard Laboratories
ACTELSAR Actavis Group PTC ehf PA1380/121/001 Tablets - TELMISARTAN 29/04/2013
ACTELSAR Actavis Group PTC ehf PA1380/121/002 Tablets - TELMISARTAN 29/04/2013
ACTELSAR Actavis Group PTC ehf PA1380/121/003 Tablets - TELMISARTAN 29/04/2013
ACTONEL ONCE A WEEK G & A Licensing Limited PPA1447/004/001 Film Coated Tablet - RISEDRONATE SODIUM 29/04/2013
ANADIN EXTRA G & A Licensing Limited PPA1447/076/001 Film Coated Tablet - ACETYLSALICYLIC ACID 29/04/2013
- PARACETAMOL
- CAFFEINE
ATACAND G & A Licensing Limited PPA1447/038/001 Tablets - CANDESARTAN 29/04/2013
CILEXETIL
AUGMENTIN G & A Licensing Limited PPA1447/002/001 Film Coated Tablet - AMOXICILLIN 29/04/2013
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CABEREX 1 MILLIGRAM Arrow Generics Limited PA1130/010/001 Tablets - CABERGOLINE 29/04/2013
TABLETS
CABEREX 2 MILLIGRAM Arrow Generics Limited PA1130/010/002 Tablets - CABERGOLINE 29/04/2013
TABLETS
CABERGOLINE 0.5 Arrow Generics Limited PA1130/014/001 Tablets - CABERGOLINE 29/04/2013
MILLIGRAM TABLETS
CALPOL SUGAR FREE G & A Licensing Limited PPA1447/075/001 Oral Suspension - PARACETAMOL 29/04/2013
INFANT
CARDURA G & A Licensing Limited PPA1447/035/001 Tablets - DOXAZOSIN MESILATE 29/04/2013
CARDURA XL G & A Licensing Limited PPA1447/035/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/04/2013
CARDURA XL G & A Licensing Limited PPA1447/035/003 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/04/2013
COSOPT G & A Licensing Limited PPA1447/040/001 Eye Drops Solution - DORZOLAMIDE 29/04/2013
HYDROCHLORIDE
- TIMOLOL MALEATE
COVERSYL ARGININE G & A Licensing Limited PPA1447/060/001 Film Coated Tablet - PERINDOPRIL ARGININE 29/04/2013
COVERSYL ARGININE G & A Licensing Limited PPA1447/060/002 Film Coated Tablet - PERINDOPRIL ARGININE 29/04/2013
COZAAR G & A Licensing Limited PPA1447/083/001 Film Coated Tablet - LOSARTAN POTASSIUM 29/04/2013
COZAAR COMP G & A Licensing Limited PPA1447/080/001 Film Coated Tablet - LOSARTAN POTASSIUM 29/04/2013
- HYDROCHLOROTHIAZIDE

CRESTOR G & A Licensing Limited PPA1447/089/001 Film Coated Tablet - ROSUVASTATIN 29/04/2013
CRESTOR G & A Licensing Limited PPA1447/089/002 Film Coated Tablet - ROSUVASTATIN 29/04/2013
CYSTOPURIN G & A Licensing Limited PPA1447/069/001 Granules for oral solution - POTASSIUM CITRATE 29/04/2013
MOVICOL G & A Licensing Limited PPA1447/088/001 Powder for Oral Solution - MACROGOL 3350 29/04/2013
- SODIUM BICARBONATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
NUROFEN G & A Licensing Limited PPA1447/051/001 Coated Tablets - IBUPROFEN 29/04/2013
NUROFEN PLUS TABLETS G & A Licensing Limited PPA1447/064/001 Tablets - IBUPROFEN 29/04/2013
- CODEINE PHOSPHATE
HEMIHYDRATE
NU-SEALS G & A Licensing Limited PPA1447/074/001 Tablets Gastro-Resistant - ACETYLSALICYLIC ACID 29/04/2013
RISPEVA Arrow Generics Limited PA1130/026/001 Film Coated Tablet - RISPERIDONE 29/04/2013
SENOKOT G & A Licensing Limited PPA1447/073/001 Tablets - SENNA 29/04/2013
SERETIDE 250 DISKUS G & A Licensing Limited PPA1447/087/002 Inhalation powder - SALMETEROL 29/04/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SYNDOL G & A Licensing Limited PPA1447/066/001 Tablets - PARACETAMOL 29/04/2013
- CODEINE PHOSPHATE
HEMIHYDRATE
- DOXYLAMINE
SUCCINATE
- CAFFEINE
VALSARTAN/HYDROCHLO Actavis Group PTC ehf PA1380/101/004 Film Coated Tablet - VALSARTAN 29/04/2013
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

VALSARTAN/HYDROCHLO Actavis Group PTC ehf PA1380/101/005 Film Coated Tablet - VALSARTAN 29/04/2013
ROTHIAZIDE - HYDROCHLOROTHIAZIDE

XYZAL G & A Licensing Limited PPA1447/086/001 Film Coated Tablet - LEVOCETIRIZINE 29/04/2013
DIHYDROCHLORIDE
ZANIDIP G & A Licensing Limited PPA1447/027/002 Film Coated Tablet - LERCANIDIPINE 29/04/2013
HYDROCHLORIDE
ZIMOVANE G & A Licensing Limited PPA1447/065/001 Film Coated Tablet - ZOPICLONE 29/04/2013
ABELCET Cephalon UK Limited PA0827/005/001 Suspension for Injection - AMPHOTERICIN B 26/04/2013
Finasteride Teva 5 mg Film- Teva Pharma B.V. PA0749/035/001 Film-coated tablet - Finasteride 26/04/2013
coated Tablets
FINOCAR 5MG FILM- Pliva Pharma Limited PA0585/027/001 Film Coated Tablet - FINASTERIDE 26/04/2013
COATED TABLETS

Human Medicines Withdrawn Products Page 175 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HAY-CROM Norton Waterford PA0436/018/004 Eye Drops Solution - CROMOGLICATE SODIUM 26/04/2013

LATANOPROST/TIMOLOL Teva Pharma B.V. PA0749/161/001 Eye Drops Solution - LANTANOPROST 26/04/2013
TEVA 50 MICROGRAMS/ML - TIMOLOL MALEATE
AND 5 MG

MELOXICAM Teva Pharma B.V. PA0749/014/001 Tablets - MELOXICAM 26/04/2013


MELOXICAM Teva Pharma B.V. PA0749/014/002 Tablets - MELOXICAM 26/04/2013
MOVOX Norton Waterford PA0436/036/001 Tablets - MELOXICAM 26/04/2013
MOVOX Norton Waterford PA0436/036/002 Tablets - MELOXICAM 26/04/2013
NASOBEC ALLERGY Norton Waterford PA0436/028/002 Nasal Spray Suspension - BECLOMETASONE 26/04/2013
DIPROPIONATE
POLYFAX OPHTHALMIC Pliva Pharma Limited PA0585/013/002 Unknown - POLYMYXIN B SULFATE 26/04/2013
OINTMENT, 10,000 IU - BACITRACIN ZINC
POLYMYXIN B
QUINAPRIL Teva Pharma B.V. PA0749/008/001 Film Coated Tablet - QUINAPRIL 26/04/2013
QUINAPRIL Teva Pharma B.V. PA0749/008/002 Film Coated Tablet - QUINAPRIL 26/04/2013
QUINAPRIL Teva Pharma B.V. PA0749/008/003 Film Coated Tablet - QUINAPRIL 26/04/2013
QUINAPRIL Teva Pharma B.V. PA0749/008/004 Film Coated Tablet - QUINAPRIL 26/04/2013
RIZATRIPTAN TEVA Teva Pharma B.V. PA0749/106/001 Orodispersible Tablet - RIZATRIPTAN 26/04/2013
SERTRALINE Teva Pharma B.V. PA0749/152/001 Film Coated Tablet - SERTRALINE 26/04/2013
HYDROCHLORIDE
SERTRALINE Teva Pharma B.V. PA0749/152/002 Film Coated Tablet - SERTRALINE 26/04/2013
HYDROCHLORIDE
SODIUM CROMOGLICATE Norton Healthcare Limited PA0282/059/002 Eye Drops Solution - CROMOGLICATE SODIUM 26/04/2013
T/A IVAX Pharmaceuticals
UK
VENIXAF XL Teva Pharma B.V. PA0749/122/001 Prolonged Release Capsules - VENLAFAXINE 26/04/2013
HYDROCHLORIDE
VENIXAF XL Teva Pharma B.V. PA0749/122/002 Prolonged Release Capsules - VENLAFAXINE 26/04/2013
HYDROCHLORIDE
IMMUCYST BCG Alliance Pharmaceuticals Ltd PA0943/018/001 Unknown - BCG BACTERIA 24/04/2013
IMMUNOTHERAPEUTIC (LYOPHILISED)
POSSIA AstraZeneca AB EU/1/10/656/001-006 Film Coated Tablet - TICAGRELOR 24/04/2013
CUENCA Laboratorios LICONSA, S.A. PA1239/009/001 Film Coated Tablet - VALSARTAN 23/04/2013

CUENCA Laboratorios LICONSA, S.A. PA1239/009/002 Film Coated Tablet - VALSARTAN 23/04/2013

CUENCA Laboratorios LICONSA, S.A. PA1239/009/003 Film Coated Tablet - VALSARTAN 23/04/2013

CUENCA Laboratorios LICONSA, S.A. PA1239/009/004 Film Coated Tablet - VALSARTAN 23/04/2013

SEROXAT LTT Pharma Limited PPA1562/030/002 Film Coated Tablet - PAROXETINE 22/04/2013
HYDROCHLORIDE
HEMIHYDRATE
LYRINEL XL Primecrown 2010 Ltd DPR1633/006/002 Tablet Prolonged Release - OXYBUTYNIN 19/04/2013
HYDROCHLORIDE
REACTINE McNeil Healthcare (Ireland) PA0823/041/001 Film Coated Tablet - CETIRIZINE 18/04/2013
Ltd DIHYDROCHLORIDE
REACTINE McNeil Healthcare (Ireland) PA0823/041/002 Oral Solution - CETIRIZINE 18/04/2013
Ltd DIHYDROCHLORIDE
AVELOX B & S Healthcare PPA1328/144/001 Film Coated Tablet - MOXIFLOXACIN 16/04/2013
CANDESARTAN CILEXETIL Ranbaxy Ireland Limited PA0408/075/001 Tablets - CANDESARTAN 16/04/2013
CILEXETIL
CANDESARTAN CILEXETIL Ranbaxy Ireland Limited PA0408/075/002 Tablets - CANDESARTAN 16/04/2013
CILEXETIL
CANDESARTAN CILEXETIL Ranbaxy Ireland Limited PA0408/075/003 Tablets - CANDESARTAN 16/04/2013
CILEXETIL
CANDESARTAN CILEXETIL Ranbaxy Ireland Limited PA0408/075/004 Tablets - CANDESARTAN 16/04/2013
CILEXETIL
SALDANAR Laboratorios LICONSA, S.A. PA1239/010/001 Film Coated Tablet - VALSARTAN 16/04/2013

SALDANAR Laboratorios LICONSA, S.A. PA1239/010/002 Film Coated Tablet - VALSARTAN 16/04/2013

SALDANAR Laboratorios LICONSA, S.A. PA1239/010/003 Film Coated Tablet - VALSARTAN 16/04/2013

SALDANAR Laboratorios LICONSA, S.A. PA1239/010/004 Film Coated Tablet - VALSARTAN 16/04/2013

PELZONT Merck Sharp and Dohme EU/1/08/460/1-11 Modified-release Tablets - NICOTINIC ACID 12/04/2013
Limited - LAROPIPRANT
TREDAPTIVE 1000 Merck Sharp and Dohme EU/1/08/459/1-11 Modified-release Tablets - NICOTINIC ACID 12/04/2013
Limited - LAROPIPRANT
SILDENAFIL ASPEN Aspen Pharma Trading PA1691/011/001 Film Coated Tablet - SILDENAFIL CITRATE 11/04/2013
Limited

Human Medicines Withdrawn Products Page 176 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SILDENAFIL ASPEN Aspen Pharma Trading PA1691/011/002 Film Coated Tablet - SILDENAFIL CITRATE 11/04/2013
Limited
SILDENAFIL ASPEN Aspen Pharma Trading PA1691/011/003 Film Coated Tablet - SILDENAFIL CITRATE 11/04/2013
Limited
GAMBROSOL TRIO 10 Fresenius Medical Care PA0953/008/001 Solution for peritoneal - GLUCOSE ANHYDROUS 10/04/2013
Deutschland GmbH dialysis - SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
GAMBROSOL TRIO 40 Fresenius Medical Care PA0953/008/002 Solution for peritoneal - GLUCOSE ANHYDROUS 10/04/2013
Deutschland GmbH dialysis - SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
REMINYL XL PROLONGED Clear Pharmacy DPR1596/024/001 Prolonged Release Capsules - GALANTAMINE 09/04/2013
RELEASE CAPSULES

REMINYL XL PROLONGED Clear Pharmacy DPR1596/024/002 Prolonged Release Capsules - GALANTAMINE 09/04/2013
RELEASE CAPSULES

REMINYL XL PROLONGED Clear Pharmacy DPR1596/024/003 Prolonged Release Capsules - GALANTAMINE 09/04/2013
RELEASE CAPSULES

TELFAST Clear Pharmacy DPR1596/006/001 Film Coated Tablet - FEXOFENADINE 09/04/2013


HYDROCHLORIDE
TELFAST Clear Pharmacy DPR1596/006/002 Film Coated Tablet - FEXOFENADINE 09/04/2013
HYDROCHLORIDE
GLIBENESE Pfizer Limited PA0019/002/002 Tablets - GLIPIZIDE 04/04/2013
RAMIPRIL NICHE Niche Generics Limited PA1063/025/001 Tablets - RAMIPRIL 03/04/2013
RAMIPRIL NICHE Niche Generics Limited PA1063/025/002 Tablets - RAMIPRIL 03/04/2013
RAMIPRIL NICHE Niche Generics Limited PA1063/025/003 Tablets - RAMIPRIL 03/04/2013
RAMIPRIL NICHE Niche Generics Limited PA1063/025/004 Tablets - RAMIPRIL 03/04/2013
EXMACHAN Creative Pharma Solutions PA1837/003/001 Film Coated Tablet - EXEMESTANE 01/04/2013
s.r.o.
ROHYPNOL Roche Products Limited PA0050/008/001 Tablets - FLUNITRAZEPAM 31/03/2013
TETABULIN Baxter Healthcare Limited PA0167/126/001 Solution for Injection - HUMAN PLASMA 31/03/2013
PROTEIN >90% GAMMA
GLOBULIN
- HUMAN TETANUS
IMMUNOGLOBULIN PH.
EUR.
ALPHAGAN IPS Healthcare Limited PPA1659/048/001 Eye Drops Solution - BRIMONIDINE TARTRATE 29/03/2013

AROMASIN IPS Healthcare Limited PPA1659/042/001 Coated Tablets - EXEMESTANE 29/03/2013


ARTHROTEC IPS Healthcare Limited PPA1659/040/001 Modified-release Tablets - DICLOFENAC 29/03/2013
- MISOPROSTOL
BRICANYL TURBOHALER IPS Healthcare Limited PPA1659/043/001 Inhalation powder - TERBUTALINE SULFATE 29/03/2013
COSOPT IPS Healthcare Limited PPA1659/049/001 Eye Drops Solution - DORZOLAMIDE 29/03/2013
HYDROCHLORIDE
- TIMOLOL MALEATE
DETRUSITOL SR IPS Healthcare Limited PPA1659/044/001 Prolonged Release Capsules - TOLTERODINE 29/03/2013
TARTRATE
ELANTAN IPS Healthcare Limited PPA1659/050/001 Tablets - ISOSORBIDE 29/03/2013
MONONITRATE
ELANTAN LA IPS Healthcare Limited PPA1659/050/002 Prolonged Release Capsules - ISOSORBIDE 29/03/2013
MONONITRATE
ELANTAN LA IPS Healthcare Limited PPA1659/050/003 Prolonged Release Capsules - ISOSORBIDE 29/03/2013
MONONITRATE
ARCOXIA IPS Healthcare Limited PPA1659/023/001 Film Coated Tablet - ETORICOXIB 28/03/2013
ARCOXIA IPS Healthcare Limited PPA1659/023/002 Film Coated Tablet - ETORICOXIB 28/03/2013
ARCOXIA IPS Healthcare Limited PPA1659/023/003 Film Coated Tablet - ETORICOXIB 28/03/2013
ARCOXIA IPS Healthcare Limited PPA1659/023/004 Film Coated Tablet - ETORICOXIB 28/03/2013
ARICEPT IPS Healthcare Limited PPA1659/001/001 Film Coated Tablet - DONEPEZIL 28/03/2013
HYDROCHLORIDE
ARICEPT IPS Healthcare Limited PPA1659/001/002 Film Coated Tablet - DONEPEZIL 28/03/2013
HYDROCHLORIDE
AUGMENTIN IPS Healthcare Limited PPA1659/015/001 Tablets - AMOXICILLIN 28/03/2013
TRIHYDRATE
- CLAVULANATE
POTASSIUM
CALCICHEW-D3 FORTE IPS Healthcare Limited PPA1659/024/001 Tablets Chewable - CALCIUM CARBONATE 28/03/2013
- COLECALCIFEROL

Human Medicines Withdrawn Products Page 177 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARDICOR IPS Healthcare Limited PPA1659/021/001 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDICOR IPS Healthcare Limited PPA1659/021/002 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDICOR IPS Healthcare Limited PPA1659/021/003 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDICOR IPS Healthcare Limited PPA1659/021/004 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDICOR IPS Healthcare Limited PPA1659/021/005 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDICOR IPS Healthcare Limited PPA1659/021/006 Film Coated Tablet - BISOPROLOL 28/03/2013
HEMIFUMARATE
CARDURA IPS Healthcare Limited PPA1659/012/003 Tablets - DOXAZOSIN MESILATE 28/03/2013
CARDURA IPS Healthcare Limited PPA1659/012/004 Tablets - DOXAZOSIN MESILATE 28/03/2013
CARDURA XL IPS Healthcare Limited PPA1659/012/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 28/03/2013
CARDURA XL IPS Healthcare Limited PPA1659/012/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 28/03/2013
CIPRAMIL IPS Healthcare Limited PPA1659/022/002 Oral Drops Solution - CITALOPRAM 28/03/2013
HYDROCHLORIDE
COVERSYL ARGININE IPS Healthcare Limited PPA1659/002/001 Film Coated Tablet - PERINDOPRIL ARGININE 28/03/2013
COVERSYL ARGININE IPS Healthcare Limited PPA1659/002/002 Film Coated Tablet - PERINDOPRIL ARGININE 28/03/2013
COZAAR IPS Healthcare Limited PPA1659/017/001 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
COZAAR IPS Healthcare Limited PPA1659/017/002 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
COZAAR IPS Healthcare Limited PPA1659/017/003 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
COZAAR COMP IPS Healthcare Limited PPA1659/016/001 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
- HYDROCHLOROTHIAZIDE

COZAAR COMP IPS Healthcare Limited PPA1659/016/002 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
- HYDROCHLOROTHIAZIDE

COZAAR COMP IPS Healthcare Limited PPA1659/016/003 Film Coated Tablet - LOSARTAN POTASSIUM 28/03/2013
- HYDROCHOLOTHIAZIDE
CRESTOR IPS Healthcare Limited PPA1659/003/001 Film Coated Tablet - ROSUVASTATIN 28/03/2013
CRESTOR IPS Healthcare Limited PPA1659/003/002 Film Coated Tablet - ROSUVASTATIN 28/03/2013
CRESTOR IPS Healthcare Limited PPA1659/003/003 Film Coated Tablet - ROSUVASTATIN 28/03/2013
CRESTOR IPS Healthcare Limited PPA1659/003/004 Film Coated Tablet - ROSUVASTATIN 28/03/2013
DIOVAN IPS Healthcare Limited PPA1659/030/001 Film Coated Tablet - VALSARTAN 28/03/2013
DIOVAN IPS Healthcare Limited PPA1659/030/002 Film Coated Tablet - VALSARTAN 28/03/2013
DIOVAN IPS Healthcare Limited PPA1659/030/003 Film Coated Tablet - VALSARTAN 28/03/2013
DOVOBET IPS Healthcare Limited PPA1659/018/001 Ointment - CALCIPOTRIOL 28/03/2013
- BETAMETHASONE
DIPROPIONATE
EFEXOR XL IPS Healthcare Limited PPA1659/004/001 Prolonged Release Capsules - VENLAFAXINE 28/03/2013
HYDROCHLORIDE
EFEXOR XL IPS Healthcare Limited PPA1659/004/002 Prolonged Release Capsules - VENLAFAXINE 28/03/2013
HYDROCHLORIDE
EZETROL IPS Healthcare Limited PPA1659/026/001 Tablets - EZETIMIBE 28/03/2013
FOSAMAX ONCE WEEKLY IPS Healthcare Limited PPA1659/025/001 Tablets - ALENDRONATE SODIUM 28/03/2013
TRIHYDRATE
FUCIBET LIPID IPS Healthcare Limited PPA1659/052/001 Cream - FUSIDIC ACID 28/03/2013
- BETAMETHASONE
INDERAL LA IPS Healthcare Limited PPA1659/053/001 Prolonged Release Capsules - PROPRANOLOL 28/03/2013
HYDROCHLORIDE
INEGY IPS Healthcare Limited PPA1659/027/001 Tablets - EZETIMIBE 28/03/2013
- SIMVASTATIN
INEGY IPS Healthcare Limited PPA1659/027/002 Tablets - EZETIMIBE 28/03/2013
- SIMVASTATIN
INEGY IPS Healthcare Limited PPA1659/027/003 Tablets - EZETIMIBE 28/03/2013
- SIMVASTATIN
Istin 10mg Tablets IPS Healthcare Limited PPA1659/014/002 Tablet - Amlodipine 28/03/2013
Istin 5mg Tablets IPS Healthcare Limited PPA1659/014/001 Tablet - Amlodipine 28/03/2013
LIPITOR IPS Healthcare Limited PPA1659/005/001 Film Coated Tablet - ATORVASTATIN CALCIUM 28/03/2013

LIPITOR IPS Healthcare Limited PPA1659/005/002 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/03/2013

LIPITOR IPS Healthcare Limited PPA1659/005/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/03/2013

LIPITOR IPS Healthcare Limited PPA1659/005/004 Film Coated Tablet - ATORVASTATIN-CALCIUM 28/03/2013

LOSEC MUPS IPS Healthcare Limited PPA1659/006/001 Tablets Gastro-Resistant - OMEPRAZOLE 28/03/2013
LOSEC MUPS IPS Healthcare Limited PPA1659/006/002 Tablets Gastro-Resistant - OMEPRAZOLE 28/03/2013
LOSEC MUPS IPS Healthcare Limited PPA1659/006/003 Tablets Gastro-Resistant - OMEPRAZOLE 28/03/2013
NEXIUM IPS Healthcare Limited PPA1659/013/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 28/03/2013
NEXIUM IPS Healthcare Limited PPA1659/013/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 28/03/2013
OMACOR IPS Healthcare Limited PPA1659/031/001 Capsules, Soft - OMEGA-3-ACID ETHYL 28/03/2013
ESTERS

Human Medicines Withdrawn Products Page 178 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ONE-ALPHA IPS Healthcare Limited PPA1659/054/001 Capsules, Soft - ALFACALCIDOL 28/03/2013
PARIET IPS Healthcare Limited PPA1659/007/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/03/2013
PARIET IPS Healthcare Limited PPA1659/007/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 28/03/2013
PROTIUM IPS Healthcare Limited PPA1659/008/001 Tablets Gastro-Resistant - PANTOPRAZOLE 28/03/2013
PROZAC IPS Healthcare Limited PPA1659/028/001 Capsules Hard - FLUOXETINE 28/03/2013
SALAZOPYRIN EN TABS IPS Healthcare Limited PPA1659/055/001 Tablets Gastro-Resistant - SULFASALAZINE 28/03/2013
SERETIDE DISKUS IPS Healthcare Limited PPA1659/009/002 Inhalation powder - SALMETEROL 28/03/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE DISKUS IPS Healthcare Limited PPA1659/009/003 Inhalation powder - SALMETEROL 28/03/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE DISKUS IPS Healthcare Limited PPA1659/009/004 Inhalation powder - SALMETEROL 28/03/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE EVOHALER IPS Healthcare Limited PPA1659/009/005 Pressurised Inhalation - SALMETEROL 28/03/2013
Suspension - FLUTICASONE
PROPIONATE
SERETIDE EVOHALER IPS Healthcare Limited PPA1659/009/006 Pressurised Inhalation - SALMETEROL 28/03/2013
Suspension - FLUTICASONE
PROPIONATE
SERETIDE EVOHALER IPS Healthcare Limited PPA1659/009/001 Pressurised Inhalation - SALMETEROL 28/03/2013
Suspension - FLUTICASONE
PROPIONATE
SINGULAIR IPS Healthcare Limited PPA1659/029/001 Film Coated Tablet - MONTELUKAST SODIUM 28/03/2013
SINGULAIR PAEDIATRIC IPS Healthcare Limited PPA1659/029/002 Tablets Chewable - MONTELUKAST SODIUM 28/03/2013
SINGULAIR PAEDIATRIC IPS Healthcare Limited PPA1659/029/003 Granules - MONTELUKAST SODIUM 28/03/2013
SPIRIVA IPS Healthcare Limited PPA1659/010/001 Inhalation powder, hard - TIOTROPIUM 28/03/2013
capsule - TIOTROPIUM BROMIDE
SYMBICORT TURBOHALE IPS Healthcare Limited PPA1659/032/001 Inhalation powder - BUDESONIDE 28/03/2013
- FORMOTEROL
FUMATRATE DIHYDRATE
SYMBICORT TURBOHALE IPS Healthcare Limited PPA1659/032/002 Inhalation powder - BUDESONIDE 28/03/2013
- FORMOTEROL
FUMATRATE DIHYDRATE
SYMBICORT TURBOHALE IPS Healthcare Limited PPA1659/032/003 Inhalation powder - BUDESONIDE 28/03/2013
- FORMOTEROL
FUMATRATE DIHYDRATE
TAMBOCOR IPS Healthcare Limited PPA1659/035/001 Tablets - FLECAINIDE ACETATE 28/03/2013
URSOFALK IPS Healthcare Limited PPA1659/047/001 Capsules Hard - URSODEOXYCHOLIC 28/03/2013
ACID
XYZAL IPS Healthcare Limited PPA1659/037/001 Film Coated Tablet - LEVOCETIRIZINE 28/03/2013
DIHYDROCHLORIDE
ZANIDIP IPS Healthcare Limited PPA1659/019/001 Film Coated Tablet - LERCANIDIPINE 28/03/2013
HYDROCHLORIDE
ZANIDIP IPS Healthcare Limited PPA1659/019/002 Film Coated Tablet - LERCANIDIPINE 28/03/2013
HYDROCHLORIDE
ZOCOR IPS Healthcare Limited PPA1659/020/001 Film Coated Tablet - SIMVASTATIN 28/03/2013
ZOCOR IPS Healthcare Limited PPA1659/020/002 Film Coated Tablet - SIMVASTATIN 28/03/2013
ZOCOR IPS Healthcare Limited PPA1659/020/003 Film Coated Tablet - SIMVASTATIN 28/03/2013
ZOCOR IPS Healthcare Limited PPA1659/020/004 Film Coated Tablet - SIMVASTATIN 28/03/2013
ZOMIG IPS Healthcare Limited PPA1659/038/001 Film Coated Tablet - ZOLMITRIPTAN 28/03/2013
ZOMIG RAPIMELT IPS Healthcare Limited PPA1659/038/002 Orodispersible Tablet - ZOLMITRIPTAN 28/03/2013
ZOTON FASTAB IPS Healthcare Limited PPA1659/011/001 Orodispersible Tablet - LANSOPRAZOLE 28/03/2013
ZOTON FASTTAB IPS Healthcare Limited PPA1659/011/002 Orodispersible Tablet - LANSOPRAZOLE 28/03/2013
IMDUR G & A Licensing Limited PPA1447/001/001 Tablet Prolonged Release - ISOSORBIDE 26/03/2013
MONONITRATE
KLACID LA G & A Licensing Limited PPA1447/034/003 Modified-release Tablets - CLARITHROMYCIN 26/03/2013
RAMIC Pinewood Laboratories Ltd, PA0281/119/001 Capsules Hard - RAMIPRIL 26/03/2013
EFAXIL Pinewood Laboratories Ltd, PA0281/136/003 Tablets - VENLAFAXINE 25/03/2013
HYDROCHLORIDE
EFAXIL XL Pinewood Laboratories Ltd, PA0281/136/001 Prolonged Release Capsules - VENLAFAXINE 25/03/2013
HYDROCHLORIDE
EFAXIL XL Pinewood Laboratories Ltd, PA0281/136/002 Prolonged Release Capsules - VENLAFAXINE 25/03/2013
HYDROCHLORIDE
VICKS ORIGINAL COUGH Procter & Gamble (Health & PA0441/007/002 Syrup - GUAIFENESIN 21/03/2013
SYRUP CHESTY Beauty Care) Limited - CETYLPYRIDINIUM
CHLORIDE
- SODIUM CITRATE
ESTELLE Clonmel Healthcare Ltd PA0126/170/001 Coated Tablets - ETHINYLESTRADIOL 20/03/2013
- GESTODENE
ANATERA Alcon Laboratories (UK) Ltd PA0290/078/001 Solution for Injection - FLUORESCEIN 19/03/2013

Human Medicines Withdrawn Products Page 179 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ASMABEC CLICKHALER 50 RPH Pharmaceuticals AB PA1638/010/001 Inhalation powder - BECLOMETASONE 19/03/2013
MICROGRAMS. DIPROPIONATE
INHALATION POWD
ATORVASTATIN Niche Generics Limited PA1063/042/002 Film Coated Tablet - ATORVASTATIN CALCIUM 13/03/2013

ATORVASTATIN 10 MG Niche Generics Limited PA1063/042/001 Film Coated Tablet - ATORVASTATIN CALCIUM 13/03/2013
FILM-COATED TABLETS
ATORVASTATIN 40 MG Niche Generics Limited PA1063/042/003 Film Coated Tablet - ATORVASTATIN CALCIUM 13/03/2013
FILM-COATED TABLETS
NAPAMIDE PR Niche Generics Limited PA1063/024/001 Tablet Prolonged Release - INDAPAMIDE 13/03/2013
VALSARTAN Niche Generics Limited PA1063/041/001 Film Coated Tablet - VALSARTAN 13/03/2013
VALSARTAN Niche Generics Limited PA1063/041/002 Film Coated Tablet - VALSARTAN 13/03/2013
VALSARTAN Niche Generics Limited PA1063/041/003 Film Coated Tablet - VALSARTAN 13/03/2013
PERSANTIN RETARD LTT Pharma Limited PPA1562/061/001 Modified-release capsule, - DIPYRIDAMOLE 11/03/2013
hard
PLAQUENIL LTT Pharma Limited PPA1562/042/001 Film Coated Tablet - HYDROXYCHLOROQUINE 11/03/2013
SULFATE

PREMPAK-C LTT Pharma Limited PPA1562/007/001 Tablets - ESTROGENS 11/03/2013


CONJUGATED
- NORGESTREL
PREMPAK-C LTT Pharma Limited PPA1562/007/002 Tablets - ESTROGENS 11/03/2013
CONJUGATED
- NORGESTREL
PROVIGIL LTT Pharma Limited PPA1562/041/001 Tablets - MODAFINIL 11/03/2013
OMACOR LTT Pharma Limited PPA1562/032/001 Capsules, Soft - OMEGA-3-ACID ETHYL 08/03/2013
ESTERS
OMNEXEL LTT Pharma Limited PPA1562/064/001 Tablet Prolonged Release - TAMSULOSIN 08/03/2013
HYDROCHLORIDE
PENTASA LTT Pharma Limited PPA1562/074/001 Tablet Prolonged Release - MESALAZINE 08/03/2013
SEROXAT LTT Pharma Limited PPA1562/030/001 Oral Suspension - PAROXETINE 08/03/2013
HYDROCHLORIDE
SPIRIVA LTT Pharma Limited PPA1562/066/002 Inhalation powder, hard - TIOTROPIUM 08/03/2013
capsule
EPANUTIN LTT Pharma Limited PPA1562/029/001 Capsules Hard - PHENYTOIN SODIUM 07/03/2013
HALF-INDERAL LA LTT Pharma Limited PPA1562/075/001 Prolonged Release Capsules - PROPRANOLOL 07/03/2013
HYDROCHLORIDE
INDERAL LA LTT Pharma Limited PPA1562/075/002 Prolonged Release Capsules - PROPRANOLOL 07/03/2013
HYDROCHLORIDE
LOSEC MUPS LTT Pharma Limited PPA1562/012/001 Tablets Gastro-Resistant - OMEPRAZOLE 07/03/2013
MAGNESIUM
LOSEC MUPS LTT Pharma Limited PPA1562/012/002 Tablets Gastro-Resistant - OMEPRAZOLE 07/03/2013
MAGNESIUM
MOLIPAXIN LTT Pharma Limited PPA1562/054/001 Capsules Hard - TRAZODONE 07/03/2013
HYDROCHLORIDE
MOLIPAXIN LTT Pharma Limited PPA1562/054/002 Capsules Hard - TRAZODONE 07/03/2013
HYDROCHLORIDE
MOLIPAXIN LTT Pharma Limited PPA1562/054/003 Film Coated Tablet - TRAZODONE 07/03/2013
HYDROCHLORIDE
SPIRIVA RESPIMAT LTT Pharma Limited PPA1562/066/001 Inhalation solution - TIOTROPIUM 07/03/2013
CELLUVISC LTT Pharma Limited PPA1562/028/001 Eye Drops Solution - CARMELLOSE SODIUM 06/03/2013
COZAAR LTT Pharma Limited PPA1562/076/001 Film Coated Tablet - LOSARTAN POTASSIUM 06/03/2013
COZAAR LTT Pharma Limited PPA1562/076/002 Film Coated Tablet - LOSARTAN POTASSIUM 06/03/2013
DILZEM XL LTT Pharma Limited PPA1562/026/001 Prolonged Release Capsules - DILTIAZEM 06/03/2013
HYDROCHLORIDE
TRUSOPT LTT Pharma Limited PPA1562/077/001 Eye Drops Solution - DORZOLAMIDE 06/03/2013
HYDROCHLORIDE
ACUPAN LTT Pharma Limited PPA1562/017/001 Film Coated Tablet - NEFOPAM 05/03/2013
HYDROCHLORIDE
ADALAT LA Profind Wholesale Ltd PPA1500/037/001 Tablet Prolonged Release - NIFEDIPINE 05/03/2013
ADALAT LA Profind Wholesale Ltd PPA1500/037/002 Tablet Prolonged Release - NIFEDIPINE 05/03/2013
ADALAT LA Profind Wholesale Ltd PPA1500/037/003 Tablet Prolonged Release - NIFEDIPINE 05/03/2013
ARCOXIA Profind Wholesale Ltd PPA1500/070/001 Film Coated Tablet - ETORICOXIB 05/03/2013
ARIMIDEX Profind Wholesale Ltd PPA1500/069/001 Film Coated Tablet - ANASTROZOLE 05/03/2013
ARYTHMOL LTT Pharma Limited PPA1562/044/001 Film Coated Tablet - PROPAFENONE 05/03/2013
HYDROCHLORIDE
AUGMENTIN LTT Pharma Limited PPA1562/009/001 Tablets - AMOXICILLIN 05/03/2013
TRIHYDRATE
- CLAVULANATE
POTASSIUM

Human Medicines Withdrawn Products Page 180 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AUGMENTIN LTT Pharma Limited PPA1562/009/002 Film Coated Tablet - AMOXICILLIN 05/03/2013
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

AVELOX LTT Pharma Limited PPA1562/087/001 Film Coated Tablet - MOXIFLOXACIN 05/03/2013
AVODART Profind Wholesale Ltd PPA1500/048/001 Capsules, Soft - DUTASTERIDE 05/03/2013
BRICANYL TURBOHALER LTT Pharma Limited PPA1562/069/001 Inhalation powder - TERBUTALINE SULFATE 05/03/2013
BRICANYL TURBOHALER Profind Wholesale Ltd PPA1500/060/001 Inhalation powder - TERBUTALINE SULFATE 05/03/2013
CARDICOR LTT Pharma Limited PPA1562/024/001 Film Coated Tablet - BISOPROLOL 05/03/2013
HEMIFUMARATE
CARDICOR LTT Pharma Limited PPA1562/024/002 Film Coated Tablet - BISOPROLOL 05/03/2013
HEMIFUMARATE
CARDURA XL LTT Pharma Limited PPA1562/003/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 05/03/2013
CASODEX LTT Pharma Limited PPA1562/025/001 Film Coated Tablet - BICALUTAMIDE 05/03/2013
CO-DIOVAN Profind Wholesale Ltd PPA1500/059/001 Film Coated Tablet - VALSARTAN 05/03/2013
- HYDROCHLOROTHIAZIDE

CO-DIOVAN Profind Wholesale Ltd PPA1500/059/002 Film Coated Tablet - VALSARTAN 05/03/2013
- HYDROCHLOROTHIAZIDE

CO-DIOVAN Profind Wholesale Ltd PPA1500/059/003 Film Coated Tablet - VALSARTAN 05/03/2013
- HYDROCHLOROTHIAZIDE

COZAAR Profind Wholesale Ltd PPA1500/020/001 Film Coated Tablet - LOSARTAN POTASSIUM 05/03/2013
COZAAR Profind Wholesale Ltd PPA1500/020/002 Film Coated Tablet - LOSARTAN POTASSIUM 05/03/2013
CRESTOR Profind Wholesale Ltd PPA1500/002/001 Film Coated Tablet - ROSUVASTATIN 05/03/2013
CRESTOR Profind Wholesale Ltd PPA1500/002/002 Film Coated Tablet - ROSUVASTATIN 05/03/2013
DOVOBET Profind Wholesale Ltd PPA1500/062/001 Ointment - CALCIPOTRIOL 05/03/2013
- BETAMETHASONE
DIPROPIONATE
ISTIN Profind Wholesale Ltd PPA1500/034/001 Tablets - AMLODIPINE BESYLATE 05/03/2013
ISTIN Profind Wholesale Ltd PPA1500/034/002 Tablets - AMLODIPINE BESYLATE 05/03/2013
KLACID LA Profind Wholesale Ltd PPA1500/025/001 Modified-release Tablets - CLARITHROMYCIN 05/03/2013
LAMICTAL Profind Wholesale Ltd PPA1500/046/002 Dispersable Tablet - LAMOTRIGINE 05/03/2013
LAMICTAL Profind Wholesale Ltd PPA1500/046/003 Dispersable Tablet - LAMOTRIGINE 05/03/2013
LAMICTAL Profind Wholesale Ltd PPA1500/046/004 Dispersable Tablet - LAMOTRIGINE 05/03/2013
LEXAPRO Profind Wholesale Ltd PPA1500/032/002 Film Coated Tablet - ESCITALOPRAM 05/03/2013
LEXAPRO Profind Wholesale Ltd PPA1500/032/003 Film Coated Tablet - ESCITALOPRAM 05/03/2013
LIPITOR Profind Wholesale Ltd PPA1500/003/001 Film Coated Tablet - ATORVASTATIN-CALCIUM 05/03/2013

LIPITOR Profind Wholesale Ltd PPA1500/003/002 Film Coated Tablet - ATORVASTATIN-CALCIUM 05/03/2013

LIPITOR Profind Wholesale Ltd PPA1500/003/004 Film Coated Tablet - ATORVASTATIN 05/03/2013
LIPOSTAT Profind Wholesale Ltd PPA1500/031/002 Tablets - PRAVASTATIN SODIUM 05/03/2013
LIPOSTAT Profind Wholesale Ltd PPA1500/031/003 Tablets - PRAVASTATIN SODIUM 05/03/2013
LOSEC MUPS Profind Wholesale Ltd PPA1500/013/002 Tablets Gastro-Resistant - OMEPRAZOLE 05/03/2013
LUSTRAL Profind Wholesale Ltd PPA1500/035/001 Film Coated Tablet - SERTRALINE 05/03/2013
HYDROCHLORIDE
LUSTRAL Profind Wholesale Ltd PPA1500/035/002 Film Coated Tablet - SERTRALINE 05/03/2013
HYDROCHLORIDE
MANNITOL Baxter Healthcare Limited PA0167/037/016 Solution for Infusion - MANNITOL 05/03/2013
NEXIUM Profind Wholesale Ltd PPA1500/008/001 Tablets - ESOMEPRAZOLE 05/03/2013
NEXIUM Profind Wholesale Ltd PPA1500/008/002 Tablets - ESOMEPRAZOLE 05/03/2013
OMACOR Profind Wholesale Ltd PPA1500/064/001 Capsules, Soft - OMEGA-3-ACID ETHYL 05/03/2013
ESTERS
OMESAR Profind Wholesale Ltd PPA1500/052/003 Film Coated Tablet - OLMESARTAN 05/03/2013
MEDOXOMIL
OMNEXEL Profind Wholesale Ltd PPA1500/080/001 Tablet Prolonged Release - TAMSULOSIN 05/03/2013
HYDROCHLORIDE
PARIET Profind Wholesale Ltd PPA1500/019/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 05/03/2013
PROTIUM Profind Wholesale Ltd PPA1500/007/001 Tablets Gastro-Resistant 05/03/2013
PROTIUM Profind Wholesale Ltd PPA1500/007/002 Tablets Gastro-Resistant 05/03/2013
PULMICORT TURBOHALER Profind Wholesale Ltd PPA1500/042/001 Inhalation powder - BUDESONIDE 05/03/2013

RIMACTAZID 150/75 Sandoz GmbH PA0111/003/003 Film Coated Tablet - RIFAMPICIN 05/03/2013
- ISONIAZID
RIMSTAR Sandoz GmbH PA0111/007/001 Film Coated Tablet - RIFAMPICIN 05/03/2013
- ISONIAZID
- PYRAZINAMIDE
- ETHAMBUTOL
DIHYDROCHLORIDE

Human Medicines Withdrawn Products Page 181 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SERETIDE 250 DISKUS Profind Wholesale Ltd PPA1500/009/003 Inhalation powder - SALMETEROL 05/03/2013
- FLUTICASONE
PROPIONATE
SEROQUEL Profind Wholesale Ltd PPA1500/068/001 Film Coated Tablet - QUETIAPINE FUMARATE 05/03/2013
SEROQUEL Profind Wholesale Ltd PPA1500/068/002 Film Coated Tablet - QUETIAPINE 05/03/2013
SINGULAIR Profind Wholesale Ltd PPA1500/083/001 Film Coated Tablet - MONTELUKAST SODIUM 05/03/2013
SPIRIVA RESPIMAT Profind Wholesale Ltd PPA1500/043/002 Inhalation powder - TIOTROPIUM 05/03/2013
SYMBICORT TURBOHALE Profind Wholesale Ltd PPA1500/065/002 Inhalation powder - BUDESONIDE 05/03/2013
- FORMOTEROL
FUMATRATE DIHYDRATE
TYLEX LTT Pharma Limited PPA1562/088/001 Capsules Hard - CODEINE PHOSPHATE 05/03/2013
HEMIHYDRATE
- PARACETAMOL
URSOFALK Profind Wholesale Ltd PPA1500/085/001 Capsules Hard - URSODEOXYCHOLIC 05/03/2013
ACID
VESITIRIM LTT Pharma Limited PPA1562/086/002 Film Coated Tablet - SOLIFENACIN 05/03/2013
SUCCINATE
ZANIDIP Profind Wholesale Ltd PPA1500/004/001 Film Coated Tablet - LERCANIDIPINE 05/03/2013
ZANIDIP Profind Wholesale Ltd PPA1500/004/002 Film Coated Tablet - LERCANIDIPINE 05/03/2013
HYDROCHLORIDE
ZOMIG RAPIMELT Profind Wholesale Ltd PPA1500/014/002 Orodispersible Tablet 05/03/2013
ZOTON FASTAB Profind Wholesale Ltd PPA1500/005/001 Orodispersible Tablet - LANSOPRAZOLE HSE 05/03/2013
ZOTON FASTAB Profind Wholesale Ltd PPA1500/005/002 Orodispersible Tablet - LANSOPRAZOLE HSE 05/03/2013
TESLASCAN GE Healthcare AS EU/1/97/040/001 Solution for Infusion - TRISODIUM 04/03/2013
MANGAFODIPIR
TESLASCAN GE Healthcare AS EU/1/97/040/002 Solution for Infusion - TRISODIUM 04/03/2013
MANGAFODIPIR
VIRACEPT Roche Registration Limited EU/1/97/054/001 Oral Powder - MESYLATE NELFINAVIR 04/03/2013
VIRACEPT Roche Registration Limited EU/1/97/054/002 Tablets - MESYLATE NELFINAVIR 04/03/2013
VIRACEPT Roche Registration Limited EU/1/97/054/003 Tablets - MESYLATE NELFINAVIR 04/03/2013
VIRACEPT Roche Registration Limited EU/1/97/054/004 Coated Tablets - MESYLATE NELFINAVIR 04/03/2013
VIRACEPT Roche Registration Limited EU/1/97/054/005 Tablets - MESYLATE NELFINAVIR 04/03/2013
KLACID FORTE G & A Licensing Limited PPA1447/034/001 Film Coated Tablet - CLARITHROMYCIN 01/03/2013
NASONEX G & A Licensing Limited PPA1447/042/001 Nasal Spray Suspension - MOMETASONE FUROATE 01/03/2013

ONE-ALPHA G & A Licensing Limited PPA1447/036/001 Capsule - ALFACALCIDOL 01/03/2013


ONE-ALPHA G & A Licensing Limited PPA1447/036/002 Capsule - ALFACALCIDOL 01/03/2013
SERETIDE 100 DISKUS G & A Licensing Limited PPA1447/087/001 Inhalation powder - SALMETEROL 01/03/2013
XINAFOATE
- FLUTICASONE
PROPIONATE
TELFAST G & A Licensing Limited PPA1447/054/001 Film Coated Tablet - FEXOFENADINE 01/03/2013
HYDROCHLORIDE
TELFAST G & A Licensing Limited PPA1447/054/002 Film Coated Tablet - FEXOFENADINE 01/03/2013
HYDROCHLORIDE
ACCUPRO G & A Licensing Limited PPA1447/003/001 Film Coated Tablet - QUINAPRIL 27/02/2013
HYDROCHLORIDE
ACCUPRO G & A Licensing Limited PPA1447/003/002 Film Coated Tablet - QUINAPRIL 27/02/2013
HYDROCHLORIDE
ADALAT RETARD G & A Licensing Limited PPA1447/058/001 Tablet Prolonged Release - NIFEDIPINE 27/02/2013
ANTHISAN G & A Licensing Limited PPA1447/070/001 Cream - MEPYRAMINE MALEATE 27/02/2013
BETNOVATE SCALP G & A Licensing Limited PPA1447/059/001 Cutaneous Solution - BETAMETHASONE 27/02/2013
APPLICATION VALERATE
BETOPTIC G & A Licensing Limited PPA1447/039/001 Eye Drops Solution - BETAXOLOL 27/02/2013
HYDROCHLORIDE
CANESTEN COMBI G & A Licensing Limited PPA1447/082/001 Cream + pessary - CLOTRIMAZOLE 27/02/2013
PESSARY & CREAM - CLOTRIMAZOLE
CATAPRES TABLETS 300 Boehringer Ingelheim Limited PA0007/014/002 Tablets - CLONIDINE 27/02/2013
MICROGRAMS. HYDROCHLORIDE
CORDARONE X G & A Licensing Limited PPA1447/052/001 Tablets - AMIODARONE 27/02/2013
HYDROCHLORIDE
DUOVENT UNIT DOSE Boehringer Ingelheim Limited PA0007/034/004 Nebuliser Solution - IPRATROPIUM BROMIDE 27/02/2013
VIALS - FENOTEROL
HYDROBROMIDE
DONA B & S Healthcare PPA1328/133/001 Powder for Oral Solution - GLUCOSAMINE SULFATE 26/02/2013
- SODIUM CHLORIDE

SILDENAFIL ARROW Arrow Generics Limited PA1130/032/001 Film Coated Tablet - SILDENAFIL 22/02/2013
SILDENAFIL ARROW Arrow Generics Limited PA1130/032/002 Film Coated Tablet - SILDENAFIL 22/02/2013
SILDENAFIL ARROW Arrow Generics Limited PA1130/032/003 Film Coated Tablet - SILDENAFIL 22/02/2013

Human Medicines Withdrawn Products Page 182 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INTRAFUSIN 22 Fresenius Kabi Limited PA0566/007/001 Solution for Infusion - ISOLEUCINE 15/02/2013
- LEUCINE
- L-LYSINE-L-GLUTAMATE
DIHYDRATE
- L-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- ACETYLCYSTEINE
- AMINOACETIC ACID
- ALANINE
- GLUTAMIC ACID
- PROLINE
- SERINE
- N-ACETYLTYROSINE PH.
EUR.
VENTOLIN DISKUS LTT Pharma Limited PPA1562/002/002 Inhalation powder - SALBUTAMOL SULFATE 12/02/2013
ZYCRON MR Clonmel Healthcare Ltd PA0126/111/002 Modified-release Tablets - GLICLAZIDE 12/02/2013
ONDATAB Arrow Generics Limited PA1130/027/001 Film Coated Tablet - ONDANSETRON 11/02/2013
ONDATAB Arrow Generics Limited PA1130/027/002 Film Coated Tablet - ONDANSETRON 11/02/2013
LIPITOR LTT Pharma Limited PPA1562/010/001 Film Coated Tablet - ATORVASTATIN 08/02/2013
DIAZEPAM Pinewood Laboratories Ltd, PA0281/007/002 Tablets - DIAZEPAM 06/02/2013
NITRAZEPAM Pinewood Laboratories Ltd, PA0281/008/001 Tablets - NITRAZEPAM 06/02/2013
TIMOPTOL LTT Pharma Limited PPA1562/052/001 Eye Drops Solution - TIMOLOL MALEATE 06/02/2013
TIMOPTOL LTT Pharma Limited PPA1562/052/002 Eye Drops Solution - TIMOLOL MALEATE 06/02/2013
ALIPZA Kowa Pharmaceutical PA1532/002/001 Film Coated Tablet - PITAVASTATIN CALCIUM 04/02/2013
Europe Co. Ltd
ALIPZA Kowa Pharmaceutical PA1532/002/002 Film Coated Tablet - PITAVASTATIN CALCIUM 04/02/2013
Europe Co. Ltd
ALIPZA 1MG FILM-COATED Kowa Pharmaceutical PA1532/002/003 Film Coated Tablet - PITAVASTATIN CALCIUM 04/02/2013
TABLETS Europe Co. Ltd
LEXAPRO LTT Pharma Limited PPA1562/070/001 Film Coated Tablet - ESCITALOPRAM 04/02/2013
OXALATE
LEXAPRO LTT Pharma Limited PPA1562/070/002 Film Coated Tablet - ESCITALOPRAM 04/02/2013
OXALATE
LEXAPRO LTT Pharma Limited PPA1562/070/003 Film Coated Tablet - ESCITALOPRAM 04/02/2013
OXALATE
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/006 Orodispersible Tablet - OLANZAPINE 31/01/2013
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/007 Orodispersible Tablet - OLANZAPINE 31/01/2013
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/008 Orodispersible Tablet - OLANZAPINE 31/01/2013
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/009 Orodispersible Tablet - OLANZAPINE 31/01/2013
ARTHROTEC LTT Pharma Limited PPA1562/035/001 Modified-release Tablets - DICLOFENAC SODIUM 30/01/2013
- MISOPROSTOL
ARTHROTEC LTT Pharma Limited PPA1562/035/002 Modified-release Tablets - DICLOFENAC SODIUM 30/01/2013
- MISOPROSTOL
NASACORT IMED Healthcare Ltd. DPR1463/003/001 Nasal Spray Suspension - TRIAMCINOLONE 30/01/2013
ACETONIDE
NASONEX IMED Healthcare Ltd. DPR1463/008/001 Nasal Spray Suspension - MOMETASONE FUROATE 30/01/2013

ACTONEL ONCE A WEEK Profind Wholesale Ltd PPA1500/015/001 Film Coated Tablet - RISEDRONATE SODIUM 29/01/2013
ARCOXIA Profind Wholesale Ltd PPA1500/070/002 Film Coated Tablet - ETORICOXIB 29/01/2013
CARDURA XL Profind Wholesale Ltd PPA1500/001/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/01/2013
CARDURA XL Profind Wholesale Ltd PPA1500/001/002 Tablet Prolonged Release - DOXAZOSIN MESILATE 29/01/2013
COVERSYL ARGININE Profind Wholesale Ltd PPA1500/011/001 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2013
COVERSYL ARGININE Profind Wholesale Ltd PPA1500/011/002 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2013
COVERSYL ARGININE Profind Wholesale Ltd PPA1500/012/001 Film Coated Tablet - PERINDOPRIL ARGININE 29/01/2013
PLUS 5MG/1.25MG FILM- - INDAPAMIDE
COATED TABL
CREON Profind Wholesale Ltd PPA1500/081/001 Capsules Gastro-Resistant - PANCREATIN 29/01/2013
DETRUSITOL SR Profind Wholesale Ltd PPA1500/021/001 Prolonged Release Capsules - TOLTERODINE L- 29/01/2013
TARTRATE
- TOLTERODINE
DIOVAN Profind Wholesale Ltd PPA1500/067/001 Film Coated Tablet - VALSARTAN 29/01/2013
IMURAN Profind Wholesale Ltd PPA1500/053/001 Film Coated Tablet - AZATHIOPRINE 29/01/2013
IXPRIM Profind Wholesale Ltd PPA1500/086/001 Film Coated Tablet - TRAMADOL 29/01/2013
HYDROCHLORIDE
- PARACETAMOL
LEXAPRO Profind Wholesale Ltd PPA1500/032/001 Film Coated Tablet - ESCITALOPRAM 29/01/2013
LIPITOR Profind Wholesale Ltd PPA1500/003/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 29/01/2013

LOSEC MUPS Profind Wholesale Ltd PPA1500/013/003 Tablets Gastro-Resistant - OMEPRAZOLE 29/01/2013

Human Medicines Withdrawn Products Page 183 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MOVICOL Profind Wholesale Ltd PPA1500/026/001 Powder for Oral Solution - 29/01/2013
MACROGOL/POLYETHYLE
NE GLYCOL 3350
- SODIUM CHLORIDE
OMESAR Profind Wholesale Ltd PPA1500/052/001 Film Coated Tablet - OLMESARTAN 29/01/2013
MEDOXOMIL
PARIET Profind Wholesale Ltd PPA1500/019/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 29/01/2013
SERETIDE 500 DISKUS Profind Wholesale Ltd PPA1500/009/001 Inhalation powder - FLUTICASONE 29/01/2013
PROPIONATE
SEROXAT Profind Wholesale Ltd PPA1500/022/001 Tablets - PAROXETINE 29/01/2013
HYDROCHLORIDE
SPIRIVA Profind Wholesale Ltd PPA1500/043/001 Inhalation powder, hard - TIOTROPIUM 29/01/2013
capsule - TIOTROPIUM BROMIDE
VENTOLIN EVOHALER Profind Wholesale Ltd PPA1500/010/001 Pressurised Inhalation - SALBUTAMOL 29/01/2013
Suspension
VESITIRIM Profind Wholesale Ltd PPA1500/082/001 Film Coated Tablet - SOLIFENACIN 29/01/2013
SUCCINATE
VESITIRIM Profind Wholesale Ltd PPA1500/082/002 Film Coated Tablet - SOLIFENACIN 29/01/2013
SUCCINATE
XATRAL Profind Wholesale Ltd PPA1500/024/001 Tablet Prolonged Release - ALFUZOSIN 29/01/2013
HYDROCHLORIDE
XYZAL Profind Wholesale Ltd PPA1500/055/001 Film Coated Tablet - LEVOCETIRIZINE 29/01/2013
DIHYDROCHLORIDE
ZANTAC Profind Wholesale Ltd PPA1500/023/001 Film Coated Tablet - RANITIDINE 29/01/2013
HYDROCHLORIDE
ZIMOVANE Profind Wholesale Ltd PPA1500/006/001 Film Coated Tablet - ZOPICLONE 29/01/2013
ZISPIN SOLTAB Profind Wholesale Ltd PPA1500/066/001 Orodispersible Tablet - MIRTAZAPINE 29/01/2013
ZISPIN SOLTAB Profind Wholesale Ltd PPA1500/066/002 Orodispersible Tablet - MIRTAZAPINE 29/01/2013
ZYDOL XL Napp Pharmaceuticals PA0913/021/001 Tablet Prolonged Release - TRAMADOL 28/01/2013
Limited HYDROCHLORIDE
ZYDOL XL Napp Pharmaceuticals PA0913/021/002 Tablet Prolonged Release - TRAMADOL 28/01/2013
Limited HYDROCHLORIDE
ZYDOL XL Napp Pharmaceuticals PA0913/021/003 Tablet Prolonged Release - TRAMADOL 28/01/2013
Limited HYDROCHLORIDE
ZYDOL XL Napp Pharmaceuticals PA0913/021/004 Tablet Prolonged Release - TRAMADOL 28/01/2013
Limited HYDROCHLORIDE
SIMVASTATIN 10MG FILM- Norton Waterford PA0436/043/001 Film Coated Tablet - SIMVASTATIN 25/01/2013
COATED TABLETS
SIMVASTATIN 20MG FILM- Norton Waterford PA0436/043/002 Film Coated Tablet - SIMVASTATIN 25/01/2013
COATED TABLET
SIMVASTATIN 40MG FILM- Norton Waterford PA0436/043/003 Film Coated Tablet - SIMVASTATIN 25/01/2013
COATED TABLET
MYZAAR McDermott Laboratories Ltd PA0577/087/001 Film Coated Tablet - LOSARTAN POTASSIUM 24/01/2013
t/a Gerard Laboratories
ZOCOR Merck Sharp & Dohme PA1286/022/005 Film Coated Tablet - SIMVASTATIN 24/01/2013
Ireland (Human Health)
Limited
SERTRANICHE Niche Generics Limited PA1063/019/001 Film Coated Tablet - SERTRALINE 22/01/2013
HYDROCHLORIDE
SERTRANICHE Niche Generics Limited PA1063/019/002 Film Coated Tablet - SERTRALINE 22/01/2013
HYDROCHLORIDE
LIDOCAINE 5% Grünenthal Ltd PA1189/010/001 Medicated Plaster - LIDOCAINE 20/01/2013
MEDICATED PLASTER
BYZESTRA Ergha Healthcare Ltd PA0966/007/001 Tablets - LISINOPRIL DIHYDRATE 17/01/2013
BYZESTRA Ergha Healthcare Ltd PA0966/007/002 Tablets - LISINOPRIL DIHYDRATE 17/01/2013
BYZESTRA Ergha Healthcare Ltd PA0966/007/003 Tablets - LISINOPRIL DIHYDRATE 17/01/2013
BYZESTRA Ergha Healthcare Ltd PA0966/007/004 Tablets - LISINOPRIL DIHYDRATE 17/01/2013
TERAZOSIN Accord Healthcare Limited PA1390/012/001 Tablets - TERAZOSIN 16/01/2013
ZESTRIL LTT Pharma Limited PPA1562/013/001 Tablets - LISINOPRIL 16/01/2013
ZESTRIL LTT Pharma Limited PPA1562/013/003 Tablets - LISINOPRIL 16/01/2013
KLACID LA Clear Pharmacy PPA1596/030/001 Modified-release Tablets - CLARITHROMYCIN 15/01/2013
CLONAMP Clonmel Healthcare Ltd PA0126/015/001 Capsules Hard - AMPICILLIN TRIHYDRATE 14/01/2013

METRONIDE Clonmel Healthcare Ltd PA0126/056/001 Tablets - METRONIDAZOLE 14/01/2013


CETIRIZINE AUROBINDO Aurobindo Pharma (Malta) PA1445/004/001 Film Coated Tablet - CETIRIZINE 08/01/2013
Limited DIHYDROCHLORIDE
GOPTEN B & S Healthcare PPA1328/094/001 Capsules Hard - TRANDOLAPRIL 08/01/2013
KLACID B & S Healthcare PPA1328/014/002 Tablets - CLARITHROMYCIN 08/01/2013
LEXAPRO B & S Healthcare PPA1328/084/004 Film Coated Tablet - ESCITALOPRAM 08/01/2013
OMACOR B & S Healthcare PPA1328/141/001 Capsules, Soft - OMEGA-3-ACID ETHYL 08/01/2013
ESTERS
REDUCTIL B & S Healthcare PPA1328/099/001 Capsule - SIBUTRAMINE 08/01/2013
HYDROCHLORIDE
MONOHYDRATE

Human Medicines Withdrawn Products Page 184 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
REDUCTIL B & S Healthcare PPA1328/099/002 Capsule - SIBUTRAMINE 08/01/2013
HYDROCHLORIDE
MONOHYDRATE
EXEMESTANE HELM Helm AG PA1466/003/001 Coated Tablets - EXEMESTANE 04/01/2013
NUELIN SA Meda Health Sales Ireland PA1332/020/001 Tablet Prolonged Release - THEOPHYLLINE 01/01/2013
Limited
NUELIN SA Meda Health Sales Ireland PA1332/020/002 Tablet Prolonged Release - THEOPHYLLINE 01/01/2013
Limited
IMIPENEM/CILASTATIN MEDREG s.r.o. PA1453/001/001 Powder for solution for - IMIPENEM ANHYDROUS 31/12/2012
MEDREG infusion - CILASTATIN
NICOPASS FRESH MINT Pierre Fabre Medicament PA0329/010/002 Lozenges - NICOTINE RESINATE 31/12/2012
NICOPASS FRESH MINT Pierre Fabre Medicament PA0329/010/004 Lozenges - NICOTINE 31/12/2012
NICOPASS LIQUORICE Pierre Fabre Medicament PA0329/010/003 Lozenges - NICOTINE 31/12/2012
MINT
NICOPASS LIQUORICE Pierre Fabre Medicament PA0329/010/001 Lozenges - NICOTINE RESINATE 31/12/2012
MINT
SILDENAFIL ADAIR Galenicum Health, S.L. PA1663/001/001 Film Coated Tablet - SILDENAFIL CITRATE 31/12/2012
SILDENAFIL ADAIR Galenicum Health, S.L. PA1663/001/002 Film Coated Tablet - SILDENAFIL CITRATE 31/12/2012
SILDENAFIL ADAIR Galenicum Health, S.L. PA1663/001/003 Film Coated Tablet - SILDENAFIL CITRATE 31/12/2012
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/003 Tablet Prolonged Release - GLYCERYL TRINITRATE 31/12/2012
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/005 Tablet Prolonged Release - GLYCERYL TRINITRATE 31/12/2012
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/006 Tablet Prolonged Release - GLYCERYL TRINITRATE 31/12/2012
ASASANTIN RETARD PCO Manufacturing PPA0465/214/001 Modified-release capsule, - DIPYRIDAMOLE 28/12/2012
hard - ACETYLSALICYLIC ACID
CARDICOR PCO Manufacturing PPA0465/204/003 Film Coated Tablet - BISOPROLOL 28/12/2012
HEMIFUMARATE
CARDICOR PCO Manufacturing PPA0465/204/004 Film Coated Tablet - BISOPROLOL 28/12/2012
HEMIFUMARATE
CARDICOR PCO Manufacturing PPA0465/204/005 Film Coated Tablet - BISOPROLOL 28/12/2012
HEMIFUMARATE
CARDICOR PCO Manufacturing PPA0465/204/006 Film Coated Tablet - BISOPROLOL 28/12/2012
HEMIFUMARATE
CRESTOR PCO Manufacturing PPA0465/140/003 Film Coated Tablet - ROSUVASTATIN (AS 28/12/2012
CALCIUM)
CRESTOR PCO Manufacturing PPA0465/140/004 Film Coated Tablet - ROSUVASTATIN 28/12/2012
DIFLUCAN PCO Manufacturing PPA0465/093/001 Capsule - FLUCONAZOLE 28/12/2012
DIFLUCAN PCO Manufacturing PPA0465/093/002 Capsule - FLUCONAZOLE 28/12/2012
DONA PCO Manufacturing PPA0465/191/001 Powder for Oral Solution - GLUCOSAMINE SULFATE 28/12/2012
- SODIUM CHLORIDE

LIPANTIL PCO Manufacturing PPA0465/229/001 Capsules Hard - FENOFIBRATE 28/12/2012


LOSEC MUPS 40 MG PCO Manufacturing PPA0465/039/006A Tablets Gastro-Resistant - OMEPRAZOLE 28/12/2012
GASTRO-RESISTANT, MAGNESIUM
FILM-COATED TABLETS
MACRODANTIN PCO Manufacturing PPA0465/242/001 Capsules Hard - NITROFURANTOIN 28/12/2012
MAXOLON PCO Manufacturing PPA0465/202/001 Tablets - METOCLOPRAMIDE 28/12/2012
HYDROCHLORIDE
NEBILET PCO Manufacturing PPA0465/239/001 Tablets - NEBIVOLOL 28/12/2012
HYDROCHLORIDE
OMACOR PCO Manufacturing PPA0465/248/001 Capsules, Soft - OMEGA-3-ACID ETHYL 28/12/2012
ESTERS
SCHERIPROCT PCO Manufacturing PPA0465/240/001 Rectal Ointment - PREDNISOLONE 28/12/2012
CAPROATE
- CINCHOCAINE
HYDROCHLORIDE
TEGRETOL PCO Manufacturing PPA0465/201/001 Tablets - CARBAMAZEPINE 28/12/2012
TEGRETOL RETARD PCO Manufacturing PPA0465/201/002 Tablets Gastro-Resistant - CARBAMAZEPINE 28/12/2012
TEGRETOL RETARD PCO Manufacturing PPA0465/201/003 Tablets Gastro-Resistant - CARBAMAZEPINE 28/12/2012
TENORET PCO Manufacturing PPA0465/245/001 Film Coated Tablet - ATENOLOL 28/12/2012
- CHLORTALIDONE
TENORETIC PCO Manufacturing PPA0465/046/001 Film Coated Tablet - ATENOLOL 28/12/2012
- CHLORTALIDONE
VALTREX 500MG FILM- PCO Manufacturing PPA0465/101/001 Tablets - VALACICLOVIR 28/12/2012
COATED TABLETS HYDROCHLORIDE
KLARAM Actavis Group PTC ehf PA1380/026/001 Film Coated Tablet - CLARITHROMYCIN 20/12/2012
KLARAM Actavis Group PTC ehf PA1380/026/002 Film Coated Tablet - CLARITHROMYCIN 20/12/2012
LAMISIL Novartis Consumer Health PA0030/044/005 Cutaneous Spray Powder - TERBINAFINE 20/12/2012
UK Limited HYDROCHLORIDE
FOSAMAX Merck Sharp and Dohme PA0035/083/001 Tablets - ALENDRONATE SODIUM 19/12/2012
Limited
ROSUVASTATIN DISPHAR Disphar International B.V. PA1031/004/001 Film Coated Tablet - ROSUVASTATIN 19/12/2012
ROSUVASTATIN DISPHAR Disphar International B.V. PA1031/004/002 Film Coated Tablet - ROSUVASTATIN 19/12/2012
ROSUVASTATIN DISPHAR Disphar International B.V. PA1031/004/003 Film Coated Tablet - ROSUVASTATIN 19/12/2012
ROSUVASTATIN DISPHAR Disphar International B.V. PA1031/004/004 Film Coated Tablet - ROSUVASTATIN 19/12/2012

Human Medicines Withdrawn Products Page 185 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TESTOSTERONE 100 MG Organon (Ireland) Limited PA0061/014/001 Implant - TESTOSTERONE 19/12/2012
IMPLANT
DIADEON MR 60 MG Les Laboratoires Servier PA0568/007/003 Modified-release Tablets - GLICLAZIDE 18/12/2012
MODIFIED RELEASE
TABLETS
NITRO-DUR 0.1 MG/H Merck Sharp & Dohme PA1286/040/001 Transdermal Patch - GLYCERYL TRINITRATE 18/12/2012
TRANSDERMAL PATCH Ireland (Human Health)
Limited
NITRO-DUR 0.2 MG/H Merck Sharp & Dohme PA1286/040/002 Transdermal Patch - GLYCERYL TRINITRATE 18/12/2012
TRANSDERMAL PATCH Ireland (Human Health)
Limited
NITRO-DUR 0.4 MG/H Merck Sharp & Dohme PA1286/040/003 Transdermal Patch - GLYCERYL TRINITRATE 18/12/2012
TRANSDERMAL PATCH Ireland (Human Health)
Limited
NITRO-DUR 0.6 MG/H Merck Sharp & Dohme PA1286/040/004 Transdermal Patch - GLYCERYL TRINITRATE 18/12/2012
TRANSDERMAL PATCH Ireland (Human Health)
Limited
RUBEX 500 MG Ricesteele Manufacturing Ltd PA0095/008/006 Tablets Chewable - ASCORBIC ACID, SILICON 18/12/2012
CHEWABLE TABLETS COATED
CAMRATA Beacon Pharmaceuticals Ltd PA1312/004/001 Concentrate for Soln for Inf - IRINOTECAN 14/12/2012
HYDROCHLORIDE
TRIHYDRATE
TRUOXIN 100 MG FILM- Sinclair IS Pharma Limited PA0915/010/001 Tablets - CIPROFLOXACIN 13/12/2012
COATED TABLETS HYDROCHLORIDE
TRUOXIN 750 MG FILM- Sinclair IS Pharma Limited PA0915/010/004 Tablets - CIPROFLOXACIN 13/12/2012
COATED TABLETS HYDROCHLORIDE
DERMAMIST DRY SKIN Alliance Pharmaceuticals Ltd PA0943/015/001 Unknown - WHITE SOFT PARAFFIN 07/12/2012
SPRAY
ESOMEPRAZOLE TEVA Teva Pharma B.V. PA0749/134/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 03/12/2012
PHARMA BV MAGNESIUM DIHYDRATE
ESOMEPRAZOLE TEVA Teva Pharma B.V. PA0749/134/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 03/12/2012
PHARMA BV MAGNESIUM DIHYDRATE
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/002 Tablets - COLISTIN SULFATE 30/11/2012
GERMOLENE OINTMENT Bayer Limited PA1410/046/001 Ointment - ZINC OXIDE 30/11/2012
- METHYL SALICYLATE
- OCTAFONIUM CHLORIDE
- PHENOL

RILONACEPT REGENERO Regeneron UK Limited EU/1/09/582/001 Pdr+Solv for Soln for Inj - RILONACEPT 30/11/2012

ANASTROZOLE Docpharma BVBA PA1506/001/001 Film Coated Tablet - ANASTRAZOLE 27/11/2012


DOCPHARMA
ZOLMITRIPTAN ACTAVIS Actavis Group PTC ehf PA1380/035/001 Film Coated Tablet - ZOLMITRIPTAN 27/11/2012
OPTIRAY 160 Covidien (UK) Commerical PA1679/001/001 Solution for Inj/Inf - IOVERSOL 23/11/2012
Limited
SILPEMAR Vaia S.A. PA1668/003/001 Film Coated Tablet - SILDENAFIL CITRATE 21/11/2012
SILPEMAR Vaia S.A. PA1668/003/002 Film Coated Tablet - SILDENAFIL CITRATE 21/11/2012
SILPEMAR Vaia S.A. PA1668/003/003 Film Coated Tablet - SILDENAFIL CITRATE 21/11/2012
OMEPRAZOLE Actavis Group PTC ehf PA1380/077/001 Capsules Gastro-Resistant - OMEPRAZOLE 20/11/2012
RABEPRAZOLE Ranbaxy Ireland Limited PA0408/089/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 19/11/2012
RABEPRAZOLE Ranbaxy Ireland Limited PA0408/089/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 19/11/2012
PANTOPRAZOLE Pliva Pharma Limited PA0585/046/001 Pdr for Soln for Injection - PANTOPRAZOLE SODIUM 16/11/2012
SESQUIHYDRATE

TRANDOPIL 0.5 MG Arrow Generics Limited PA1130/007/001 Capsule - TRANDOLAPRIL 12/11/2012


CAPSULES
TRANDOPIL 1 MG Arrow Generics Limited PA1130/007/002 Capsule - TRANDOLAPRIL 12/11/2012
CAPSULES
TRANDOPIL 2 MG Arrow Generics Limited PA1130/007/003 Capsule - TRANDOLAPRIL 12/11/2012
CAPSULES
TRANDOPIL 4 MG Arrow Generics Limited PA1130/007/004 Capsule - TRANDOLAPRIL 12/11/2012
CAPSULES
ARIZIME Niche Generics Limited PA1063/036/001 Film Coated Tablet - DONEPEZIL 09/11/2012
HYDROCHLORIDE
MONOHYDRATE
ARIZIME Niche Generics Limited PA1063/036/002 Film Coated Tablet - DONEPEZIL 09/11/2012
HYDROCHLORIDE
MONOHYDRATE
LINEZOLID TEVA Teva Pharma B.V. PA0749/091/001 Film Coated Tablet - LINEZOLID 09/11/2012
GEMCITABINE Hospira UK Limited PA0437/058/001 Powder for solution for - GEMCITABINE 08/11/2012
infusion
GEMCITABINE Hospira UK Limited PA0437/058/002 Powder for solution for - GEMCITABINE 08/11/2012
infusion
GEMCITABINE Hospira UK Limited PA0437/058/003 Powder for solution for - GEMCITABINE 08/11/2012
infusion
REQUIP-MODUTAB LTT Pharma Limited PPA1562/068/001 Tablet Prolonged Release - ROPINIROLE 02/11/2012

Human Medicines Withdrawn Products Page 186 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
REQUIP-MODUTAB LTT Pharma Limited PPA1562/068/002 Tablet Prolonged Release - ROPINIROLE 02/11/2012
REQUIP-MODUTAB LTT Pharma Limited PPA1562/068/003 Tablet Prolonged Release - ROPINIROLE 02/11/2012
GINSANA G115 Boehringer Ingelheim Limited PA0007/062/001 Capsules, Soft - PANAX GINSENG 01/11/2012

GINSANA G115 TONIC Boehringer Ingelheim Limited PA0007/062/002 Oral Solution - PANAX GINSENG 01/11/2012

ONEZYP IWA Consulting ApS PA1367/005/001 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/002 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/003 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/004 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/005 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/006 Film Coated Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/007 Orodispersible Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/008 Orodispersible Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/009 Orodispersible Tablet - OLANZAPINE 01/11/2012
ONEZYP IWA Consulting ApS PA1367/005/010 Orodispersible Tablet - OLANZAPINE 01/11/2012
SITRANE Rowex Ltd PA0711/179/001 Capsules Hard - SIBUTRAMINE 31/10/2012
HYDROCHLORIDE
MONOHYDRATE
SITRANE Rowex Ltd PA0711/179/002 Capsules Hard - SIBUTRAMINE 31/10/2012
HYDROCHLORIDE
MONOHYDRATE
Mirexel 0.7mg Tablets Niche Generics Limited PA1063/054/004 Tablet - Pramipexole 30/10/2012
dihydrochloride monohydrate
- Pramipexole

BUPLEX RX Actavis Group PTC ehf PA1380/088/004 Film Coated Tablet - IBUPROFEN 24/10/2012
PAROXETINE Actavis Group PTC ehf PA1380/009/001 Film Coated Tablet - PAROXETINE 24/10/2012
RAPONER Actavis Group PTC ehf PA1380/110/001 Prolonged Release Capsules - ROPINIROLE 24/10/2012
HYDROCHLORIDE
RAPONER Actavis Group PTC ehf PA1380/110/002 Prolonged Release Capsules - ROPINIROLE 24/10/2012
HYDROCHLORIDE
RAPONER Actavis Group PTC ehf PA1380/110/003 Prolonged Release Capsules - ROPINIROLE 24/10/2012
HYDROCHLORIDE
FLUOXETINE AUROBINDO Milpharm Limited PA1050/006/001 Oral Solution - FLUOXETINE 20/10/2012
HYDROCHLORIDE
ZERENE Meda AB EU/1/99/099/002 Capsule - ZALEPLON 19/10/2012
ZERENE Meda AB EU/1/99/099/003 Capsule - ZALEPLON 19/10/2012
ZERENE Meda AB EU/1/99/099/004 Capsule - ZALEPLON 19/10/2012
ZERENE Meda AB EU/1/99/099/005 Capsule - ZALEPLON 19/10/2012
ZERENE Meda AB EU/1/99/099/006 Capsule - ZALEPLON 19/10/2012
POTASSIUM CHLORIDE & Baxter Healthcare Limited PA0167/051/005A Solution for infusion - GLUCOSE 18/10/2012
GLUCOSE BP MONOHYDRATE
- POTASSIUM CHLORIDE
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/052/009A Solution for Infusion - POTASSIUM CHLORIDE 18/10/2012
0.3% W/V AND SODIUM - SODIUM CHLORIDE
CHLORIDE 0.
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/004/007 Solution for Infusion - POTASSIUM CHLORIDE 18/10/2012
AND SODIUM CHLORIDE IN - SODIUM CHLORIDE
GLUCOSE - GLUCOSE
MONOHYDRATE
POTASSIUM CHLORIDE, Baxter Healthcare Limited PA0167/004/001A Solution for infusion - POTASSIUM CHLORIDE 18/10/2012
SODIUM CHLORIDE AND - SODIUM CHLORIDE
GLUCOSE BP - GLUCOSE
MONOHYDRATE
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/009A Solution for Infusion - SODIUM CHLORIDE 18/10/2012
INTRAVENOUS INFUSION
BP
CAPOTEN 12.5 MG Bristol-Myers Squibb PA0002/039/004 Tablets - CAPTOPRIL 16/10/2012
TABLETS Pharmaceuticals uc
MIREXEL Niche Generics Limited PA1063/054/001 Tablets - PRAMIPEXOLE 15/10/2012
DIHYDROCHLORIDE
MONOHYDRATE
MIREXEL Niche Generics Limited PA1063/054/002 Tablets - PRAMIPEXOLE 15/10/2012
DIHYDROCHLORIDE
MONOHYDRATE
- PRAMIPEXOLE
MIROLE Niche Generics Limited PA1063/054/003 Tablets - PRAMIPEXOLE 15/10/2012
DIHYDROCHLORIDE
MONOHYDRATE
- PRAMIPEXOLE
NOVIANA Novo Nordisk A/S PA0218/054/001 Film Coated Tablet - ESTRADIOL 11/10/2012
- NORETHISTERONE
ACETATE
RIVASTIGMINE ORION Orion Corporation PA1327/013/001 Capsules Hard - RIVASTIGMINE 10/10/2012

Human Medicines Withdrawn Products Page 187 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RIVASTIGMINE ORION Orion Corporation PA1327/013/002 Capsules Hard - RIVASTIGMINE 10/10/2012
RIVASTIGMINE ORION Orion Corporation PA1327/013/003 Capsules Hard - RIVASTIGMINE 10/10/2012
ANASTROZOLE Ranbaxy Ireland Limited PA0408/078/001 Film Coated Tablet - ANASTROZOLE 09/10/2012
BELLVIRAX Ranbaxy Ireland Limited PA0408/053/001 Tablets - ACICLOVIR 09/10/2012
BELLVIRAX Ranbaxy Ireland Limited PA0408/053/002 Tablets - ACICLOVIR 09/10/2012
BELLVIRAX Ranbaxy Ireland Limited PA0408/053/003 Tablets - ACICLOVIR 09/10/2012
DONEPEZIL Ranbaxy Ireland Limited PA0408/077/001 Film Coated Tablet - DONEPEZIL 09/10/2012
HYDROCHLORIDE HYDROCHLORIDE
RANBAXY
DONEPEZIL Ranbaxy Ireland Limited PA0408/077/002 Film Coated Tablet - DONEPEZIL 09/10/2012
HYDROCHLORIDE HYDROCHLORIDE
RANBAXY
MOBIC Boehringer Ingelheim PA0775/001/003 Suppositories - MELOXICAM 09/10/2012
International GmbH
PEDIACEL Sanofi Pasteur MSD Ltd PA0544/041/001 Suspension for Injection - DIPHTHERIA TOXOID 09/10/2012
ADSORBED
- TETANUS TOXOID
ADSORBED
- PERTUSSIS TOXOID
ADSORBED (PT)
- FILAMENTOUS
HAEMAGGLUTININ
ADSORBED (FHA)
- FIMBRIAE TYPES 2 AND 3
ADSORBED (FIM)
- PERTACTIN ADSORBED
(PRN)
- INACTIVATED
POLIOMYELITIS VACCINE
TYPE 1 (MAHONEY)
- INACTIVATED
POLIOMYELITIS VACCINE
TYPE 2 (MEF-1)
- INACTIVATED
POLIOMYELITIS VACCINE
TYPE 3 (SAUKETT)
- HAEMOPHILUS
INFLUENZAE B
CONJUGATE VACCINE
(PRP-T)
- CONJUGATED TO
TENANUS PROTEIN
- ALUMINIUM PHOSPHATE
(A1)
PANTOPRAZOLE NICHE Niche Generics Limited PA1063/038/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 05/10/2012
SESQUIHYDRATE

PANTOPRAZOLE NICHE Niche Generics Limited PA1063/038/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 05/10/2012
SESQUIHYDRATE

LOSARTAN RANBAXY Ranbaxy Ireland Limited PA0408/074/001 Film Coated Tablet - LOSARTAN POTASSIUM 04/10/2012
LOSARTAN RANBAXY Ranbaxy Ireland Limited PA0408/074/002 Film Coated Tablet - LOSARTAN POTASSIUM 04/10/2012
RUBEX CHEWABLE Ricesteele Manufacturing Ltd PA0095/008/003 Tablets - ASCORBIC ACID, SILICON 02/10/2012
COATED
ALENDRONIC ACID Apotex Europe B.V. PA1513/004/001 Tablets - ALENDRONATE SODIUM 01/10/2012
APOTEX ONCE WEEKLY 70 TRIHYDRATE
MG TABLETS
ICG-PULSION PULSION Medical Systems PA1177/001/001 Pdr for Soln for Injection - INDOCYANINE GREEN 01/10/2012
AG
ICG-PULSION PULSION Medical Systems PA1177/001/002 Pdr for Soln for Injection - INDOCYANINE GREEN 01/10/2012
AG
ZYDOL SR PCO Manufacturing PPA0465/189/002 Tablet Prolonged Release - TRAMADOL 28/09/2012
HYDROCHLORIDE
ZYDOL SR PCO Manufacturing PPA0465/189/003 Tablet Prolonged Release - TRAMADOL 28/09/2012
HYDROCHLORIDE
ZYDOL SR PCO Manufacturing PPA0465/189/004 Tablet Prolonged Release - TRAMADOL 28/09/2012
HYDROCHLORIDE
CARVEDILOL McDermott Laboratories Ltd PA0577/053/001 Film Coated Tablet - CARVEDILOL 24/09/2012
t/a Gerard Laboratories
CARVEDILOL McDermott Laboratories Ltd PA0577/053/002 Film Coated Tablet - CARVEDILOL 24/09/2012
t/a Gerard Laboratories
CARVEDILOL McDermott Laboratories Ltd PA0577/053/003 Film Coated Tablet - CARVEDILOL 24/09/2012
t/a Gerard Laboratories
CARVEDILOL McDermott Laboratories Ltd PA0577/053/004 Film Coated Tablet - CARVEDILOL 24/09/2012
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 188 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KETOZOL 2% W/W Rowex Ltd PA0711/076/001 Shampoo - KETOCONAZOLE 24/09/2012
SHAMPOO
MYOSTIN Norton Waterford PA0436/039/001 Tablets - AMLODIPINE MALEATE 24/09/2012
MYOSTIN Norton Waterford PA0436/039/002 Tablets - AMLODIPINE MALEATE 24/09/2012
RISPERGER McDermott Laboratories Ltd PA0577/096/005 Film Coated Tablet - RISPERIDONE 24/09/2012
t/a Gerard Laboratories
RISPERGER McDermott Laboratories Ltd PA0577/096/006 Film Coated Tablet - RISPERIDONE 24/09/2012
t/a Gerard Laboratories
MABCAMPATH ILEX Pharmaceuticals Ltd EU/1/01/193/002 Solution for Infusion - ALEMTUZUMAB 19/09/2012
RIPRAZO HCT Novartis Europharm Limited EU/1/11/680/001-020 Film Coated Tablet - ALISKIREN 19/09/2012
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

RIPRAZO HCT Novartis Europharm Limited EU/1/11/680/021-040 Film Coated Tablet - ALISKIREN 19/09/2012
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

RIPRAZO HCT Novartis Europharm Limited EU/1/11/680/041-060 Film Coated Tablet - ALISKIREN 19/09/2012
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

RIPRAZO HCT Novartis Europharm Limited EU/1/11/680/061-080 Film Coated Tablet - ALISKIREN 19/09/2012
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

RIVASTIGMINE TEVA Teva Pharma B.V. EU/1/09/513/11-15 Capsules Hard - RIVASTIGMINE 19/09/2012
HYDROGEN TARTRATE
RIVASTIGMINE TEVA Teva Pharma B.V. EU/1/09/513/1-5 Capsules Hard - RIVASTIGMINE 19/09/2012
HYDROGEN TARTRATE
RIVASTIGMINE TEVA Teva Pharma B.V. EU/1/09/513/16-20 Capsules Hard - RIVASTIGMINE 19/09/2012
HYDROGEN TARTRATE
RIVASTIGMINE TEVA Teva Pharma B.V. EU/1/09/513/6-10 Capsules Hard - RIVASTIGMINE 19/09/2012
HYDROGEN TARTRATE
ROPINIROLE Actavis Group PTC ehf PA1380/004/001 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
ROPINIROLE Actavis Group PTC ehf PA1380/004/002 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
ROPINIROLE Actavis Group PTC ehf PA1380/004/003 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
ROPINIROLE Actavis Group PTC ehf PA1380/004/004 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
ROPINIROLE Actavis Group PTC ehf PA1380/004/006 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
ROPINIROLE Actavis Group PTC ehf PA1380/004/007 Tablets - ROPINIROLE 18/09/2012
HYDROCHLORIDE
PROSTAMIDE Generics (UK) Limited PA0405/035/001 Tablets - FLUTAMIDE 14/09/2012
DILTIAZEM Generics (UK) Limited PA0405/030/001 Tablet Prolonged Release - DILTIAZEM 11/09/2012
HYDROCHLORIDE HYDROCHLORIDE
TABLETS 60 MG
(PROLONGED R
GERFORMIN McDermott Laboratories Ltd PA0577/112/001 - METFORMIN 10/09/2012
t/a Gerard Laboratories HYDROCHLORIDE
GERFORMIN McDermott Laboratories Ltd PA0577/112/002 Not assigned - METFORMIN 10/09/2012
t/a Gerard Laboratories HYDROCHLORIDE
GERFORMIN McDermott Laboratories Ltd PA0577/112/003 - METFORMIN 10/09/2012
t/a Gerard Laboratories HYDROCHLORIDE
BYTRITE Sinclair IS Pharma Limited PA0915/009/003 Capsule - RAMIPRIL 01/09/2012
BYTRITE 2.5MG CAPSULE Sinclair IS Pharma Limited PA0915/009/002 Capsule - RAMIPRIL 01/09/2012

FER-IN-SOL Mead Johnson Nutrition PA1751/001/001 Oral Drops Solution - FERROUS SULFATE 31/08/2012
ITCH RELIEF Reckitt Benckiser Ireland Ltd PA0979/044/001 Cream - LAUROMACROGOL 400 27/08/2012
- UREA
METFORMIN Morningside Healthcare PA1333/001/001 Film Coated Tablet - METFORMIN 23/08/2012
Limited HYDROCHLORIDE
METFORMIN Morningside Healthcare PA1333/001/002 Film Coated Tablet - METFORMIN 23/08/2012
Limited HYDROCHLORIDE
ZYDOL PCO Manufacturing PPA0465/189/001 Capsule - TRAMADOL 23/08/2012
HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/006 Tablets - SOTALOL 17/08/2012
(Holdings) Limited HYDROCHLORIDE
FLUCONAZOLE NICHE Niche Generics Limited PA1063/034/001 Solution for Infusion - FLUCONAZOLE 16/08/2012
LOSARTAN POTASSIUM Ranbaxy Ireland Limited PA0408/073/001 Film Coated Tablet - LOSARTAN POTASSIUM 16/08/2012
/HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE

Human Medicines Withdrawn Products Page 189 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LOSARTAN POTASSIUM Ranbaxy Ireland Limited PA0408/073/002 Film Coated Tablet - LOSARTAN POTASSIUM 16/08/2012
/HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE

GLUCOSE INTRAVENOUS B. Braun Medical Limited PA0179/001/027 Solution for Infusion - GLUCOSE 15/08/2012
INFUSION MONOHYDRATE
GLUCOSE INTRAVENOUS B. Braun Medical Limited PA0179/001/030 Solution for Infusion - GLUCOSE ANHYDROUS 15/08/2012
INFUSION BP
GLUCOSE INTRAVENOUS B. Braun Medical Limited PA0179/001/038 Solution for Infusion - GLUCOSE ANHYDROUS 15/08/2012
INFUSION BP
GLUCOSE INTRAVENOUS B. Braun Medical Limited PA0179/001/036 Solution for Infusion - GLUCOSE ANHYDROUS 15/08/2012
INFUSION BP
SCIPPA 10 MG FILM- Gedeon Richter Plc PA1330/003/002 Film Coated Tablet - ESCITALOPRAM 15/08/2012
COATED TABLETS OXALATE
SCIPPA 15 MG FILM- Gedeon Richter Plc PA1330/003/003 Film Coated Tablet - ESCITALOPRAM 15/08/2012
COATED TABLETS OXALATE
SCIPPA 20 MG FILM- Gedeon Richter Plc PA1330/003/004 Film Coated Tablet - ESCITALOPRAM 15/08/2012
COATED TABLETS OXALATE
SCIPPA 5 MG FILM- Gedeon Richter Plc PA1330/003/001 Film Coated Tablet - ESCITALOPRAM 15/08/2012
COATED TABLETS OXALATE
STRUCTOKABIVEN, Fresenius Kabi Limited PA0566/033/002 Emulsion for Infusion - TRIGLYCERIDES 15/08/2012
BIOFINE CONTAINER - GLUCOSE
MONOHYDRATE
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYCINE ACETATE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- TAURINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- CALCIUM CHLORIDE
DIHYDRATE
- SODIUM
GLYCEROPHOSPHATE
- MAGNESIUM SULFATE
HEPTAHYDRATE
- POTASSIUM CHLORIDE
- SODIUM ACETATE
- ZINC SULFATE
STRUCTOKABIVEN, Fresenius Kabi Limited PA0566/034/002 Emulsion for Infusion - TRIGLYCERIDES 15/08/2012
BIOFINE CONTAINER, - GLUCOSE
ELECTROLYTE FRE MONOHYDRATE
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE ACETATE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- TAURINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE

Human Medicines Withdrawn Products Page 190 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STRUCTOKABIVEN, EXCEL Fresenius Kabi Limited PA0566/033/001 Emulsion for Infusion - TRIGLYCERIDES 15/08/2012
CONTAINER - GLUCOSE
MONOHYDRATE
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYCINE ACETATE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- TAURINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- CALCIUM CHLORIDE
DIHYDRATE
- SODIUM
GLYCEROPHOSPHATE
ANHYDROUS
- MAGNESIUM SULFATE
- POTASSIUM CHLORIDE
- SODIUM ACETATE
- ZINC SULFATE
STRUCTOKABIVEN, EXCEL Fresenius Kabi Limited PA0566/034/001 Emulsion for Infusion - TRIGLYCERIDES 15/08/2012
CONTAINER, ELECTOLYTE - GLUCOSE
FREE MONOHYDRATE
- ALANINE
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE ACETATE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- TAURINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
EPIRUBICINE HCL Pharmachemie BV PA0937/010/001 Solution for Inj/Inf - EPIRUBICIN 14/08/2012
HYDROCHLORIDE
FLUCONAZOLE Teva UK Limited PA0237/064/001 Solution for Infusion - FLUCONAZOLE 14/08/2012
ALENDROMAX 10MG Arrow Generics Limited PA1130/020/001 Tablets - SODIUM ALENDRONATE 10/08/2012
TABLETS
ALENDROMAX ONCE Arrow Generics Limited PA1130/020/002 Tablets - SODIUM ALENDRONATE 10/08/2012
WEEKLY 70MG TABLETS
NYOGEL 0.1% W/W EYE Novartis Pharmaceuticals UK PA0013/100/001 Eyegel - TIMOLOL 09/08/2012
GEL Ltd
DDAVP DESMOPRESSIN Ferring Ireland Ltd PA1009/001/004 Tablets - DESMOPRESSIN 08/08/2012
ACETATE
NORDURINE MELT Ferring Ireland Ltd PA1009/017/003 Oral Lyophilisate - DESMOPRESSIN 08/08/2012
ACETATE
NORDURINE MELT Ferring Ireland Ltd PA1009/017/004 Oral Lyophilisate - DESMOPRESSIN 08/08/2012
ACETATE
NORDURINE MELT Ferring Ireland Ltd PA1009/017/005 Oral Lyophilisate - DESMOPRESSIN 08/08/2012
ACETATE
RISDONE Arrow Generics Limited PA1130/008/002 Film Coated Tablet - RISPERIDONE 08/08/2012
RISDONE Arrow Generics Limited PA1130/008/003 Film Coated Tablet - RISPERIDONE 08/08/2012
RISDONE Arrow Generics Limited PA1130/008/004 Film Coated Tablet - RISPERIDONE 08/08/2012
RISDONE Arrow Generics Limited PA1130/008/005 Film Coated Tablet - RISPERIDONE 08/08/2012
REGRANEX Janssen-Cilag Ltd EU/1/99/101/001 Gel - BECAPLERMIN 07/08/2012
VALACICLOVIR Arrow Generics Limited PA1130/025/001 Film Coated Tablet - VALACICLOVIR 06/08/2012
FAMLOV Arrow Generics Limited PA1130/013/001 Film Coated Tablet - FAMCICLOVIR 03/08/2012
FAMLOV Arrow Generics Limited PA1130/013/002 Film Coated Tablet - FAMCICLOVIR 03/08/2012
FAMLOV Arrow Generics Limited PA1130/013/003 Film Coated Tablet - FAMCICLOVIR 03/08/2012
GLIMEPIRIDE Arrow Generics Limited PA1130/017/001 Tablets - GLIMEPIRIDE 03/08/2012
GLIMEPIRIDE Arrow Generics Limited PA1130/017/002 Tablets - GLIMEPIRIDE 03/08/2012
GLIMEPIRIDE Arrow Generics Limited PA1130/017/003 Tablets - GLIMEPIRIDE 03/08/2012

Human Medicines Withdrawn Products Page 191 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GLIMEPIRIDE Arrow Generics Limited PA1130/017/004 Tablets - GLIMEPIRIDE 03/08/2012
ENAPRIL STADA Stada Arzneimittel AG PA0593/024/001 Tablets - ENALAPRIL MALEATE 02/08/2012
ENAPRIL STADA Stada Arzneimittel AG PA0593/024/002 Tablets - ENALAPRIL MALEATE 02/08/2012
ENAPRIL STADA Stada Arzneimittel AG PA0593/024/003 Tablets - ENALAPRIL MALEATE 02/08/2012
ENAPRIL STADA Stada Arzneimittel AG PA0593/024/004 Tablets - ENALAPRIL MALEATE 02/08/2012
RUSTIN Ergha Healthcare Ltd PA0966/010/001 Tablets - AMLODIPINE BESILATE 02/08/2012
RUSTIN Ergha Healthcare Ltd PA0966/010/002 Tablets - AMLODIPINE BESILATE 02/08/2012
BIRAVID Sinclair IS Pharma Limited PA0915/008/001 Film Coated Tablet - OFLOXACIN 01/08/2012
BY-MADOL Sinclair IS Pharma Limited PA0915/026/001 Capsule - TRAMADOL 01/08/2012
HYDROCHLORIDE
CALMAX Sinclair IS Pharma Limited PA0915/025/001 Tablets - ALPRAZOLAM 01/08/2012
CALMAX Sinclair IS Pharma Limited PA0915/025/002 Tablets - ALPRAZOLAM 01/08/2012
CALMAX Sinclair IS Pharma Limited PA0915/025/003 Tablets - ALPRAZOLAM 01/08/2012
DISTAMINE Alliance Pharmaceuticals Ltd PA0943/003/001 Film Coated Tablet - PENICILLAMINE 01/08/2012

DISTAMINE Alliance Pharmaceuticals Ltd PA0943/003/002 Film Coated Tablet - PENICILLAMINE 01/08/2012

FINTEX Sinclair IS Pharma Limited PA0915/016/001 Film Coated Tablet - FINASTERIDE 01/08/2012
MYTANYL Lavipharm S.A. PA1676/001/001 Transdermal Patch - FENTANYL 01/08/2012
MYTANYL Lavipharm S.A. PA1676/001/002 Transdermal Patch - FENTANYL 01/08/2012
MYTANYL Lavipharm S.A. PA1676/001/003 Transdermal Patch - FENTANYL 01/08/2012
MYTANYL Lavipharm S.A. PA1676/001/004 Transdermal Patch - FENTANYL 01/08/2012
ROPINIROLE Arrow Generics Limited PA1130/019/001 Film Coated Tablet - ROPINIROLE 01/08/2012
HYDROCHLORIDE
ROPINIROLE Arrow Generics Limited PA1130/019/002 Film Coated Tablet - ROPINIROLE 01/08/2012
HYDROCHLORIDE
ROPINIROLE Arrow Generics Limited PA1130/019/003 Film Coated Tablet - ROPINIROLE 01/08/2012
HYDROCHLORIDE
ROPINIROLE Arrow Generics Limited PA1130/019/004 Film Coated Tablet - ROPINIROLE 01/08/2012
HYDROCHLORIDE
ROPINIROLE Arrow Generics Limited PA1130/019/005 Film Coated Tablet - ROPINIROLE 01/08/2012
SOLVATAN Sinclair IS Pharma Limited PA0915/017/001 Film Coated Tablet - LOSARTAN POTASSIUM 01/08/2012
SOLVATAN Sinclair IS Pharma Limited PA0915/017/002 Film Coated Tablet - LOSARTAN POTASSIUM 01/08/2012
SOLVATAN Sinclair IS Pharma Limited PA0915/017/003 Film Coated Tablet - LOSARTAN POTASSIUM 01/08/2012
SOLVATAN Sinclair IS Pharma Limited PA0915/017/004 Film Coated Tablet - LOSARTAN POTASSIUM 01/08/2012
BUDFOR AstraZeneca UK Limited PA0970/061/001 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
BUDFOR AstraZeneca UK Limited PA0970/061/002 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
BUDFOR AstraZeneca UK Limited PA0970/061/003 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
DONEPEZIL Orion Corporation PA1327/011/001 Film Coated Tablet - DONEPEZIL 31/07/2012
HYDROCHORIDE HYDROCHLORIDE
DONEPEZIL Orion Corporation PA1327/011/002 Film Coated Tablet - DONEPEZIL 31/07/2012
HYDROCHORIDE HYDROCHLORIDE
EDOFLO AstraZeneca UK Limited PA0970/062/001 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
EDOFLO AstraZeneca UK Limited PA0970/062/002 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
EDOFLO AstraZeneca UK Limited PA0970/062/003 Inhalation powder - BUDESONIDE 31/07/2012
- FORMOTEROL
FUMATRATE DIHYDRATE
TISSEEL KIT Baxter Healthcare Limited PA0167/129/002 Unknown - FACTOR I (FIBRINOGEN) 31/07/2012
- PLASMAFIBRONECTIN
- FACTOR XIII
- PROFIBRINOLYSIN
- APROTININ
- THROMBIN
- PROTEIN
- THROMBIN
- PROTEIN
- CALCIUM CHLORIDE
DIHYDRATE

Human Medicines Withdrawn Products Page 192 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TISSEEL KIT Baxter Healthcare Limited PA0167/129/003 Cutaneous Solution - FACTOR I (FIBRINOGEN) 31/07/2012
- PLASMAFIBRONECTIN
- FACTOR XIII
- PROFIBRINOLYSIN
- APROTININ
- THROMBIN
- PROTEIN
- THROMBIN
- PROTEIN
- CALCIUM CHLORIDE
DIHYDRATE
BELLRAMIL Ranbaxy Ireland Limited PA0408/092/001 Capsules Hard - RAMIPRIL 26/07/2012
BELLRAMIL Ranbaxy Ireland Limited PA0408/092/002 Capsules Hard - RAMIPRIL 26/07/2012
BELLRAMIL Ranbaxy Ireland Limited PA0408/092/003 Capsules Hard - RAMIPRIL 26/07/2012
CIPROFLOXACIN NICHE Niche Generics Limited PA1063/037/001 Solution for Infusion - CIPROFLOXACIN 26/07/2012
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/001 Tablets - OLANZAPINE 26/07/2012
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/002 Tablets - OLANZAPINE 26/07/2012
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/003 Tablets - OLANZAPINE 26/07/2012
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/004 Tablets - OLANZAPINE 26/07/2012
SPRIMEO Novartis Europharm Limited EU/1/07/407/1-10,21-30 Film Coated Tablet - ALISKIREN 23/07/2012
HEMIFUMARATE
SPRIMEO Novartis Europharm Limited EU/1/07/407/11-20,31-40 Film Coated Tablet - ALISKIREN 23/07/2012
HEMIFUMARATE
OLANZAPINE Sigillata Ltd PA1493/002/001 Orodispersible Tablet - OLANZAPINE 19/07/2012
OLANZAPINE Sigillata Ltd PA1493/002/002 Orodispersible Tablet - OLANZAPINE 19/07/2012
OLANZAPINE Sigillata Ltd PA1493/002/003 Orodispersible Tablet - OLANZAPINE 19/07/2012
OLANZAPINE Sigillata Ltd PA1493/002/004 Orodispersible Tablet - OLANZAPINE 19/07/2012
ROBINUL SOLUTION FOR MercuryPharm Ltd PA0857/001/003 Solution for Injection - GLYCOPYRRONIUM 18/07/2012
IONTOPHORESIS BROMIDE
ZOMIG 5 MG TABLETS AstraZeneca UK Limited PA0970/026/002 Film Coated Tablet - ZOLMITRIPTAN 18/07/2012
BENADRYL SKIN ALLERGY McNeil Healthcare (Ireland) PA0823/016/001 Cream - DIPHENHYDRAMINE 17/07/2012
RELIEF Ltd HYDROCHLORIDE
- ZINC OXIDE
- CAMPHOR
ESOMEPRAZOLE Teva Pharma B.V. PA0749/137/001 Tablets Gastro-Resistant - ESOMEPRAZOLE 17/07/2012
MAGNESIUM
(AMORPHOUS)
ESOMEPRAZOLE Teva Pharma B.V. PA0749/137/002 Tablets Gastro-Resistant - ESOMEPRAZOLE 17/07/2012
MAGNESIUM
(AMORPHOUS)
NICORETTE McNeil Healthcare (Ireland) PA0823/049/016 Nasal Spray Solution - NICOTINE 17/07/2012
Ltd
REPAGLINIDE ARROW Arrow ApS PA1522/002/001 Tablets - REPAGLINIDE 17/07/2012
REPAGLINIDE ARROW Arrow ApS PA1522/002/002 Tablets - REPAGLINIDE 17/07/2012
REPAGLINIDE ARROW Arrow ApS PA1522/002/003 Tablets - REPAGLINIDE 17/07/2012
PERISOM Strandhaven Ltd trading as PA1739/001/001 Film Coated Tablet - PERINDOPRIL TERT- 16/07/2012
Somex Pharma BUTYLAMINE
PERISOM Strandhaven Ltd trading as PA1739/001/002 Film Coated Tablet - PERINDOPRIL TERT- 16/07/2012
Somex Pharma BUTYLAMINE
PERISOM Strandhaven Ltd trading as PA1739/001/003 Film Coated Tablet - PERINDOPRIL TERT- 16/07/2012
Somex Pharma BUTYLAMINE
TOPIRAMA 15MG Arrow Generics Limited PA1130/009/008 Capsule - TOPIRAMATE 16/07/2012
CAPSULES, HARD
TOPIRAMA 25MG Arrow Generics Limited PA1130/009/009 Capsule - TOPIRAMATE 16/07/2012
CAPSULES, HARD
TOPIRAMA CAPSULES Arrow Generics Limited PA1130/009/007 Capsules Hard - TOPIRAMATE 16/07/2012
DECA DURABOLIN NV Organon PA0964/008/001 Solution for Injection - NANDROLONE 12/07/2012
DECANOATE
GAVISCON SACHETS Reckitt Benckiser Ireland Ltd PA0979/015/009 Oral Powder - SODIUM ALGINATE 12/07/2012
FRESH TROPICAL - SODIUM BICARBONATE
FLAVOUR - CALCIUM CARBONATE
BELLCITAL Ranbaxy Ireland Limited PA0408/061/001 Film Coated Tablet - CITALOPRAM 11/07/2012
HYDROBROMIDE
BELLCITAL Ranbaxy Ireland Limited PA0408/061/002 Film Coated Tablet - CITALOPRAM 11/07/2012
HYDROBROMIDE
BELLCITAL Ranbaxy Ireland Limited PA0408/061/003 Film Coated Tablet - CITALOPRAM 11/07/2012
HYDROBROMIDE
ZOMIG RAPIMELT LTT Pharma Limited PPA1562/083/001 Orodispersible Tablet - ZOLMITRIPTAN 10/07/2012
ZOMIG LTT Pharma Limited PPA1562/014/001 Film Coated Tablet - ZOLMITRIPTAN 06/07/2012
BETA-ADALAT Bayer Limited PA1410/026/001 Capsule - NIFEDIPINE 02/07/2012
- ATENOLOL
BYFLUC Sinclair IS Pharma Limited PA0915/028/001 Capsules Hard - FLUCONAZOLE 01/07/2012
BYFLUC Sinclair IS Pharma Limited PA0915/028/002 Capsules Hard - FLUCONAZOLE 01/07/2012
BYFLUC Sinclair IS Pharma Limited PA0915/028/003 Capsules Hard - FLUCONAZOLE 01/07/2012
BYSEC Ergha Healthcare Ltd PA0966/015/001 Capsules Gastro-Resistant - OMEPRAZOLE 01/07/2012

Human Medicines Withdrawn Products Page 193 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BYSEC Ergha Healthcare Ltd PA0966/015/002 Capsules Gastro-Resistant - OMEPRAZOLE 01/07/2012
MEGALOTECT Biotest Pharma GmbH PA0592/004/002 Solution for Infusion - HUMAN PLASMA 01/07/2012
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
CYTOMEGALOVIRUS
MEGALOTECT Biotest Pharma GmbH PA0592/004/004 Solution for Infusion - HUMAN PLASMA 01/07/2012
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
CYTOMEGALOVIRUS
PROSTAP 3, 11.25 MG, Takeda UK Limited PA1547/003/002 Pdr+Solv for Susp for Inj - LEUPRORELIN ACETATE 01/07/2012
POWDER AND SOLVENT
FOR PROLON
PRAMIPEXOLE ARROW Arrow ApS PA1522/005/001 Tablets - PRAMIPEXOLE BASE 30/06/2012
PRAMIPEXOLE ARROW Arrow ApS PA1522/005/002 Tablets - PRAMIPEXOLE BASE 30/06/2012
PRAMIPEXOLE ARROW Arrow ApS PA1522/005/003 Tablets - PRAMIPEXOLE BASE 30/06/2012
PRAMIPEXOLE ARROW Arrow ApS PA1522/005/004 Tablets - PRAMIPEXOLE BASE 30/06/2012
IBANDRONIC ACID ARROW Arrow ApS PA1522/004/002 Tablets - SODIUM IBANDRONATE 29/06/2012
150 MG TABLETS MONOHYDRATE
OLANZAPINE ARROW Arrow ApS PA1522/003/001 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/002 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/003 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/004 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/005 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/006 Film Coated Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/007 Orodispersible Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/008 Orodispersible Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/009 Orodispersible Tablet - OLANZAPINE 29/06/2012
OLANZAPINE ARROW Arrow ApS PA1522/003/010 Orodispersible Tablet - OLANZAPINE 29/06/2012
OLANZAPINE RANBAXY Ranbaxy Ireland Limited PA0408/072/005 Tablets - OLANZAPINE 26/06/2012
BETADINE ANTISEPTIC Medlock Medical Ltd PA1175/002/015 Impregnated Dressing - POVIDONE-IODINE 25/06/2012
TULLE
HIBITANE Regent Medical Overseas PA1218/003/001 Cutaneous Solution - CHLORHEXIDINE 25/06/2012
Limited Concentrate DIGLUCONATE (AS
CHLORHEXIDINE
DIGLUCONATE SOLUTION
(20% W/V) PH.EUR.

STERETS PRE-INJECTION Medlock Medical Ltd PA1175/009/001 Impregnated Dressing - ISOPROPANOL 25/06/2012
SWABS
STERIPASTE MEDICATED Medlock Medical Ltd PA1175/012/001 Impregnated Dressing - ZINC OXIDE 25/06/2012
PASTE BANDAGE
MOXICLAV Ranbaxy (UK) Limited PA0967/002/001 Film Coated Tablet - AMOXICILLIN 20/06/2012
- CLAVULANIC ACID
MOXICLAV Ranbaxy (UK) Limited PA0967/002/002 Film Coated Tablet - AMOXICILLIN 20/06/2012
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

QUINAPRIL/HYDROCHLOR Aurobindo Pharma Limited PA1311/009/001 Film Coated Tablet - QUINAPRIL 20/06/2012
OTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE
10MG/12.5M
QUINAPRIL/HYDROCHLOR Aurobindo Pharma Limited PA1311/009/002 Film Coated Tablet - QUINAPRIL 20/06/2012
OTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE
20MG/12.5M
QUINAPRIL/HYDROCHLOR Aurobindo Pharma Limited PA1311/009/003 Film Coated Tablet - QUINAPRIL 20/06/2012
OTHIAZIDE AUROBINDO - HYDROCHLOROTHIAZIDE
20MG/25MG
SODIUM B. Braun Medical Limited PA0179/003/008 Solution for Infusion - SODIUM CHLORIDE 20/06/2012
CHLORIDE/GLUCOSE - GLUCOSE ANHYDROUS
INTRAVENOUS BP
ONDANSETRON Teva UK Limited PA0237/062/001 Solution for Injection - ONDANSETRON 19/06/2012
HYDROCHLORIDE
DOCEFREZ Sun Phamaceutical EU/1/10/630/002 Pdr+Solv for soln for Inf - DOCETAXEL 18/06/2012
Industries Europe B.V. (ANHYDROUS)
Sodium Chloride Intravenous Baxter Healthcare Limited PA0167/008/009 Solution for infusion - Sodium chloride 14/06/2012
Infusion BP
DOCEFREZ Sun Phamaceutical EU/1/10/630/001 Pdr+Solv for soln for Inf - DOCETAXEL 12/06/2012
Industries Europe B.V. (ANHYDROUS)
FINASTERIDE Primecrown 2010 Ltd DPR1633/013/001 Film Coated Tablet - FINASTERIDE 12/06/2012

Human Medicines Withdrawn Products Page 194 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NUTRIFLEX LIPID PLUS B. Braun Melsungen AG PA0736/014/001 Emulsion for Infusion - GLUCOSE 12/06/2012
MONOHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- ZINC ACETATE
DIHYDRATE
- SOYA OIL
- MEDIUM CHAIN
TRIGLYCERIDES
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
HYPROCHLORIDE
MONOHYDRATE
- ALANINE
- ASPARTIC ACID
- GLUTAMIC ACID
- GLYCINE
- PROLINE
- SERINE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM ACETATE
TETRAHYDRATE
- SODIUM ACETATE
- SODIUM CHLORIDE
- POTASSIUM ACETATE
- SODIUM HYDROXIDE
NUTRIFLEX LIPID SPECIAL B. Braun Melsungen AG PA0736/015/001 Emulsion for Infusion - GLUCOSE 12/06/2012
MONOHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- ZINC ACETATE
DIHYDRATE
- SOYA OIL
- MEDIUM CHAIN
TRIGLYCERIDES
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
HYPROCHLORIDE
MONOHYDRATE
- ALANINE
- ASPARTIC ACID
- GLUTAMIC ACID
- GLYCINE
- PROLINE
- SERINE
- MAGNESIUM ACETATE
TETRAHYDRATE
- SODIUM ACETATE
- SODIUM CHLORIDE
- POTASSIUM ACETATE
- SODIUM HYDROXIDE
- CALCIUM CHLORIDE
DIHYDRATE (= 2H2O)
RISPERIDONE Primecrown 2010 Ltd DPR1633/012/001 Film Coated Tablet - RISPERIDONE 12/06/2012
RISPERIDONE Primecrown 2010 Ltd DPR1633/012/002 Film Coated Tablet - RISPERIDONE 12/06/2012
RISPERIDONE Primecrown 2010 Ltd DPR1633/012/003 Film Coated Tablet - RISPERIDONE 12/06/2012
RISPERIDONE Primecrown 2010 Ltd DPR1633/012/004 Film Coated Tablet - RISPERIDONE 12/06/2012
RISPERIDONE Primecrown 2010 Ltd DPR1633/012/005 Film Coated Tablet - RISPERIDONE 12/06/2012

Human Medicines Withdrawn Products Page 195 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CEFODOX PAEDIATRIC Sanofi-Aventis Ireland PA0540/033/001 Granules for Oral - CEFPODOXIME 11/06/2012
40MG/5ML GRANULES FOR Limited T/A SANOFI Suspension PROXETIL
ORAL SUSP
SUPREFACT DEPOT 6.3 Sanofi-Aventis Ireland PA0540/074/002 Implant - BUSERELIN 11/06/2012
MG IMPLANT Limited T/A SANOFI
TILADE CFC-FREE Sanofi-Aventis Ireland PA0540/130/002 Pressurised Inhalation - NEDOCROMIL SODIUM 11/06/2012
Limited T/A SANOFI Suspension
LOSARTAN POTASSIUM Primecrown 2010 Ltd DPR1633/011/001 Film Coated Tablet - LOSARTAN POTASSIUM 09/06/2012
LOSARTAN POTASSIUM Primecrown 2010 Ltd DPR1633/011/002 Film Coated Tablet - LOSARTAN POTASSIUM 09/06/2012
OXCARBAZEPINE TEVA Teva Pharma B.V. PA0749/073/002 Film Coated Tablet - OXCARBAZEPINE 06/06/2012
OXCARBAZEPINE TEVA Teva Pharma B.V. PA0749/073/003 Film Coated Tablet - OXCARBAZEPINE 06/06/2012
PAROXETINE TEVA Teva Pharma B.V. PA0749/062/001 Film Coated Tablet - PAROXETINE 06/06/2012
HYDROCHLORIDE
HEMIHYDRATE
PAROXETINE TEVA Teva Pharma B.V. PA0749/062/002 Film Coated Tablet - PAROXETINE 06/06/2012
HYDROCHLORIDE
HEMIHYDRATE
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/001 Film Coated Tablet - TOPIRAMATE 06/06/2012
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/002 Film Coated Tablet - TOPIRAMATE 06/06/2012
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/003 Film Coated Tablet - TOPIRAMATE 06/06/2012
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/004 Film Coated Tablet - TOPIRAMATE 06/06/2012
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/005 Film Coated Tablet - TOPIRAMATE 06/06/2012
TOPIRAMATE TEVA Teva Pharma B.V. PA0749/066/006 Film Coated Tablet - TOPIRAMATE 06/06/2012
ARIPEZ Teva Pharma B.V. PA0749/034/003 Orodispersible Tablet - DONEPEZIL 01/06/2012
HYDROCHLORIDE
ARIPEZ Teva Pharma B.V. PA0749/034/004 Orodispersible Tablet - DONEPEZIL 01/06/2012
HYDROCHLORIDE
AZITHROMYCIN TEVA Teva Pharma B.V. PA0749/039/001 Powder for Oral Suspension - AZITHROMYCIN 01/06/2012
DIHYDRATE
DALZIOR Norton Waterford PA0436/045/001 Tablets - CABERGOLINE 01/06/2012
DORTIM Teva Pharma B.V. PA0749/079/001 Eye Drops Solution - DORZOLAMIDE 01/06/2012
HYDROCHLORIDE
- TIMOLOL MALEATE
CELANCE Eli Lilly and Company Limite PA0047/073/001 Tablets - PERGOLIDE MESILATE 31/05/2012

CELANCE Eli Lilly and Company Limite PA0047/073/002 Tablets - PERGOLIDE MESILATE 31/05/2012

CELANCE Eli Lilly and Company Limite PA0047/073/003 Tablets - PERGOLIDE MESILATE 31/05/2012

GABAPENTIN Masterfarm SL PA1146/001/001 Capsules Hard - GABAPENTIN 31/05/2012


MASTERFARM
GABAPENTIN Masterfarm SL PA1146/001/002 Capsules Hard - GABAPENTIN 31/05/2012
MASTERFARM
GABAPENTIN Masterfarm SL PA1146/001/003 Capsules Hard - GABAPENTIN 31/05/2012
MASTERFARM
LACTULOSE LIQUID PH. Novartis Consumer Health PA0030/043/001 Oral Solution - LACTULOSE 31/05/2012
EUR. UK Limited
OTRIVINE CHILD NASAL Novartis Consumer Health PA0030/026/003 Nasal Drops Soln - XYLOMETAZOLINE 31/05/2012
DROPS UK Limited HYDROCHLORIDE
TIXYLIX CHESTY COUGH Novartis Consumer Health PA0030/022/001 Oral Solution - GUAIFENESIN 31/05/2012
UK Limited
MOBIC G & A Licensing Limited PPA1447/053/001 Tablets - MELOXICAM 29/05/2012
DITROPAN Sanofi-Aventis Ireland PA0540/146/001 Oral Solution - OXYBUTYNIN 28/05/2012
Limited T/A SANOFI HYDROCHLORIDE
VALLERGAN Sanofi-Aventis Ireland PA0540/132/001 Syrup - TRIMEPRAZINE TARTARE 28/05/2012
Limited T/A SANOFI
VALLERGAN Sanofi-Aventis Ireland PA0540/132/002 Tablets - TRIMEPRAZINE TARTARE 28/05/2012
Limited T/A SANOFI
VALLERGAN FORTE Sanofi-Aventis Ireland PA0540/131/001 Syrup - TRIMEPRAZINE TARTARE 28/05/2012
Limited T/A SANOFI
TAMSULOSIN Stichting Registratiebeheer PA1319/001/001 Tablets - TAMSULOSIN 25/05/2012
HYDROCHLORIDE
SALAZOPYRIN 250MG/5ML Rosemont Pharmaceuticals PA0312/019/001 Oral Suspension - SULFASALAZINE 23/05/2012
ORAL SUSPENSION. Ltd

CLARITYN G & A Licensing Limited PPA1447/077/001 Tablets - LORATADINE 21/05/2012


DIORALYTE G & A Licensing Limited PPA1447/072/001 Powder for Oral Solution - SODIUM CHLORIDE 21/05/2012
BLACKCURRANT - POTASSIUM CHLORIDE
- GLUCOSE
- SODIUM CITRATE ACID
EURAX G & A Licensing Limited PPA1447/068/001 Cream - CROTAMITON 21/05/2012
BREVIBLOC Baxter Healthcare Limited PA0167/099/001 Solution for Injection - ESMOLOL 18/05/2012
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 196 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COMPOUND SODIUM Baxter Healthcare Limited PA0167/063/005 Solution for Infusion - SODIUM CHLORIDE 18/05/2012
LACTATE & GLUCOSE 5% - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- SODIUM LACTATE
- GLUCOSE
MONOHYDRATE
POTASSIUM CHLORIDE & Baxter Healthcare Limited PA0167/051/001A Solution for infusion - GLUCOSE 18/05/2012
GLUCOSE BP MONOHYDRATE
- POTASSIUM CHLORIDE
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/052/001A Solution for Infusion - POTASSIUM CHLORIDE 18/05/2012
0.15% W/V AND SODIUM - SODIUM CHLORIDE
CHLORIDE 0
POTASSIUM CHLORIDE, Baxter Healthcare Limited PA0167/004/005A Solution for infusion - POTASSIUM CHLORIDE 18/05/2012
SODIUM CHLORIDE AND - SODIUM CHLORIDE
GLUCOSE - GLUCOSE
PRAMIPEXOLE APOTEX Apotex Europe B.V. PA1513/003/001 Tablets - PRAMIPEXOLE 18/05/2012
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE APOTEX Apotex Europe B.V. PA1513/003/002 Tablets - PRAMIPEXOLE 18/05/2012
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE APOTEX Apotex Europe B.V. PA1513/003/003 Tablets - PRAMIPEXOLE 18/05/2012
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE APOTEX Apotex Europe B.V. PA1513/003/004 Tablets - PRAMIPEXOLE 18/05/2012
DIHYDROCHLORIDE
MONOHYDRATE
PROZAC Imbat Limited PPA1151/024/001 Capsules Hard - FLUOXETINE 17/05/2012
HYDROCHLORIDE
SODIUM CHLORIDE AND Baxter Healthcare Limited PA0167/050/009A Solution for Infusion - SODIUM CHLORIDE 17/05/2012
GLUCOSE - GLUCOSE
NIASPAN Abbott Laboratories Ireland PA0038/093/001 Tablet Prolonged Release - NICOTINIC ACID 16/05/2012
Ltd
NIASPAN Abbott Laboratories Ireland PA0038/093/002 Tablet Prolonged Release - NICOTINIC ACID 16/05/2012
Ltd
NIASPAN Abbott Laboratories Ireland PA0038/093/003 Tablet Prolonged Release - NICOTINIC ACID 16/05/2012
Ltd
NIASPAN Abbott Laboratories Ireland PA0038/093/004 Tablet Prolonged Release - NICOTINIC ACID 16/05/2012
Ltd
GYNO-DAKTARIN Janssen-Cilag Ltd PA0748/020/003 Pessary - MICONAZOLE NITRATE 15/05/2012
GYNO-PEVARYL 150 MG Janssen-Cilag Ltd PA0748/017/003 Pessary - ECONAZOLE NITRATE 15/05/2012
VAGINAL PESSARIES
PREMARIN LTT Pharma Limited PPA1562/027/001 Coated Tablets - ESTROGENS 14/05/2012
CONJUGATED
RHINOLAST LTT Pharma Limited PPA1562/034/001 Nasal Spray Solution - AZELASTINE 14/05/2012
HYDROCHLORIDE
LOSEC MUPS G & A Licensing Limited PPA1447/018/002 Tablets Gastro-Resistant - OMEPRAZOLE 08/05/2012
MAGNESIUM
PARIET G & A Licensing Limited PPA1447/005/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 08/05/2012
PARIET G & A Licensing Limited PPA1447/005/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM 08/05/2012
PROTIUM G & A Licensing Limited PPA1447/029/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 08/05/2012
SESQUIHYDRATE

PROTIUM G & A Licensing Limited PPA1447/029/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 08/05/2012
SESQUIHYDRATE

FEMSEVEN CONTI Merck Serono Limited PA0654/015/001 Transdermal Patch - ESTRADIOL 01/05/2012
HEMIHYDRATE
- LEVONORGESTREL
ALENDRONIC ACID ONCE Laboratorios Davur S.L.U. PA1271/006/001 Tablets - ALENDRONATE 30/04/2012
WEEKLY MONOSODIUM
TRIHYDRATE
IMMUNINE Baxter Healthcare Limited PA0167/132/002 Pdr+Solv for soln for inf/inj - HUMAN COAGULATION 30/04/2012
FACTOR IX
IMMUNINE Baxter Healthcare Limited PA0167/132/003 Pdr+Solv for soln for inf/inj - HUMAN COAGULATION 30/04/2012
FACTOR IX
METRONIDAZOLE Norton Healthcare Limited PA0282/026/001 Tablets - METRONIDAZOLE 30/04/2012
T/A IVAX Pharmaceuticals
UK
METRONIDAZOLE Norton Healthcare Limited PA0282/026/002 Tablets - METRONIDAZOLE 30/04/2012
T/A IVAX Pharmaceuticals
UK
OMEPRAZOLE TEVA 10MG Teva Pharma B.V. PA0749/042/002 Capsules Gastro-Resistant - OMEPRAZOLE 30/04/2012
GASTRO-RESISTANT
CAPSULES

Human Medicines Withdrawn Products Page 197 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OMEPRAZOLE TEVA 20MG, Teva Pharma B.V. PA0749/042/003 Capsules Gastro-Resistant - OMEPRAZOLE 30/04/2012
GASTRO-RESISTANT
CAPSULES
OMEPRAZOLE TEVA 40MG, Teva Pharma B.V. PA0749/042/004 Capsules Gastro-Resistant - OMEPRAZOLE 30/04/2012
GASTRO-RESISTANT
CAPSULES
PUGRITEX Laboratorios Davur S.L.U. PA1271/003/003 Capsules Gastro-Resistant - OMEPRAZOLE 30/04/2012
RAMIPRIL TEVA Teva Pharma B.V. PA0749/107/001 Tablets - RAMIPRIL 30/04/2012
RAMIPRIL TEVA Teva Pharma B.V. PA0749/107/002 Tablets - RAMIPRIL 30/04/2012
TIBOLONE TEVA Teva Pharma B.V. PA0749/045/001 Tablets - TIBOLONE 30/04/2012
REFLUDAN Pharmion Limited EU/1/97/035/003 Pdr for Soln for Injection - LEPIRUDIN 27/04/2012
REFLUDAN Pharmion Limited EU/1/97/035/004 Pdr for Soln for Injection - LEPIRUDIN 27/04/2012
ALENDRONIC ACID PFIZER Pfizer Healthcare Ireland PA0822/079/001 Tablets - SODIUM ALENDRONATE 26/04/2012
70 MG TABLETS
AMISULPRIDE TEVA Teva Pharma B.V. PA0749/075/001 Tablets - AMISULPRIDE 26/04/2012
AMISULPRIDE TEVA Teva Pharma B.V. PA0749/075/002 Tablets - AMISULPRIDE 26/04/2012
AMISULPRIDE TEVA Teva Pharma B.V. PA0749/075/003 Tablets - AMISULPRIDE 26/04/2012
AMISULPRIDE TEVA Teva Pharma B.V. PA0749/075/004 Tablets - AMISULPRIDE 26/04/2012
ATORVASTATIN 10 MG Teva Pharma B.V. PA0749/093/001 Film Coated Tablet - ATORVASTATIN 26/04/2012
FILM-COATED TABLETS
ATORVASTATIN 20 MG Teva Pharma B.V. PA0749/093/002 Film Coated Tablet - ATORVASTATIN 26/04/2012
FILM-COATED TABLETS
ATORVASTATIN 40 MG Teva Pharma B.V. PA0749/093/003 Film Coated Tablet - ATORVASTATIN 26/04/2012
FILM-COATED TABLETS
ATORVASTATIN 80 MG Teva Pharma B.V. PA0749/093/004 Film Coated Tablet - ATORVASTATIN 26/04/2012
FILM-COATED TABLETS
BISOPROLOL Pfizer Healthcare Ireland PA0822/058/001 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISOPROLOL Pfizer Healthcare Ireland PA0822/058/002 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/001 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/002 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/003 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/004 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/005 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

BISPROLOL PFIZER Pfizer Healthcare Ireland PA0822/062/006 Film Coated Tablet - BISOPROLOL FUMARATE 26/04/2012

CARVEDILOL PFIZER Pfizer Healthcare Ireland PA0822/044/001 Film Coated Tablet - CARVEDILOL 26/04/2012
CARVEDILOL PFIZER Pfizer Healthcare Ireland PA0822/044/002 Film Coated Tablet - CARVEDILOL 26/04/2012
CARVEDILOL PFIZER Pfizer Healthcare Ireland PA0822/044/003 Film Coated Tablet - CARVEDILOL 26/04/2012
CARVEDILOL PFIZER Pfizer Healthcare Ireland PA0822/044/004 Film Coated Tablet - CARVEDILOL 26/04/2012
CATAFLAM SACHETS Novartis Pharmaceuticals UK PA0013/088/003 Powder for Oral Solution - DICLOFENAC 26/04/2012
Ltd POTASSIUM
CIPROFLOXACIN PFIZER Pfizer Healthcare Ireland PA0822/028/001 Film Coated Tablet - CIPROFLOXACIN 26/04/2012
HYDROCHLORIDE
CIPROFLOXACIN PFIZER Pfizer Healthcare Ireland PA0822/028/002 Film Coated Tablet - CIPROFLOXACIN 26/04/2012
500 MG FILM-COATED HYDROCHLORIDE
TABLETS
CIPROFLOXACIN PFIZER Pfizer Healthcare Ireland PA0822/028/003 Film Coated Tablet - CIPROFLOXACIN 26/04/2012
750 MG FILM-COATED HYDROCHLORIDE
TABLETS
CITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/034/001 Film Coated Tablet - CITALOPRAM 26/04/2012
HYDROBROMIDE
CITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/034/002 Film Coated Tablet - CITALOPRAM 26/04/2012
HYDROBROMIDE
CITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/034/003 Film Coated Tablet - CITALOPRAM 26/04/2012
HYDROBROMIDE
CLARITHROMYCIN Pfizer Healthcare Ireland PA0822/103/001 Film Coated Tablet - CLARITHROMYCIN 26/04/2012
CLARITHROMYCIN Pfizer Healthcare Ireland PA0822/103/002 Film Coated Tablet - CLARITHROMYCIN 26/04/2012
CO-AMOXICLAV PFIZER Pfizer Healthcare Ireland PA0822/085/001 Film Coated Tablet - AMOXICILLIN 26/04/2012
TRIHYDRATE
- POTASSIUM
CLAVULANATE, DILUTED
(WITH
MICROCRYSTALLINE
CELLULOSE IN A RATIO OF
1:1)

Human Medicines Withdrawn Products Page 198 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CO-AMOXICLAV PFIZER Pfizer Healthcare Ireland PA0822/085/002 Film Coated Tablet - AMOXICILLIN 26/04/2012
TRIHYDRATE
- POTASSIUM
CLAVULANATE, DILUTED
(WITH
MICROCRYSTALLINE
CELLULOSE IN A RATIO OF
1:1)
ESCITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/054/001 Film Coated Tablet - ESCITALOPRAM 26/04/2012
ESCITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/054/002 Film Coated Tablet - ESCITALOPRAM 26/04/2012
ESCITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/054/003 Film Coated Tablet - ESCITALOPRAM 26/04/2012
ESCITALOPRAM PFIZER Pfizer Healthcare Ireland PA0822/054/004 Film Coated Tablet - ESCITALOPRAM 26/04/2012
FINASTERIDE PFIZER 5 Pfizer Healthcare Ireland PA0822/033/001 Film Coated Tablet - FINASTERIDE 26/04/2012
MG FILM-COATED
TABLETS
FLUCLOXACILLIN ORAL Norton Healthcare Limited PA0282/041/003 Oral Solution - FLUCLOXACILLIN 26/04/2012
SOLUTION BP 125 MG/5ML T/A IVAX Pharmaceuticals SODIUM
UK
GABAPENTIN TEVA Norton Healthcare Limited PA0282/074/001 Capsules Hard - GABAPENTIN 26/04/2012
T/A IVAX Pharmaceuticals
UK
GABAPENTIN TEVA Norton Healthcare Limited PA0282/074/002 Capsules Hard - GABAPENTIN 26/04/2012
T/A IVAX Pharmaceuticals
UK
GABAPENTIN TEVA Norton Healthcare Limited PA0282/074/003 Capsules Hard - GABAPENTIN 26/04/2012
T/A IVAX Pharmaceuticals
UK
IRBESARTAN PFIZER Pfizer Healthcare Ireland PA0822/042/001 Tablets - IRBESARTAN 26/04/2012
IRBESARTAN PFIZER Pfizer Healthcare Ireland PA0822/042/002 Tablets - IRBESARTAN 26/04/2012
IRBESARTAN PFIZER Pfizer Healthcare Ireland PA0822/042/003 Tablets - IRBESARTAN 26/04/2012
LEVETIRACETAM PFIZER Pfizer Healthcare Ireland PA0822/078/001 Film Coated Tablet - LEVETIRACETAM 26/04/2012
LEVETIRACETAM PFIZER Pfizer Healthcare Ireland PA0822/078/002 Film Coated Tablet - LEVETIRACETAM 26/04/2012
LEVETIRACETAM PFIZER Pfizer Healthcare Ireland PA0822/078/003 Film Coated Tablet - LEVETIRACETAM 26/04/2012
LEVETIRACETAM PFIZER Pfizer Healthcare Ireland PA0822/078/004 Film Coated Tablet - LEVETIRACETAM 26/04/2012
LEVETIRACETAM PFIZER Pfizer Healthcare Ireland PA0822/078/005 Oral Solution - LEVETIRACETAM 26/04/2012
LEVOFLOXACIN PFIZER Pfizer Healthcare Ireland PA0822/061/001 Film Coated Tablet - LEVOFLOXACIN 26/04/2012
HEMIHYDRATE
LEVOFLOXACIN PFIZER Pfizer Healthcare Ireland PA0822/061/002 Film Coated Tablet - LEVOFLOXACIN 26/04/2012
HEMIHYDRATE
LOSARTAN POTASSIUM / Pfizer Healthcare Ireland PA0822/050/001 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
HYDROCHLORTHIAZIDE - HYDROCHLOROTHIAZIDE
PFIZER
LOSARTAN POTASSIUM / Pfizer Healthcare Ireland PA0822/050/002 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
HYDROCHLORTHIAZIDE - HYDROCHLOROTHIAZIDE
PFIZER
LOSARTAN POTASSIUM / Pfizer Healthcare Ireland PA0822/050/003 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
HYDROCHLORTHIAZIDE - HYDROCHLOROTHIAZIDE
PFIZER
LOSARTAN POTASSIUM Pfizer Healthcare Ireland PA0822/040/001 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
PFIZER
LOSARTAN POTASSIUM Pfizer Healthcare Ireland PA0822/040/002 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
PFIZER
LOSARTAN POTASSIUM Pfizer Healthcare Ireland PA0822/040/003 Film Coated Tablet - LOSARTAN POTASSIUM 26/04/2012
PFIZER
METFORMIN PFIZER Pfizer Healthcare Ireland PA0822/035/001 Film Coated Tablet - METFORMIN 26/04/2012
HYDROCHLORIDE
METFORMIN PFIZER Pfizer Healthcare Ireland PA0822/035/002 Film Coated Tablet - METFORMIN 26/04/2012
HYDROCHLORIDE
METFORMIN PFIZER Pfizer Healthcare Ireland PA0822/035/003 Film Coated Tablet - METFORMIN 26/04/2012
HYDROCHLORIDE
MIRTAZAPINE PFIZER Pfizer Healthcare Ireland PA0822/047/001 Orodispersible Tablet - MIRTAZAPINE 26/04/2012
MIRTAZAPINE PFIZER Pfizer Healthcare Ireland PA0822/047/002 Orodispersible Tablet - MIRTAZAPINE 26/04/2012
MIRTAZAPINE PFIZER Pfizer Healthcare Ireland PA0822/047/003 Orodispersible Tablet - MIRTAZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/001 Tablets - OLANZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/002 Tablets - OLANZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/003 Tablets - OLANZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/004 Tablets - OLANZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/005 Tablets - OLANZAPINE 26/04/2012
OLANZAPINE PFIZER Pfizer Healthcare Ireland PA0822/077/006 Tablets - OLANZAPINE 26/04/2012
OMEPRAZOLE PFIZER Pfizer Healthcare Ireland PA0822/045/001 Capsules Gastro-Resistant - OMEPRAZOLE 26/04/2012
OMEPRAZOLE PFIZER Pfizer Healthcare Ireland PA0822/045/002 Capsules Gastro-Resistant - OMEPRAZOLE 26/04/2012
OMEPRAZOLE PFIZER Pfizer Healthcare Ireland PA0822/045/003 Capsules Gastro-Resistant - OMEPRAZOLE 26/04/2012
PERINDOPRIL PFIZER Pfizer Healthcare Ireland PA0822/041/002 Tablets - PERINDOPRIL TERT- 26/04/2012
BUTYLAMINE

Human Medicines Withdrawn Products Page 199 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PERINDOPRIL TERT- Pfizer Healthcare Ireland PA0822/041/001 Tablets - PERINDOPRIL TERT- 26/04/2012
BUTYLAMINE PFIZER 4 MG BUTYLAMINE
TABLETS
QUETIAPINE PFIZER Pfizer Healthcare Ireland PA0822/053/001 Film Coated Tablet - QUETIAPINE FUMARATE 26/04/2012
QUETIAPINE PFIZER Pfizer Healthcare Ireland PA0822/053/002 Film Coated Tablet - QUETIAPINE FUMARATE 26/04/2012
QUETIAPINE PFIZER Pfizer Healthcare Ireland PA0822/053/003 Film Coated Tablet - QUETIAPINE FUMARATE 26/04/2012
QUETIAPINE PFIZER Pfizer Healthcare Ireland PA0822/053/004 Film Coated Tablet - QUETIAPINE FUMARATE 26/04/2012
QUETIAPINE PFIZER Pfizer Healthcare Ireland PA0822/053/005 Film Coated Tablet - QUETIAPINE FUMARATE 26/04/2012
RAMIPRIL PFIZER Pfizer Healthcare Ireland PA0822/024/001 Tablets - RAMIPRIL 26/04/2012
RAMIPRIL PFIZER Pfizer Healthcare Ireland PA0822/024/002 Tablets - RAMIPRIL 26/04/2012
RISEDRONATE SODIUM Pfizer Healthcare Ireland PA0822/049/001 Film Coated Tablet - RISEDRONATE SODIUM 26/04/2012
PFIZER (HEMIPENTAHYDRATE)
RISEDRONATE SODIUM Pfizer Healthcare Ireland PA0822/049/002 Film Coated Tablet - RISEDRONATE SODIUM 26/04/2012
PFIZER (HEMIPENTAHYDRATE)
RISEDRONATE SODIUM Pfizer Healthcare Ireland PA0822/049/003 Film Coated Tablet - RISEDRONATE SODIUM 26/04/2012
PFIZER ONCE A WEEK (HEMIPENTAHYDRATE)
RISPAL Pinewood Laboratories Ltd, PA0281/129/001 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/002 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/003 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/004 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/005 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/006 Tablets - RISPERIDONE 26/04/2012
RISPAL Pinewood Laboratories Ltd, PA0281/129/007 Tablets - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/001 Film Coated Tablet - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/002 Film Coated Tablet - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/003 Film Coated Tablet - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/004 Film Coated Tablet - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/005 Film Coated Tablet - RISPERIDONE 26/04/2012
RISPERIDONE PFIZER Pfizer Healthcare Ireland PA0822/038/006 Film Coated Tablet - RISPERIDONE 26/04/2012
SERENACE 5 MG/ML Norton Healthcare Limited PA0282/063/001 Solution for Injection - HALOPERIDOL 26/04/2012
AMPOULE SOLUTION FOR T/A IVAX Pharmaceuticals
INJECTION. UK
SIMVASTATIN PFIZER Pfizer Healthcare Ireland PA0822/032/001 Film Coated Tablet - SIMVASTATIN 26/04/2012
SIMVASTATIN PFIZER Pfizer Healthcare Ireland PA0822/032/002 Film Coated Tablet - SIMVASTATIN 26/04/2012
SIMVASTATIN PFIZER Pfizer Healthcare Ireland PA0822/032/003 Film Coated Tablet - SIMVASTATIN 26/04/2012
SIMVASTATIN PFIZER Pfizer Healthcare Ireland PA0822/032/004 Film Coated Tablet - SIMVASTATIN 26/04/2012
SIMVASTATIN PFIZER Pfizer Healthcare Ireland PA0822/032/005 Film Coated Tablet - SIMVASTATIN 26/04/2012
SUMATRIPTAN PFIZER Pfizer Healthcare Ireland PA0822/048/001 Tablets - SUMATRIPTAN 26/04/2012
SUCCINATE
SUMATRIPTAN PFIZER Pfizer Healthcare Ireland PA0822/048/002 Tablets - SUMATRIPTAN 26/04/2012
SUCCINATE
TERBINAFINE PFIZER Pfizer Healthcare Ireland PA0822/039/001 Tablets - TERBINAFINE 26/04/2012
HYDROCHLORIDE
TERBINAFINE PFIZER Pfizer Healthcare Ireland PA0822/039/002 Tablets - TERBINAFINE 26/04/2012
HYDROCHLORIDE
VALACICLOVIR PFIZER Pfizer Healthcare Ireland PA0822/057/001 Film Coated Tablet - VALACICLOVIR 26/04/2012
HYDROCHLORIDE
MONOHYDRATE
VALSARTAN Pfizer Healthcare Ireland PA0822/074/001 Film Coated Tablet - VALSARTAN 26/04/2012
VALSARTAN Pfizer Healthcare Ireland PA0822/074/003 Film Coated Tablet - VALSARTAN 26/04/2012
VALSARTAN Pfizer Healthcare Ireland PA0822/074/004 Film Coated Tablet - VALSARTAN 26/04/2012
VALSARTAN PFIZER Pfizer Healthcare Ireland PA0822/074/002 Film Coated Tablet - VALSARTAN 26/04/2012
BOOTS NICASSIST Novartis Consumer Health PA0030/057/001 Lozenges - NICOTINE 25/04/2012
UK Limited
NCH MINT Novartis Consumer Health PA0030/052/001 Lozenges - NICOTINE 25/04/2012
UK Limited
LEVOFLOXACIN Rowex Ltd PA0711/152/001 Solution for Infusion - LEVOFLOXACIN 24/04/2012
EXALIEF BIAL - Portela & Cª, S.A. EU/1/09/520/12-20 Tablets - ESLICARBAZEPINE 21/04/2012
ACETATE
EXALIEF BIAL - Portela & Cª, S.A. EU/1/09/520/7-11 Tablets - ESLICARBAZEPINE 21/04/2012
ACETATE
ORANGE FLAVOUR Procter & Gamble (Health & PA0441/034/002 Powder for Oral Solution - ISPAGHULA HUSKS 18/04/2012
REGULAN 3.4G PER Beauty Care) Limited
SACHET POWDER FOR
REGULAN LEMON/LIME Procter & Gamble (Health & PA0441/034/001 Powder for Oral Solution - ISPAGHULA HUSKS 18/04/2012
FLAVOUR 3.4G PER Beauty Care) Limited
SACHET POWDER
ANASTROZOLE Niche Generics Limited PA1063/032/001 Film Coated Tablet - ANASTROZOLE 16/04/2012
VELEXOR Actavis Group PTC ehf PA1380/063/002 Film Coated Tablet - VENLAFAXINE 16/04/2012
HYDROCHLORIDE
VELEXOR Actavis Group PTC ehf PA1380/063/004 Film Coated Tablet - VENLAFAXINE 16/04/2012
HYDROCHLORIDE
SIMVASTATIN 10 MG FILM- Laboratorios Davur S.L.U. PA1271/005/001 Film Coated Tablet - SIMVASTATIN 13/04/2012
COATED TABLETS

Human Medicines Withdrawn Products Page 200 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SIMVASTATIN 20 MG FILM- Laboratorios Davur S.L.U. PA1271/005/002 Film Coated Tablet - SIMVASTATIN 13/04/2012
COATED TABLETS
SIMVASTATIN 40 MG FILM- Laboratorios Davur S.L.U. PA1271/005/003 Film Coated Tablet - SIMVASTATIN 13/04/2012
COATED TABLETS
SIMVASTATIN 80 MG FILM- Laboratorios Davur S.L.U. PA1271/005/004 Film Coated Tablet - SIMVASTATIN 13/04/2012
COATED TABLETS
TOPAMAX G & A Licensing Limited PPA1447/015/001 Film Coated Tablet - TOPIRAMATE 13/04/2012
TOPAMAX G & A Licensing Limited PPA1447/015/002 Film Coated Tablet - TOPIRAMATE 13/04/2012
TOPAMAX G & A Licensing Limited PPA1447/015/003 Film Coated Tablet - TOPIRAMATE 13/04/2012
TOPAMAX G & A Licensing Limited PPA1447/015/004 Film Coated Tablet - TOPIRAMATE 13/04/2012
ONDANSETRON PFIZER Pfizer Healthcare Ireland PA0822/027/002 Film Coated Tablet - ONDANSETRON 11/04/2012
HYDROCHLORIDE
DIHYDRATE
ONDANSETRON PFIZER Pfizer Healthcare Ireland PA0822/027/003 Film Coated Tablet - ONDANSETRON 11/04/2012
HYDROCHLORIDE
DIHYDRATE
DONELINN 10 MG FILM- Sinclair IS Pharma Limited PA0915/020/002 Film Coated Tablet - DONEPEZIL 05/04/2012
COATED TABLETS HYDROCHLORIDE
DONELINN 5 MG FILM- Sinclair IS Pharma Limited PA0915/020/001 Film Coated Tablet - DONEPEZIL 05/04/2012
COATED TABLETS HYDROCHLORIDE
ISOPRINOSINE Newport Pharmaceuticals PA0336/001/001 Tablets - INOSINE ACEDOBEN 05/04/2012
Limited DIMEPRANOL
Meroximer 0.088 mg tablets Actavis Group PTC ehf PA1380/037/001 Tablet - Pramipexole 02/04/2012
dihydrochloride monohydrate

Meroximer 0.18 mg tablets Actavis Group PTC ehf PA1380/037/002 Tablet - Pramipexole 02/04/2012
dihydrochloride monohydrate

Meroximer 0.35 mg tablets Actavis Group PTC ehf PA1380/037/003 Tablet - Pramipexole 02/04/2012
dihydrochloride monohydrate

Meroximer 0.7 mg tablets Actavis Group PTC ehf PA1380/037/004 Tablet - Pramipexole 02/04/2012
dihydrochloride monohydrate

Meroximer 1.1 mg tablets Actavis Group PTC ehf PA1380/037/005 Tablet - Pramipexole 02/04/2012
dihydrochloride monohydrate

COSMEGEN LYOVAC Lundbeck Pharmaceuticals PA1301/003/001 Pdr for Soln for Injection - DACTINOMYCIN 01/04/2012
POWDER FOR SOLUTION Ireland
FOR INJECTION
PROLEUKIN Novartis Pharmaceuticals UK PA0013/122/001 Powder for solution for - Aldesleukin 01/04/2012
Ltd injection/infusion
DIANEAL PD1 GLUCOSE Baxter Healthcare Limited PA0167/017/011 Solution for peritoneal - GLUCOSE 31/03/2012
2.27% W/V (22.7 MG/ML) dialysis - SODIUM CHLORIDE
SOLUTIO - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
OLANZAPINE SYNTHON Synthon BV PA0840/005/001 Tablets - OLANZAPINE BENZOATE 31/03/2012

OLANZAPINE SYNTHON Synthon BV PA0840/005/002 Tablets - OLANZAPINE BENZOATE 31/03/2012

OLANZAPINE SYNTHON Synthon BV PA0840/005/003 Tablets - OLANZAPINE BENZOATE 31/03/2012

OLANZAPINE SYNTHON Synthon BV PA0840/005/004 Tablets - OLANZAPINE BENZOATE 31/03/2012

APOMORPHINE Archimedes Pharma UK PA0757/008/001 Solution for Inj/Inf - APOMORPHINE 30/03/2012


HYDROCHLORIDE Limited HYDROCHLORIDE
MIRZATEN 15 MG Niche Generics Limited PA1063/027/001 Orodispersible Tablet - MIRTAZAPINE 30/03/2012
ORODISPERSIBLE
TABLETS
MIRZATEN 30 MG Niche Generics Limited PA1063/027/002 Orodispersible Tablet - MIRTAZAPINE 30/03/2012
ORODISPERSIBLE
TABLETS
MIRZATEN 45 MG Niche Generics Limited PA1063/027/003 Orodispersible Tablet - MIRTAZAPINE 30/03/2012
ORODISPERSIBLE
TABLETS
ATORVASTATIN ACTAVIS Actavis Group PTC ehf PA1380/023/001 Film Coated Tablet - ATORVASTASTIN 27/03/2012
MAGNESIUM TRIHYDRATE

ATORVASTATIN ACTAVIS Actavis Group PTC ehf PA1380/023/002 Film Coated Tablet - ATORVASTASTIN 27/03/2012
MAGNESIUM TRIHYDRATE

Human Medicines Withdrawn Products Page 201 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ATORVASTATIN ACTAVIS Actavis Group PTC ehf PA1380/023/003 Film Coated Tablet - ATORVASTASTIN 27/03/2012
MAGNESIUM TRIHYDRATE

RISPERDAL QUICKLET PCO Manufacturing PPA0465/078/008 Orodispersible Tablet - RISPERIDONE 23/03/2012


FERROUS GLUCONATE Clonmel Healthcare Ltd PA0126/058/001 Coated Tablets - FERROUS GLUCONATE 21/03/2012
VELEXOR Ranbaxy (UK) Limited PA0967/017/002 Prolonged Release Capsules - VENLAFAXINE 20/03/2012

VELEXOR Ranbaxy (UK) Limited PA0967/017/003 Prolonged Release Capsules - VENLAFAXINE 20/03/2012
HYDROCHLORIDE
ANASTROZOLE Niche Generics Limited PA1063/031/001 Film Coated Tablet - ANASTROZOLE 16/03/2012
CARDOX SR Ethypharm PA0549/003/001 Prolonged Release Capsules - ISOSORBIDE 16/03/2012
MONONITRATE
CARDOX SR Ethypharm PA0549/003/002 Prolonged Release Capsules - ISOSORBIDE 16/03/2012
MONONITRATE
CARDOX SR Ethypharm PA0549/003/003 Prolonged Release Capsules - ISOSORBIDE 16/03/2012
MONONITRATE
DOBUTAMINE PFIZER Pfizer Healthcare Ireland PA0822/046/001 Concentrate for Soln for Inf - DOBUTAMINE 16/03/2012
HYDROCHLORIDE
ONDANSETRON Wockpharma Ireland Limited PA1448/001/001 Solution for Inj/Inf - ONDANSETRON 16/03/2012
HYDROCHLORIDE
DIHYDRATE
BELLIMCOR Ranbaxy Ireland Limited PA0408/054/001 Tablets - BISOPROLOL FUMARATE 15/03/2012

BELLIMCOR Ranbaxy Ireland Limited PA0408/054/002 Tablets - BISOPROLOL FUMARATE 15/03/2012

CRESTOR B & S Healthcare PPA1328/059/004 Film Coated Tablet - ROSUVASTATIN (AS 15/03/2012
CALCIUM)
LAMICTAL G & A Licensing Limited PPA1447/032/001 Dispersable Tablet - LAMOTRIGINE 15/03/2012
LIPITOR LTT Pharma Limited PPA1562/010/002 Film Coated Tablet - ATORVASTATIN 15/03/2012
LIPITOR LTT Pharma Limited PPA1562/010/003 Film Coated Tablet - ATORVASTATIN 15/03/2012
LIPITOR LTT Pharma Limited PPA1562/010/004 Film Coated Tablet - ATORVASTATIN 15/03/2012
PHOTOFRIN Axcan Pharma International PA0960/001/001 Pdr for Soln for Injection - PORFIMER SODIUM 14/03/2012
B.V.
ACULAR G & A Licensing Limited PPA1447/019/001 Eye Drops Solution - KETOROLAC 13/03/2012
TROMETAMOL
ALPHAGAN G & A Licensing Limited PPA1447/085/001 Eye Drops Solution - BRIMONIDINE TARTRATE 13/03/2012

MONOSOL Baxter Healthcare Limited PA0167/103/001 Solution for Haemofiltration - GLUCOSE 13/03/2012
MONOHYDRATE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
MONOSOL-K WITH 2 Baxter Healthcare Limited PA0167/104/001 Solution for Haemofiltration - GLUCOSE 13/03/2012
MEQ/L POTASSIUM MONOHYDRATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
MONOSOL-K WITH 4 Baxter Healthcare Limited PA0167/104/002 Solution for Haemofiltration - GLUCOSE 13/03/2012
MEQ/L POTASSIUM MONOHYDRATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
NEURONTIN G & A Licensing Limited PPA1447/056/001 Capsules Hard - GABAPENTIN 13/03/2012
SINEMET CR G & A Licensing Limited PPA1447/016/002 Tablet Prolonged Release - LEVODOPA 13/03/2012
- CARBIDOPA
SPORANOX G & A Licensing Limited PPA1447/022/001 Capsules Hard - ITRACONAZOLE 13/03/2012
TRITACE G & A Licensing Limited PPA1447/046/001 Tablets - RAMIPRIL 13/03/2012
TRITACE G & A Licensing Limited PPA1447/046/002 Tablets - RAMIPRIL 13/03/2012
TRITACE G & A Licensing Limited PPA1447/046/003 Tablets - RAMIPRIL 13/03/2012
TROSYL G & A Licensing Limited PPA1447/043/001 Medicated Nail Lacquer - TIOCONAZOLE 13/03/2012
VASCACE G & A Licensing Limited PPA1447/007/001 Film Coated Tablet - CILAZAPRIL 13/03/2012
VASCACE G & A Licensing Limited PPA1447/007/002 Film Coated Tablet - CILAZAPRIL 13/03/2012
VASCACE G & A Licensing Limited PPA1447/007/003 Film Coated Tablet - CILAZAPRIL 13/03/2012
ZANAFLEX G & A Licensing Limited PPA1447/026/001 Tablets - TIZANIDINE 13/03/2012
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 202 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZANAFLEX G & A Licensing Limited PPA1447/026/002 Tablets - TIZANIDINE 13/03/2012
HYDROCHLORIDE
ZISPIN SOLTABS G & A Licensing Limited PPA1447/008/001 Orodispersible Tablet - MIRTAZAPINE 13/03/2012
ZISPIN SOLTABS G & A Licensing Limited PPA1447/008/002 Orodispersible Tablet - MIRTAZAPINE 13/03/2012
ZISPIN SOLTABS G & A Licensing Limited PPA1447/008/003 Orodispersible Tablet - MIRTAZAPINE 13/03/2012
ZOMIG RAPIMELT G & A Licensing Limited PPA1447/009/001 Orodispersible Tablet - ZOLMITRIPTAN 13/03/2012
ZYLORIC G & A Licensing Limited PPA1447/055/001 Tablets - ALLOPURINOL 13/03/2012
ZYLORIC G & A Licensing Limited PPA1447/055/002 Tablets - ALLOPURINOL 13/03/2012
FLAMAZINE B & S Healthcare PPA1328/140/001 Cream - SULFADIAZINE SILVER 12/03/2012
LESCOL XL B & S Healthcare PPA1328/131/001 Tablet Prolonged Release - FLUVASTATIN SODIUM 12/03/2012
PROTIUM B & S Healthcare PPA1328/001/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 12/03/2012
SESQUIHYDRATE

SALAZOPYRIN EN B & S Healthcare PPA1328/129/001 Tablets Gastro-Resistant - SULFASALAZINE 12/03/2012


RISPERIDONE McDowell Pharmaceuticals DPR1473/060/002 Film Coated Tablet - RISPERIDONE 10/03/2012
RISPERIDONE McDowell Pharmaceuticals DPR1473/060/003 Film Coated Tablet - RISPERIDONE 10/03/2012
RISPERIDONE McDowell Pharmaceuticals DPR1473/060/004 Film Coated Tablet - RISPERIDONE 10/03/2012
RISPERIDONE McDowell Pharmaceuticals DPR1473/060/005 Film Coated Tablet - RISPERIDONE 10/03/2012
TOPIRAMATE PFIZER Pfizer Healthcare Ireland PA0822/051/001 Film Coated Tablet - TOPIRAMATE 08/03/2012
TOPIRAMATE PFIZER Pfizer Healthcare Ireland PA0822/051/002 Film Coated Tablet - TOPIRAMATE 08/03/2012
TOPIRAMATE PFIZER Pfizer Healthcare Ireland PA0822/051/003 Film Coated Tablet - TOPIRAMATE 08/03/2012
TOPIRAMATE PFIZER Pfizer Healthcare Ireland PA0822/051/004 Film Coated Tablet - TOPIRAMATE 08/03/2012
LATANOPROST/TIMOLOL Laboratorios Normon S.A. PA1704/001/001 Eye Drops Solution - LATANOPROST 05/03/2012
NORMON - TIMOLOL MALEATE
LOAVEL Sanofi-Aventis Ireland PA0540/138/005 Tablets - RAMIPRIL 05/03/2012
Limited T/A SANOFI
LOAVEL Sanofi-Aventis Ireland PA0540/138/006 Tablets - RAMIPRIL 05/03/2012
Limited T/A SANOFI
LOAVEL Sanofi-Aventis Ireland PA0540/138/007 Tablets - RAMIPRIL 05/03/2012
Limited T/A SANOFI
LOAVEL Sanofi-Aventis Ireland PA0540/138/008 Tablets - RAMIPRIL 05/03/2012
Limited T/A SANOFI
RANGABAX Ranbaxy Ireland Limited PA0408/065/001 Capsules Hard - GABAPENTIN 02/03/2012
RANGABAX Ranbaxy Ireland Limited PA0408/065/002 Capsules Hard - GABAPENTIN 02/03/2012
RANGABAX Ranbaxy Ireland Limited PA0408/065/003 Capsules Hard - GABAPENTIN 02/03/2012
RANGABAX Ranbaxy Ireland Limited PA0408/065/004 Film Coated Tablet - GABAPENTIN 02/03/2012
INDOCID PDA 1 MG Lundbeck Pharmaceuticals PA1301/002/001 Pdr for Soln for Injection - INDOMETACIN SODIUM 01/03/2012
POWDER FOR SOLUTION Ireland TRIHYDRATE
FOR INJECTION
MAXOLON Rosemont Pharmaceuticals PA0312/021/001 Syrup - METOCLOPRAMIDE 01/03/2012
Ltd HYDROCHLORIDE
MAXOLON PAEDIATRIC Rosemont Pharmaceuticals PA0312/021/002 Oral Drops Solution - METOCLOPRAMIDE 01/03/2012
LIQUID Ltd HYDROCHLORIDE
OXIS TURBOHALER G & A Licensing Limited PPA1447/025/001 Inhalation powder - FORMOTEROL 01/03/2012
FUMATRATE DIHYDRATE
OXIS TURBOHALER G & A Licensing Limited PPA1447/025/002 Inhalation powder - FORMOTEROL 01/03/2012
FUMATRATE DIHYDRATE
ROLYPREXA Rowex Ltd PA0711/124/006 Film Coated Tablet - OLANZAPINE 01/03/2012
TRENTAL 400 MG Sanofi-Aventis Ireland PA0540/080/003 Modified-release Tablets - PENTOXIFYLLINE 01/03/2012
MODIFIED-RELEASE, Limited T/A SANOFI
COATED TABLETS.
TRILOBAL Intersan GmbH PA0414/001/002 Film Coated Tablet - GINKGO BILOBA 01/03/2012
ACUPAN Meda Health Sales Ireland PA1332/019/001 Film Coated Tablet - NEFOPAM 29/02/2012
Limited HYDROCHLORIDE
AMISULPRIDE MYLAN McDermott Laboratories Ltd PA0577/125/002 Tablets - AMISULPRIDE 29/02/2012
t/a Gerard Laboratories
ANIALL 500 / 50 MG Pfizer Consumer Healthcare PA0172/004/007 Tablets - ACETYLSALICYLIC ACID 29/02/2012
TABLETS Ltd - CAFFEINE
FUROSEMIDE PFIZER Pfizer Healthcare Ireland PA0822/026/001 Solution for Injection - FUROSEMIDE 29/02/2012
GEMCITABINE MEDAC Medac Gesellschaft fur PA0623/012/001 Powder for solution for - GEMCITABINE 29/02/2012
Klinische Spezialpraparate infusion
mbH
GEMCITABINE MEDAC Medac Gesellschaft fur PA0623/012/002 Powder for solution for - GEMCITABINE 29/02/2012
Klinische Spezialpraparate infusion
mbH
GEMCITABINE MEDAC Medac Gesellschaft fur PA0623/012/003 Powder for solution for - GEMCITABINE 29/02/2012
Klinische Spezialpraparate infusion
mbH
BICALINN Sinclair IS Pharma Limited PA0915/015/001 Film Coated Tablet - BICALUTAMIDE 28/02/2012
BYTRITE Sinclair IS Pharma Limited PA0915/009/004 Capsule - RAMIPRIL 28/02/2012
BYTRITE 1.25MG Sinclair IS Pharma Limited PA0915/009/001 Capsule - RAMIPRIL 28/02/2012
CAPSULES
EURAX HC Novartis Consumer Health PA0030/018/001 Cream - CROTAMITON 28/02/2012
UK Limited - HYDROCORTISONE

Human Medicines Withdrawn Products Page 203 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EURAX Novartis Consumer Health PA0030/014/001 Cream - CROTAMITON 28/02/2012
HYDROCORTISONE UK Limited - HYDROCORTISONE
CREAM
ISOTRETINOIN McDermott Laboratories Ltd PA0577/064/001 Capsules, Soft - ISOTRETINOIN 28/02/2012
t/a Gerard Laboratories
ISOTRETINOIN McDermott Laboratories Ltd PA0577/064/002 Capsules, Soft - ISOTRETINOIN 28/02/2012
t/a Gerard Laboratories
ISOTRETINOIN McDermott Laboratories Ltd PA0577/064/003 Capsules, Soft - ISOTRETINOIN 28/02/2012
t/a Gerard Laboratories
PROSTAP SR 3.75 MG Takeda UK Limited PA1547/003/001 Pdr+Solv for Susp for Inj - LEUPRORELIN ACETATE 28/02/2012
POWDER AND SOLVENT
FOR PROLONGE
TOPIRAXE Sinclair IS Pharma Limited PA0915/022/001 Film Coated Tablet - TOPIRAMATE 28/02/2012
TOPIRAXE Sinclair IS Pharma Limited PA0915/022/002 Film Coated Tablet - TOPIRAMATE 28/02/2012
TOPIRAXE Sinclair IS Pharma Limited PA0915/022/003 Film Coated Tablet - TOPIRAMATE 28/02/2012
TOPIRAXE Sinclair IS Pharma Limited PA0915/022/004 Film Coated Tablet - TOPIRAMATE 28/02/2012
VALHERP Sinclair IS Pharma Limited PA0915/019/001 Film Coated Tablet - VALACICLOVIR 28/02/2012
HYDROCHLORIDE
XATGER McDermott Laboratories Ltd PA0577/079/001 Tablet Prolonged Release - ALFUZOSIN 28/02/2012
t/a Gerard Laboratories HYDROCHLORIDE
COMBIVENT METERED Imbat Limited PPA1151/032/001 Unknown - IPRATROPIUM 24/02/2012
AERSOL BROMIDE/SALBUTAMOL
DULCOLAX Imbat Limited PPA1151/045/002 Suppositories - BISACODYL 24/02/2012
RANITIDINE WPR Healthcare Limited PPA0565/006/001 Film Coated Tablet - RANITIDINE 22/02/2012
HYDROCHLORIDE
RANITIDINE WPR Healthcare Limited PPA0565/006/002 Film Coated Tablet - RANITIDINE 22/02/2012
HYDROCHLORIDE
ATROVENT 250 UDVS B & S Healthcare PPA1328/070/001 Nebuliser Solution - IPRATROPIUM BROMIDE 17/02/2012
MONOHYDRATE
ATROVENT 500 UDVS B & S Healthcare PPA1328/070/002 Nebuliser Solution - IPRATROPIUM BROMIDE 17/02/2012
MONOHYDRATE
ORUVAIL 2.5% W/W GEL. Sanofi-Aventis Ireland PA0540/119/004 Gel - KETOPROFEN 10/02/2012
Limited T/A SANOFI
PARACETAMOL Docpharma BVBA PA1506/002/001 Solution for Infusion - PARACETAMOL 07/02/2012
DOCPHARMA
SEMI-DAONIL Sanofi-Aventis Ireland PA0540/040/001 Tablets - GLIBENCLAMIDE 07/02/2012
Limited T/A SANOFI
FLAGYL Sanofi-Aventis Ireland PA0540/100/006 Suppositories - METRONIDAZOLE 02/02/2012
Limited T/A SANOFI
PENTACARINAT READY- Sanofi-Aventis Ireland PA0540/120/001 Nebuliser Solution - PENTAMIDINE 02/02/2012
TO-USE Limited T/A SANOFI ISETHIONATE
AUGMENTIN B & S Healthcare PPA1328/089/001 Tablets - AMOXICILLIN 13/01/2012
TRIHYDRATE
- CLAVULANATE
POTASSIUM
AXID B & S Healthcare PPA1328/071/001 Capsules Hard - NIZATIDINE 13/01/2012
ZOVIRAX B & S Healthcare PPA1328/067/002 Not assigned - ACICLOVIR 13/01/2012
AMERSCAN MEDRONATE GE Healthcare Limited PA0240/022/001 Pdr for Soln for Injection - METHYLENE 01/01/2012
II AGENT 6.25 MILLIGRAMS DIPHOSPHONIC ACID DI-
KIT FO AND TRISODIUM SALT
KLACID PCO Manufacturing PPA0465/051/001A Film Coated Tablet - CLARITHROMYCIN 31/12/2011
INFANRIX PENTA SmithKline Beecham EU/1/00/153/001 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals
INFANRIX PENTA SmithKline Beecham EU/1/00/153/002 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED

Human Medicines Withdrawn Products Page 204 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFANRIX PENTA SmithKline Beecham EU/1/00/153/003 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
INFANRIX PENTA SmithKline Beecham EU/1/00/153/004 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
INFANRIX PENTA SmithKline Beecham EU/1/00/153/005 Solution for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
INFANRIX PENTA SmithKline Beecham EU/1/00/153/006 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
INFANRIX PENTA SmithKline Beecham EU/1/00/153/007 Suspension for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals
INFANRIX-PENTA SmithKline Beecham EU/1/00/153/008 Solution for Injection - DIPHTHERIA TOXOID 21/12/2011
Biologicals
LETROZOLE Caduceus Pharma Ltd PA1399/002/001 Film Coated Tablet - LETROZOLE 14/12/2011
NORADRENALINE Martindale Pharmaceuticals PA0361/034/001 - NORADRENALINE ACID 10/12/2011
(NOREPINEPHRINE) Ltd TARTRATE
VALACICLOVIR ACTAVIS Actavis Group PTC ehf PA1380/013/001 Film Coated Tablet - VALACICLOVIR 05/12/2011
HYDROCHLORIDE
MONOHYDRATE
VALACICLOVIR ACTAVIS Actavis Group PTC ehf PA1380/013/003 Tablets - VALACICLOVIR 05/12/2011
HYDROCHLORIDE
MONOHYDRATE
Riluzole Actavis 50 mg film- Actavis Group PTC ehf PA1380/020/001 Film-coated tablet - Riluzole 01/12/2011
coated tablets
LAMISIL AT Novartis Consumer Health PA0030/056/001 Cutaneous Spray Solution - TERBINAFINE 19/10/2011
UK Limited HYDROCHLORIDE
ALISADE 27.5 Glaxo Group Limited EU/1/08/474/1-3 Nasal Spray Suspension - FLUTICASONE FUROATE 18/10/2011
MICROGRAMS/SPRAY (MICRONISED)

Human Medicines Withdrawn Products Page 205 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PREPANDEMIC GlaxoSmithKline Biologicals EU/1/08/478/1 Unknown - PURIFIED ANTIGEN 03/10/2011
INFLUENZA VACCINE FRACTIONS OF
(H5N1) (SPLIT VIRION INACTIVATED SPLIT
VIRIONS
A/VIETNAM/1194/2004
NIBRG-14 (H5N1)
SOLPADEINE SOLUBLE PCO Manufacturing PPA0465/181/001 Tablets - PARACETAMOL 21/09/2011
- CAFFEINE
- CODEINE PHOSPHATE
CARDICOR B & S Healthcare PPA1328/013/005 Tablets - BISOPROLOL FUMARATE 07/09/2011

LAMEUTRAL Teva Pharma B.V. PA0749/020/001 Tablets - LAMOTRIGINE 10/08/2011


LAMEUTRAL Teva Pharma B.V. PA0749/020/002 Tablets - LAMOTRIGINE 10/08/2011
LAMEUTRAL Teva Pharma B.V. PA0749/020/003 Tablets - LAMOTRIGINE 10/08/2011
LAMEUTRAL Teva Pharma B.V. PA0749/020/004 Tablets - LAMOTRIGINE 10/08/2011
MIRTAZAPINE Relon Chem Limited PA1128/006/001 Film Coated Tablet - MIRTAZAPINE 06/07/2011
ONDANSETRON Hospira UK Limited PA0437/053/001 Solution for Injection - ONDANSETRON 29/06/2011
GLYCEMAGER 1 MG McDermott Laboratories Ltd PA0577/075/001 Tablets - GLIMEPIRIDE 22/06/2011
TABLETS t/a Gerard Laboratories
GLYCEMAGER 2 MG McDermott Laboratories Ltd PA0577/075/002 Tablets - GLIMEPIRIDE 22/06/2011
TABLETS t/a Gerard Laboratories
GLYCEMAGER 3 MG McDermott Laboratories Ltd PA0577/075/003 Tablets - GLIMEPIRIDE 22/06/2011
TABLETS t/a Gerard Laboratories
GLYCEMAGER 4 MG McDermott Laboratories Ltd PA0577/075/004 Tablets - GLIMEPIRIDE 22/06/2011
TABLETS t/a Gerard Laboratories
HUMENZA (PANDEMIC Sanofi Pasteur MSD EU/1/10/629/001 Emulsion and suspension for 14/06/2011
INFLUENZA VACCINE emulsion for injection
H1N1)
Eflavex 1 mg Tablets Norton Waterford PA0436/044/001 Tablet - Cabergoline 23/05/2011
Eflavex 2 mg Tablets Norton Waterford PA0436/044/002 Tablet - Cabergoline 23/05/2011
FILGRASTIM RATIOPHARM Ratiopharm GmbH EU/1/08/449/1-4 Solution for Injection - FILGRASTIM 20/04/2011
30 MU/0.5 ML SOLUTION
FOR I
FILGRASTIM RATIOPHARM Ratiopharm GmbH EU/1/08/449/5-8 Solution for Injection - FILGRASTIM 20/04/2011
48 MIU/0.8 ML SOLUTION
FOR I
LIPOFUNDIN MCT/LCT 10% B. Braun Medical Limited PA0179/031/001 Emulsion for Infusion - SOYA OIL 13/04/2011
- TRIGLYCERIDES
LIPOFUNDIN MCT/LCT 20% B. Braun Medical Limited PA0179/031/004 Emulsion for Infusion - SOYA OIL 13/04/2011
- TRIGLYCERIDES
Lamotrigine 100 mg Ranbaxy Ireland Limited PA0408/071/004 Dispersible tablet - Lamotrigine 12/04/2011
Dispersible Tablets
Lamotrigine 200 mg Ranbaxy Ireland Limited PA0408/071/005 Dispersible tablet - Lamotrigine 12/04/2011
Dispersible Tablets
Lamotrigine 25 mg Ranbaxy Ireland Limited PA0408/071/002 Dispersible tablet - Lamotrigine 12/04/2011
Dispersible Tablets
Lamotrigine 50mg Ranbaxy Ireland Limited PA0408/071/003 Dispersible tablet - Lamotrigine 12/04/2011
Dispersible Tablets
DIASTABOL Sanofi-Aventis Ireland PA0540/144/001 Tablets - MIGLITOL 11/04/2011
Limited T/A SANOFI
DIASTABOL Sanofi-Aventis Ireland PA0540/144/002 Tablets - MIGLITOL 11/04/2011
Limited T/A SANOFI
VENLIFT XL Ranbaxy (UK) Limited PA0967/009/004 Prolonged Release Capsules - VENLAFAXINE 11/04/2011

VENLIFT XL Ranbaxy (UK) Limited PA0967/009/005 Prolonged Release Capsules - VENLAFAXINE 11/04/2011

CIPROFLOXACIN REDIBAG Baxter Healthcare Limited PA0167/130/001 Solution for Injection - CIPROFLOXACIN 04/04/2011

YTTRIUM COLLOID CIS bio International PA0677/013/001 Suspension for Injection - YTTRIUM [Y-90] CITRATE 01/04/2011
AIDEX FIRST AID Ovelle Limited PA0206/029/001 Cream - AMINOACRIDINE 31/03/2011
ANTISEPTIC HYDROCHLORIDE
- BENZOCAINE
- PHENOXYETHANOL
ALBUMINATIV Octapharma Limited PA0521/008/001 Solution for Infusion - HUMAN ALBUMIN 31/03/2011
ALBUMINATIV Octapharma Limited PA0521/008/002 Solution for Infusion - HUMAN ALBUMIN 31/03/2011
BISODOL HEARTBURN Forest Laboratories UK Ltd PA0100/048/001 Tablets Chewable - MAGALDRATE 31/03/2011
- ALGINIC ACID
- SODIUM BICARBONATE
DIANEAL PD1 GLUCOSE Baxter Healthcare Limited PA0167/017/001 Solution for peritoneal - GLUCOSE 31/03/2011
1.36% W/V (13.6MG/ML) dialysis - SODIUM CHLORIDE
SOLUTION - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE

Human Medicines Withdrawn Products Page 206 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIANEAL PD1 GLUCOSE Baxter Healthcare Limited PA0167/017/002 Solution for peritoneal - GLUCOSE 31/03/2011
3.86% W/V (38.6 MG/ML) dialysis - SODIUM CHLORIDE
SOLUTIO - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
Invivac 2005/2006, Abbott Healthcare Products PA0108/028/001 Suspension for injection - A/california/7/2004 (h3n2) – 31/03/2011
suspension for injection Ltd like strain
(influenza vaccine, surface - A/new caledonia/20/99
antigen, inactivated, (h1h1)-like strain
virosome) - B/shanghai/361/2002 – like
strain
LOCOID C Astellas Pharma Co. Ltd PA1241/004/001 Cream - HYDROCORTISONE 31/03/2011
BUTYRATE
- CHLORQUINALDOL
LOCOID C Astellas Pharma Co. Ltd PA1241/004/002 Ointment - HYDROCORTISONE 31/03/2011
BUTYRATE
- CHLORQUINALDOL
ALBUMIN HUMAN 200G/L Octapharma Limited PA0521/002/007 Solution for Infusion - ALBUMIN HUMAN 30/03/2011
CLARITHROMYCIN Pliva Pharma Limited PA0585/011/001 Coated Tablets - CLARITHROMYCIN 30/03/2011
CLARITHROMYCIN Pliva Pharma Limited PA0585/011/002 Coated Tablets - CLARITHROMYCIN 30/03/2011
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/018 Solution for Infusion - GLUCOSE 28/03/2011
INFUSION BP 10% W/V
KLACID G & A Licensing Limited PPA1447/034/002 Tablets - CLARITHROMYCIN 24/03/2011
LOSEC MUPS G & A Licensing Limited PPA1447/018/001 Tablets Gastro-Resistant - OMEPRAZOLE 24/03/2011
MAGNESIUM
LOSEC MUPS G & A Licensing Limited PPA1447/018/003 Tablets Gastro-Resistant - OMEPRAZOLE 24/03/2011
MAGNESIUM
ONSENAL Pharmacia-Pfizer EEIG EU/1/03/259/1-6 Capsules Hard - CELECOXIB 24/03/2011
SAVLON ANTISEPTIC G & A Licensing Limited PPA1447/049/001 Cream - CETRIMONIUM BROMIDE 24/03/2011
- CHLORHEXIDINE
GLUCONATE

VOLTAROL RETARD G & A Licensing Limited PPA1447/062/002 Film Coated Tablet - DICLOFENAC SODIUM 24/03/2011
ZANTAC G & A Licensing Limited PPA1447/061/001 Film Coated Tablet - RANITIDINE 24/03/2011
HYDROCHLORIDE
ZANTAC G & A Licensing Limited PPA1447/061/002 Film Coated Tablet - RANITIDINE 24/03/2011
HYDROCHLORIDE
RISPERDAL QUICKLET PCO Manufacturing PPA0465/078/007 Orodispersible Tablet - RISPERIDONE 23/03/2011
ALBUMIN HUMAN 50G/L Octapharma Limited PA0521/002/001 Solution for Infusion - ALBUMIN HUMAN 18/03/2011
ACCOLATE B & S Healthcare PPA1328/044/001 Film Coated Tablet - ZAFIRLUKAST 16/03/2011
AMARYL B & S Healthcare PPA1328/048/002 Tablets - GLIMEPIRIDE 16/03/2011
BECONASE AQUEOUS B & S Healthcare PPA1328/019/001 Nasal Spray Suspension - BECLOMETASONE 16/03/2011
DIPROPIONATE
BETALOC B & S Healthcare PPA1328/020/002 Tablets - METOPROLOL TARTRATE 16/03/2011

BETALOC B & S Healthcare PPA1328/053/001 Tablet Prolonged Release - METOPROLOL TARTRATE 16/03/2011

CAPOTEN B & S Healthcare PPA1328/056/001 Tablets - CAPTOPRIL 16/03/2011


CELEBREX 100 MG B & S Healthcare PPA1328/057/001 Capsule - CELECOXIB 16/03/2011
CAPSULES.
COVERSYL B & S Healthcare PPA1328/022/001 Tablets - PERINDOPRIL TERT- 16/03/2011
BUTYLAMINE SALT
DAONIL B & S Healthcare PPA1328/060/001 Tablets - GLIBENCLAMIDE 16/03/2011
DETRUSITOL B & S Healthcare PPA1328/061/001 Film Coated Tablet - TOLTERODINE L- 16/03/2011
TARTRATE
DETRUSITOL B & S Healthcare PPA1328/061/002 Film Coated Tablet - TOLTERODINE L- 16/03/2011
TARTRATE
DIAMICRON MR B & S Healthcare PPA1328/010/002 Modified-release Tablets - GLICLAZIDE 16/03/2011
IMDUR B & S Healthcare PPA1328/009/001 Tablet Prolonged Release - ISOSORBIDE 16/03/2011
MONONITRATE
LIVIAL B & S Healthcare PPA1328/006/001 Tablets - TIBOLONE 16/03/2011
SOLARAZE B & S Healthcare PPA1328/062/001 Gel - DICLOFENAC SODIUM 16/03/2011
ZYDOL B & S Healthcare PPA1328/008/001 Capsules Hard - TRAMADOL 16/03/2011
HYDROCHLORIDE
WOODWARDS GRIPE SSL International PLC PA0618/020/001 - SODIUM BICARBONATE 03/03/2011
WATER ALCOHOL FREE - DILL SEED OIL
TERPENELESS
GERMOLENE FIRST AID G & A Licensing Limited PPA1447/048/001 Cream - PHENOL 02/03/2011
- CHLORHEXIDINE
DIGLUCONATE (AS
CHLORHEXIDINE
DIGLUCONATE SOLUTION
(20% W/V) PH.EUR.

Human Medicines Withdrawn Products Page 207 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MST CONTINUS Napp Pharmaceuticals PA0913/005/005 Tablet Prolonged Release - MORPHINE SULFATE 28/02/2011
Limited
LIPITOR McDowell Pharmaceuticals PPA1473/002/001 Film Coated Tablet - ATORVASTATIN-CALCIUM 22/02/2011

LIPITOR McDowell Pharmaceuticals PPA1473/002/002 Film Coated Tablet - ATORVASTATIN-CALCIUM 22/02/2011

LIPITOR McDowell Pharmaceuticals PPA1473/002/003 Film Coated Tablet - ATORVASTATIN-CALCIUM 22/02/2011

SORBISTERIT Fresenius Medical Care PA1350/002/001 Powder for Oral Suspension - CALCIUM POLYSTYRENE 22/02/2011
Nephrologica Deutschland SULFONATE
GmbH
ADIZEM-XL Napp Pharmaceuticals PA0913/014/008 Prolonged Release Capsules - DILTIAZEM 18/02/2011
Limited HYDROCHLORIDE
IMITAG Pliva Pharma Limited PA0585/023/001 Tablets - SUMATRIPTAN 11/02/2011
SUCCINATE
IMITAG Pliva Pharma Limited PA0585/023/002 Tablets - SUMATRIPTAN 11/02/2011
SUCCINATE
MODAFINIL TEVA Teva Pharma B.V. PA0749/018/001 Tablets - MODAFINIL 11/02/2011
SODIUM CHLORIDE Organon Laboratories PA0261/029/001 Solvent for Parenteral Use - SODIUM CHLORIDE 03/02/2011
Limited
NANOTIV Octapharma Limited PA0521/010/001 Pdr+Solv for Soln for Inj - FACTOR IX, HUMAN 01/02/2011
NANOTIV Octapharma Limited PA0521/010/002 Pdr+Solv for Soln for Inj - FACTOR IX, HUMAN 01/02/2011
LESCOL B & S Healthcare PPA1328/131/002 Capsule - FLUVASTATIN SODIUM 24/01/2011
LESCOL B & S Healthcare PPA1328/131/003 Capsule - FLUVASTATIN SODIUM 24/01/2011
CIPRAMIL B & S Healthcare PPA1328/021/001 Tablets - CITALOPRAM 21/01/2011
HYDROBROMIDE’
FAMLOV Arrow Generics Limited PA1130/013/004 Film Coated Tablet - FAMCICLOVIR 20/01/2011
MOOV HEAD LICE Ego Pharmaceuticals (UK) PA0863/007/001 Cutaneous Solution - EUCALYPTUS GLOBULUS 20/01/2011
Limited
BETALOC B & S Healthcare PPA1328/020/001 Tablets - METOPROLOL TARTRATE 11/01/2011

CIPRAMIL B & S Healthcare PPA1328/021/002 Tablets - CITALOPRAM 11/01/2011


DOVONEX B & S Healthcare PPA1328/023/001 Ointment - CALCIPOTRIOL 11/01/2011
IKOREL B & S Healthcare PPA1328/025/001 Tablets - NICORANDIL 11/01/2011
PROTIUM B & S Healthcare PPA1328/001/001 Tablets Gastro-Resistant 11/01/2011
TEVARYL 4MG TABLETS Teva Pharma B.V. PA0749/058/001 Tablets - PERINDOPRIL TERT- 11/01/2011
BUTYLAMINE
TEVARYL 8MG TABLETS Teva Pharma B.V. PA0749/058/002 Tablets - PERINDOPRIL ERBUMINE 11/01/2011

ZYVOX Pharmacia Healthcare PA0936/011/002 Film Coated Tablet - LINEZOLID 03/01/2011


Ireland
ZAMADOL MEDA Pharmaceuticals Ltd PA1058/008/006 Solution for Injection - TRAMADOL 01/01/2011
HYDROCHLORIDE
ATROVENT 250 UDVS 250 PCO Manufacturing PPA0465/173/003 Nebuliser Solution - IPRATROPIUM BROMIDE 31/12/2010
MICROGRAMS/ 1ML
NEBULISER SOLUTION
BECONASE 50 PCO Manufacturing PPA0465/072/001A Nasal Spray Suspension - BECLOMETASONE 31/12/2010
MICROGRAMS AQUEOUS DIPROPIONATE
NASAL SPRAY MONOHYDRATE
CAPOZIDE PCO Manufacturing PPA0465/043/001A Tablets - CAPTOPRIL 31/12/2010
- HYDROCHLOROTHIAZIDE

DELTACORTRIL ENTERIC PCO Manufacturing PPA0465/179/002 Tablets - PREDNISOLONE 31/12/2010


DIAMICRON MR PCO Manufacturing PPA0465/045/002A Modified-release Tablets - GLICLAZIDE 31/12/2010
EFEXOR PCO Manufacturing PPA0465/085/002A Tablets - VENLAFAXINE 31/12/2010
HYDROCHLORIDE
LIORESAL PCO Manufacturing PPA0465/054/001A Tablets - BACLOFEN 31/12/2010
MOBIC PCO Manufacturing PPA0465/112/002A Tablets - MELOXICAM 31/12/2010
NAPROSYN EC 500MG PCO Manufacturing PPA0465/031/004A Tablets Gastro-Resistant - NAPROXEN 31/12/2010
TABLETS
NATRILIX SR PCO Manufacturing PPA0465/219/001 Tablet Prolonged Release - INDAPAMIDE 31/12/2010
NOLVADEX D PCO Manufacturing PPA0465/133/001A Film Coated Tablet - TAMOXIFEN CITRATE 31/12/2010
REDUCTIL PCO Manufacturing PPA0465/208/001 Capsules Hard - SIBUTRAMINE 31/12/2010
HYDROCHLORIDE
MONOHYDRATE
REDUCTIL PCO Manufacturing PPA0465/208/002 Capsules Hard - SIBUTRAMINE 31/12/2010
HYDROCHLORIDE
MONOHYDRATE
REQUIP PCO Manufacturing PPA0465/174/001 Tablets - ROPINIROLE 31/12/2010
HYDROCHLORIDE
REQUIP PCO Manufacturing PPA0465/174/002 Tablets - ROPINIROLE 31/12/2010
HYDROCHLORIDE
REQUIP PCO Manufacturing PPA0465/174/003 Tablets - ROPINIROLE 31/12/2010
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 208 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SELECTOL PCO Manufacturing PPA0465/121/001A Tablets - CELIPROLOL 31/12/2010
HYDROCHLORIDE
SELECTOL PCO Manufacturing PPA0465/121/002A Tablets - CELIPROLOL 31/12/2010
HYDROCHLORIDE
SERC PCO Manufacturing PPA0465/005/001A Tablets - BETAHISTINE 31/12/2010
HYDROCHLORIDE
SERC PCO Manufacturing PPA0465/005/002 Tablets - BETAHISTINE 31/12/2010
DIHYDROCHLORIDE
SEROXAT PCO Manufacturing PPA0465/055/003 Film Coated Tablet - PAROXETINE 31/12/2010
HYDROCHLORIDE
HEMIHYDRATE
STEMETIL PCO Manufacturing PPA0465/238/001 Tablets - PROCHLORPERAZINE 31/12/2010
MALEATE
VENTOLIN NEBULES PCO Manufacturing PPA0465/064/002 Nebuliser Solution - SALBUTAMOL SULFATE 31/12/2010
ZINNAT PCO Manufacturing PPA0465/123/001A Film Coated Tablet - CEFUROXIME AXETIL 31/12/2010
ZINNAT PCO Manufacturing PPA0465/123/002 Tablets - CEFUROXIME AXETIL 31/12/2010
ZOFRAN ZYDIS PCO Manufacturing PPA0465/113/003 Oral Lyophilisate - ONDANSETRON 31/12/2010
ZOFRAN ZYDIS PCO Manufacturing PPA0465/113/004 Oral Lyophilisate - ONDANSETRON 31/12/2010
ZYBAN PCO Manufacturing PPA0465/089/001A Tablets - AMFEBUTAMONE 31/12/2010
HYDROCHLORIDE
ALUPENT Boehringer Ingelheim Limited PA0007/015/004 Syrup - ORCIPRENALINE 17/12/2010
SULFATE
ESCITALOPRAM Pliva Pharma Limited PA0585/037/001 Film Coated Tablet - ESCITALOPRAM 17/12/2010
ESCITALOPRAM Pliva Pharma Limited PA0585/037/002 Film Coated Tablet - ESCITALOPRAM 17/12/2010
ESCITALOPRAM Pliva Pharma Limited PA0585/037/003 Film Coated Tablet - ESCITALOPRAM 17/12/2010
ESCITALOPRAM Pliva Pharma Limited PA0585/037/004 Film Coated Tablet - ESCITALOPRAM 17/12/2010
FLIXONASE AQUEOUS PCO Manufacturing PPA0465/167/001 Nasal Spray Suspension - FLUTICASONE 15/12/2010
PROPIONATE
GLICLAZIDE ACTAVIS Actavis Group PTC ehf PA1380/075/001 Tablets - GLICLAZIDE 15/12/2010
SEGLICOL MR ESP Pharma Limited PA1505/003/001 Modified-release Tablets - GLICLAZIDE 15/12/2010
SUSTAC Chemidex Pharma Limited PA1161/006/001 Tablets - GLYCERYL TRINITRATE 14/12/2010
SUSTAC Chemidex Pharma Limited PA1161/006/002 Tablets - GLYCERYL TRINITRATE 14/12/2010
CEFAGER McDermott Laboratories Ltd PA0577/045/001 Powder for Oral Suspension - CEFACLOR 12/12/2010
t/a Gerard Laboratories MONOHYDRATE
CEFAGER McDermott Laboratories Ltd PA0577/045/002 Powder for Oral Suspension - CEFACLOR 12/12/2010
t/a Gerard Laboratories MONOHYDRATE
ANASTROZOLE Pliva Pharma Limited PA0585/036/001 Film Coated Tablet - ANASTROZOLE 10/12/2010
CITALOPRAM Pliva Pharma Limited PA0585/018/001 Tablets - CITALOPRAM 10/12/2010
CITALOPRAM Pliva Pharma Limited PA0585/018/002 Tablets - CITALOPRAM 10/12/2010
CITALOPRAM Pliva Pharma Limited PA0585/018/003 Tablets - CITALOPRAM 10/12/2010
FLUVASTATIN TEVA Teva Pharma B.V. PA0749/043/001 Capsule - FLUVASTATIN SODIUM 10/12/2010
FLUVASTATIN TEVA Teva Pharma B.V. PA0749/043/002 Capsule - FLUVASTATIN SODIUM 10/12/2010
GABAPENTIN Pliva Pharma Limited PA0585/034/001 Film Coated Tablet - GABAPENTIN 10/12/2010
GABAPENTIN Pliva Pharma Limited PA0585/034/002 Film Coated Tablet - GABAPENTIN 10/12/2010
ADARTREL GlaxoSmithKline (Ireland) PA1077/106/001 Film Coated Tablet - ROPINIROLE 09/12/2010
Limited HYDROCHLORIDE
ADARTREL GlaxoSmithKline (Ireland) PA1077/106/002 Film Coated Tablet - ROPINIROLE 09/12/2010
Limited HYDROCHLORIDE
ADARTREL GlaxoSmithKline (Ireland) PA1077/106/004 Film Coated Tablet - ROPINIROLE 09/12/2010
Limited HYDROCHLORIDE
BATRAFEN Sanofi-Aventis Ireland PA0540/032/001 Cream - CICLOPIROX OLAMINE 09/12/2010
Limited T/A SANOFI
BATRAFEN Sanofi-Aventis Ireland PA0540/032/006 Cutaneous Solution - CICLOPIROX OLAMINE 09/12/2010
Limited T/A SANOFI
VENTOLIN GlaxoSmithKline (Ireland) PA1077/049/013 Tablets - SALBUTAMOL SULFATE 09/12/2010
Limited
VENTOLIN GlaxoSmithKline (Ireland) PA1077/049/014 Tablets - SALBUTAMOL SULFATE 09/12/2010
Limited
VENTOLIN RESPIRATOR GlaxoSmithKline (Ireland) PA1077/049/006 Nebuliser Solution - SALBUTAMOL SULFATE 09/12/2010
SOLUTION Limited
POTTER’S SKIN CLEAR Potters (Herbal Supplies) Ltd PA0471/011/001 Ointment - STARCH 07/12/2010
OINTMENT - SULFUR
- ZINC OXIDE
ATACAND AstraZeneca UK Limited PA0970/030/001 Tablets - CANDESARTAN 01/12/2010
CILEXETIL
ATACAND AstraZeneca UK Limited PA0970/030/005 Tablets - CANDESARTAN 01/12/2010
CILEXETIL
CICATRIN GlaxoSmithKline (Ireland) PA1077/054/001 Cream - NEOMYCIN SULFATE 01/12/2010
Limited - BACITRACIN ZINC
- CYSTEINE
- THREONINE
- AMINOACETIC ACID

Human Medicines Withdrawn Products Page 209 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CICATRIN GlaxoSmithKline (Ireland) PA1077/054/002 Cutaneous Powder - NEOMYCIN SULFATE 01/12/2010
Limited - BACITRACIN ZINC
- CYSTEINE
- THREONINE
- AMINOACETIC ACID
IMDUR PROLONGED- AstraZeneca UK Limited PA0970/041/001 Film Coated Tablet - ISOSORBIDE 01/12/2010
RELEASE MONONITRATE
SEROQUEL AstraZeneca UK Limited PA0970/018/006 Film Coated Tablet - QUETIAPINE FUMARATE 01/12/2010
OMEPRAZOLE Actavis Group PTC ehf PA1380/077/002 Capsules Gastro-Resistant - OMEPRAZOLE 30/11/2010
OMEPRAZOLE Actavis Group PTC ehf PA1380/077/003 Capsule - OMEPRAZOLE 30/11/2010
ZOLMILES Actavis Group PTC ehf PA1380/035/004 Orodispersible Tablet - ZOLMITRIPTAN 30/11/2010
NUTRIZYM 10,000 E. Merck Ltd PA0054/064/002 Capsule - PANCREATIN 26/11/2010
NUTRIZYM 22,000 E. Merck Ltd PA0054/064/003 Capsule - PANCREATIN 26/11/2010
PECTODRILL FOR CHESTY Pierre Fabre Medicament PA0329/009/001 Oral Solution - CARBOCISTEINE 25/11/2010
COUGHS
TUSSIDRILL SUGAR-FREE Pierre Fabre Medicament PA0329/009/003 Oral Solution - DEXTROMETHORPHAN 25/11/2010
FOR DRY COUGHS HYDROBROMIDE
LEXAPRO H. Lundbeck A/S PA0805/002/005 Oral Drops Solution - ESCITALOPRAM 15/11/2010
COMBIVENT METERED Boehringer Ingelheim Limited PA0007/052/001 Pressurised Inhalation - IPRATROPIUM BROMIDE 12/11/2010
AEROSOL 20 Suspension - SALBUTAMOL SULFATE
MICROGRAMS/100
MICROG
MONURIL Zambon S.p.A. PA1441/002/001 Granules for oral solution - FOSFOMYCIN 12/11/2010
TROMETAMOL
CLOPIDOGREL ROWEX Rowex Ltd PA0711/167/001 Film Coated Tablet - CLOPIDOGREL BESILATE 11/11/2010

PANADOL EXTRA PCO Manufacturing PPA0465/157/001 Film Coated Tablet - PARACETAMOL 05/11/2010
- CAFFEINE
BISODOL ANTACID Forest Laboratories UK Ltd PA0100/047/003 Powder for Oral Suspension - SODIUM HYDROGEN 04/11/2010
CARBONATE
- MAGNESIUM
CARBONATE LIGHT
- MAGNESIUM
CARBONATE HEAVY
FOSALEN Pliva Pharma Limited PA0585/025/001 Tablets - ALENDRONIC ACID 04/11/2010
Panretin Amdipharm Limited EU/1/00/149/001 Gel - Alitretinoin 03/11/2010
NOLVADEX D B & S Healthcare PPA1328/109/001 Tablets - TAMOXIFEN 01/11/2010
PROSCAR IMED Healthcare Ltd. PPA1463/013/001 Film Coated Tablet - FINASTERIDE 01/11/2010
VENLIFT Ranbaxy (UK) Limited PA0967/009/001 Tablets - VENLAFAXINE 01/11/2010
HYDROCHLORIDE
VENLIFT Ranbaxy (UK) Limited PA0967/009/002 Tablets - VENLAFAXINE 01/11/2010
HYDROCHLORIDE
AEROLIN AUTOHALER Norton Waterford PA0436/034/001 Pressurised Inhalation - SALBUTAMOL SULFATE 31/10/2010
CFC-FREE 100 Suspension
MICROGRAMS PER METE
AIROMIR AUTOHALER 100 Norton Waterford PA0436/033/002 Pressurised Inhalation - SALBUTAMOL SULFATE 31/10/2010
MICROGRAMS PER Suspension
METERED DOSE,
BEROTEC 100 INHALER Boehringer Ingelheim Limited PA0007/033/005 Inhalation solution - FENOTEROL 31/10/2010
CFC-FREE HYDROBROMIDE
MESULID Sinclair IS Pharma Limited PA0915/001/003 Gel - NIMESULIDE 31/10/2010
KETAMINE hameln pharma r&d gmbh PA1267/001/003 Solution for Inj/Inf - KETAMINE 20/10/2010
KETAMINE hameln pharma r&d gmbh PA1267/001/001 Solution for Inj/Inf - KETAMINE 20/10/2010
KETAMINE MULTIDOSE hameln pharma r&d gmbh PA1267/001/002 Solution for Inj/Inf - KETAMINE 20/10/2010
KETAMINE MULTIDOSE hameln pharma r&d gmbh PA1267/001/004 Solution for Inj/Inf - KETAMINE 20/10/2010
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/096/003 Solution for Infusion - GLUCOSE 16/10/2010
INFUSION BP
ALLURENE Bayer Limited PA1410/014/001 Film Coated Tablet - ESTRADIOL 15/10/2010
- DROSPIRENONE
AUGMENTIN McDowell Pharmaceuticals PPA1473/015/001 Film Coated Tablet - CO-AMOXICLAV 13/10/2010
COZAAR McDowell Pharmaceuticals PPA1473/017/001 Film Coated Tablet - LOSARTAN POTASSIUM 13/10/2010
DIAMICRON MR McDowell Pharmaceuticals PPA1473/031/001 Modified-release Tablets - GLICLAZIDE 13/10/2010
NIZORAL McDowell Pharmaceuticals PPA1473/010/001 Shampoo - KETOCONAZOLE 13/10/2010
PROSCAR McDowell Pharmaceuticals PPA1473/008/001 Film Coated Tablet - FINASTERIDE 13/10/2010
PROTIUM McDowell Pharmaceuticals PPA1473/003/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 13/10/2010
SESQUIHYDRATE

PROTIUM McDowell Pharmaceuticals PPA1473/003/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 13/10/2010


SESQUIHYDRATE

ZYDOL McDowell Pharmaceuticals PPA1473/036/001 Capsules Hard - TRAMADOL 13/10/2010


HYDROCHLORIDE
KENALOG Bristol-Myers Squibb PA0002/023/001 Suspension for Injection - TRIAMCINOLONE 12/10/2010
Pharmaceuticals uc ACETONIDE

Human Medicines Withdrawn Products Page 210 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BECONASE AQUEOUS Primecrown Ltd. PPA1071/011/001A Nasal Spray Suspension - BECLOMETASONE 07/10/2010
DIPROPIONATE
COVERSYL Primecrown Ltd. PPA1071/003/001A Tablets - PERINDOPRIL TERT- 07/10/2010
BUTYLAMINE SALT
IMDUR Primecrown Ltd. PPA1071/005/001A Tablets - ISOSORBIDE 07/10/2010
MONONITRATE
SEREVENT INHALER Primecrown Ltd. PPA1071/004/001A Pressurised Inhalation - SALMETEROL 07/10/2010
Suspension XINAFOATE
VENTOLIN EVOHALER Primecrown Ltd. PPA1071/007/001A Pressurised Inhalation - SALBUTAMOL SULFATE 07/10/2010
Suspension
ZANTAC Primecrown Ltd. PPA1071/009/002A Coated Tablets - RANITIDINE 07/10/2010
HYDROCHLORIDE
ZANTAC TABLETS 150 MG Primecrown Ltd. PPA1071/009/001A Coated Tablets - RANITIDINE 07/10/2010
HYDROCHLORIDE
ZESTRIL Primecrown Ltd. PPA1071/002/001A Tablets - LISINOPRIL DIHYDRATE 07/10/2010
ZESTRIL Primecrown Ltd. PPA1071/002/001B Tablets - LISINOPRIL DIHYDRATE 07/10/2010
ZESTRIL Primecrown Ltd. PPA1071/002/002A Tablets - LISINOPRIL DIHYDRATE 07/10/2010
DOPACARD Cephalon Limited PA1260/004/001 Concentrate for Soln for Inf - DOPEXAMINE 01/10/2010
HYDROCHLORIDE
LOSEC MUPS 10MG IMED Healthcare Ltd. PPA1463/021/001 Tablets Gastro-Resistant - OMEPRAZOLE 01/10/2010
GASTRO-RESISTANT MAGNESIUM
TABLETS
LOSEC MUPS McDowell Pharmaceuticals PPA1473/019/001 Tablets Gastro-Resistant - OMEPRAZOLE 29/09/2010
MAGNESIUM
LOSEC MUPS McDowell Pharmaceuticals PPA1473/019/002 Tablets Gastro-Resistant - OMEPRAZOLE 29/09/2010
MAGNESIUM
LOSEC MUPS McDowell Pharmaceuticals PPA1473/019/003 Tablets Gastro-Resistant - OMEPRAZOLE 29/09/2010
MAGNESIUM
NCH 14 MG/24 HOURS Novartis Consumer Health PA0030/021/011 Transdermal Patch - NICOTINE 22/09/2010
TRANSDERMAL PATCH UK Limited
NCH 21 MG/24 HOURS Novartis Consumer Health PA0030/021/012 Transdermal Patch - NICOTINE 22/09/2010
TRANSDERMAL PATCH UK Limited
NCH 7 MG/24 HOURS Novartis Consumer Health PA0030/021/010 Transdermal Patch - NICOTINE 22/09/2010
TRANSDERMAL PATCH UK Limited
VELEXOR Ranbaxy (UK) Limited PA0967/017/001 Prolonged Release Capsules - VENLAFAXINE 20/09/2010
HYDROCHLORIDE
VENLIFT XL Ranbaxy (UK) Limited PA0967/009/003 Prolonged Release Capsules - VENLAFAXINE 20/09/2010

AIROMIR INHALER 100 Norton Waterford PA0436/033/001 Pressurised Inhalation - SALBUTAMOL SULFATE 17/09/2010
MICROGRAMS PER Suspension
METERED DOSE PR
CARDURA PCO Manufacturing PPA0465/063/002A Tablets - DOXAZOSIN MESILATE 17/09/2010
EIRONIL Pliva Pharma Limited PA0585/032/001 Film Coated Tablet - ROPINIROLE (AS 17/09/2010
HYDROCHLORIDE)
EIRONIL Pliva Pharma Limited PA0585/032/002 Film Coated Tablet - ROPINIROLE (AS 17/09/2010
HYDROCHLORIDE)
EIRONIL Pliva Pharma Limited PA0585/032/003 Film Coated Tablet - ROPINIROLE (AS 17/09/2010
HYDROCHLORIDE)
EIRONIL Pliva Pharma Limited PA0585/032/004 Film Coated Tablet - ROPINIROLE (AS 17/09/2010
HYDROCHLORIDE)
EIRONIL Pliva Pharma Limited PA0585/032/005 Tablets - ROPINIROLE (AS 17/09/2010
HYDROCHLORIDE)
ROPINIROLE TEVA Teva Pharma B.V. PA0749/074/001 Film Coated Tablet - ROPINIROLE 17/09/2010
ROPINIROLE TEVA Teva Pharma B.V. PA0749/074/002 Film Coated Tablet - ROPINIROLE 17/09/2010
ROPINIROLE TEVA Teva Pharma B.V. PA0749/074/003 Film Coated Tablet - ROPINIROLE 17/09/2010
TRITAZIDE Sanofi-Aventis Ireland PA0540/085/001 Tablets - RAMIPRIL 17/09/2010
Limited T/A SANOFI - HYDROCHLOROTHIAZIDE

Full Marks Mousse SSL International plc PA1138/005/002 Cutaneous foam - Phenothrin 16/09/2010
MAXEPA Seven Seas Ltd PA0417/001/001 Capsules, Soft - EICOSAPENTAENOIC 16/09/2010
ACID
- DOCOSAHEXANOIC ACID

MAXEPA LIQUID Seven Seas Ltd PA0417/001/002 Unknown - EICOSAPENTAENOIC 16/09/2010


ACID
- DOCOSAHEXANOIC ACID

BEXMIRT Ergha Healthcare Ltd PA0966/017/001 Orodispersible Tablet - MIRTAZAPINE 15/09/2010


BEXMIRT Ergha Healthcare Ltd PA0966/017/002 Orodispersible Tablet - MIRTAZAPINE 15/09/2010
BEXMIRT Ergha Healthcare Ltd PA0966/017/003 Orodispersible Tablet - MIRTAZAPINE 15/09/2010
ETRIVEX Galderma (UK) Ltd PA0590/022/001 Cutaneous Emulsion - CLOBETASOL 15/09/2010
PROPIONATE
MINIMS Chauvin Pharmaceuticals PA0118/012/002 Eye Drops Solution - CYCLOPENTOLATE 15/09/2010
CYCLOPENTOLATE Limited HYDROCHLORIDE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 211 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BECLO-RHINO ALLERGY Mercury Pharmaceuticals Ltd PA0899/017/002 Nasal Spray Suspension - BECLOMETASONE 14/09/2010

CARDILATE 10MG Norton Healthcare Limited PA0282/070/001 Tablets - NIFEDIPINE 14/09/2010


T/A IVAX Pharmaceuticals
UK
CARDILATE 20MG Norton Healthcare Limited PA0282/070/002 Tablets - NIFEDIPINE 14/09/2010
T/A IVAX Pharmaceuticals
UK
CARDILATE XL 40MG Norton Healthcare Limited PA0282/070/003 Tablets - NIFEDIPINE 14/09/2010
T/A IVAX Pharmaceuticals
UK
FENTAZIN 2MG COATED Mercury Pharmaceuticals Ltd PA0899/029/001 Coated Tablets - PERPHENAZINE 14/09/2010
TABLETS
GRANISETRON TEVA Teva Pharma B.V. PA0749/027/001 Film Coated Tablet - GRANISETRON 14/09/2010
HYDROCHLORIDE
GRANISETRON TEVA Teva Pharma B.V. PA0749/027/002 Film Coated Tablet - GRANISETRON 14/09/2010
HYDROCHLORIDE
NAROPIN AstraZeneca UK Limited PA0970/047/001 Solution for Infusion - ROPIVACAINE 14/09/2010
HYDROCHLORIDE
NAROPIN AstraZeneca UK Limited PA0970/047/009 Solution for Injection - ROPIVACAINE 14/09/2010
HYDROCHLORIDE
SIMVASTATIN Teva UK Limited PA0237/061/001 Tablets - SIMVASTATIN 14/09/2010
SUMATRIPTAN TEVA Teva Pharma B.V. PA0749/037/001 Film Coated Tablet - SUMATRIPTAN 14/09/2010
SUMATRIPTAN TEVA Teva Pharma B.V. PA0749/037/002 Film Coated Tablet - SUMATRIPTAN 14/09/2010
UFT Merck Serono Limited PA0654/017/001 Capsules Hard - TEGAFUR 14/09/2010
- URACIL
ALFUZOSIN WINTHROP Sanofi-Aventis Ireland PA0540/163/001 Tablet Prolonged Release - ALFUZOSIN 10/09/2010
10MG PROLONGED Limited T/A SANOFI HYDROCHLORIDE
RELEASE TABLETS
ALLOPURINOL TABLETS Ranbaxy Ireland Limited PA0408/013/001 Tablets - ALLOPURINOL 10/09/2010
BP 100MG
ALLOPURINOL TABLETS Ranbaxy Ireland Limited PA0408/013/002 Tablets - ALLOPURINOL 10/09/2010
BP 300MG
CELIPROLOL Ranbaxy Ireland Limited PA0408/058/001 Film Coated Tablet - CELIPROLOL 10/09/2010
HYDROCHLORIDE HYDROCHLORIDE
CELIPROLOL Ranbaxy Ireland Limited PA0408/058/002 Film Coated Tablet - CELIPROLOL 10/09/2010
HYDROCHLORIDE HYDROCHLORIDE
CODEINE PHOSPHATE Ranbaxy Ireland Limited PA0408/042/001 Tablets - CODEINE PHOSPHATE 10/09/2010
TABLETS BP 15 MG
CODEINE PHOSPHATE Ranbaxy Ireland Limited PA0408/042/002 Tablets - CODEINE PHOSPHATE 10/09/2010
TABLETS BP 30 MG
CODEINE PHOSPHATE Ranbaxy Ireland Limited PA0408/042/003 Tablets - CODEINE PHOSPHATE 10/09/2010
TABLETS BP 60 MG
ELOXATIN Sanofi-Aventis Ireland PA0540/148/002 Powder for solution for - OXALIPLATIN 10/09/2010
Limited T/A SANOFI infusion
EPI-CHRONO 200 MG Sanofi-Aventis Ireland PA0540/149/001 Prolonged Release Capsules - VALPROATE SODIUM 10/09/2010
PROLONGED-RELEASE Limited T/A SANOFI - VALPROIC ACID
TABLETS
EPI-CHRONO 300 MG Sanofi-Aventis Ireland PA0540/149/002 Prolonged Release Capsules - VALPROATE SODIUM 10/09/2010
PROLONGED-RELEASE Limited T/A SANOFI - VALPROIC ACID
TABLETS
EPI-CHRONO 500 MG Sanofi-Aventis Ireland PA0540/149/003 Prolonged Release Capsules - VALPROATE SODIUM 10/09/2010
PROLONGED-RELEASE Limited T/A SANOFI - VALPROIC ACID
TABLETS
NITRAZEPAM Ranbaxy Ireland Limited PA0408/026/001 Tablets - NITRAZEPAM 10/09/2010
OXALIPLATIN WINTHROP Sanofi-Aventis Ireland PA0540/153/001 Concentrate for Soln for Inf - OXALIPLATIN 10/09/2010
Limited T/A SANOFI
OXALIPLATIN WINTHROP Sanofi-Aventis Ireland PA0540/153/002 Powder for solution for - OXALIPLATIN 10/09/2010
Limited T/A SANOFI infusion
RIMA 10 Ranbaxy Ireland Limited PA0408/002/001 Capsules Hard - CHLORDIAZEPOXIDE 10/09/2010
CHLORDIAZEPOXIDE HYDROCHLORIDE
RIMACILLIN Ranbaxy Ireland Limited PA0408/001/004 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE 10/09/2010

RIMACILLIN Ranbaxy Ireland Limited PA0408/001/001 Capsules Hard - AMPICILLIN TRIHYDRATE 10/09/2010

RIMACILLIN Ranbaxy Ireland Limited PA0408/001/002 Capsules Hard - AMPICILLIN TRIHYDRATE 10/09/2010

RIMADOL PARACETAMOL Ranbaxy Ireland Limited PA0408/004/001 Tablets - PARACETAMOL 10/09/2010


RIMAPAM DIAZEPAM BP Ranbaxy Ireland Limited PA0408/006/001 Tablets - DIAZEPAM 10/09/2010
RIMAPAM DIAZEPAM BP Ranbaxy Ireland Limited PA0408/006/002 Tablets - DIAZEPAM 10/09/2010
RIMAPAM DIAZEPAM BP Ranbaxy Ireland Limited PA0408/006/003 Tablets - DIAZEPAM 10/09/2010
RIMATIDINE Ranbaxy Ireland Limited PA0408/029/001 Film Coated Tablet - CIMETIDINE 10/09/2010
RIMATIDINE Ranbaxy Ireland Limited PA0408/029/002 Film Coated Tablet - CIMETIDINE 10/09/2010
RIMOXALLIN Ranbaxy Ireland Limited PA0408/012/003 Capsules Hard - AMOXICILLIN 10/09/2010
TRIHYDRATE

Human Medicines Withdrawn Products Page 212 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RIMOXALLIN Ranbaxy Ireland Limited PA0408/012/004 Capsules Hard - AMOXICILLIN 10/09/2010
TRIHYDRATE
SERTRALINE RANBAXY Ranbaxy Ireland Limited PA0408/059/001 Film Coated Tablet - SERTRALINE 10/09/2010
HYDROCHLORIDE
SERTRALINE RANBAXY Ranbaxy Ireland Limited PA0408/059/002 Film Coated Tablet - SERTRALINE 10/09/2010
HYDROCHLORIDE
VELOSEF Bristol-Myers Squibb PA0002/014/009 Pdr for Soln Inj/Inf - CEFRADINE 08/09/2010
Pharmaceuticals uc
VELOSEF Bristol-Myers Squibb PA0002/014/010 Pdr for Soln Inj/Inf - CEFRADINE 08/09/2010
Pharmaceuticals uc - ARGININE
VELOSEF 250 MG HARD Bristol-Myers Squibb PA0002/014/001 Capsules Hard - CEFRADINE 08/09/2010
CAPSULES Pharmaceuticals uc
VELOSEF 500 MG HARD Bristol-Myers Squibb PA0002/014/002 Capsules Hard - CEFRADINE 08/09/2010
CAPSULES Pharmaceuticals uc
VELOSEF SYRUP Bristol-Myers Squibb PA0002/014/004 Powder for Oral Suspension - CEFRADINE 08/09/2010
Pharmaceuticals uc
GEMABIN Rowex Ltd PA0711/112/001 Powder for solution for - GEMCITABINE 07/09/2010
infusion
GEMABIN Rowex Ltd PA0711/112/002 Powder for solution for - GEMCITABINE 07/09/2010
infusion HYDROCHLORIDE
DELSYM Bayer Limited PA1410/043/001 Oral Suspension - DEXTROMETHORPHAN 02/09/2010
HYDROBROMIDE
RIMCURE Sandoz GmbH PA0111/006/001 Film Coated Tablet - RIFAMPICIN 02/09/2010
- ISONIAZID
- PYRAZINAMIDE
ALOMIDE ALLERGY 0.1% Alcon Laboratories (UK) Ltd PA0290/063/002 Eye Drops Solution - LODOXAMIDE 01/09/2010
W/V EYE DROPS,
SOLUTION
TRANSVASIN HEAT RUB Thornton & Ross Limited PA0610/011/001 Cream - ETHYL NICOTINATE 01/09/2010
- HEXYL NICOTINATE
- THURFYL SALICYLATE
VAMINOVEN 18 Fresenius Kabi Limited PA0566/028/001 Solution for Infusion - ALANINE 01/09/2010
- ARGININE
- ASPARTIC ACID
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- SODIUM
GLYCEROPHOSPHATE
ANHYDROUS
- MAGNESIUM SULFATE
VAMINOVEN 18 Fresenius Kabi Limited PA0566/029/001 Solution for Infusion - ALANINE 01/09/2010
ELECTROLYTE FREE - ARGININE
- ASPARTIC ACID
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
ZISPIN SOLTAB IMED Healthcare Ltd. PPA1463/034/001 Orodispersible Tablet - MIRTAZAPINE 01/09/2010
VICKS ACTION Procter & Gamble (Health & PA0441/038/001 Film Coated Tablet - IBUPROFEN 31/08/2010
Beauty Care) Limited - PSEUDOEPHEDRINE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 213 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DACARBAZINE Hospira UK Limited PA0437/040/001 Pdr for Soln for Injection - DACARBAZINE 27/08/2010
DACARBAZINE FOR Hospira UK Limited PA0437/040/002 Pdr for Soln for Injection - DACARBAZINE 27/08/2010
INJECTION BP
BATRAFEN 10MG/G Sanofi-Aventis Ireland PA0540/032/005 Shampoo - CICLOPIROX 25/08/2010
Limited T/A SANOFI
DILZEM SR PCO Manufacturing PPA0465/164/001 Capsules Hard - DILTIAZEM 25/08/2010
HYDROCHLORIDE
DILZEM SR PCO Manufacturing PPA0465/164/002 Capsules Hard - DILTIAZEM 25/08/2010
HYDROCHLORIDE
PREGNACARE Vitabiotics Limited PA0256/005/001 Capsules Hard - BETACAROTENE 25/08/2010
- COLECALCIFEROL
- TOCOPHERYL ACID
SUCCINATE
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- PHYTOMENADIONE
- FOLIC ACID
- NICOTINAMIDE
- ASCORBIC ACID
- FERROUS FUMARATE
- ZINC SULFATE
- MAGNESIUM OXIDE
- POTASSIUM IODIDE
- COPPER SULPHATE
MONOHYDRATE

BENTOME Medana Pharma SA PA1483/001/001 Capsule - OMEPRAZOLE 23/08/2010


BENTOME Medana Pharma SA PA1483/001/002 Capsules Hard - OMEPRAZOLE 23/08/2010
BENTOME Medana Pharma SA PA1483/001/003 Capsules Hard - OMEPRAZOLE 23/08/2010
SUMALIEVE 100 MG Clonmel Healthcare Ltd PA0126/164/002 Tablets - SUMATRIPTAN 19/08/2010
TABLETS
SUMALIEVE 50 MG Clonmel Healthcare Ltd PA0126/164/001 Tablets - SUMATRIPTAN 19/08/2010
TABLETS
MYDRIACYL 0.5% EYE Alcon Laboratories (UK) Ltd PA0290/002/001 Eye Drops Solution - TROPICAMIDE 14/08/2010
DROPS
MYDRIACYL 1% EYE Alcon Laboratories (UK) Ltd PA0290/002/002 Eye Drops Solution - TROPICAMIDE 14/08/2010
DROPS
PILOGEL Alcon Laboratories (UK) Ltd PA0290/064/001 Eyegel - PILOCARPINE 14/08/2010
HYDROCHLORIDE
EFEXOR 37.5 MG TABLETS John Wyeth & Brother PA0022/065/002 Tablets - VENLAFAXINE 13/08/2010
Limited HYDROCHLORIDE
EFEXOR 75 MG TABLETS John Wyeth & Brother PA0022/065/004 Tablets - VENLAFAXINE 13/08/2010
Limited HYDROCHLORIDE
DEPONIT 10MG/24 HOURS UCB Pharma Limited PA0365/088/002 Transdermal Patch - GLYCERYL TRINITRATE 12/08/2010
TRANSDERMAL PATCH

DEPONIT 5MG/24 HOURS UCB Pharma Limited PA0365/088/001 Transdermal Patch - GLYCERYL TRINITRATE 12/08/2010
TRANSDERMAL PATCH
OCULOTECT Novartis Pharmaceuticals UK PA0013/104/001 Eye Drops Solution - POLYVIDONE 25 12/08/2010
Ltd
OCULOTECT Novartis Pharmaceuticals UK PA0013/104/002 Eye Drops Solution - POLYVIDONE 25 12/08/2010
Ltd
SINEMET Imbat Limited PPA1151/001/002A Tablets - CARBIDOPA 11/08/2010
- LEVODOPA
ZORAC Allergan Pharmaceuticals PA0148/061/001 Gel - TAZAROTENE 11/08/2010
Ireland
ZORAC Allergan Pharmaceuticals PA0148/061/002 Gel - TAZAROTENE 11/08/2010
Ireland
EPIPEN ALK-Abello A/S PA1255/002/002 Solution for Injection - EPINEPHRINE 05/08/2010
EPIPEN JUNIOR ALK-Abello A/S PA1255/002/001 Solution for Injection - EPINEPHRINE 05/08/2010
ESTROFEM Novo Nordisk A/S PA0218/050/002 Tablets - ESTRADIOL 05/08/2010
HEMIHYDRATE
MELOXICAM FAL F.A.L. Duiven BV PA1103/001/001 Tablets - MELOXICAM 05/08/2010
MELOXICAM FAL F.A.L. Duiven BV PA1103/001/002 Tablets - MELOXICAM 05/08/2010
POSALFILIN Norgine Limited PA0102/017/001 Ointment - PODOPHYLLUM RESIN 05/08/2010
- SALICYLIC ACID
RISPATAL Chanelle Medical PA0688/007/001 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/002 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/003 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/004 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/005 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/006 Film Coated Tablet - RISPERIDONE 05/08/2010
RISPATAL Chanelle Medical PA0688/007/007 Film Coated Tablet - RISPERIDONE 05/08/2010

Human Medicines Withdrawn Products Page 214 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SEVEN SEAS FIZZIES Seven Seas Ltd PA0417/004/001 Tablets Effervescent - THIAMINE MONONITRATE 05/08/2010
MULTIVITAMIN TABLETS - RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- ASCORBIC ACID
- CYANOCOBALAMIN
- TOCOPHERYL ACETATE
- CALCIUM
PANTOTHENATE
- NICOTINAMIDE
- FOLIC ACID
- BIOTIN

LOSAPOL Heumann Pharma GmbH & PA1484/001/001 Capsules Hard - OMEPRAZOLE 04/08/2010
Co. Generica KG
LOSAPOL Heumann Pharma GmbH & PA1484/001/002 Capsules Hard - OMEPRAZOLE 04/08/2010
Co. Generica KG
LOSAPOL Heumann Pharma GmbH & PA1484/001/003 Capsules Hard - OMEPRAZOLE 04/08/2010
Co. Generica KG
RAPOLYTE Sinclair IS Pharma Limited PA0915/011/001 Powder for Oral Solution - POTASSIUM CHLORIDE 01/08/2010
- SODIUM CITRATE
- SODIUM CHLORIDE
- GLUCOSE
RAPOLYTE - NATURAL Sinclair IS Pharma Limited PA0915/011/005 Powder for Oral Solution - SODIUM CHLORIDE 01/08/2010
- POTASSIUM CHLORIDE
- SODIUM CITRATE
- GLUCOSE ANHYDROUS
RAPOLYTE - TUTTI Sinclair IS Pharma Limited PA0915/011/004 Powder for Oral Solution - SODIUM CHLORIDE 01/08/2010
FRUITTI - POTASSIUM CHLORIDE
- SODIUM CITRATE
- GLUCOSE ANHYDROUS
RAPOLYTE- Sinclair IS Pharma Limited PA0915/011/003 Powder for Oral Solution - SODIUM CHLORIDE 01/08/2010
BLACKCURRANT - POTASSIUM CHLORIDE
- SODIUM CITRATE
- GLUCOSE ANHYDROUS
RAPOLYTE-ORANGE Sinclair IS Pharma Limited PA0915/011/002 Powder for Oral Solution - SODIUM CHLORIDE 01/08/2010
- POTASSIUM CHLORIDE
- SODIUM CITRATE
- GLUCOSE ANHYDROUS
IBULEVE Diomed Developments PA0727/001/001 Gel - IBUPROFEN 31/07/2010
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/001 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/002 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/003 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/004 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/005 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
BYMOT DISPERSIBLE Ergha Healthcare Ltd PA0966/016/006 Tablets - LAMOTRIGINE 30/07/2010
TABLETS
DTZ Sinclair IS Pharma Limited PA0915/005/001 Modified-release capsule, - DILTIAZEM 30/07/2010
hard HYDROCHLORIDE
DTZ Sinclair IS Pharma Limited PA0915/005/002 Modified-release capsule, - DILTIAZEM 30/07/2010
hard HYDROCHLORIDE
DTZ Sinclair IS Pharma Limited PA0915/005/003 Modified-release capsule, - DILTIAZEM 30/07/2010
hard HYDROCHLORIDE
CEFTAL Rowex Ltd PA0711/101/001 Coated Tablets - CEFUROXIME AXETIL 27/07/2010
DAVLIET Volkspharma GmbH PA1499/001/001 Capsules Hard - OMEPRAZOLE 27/07/2010
DAVLIET Volkspharma GmbH PA1499/001/002 Capsules Hard - OMEPRAZOLE 27/07/2010
DAVLIET Volkspharma GmbH PA1499/001/003 Capsules Hard - OMEPRAZOLE 27/07/2010
GLICLAZIDE SERVIER Les Laboratoires Servier PA0568/007/002 Modified-release Tablets - GLICLAZIDE 27/07/2010
NICORETTE CITRUS McNeil Healthcare (Ireland) PA0823/049/007 Medicated Chewing Gum - NICOTINE RESIN 27/07/2010
Ltd
NICORETTE CITRUS McNeil Healthcare (Ireland) PA0823/049/008 Medicated Chewing Gum - NICOTINE RESIN 27/07/2010
Ltd
LOSEC IV AstraZeneca UK Limited PA0970/044/004 Pdr+Solv for Soln for Inj - OMEPRAZOLE SODIUM 26/07/2010
BETOPTIC 0.25% Alcon Laboratories (UK) Ltd PA0290/061/002 Eye Drops Suspension - BETAXOLOL 24/07/2010
EYEDROPS HYDROCHLORIDE
CILOXAN 0.3 % W/V EYE Alcon Laboratories (UK) Ltd PA0290/069/001 Eye Drops Solution - CIPROFLOXACIN 24/07/2010
DROPS, SOLUTION. HYDROCHLORIDE
CILOXAN 3 MG/G EYE Alcon Laboratories (UK) Ltd PA0290/069/002 Eye Ointment - CIPROFLOXACIN 24/07/2010
OINTMENT. HYDROCHLORIDE

Human Medicines Withdrawn Products Page 215 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHYSIOTEARS Alcon Laboratories (UK) Ltd PA0290/075/001 Eye Drops Solution - HYPROMELLOSE 24/07/2010
- DEXTRAN 70
TIMOLOL Alcon Laboratories (UK) Ltd PA0290/072/001 Eye Drops Solution - TIMOLOL MALEATE 24/07/2010
TIMOLOL Alcon Laboratories (UK) Ltd PA0290/072/002 Eye Drops Solution - TIMOLOL MALEATE 24/07/2010
TOBRAVISC 3.0MG/ML EYE Alcon Laboratories (UK) Ltd PA0290/077/001 Eye Drops Solution - TOBRAMYCIN 24/07/2010
DROPS, SOLUTION
META- GE Healthcare Limited PA0240/008/001 Solution for Infusion - IOBENGUANE CHLORIDE 23/07/2010
IODOBENZYLGUANIDINE
AMARYL PCO Manufacturing PPA0465/104/004 Tablets - GLIMEPIRIDE 21/07/2010
LIQUID PARAFFIN BP Pinewood Laboratories Ltd, PA0281/052/001 Oral Solution - PARAFFIN, LIQUID 21/07/2010
TRITACE PCO Manufacturing PPA0465/163/002 Tablets - RAMIPRIL 21/07/2010
ONDANSETRON RMR Pharmaceuticals PA1236/001/001 Syrup - ONDANSETRON 16/07/2010
Limited HYDROCHLORIDE
DIHYDRATE
ONDANSETRON RMR Pharmaceuticals PA1236/001/002 Solution for Inj/Inf - ONDANSETRON 16/07/2010
Limited HYDROCHLORIDE
DIHYDRATE
SUMATRIPTAN Chanelle Medical PA0688/010/001 Film Coated Tablet - SUMATRIPTAN 14/07/2010
SUMATRIPTAN Chanelle Medical PA0688/010/002 Film Coated Tablet - SUMATRIPTAN 14/07/2010
VINORELBINE CADUCEUS Actavis Group PTC ehf PA1380/061/001 Concentrate for Soln for Inf - VINORELBINE 14/07/2010
DITARTRATE
MINADEX TONIC HALF Seven Seas Ltd PA0417/007/001 Oral Emulsion - RETINOL PALMITATE 12/07/2010
STRENGTH ORAL - COLECALCIFEROL
EMULSION - FERRIC AMMONIUM
CITRATE
- POTASSIUM
GLYCEROPHOSPHATE
- CALCIUM
GLYCEROPHOSPHATE
- MANGANESE SULFATE
- COPPER SULFATE
SODIUM CROMOGLICATE Freynes & Co Limited PA1640/001/001 Ear/Eye Drops, solution - CROMOGLICATE SODIUM 11/07/2010
EYEDROPS
Amphocil powder Samaritan Pharmaceuticals PA1475/001/001 Concentrate for solution for - Amphotericin b 09/07/2010
Ireland, Inc., Limited infusion
Amphocil powder Samaritan Pharmaceuticals PA1475/001/002 Concentrate for solution for - Amphotericin b 09/07/2010
Ireland, Inc., Limited infusion
EPIESTROL-SEPTEM Rottapharm Ltd PA0868/007/001 Transdermal Patch - ESTRADIOL 08/07/2010
HEMIHYDRATE
EPIESTROL-SEPTEM Rottapharm Ltd PA0868/007/002 Transdermal Patch - ESTRADIOL 08/07/2010
HEMIHYDRATE
EPIESTROL-SEPTEM Rottapharm Ltd PA0868/007/003 Transdermal Patch - ESTRADIOL 08/07/2010
HEMIHYDRATE
EVEROSE Fresenius Medical Care PA1350/003/001 Film Coated Tablet - CALCIUM ACETATE 06/07/2010
Nephrologica Deutschland
GmbH
CENTYL Leo Laboratories Limited PA0046/018/001 Tablets - BENDROFLUMETHIAZIDE 01/07/2010

CENTYL Leo Laboratories Limited PA0046/018/002 Tablets - BENDROFLUMETHIAZIDE 01/07/2010

GENOXEN Mercury Pharmaceuticals PA0073/090/001 Tablets - NAPROXEN 01/07/2010


(Ireland) Ltd
GENOXEN Mercury Pharmaceuticals PA0073/090/002 Tablets - NAPROXEN 01/07/2010
(Ireland) Ltd
TISSEEL KIT Baxter Healthcare Limited PA0167/129/001 Cutaneous Solution - FACTOR I (FIBRINOGEN) 01/07/2010
- PLASMAFIBRONECTIN
- FACTOR XIII
- PROFIBRINOLYSIN
- APROTININ
- THROMBIN
- PROTEIN
- THROMBIN
- PROTEIN
- CALCIUM CHLORIDE
DIHYDRATE
KESTINE Almirall, S.A. PA0968/002/001 Tablets - EBASTINE 30/06/2010
KESTINE Almirall, S.A. PA0968/002/003 Oral Lyophilisate - EBASTINE 30/06/2010
KESTINE Almirall, S.A. PA0968/002/004 Oral Lyophilisate - EBASTINE 30/06/2010
MOTILIUM McNeil Healthcare (Ireland) PA0823/051/003 Suppositories - DOMPERIDONE 29/06/2010
Ltd
MOTILIUM McNeil Healthcare (Ireland) PA0823/051/005 Suppositories - DOMPERIDONE 29/06/2010
Ltd
OXAMED Medac Gesellschaft fur PA0623/011/001 Powder for solution for - OXALIPLATIN 24/06/2010
Klinische Spezialpraparate infusion
mbH

Human Medicines Withdrawn Products Page 216 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FELODIPINE 10 MG Selana Healthcare Ltd PA1363/003/002 Tablet Prolonged Release - FELODIPINE 23/06/2010
PROLONGED RELEASE
TABLETS
FELODIPINE 5 MG, Selana Healthcare Ltd PA1363/003/001 Tablet Prolonged Release - FELODIPINE 23/06/2010
PROLONGED RELEASE
TABLETS
SOFT-CORN REMOVAL Scholl Consumer Products PA0455/006/002 Impregnated Dressing - SALICYLIC ACID 23/06/2010
PADS Limited
CAPRIN 300 MG TABLETS Pinewood Laboratories Ltd, PA0281/130/002 Tablets - ACETYLSALICYLIC ACID 22/06/2010
CEFUROXIME Hospira UK Limited PA0437/045/001 Powder for suspension for - CEFUROXIME SODIUM 22/06/2010
injection
CEFUROXIME Hospira UK Limited PA0437/045/004 Powder for solution for - CEFUROXIME SODIUM 22/06/2010
infusion
CEFUROXIME Hospira UK Limited PA0437/045/005 Powder for solution for - CEFUROXIME SODIUM 22/06/2010
infusion
ACNECIDE Galderma (UK) Ltd PA0590/007/002 Gel - BENZOYL PEROXIDE 21/06/2010
ACNECIDE WASH Galderma (UK) Ltd PA0590/007/004 Gel - BENZOYL PEROXIDE 21/06/2010
HYDROUS
SIMVASTATIN IREX Laboratoires Irex - Groupe PA1190/001/001 Film Coated Tablet - SIMVASTATIN 21/06/2010
Sanofi-Synthelabo
SIMVASTATIN IREX Laboratoires Irex - Groupe PA1190/001/002 Film Coated Tablet - SIMVASTATIN 21/06/2010
Sanofi-Synthelabo
SIMVASTATIN IREX Laboratoires Irex - Groupe PA1190/001/003 Film Coated Tablet - SIMVASTATIN 21/06/2010
Sanofi-Synthelabo
SIMVASTATIN IREX Laboratoires Irex - Groupe PA1190/001/004 Film Coated Tablet - SIMVASTATIN 21/06/2010
Sanofi-Synthelabo
FETANEX Rowex Ltd PA0711/137/004 Transdermal Patch - FENTANYL 18/06/2010
FETANEX Rowex Ltd PA0711/137/005 Transdermal Patch - FENTANYL 18/06/2010
FETANEX Rowex Ltd PA0711/137/006 Transdermal Patch - FENTANYL 18/06/2010
FETANEX Rowex Ltd PA0711/137/002 Transdermal Patch - FENTANYL 18/06/2010
SEVEN SEAS FOLIC ACID Seven Seas Ltd PA0417/009/001 Capsules, Soft - FOLIC ACID 17/06/2010
CAPSULES
SEVEN SEAS SUPER Seven Seas Health Care Ltd PA0416/001/001 Capsule - TOCOPHERYL ACETATE 17/06/2010
VITAMIN E
BOOTS NICOTINE Novartis Consumer Health PA0030/040/001 Unknown - NICOTINE 13/06/2010
CHEWING GUM UK Limited
BOOTS NICOTINE Novartis Consumer Health PA0030/040/002 Unknown - NICOTINE 13/06/2010
CHEWING GUM UK Limited
BOOTS NICOTINE Novartis Consumer Health PA0030/040/004 Transdermal Patch - NICOTINE 13/06/2010
TRANSDERMAL PATCH UK Limited
24HOUR
BOOTS NICOTINE Novartis Consumer Health PA0030/040/005 Transdermal Patch - NICOTINE 13/06/2010
TRANSDERMAL PATCH UK Limited
24HOUR
BOOTS NICOTINE Novartis Consumer Health PA0030/040/006 Transdermal Patch - NICOTINE 13/06/2010
TRANSDERMAL PATCH UK Limited
24HOUR
BEXZIS Ergha Healthcare Ltd PA0966/013/001 Film Coated Tablet - MIRTAZAPINE 11/06/2010
ROCEPHIN Roche Products Limited PA0050/062/007 Pdr for Soln Inj/Inf - CEFTRIAXONE SODIUM 11/06/2010
BELLRAMIL Ranbaxy (UK) Limited PA0967/006/001 Capsules Hard - RAMIPRIL 04/06/2010
VENLAFAXINE Ranbaxy (UK) Limited PA0967/010/001 Tablets - VENLAFAXINE 04/06/2010
HYDROCHLORIDE
VENLAFAXINE Ranbaxy (UK) Limited PA0967/010/002 Tablets - VENLAFAXINE 04/06/2010
HYDROCHLORIDE
ZISPIN SOLTABS McDowell Pharmaceuticals PPA1473/025/001 Orodispersible Tablet - MIRTAZAPINE 02/06/2010
BRICANYL RESPULES AstraZeneca UK Limited PA0970/036/004 Inhalation solution - TERBUTALINE SULFATE 01/06/2010
CENTRADOL Grunenthal GmbH PA1032/002/001 Transdermal Patch - BUPRENORPHINE 01/06/2010
CENTRADOL Grunenthal GmbH PA1032/002/002 Transdermal Patch - BUPRENORPHINE 01/06/2010
CENTRADOL Grunenthal GmbH PA1032/002/003 Transdermal Patch - BUPRENORPHINE 01/06/2010
COZAAR INITIATION PACK Merck Sharp and Dohme PA0035/082/002 Film Coated Tablet - LOSARTAN POTASSIUM 01/06/2010
FOR HEART FAILURE Limited - LOSARTAN POTASSIUM

DIPRIVAN 1% W/V AstraZeneca UK Limited PA0970/005/001 Emulsion for Inj/Inf - PROPOFOL 01/06/2010
EMULSION FOR
INTRAVENOUS INJECTION

GOPTEN 0.5 MG HARD Abbott Laboratories Ireland PA0038/084/001 Capsules Hard - TRANDOLAPRIL 01/06/2010
CAPSULES Ltd
GOPTEN 1.0 MG HARD Abbott Laboratories Ireland PA0038/084/002 Capsules Hard - TRANDOLAPRIL 01/06/2010
CAPSULES Ltd
GOPTEN 2 MG HARD Abbott Laboratories Ireland PA0038/084/003 Capsules Hard - TRANDOLAPRIL 01/06/2010
CAPSULES Ltd
LOSEC 40 MG POWDER AstraZeneca UK Limited PA0970/044/005 Powder for solution for - OMEPRAZOLE SODIUM 01/06/2010
FOR SOLUTION FOR infusion
INFUSION.

Human Medicines Withdrawn Products Page 217 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MYLCER Flexopharm GmbH & Co. KG PA1509/001/001 Capsules Hard - OMEPRAZOLE 01/06/2010

MYLCER Flexopharm GmbH & Co. KG PA1509/001/002 Capsules Hard - OMEPRAZOLE 01/06/2010

MYLCER Flexopharm GmbH & Co. KG PA1509/001/003 Capsules Hard - OMEPRAZOLE 01/06/2010

PULMOCLASE PAEDIATRI UCB S.A. PA0230/006/003 Syrup - CARBOCISTEINE 01/06/2010

HIBISOL Regent Medical Overseas PA1218/002/001 Cutaneous Solution - CHLORHEXIDINE 29/05/2010


Limited DIGLUCONATE (AS
CHLORHEXIDINE
DIGLUCONATE SOLUTION
(20% W/V) PH.EUR.

COVERSYL ARGININE S.C.A.C Limited PPA1593/001/001 Film Coated Tablet - PERINDOPRIL ARGININE 26/05/2010
COVERSYL ARGININE S.C.A.C Limited PPA1593/001/002 Film Coated Tablet - PERINDOPRIL ARGININE 26/05/2010
ClinOleic 20%, emulsion for Baxter Healthcare Limited PA0167/141/001 Emulsion for infusion - Refined olive oil 25/05/2010
infusion - SOYA BEAN OIL,
REFINED PH. EUR.
ClinOleic 20%, emulsion for Baxter Healthcare Limited PA0167/141/002 Emulsion for infusion - Refined olive oil 25/05/2010
infusion - SOYA BEAN OIL,
REFINED PH. EUR.
OLICLINOMEL N8-800, Baxter Healthcare Limited PA0167/109/010 Emulsion for infusion - L-serine 25/05/2010
emulsion for infusion - Glycine
- L-valine
- L-leucine
- L-histidine
- L-proline
- L-tryptophan
- L-alanine
- Olive oil
- L-phenylalanine
- L-tyrosine
- Glucose anhydrous
- L-arginine
- L-isoleucine
- L-lysine
- L-methionine
- L-threonine
NICOTINELL LIQUORICE Novartis Consumer Health PA0030/050/001 Medicated Chewing Gum - NICOTINE 24/05/2010
UK Limited
NICOTINELL LIQUORICE Novartis Consumer Health PA0030/050/002 Medicated Chewing Gum - NICOTINE 24/05/2010
UK Limited
AMARYL Sanofi-Aventis Ireland PA0540/028/005 Tablets - GLIMEPIRIDE 19/05/2010
Limited T/A SANOFI
DYAZIDE B & S Healthcare PPA1328/116/001 Tablets - TRIAMTERENE 19/05/2010
KALGRIFF KSK-Pharma Vertriebs AG PA1495/001/001 Capsule - OMEPRAZOLE 19/05/2010
KALGRIFF KSK-Pharma Vertriebs AG PA1495/001/002 Capsule - OMEPRAZOLE 19/05/2010
KALGRIFF KSK-Pharma Vertriebs AG PA1495/001/003 Capsule - OMEPRAZOLE 19/05/2010
AERODIOL Les Laboratoires Servier PA0568/014/001 Nasal Spray Solution - ESTRADIOL 18/05/2010
HEMIHYDRATE
ESTRADIOL SERVIER Les Laboratoires Servier PA0568/015/001 Nasal Spray Solution - ESTRADIOL 18/05/2010
HEMIHYDRATE
HYPERHAES Fresenius Kabi Limited PA0566/027/001 Solution for Infusion - POLY(O-2- 16/05/2010
HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

ARICEPT LTT Pharma Limited PPA1562/018/001 Film Coated Tablet - DONEPEZIL 13/05/2010
HYDROCHLORIDE
MOBIC Boehringer Ingelheim PA0775/001/006 Suppositories - MELOXICAM 07/05/2010
International GmbH

Human Medicines Withdrawn Products Page 218 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OLICLINOMEL N 4-550, Baxter Healthcare Limited PA0167/109/001 Emulsion for infusion - Phenylalanine 05/05/2010
emulsion for infusion - Valine
- Glucose monohydrate
- Threonine
- Arginine
- Tryptophan
- Serine
- Tyrosine
- Lysine hydrochloride
- Leucine
- Glycine
- Alanine
- Isoleucine
- Olive oil
- Histidine
- Methionine
- Proline
OLICLINOMEL N 5-800, Baxter Healthcare Limited PA0167/109/003 Emulsion for infusion - Glycine 05/05/2010
emulsion for infusion - Arginine
- Tryptophan
- Serine
- Proline
- Methionine
- Alanine
- Leucine
- Valine
- Isoleucine
- Glucose monohydrate
- Lysine hydrochloride
- Phenylalanine
- Histidine
- Olive oil
- Threonine
- Tyrosine
OLICLINOMEL N 6-900, Baxter Healthcare Limited PA0167/109/005 Emulsion for infusion - Glycine 05/05/2010
emulsion for infusion - Alanine
- Threonine
- Tryptophan
- Methionine
- Phenylalanine
- Arginine
- Valine
- Serine
- Lysine hydrochloride
- Isoleucine
- Tyrosine
- Glucose monohydrate
- Proline
- Histidine
- Olive oil
- Leucine
Synthamin 14, 8.5% w/v Baxter Healthcare Limited PA0167/092/004 Solution for infusion - Lysine hydrochloride 05/05/2010
Amino Acid Intravenous - Tyrosine
Infusion without Electrolytes, - Proline
Solution for Infusion - Serine
- Isoleucine
- Valine
- Threonine
- Glycine
- Methionine
- Phenylalanine
- Histidine
- Arginine
- Alanine
- Leucine
- Tryptophan

Human Medicines Withdrawn Products Page 219 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
Synthamin 17, 10.0% w/v Baxter Healthcare Limited PA0167/092/007 Solution for infusion - Proline 05/05/2010
Amino Acid Intravenous - Histidine
Infusion without Electrolytes, - Lysine hydrochloride
Solution for Infusion - Tyrosine
- Alanine
- Valine
- Isoleucine
- Phenylalanine
- Glycine
- Methionine
- Serine
- Tryptophan
- Arginine
- Threonine
- Leucine
Synthamin 9, 5.5% w/v Baxter Healthcare Limited PA0167/092/001 Solution for infusion - Lysine hydrochloride 05/05/2010
Amino Acid Intravenous - Proline
Infusion without Electrolytes, - Tryptophan
Solution for Infusion - Threonine
- Glycine
- Valine
- Histidine
- Methionine
- Leucine
- Phenylalanine
- Isoleucine
- Serine
- Arginine
- Alanine
- Tyrosine
IDROLAX Ipsen Limited PA0583/006/002 Powder for Oral Solution - MACROGOL 4000 04/05/2010
GABAPENTIN Winthrop Pharmaceuticals PA1046/001/001 Capsules Hard - GABAPENTIN 01/05/2010
UK Limited
GABAPENTIN Winthrop Pharmaceuticals PA1046/001/002 Capsules Hard - GABAPENTIN 01/05/2010
UK Limited
GABAPENTIN Winthrop Pharmaceuticals PA1046/001/003 Capsules Hard - GABAPENTIN 01/05/2010
UK Limited
SODIUM IODIDE (I131) D Mallinckrodt Medical B.V. PA0690/006/001 Capsule - SODIUM IODIDE (131 I) 01/05/2010
ADENOSCAN Sanofi-Aventis Ireland PA0540/140/001 Solution for Infusion - ADENOSINE 30/04/2010
Limited T/A SANOFI
INTAL CFC-FREE INHALER Sanofi-Aventis Ireland PA0540/103/002 Unknown - SODIUM CROMOGLICATE 30/04/2010
5MG PRESSURISED Limited T/A SANOFI
INHALATION

RAMIPRIL 1.25MG Sanofi-Aventis Ireland PA0540/137/001 Capsules Hard - RAMIPRIL 30/04/2010


CAPSULES Limited T/A SANOFI
RAMIPRIL 1.25MG Sanofi-Aventis Ireland PA0540/137/005 Tablets - RAMIPRIL 30/04/2010
TABLETS Limited T/A SANOFI
RAMIPRIL 10MG Sanofi-Aventis Ireland PA0540/137/004 Capsules Hard - RAMIPRIL 30/04/2010
CAPSULES Limited T/A SANOFI
RAMIPRIL 10MG TABLETS Sanofi-Aventis Ireland PA0540/137/008 Tablets - RAMIPRIL 30/04/2010
Limited T/A SANOFI
RAMIPRIL 2.5MG Sanofi-Aventis Ireland PA0540/137/002 Capsules Hard - RAMIPRIL 30/04/2010
CAPSULES Limited T/A SANOFI
RAMIPRIL 2.5MG TABLETS Sanofi-Aventis Ireland PA0540/137/006 Tablets - RAMIPRIL 30/04/2010
Limited T/A SANOFI
RAMIPRIL 5MG CAPSULES Sanofi-Aventis Ireland PA0540/137/003 Capsules Hard - RAMIPRIL 30/04/2010
Limited T/A SANOFI
RAMIPRIL 5MG TABLETS Sanofi-Aventis Ireland PA0540/137/007 Tablets - RAMIPRIL 30/04/2010
Limited T/A SANOFI
TILADE AEROSOL Sanofi-Aventis Ireland PA0540/130/001 Pressurised Inhalation - NEDOCROMIL SODIUM 30/04/2010
Limited T/A SANOFI Suspension
XATRAL Sanofi-Aventis Ireland PA0540/162/002 Tablets - ALFUZOSIN 30/04/2010
Limited T/A SANOFI HYDROCHLORIDE
MELTUS DECONGESTANT Cupal Limited PA0258/047/001 Oral Solution - PSEUDOEPHEDRINE 28/04/2010
HYDROCHLORIDE
NITROMIN EGIS UK Ltd PA1117/001/001 Oromucosal Spray, Soln - GLYCERYL TRINITRATE 28/04/2010
Canesten Thrush LTT Pharma Limited DPR1562/003/002 Cream - Clotrimazole 22/04/2010
HERPETAD COLD SORE TAD Pharma GmbH PA0876/002/001 Cream - ACICLOVIR 22/04/2010
TRANSIPEG IN SACHET Bayer Limited PA1410/055/002 Powder for Oral Solution - MACROGOL 3350 22/04/2010
FULL MARKS LOTION SSL International plc PA1138/005/001 Cutaneous Solution - PHENOTHRIN 21/04/2010
TRANSIPEG IN SACHET Bayer Limited PA1410/055/001 Powder for Oral Solution - MACROGOL 3350 21/04/2010

Human Medicines Withdrawn Products Page 220 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CERNEVIT BIO-SET Baxter Healthcare Limited PA0167/097/002 Pdr for Soln Inj/Inf - RETINOL PALMITATE 20/04/2010
- COLECALCIFEROL
- DL-ALFA-TOCOFEROL
- ASCORBIC ACID
- COCARBOXYLASE
TETRAHYDRATE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- FOLIC ACID
- DEXPANTHENOL
- BIOTIN
- NICOTINAMIDE
ENALAPRIL MALEATE Teva Pharma B.V. PA0749/029/001 Tablets - ENALAPRIL MALEATE 19/04/2010
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE
TEVA
GLIMEPIRIDE Teva Pharma B.V. PA0749/033/001 Tablets - GLIMEPIRIDE 19/04/2010
GLIMEPIRIDE Teva Pharma B.V. PA0749/033/002 Tablets - GLIMEPIRIDE 19/04/2010
GLIMEPIRIDE Teva Pharma B.V. PA0749/033/003 Tablets - GLIMEPIRIDE 19/04/2010
GLIMEPIRIDE Teva Pharma B.V. PA0749/033/004 Tablets - GLIMEPIRIDE 19/04/2010
PAMIDRONATE DISODIUM Teva Pharmaceuticals PA1233/001/001 Concentrate for Soln for Inf - PAMIDRONIC ACID 19/04/2010
TEVA 3MG/ML Europe B.V.
CONCENTRATE FOR S
RIVASTIGMINE PLIVA Pliva Pharma Limited PA0585/047/005 Oral Solution - RIVASTIGMINE 19/04/2010
Inegy Tablets LTT Pharma Limited DPR1562/016/001 Tablet - Ezetimibe 16/04/2010
- Simvastatin
Inegy Tablets LTT Pharma Limited DPR1562/016/002 Tablet - Ezetimibe 16/04/2010
- Simvastatin
Inegy Tablets LTT Pharma Limited DPR1562/016/003 Tablet - Simvastatin 16/04/2010
- Ezetimibe
EFEXOR 37.5 MG TABLETS Imbat Limited PPA1151/076/001 Tablets - VENLAFAXINE 15/04/2010
HYDROCHLORIDE
EFEXOR 75 MG TABLETS Imbat Limited PPA1151/076/002 Tablets - VENLAFAXINE 15/04/2010
HYDROCHLORIDE
ETOPOPHOS Bristol-Myers Squibb PA0002/064/001 Pdr for Soln for Injection - ETOPOSIDE PHOSPHATE 15/04/2010
Pharmaceuticals uc
SCHOLL ATHLETE’S FOOT Scholl Consumer Products PA0455/001/003 Cutaneous Solution - TOLNAFTATE 15/04/2010
SOLUTION Limited
SEROXAT Imbat Limited PPA1151/034/002 Film Coated Tablet - PAROXETINE 15/04/2010
HYDROCHLORIDE
XYLOCAINE AstraZeneca UK Limited PA0970/054/001 Cutaneous Solution - LIDOCAINE 15/04/2010
HYDROCHLORIDE
CLONOCID Clonmel Healthcare Ltd PA0126/136/003 Granules for Oral - CLARITHROMYCIN 14/04/2010
Suspension
CLONOCID Clonmel Healthcare Ltd PA0126/136/004 Granules for Oral - CLARITHROMYCIN 14/04/2010
Suspension
FEMSEVEN SEQUI Merck Serono Limited PA0654/010/001 Transdermal Patch - ESTRADIOL 14/04/2010
HEMIHYDRATE
- LEVONORGESTREL
KESTINE Almirall, S.A. PA0968/002/002 Tablets - EBASTINE 14/04/2010
Clorom 125 mg/5 ml granules Rowex Ltd PA0711/061/003 Oral suspension - Clarithromycin 12/04/2010
for oral suspension
Clorom 250 mg/5 ml granules Rowex Ltd PA0711/061/004 Oral suspension - Clarithromycin 12/04/2010
for oral suspension
MALATHION LOTION SSL International PLC PA0618/016/002 Unknown - MALATHION 07/04/2010
PRIODERM 1% W/W SSL International PLC PA0618/016/001 Shampoo - MALATHION 07/04/2010
CREAM SHAMPOO
RALGEX SSL International PLC PA0618/025/001 Cutaneous Spray Solution - GLYCOL 07/04/2010
MONOSALICYLATE
- ETHYL SALICYLATE
- METHYL SALICYLATE
- METHYL NICOTINATE
PENTASTARCH Baxter Healthcare Limited PA0167/110/002 Solution for Infusion - SODIUM CHLORIDE 04/04/2010
ENDOREM GUERBET PA0686/001/001 Concentrate for solution for - IRON OXIDE 01/04/2010
infusion SUPERPAROMAGNETIC
OMNIC Astellas Pharma Co. Ltd PA1241/007/001 Capsule - TAMSULOSIN 01/04/2010
HYDROCHLORIDE
VESIKUR Astellas Pharma Co. Ltd PA1241/008/001 Tablets - SOLIFENACIN 01/04/2010
SUCCINATE
VESIKUR Astellas Pharma Co. Ltd PA1241/008/002 Tablets - SOLIFENACIN 01/04/2010
SUCCINATE
ESTRADERM TTS Novartis Pharmaceuticals UK PA0013/070/002 Transdermal Patch - ESTRADIOL 31/03/2010
Ltd HEMIHYDRATE
PACLITAXEL Pliva Pharma Limited PA0585/029/001 Concentrate for Soln for Inf - PACLITAXEL 30/03/2010

Human Medicines Withdrawn Products Page 221 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TOPOTECAN PLIVA Pliva Pharma Limited PA0585/038/001 Powder for concentrate for - TOPOTECAN 30/03/2010
solution for infusion HYDROCHLORIDE
FUCIDIN H Leo Laboratories Limited PA0046/005/003 Ointment - FUSIDATE SODIUM 28/03/2010
- HYDROCORTISONE
ACETATE
BLEOMYCIN Pharmachemie BV PA0937/008/001 Pdr for Soln for Injection - BLEOMYCIN SULFATE 25/03/2010
Canesten Thrush Vaginal G & A Licensing Ltd DPR1447/001/001 Vaginal cream - Clotrimazole 25/03/2010
Cream
OXALIPLATIN 5 MG/ML Pliva Pharma Limited PA0585/030/001 Powder for solution for - OXALIPLATIN 25/03/2010
POWDER FOR SOLUTION infusion
FOR INFUSI
VIBRAMYCIN Pfizer Limited PA0019/013/006 Capsule - DOXYCYCLINE HYCLATE 24/03/2010

ESTRADERM TTS Novartis Pharmaceuticals UK PA0013/070/001 Transdermal Patch - ESTRADIOL 22/03/2010


Ltd HEMIHYDRATE
PLETAL Otsuka Pharmaceutical PA0985/001/001 Tablets - CILOSTAZOL 19/03/2010
Europe Ltd
PLETAL Otsuka Pharmaceutical PA0985/001/002 Tablets - CILOSTAZOL 19/03/2010
Europe Ltd
ALLOPURINOL McDermott Laboratories Ltd PA0577/013/001 Tablets - ALLOPURINOL 18/03/2010
t/a Gerard Laboratories
ALLOPURINOL McDermott Laboratories Ltd PA0577/013/002 Tablets - ALLOPURINOL 18/03/2010
t/a Gerard Laboratories
NYSTAFORM Typharm Limited PA0219/003/001 Cream - NYSTATIN 18/03/2010
- CHLORHEXIDINE
HYDROCHLORIDE
NYSTAFORM H.C. CREAM Typharm Limited PA0219/004/001 Cream - NYSTATIN 18/03/2010
- CHLORHEXIDINE
HYDROCHLORIDE
- HYDROCORTISONE
- OCTYLDODECANOL
NYSTAFORM H.C. Typharm Limited PA0219/004/002 Ointment - NYSTATIN 18/03/2010
OINTMENT - CHLORHEXIDINE
DIACETATE
- HYDROCORTISONE
XEPIN Cambridge Healthcare PA0980/002/001 Cream - DOXEPIN 18/03/2010
Supplies Limited HYDROCHLORIDE
Roaccutane 5 mg soft Roche Products Limited PA0050/053/002 Capsule, soft - Isotretinoin 15/03/2010
capsules
CACIT Procter & Gamble PA0170/015/001 Tablets Effervescent - CALCIUM CARBONATE 11/03/2010
Pharmaceuticals UK Limited
CACIT Procter & Gamble PA0170/015/002 Tablets Effervescent - CALCIUM CARBONATE 11/03/2010
Pharmaceuticals UK Limited
CACIT D3 Procter & Gamble PA0170/018/002 Granules Effervescent - COLECALCIFEROL 11/03/2010
Pharmaceuticals UK Limited - CALCIUM CARBONATE
CACIT D3 500MG/440 IU Procter & Gamble PA0170/018/001 Granules Effervescent - COLECALCIFEROL 11/03/2010
EFFERVESCENT Pharmaceuticals UK Limited - CALCIUM CARBONATE
GRANULES FOR OR
DIDRONEL PMO Procter & Gamble PA0170/017/001 Tablets - ETIDRONATE DISODIUM 11/03/2010
Pharmaceuticals UK Limited - CALCIUM CARBONATE
MYCOSPOR Bayer Limited PA1410/049/001 Gel - BIFONAZOLE 10/03/2010
MYCOSPOR Bayer Limited PA1410/049/002 Cream - BIFONAZOLE 10/03/2010
MYCOSPOR Bayer Limited PA1410/049/003 Cutaneous Powder - BIFONAZOLE 10/03/2010
MYCOSPOR Bayer Limited PA1410/049/004 Cutaneous Solution - BIFONAZOLE 10/03/2010
HALLS MENTHOLYPTUS Cadbury Trebor Bassett PA1326/001/003 Lozenges - LEVOMENTHOL 05/03/2010
BLACKCURRANT - EUCALYPTUS GLOBULUS
LOZENGE
HALLS MENTHOLYPTUS Cadbury Trebor Bassett PA1326/001/002 Lozenges - LEVOMENTHOL 05/03/2010
EXTRA STRONG LOZENGE - EUCALYPTUS GLOBULUS

HALLS MENTHOLYPTUS Cadbury Trebor Bassett PA1326/001/004 Lozenges - LEVOMENTHOL 05/03/2010


HONEY AND LEMON - EUCALYPTUS GLOBULUS
LOZENGE
HALLS MENTHOLYPTUS Cadbury Trebor Bassett PA1326/001/001 Lozenges - LEVOMENTHOL 05/03/2010
ORIGINAL LOZENGE - EUCALYPTUS GLOBULUS

NATRILIX Servier Laboratories (Ireland) PA0068/001/001 Tablets - INDAPAMIDE 05/03/2010


Ltd HEMIHYDRATE
INDIUM CHLORIDE GE Healthcare Limited PA0240/005/003 Radio-Pharm Precursor - INDIUM (111 IN) 02/03/2010
STERILE CHLORIDE SOLUTION
TRITACE PCO Manufacturing PPA0465/163/003 Tablets - RAMIPRIL 02/03/2010
TAXOL Bristol-Myers Squibb PA0002/059/001A Concentrate for Soln for Inf - PACLITAXEL 01/03/2010
Pharmaceuticals uc
VEPESID Bristol-Myers Squibb PA0048/022/005 Concentrate for Soln for Inf - ETOPOSIDE 01/03/2010
(Holdings) Limited

Human Medicines Withdrawn Products Page 222 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STRATTERA Eli Lilly and Company Limite PA0047/095/001 Capsules Hard - ATOMOXETINE 28/02/2010
HYDROCHLORIDE
BECONASE AQUEOUS McDowell Pharmaceuticals PPA1473/016/001 Nasal Spray Suspension - BECLOMETASONE 25/02/2010
NASAL SPRAY DIPROPIONATE
PERGOLIDE McDermott Laboratories Ltd PA0577/063/001 Tablets - PERGOLIDE MESILATE 24/02/2010
t/a Gerard Laboratories
PERGOLIDE McDermott Laboratories Ltd PA0577/063/002 Tablets - PERGOLIDE MESILATE 24/02/2010
t/a Gerard Laboratories
PERGOLIDE McDermott Laboratories Ltd PA0577/063/003 Tablets - PERGOLIDE MESILATE 24/02/2010
t/a Gerard Laboratories
KONAKION Roche Products Limited PA0050/051/001 Coated Tablets - PHYTOMENADIONE 23/02/2010
ADDIFLU SUSPENSION Sanofi Pasteur MSD S.p.A. PA0973/001/001 Solution for Injection - A/BRISBANE/59/2007 22/02/2010
FOR INJECTION (H1N1) - LIKE STRAIN
(A/BRISBANE/59/2007, IVR-
148) PH.EUR
- A/BRISBANE/10/2007
(H3N2) - LIKE STRAIN
(A/URUGUAY/716/2007,NY
MC X-175-C)
- B/BRISBANE/60/2008 -
LIKE STRAIN
(B/BRISBANE/60/2008)
RHOPHYLAC CSL Behring GmbH PA0800/006/001 Solution for Injection - IMMUNOGLOBULIN 19/02/2010
HUMAN NORMAL
ALDACTIDE 25 FILM- Pharmacia Healthcare PA0936/015/001 Tablets - SPIRONOLACTONE 16/02/2010
COATED TABLETS Ireland - HYDROFLUMETHIAZIDE
ALDACTIDE 50 FILM- Pharmacia Healthcare PA0936/015/002 Tablets - SPIRONOLACTONE 16/02/2010
COATED TABLETS Ireland - HYDROFLUMETHIAZIDE
BALANCE 1.5% GLUCOSE, Fresenius Medical Care PA0953/006/001 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
1.25MMOL/L CALCIUM Deutschland GmbH - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
BALANCE 1.5% GLUCOSE, Fresenius Medical Care PA0953/005/001 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
1.75MMOL/L CALCIUM Deutschland GmbH - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
BALANCE 2.3% GLUCOSE, Fresenius Medical Care PA0953/006/002 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
1.25MMOL/L CALCIUM Deutschland GmbH - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
BALANCE 2.3% GLUCOSE, Fresenius Medical Care PA0953/005/003 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
1.75MMOL/L CALCIUM Deutschland GmbH - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
BALANCE 4.25% Fresenius Medical Care PA0953/006/003 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
GLUCOSE, 1.25MMOL/L Deutschland GmbH - CALCIUM CHLORIDE
CALCIUM DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
SOLUTION
BALANCE 4.25% Fresenius Medical Care PA0953/005/002 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
GLUCOSE, 1.75MMOL/L Deutschland GmbH - CALCIUM CHLORIDE
CALCIUM DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE ANHYDROUS
- SODIUM LACTATE
SOLUTION

Human Medicines Withdrawn Products Page 223 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BICAVERA Fresenius Medical Care PA0953/004/001 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM BICARBONATE
BICAVERA Fresenius Medical Care PA0953/004/002 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH - SODIUM BICARBONATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
BICAVERA Fresenius Medical Care PA0953/004/003 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH - SODIUM BICARBONATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
CAPD/DPCA 17 Fresenius Medical Care PA0953/001/001 Solution for peritoneal - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH dialysis - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
CAPD/DPCA 18 Fresenius Medical Care PA0953/002/001 Solution for peritoneal - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH dialysis - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
CAPD/DPCA 19 Fresenius Medical Care PA0953/003/001 Solution for peritoneal - SODIUM CHLORIDE 16/02/2010
Deutschland GmbH dialysis - SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
MONOHYDRATE
GEMCITABINE Rowex Ltd PA0711/178/001 Powder for solution for - GEMCITABINE 16/02/2010
infusion HYDROCHLORIDE
GEMCITABINE Rowex Ltd PA0711/178/002 Powder for solution for - GEMCITABINE 16/02/2010
infusion HYDROCHLORIDE
LIPANTIL MICRO Abbott Healthcare Products PA0108/030/002 Capsule - FENOFIBRATE 15/02/2010
Ltd
ADARTREL GlaxoSmithKline (Ireland) PA1077/106/003 Coated Tablets - ROPINIROLE 08/02/2010
Limited HYDROCHLORIDE
REQUIP-MODUTAB GlaxoSmithKline (Ireland) PA1077/037/007 Tablet Prolonged Release - ROPINIROLE 08/02/2010
Limited
ALMIRID 20MG TABLETS Polichem S.A. PA1005/001/002 Tablets - DIHYDROERGOTAMINE 03/02/2010
MESILATE
ALMIRID 5MG CAPSULES Polichem S.A. PA1005/001/001 Capsule - 03/02/2010
DIHYDROERGOCRYPTINE
MESILATE
PINETARSOL Ego Pharmaceuticals (UK) PA0863/006/001 Cutaneous Solution - COAL TAR 03/02/2010
Limited
AGIOLAX PICO Madaus GmbH PA1288/004/001 Lozenges - SODIUM PICOSULFATE 02/02/2010
ETHINYLESTRADIOL/DRO Laboratorios Leon Farma, PA1474/007/001 Film Coated Tablet - DROSPIRENONE 02/02/2010
SPIRENONE LEON FARMA S.A. - ETHINYLESTRADIOL
& PLACEBO
ETHINYLESTRADIOL/DRO Laboratorios Leon Farma, PA1474/007/002 Film Coated Tablet - DROSPIRENONE 02/02/2010
SPIRENONE LEON FARMA S.A. - ETHINYLESTRADIOL
& PLACEBO
BUSPAR Bristol-Myers Squibb PA0048/041/001 Tablets - BUSPIRONE 01/02/2010
(Holdings) Limited HYDROCHLORIDE
BUSPAR Bristol-Myers Squibb PA0048/041/002 Tablets - BUSPIRONE 01/02/2010
(Holdings) Limited HYDROCHLORIDE

Human Medicines Withdrawn Products Page 224 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EMITAL 4MG FILM-COATED Pliva Pharma Limited PA0585/021/001 Tablets - ONDANSETRON 01/02/2010
TABLETS HYDROCHLORIDE
EMITAL 8MG FILM-COATED Pliva Pharma Limited PA0585/021/002 Tablets - ONDANSETRON 01/02/2010
TABLETS HYDROCHLORIDE
PRAVALO Ratiopharm GmbH PA0819/030/001 Tablets - PRAVASTATIN SODIUM 01/02/2010
PRAVALO Ratiopharm GmbH PA0819/030/002 Tablets - PRAVASTATIN SODIUM 01/02/2010
PRAVALO Ratiopharm GmbH PA0819/030/003 Tablets - PRAVASTATIN SODIUM 01/02/2010
INTAL 5 Fisons Limited PA0018/040/001 Unknown - CROMOGLICATE SODIUM 30/01/2010

TARDCAPS XL 150 MG IXL Pharma Limited PA1038/002/002 Prolonged Release Capsules - VENLAFAXINE 29/01/2010
HYDROCHLORIDE
TARDCAPS XL 75 MG IXL Pharma Limited PA1038/002/001 Prolonged Release Capsules - VENLAFAXINE 29/01/2010
HYDROCHLORIDE
AMOXICILLIN SANDOZ Sandoz GmbH PA0111/004/001 Capsules Hard - AMOXICILLIN 25/01/2010
TRIHYDRATE
AMOXICILLIN SANDOZ Sandoz GmbH PA0111/004/002 Capsules Hard - AMOXICILLIN 25/01/2010
TRIHYDRATE
RIDAURA TILTAB 3MG Mercury Pharmaceuticals Ltd PA0899/011/001 Film Coated Tablet - AURANOFIN 24/01/2010
FILM-COATED TABLETS
MACROTEC Amersham Health Srl PA0401/003/001 Unknown - HUMAN ALBUMIN MACRO 22/01/2010
AGGREGATED
ISTAMEL Clonmel Healthcare Ltd PA0126/168/001 Tablets - AMLODIPINE 21/01/2010
ISTAMEL Clonmel Healthcare Ltd PA0126/168/002 Tablets - AMLODIPINE 21/01/2010
LOSAMEL Clonmel Healthcare Ltd PA0126/181/001 Capsules Gastro-Resistant - OMEPRAZOLE (I.N.N.) 21/01/2010
LOSAMEL Clonmel Healthcare Ltd PA0126/181/002 Capsules Gastro-Resistant - OMEPRAZOLE (I.N.N.) 21/01/2010
LOSAMEL Clonmel Healthcare Ltd PA0126/181/003 Capsules Gastro-Resistant - OMEPRAZOLE (I.N.N.) 21/01/2010
OXYTETRACYCLINE 250 Clonmel Healthcare Ltd PA0126/032/001 Tablets - OXYTETRACYCLINE 21/01/2010
MILLIGRAM TABLETS DIHYDRATE
ONDANSETRON 2 MG/ML. Clonmel Healthcare Ltd PA0126/142/001 Solution for Injection - ONDANSETRON 20/01/2010
SOLUTION FOR INJECTIO

RENNIE LIQUID RELIEF, Bayer Limited PA1410/052/002 Oral Suspension - CALCIUM CARBONATE 20/01/2010
ORAL SUSPENSION - LIGHT MAGNESIUM
CARBONATE
- SODIUM ALGINATE
TRADOREC XL HGH Regulatory Sciences PA1498/001/001 Tablet Prolonged Release - TRAMADOL 18/01/2010
Limited HYDROCHLORIDE
TRADOREC XL HGH Regulatory Sciences PA1498/001/002 Tablet Prolonged Release - TRAMADOL 18/01/2010
Limited HYDROCHLORIDE
LEMOWAN acis Arzneimittel GmbH PA1486/001/001 Capsules Hard - OMEPRAZOLE 15/01/2010
LEMOWAN acis Arzneimittel GmbH PA1486/001/002 Capsules Hard - OMEPRAZOLE 15/01/2010
LEMOWAN acis Arzneimittel GmbH PA1486/001/003 Capsules Hard - OMEPRAZOLE 15/01/2010
SOOTHOME mibe GmbH Arzneimittel PA1485/001/001 Capsule - OMEPRAZOLE 15/01/2010
SOOTHOME mibe GmbH Arzneimittel PA1485/001/002 Capsule - OMEPRAZOLE 15/01/2010
SOOTHOME mibe GmbH Arzneimittel PA1485/001/003 Capsule - OMEPRAZOLE 15/01/2010
COMBUDORON Weleda (UK) Limited PA0407/007/001 Cutaneous Solution - ARNICA MONTANA 14/01/2010
LAMOTRIGINE Rowex Ltd PA0711/096/001 Tablets - LAMOTRIGINE 14/01/2010
LAMOTRIGINE Rowex Ltd PA0711/096/002 Tablets - LAMOTRIGINE 14/01/2010
LAMOTRIGINE Rowex Ltd PA0711/096/003 Tablets - LAMOTRIGINE 14/01/2010
LAMOTRIGINE Rowex Ltd PA0711/096/004 Tablets - LAMOTRIGINE 14/01/2010
ESTRADERM TTS Novartis Pharmaceuticals UK PA0013/070/003 Transdermal Patch - ESTRADIOL 08/01/2010
Ltd HEMIHYDRATE
HONEY & LEMON MELTUS Cupal Limited PA0258/038/001 Syrup - GUAIFENESIN 08/01/2010
COUGH LICTUS
PROPOFOL Genthon BV PA0740/010/001 Not assigned - PROPOFOL 07/01/2010
PROPOFOL Genthon BV PA0740/010/002 Emulsion for Inj/Inf - PROPOFOL 07/01/2010
PROPOFOL Genthon BV PA0740/010/003 Emulsion for Inj/Inf - PROPOFOL 07/01/2010
PROPOFOL Genthon BV PA0740/010/004 Emulsion for Inj/Inf - PROPOFOL 07/01/2010
RESOVIST HE Clissmann PA0012/093/001 Solution for Injection - FERUCARBOTRAN 07/01/2010
BOCASAN Gillette Group UK Ltd PA1261/001/001 Powder for Oral Solution - SODIUM PERBORATE 01/01/2010
- SODIUM BITARTRATE
SIBELIUM Janssen-Cilag Ltd PA0748/031/001 Capsule - FLUNARIZINE 01/01/2010
DIHYDROCHLORIDE
SILCOCK'S BASE Rowa Pharmaceuticals PA0074/049/001 Cream 01/01/2010
Limited
CALPOL 120MG/5ML PCO Manufacturing PPA0465/172/001 Oral Suspension - PARACETAMOL 31/12/2009
SUGAR FREE INFANT
ORAL SUSPENSION
CATAFLAM PCO Manufacturing PPA0465/079/001A Tablets - DICLOFENAC 31/12/2009
POTASSIUM
- TITANIUM DIOXIDE (E171)

CHROMIUM [51CR] EDTA GE Healthcare Limited PA0240/020/001 Solution for Injection - CHROMIUM [CR-51] EDTA 31/12/2009
INJECTION ,CHROMIUM
[51CR] ED

Human Medicines Withdrawn Products Page 225 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DELTACORTRIL ENTERIC PCO Manufacturing PPA0465/179/001 Tablets - PREDNISOLONE 31/12/2009
DEPO-PROVERA PCO Manufacturing PPA0465/175/001 Solution for Injection - 31/12/2009
MEDROXYPROGESTERO
NE ACETATE
EFEXOR PCO Manufacturing PPA0465/085/001A Tablets - VENLAFAXINE 31/12/2009
HYDROCHLORIDE
EPREX 40,000 IU/ml solution Janssen-Cilag Ltd PA0748/025/010 Solution for injection - Epoetin alfa 31/12/2009
for injection
HEXVIX GE Healthcare AS PA0735/010/001 Powder and solvent for - HEXAMINOLEVULINATE 31/12/2009
intravesical solution HYDROCHLORIDE
LEVONELLE PCO Manufacturing PPA0465/145/001A Tablets - LEVONORGESTREL 31/12/2009
LOCOID PCO Manufacturing PPA0465/177/001 Cream - HYDROCORTISONE 31/12/2009
BUTYRATE
LOCOID LIPOCREAM PCO Manufacturing PPA0465/177/002 Cream - HYDROCORTISONE 31/12/2009
BUTYRATE
MERCILON PCO Manufacturing PPA0465/154/001 Unknown - DESOGESTREL 31/12/2009
- ETHINYLESTRADIOL
SEREVENT DISKUS PCO Manufacturing PPA0465/127/002 Pressurised Inhalation - SALMETEROL 31/12/2009
Suspension
XANAX PCO Manufacturing PPA0465/182/001 Tablets - ALPRAZOLAM 31/12/2009
XANAX PCO Manufacturing PPA0465/182/002 Tablets - ALPRAZOLAM 31/12/2009
XANAX PCO Manufacturing PPA0465/182/003 Tablets - ALPRAZOLAM 31/12/2009
NAVELBINE 40 MG SOFT PIERRE FABRE Ltd PA1287/001/003 Capsules, Soft - VINORELBINE TARTRATE 22/12/2009
CAPSULE
PIPERACILLIN/TAZOBACT Clonmel Healthcare Ltd PA0126/180/001 Pdr for Soln Inj/Inf - PIPERACILLIN 22/12/2009
AM STRAGEN - TAZOBACTAM
Agelan Tablets 2.5 mg Mercury Pharmaceuticals PA0073/102/001 Tablet - INDAPAMIDE 21/12/2009
(Ireland) Ltd HEMIHYDRATE
Antimet Mercury Pharmaceuticals PA0073/060/001 Tablet - Metoclopramide 21/12/2009
(Ireland) Ltd hydrochloride
Folic Acid Tablets BP 5 mg Mercury Pharmaceuticals PA0073/057/001 Tablet - Folic acid 21/12/2009
(Ireland) Ltd
HEMOHES 10% B. Braun Melsungen AG PA0736/001/004 Solution for Infusion - POLY(O-2- 21/12/2009
HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

HEMOHES 6% B. Braun Melsungen AG PA0736/001/003 Solution for Infusion - POLY(O-2- 21/12/2009


HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

METRONIDE 400MG Clonmel Healthcare Ltd PA0126/056/002 Tablets - METRONIDAZOLE 21/12/2009


TABLETS
VALTREX GlaxoSmithKline (Ireland) PA1077/082/003 Film Coated Tablet - VALACICLOVIR 19/12/2009
Limited HYDROCHLORIDE
CLAFORAN Sanofi-Aventis Ireland PA0540/037/004 Pdr for Soln for Injection - CEFOTAXIME SODIUM 17/12/2009
Limited T/A SANOFI
PREMIQUE LD John Wyeth & Brother PA0022/069/011 Coated Tablets - ESTROGENS 16/12/2009
Limited CONJUGATED
-
MEDROXYPROGESTERO
NE
BEECHAMS COLD & FLU GlaxoSmithKline Consumer PA0678/106/002 Powder for Oral Solution - PARACETAMOL 14/12/2009
BLACKCURRANT POWDER Healthcare (Ireland) Limited - ASCORBIC ACID

BEECHAMS COLD & FLU GlaxoSmithKline Consumer PA0678/106/003 Powder for Oral Solution - PARACETAMOL 14/12/2009
LEMON WITH HONEY Healthcare (Ireland) Limited - ASCORBIC ACID
BEECHAMS MAX GlaxoSmithKline Consumer PA0678/104/001 Oral Powder - PARACETAMOL 14/12/2009
STRENGTH COLD AND FL Healthcare (Ireland) Limited

LERCANIDIPINE Gentian Generics Limited PA1469/001/001 Film Coated Tablet - LERCANIDIPNE HCI, 14/12/2009
HYDROCHLORIDE ANHYDR.
LERCANIDIPINE Gentian Generics Limited PA1469/001/002 Film Coated Tablet - LERCANIDIPNE HCI, 14/12/2009
HYDROCHLORIDE ANHYDR.

Human Medicines Withdrawn Products Page 226 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLINIMIX N12G20 Baxter Healthcare Limited PA0167/098/006 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- GLUCOSE
CLINIMIX N12G20E Baxter Healthcare Limited PA0167/098/003 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
- CALCIUM CHLORIDE
DIHYDRATE
CLINIMIX N14G30 Baxter Healthcare Limited PA0167/098/007 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- GLUCOSE
CLINIMIX N17G35 Baxter Healthcare Limited PA0167/098/008 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- GLUCOSE

Human Medicines Withdrawn Products Page 227 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLINIMIX N17G35E Baxter Healthcare Limited PA0167/098/005 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
- CALCIUM CHLORIDE
DIHYDRATE
CLINIMIX N9G15E Baxter Healthcare Limited PA0167/098/001 Solution for Infusion - LEUCINE 11/12/2009
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
- CALCIUM CHLORIDE
DIHYDRATE
RADLINN Sinclair IS Pharma Limited PA0915/014/001 Film Coated Tablet - RISPERIDONE 11/12/2009
RADLINN Sinclair IS Pharma Limited PA0915/014/002 Film Coated Tablet - RISPERIDONE 11/12/2009
RADLINN Sinclair IS Pharma Limited PA0915/014/003 Film Coated Tablet - RISPERIDONE 11/12/2009
RADLINN Sinclair IS Pharma Limited PA0915/014/004 Film Coated Tablet - RISPERIDONE 11/12/2009
RADLINN Sinclair IS Pharma Limited PA0915/014/005 Film Coated Tablet - RISPERIDONE 11/12/2009
RADLINN Sinclair IS Pharma Limited PA0915/014/006 Film Coated Tablet - RISPERIDONE 11/12/2009
HALOPERIDOL Clonmel Healthcare Ltd PA0126/055/004 Tablets - HALOPERIDOL 08/12/2009
PONMEL 250 Clonmel Healthcare Ltd PA0126/081/001 Capsule - MEFENAMIC ACID 08/12/2009
PONMEL 500 Clonmel Healthcare Ltd PA0126/081/002 Tablets - MEFENAMIC ACID 08/12/2009
PACLITAXEL Stragen UK Limited PA1294/003/001 Concentrate for Soln for Inf - PACLITAXEL 07/12/2009
CEDINE 200 MG FILM- Rowex Ltd PA0711/044/001 Film Coated Tablet - CIMETIDINE 02/12/2009
COATED TABLETS
Efalith Scotia Pharmaceuticals PA0457/002/002 Cream - Lithium succinate 01/12/2009
Limited - Zinc sulfate
Efalith Ointment Scotia Pharmaceuticals PA0457/002/001 Ointment - Lithium succinate 01/12/2009
Limited - Zinc sulfate
LIMCLAIR CONCENTRATE Sinclair Pharmaceuticals PA0251/011/001 Solution for Infusion - TRISODIUM EDETATE 01/12/2009
Limited
LYRINEL XL Janssen-Cilag Ltd PA0748/052/003 Tablet Prolonged Release - OXYBUTYNIN 01/12/2009
HYDROCHLORIDE
LEDCLAIR STERILE Sinclair Pharmaceuticals PA0251/010/001 Concentrate for Soln for Inj - SODIUM CALCIUM 30/11/2009
SODIUM CALCIUM Limited EDETATE
EDETATE
BELLZAC Ranbaxy Ireland Limited PA0408/055/001 Capsules Hard - FLUOXETINE 29/11/2009
HYDROCHLORIDE
DOXANE Rowex Ltd PA0711/098/002 Tablets - DOXAZOSIN MESILATE 25/11/2009

Human Medicines Withdrawn Products Page 228 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ESTALIS 50/250 Novartis Pharmaceuticals UK PA0013/095/001 Transdermal Patch - ESTRADIOL 24/11/2009
Ltd HEMIHYDRATE
- NORETHISTERONE
ACETATE
ESTALIS SEQUI Novartis Pharmaceuticals UK PA0013/096/001 Transdermal Patch - ESTRADIOL 24/11/2009
Ltd HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
- NORETHISTERONE
ACETATE
SEQUIDOT Novartis Pharmaceuticals UK PA0013/096/002 Transdermal Patch - ESTRADIOL 24/11/2009
Ltd HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
- NORETHISTERONE
ACETATE
ORATAN Clonmel Healthcare Ltd PA0126/130/001 Capsules, Soft - ISOTRETINOIN 23/11/2009
ORATAN Clonmel Healthcare Ltd PA0126/130/002 Capsules, Soft - ISOTRETINOIN 23/11/2009
TAMSULAS Biokanol Pharma GmbH PA1304/001/001 Prolonged Release Capsules - TAMSULOSIN 20/11/2009
HYDROCHLORIDE
VECTARION Servier Laboratories (Ireland) PA0068/011/001 Tablets - ALMITRINE 12/11/2009
Ltd BISMESYLATE
AUGMENTIN GlaxoSmithKline (Ireland) PA1077/093/008 Dispersable Tablet - AMOXICILLIN 11/11/2009
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
MYCOSTATIN Bristol-Myers Squibb PA0002/007/009 Vaginal Cream - NYSTATIN 11/11/2009
Pharmaceuticals uc
MYCOSTATIN Bristol-Myers Squibb PA0002/007/002 Cream - NYSTATIN 11/11/2009
Pharmaceuticals uc
TRACUTIL B. Braun Melsungen AG PA0736/019/001 Solution for Infusion - IRON (III) CHLORIDE 11/11/2009
TETRAHYDRATE
- ZINC CHLORIDE
- MANGANESE CHLORIDE
TETRAHYDRATE
- CUPRIC CHLORIDE
DIHYDRATE
- CHROMIUM CHLORIDE
- SODIUM SELENITE
PENTAHYDRATE
- SODIUM MOLYBDATE
DIHYDRATE
- POTASSIUM IODIDE
- SODIUM FLUORIDE
AMIKIN Bristol-Myers Squibb PA0048/004/006 Solution for Injection - AMIKACIN SULFATE 09/11/2009
(Holdings) Limited
AZACTAM Bristol-Myers Squibb PA0002/052/001 Pdr for Soln Inj/Inf - AZTREONAM 09/11/2009
Pharmaceuticals uc
ZOTON John Wyeth & Brother PA0022/089/002 Capsules Gastro-Resistant - LANSOPRAZOLE 08/11/2009
Limited
LIPANTIL SUPRA Abbott Healthcare Products PA0108/030/006 Coated Tablets - FENOFIBRATE 03/11/2009
Ltd
PREDNISOLONE Clonmel Healthcare Ltd PA0126/027/003 Tablets - PREDNISOLONE 03/11/2009
AMERSCAN HEPTONATE II GE Healthcare Limited PA0240/023/001 Pdr for Soln for Injection - STANNOUS FLUORIDE 28/10/2009
AGENT
DEEP FREEZE The Mentholatum Company PA0076/001/001 Cutaneous Spray Solution - PENTANE 23/10/2009
CUTANEOUS SPRAY Ltd. - LEVOMENTHOL
SOLUTION
NYSTAFORM Typharm Limited PA0219/003/002 Ointment - NYSTATIN 22/10/2009
- CHLORHEXIDINE
DIACETATE
CIPRALAM 40 MG FILM- Actavis Group PTC ehf PA1380/027/003 Film Coated Tablet - CITALOPRAM 13/10/2009
COATED TABLETS HYDROBROMIDE’
COSARTAL Actavis Group PTC ehf PA1380/046/001 Tablets - LOSARTAN POTASSIUM 13/10/2009
COSARTAL Actavis Group PTC ehf PA1380/046/002 Tablets - LOSARTAN POTASSIUM 13/10/2009
KYFLAM Actavis Group PTC ehf PA1380/078/001 Film Coated Tablet - DICLOFENAC 13/10/2009
POTASSIUM
PAROXETINE Actavis Group PTC ehf PA1380/009/002 Film Coated Tablet - PAROXETINE 13/10/2009
RAMYTE Actavis Group PTC ehf PA1380/024/001 Capsule - RAMIPRIL 13/10/2009
VELEXOR Actavis Group PTC ehf PA1380/063/001 Film Coated Tablet - VENLAFAXINE 13/10/2009
HYDROCHLORIDE
VELEXOR Actavis Group PTC ehf PA1380/063/003 Film Coated Tablet - VENLAFAXINE 13/10/2009
HYDROCHLORIDE
ORUGESIC 2.5% W/W GEL Sanofi-Aventis Ireland PA0540/118/001 Gel - KETOPROFEN 11/10/2009
Limited T/A SANOFI
GRANISETRON Actavis Group PTC ehf PA1380/001/001 Concentrate for Soln for Inf - GRANISETRON 06/10/2009

Human Medicines Withdrawn Products Page 229 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GRANISETRON Actavis Group PTC ehf PA1380/001/002 Concentrate for Soln for Inf
- GRANISETRON 06/10/2009
MADOPAR Roche Products Limited PA0050/043/001 Capsules Hard - LEVODOPA 06/10/2009
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR Roche Products Limited PA0050/043/003 Capsules Hard - LEVODOPA 06/10/2009
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR CR Roche Products Limited PA0050/043/007 Prolonged Release Capsules - LEVODOPA 06/10/2009
- BENSERAZIDE
HYDROCHLORIDE
ORTHO-GYNEST 0.5MG Janssen-Cilag Ltd PA0748/034/001 Pessary - ESTRIOL 05/10/2009
PESSARIES.
CALCIL 50 MICROGRAM/G Rowex Ltd PA0711/104/001 Cream - CALCIPOTRIOL 02/10/2009
CREAM ANHYDROUS
DOXANE Rowex Ltd PA0711/098/001 Tablets - DOXAZOSIN MESILATE 02/10/2009
DOXANE Rowex Ltd PA0711/098/003 Tablets - DOXAZOSIN MESILATE 02/10/2009
LOSARTAN Rowex Ltd PA0711/123/004 Film Coated Tablet - LOSARTAN POTASSIUM 02/10/2009
LOSARTAN Rowex Ltd PA0711/123/002 Film Coated Tablet - LOSARTAN POTASSIUM 02/10/2009
NIFED Rowex Ltd PA0711/011/008 Capsule - NIFEDIPINE 02/10/2009
OMEPRAZOLE 20MG Rowex Ltd PA0711/090/001 Capsules Gastro-Resistant - OMEPRAZOLE 02/10/2009
GASTRO-RESISTANT
CAPSULES
QUINAPRIL Ranbaxy Ireland Limited PA0408/068/001 Film Coated Tablet - QUINAPRIL 02/10/2009
HYDROCHLORIDE
QUINAPRIL Ranbaxy Ireland Limited PA0408/068/002 Film Coated Tablet - QUINAPRIL 02/10/2009
HYDROCHLORIDE
QUINAPRIL Ranbaxy Ireland Limited PA0408/068/003 Film Coated Tablet - QUINAPRIL 02/10/2009
HYDROCHLORIDE
QUINAPRIL Ranbaxy Ireland Limited PA0408/068/004 Film Coated Tablet - QUINAPRIL 02/10/2009
HYDROCHLORIDE
PRAVASTATIN Winthrop Pharmaceuticals PA1046/014/001 Tablets - PRAVASTATIN SODIUM 01/10/2009
UK Limited
PRAVASTATIN Winthrop Pharmaceuticals PA1046/014/002 Tablets - PRAVASTATIN SODIUM 01/10/2009
UK Limited
PRAVASTATIN Winthrop Pharmaceuticals PA1046/014/003 Tablets - PRAVASTATIN SODIUM 01/10/2009
UK Limited
BALMOSA CREAM Galen Consumer Ltd. PA1443/001/001 Cream - MENTHOL 29/09/2009
- CAMPHOR
- METHYL SALICYLATE
EDRONAX Pharmacia Healthcare PA0936/089/001 Tablets - REBOXETINE MESYLATE 29/09/2009
Ireland
VISKALDIX Novartis Pharmaceuticals UK PA0013/026/001 Tablets - PINDOLOL 29/09/2009
Ltd - CLOPAMIDE
VISKEN Novartis Pharmaceuticals UK PA0013/001/002 Tablets - PINDOLOL 29/09/2009
Ltd
NOCUTIL 0.1 MG TABLETS Gebro Pharma GmbH PA1262/001/001 Tablets - DESMOPRESSIN 25/09/2009
ACETATE
NOCUTIL 0.2 MG TABLETS Gebro Pharma GmbH PA1262/001/002 Tablets - DESMOPRESSIN 25/09/2009
ACETATE
ABSTRAL Kyowa Kirin Ltd PA1049/006/001 Tablet Sublingual - FENTANYL 23/09/2009
QUIXIL Omrix Biopharmaceuticals PA0986/001/001 Solution for Sealant - HUMAN CLOTTABLE 18/09/2009
S.A. PROTEIN
- HUMAN ALPHA
THROMBIN
- CALCIUM CHLORIDE
DIHYDRATE
- TRANEXAMIC ACID
CLAVAMEL 125MG/62.5MG Clonmel Healthcare Ltd PA0126/103/003 Powder for Oral Suspension - AMOXICILLIN 16/09/2009
PER 5ML JUNIOR POWDER TRIHYDRATE
FOR OR - CLAVULANATE
POTASSIUM
PULMOCLASE UCB S.A. PA0230/006/001 Oral Suspension - CARBOCISTEINE 11/09/2009
EMVASC Norton Healthcare Limited PA0282/081/001 Film Coated Tablet - BISOPROLOL FUMARATE 09/09/2009
T/A IVAX Pharmaceuticals
UK
EMVASC Norton Healthcare Limited PA0282/081/002 Film Coated Tablet - BISOPROLOL FUMARATE 09/09/2009
T/A IVAX Pharmaceuticals
UK
ALLOPURINOL Norton Healthcare Limited PA0282/021/001 Tablets - ALLOPURINOL 08/09/2009
T/A IVAX Pharmaceuticals
UK
ALLOPURINOL Norton Healthcare Limited PA0282/021/002 Tablets - ALLOPURINOL 08/09/2009
T/A IVAX Pharmaceuticals
UK
GEROTEN McDermott Laboratories Ltd PA0577/024/001 Tablets - CAPTOPRIL 08/09/2009
t/a Gerard Laboratories

Human Medicines Withdrawn Products Page 230 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GEROTEN McDermott Laboratories Ltd PA0577/024/002 Tablets - CAPTOPRIL 08/09/2009
t/a Gerard Laboratories
GEROTEN McDermott Laboratories Ltd PA0577/024/003 Tablets - CAPTOPRIL 08/09/2009
t/a Gerard Laboratories
MORPHINE SULPHATE Pharmachemie BV PA0937/002/001 Tablet Prolonged Release - MORPHINE SULPHATE 08/09/2009
PENTAHYDRATE
MORPHINE SULPHATE Pharmachemie BV PA0937/002/002 Tablet Prolonged Release - MORPHINE SULPHATE 08/09/2009
PENTAHYDRATE
MORPHINE SULPHATE Pharmachemie BV PA0937/002/003 Tablet Prolonged Release - MORPHINE SULPHATE 08/09/2009
PENTAHYDRATE
MORPHINE SULPHATE Pharmachemie BV PA0937/002/004 Tablet Prolonged Release - MORPHINE SULPHATE 08/09/2009
PENTAHYDRATE
MORPHINE SULPHATE Pharmachemie BV PA0937/009/001 Tablet Prolonged Release - MORPHINE SULPHATE 08/09/2009
PERDAMEL Clonmel Healthcare Ltd PA0126/169/008 Oral Solution - RISPERIDONE 08/09/2009
METOCYL Rowa Pharmaceuticals PA0074/010/002 Tablets - METOCLOPRAMIDE 07/09/2009
Limited HYDROCHLORIDE
AVLOCLOR TABLETS 250 AstraZeneca UK Limited PA0970/029/001 Tablets - CHLOROQUINE 01/09/2009
MG PHOSPHATE
DIPRIVAN 1% W/V AstraZeneca UK Limited PA0970/005/002 Emulsion for Inj/Inf - PROPOFOL 01/09/2009
EMULSION FOR
INJECTION OR INFUSION
CYANOCOBALAMIN GE Healthcare Limited PA0240/016/001 Capsule - CYANOCOBALAMIN (57 31/08/2009
CO)
DHC Continus Prolonged- Napp Pharmaceuticals PA0913/008/001 Tablet - Dihydrocodeine tartrate 31/08/2009
release Tablets 60 mg Limited
ESTRACOMBI TTS Novartis Pharmaceuticals UK PA0013/075/001 Transdermal Patch - ESTRADIOL 31/08/2009
Ltd HEMIHYDRATE
- NORETHISTERONE
ACETATE
- ESTRADIOL
HEMIHYDRATE
LOPRESOR SR Novartis Pharmaceuticals UK PA0013/083/003 Tablet Prolonged Release - METOPROLOL TARTRATE 31/08/2009
Ltd
CABASER 4MG TABLETS Pharmacia Laboratories PA0187/061/003 Tablets - CABERGOLINE 27/08/2009
Limited
ASPRO C EFFERVESCENT Bayer Limited PA1410/036/001 Tablets Effervescent - ACETYLSALICYLIC ACID 26/08/2009
TABLETS - ASCORBIC ACID

FLUTAPLEX Pharmachemie BV PA0937/001/001 Tablets - FLUTAMIDE 22/08/2009


SIMVASTATIN SH Ratiopharm GmbH PA0819/028/001 Coated Tablets - SIMVASTATIN 21/08/2009
SIMVASTATIN SH Ratiopharm GmbH PA0819/028/002 Coated Tablets - SIMVASTATIN 21/08/2009
SIMVASTATIN SH Ratiopharm GmbH PA0819/028/003 Coated Tablets - SIMVASTATIN 21/08/2009
SIMVASTATIN SH Ratiopharm GmbH PA0819/028/004 Coated Tablets - SIMVASTATIN 21/08/2009
AMOXICILLIN/CLAVULANIC Rowex Ltd PA0711/095/001 Coated Tablets - AMOXICILLIN 20/08/2009
ACID 250/125MG FILM- TRIHYDRATE
COATED - CLAVULANATE
POTASSIUM
ONDANSETRON Rowa Pharmaceuticals PA0074/054/003 Solution for Injection - ONDANSETRON 20/08/2009
Limited HYDROCHLORIDE
DIHYDRATE
ONDANSETRON Rowa Pharmaceuticals PA0074/054/004 Solution for Injection - ONDANSETRON 20/08/2009
Limited HYDROCHLORIDE
DIHYDRATE
RISPERIDONE Rowa Pharmaceuticals PA0074/061/001 Oral Solution - RISPERIDONE 20/08/2009
Limited
DIAZEPAM RECTUBES CP Pharmaceuticals Ltd PA0409/003/008 Rectal Solution - DIAZEPAM 14/08/2009
trading as Wockhardt UK
SIMVASTATIN CT CT Arzneimittel GmbH PA1081/001/001 Film Coated Tablet - SIMVASTATIN 13/08/2009
SIMVASTATIN CT CT Arzneimittel GmbH PA1081/001/002 Film Coated Tablet - SIMVASTATIN 13/08/2009
SIMVASTATIN CT CT Arzneimittel GmbH PA1081/001/003 Film Coated Tablet - SIMVASTATIN 13/08/2009
SIMVASTATIN CT CT Arzneimittel GmbH PA1081/001/004 Film Coated Tablet - SIMVASTATIN 13/08/2009
PERCARNIL Actavis Group PTC ehf PA1380/045/001 Tablets - PERINDOPRIL TERT- 12/08/2009
BUTYLAMINE
PREDENEMA Chemidex Pharma Limited PA1161/005/001 Rectal Solution - PREDNISOLONE SODIUM 12/08/2009
SULFOBENZOATE

FLUDARABINE Actavis Group PTC ehf PA1380/003/001 Lyophilisate for solution for - FLUDARABINE 11/08/2009
PHOSPHATE ACTAVIS injection PHOSPHATE
GLEMIDE Actavis Group PTC ehf PA1380/019/001 Tablets - GLIMEPIRIDE 11/08/2009
GLEMIDE Actavis Group PTC ehf PA1380/019/002 Tablets - GLIMEPIRIDE 11/08/2009
GLEMIDE Actavis Group PTC ehf PA1380/019/003 Tablets - GLIMEPIRIDE 11/08/2009
GLEMIDE Actavis Group PTC ehf PA1380/019/004 Tablets - GLIMEPIRIDE 11/08/2009
OXALIPLATIN Actavis Group hf PA1384/001/001 Powder for solution for - OXALIPLATIN 11/08/2009
infusion

Human Medicines Withdrawn Products Page 231 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROPINIROLE Actavis Group PTC ehf PA1380/004/005 Tablets - ROPINIROLE 11/08/2009
HYDROCHLORIDE
DEXA-RHINASPRAY DUO Boehringer Ingelheim Limited PA0007/053/001 Nasal Spray Suspension - TRAMAZOLINE 10/08/2009
HYDROCHLORIDE
- DEXAMETHASONE
ISONICOTINATE
TOPAMAT FILM COATED Generics (UK) Limited PA0405/054/001 Film Coated Tablet - TOPIRAMATE 06/08/2009
TABLETS
TOPAMAT FILM COATED Generics (UK) Limited PA0405/054/002 Film Coated Tablet - TOPIRAMATE 06/08/2009
TABLETS
TOPAMAT FILM COATED Generics (UK) Limited PA0405/054/003 Film Coated Tablet - TOPIRAMATE 06/08/2009
TABLETS
TOPAMAT FILM COATED Generics (UK) Limited PA0405/054/004 Film Coated Tablet - TOPIRAMATE 06/08/2009
TABLETS
RESPINTEL Chanelle Medical PA0688/012/001 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/002 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/003 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/004 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/005 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/006 Film Coated Tablet - RISPERIDONE 05/08/2009
RESPINTEL Chanelle Medical PA0688/012/007 Film Coated Tablet - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/001 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/002 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/003 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/004 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/005 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/006 Tablets - RISPERIDONE 05/08/2009
RISPERIDONE Chanelle Medical PA0688/006/007 Tablets - RISPERIDONE 05/08/2009
GALTAM Rowex Ltd PA0711/114/001 Film Coated Tablet - GALANTAMINE 04/08/2009
HYDROBROMIDE
GALTAM Rowex Ltd PA0711/114/002 Film Coated Tablet - GALANTAMINE 04/08/2009
HYDROBROMIDE
GALTAM Rowex Ltd PA0711/114/003 Film Coated Tablet - GALANTAMINE 04/08/2009
HYDROBROMIDE
DOXAZOSIN DISPHAR Sinclair IS Pharma Limited PA0915/012/001 Tablets - DOXAZOSIN MESILATE 03/08/2009
DOXAZOSIN DISPHAR Sinclair IS Pharma Limited PA0915/012/002 Tablets - DOXAZOSIN MESILATE 03/08/2009
DOXAZOSIN DISPHAR Sinclair IS Pharma Limited PA0915/012/003 Tablets - DOXAZOSIN MESILATE 03/08/2009
HYRAZ 1 MG AND 2 MG Ergha Healthcare Ltd PA0966/009/005 Tablets - TERAZOSIN 03/08/2009
TABLETS. TITRATION HYDROCHLORIDE
PACK. - TERAZOSIN
HYDROCHLORIDE
HYRAZ 1 MG TABLETS Ergha Healthcare Ltd PA0966/009/004 Tablets - TERAZOSIN 03/08/2009
HYDROCHLORIDE
HYRAZ 10 MG TABLETS Ergha Healthcare Ltd PA0966/009/003 Tablets - TERAZOSIN 03/08/2009
HYDROCHLORIDE
HYRAZ 2 MG TABLETS Ergha Healthcare Ltd PA0966/009/001 Tablets - TERAZOSIN 03/08/2009
HYDROCHLORIDE
HYRAZ 5 MG TABLETS Ergha Healthcare Ltd PA0966/009/002 Tablets - TERAZOSIN 03/08/2009
HYDROCHLORIDE
QUINAPRO Ergha Healthcare Ltd PA0966/012/001 Coated Tablets - QUINAPRIL 03/08/2009
HYDROCHLORIDE
QUINAPRO Ergha Healthcare Ltd PA0966/012/002 Coated Tablets - QUINAPRIL 03/08/2009
HYDROCHLORIDE
QUINAPRO Ergha Healthcare Ltd PA0966/012/003 Coated Tablets - QUINAPRIL 03/08/2009
HYDROCHLORIDE
QUINAPRO Ergha Healthcare Ltd PA0966/012/004 Coated Tablets - QUINAPRIL 03/08/2009
INDIUM OXINE GE Healthcare Limited PA0240/026/001 Radio-Pharm Precursor - INDIUM OXINE (IN-111) 01/08/2009
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/007 Pdr for Soln Inj/Inf - COLISTIN MESILATE 31/07/2009
SODIUM
SYMBICORT TURBOHALER B & S Healthcare PPA1328/038/001 Inhalation powder - BUDESONIDE 30/07/2009
100/6 INHALATION - FORMOTEROL
POWDER FUMARATE
SYNERCID Monarch Pharmaceuticals PA1272/001/001 Powder for solution for - QUINUPRISTIN 28/07/2009
Ireland infusion - DALFOPRISTIN
DUAGEN GlaxoSmithKline (Ireland) PA1077/105/001 Capsules, Soft - DUTASTERIDE 23/07/2009
Limited
SERC B & S Healthcare PPA1328/034/001 Tablets - BETAHISTINE 20/07/2009
HYDROCHLORIDE
WINRHO SDF Cangene Europe Limited PA1027/002/002 Pdr+Solv for Soln for Inj - ANTI-D 17/07/2009
IMMUNOGLOBULIN
- SODIUM CHLORIDE
WINRHO SDF Cangene Europe Limited PA1027/002/003 Pdr+Solv for Soln for Inj - ANTI-D 17/07/2009
IMMUNOGLOBULIN
- SODIUM CHLORIDE
SIMVASTATIN CT Arzneimittel GmbH PA1081/002/001 Film Coated Tablet - SIMVASTATIN 13/07/2009

Human Medicines Withdrawn Products Page 232 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SIMVASTATIN CT Arzneimittel GmbH PA1081/002/002 Film Coated Tablet - SIMVASTATIN 13/07/2009
SIMVASTATIN CT Arzneimittel GmbH PA1081/002/003 Film Coated Tablet - SIMVASTATIN 13/07/2009
SUMATRIPTAN NICHE Niche Generics Limited PA1063/022/001 Coated Tablets - SUMATRIPTAN 13/07/2009
SUCCINATE
SUMATRIPTAN NICHE Niche Generics Limited PA1063/022/002 Coated Tablets - SUMATRIPTAN 13/07/2009
SUCCINATE
MELOXICAM Sandoz Ltd PA0372/010/001 Tablets - MELOXICAM 08/07/2009
MELOXICAM Sandoz Ltd PA0372/010/002 Tablets - MELOXICAM 08/07/2009
SOLPAFLEX SUSTAINED GlaxoSmithKline Consumer PA0678/061/001 Capsule - IBUPROFEN 08/07/2009
RELEASE Healthcare (Ireland) Limited
CHOLSTAT 20MG TABLET Pliva Pharma Limited PA0585/019/002 Tablets - PRAVASTATIN SODIUM 06/07/2009

CHOLSTAT 40MG TABLET Pliva Pharma Limited PA0585/019/003 Tablets - PRAVASTATIN SODIUM 06/07/2009

FORTINOL LA Chauvin Pharmaceuticals PA0118/048/001 Eye Drops Prolonged Rel. - CARTEOLOL 01/07/2009
Limited HYDROCHLORIDE
FORTINOL LA Chauvin Pharmaceuticals PA0118/048/002 Eye Drops Prolonged Rel. - CARTEOLOL 01/07/2009
Limited HYDROCHLORIDE
MENINGITEC John Wyeth & Brother PA0022/078/001 Suspension for Injection - MENINGOCOCCAL 30/06/2009
Limited POLYSACCHARIDE
GROUP C
ROFERON-A PRE-FILLED Roche Products Limited PA0050/068/025 Solution for Injection - INTERFERON ALFA-2A 25/06/2009
SYRINGE 18MIU/0.5ML
GAMMADERM 200MG/G Dr. August Wolff GmbH & PA0988/002/001 Cream - OENOTHERA BIENNIS 24/06/2009
CREAM Co.
RANITISTAD 300 Stada Arzneimittel AG PA0593/012/002 Coated Tablets - RANITIDINE 24/06/2009
HYDROCHLORIDE
PSORIMED Dr. August Wolff GmbH & PA0988/001/001 Cutaneous Solution - SALICYLIC ACID 18/06/2009
Co.
REMINYL XL (STARTER Shire Pharmaceuticals PA0535/006/008 Capsules Hard - GALANTAMINE 17/06/2009
PACK) Limited
VEDIXAL 150 MG TABLETS Rowex Ltd PA0711/161/005 Tablets - VENLAFAXINE 16/06/2009

VEDIXAL 25 MG TABLETS Rowex Ltd PA0711/161/001 Tablets - VENLAFAXINE 16/06/2009


VEDIXAL 50 MG TABLETS Rowex Ltd PA0711/161/003 Tablets - VENLAFAXINE 16/06/2009
EQUORAL Norton Healthcare Limited PA0282/078/001 Unknown - CICLOSPORIN 11/06/2009
T/A IVAX Pharmaceuticals
UK
EQUORAL Norton Healthcare Limited PA0282/078/002 Capsule - CICLOSPORIN 11/06/2009
T/A IVAX Pharmaceuticals
UK
EQUORAL Norton Healthcare Limited PA0282/078/003 Capsule - CICLOSPORIN 11/06/2009
T/A IVAX Pharmaceuticals
UK
EQUORAL Norton Healthcare Limited PA0282/078/004 Capsule - CICLOSPORIN 11/06/2009
T/A IVAX Pharmaceuticals
UK
GAMMANORM Octapharma Limited PA0521/014/001 Solution for Injection - IMMUNOGLOBULIN G 11/06/2009
DOVONEX PCO Manufacturing PPA0465/132/002A Ointment - CALCIPOTRIOL 10/06/2009
IBUPROFEN Crookes Healthcare Ltd PA0043/006/001 Tablets - IBUPROFEN 10/06/2009
GRANEODIN OINTMENT Bristol-Myers Squibb PA0002/008/002 Ointment - NEOMYCIN SULFATE 05/06/2009
Pharmaceuticals uc - GRAMICIDIN
PRONESTYL Bristol-Myers Squibb PA0002/034/002 Solution for Injection - PROCAINAMIDE 05/06/2009
Pharmaceuticals uc HYDROCHLORIDE
CEFUROXIME Sandoz Ltd PA0372/009/001 Tablets - CEFUROXIME AXETIL 02/06/2009
CEFUROXIME Sandoz Ltd PA0372/009/002 Tablets - CEFUROXIME AXETIL 02/06/2009
ZOPICLONE Meda Health Sales Ireland PA1332/008/001 Tablets - ZOPICLONE 02/06/2009
Limited
ALPROX Orion Corporation PA1327/001/001 Tablets - ALPRAZOLAM 01/06/2009
META- GE Healthcare Limited PA0240/008/002 Solution for Injection - IOBENGUANE CHLORIDE 01/06/2009
IODOBENZYLGUANIDINE
SODIUM IODIDE GE Healthcare Limited PA0240/018/001 Solution for Injection - SODIUM IODIDE (131 I) 01/06/2009
SODIUM IODIDE GE Healthcare Limited PA0240/018/002 Solution for Injection - SODIUM IODIDE (131 I) 01/06/2009
SODIUM IODIDE GE Healthcare Limited PA0240/018/003 Capsule - SODIUM IODIDE (131 I) 01/06/2009
THERACAP GE Healthcare Limited PA0240/031/001 Capsule - SODIUM IODIDE 01/06/2009
ADCORTYL IN ORABASE Bristol-Myers Squibb PA0002/018/001 Oromucosal Paste - TRIAMCINOLONE 31/05/2009
0.1% W/W OROMUCOSAL Pharmaceuticals uc ACETONIDE
PASTE
AYRTONS ANTISEPTIC Ayrton Saunders Ltd PA0501/001/001 Ointment - ZINC OXIDE 31/05/2009
OINTMENT - DICHLOROBENZYL
ALCOHOL

Human Medicines Withdrawn Products Page 233 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KENACOMB CREAM Bristol-Myers Squibb PA0002/009/002 Cream - TRIAMCINOLONE 31/05/2009
Pharmaceuticals uc ACETONIDE
- NYSTATIN
- NEOMYCIN SULFATE
- GRAMICIDIN
KENACOMB OINTMENT Bristol-Myers Squibb PA0002/009/001 Ointment - TRIAMCINOLONE 31/05/2009
Pharmaceuticals uc ACETONIDE
- NYSTATIN
- NEOMYCIN SULFATE
- GRAMICIDIN
KENACOMB OTIC Bristol-Myers Squibb PA0002/033/001 Ointment - TRIAMCINOLONE 31/05/2009
OINTMENT. Pharmaceuticals uc ACETONIDE
- NEOMYCIN SULFATE
- GRAMICIDIN
- NYSTATIN
ALENDRONIC ACID 70MG Gedeon Richter Plc PA1330/002/001 Film Coated Tablet - ALENDRONATE SODIUM 30/05/2009
'ONCE WEEKLY'
OCCLUSAL LS Alliance Pharmaceuticals Ltd PA0943/007/001 Cutaneous Solution - SALICYLIC ACID 30/05/2009

DIABEX Lipha Pharmaceuticals PA0289/009/001 Coated Tablets - METFORMIN 29/05/2009


Limited
PALUDRINE TABLETS AstraZeneca UK Limited PA0970/016/001 Tablets - PROGUANIL 29/05/2009
100MG HYDROCHLORIDE
VIOFORM Novartis Consumer Health PA0030/015/002 Ointment - CLIOQUINOL 29/05/2009
HYDROCORTISONE UK Limited - HYDROCORTISONE
VIOFORM- Novartis Consumer Health PA0030/015/001 Cream - CLIOQUINOL 29/05/2009
HYDOCORTISONE UK Limited - HYDROCORTISONE
BENPROTAN Clonmel Healthcare Ltd PA0126/160/002 Tablet Prolonged Release - ALFUZOSIN 28/05/2009
HYDROCHLORIDE
COVERSYL B & S Healthcare PPA1328/022/002 Tablets - PERINDOPRIL TERT- 28/05/2009
BUTYLAMINE SALT
RANITISTAD 150 Stada Arzneimittel AG PA0593/012/001 Tablets - RANITIDINE 26/05/2009
HYDROCHLORIDE
ZOTON Imbat Limited PPA1151/003/001A Capsules Gastro-Resistant - LANSOPRAZOLE 20/05/2009
ZOTON Imbat Limited PPA1151/003/002A Capsules Gastro-Resistant - LANSOPRAZOLE 20/05/2009
CIPROXIN B & S Healthcare PPA1328/074/001 Film Coated Tablet - CIPROFLOXACIN 18/05/2009
HYDROCHLORIDE
ZINNAT B & S Healthcare PPA1328/004/001 Tablets - CEFUROXIME AXETIL 18/05/2009
Climara 25 micrograms/24 Bayer Limited PA1410/015/003 Transdermal patch - Estradiol 15/05/2009
hours Transdermal Patch
Fludarabine phosphate 50 Bayer Limited PA1410/017/001 Powder for solution for - Fludarabine phosphate 15/05/2009
mg powder for solution for injection/infusion
injection or infusion
BECLO-RHINO AQUEOUS Mercury Pharmaceuticals Ltd PA0899/017/001 Nasal Spray Suspension - BECLOMETASONE 13/05/2009
DIPROPIONATE
NUROFEN 200 MG Reckitt Benckiser Ireland Ltd PA0979/032/004 Tablets - IBUPROFEN 13/05/2009
MELTLETS
ACETOXYL Stiefel Laboratories (U.K.) PA0144/010/001 Gel - BENZOYL PEROXIDE 08/05/2009
Ltd.
ACETOXYL 10 Stiefel Laboratories (U.K.) PA0144/010/003 Gel - BENZOYL PEROXIDE 08/05/2009
Ltd.
ACETOXYL 5 Stiefel Laboratories (U.K.) PA0144/010/002 Gel - BENZOYL PEROXIDE 08/05/2009
Ltd.
ACNEGEL Stiefel Laboratories (U.K.) PA0144/028/001 Gel - BENZOYL PEROXIDE 08/05/2009
Ltd.
ANTHRANOL 0.4 Stiefel Laboratories (U.K.) PA0144/017/004 Ointment - DITHRANOL 08/05/2009
Ltd.
ANTHRANOL 1.0 Stiefel Laboratories (U.K.) PA0144/017/001 Ointment - DITHRANOL 08/05/2009
Ltd.
ANTHRANOL 2.0 Stiefel Laboratories (U.K.) PA0144/017/002 Ointment - DITHRANOL 08/05/2009
Ltd.
BRASIVOL FINE Stiefel Laboratories (U.K.) PA0144/025/001 Cutaneous Paste - ALUMINIUM OXIDE 08/05/2009
Ltd.
BRASIVOL MEDIUM Stiefel Laboratories (U.K.) PA0144/025/002 Cutaneous Paste - ALUMINIUM OXIDE 08/05/2009
Ltd.
DRICLOR Stiefel Laboratories (U.K.) PA0144/012/002 Cutaneous Powder - ALDIOXA 08/05/2009
Ltd.
OILATUM FRAGRANCE Stiefel Laboratories (U.K.) PA0144/022/005 Unknown - LIQUID PARAFFIN LIGHT 08/05/2009
FREE Ltd.
PANOXLY 5 Stiefel Laboratories (U.K.) PA0144/011/008 Cream - BENZOYL PEROXIDE 08/05/2009
Ltd.
PANOXYL 5 Stiefel Laboratories (U.K.) PA0144/011/009 Cutaneous Emulsion - BENZOYL PEROXIDE 08/05/2009
Ltd.
POLYTAR ANTI-FUNGAL Stiefel Laboratories (U.K.) PA0144/030/001 Shampoo - COAL TAR 08/05/2009
Ltd. - PYRITHIONE ZINC

Human Medicines Withdrawn Products Page 234 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROSAC METRONIDAZOLE Stiefel Laboratories (U.K.) PA0144/035/001 Gel - METRONIDAZOLE 08/05/2009
GEL Ltd.
SPECTRABAN 4 Stiefel Laboratories (U.K.) PA0144/021/001 Cutaneous Solution - PADIMATE O 08/05/2009
Ltd.
STIEFEL ACNE Stiefel Laboratories (U.K.) PA0144/027/001 Soap - SULPHONATED OIL 08/05/2009
Ltd. - MINERAL OIL EMULSION
- SORBITAN MONO-
OLETAE
STIEFEL ANTI- Stiefel Laboratories (U.K.) PA0144/041/001 Cutaneous Solution - ALUMINIUM CHLORIDE 08/05/2009
PERSPIRANT SOLUTION Ltd. HEXAHYDRATE
STIEFEL DRY SKIN Stiefel Laboratories (U.K.) PA0144/023/002 Cream - ARACHIS OIL 08/05/2009
Ltd.
STIEFEL EMOLLIENT Stiefel Laboratories (U.K.) PA0144/044/001 Soap - PARAFFIN, LIQUID 08/05/2009
Ltd.
STIEFEL SUNBLOCK Stiefel Laboratories (U.K.) PA0144/043/001 Cutaneous Solution - PADIMATE O 08/05/2009
LOTION Ltd. - AVOBENZONE
- ETHYLHEXYL P-
METHOXYCINNAMATE
STIEMYCIN Stiefel Laboratories (U.K.) PA0144/016/002 Gel - ERYTHROMYCIN 08/05/2009
Ltd.
INTRALIPID Fresenius Kabi Limited PA0566/019/012 Emulsion for Infusion - SOYA OIL 01/05/2009
M-M-R ™ II POWDER AND Sanofi Pasteur MSD Ltd PA0544/024/002 Pdr+Solv for Soln for Inj - MEASLES VIRUS LIVE 01/05/2009
SOLVENT FOR SOLUTION ATTENUATED DERIVED
FOR INJ FROM THE EDMONSTON B
STRAIN
- MUMPS VIRUS -
JERYLYNN STRAIN
- RUBELLA VIRUS (WISTAR
RA 27/3 STRAIN) LIVE
ATTENUATED
M-M-RTM II POWDER AND Sanofi Pasteur MSD Ltd PA0544/024/001 Not assigned - MEASLES VIRUS - 01/05/2009
SOLVENT FOR SOLUTION ENDERS EDMONSTON
FOR INJ STRAIN
- MUMPS VIRUS -
JERYLYNN STRAIN
- RUBELLA VIRUS -
WISTAR RA27/3 STRAIN
VAMIN 14 ELECTROLYTE - Fresenius Kabi Limited PA0566/023/001 Solution for Infusion - ALANINE 01/05/2009
FREE SOLUTION FOR - ARGININE
INFUSION, - ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- LYSINE ACETATE

Human Medicines Withdrawn Products Page 235 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VAMIN 14 ELECTROLYTE - Fresenius Kabi Limited PA0566/023/002 Solution for Infusion - ALANINE 01/05/2009
FREE SOLUTION FOR - ARGININE
INFUSION, - ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- ACETIC ACID
- WATER FOR INJECTIONS
- LYSINE ACETATE

VAMIN 14 SOLUTION FOR Fresenius Kabi Limited PA0566/022/002 Solution for Infusion - ALANINE 01/05/2009
INFUSION, 1000ML - ARGININE
- ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- MAGNESIUM SULFATE
- POTASSIUM CHLORIDE
- CALCIUM GLUCONATE
- SODIUM ACETATE
VAMIN 14 SOLUTION FOR Fresenius Kabi Limited PA0566/022/001 Solution for Infusion - ALANINE 01/05/2009
INFUSION, 500ML - ARGININE
- ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- MAGNESIUM SULFATE
- POTASSIUM CHLORIDE
- CALCIUM GLUCONATE
- SODIUM ACETATE

Human Medicines Withdrawn Products Page 236 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VAMIN 18 ELECTROLYTE - Fresenius Kabi Limited PA0566/024/001 Solution for Infusion - ALANINE 01/05/2009
FREE SOLUTION FOR - ARGININE
INFUSION, - ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
VAMIN 18 ELECTROLYTE - Fresenius Kabi Limited PA0566/024/002 Solution for Infusion - ALANINE 01/05/2009
FREE SOLUTION FOR - ARGININE
INFUSION, - ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
VAMIN 9 GLUCOSE Fresenius Kabi Limited PA0566/012/002 Solution for Infusion - ALANINE 01/05/2009
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
VAMIN 9 GLUCOSE Fresenius Kabi Limited PA0566/012/003 Solution for Infusion - ALANINE 01/05/2009
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
CARACE Bristol-Myers Squibb PA0002/072/001 Tablets - LISINOPRIL DIHYDRATE 30/04/2009
Pharmaceuticals uc
CARACE Bristol-Myers Squibb PA0002/072/002 Tablets - LISINOPRIL DIHYDRATE 30/04/2009
Pharmaceuticals uc

Human Medicines Withdrawn Products Page 237 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARACE Bristol-Myers Squibb PA0002/072/003 Tablets - LISINOPRIL DIHYDRATE 30/04/2009
Pharmaceuticals uc
CARACE 10 PLUS Bristol-Myers Squibb PA0002/073/001 Tablets - LISINOPRIL DIHYDRATE 30/04/2009
Pharmaceuticals uc - HYDROCHLOROTHIAZIDE

CARACE 20 PLUS Bristol-Myers Squibb PA0002/073/002 Tablets - LISINOPRIL DIHYDRATE 30/04/2009


Pharmaceuticals uc - HYDROCHLOROTHIAZIDE

DIDRONEL Procter & Gamble PA0170/014/001 Tablets - ETIDRONATE DISODIUM 30/04/2009


Pharmaceuticals UK Limited
LEVONELLE Medimpex (UK) Limited PA0818/004/001 Tablets - LEVONORGESTREL 30/04/2009
INTRALIPID 10%,100ML Fresenius Kabi Limited PA0566/019/001 Emulsion for Infusion - SOYA OIL 26/04/2009
EMULSION FOR INFUSION

INTRALIPID 10%,500ML Fresenius Kabi Limited PA0566/019/002 Emulsion for Infusion - SOYA OIL 26/04/2009
EMULSION FOR INFUSION

INTRALIPID 20%,100ML Fresenius Kabi Limited PA0566/019/003 Emulsion for Infusion - SOYA OIL 26/04/2009
EMULSION FOR INFUSION

INTRALIPID 20%,250ML Fresenius Kabi Limited PA0566/019/004 Emulsion for Infusion - SOYA OIL 26/04/2009
EMULSION FOR INFUSION

INTRALIPID 30%, 333ML Fresenius Kabi Limited PA0566/019/007 Emulsion for Infusion - SOYA OIL 26/04/2009
EMULSION FOR INFUSION

BATRAFEN Sanofi-Aventis Ireland PA0540/032/002 Cutaneous Powder - CICLOPIROX OLAMINE 15/04/2009


Limited T/A SANOFI
BENTIFEN Novartis Pharmaceuticals UK PA0013/113/001 Eye Drops Solution - KETOTIFEN FUMARATE 15/04/2009
Ltd
BENTIFEN SINGLE DOSE Novartis Pharmaceuticals UK PA0013/113/002 Eye Drops Solution - KETOTIFEN FUMARATE 15/04/2009
UNIT Ltd
CO-TAREG Novartis Pharmaceuticals UK PA0013/118/001 Film Coated Tablet - VALSARTAN 15/04/2009
Ltd - HYDROCHLOROTHIAZIDE

CO-TAREG Novartis Pharmaceuticals UK PA0013/118/002 Film Coated Tablet - VALSARTAN 15/04/2009


Ltd - HYDROCHLOROTHIAZIDE

CO-TAREG Novartis Pharmaceuticals UK PA0013/118/003 Film Coated Tablet - VALSARTAN 15/04/2009


Ltd - HYDROCHLOROTHIAZIDE

CO-TAREG Novartis Pharmaceuticals UK PA0013/118/004 Film Coated Tablet - VALSARTAN 15/04/2009


Ltd -
HYDROCHLOROTHIAZIDE,
MICRONIZED
CO-TAREG Novartis Pharmaceuticals UK PA0013/118/005 Film Coated Tablet - VALSARTAN 15/04/2009
Ltd -
HYDROCHLOROTHIAZIDE,
MICRONIZED
CANESTEN Bayer PLC PA0021/004/005 Cutaneous Spray Solution - CLOTRIMAZOLE 14/04/2009
CODIS DISPERSIBLE Reckitt Benckiser Ireland Ltd PA0979/003/001 Dispersable Tablet - ACETYLSALICYLIC ACID 14/04/2009
TABLETS, 500MG ASPIRIN, - CODEINE PHOSPHATE
8MG CODE
DETTOL ANTISEPTIC Reckitt Benckiser Ireland Ltd PA0979/004/001 Cream - CHLOROXYLENOL 14/04/2009
- TRICLOSAN
- EDETATE POTASSIUM
DISPROL PARACETAMOL Reckitt Benckiser Ireland Ltd PA0979/008/001 Oral Suspension - PARACETAMOL 14/04/2009
ORAL SUSPENSION
DISPROL SOLUBLE Reckitt Benckiser Ireland Ltd PA0979/008/002 Tablets Effervescent - PARACETAMOL 14/04/2009
PARACETAMOL
NALCROM Italchimici S.p.A. PA1249/001/001 Capsule - CROMOGLICATE SODIUM 10/04/2009

FORADIL CERTIHALER Novartis Pharmaceuticals UK PA0013/089/002 Inhalation powder - FORMOTEROL 08/04/2009


Ltd FUMARATE
ANTHISAN PLUS STING Sanofi-Aventis Ireland PA0540/013/001 Cutaneous Spray Solution - MEPYRAMINE MALEATE 03/04/2009
RELIEF (SPRAY) Limited T/A SANOFI - BENZOCAINE
BICALUTAMIDE Pliva Pharma Limited PA0585/033/001 Film Coated Tablet - BICALUTAMIDE 03/04/2009
BICALUTAMIDE Pliva Pharma Limited PA0585/033/002 Film Coated Tablet - BICALUTAMIDE 03/04/2009
CHOLSTAT 10MG TABLET Pliva Pharma Limited PA0585/019/001 Tablets - PRAVASTATIN SODIUM 03/04/2009

DILTIAZEM Sanofi-Aventis Ireland PA0540/145/001 Tablets - DILTIAZEM 03/04/2009


HYDROCHLORIDE 60MG Limited T/A SANOFI HYDROCHLORIDE
PROLONGED - RELEASE T

LOAVEL Sanofi-Aventis Ireland PA0540/138/001 Capsules Hard - RAMIPRIL 03/04/2009


Limited T/A SANOFI

Human Medicines Withdrawn Products Page 238 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LOAVEL Sanofi-Aventis Ireland PA0540/138/002 Capsules Hard - RAMIPRIL 03/04/2009
Limited T/A SANOFI
LOAVEL Sanofi-Aventis Ireland PA0540/138/004 Capsules Hard - RAMIPRIL 03/04/2009
Limited T/A SANOFI
MIZOLLEN Sanofi-Aventis Ireland PA0540/151/001 Tablets - MIZOLASTINE 03/04/2009
Limited T/A SANOFI
VENLAFAXINE Pliva Pharma Limited PA0585/028/001 Tablets - VENLAFAXINE 03/04/2009
VENLAFAXINE Pliva Pharma Limited PA0585/028/002 Tablets - VENLAFAXINE 03/04/2009
VENLAFAXINE Pliva Pharma Limited PA0585/028/003 Tablets - VENLAFAXINE 03/04/2009
ALUTARD AVANZ ALK-Abello A/S PA1255/001/001 Suspension for Injection - ALUMINIUM HYDROXIDE 02/04/2009
- ALLERGAN PHLEUM
PRATENSE
ALUTARD AVANZ ALK-Abello A/S PA1255/001/002 Suspension for Injection - ALLERGAN PHLEUM 02/04/2009
PRATENSE
- ALUMINIUM HYDROXIDE
ALUTARD AVANZ ALK-Abello A/S PA1255/001/003 Suspension for Injection - ALLERGAN PHLEUM 02/04/2009
PRATENSE
- ALUMINIUM HYDROXIDE
LOAVEL Sanofi-Aventis Ireland PA0540/138/003 Capsules Hard - RAMIPRIL 02/04/2009
Limited T/A SANOFI
Airtal 100mg Film-coated Almirall, S.A. PA0968/003/001 Tablet - Aceclofenac 01/04/2009
Tablets
NITRONAL Lipha Pharmaceuticals PA0289/005/001 Solution for Infusion - GLYCERYL TRINITRATE 01/04/2009
Limited
NITRONAL Lipha Pharmaceuticals PA0289/005/002 Solution for Infusion - GLYCERYL TRINITRATE 01/04/2009
Limited
NITRONAL Lipha Pharmaceuticals PA0289/005/003 Solution for Infusion - GLYCERYL TRINITRATE 01/04/2009
Limited
SOLPADOL Sanofi-Aventis Ireland PA0540/159/002 Capsule - PARACETAMOL 01/04/2009
Limited T/A SANOFI - CODEINE PHOSPHATE
ACI-JEL THERAPEUTIC Janssen-Cilag Ltd PA0748/019/001 Vaginal Gel - ACETIC ACID 31/03/2009
VAGINAL JELLY
ALUPENT EXPECTORANT Boehringer Ingelheim Limited PA0007/015/002 Oral Suspension - ORCIPRENALINE 31/03/2009
SULFATE
- BROMHEXINE
HYDROCHLORIDE
AUGMENTION JUNIOR GlaxoSmithKline (Ireland) PA1077/093/006 Powder for Oral Suspension - AMOXICILLIN 31/03/2009
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
CICLOSPORIN DUMEX Actavis Group PTC ehf PA1380/028/001 Capsule - CICLOSPORIN 31/03/2009
CICLOSPORIN DUMEX Actavis Group PTC ehf PA1380/028/002 Capsule - CICLOSPORIN 31/03/2009
CICLOSPORIN DUMEX Actavis Group PTC ehf PA1380/028/003 Capsule - CICLOSPORIN 31/03/2009
CICLOSPORIN Actavis Group PTC ehf PA1380/029/001 Capsule - CICLOSPORIN 31/03/2009
PHARMACHEMIE
CICLOSPORIN Actavis Group PTC ehf PA1380/029/002 Capsule - CICLOSPORIN 31/03/2009
PHARMACHEMIE
CICLOSPORIN Actavis Group PTC ehf PA1380/029/003 Capsule - CICLOSPORIN 31/03/2009
PHARMACHEMIE
DERMESTRIL Rottapharm Ltd PA0868/002/001 Transdermal Patch - OESTRADIOL 31/03/2009
HEMIHYDRATE
DERMESTRIL Rottapharm Ltd PA0868/002/002 Transdermal Patch - OESTRADIOL 31/03/2009
HEMIHYDRATE
DERMESTRIL Rottapharm Ltd PA0868/002/003 Transdermal Patch - OESTRADIOL 31/03/2009
HEMIHYDRATE
ILIADIN Seven Seas Ltd PA0417/012/004 Nasal Spray Solution - OXYMETAZOLINE 31/03/2009
HYDROCHLORIDE
ILIADIN Seven Seas Ltd PA0417/012/001 Nasal Drops Soln - OXYMETAZOLINE 31/03/2009
HYDROCHLORIDE
ILIADIN MINI Seven Seas Ltd PA0417/012/002 Nasal Drops Soln - OXYMETAZOLINE 31/03/2009
HYDROCHLORIDE
ILIADIN MINI PAEDIATRIC Seven Seas Ltd PA0417/012/003 Nasal Drops Soln - OXYMETAZOLINE 31/03/2009
HYDROCHLORIDE
ISOPTO ALKALINE Alcon Laboratories (UK) Ltd PA0290/013/001 Eye Drops Solution - HYPROMELLOSE 31/03/2009
ISOPTO PLAIN Alcon Laboratories (UK) Ltd PA0290/012/001 Eye Drops Solution - HYPROMELLOSE 31/03/2009
MYCOSTATIN PASTILLES Bristol-Myers Squibb PA0002/007/010 Lozenges - NYSTATIN 31/03/2009
Pharmaceuticals uc
PERIACTIN Merck Sharp and Dohme PA0035/045/001 Tablets - CYPROHEPTADINE 31/03/2009
Limited HYDROCHLORIDE
ALKA ANTACID Bayer Limited PA1410/033/001 Tablets Chewable - HYDROTALCITE 27/03/2009
NCH FRUIT G Novartis Consumer Health PA0030/021/004 Medicated Chewing Gum - NICOTINE 25/03/2009
UK Limited
NCH FRUIT G Novartis Consumer Health PA0030/021/005 Medicated Chewing Gum - NICOTINE 25/03/2009
UK Limited

Human Medicines Withdrawn Products Page 239 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NCH MINT G Novartis Consumer Health PA0030/021/006 Medicated Chewing Gum - NICOTINE 25/03/2009
UK Limited
NCH MINT G Novartis Consumer Health PA0030/021/007 Medicated Chewing Gum - NICOTINE 25/03/2009
UK Limited
LEMSIP PHARMACY WITH Reckitt Benckiser Ireland Ltd PA0979/013/002 Powder for Oral Solution - PARACETAMOL 20/03/2009
PHENYLEPHRINE - ASCORBIC ACID
- PHENYLEPHRINE
HYDROCHLORIDE
NUROFEN CAPLETS Crookes Healthcare Ltd PA0043/006/007 Coated Tablets - IBUPROFEN 20/03/2009
RIMOXALLIN (AMOXICILLIN Ranbaxy Ireland Limited PA0408/012/001 Powder for Oral Suspension - AMOXICILLIN 20/03/2009
ORAL SUSPENSION BP) TRIHYDRATE

RIMOXALLIN (AMOXICILLIN Ranbaxy Ireland Limited PA0408/012/002 Powder for Oral Suspension - AMOXICILLIN 20/03/2009
ORAL SUSPENSION BP) TRIHYDRATE

OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/010 Film Coated Tablet - OLANZAPINE 13/03/2009
SOLIAN 100MG/ML ORAL Sanofi-Aventis Ireland PA0540/158/005 Oral Solution - AMISULPRIDE 13/03/2009
SOLUTION Limited T/A SANOFI
STRIANT SR Ardana Bioscience Limited PA1228/001/001 Buccal Tablet - TESTOSTERONE 13/03/2009
MUCOADHESIVE
SEREVENT INHALER B & S Healthcare PPA1328/036/001 Pressurised Inhalation - SALMETEROL 11/03/2009
Suspension
TRITACE 1.25MG Sanofi-Aventis Ireland PA0540/084/001 Capsule - RAMIPRIL 07/03/2009
CAPSULES Limited T/A SANOFI
TRITACE 10MG CAPSULES Sanofi-Aventis Ireland PA0540/084/004 Capsule - RAMIPRIL 07/03/2009
Limited T/A SANOFI
TRITACE 2.5MG Sanofi-Aventis Ireland PA0540/084/002 Capsule - RAMIPRIL 07/03/2009
CAPSULES Limited T/A SANOFI
TRITACE 5MG CAPSULES Sanofi-Aventis Ireland PA0540/084/003 Capsule - RAMIPRIL 07/03/2009
Limited T/A SANOFI
BETALOC 200MG AstraZeneca UK Limited PA0970/033/001 Tablets - METOPROLOL TARTRATE 06/03/2009
PROLONGED RELEASE
TABLETS
HEMINEVRIN AstraZeneca UK Limited PA0970/040/003 Syrup - CLOMETHIAZOLE 06/03/2009
EDISILATE
HEMINEVRIN 192 MG AstraZeneca UK Limited PA0970/040/002 Capsule - CLOMETHIAZOLE 06/03/2009
CAPSULES
NEOSTIGMINE BROMIDE Lifehealth Limited PA0809/003/001 Tablets - NEOSTIGMINE BROMIDE 06/03/2009
XYLOPROCT AstraZeneca UK Limited PA0970/056/001 Rectal Ointment - LIDOCAINE 06/03/2009
- HYDROCORTISONE
ACETATE
CABEREX 4 MILLIGRAM Arrow Generics Limited PA1130/010/003 Tablets - CABERGOLINE 05/03/2009
TABLETS
NORFLOCUX TAD Pharma GmbH PA0876/003/001 Film Coated Tablet - NORFLOXACIN 05/03/2009
ALEVE Bayer PLC PA0021/055/001 Tablets - NAPROXEN SODIUM 03/03/2009
OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/001 Film Coated Tablet - OLANZAPINE 03/03/2009
OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/002 Film Coated Tablet - OLANZAPINE 03/03/2009
OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/003 Film Coated Tablet - OLANZAPINE 03/03/2009
OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/004 Film Coated Tablet - OLANZAPINE 03/03/2009
OLANZAPINE PLIVA Pliva Pharma Limited PA0585/031/009 Film Coated Tablet - OLANZAPINE 03/03/2009
CEFUROXIME SODIUM Sandoz Ltd PA0372/007/001 Pdr for Soln for Injection - CEFUROXIME SODIUM 02/03/2009
CEFUROXIME SODIUM Sandoz Ltd PA0372/007/002 Pdr for Soln for Injection - CEFUROXIME SODIUM 02/03/2009
CEFUROXIME SODIUM Sandoz Ltd PA0372/007/003 Pdr for Soln for Injection - CEFUROXIME SODIUM 02/03/2009
NEGRAM Sanofi-Aventis Ireland PA0540/152/001 Tablets - NALIDIXIC ACID 01/03/2009
Limited T/A SANOFI
PRIADEL Sanofi-Aventis Ireland PA0540/156/003 Syrup - LITHIUM CITRATE 01/03/2009
Limited T/A SANOFI
RYNACROM Sanofi-Aventis Ireland PA0540/123/002 Nasal Spray Solution - CROMOGLICATE SODIUM 01/03/2009
Limited T/A SANOFI
TENSOPRIL Medimpex (UK) Limited PA0818/001/001 Tablets - CAPTOPRIL 01/03/2009
TENSOPRIL Medimpex (UK) Limited PA0818/001/002 Tablets - CAPTOPRIL 01/03/2009
TENSOPRIL Medimpex (UK) Limited PA0818/001/003 Tablets - CAPTOPRIL 01/03/2009
GEROTIDE McDermott Laboratories Ltd PA0577/040/002 Tablets - CAPTOPRIL 25/02/2009
t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

HALF-GEROTIDE McDermott Laboratories Ltd PA0577/040/001 Tablets - CAPTOPRIL 25/02/2009


t/a Gerard Laboratories - HYDROCHLOROTHIAZIDE

LAMIDUS Ranbaxy (UK) Limited PA0967/011/001 Tablets - LAMOTRIGINE 17/02/2009


LAMIDUS Ranbaxy (UK) Limited PA0967/011/002 Tablets - LAMOTRIGINE 17/02/2009
LAMIDUS Ranbaxy (UK) Limited PA0967/011/003 Tablets - LAMOTRIGINE 17/02/2009
LAMIDUS Ranbaxy (UK) Limited PA0967/011/004 Tablets - LAMOTRIGINE 17/02/2009
LAMOTRIGINE RANBAXY Ranbaxy (UK) Limited PA0967/012/001 Tablets - LAMOTRIGINE 17/02/2009
LAMOTRIGINE RANBAXY Ranbaxy (UK) Limited PA0967/012/002 Tablets - LAMOTRIGINE 17/02/2009
LAMOTRIGINE RANBAXY Ranbaxy (UK) Limited PA0967/012/003 Tablets - LAMOTRIGINE 17/02/2009

Human Medicines Withdrawn Products Page 240 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LAMOTRIGINE RANBAXY Ranbaxy (UK) Limited PA0967/012/004 Tablets - LAMOTRIGINE 17/02/2009
VOMLEZ biomo pharma GmbH PA1471/001/001 Capsule - OMEPRAZOLE 16/02/2009
VOMLEZ biomo pharma GmbH PA1471/001/002 Capsule - OMEPRAZOLE 16/02/2009
VOMLEZ biomo pharma GmbH PA1471/001/003 Capsule - OMEPRAZOLE 16/02/2009
GERAMIL McDermott Laboratories Ltd PA0577/031/001 Film Coated Tablet - LOFEPRAMINE 11/02/2009
t/a Gerard Laboratories HYDROCHLORIDE
ALKA RAPID CRYSTALS Bayer PLC PA0021/052/001 Granules - ACETYLSALICYLIC ACID 10/02/2009
BICNU 100 MG POWDER Bristol-Myers Squibb PA0048/016/001 Pdr+Solv for Soln for Inj - CARMUSTINE 05/02/2009
AND SOLVENT FOR (Holdings) Limited
SOLUTION FOR I
SYNERCID Monarch Pharmaceuticals PA1272/001/002 Powder for solution for - QUINUPRISTIN 05/02/2009
Ireland infusion - DALFOPRISTIN
ADVIL JUNIOR Pfizer Consumer Healthcare PA0172/029/004 Oral Suspension - IBUPROFEN 04/02/2009
Ltd
HYSTREAM Astellas Pharma Europe BV PA1244/002/001 Modified-release capsule, - TAMSULOSIN 04/02/2009
hard HYDROCHLORIDE
TAMSULOSIN Astellas Pharma Europe BV PA1244/001/001 Modified-release capsule, - TAMSULOSIN 04/02/2009
HYDROCHLORIDE hard HYDROCHLORIDE
NUTRIFLEX LIPID PLUS B. Braun Melsungen AG PA0736/016/001 Emulsion for Infusion - GLUCOSE 03/02/2009
WITHOUT ELECTROLYTES MONOHYDRATE
- SOYA OIL
- TRIGLYCERIDES
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
HYPROCHLORIDE
MONOHYDRATE
- ALANINE
- ASPARTIC ACID
- GLUTAMIC ACID
- AMINOACETIC ACID
- PROLINE
- SERINE
SARNOL Stiefel Laboratories (U.K.) PA0144/014/001 Cutaneous Solution - MENTHOL 02/02/2009
Ltd. - CAMPHOR
- BENZYL ALCOHOL
FLUTAMIDE TAD Pharma GmbH PA0876/005/001 Tablets - FLUTAMIDE 01/02/2009
SIMVACUX TAD Pharma GmbH PA0876/006/001 Tablets - SIMVASTATIN 01/02/2009
SIMVACUX TAD Pharma GmbH PA0876/006/002 Tablets - SIMVASTATIN 01/02/2009
SIMVACUX TAD Pharma GmbH PA0876/006/003 Tablets - SIMVASTATIN 01/02/2009
SIMVACUX TAD Pharma GmbH PA0876/006/004 Tablets - SIMVASTATIN 01/02/2009
VASTATIFIX Alfred E Tiefenbacher PA1178/001/001 Tablets - PRAVASTATIN SODIUM 01/02/2009
(GmbH & Co. KG)
VASTATIFIX Alfred E Tiefenbacher PA1178/001/002 Tablets - PRAVASTATIN SODIUM 01/02/2009
(GmbH & Co. KG)
VASTATIFIX Alfred E Tiefenbacher PA1178/001/003 Tablets - PRAVASTATIN SODIUM 01/02/2009
(GmbH & Co. KG)
MEXITIL Boehringer Ingelheim Limited PA0007/001/001 Capsule - MEXILETINE 31/01/2009
HYDROCHLORIDE
MEXITIL Boehringer Ingelheim Limited PA0007/001/003 Capsule - MEXILETINE 31/01/2009
HYDROCHLORIDE
MEXITIL Boehringer Ingelheim Limited PA0007/001/004 Solution for Injection - MEXILETINE 31/01/2009
HYDROCHLORIDE
PULMICORT INHALER AstraZeneca UK Limited PA0970/050/001 Pressurised Inhalation - BUDESONIDE 29/01/2009
Suspension
PULMICORT LS AstraZeneca UK Limited PA0970/050/002 Pressurised Inhalation - BUDESONIDE 29/01/2009
Suspension
GLIMEPIRIDE 1 MG Medis ehf PA1285/016/001 Tablets - GLIMEPIRIDE 26/01/2009
TABLETS
GLIMEPIRIDE 2 MG Medis ehf PA1285/016/002 Tablets - GLIMEPIRIDE 26/01/2009
TABLETS
GLIMEPIRIDE 3 MG Medis ehf PA1285/016/003 Tablets - GLIMEPIRIDE 26/01/2009
TABLETS
GLIMEPIRIDE 4 MG Medis ehf PA1285/016/004 Tablets - GLIMEPIRIDE 26/01/2009
TABLETS
MOBIC PCO Manufacturing PPA0465/112/001A Tablets - MELOXICAM 25/01/2009
CALCIL Rowex Ltd PA0711/093/001 Ointment - CALCIPOTRIOL 23/01/2009
ANHYDROUS

Human Medicines Withdrawn Products Page 241 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NORCHOLESTEROL (131I) Mallinckrodt Medical B.V. PA0690/002/001 Solution for Injection - 21/01/2009
IODOMETHYLNORCHOLE
STEROL (I-131)
LOPRESOR 100 MG FILM- Novartis Pharmaceuticals UK PA0013/083/002 Tablets - METOPROLOL TARTRATE 20/01/2009
COATED TABLETS Ltd
MEASAVAX Sanofi Pasteur MSD Ltd PA0544/003/001 Pdr+Solv for Susp for Inj - MEASLES VIRUS - 20/01/2009
SCHWARZ STRAIN LIVE
ATTENUATED
MEBEVERINE 50MG/5ML Chemidex Pharma Limited PA1161/003/001 Oral Suspension - MEBEVERINE PAMOATE 20/01/2009
SUGAR FREE ORAL
SUSPENSION
RUBAVAX Sanofi Pasteur MSD Ltd PA0544/002/001 Pdr+Solv for Soln for Inj - RUBELLA VIRUS (RA 27/3 20/01/2009
STRAIN)
RUBAVAX VACCINE LIVE Sanofi Pasteur MSD Ltd PA0544/002/004 Pdr+Solv for Soln for Inj - RUBELLA VIRUS (RA 27/3 20/01/2009
STRAIN)
XYMEL Kellpharm Limited PA1044/004/002 Tablets - TRAMADOL 16/01/2009
HYDROCHLORIDE
CAPTOR Rowex Ltd PA0711/002/004 Tablets - CAPTOPRIL 10/01/2009
LARIG 5 MG DISPERSIBLE Rowex Ltd PA0711/085/001 Tablets - LAMOTRIGINE 10/01/2009
TABLETS
MOTIVAL Bristol-Myers Squibb PA0002/015/001 Tablets - NORTRIPTYLINE 05/01/2009
Pharmaceuticals uc HYDROCHLORIDE
- FLUPHENAZINE
HYDROCHLORIDE
SOLABAN A + B Stiefel Laboratories (U.K.) PA0144/032/001 Cutaneous Solution - PADIMATE O 03/01/2009
Ltd. - AVOBENZONE
- OXYBENZONE
AUGMENTIN ES GlaxoSmithKline (Ireland) PA1077/093/009 Powder for Oral Suspension - AMOXICILLIN 01/01/2009
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
DICLO (ENTERIC-COATED) Pinewood Laboratories Ltd, PA0281/085/002 Tablets - DICLOFENAC SODIUM 01/01/2009

TEOPTIC Novartis Pharmaceuticals UK PA0013/102/001 Eye Drops Solution - CARTEOLOL 01/01/2009


Ltd HYDROCHLORIDE
TEOPTIC Novartis Pharmaceuticals UK PA0013/102/002 Eye Drops Solution - CARTEOLOL 01/01/2009
Ltd HYDROCHLORIDE
ATROVENT UDV'S PCO Manufacturing PPA0465/173/001 Nebuliser Solution - IPRATROPIUM BROMIDE 31/12/2008
ATROVENT UDV'S PCO Manufacturing PPA0465/173/002 Nebuliser Solution - IPRATROPIUM BROMIDE 31/12/2008
BETALOC PCO Manufacturing PPA0465/200/001 Tablets - METOPROLOL TARTRATE 31/12/2008

CARDIOLITE Bristol-Myers Squibb Pharma PA1052/001/001 Kit for radiopharmaceutical - STANNOUS CHLORIDE 31/12/2008
Belgium SPRL preparation DIHYDRATE
- TETRAKIS (2-METHOXY
ISOBUTYL ISONITRILE)
COPPER (I)
TETRAFLUOROLBORATE
- CYSTEINE
HYDROCHLORIDE
MONOHYDRATE
COVERSYL PCO Manufacturing PPA0465/067/001A Tablets - PERINDOPRIL TERT- 31/12/2008
BUTYLAMINE SALT
COVERSYL PCO Manufacturing PPA0465/067/002 Tablets - PERINDOPRIL 31/12/2008
COVERSYL PLUS PCO Manufacturing PPA0465/067/003 Tablets - PERINDOPRIL TERT- 31/12/2008
BUTYLAMINE
- INDAPAMIDE
DIAMICRON PCO Manufacturing PPA0465/045/001A Tablets - GLICLAZIDE 31/12/2008
DYAZIDE PCO Manufacturing PPA0465/126/001A Tablets - TRIAMTERENE 31/12/2008
- HYDROCHLOROTHIAZIDE

ESTRADERM TTS 50 PCO Manufacturing PPA0465/044/002B Transdermal Patch - ESTRADIOL 31/12/2008


MICROGRAMS/24HOURS HEMIHYDRATE
TRANSDERMAL PA
KLIOGEST PCO Manufacturing PPA0465/124/001A Tablets - ESTRADIOL 31/12/2008
HEMIHYDRATE
- NORETHISTERONE
ACETATE
LEXOTAN PCO Manufacturing PPA0465/152/001 Tablets - BROMAZEPAM 31/12/2008
LEXOTAN PCO Manufacturing PPA0465/152/002 Tablets - BROMAZEPAM 31/12/2008
NAPROSYN EC 250 MG PCO Manufacturing PPA0465/031/003A Tablets Gastro-Resistant - NAPROXEN 31/12/2008
TABLETS
NICORETTE PCO Manufacturing PPA0465/187/001 Medicated Chewing Gum - NICOTINE 31/12/2008
NICORETTE PCO Manufacturing PPA0465/187/002 Medicated Chewing Gum - NICOTINE 31/12/2008
NICORETTE MINT PCO Manufacturing PPA0465/187/003 Medicated Chewing Gum - NICOTINE 31/12/2008
NICORETTE MINT PCO Manufacturing PPA0465/187/004 Medicated Chewing Gum - NICOTINE 31/12/2008

Human Medicines Withdrawn Products Page 242 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROZAC PCO Manufacturing PPA0465/040/002 Capsules Hard - FLUOXETINE 31/12/2008
HYDROCHLORIDE
REQUIP PCO Manufacturing PPA0465/174/004 Tablets - ROPINIROLE 31/12/2008
HYDROCHLORIDE
RISPERDAL Janssen-Cilag Ltd PA0748/003/008 Tablets - RISPERIDONE 31/12/2008
Risperdal PCO Manufacturing Ltd. PPA0465/078/005 Film-coated tablet - Risperidone 31/12/2008

Interchangeable List Code:


IC0012-046-003
RISPERDAL PCO Manufacturing PPA0465/078/005A Tablets - RISPERIDONE 31/12/2008
SINEMET PCO Manufacturing PPA0465/148/001 Tablets - CARBIDOPA 31/12/2008
SINEMET PCO Manufacturing PPA0465/148/002 Tablets - CARBIDOPA 31/12/2008
SOTACOR PCO Manufacturing PPA0465/102/001A Tablets - SOTALOL 31/12/2008
SOTACOR PCO Manufacturing PPA0465/102/002A Tablets - SOTALOL 31/12/2008
XATRAL 2.5MG TABLETS PCO Manufacturing PPA0465/138/001A Tablets - ALFUZOSIN 31/12/2008
HYDROCHLORIDE
ZYLORIC PCO Manufacturing PPA0465/017/001A Tablets - ALLOPURINOL 31/12/2008
CLAROSIP Grünenthal Ltd PA1189/002/001 Granules for Oral - CLARITHROMYCIN 29/12/2008
Suspension
CLAROSIP Grünenthal Ltd PA1189/002/002 Granules for Oral - CLARITHROMYCIN 29/12/2008
Suspension
CLAROSIP Grünenthal Ltd PA1189/002/003 Granules for Oral - CLARITHROMYCIN 29/12/2008
Suspension
FLUVIRIN (INACTIVATED Chiron Vaccines Limited PA1001/005/001 Suspension for Injection - A/SINGAPORE\6\86 - LIKE 29/12/2008
INFLUENZA VACCINE) STRAIN (H1N1)
- A/WUHAN /359/95 (H3N2)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
LEDERFEN 300 MG Mercury Pharmaceuticals Ltd PA0899/026/001 Tablets - FENBUFEN 24/12/2008
TABLETS
LEDERFEN 450 MG Mercury Pharmaceuticals Ltd PA0899/026/002 Tablets - FENBUFEN 24/12/2008
TABLETS
BELLRAN Ranbaxy (UK) Limited PA0967/001/001 Tablets - RANITIDINE 23/12/2008
HYDROCHLORIDE
GENTAMICIN INJECTION Hospira UK Limited PA0437/016/008 Solution for Injection - GENTAMICIN SULFATE 22/12/2008
BP
TERTROXIN 20 Mercury Pharma Group PA0701/003/001 Tablets - LIOTHYRONINE SODIUM 19/12/2008
MICROGRAM TABLETS Limited
CLICKHALER Innovata Biomed Ltd PA0486/002/001 Inhalation powder - BECLOMETASONE 18/12/2008
BECLOMETASONE DIPROPIONATE
CLICKHALER Innovata Biomed Ltd PA0486/002/002 Inhalation powder - BECLOMETASONE 18/12/2008
BECLOMETASONE DIPROPIONATE
CLICKHALER Innovata Biomed Ltd PA0486/002/003 Inhalation powder - BECLOMETASONE 18/12/2008
BECLOMETASONE DIPROPIONATE
CLICKHALER Innovata Biomed Ltd PA0486/001/001 Inhalation powder - SALBUTAMOL SULFATE 18/12/2008
SALBUTAMOL
DECA DURABOLIN 25 MG / Organon Laboratories PA0261/003/002 Solution for Injection - NANDROLONE 17/12/2008
ML SOLUTION FOR Limited DECANOATE
INJECTION (
DECA DURABOLIN 50 Organon Laboratories PA0261/003/005 Solution for Injection - NANDROLONE 17/12/2008
MG/ML SOLUTION FOR Limited DECANOATE
INJECTION (AM
FLUCOMEL Kellpharm Limited PA1044/005/001 Capsule - FLUCONAZOLE 16/12/2008
FLUCOMEL Kellpharm Limited PA1044/005/002 Capsule - FLUCONAZOLE 16/12/2008
FLUCOMEL Kellpharm Limited PA1044/005/003 Capsule - FLUCONAZOLE 16/12/2008
OSTEOMEL Clonmel Healthcare Ltd PA0126/148/001 Tablets - ALENDRONIC ACID 16/12/2008
PROFLOXIN 750 MG FILM- Kellpharm Limited PA1044/002/003 Tablets - CIPROFLOXACIN 16/12/2008
COATED TABLETS HYDROCHLORIDE
XYMEL Kellpharm Limited PA1044/004/003 Tablets - TRAMADOL 16/12/2008
HYDROCHLORIDE
FLEET MICRO ENEMA E.C. De Witt & Company PA0299/014/001 Rectal Solution - SODIUM CITRATE 12/12/2008
Limited - SODIUM LAURYL
SULFOACETATE
CARBOPLATIN Pliva Pharma Limited PA0585/024/001 Solution for Infusion - CARBOPLATIN 10/12/2008
PANOXYL AQUACREAM Stiefel Laboratories (U.K.) PA0144/011/011 Cream - BENZOYL PEROXIDE 09/12/2008
Ltd.
ZYDOL Grünenthal Ltd PA1189/001/002 Oral Drops Solution - TRAMADOL 09/12/2008
HYDROCHLORIDE
PHARMATEX OVULE Innothera Ireland Ltd PA0334/001/001 Pessary - BENZALKONIUM 06/12/2008
CHLORIDE
COLOFIBRE Madaus GmbH PA1288/003/001 Granules - ISPAGHULA HUSKS 05/12/2008
DECA DURABOLIN Organon Laboratories PA0261/003/001 Solution for Injection - NANDROLONE 04/12/2008
100MG/ML, SOLUTION FOR Limited DECANOATE
INJECTION (A

Human Medicines Withdrawn Products Page 243 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NOVIAL Organon (Ireland) Limited PA0061/006/001 Film Coated Tablet - DESOGESTREL 04/12/2008
- ETHINYLESTRADIOL
NOVIAL 28 Organon (Ireland) Limited PA0061/006/002 Film Coated Tablet - DESOGESTREL 04/12/2008
- ETHINYLESTRADIOL
SUSTANON 100 Organon Laboratories PA0261/009/001 Solution for Injection - TESTOSTERONE 04/12/2008
AMPOULES Limited PROPIONATE
- TESTOSTERONE
PHENYLPROPIONATE
- TESTOSTERONE
ISOCAPROATE
SUSTANON 250 Organon Laboratories PA0261/009/003 Solution for Injection - TESTOSTERONE 04/12/2008
AMPOULES Limited PROPIONATE
- TESTOSTERONE
PHENYLPROPIONATE
- TESTOSTERONE
ISOCAPROATE
- TESTOSTERONE
DECANOATE
EFLAVEX 4 MG TABLETS Norton Waterford PA0436/044/003 Tablets - CABERGOLINE 01/12/2008
PROFLEX Novartis Consumer Health PA0030/020/003 Film Coated Tablet - IBUPROFEN 01/12/2008
UK Limited
TUMELIN Hennig Arzneimittel GmbH & PA1238/002/001 Capsule - OMEPRAZOLE 01/12/2008
Co KG
TUMELIN Hennig Arzneimittel GmbH & PA1238/002/002 Capsule - OMEPRAZOLE 01/12/2008
Co KG
TUMELIN Hennig Arzneimittel GmbH & PA1238/002/003 Capsule - OMEPRAZOLE 01/12/2008
Co KG
POLIOMYELITIS LIVE GlaxoSmithKline (Ireland) PA1077/035/001 Solution for Injection - POLIOVIRUS, TYPE 1 30/11/2008
ATTENUATED (ORAL) Limited - POLIOVIRUS, TYPE 2
MONODOSE - POLIOVIRUS, TYPE 3
PHARMATEX Innothera Ireland Ltd PA0334/001/002 Vaginal Cream - BENZALKONIUM 29/11/2008
CHLORIDE
GERCOR McDermott Laboratories Ltd PA0577/033/001 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
GERCOR McDermott Laboratories Ltd PA0577/033/002 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
GERCOR McDermott Laboratories Ltd PA0577/033/003 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
GERCOR McDermott Laboratories Ltd PA0577/033/004 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
GERCOR McDermott Laboratories Ltd PA0577/033/005 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
GERCOR McDermott Laboratories Ltd PA0577/033/006 Tablets - BISOPROLOL 28/11/2008
t/a Gerard Laboratories HEMIFUMARATE
METFORMIN GERMANIA Germania Pharmazeutika PA0929/001/001 Tablets - METFORMIN 22/11/2008
GesmbH HYDROCHLORIDE
CODELLA SSL International PLC PA0618/007/001 Cream - WOOL ALCOHOLS 21/11/2008
- KAOLIN, LIGHT
- POVIDONE-IODINE
QUELLADA-M CREAM Ultra Chemicals Limited PA0858/001/002 Shampoo - MALATHION 21/11/2008
RIMOXYN NAPROXEN Ranbaxy Ireland Limited PA0408/020/001 Tablets - NAPROXEN 17/11/2008
RIMOXYN NAPROXEN Ranbaxy Ireland Limited PA0408/020/002 Tablets - NAPROXEN 17/11/2008
WARTICON Stiefel Laboratories (U.K.) PA0144/040/001 Cutaneous Solution - PODOPHYLLOTOXIN 16/11/2008
Ltd.
FAMULCO FILM-COATED Stada Arzneimittel AG PA0593/019/001 Tablets - FAMOTIDINE 15/11/2008
FAMULCO FILM-COATED Stada Arzneimittel AG PA0593/019/002 Tablets - FAMOTIDINE 15/11/2008
PREMIQUE CYCLE 10 John Wyeth & Brother PA0022/069/009 Unknown - ESTROGENS 14/11/2008
Limited CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
BENADRYL SKIN ALLERGY McNeil Healthcare (Ireland) PA0823/016/002 Cutaneous Suspension - DIPHENHYDRAMINE 13/11/2008
RELIEF LOTION Ltd HYDROCHLORIDE
- ZINC OXIDE
- CAMPHOR
FENTANYL 100 Rowex Ltd PA0711/070/004 Transdermal Patch - FENTANYL 13/11/2008
MICROGRAMS/HOUR
TRANSDERMAL PATCH
FENTANYL 25 Rowex Ltd PA0711/070/001 Transdermal Patch - FENTANYL 13/11/2008
MICROGRAMS/HOUR
TRANSDERMAL PATCH
FENTANYL 50 Rowex Ltd PA0711/070/002 Transdermal Patch - FENTANYL 13/11/2008
MICROGRAMS/HOUR
TRANSDERMAL PATCH

Human Medicines Withdrawn Products Page 244 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FENTANYL 75 Rowex Ltd PA0711/070/003 Transdermal Patch - FENTANYL 13/11/2008
MICROGRAMS/HOUR
TRANSDERMAL PATCH
SALAGEN 5MG FILM- Novartis Pharmaceuticals UK PA0013/107/001 Tablets - PILOCARPINE 13/11/2008
COATED TABLETS Ltd HYDROCHLORIDE
ANABACT Cambridge Healthcare PA0980/003/001 Gel - METRONIDAZOLE 12/11/2008
Supplies Limited
CURATODERM Crookes Healthcare Ltd PA0043/027/001 Ointment - TACALCITOL 12/11/2008
QUELLADA-M Ultra Chemicals Limited PA0858/001/001 Cutaneous Emulsion - MALATHION 12/11/2008
LIQUID PARAFFIN BP Ricesteele Manufacturing Ltd PA0095/020/001 Oral Solution - PARAFFIN, LIQUID 09/11/2008

DOBUTAMINE-HAMELN 250 Hameln Pharmaceuticals PA0971/002/004 Concentrate for Soln for Inf - DOBUTAMINE 04/11/2008
MG/ 5 ML AMPOULE GmbH HYDROCHLORIDE
DOBUTAMINE-HAMELN 250 Hameln Pharmaceuticals PA0971/002/002 Solution for Infusion - DOBUTAMINE 04/11/2008
MG/ 50 ML VIAL GmbH HYDROCHLORIDE
DOBUTAMINE-HAMELN 250 Hameln Pharmaceuticals PA0971/002/003 Concentrate for Soln for Inf - DOBUTAMINE 04/11/2008
MG/20 ML AMPOULE GmbH HYDROCHLORIDE
DOBUTAMINE-HAMELN 250 Hameln Pharmaceuticals PA0971/002/001 Solution for Infusion - DOBUTAMINE 04/11/2008
MG/50 ML AMPOULE GmbH HYDROCHLORIDE
CLOPIXOL Lundbeck Limited PA0115/005/006 Film Coated Tablet - ZUCLOPENTHIXOL 31/10/2008
DIHYDROCHLORIDE
CLOPIXOL ACUPHASE 100 Lundbeck Limited PA0115/005/010 Solution for Injection - ZUCLOPENTHIXOL 31/10/2008
MG/2ML SOLUTION FOR ACETATE
INJECTIO
COGENTIN Merck Sharp and Dohme PA0035/046/002 Solution for Injection - BENZATROPINE 31/10/2008
Limited MESILATE
DEPIXOL Lundbeck Limited PA0115/001/002 Solution for Injection - FLUPENTIXOL 31/10/2008
DECANOATE
EPREX Janssen-Cilag Ltd PA0748/025/001 Solution for Injection - EPOETIN ALFA 30/10/2008
EPREX Janssen-Cilag Ltd PA0748/025/002 Solution for Injection - EPOETIN ALFA 30/10/2008
EPREX Janssen-Cilag Ltd PA0748/025/003 Solution for Injection - EPOETIN ALFA 30/10/2008
RHESONATIV Octapharma Limited PA0521/011/001 Pdr+Solv for Soln for Inj - ANTI-D 30/10/2008
IMMUNOGLOBULIN
WINRHO SDF Cangene Europe Limited PA1027/002/001 Pdr+Solv for Soln for Inj - ANTI-D 30/10/2008
IMMUNOGLOBULIN
- SODIUM CHLORIDE
TOPICYCLINE Amdipharm Limited PA1142/012/001 Unknown - TETRACYCLINE 29/10/2008
HYDROCHLORIDE
COPAXONE Teva Pharmaceuticals PA1014/001/001 Pdr+Solv for Soln for Inj - GLATIRAMER ACETATE 21/10/2008
Limited
LEDERFOLIN 350 MG/35ML Cyanamid of Great Britain PA0037/063/002 Solution for Inj/Inf - CALCIUM FOLINATE 17/10/2008
SOLUTION FOR INJECTION
OR I
CLINDAMYCIN Ranbaxy Ireland Limited PA0408/060/001 Capsule - CLINDAMYCIN 15/10/2008
HYDROCHLORIDE
FERSADAY Mercury Pharma Group PA0701/004/001 Tablets - FERROUS FUMARATE 15/10/2008
Limited
ACICLOVIR TAD Pharma GmbH PA0876/001/001 Cream - ACICLOVIR 10/10/2008
PEROXYL 1.5% Colgate-Palmolive (U.K.) Ltd PA0320/006/001 Oromucosal Solution - HYDROGEN PEROXIDE 10/10/2008
MOUTHWASH
NORACE Norton Healthcare Limited PA0282/073/001 Tablets - ENALAPRIL MALEATE 09/10/2008
T/A IVAX Pharmaceuticals
UK
NORACE Norton Healthcare Limited PA0282/073/002 Tablets - ENALAPRIL MALEATE 09/10/2008
T/A IVAX Pharmaceuticals
UK
NORACE Norton Healthcare Limited PA0282/073/003 Tablets - ENALAPRIL MALEATE 09/10/2008
T/A IVAX Pharmaceuticals
UK
NORACE Norton Healthcare Limited PA0282/073/004 Tablets - ENALAPRIL MALEATE 09/10/2008
T/A IVAX Pharmaceuticals
UK
AUGMENTIN 1000/62.5 MG GlaxoSmithKline Consumer PA0678/012/008 Tablet Prolonged Release - AMOXICILLIN 08/10/2008
PROLONGED RELEASE Healthcare (Ireland) Limited TRIHYDRATE
FILM-COAT - AMOXICILLIN SODIUM
- CLAVULANATE
POTASSIUM
FELODIPINE Rowex Ltd PA0711/135/001 Tablet Prolonged Release - FELODIPINE 08/10/2008
SIVATIN Rowex Ltd PA0711/050/004 Tablets - SIMVASTATIN 08/10/2008
TERNAF Rowex Ltd PA0711/071/001 Tablets - TERBINAFINE 08/10/2008
HYDROCHLORIDE
ZYNOR Norton Healthcare Limited PA0282/075/001 Film Coated Tablet - CETIRIZINE 08/10/2008
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK

Human Medicines Withdrawn Products Page 245 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZYNOR ALLERGY Norton Healthcare Limited PA0282/075/002 Film Coated Tablet - CETIRIZINE 08/10/2008
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
NEUROLITE Bristol-Myers Squibb Pharma PA1052/002/001 Radionuclide Generator - BICISATE 07/10/2008
Belgium SPRL DIHYDROCHLORIDE
- STANNOUS CHLORIDE
DIHYDRATE
BAYER MULTIVITAMIN & Bayer PLC PA0021/061/001 Tablets Effervescent - ASCORBIC ACID 01/10/2008
MINERAL EFFERVESCENT - THIAMINE
TABLETS HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- FOLIC ACID
- BIOTIN
- CALCIUM CARBONATE
- MAGNESIUM
CARBONATE
- MAGNESIUM SULFATE
- ZINC CITRATE
TRIHYDRATE
FUNGSTER PIERRE FABRE PA1230/002/001 Tablets - TERBINAFINE 01/10/2008
DERMATOLOGIE
GAVISCON LEMON Reckitt Benckiser Ireland Ltd PA0979/011/003 Tablets Chewable - ALGINIC ACID 01/10/2008
FLAVOUR - SODIUM BICARBONATE
- ALUMINIUM HYDROXIDE
GEL
- MAGNESIUM TRISILICATE

HFA-134A 3M Health Care Limited PA0057/068/001 Pressurised Inhalation Soln - BECLOMETASONE 01/10/2008
BECLOMETASONE DIPROPIONATE
DIPROPIONATE
HFA-134A 3M Health Care Limited PA0057/068/002 Pressurised Inhalation Soln - BECLOMETASONE 01/10/2008
BECLOMETASONE DIPROPIONATE
DIPROPIONATE
HFA-134A 3M Health Care Limited PA0057/068/003 Pressurised Inhalation Soln - BECLOMETASONE 01/10/2008
BECLOMETASONE DIPROPIONATE
DIPROPIONATE
AUTOHALER
HFA-134A 3M Health Care Limited PA0057/068/004 Pressurised Inhalation Soln - BECLOMETASONE 01/10/2008
BECLOMETASONE DIPROPIONATE
DIPROPIONATE
AUTOHALER
ISOTREX CREAM 0.05% Stiefel Laboratories (U.K.) PA0144/031/002 Cream - ISOTRETINOIN 01/10/2008
Ltd.
ISOTREX CREAM 0.10% Stiefel Laboratories (U.K.) PA0144/031/003 Cream - ISOTRETINOIN 01/10/2008
Ltd.
Saizen Use with Syringe & Serono Limited PA0285/005/005 Powder and solvent for - Somatotropin 01/10/2008
Bacteriostatic Solvent solution for injection
CEDINE Rowex Ltd PA0711/044/002 Coated Tablets - CIMETIDINE 30/09/2008
DICLAC 150 MG Rowex Ltd PA0711/009/004 Tablet Prolonged Release - DICLOFENAC SODIUM 30/09/2008
PROLONGED-RELEASE
TABLETS
FLUCOL Rowex Ltd PA0711/057/002 Capsules Hard - FLUCONAZOLE 30/09/2008
FLUCOL Rowex Ltd PA0711/057/005 Solution for Infusion - FLUCONAZOLE 30/09/2008
FLUCOL Rowex Ltd PA0711/057/007 Solution for Infusion - FLUCONAZOLE 30/09/2008
GALLIUM CITRATE GE Healthcare Limited PA0240/014/001 Solution for Injection - GALLIUM (67 GA) 30/09/2008
CITRATE
LISPRIL Rowex Ltd PA0711/047/001 Tablets - LISINOPRIL DIHYDRATE 30/09/2008
PAROXETINE Rowex Ltd PA0711/052/002 Tablets - PAROXETINE 30/09/2008
HYDROCHLORIDE
RISPERIDONE Rowex Ltd PA0711/091/001 Tablets - RISPERIDONE 30/09/2008
RISPERIDONE Rowex Ltd PA0711/091/002 Tablets - RISPERIDONE 30/09/2008
RISPERIDONE Rowex Ltd PA0711/091/003 Tablets - RISPERIDONE 30/09/2008
RISPERIDONE Rowex Ltd PA0711/091/004 Tablets - RISPERIDONE 30/09/2008
RUBEX 100 MG TABLETS Ricesteele Manufacturing Ltd PA0095/008/004 Tablets - ASCORBIC ACID, SILICON 30/09/2008
COATED
RUBEX 200 MG TABLETS Ricesteele Manufacturing Ltd PA0095/008/005 Tablets - ASCORBIC ACID, SILICON 30/09/2008
COATED
RUBEX LEMON Ricesteele Manufacturing Ltd PA0095/008/001 Tablets Effervescent - ASCORBIC ACID 30/09/2008

Human Medicines Withdrawn Products Page 246 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SODIUM NITROPRUSSIDE Hospira UK Limited PA0437/002/001 Powder for solution for - NITROPRUSSIDE SODIUM 30/09/2008
infusion
TERBINAFINE Medimpex France S.A. PA0969/007/001 Tablets - TERBINAFINE 30/09/2008
HYDROCHLORIDE
THALLOUS CHLORIDE GE Healthcare Limited PA0240/025/001 Solution for Injection - THALLIUM CHLORIDE 30/09/2008
VERAP Rowex Ltd PA0711/016/001 Tablets - VERAPAMIL 30/09/2008
HYDROCHLORIDE
VERAP Rowex Ltd PA0711/016/002 Tablets - VERAPAMIL 30/09/2008
HYDROCHLORIDE
DURAPHAT 2800 PPM Colgate-Palmolive (U.K.) Ltd PA0320/008/001 Toothpaste - SODIUM FLUORIDE 25/09/2008
FLUORIDE
CURATODERM Crookes Healthcare Ltd PA0043/027/002 Cutaneous Emulsion - TACALCITOL 23/09/2008
FYBOGEL LEMON Reckitt Benckiser Ireland Ltd PA0979/009/003 Granules Effervescent - ISPAGHULA HUSKS 23/09/2008

GALOXIWAY Crookes Healthcare Ltd PA0043/043/001 Tablets - MELOXICAM 23/09/2008


GALOXIWAY Crookes Healthcare Ltd PA0043/043/002 Tablets - MELOXICAM 23/09/2008
GAVISCON LEMON Reckitt Benckiser Ireland Ltd PA0979/015/007 Tablets Chewable - SODIUM ALGINATE 23/09/2008
TABLETS 500 - SODIUM BICARBONATE
- CALCIUM CARBONATE
GAVISCON PEPPERMINT Reckitt Benckiser Ireland Ltd PA0979/015/006 Tablets Chewable - SODIUM ALGINATE 23/09/2008
TABLETS 500 - SODIUM BICARBONATE
- CALCIUM CARBONATE
KARVOL DECONGESTANT Crookes Healthcare Ltd PA0043/004/002 Inhalation Vapour Liquid - CHLOROBUTANOL 23/09/2008
- LEVOMENTHOL
- PINE OIL
- THYMOL
- PINUS SYLVESTRIS
- TERPINEOL
NUROFEN Crookes Healthcare Ltd PA0043/006/004 Granules Effervescent - IBUPROFEN 23/09/2008
STREPSILS CHESTY Crookes Healthcare Ltd PA0043/042/001 Oral Solution - GUAIFENESIN 23/09/2008
COUGH
Formoterol Sandoz Ltd PA0372/008/001 Inhalation powder, hard - Formoterol fumarate 19/09/2008
capsule
LORAMET Meda Health Sales Ireland PA1332/026/001 Tablets - LORMETAZEPAM 17/09/2008
Limited
NORMISON Meda Health Sales Ireland PA1332/025/001 Tablets - TEMAZEPAM 17/09/2008
Limited
NORMISON Meda Health Sales Ireland PA1332/025/002 Tablets - TEMAZEPAM 17/09/2008
Limited
NOVANTRONE Meda Health Sales Ireland PA1332/024/001 Concentrate for Soln for Inf
- MITOXANTRONE 17/09/2008
Limited HYDROCHLORIDE
VALPROAT Rowex Ltd PA0711/099/001 Prolonged Release Capsules - VALPROATE SODIUM 10/09/2008
- VALPROIC ACID
VALPROAT Rowex Ltd PA0711/099/002 Prolonged Release Capsules - VALPROATE SODIUM 10/09/2008
- VALPROIC ACID
METRONIDAZOLE/METRO Gambro Northern Ireland PA1317/001/001 Solution for Infusion - METRONIDAZOLE 05/09/2008
VEX Limited
TEVETEN Abbott Healthcare Products PA0108/023/002 Film Coated Tablet - EPROSARTAN MESYLATE 05/09/2008
Ltd
MEBENDAZOLE TABLETS Cupal Limited PA0258/046/001 Not assigned - MEBENDAZOLE 04/09/2008
CONTRAMAL RETARD Grünenthal Ltd PA1189/004/001 Tablet Prolonged Release - TRAMADOL 03/09/2008
HYDROCHLORIDE
ETHYPHARM Ethypharm PA0549/009/001 Capsule - KETOPROFEN 01/09/2008
KETOPROFEN SR
ETHYPHARM Ethypharm PA0549/009/002 Capsule - KETOPROFEN 01/09/2008
KETOPROFEN SR
SLO-PHYLLIN Rona Laboratories Limited PA0087/002/004 Modified-release capsule, - THEOPHYLLINE 01/09/2008
hard
SLO-PHYLLIN Rona Laboratories Limited PA0087/002/005 Capsule - THEOPHYLLINE 01/09/2008
SLO-PHYLLIN Rona Laboratories Limited PA0087/002/006 Modified-release capsule, - THEOPHYLLINE 01/09/2008
hard
ACTAL Seven Seas Ltd PA0417/013/001 Tablets - ALEXITOL SODIUM 31/08/2008
VARITECT Biotest Pharma GmbH PA0592/003/001 Solution for Injection - HUMAN PLASMA 30/08/2008
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
VARICELLA-ZOSTER
VARITECT Biotest Pharma GmbH PA0592/003/003 Solution for Injection - HUMAN PLASMA 30/08/2008
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
VARICELLA-ZOSTER
METHOTREXATE TEVA Teva Pharma B.V. PA0749/003/002 Solution for Inj/Inf - METHOTREXATE 29/08/2008
METHOTREXATE TEVA Teva Pharma B.V. PA0749/003/003 Solution for Inj/Inf - METHOTREXATE 29/08/2008

Human Medicines Withdrawn Products Page 247 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LACTICARE Stiefel Laboratories (U.K.) PA0144/003/001 Cutaneous Emulsion - SODIUM PYRROLIDONE 27/08/2008
Ltd. CARBOXYLATE
- LACTIC ACID
TARMED AF Stiefel Laboratories (U.K.) PA0144/036/001 Shampoo - COAL TAR 27/08/2008
Ltd. - CICLOPIROX OLAMINE
DILZEM XL PCO Manufacturing PPA0465/164/003 Capsules Hard - DILTIAZEM 25/08/2008
HYDROCHLORIDE
DILZEM XL PCO Manufacturing PPA0465/164/004 Capsules Hard - DILTIAZEM 25/08/2008
HYDROCHLORIDE
JUNIOR KWELLS Bayer PLC PA0021/070/001 Tablets - HYOSCINE 19/08/2008
HYDROBROMIDE
RENNIE RAP-EZE ORANGE Bayer PLC PA0021/078/002 Tablets Chewable - CALCIUM CARBONATE 19/08/2008
FLAVOUR
LIGNOCAINE Mercury Pharmaceuticals PA0073/112/015 Solution for Injection - LIDOCAINE 18/08/2008
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
CALCICHEW D3 Shire Pharmaceuticals PA0535/001/001 Tablets Chewable - CALCIUM CARBONATE 15/08/2008
Limited - COLECALCIFEROL
RENNIE DUO Bayer PLC PA0021/076/001 Tablets Chewable - ALGINIC ACID 15/08/2008
- CALCIUM CARBONATE
- MAGNESIUM
CARBONATE
ALFU Rowex Ltd PA0711/083/001 Tablet Prolonged Release - ALFUZOSIN 12/08/2008
HYDROCHLORIDE
PONSTAN PAEDIATRIC Chemidex Pharma Limited PA1161/001/003 Oral Suspension - MEFENAMIC ACID 12/08/2008
ISOKET RETARD 20MG SCHWARZ PHARMA Limite PA0271/002/007 Tablet Prolonged Release - ISOSORBIDE DINITRATE 08/08/2008
TABLET PROLONGED
RELEASE
ISOKET RETARD 40 SCHWARZ PHARMA Limite PA0271/002/009 Tablets - ISOSORBIDE DINITRATE 08/08/2008

VISCLAIR Sinclair Pharmaceuticals PA0251/001/001 Tablets Gastro-Resistant - MECYSTEINE 03/08/2008


Limited HYDROCHLORIDE
OMEPRAZOLE Stada Arzneimittel AG PA0593/035/001 Tablets Gastro-Resistant - OMEPRAZOLE 01/08/2008
PARAPLATIN Bristol-Myers Squibb PA0048/044/004A Concentrate for Soln for Inf - CARBOPLATIN 01/08/2008
(Holdings) Limited
FENTANYL-HAMELN Hameln Pharmaceuticals PA0971/001/001 Solution for Injection - FENTANYL CITRATE 31/07/2008
GmbH
VINORELBINE Hospira UK Limited PA0437/055/001 Concentrate for Soln for Inf - VINORELBINE TARTRATE 24/07/2008

PANOXYL 10 Stiefel Laboratories (U.K.) PA0144/011/010 Cutaneous Emulsion - BENZOYL PEROXIDE 18/07/2008
Ltd.
RIMARIN Ranbaxy Ireland Limited PA0408/019/001 Tablets - CHLORPHENAMINE 17/07/2008
CHLORPHENIRAMINE MALEATE
SIVATIN Rowex Ltd PA0711/050/005 Tablets - SIMVASTATIN 17/07/2008
RYTHMODAN Hoechst Marion Roussel Irl PA0855/037/002 Capsule - DISOPYRAMIDE 14/07/2008
Ltd PHOSPHATE
CARYLDERM SSL International PLC PA0618/017/002 Shampoo - CARBARIL 12/07/2008
CARYLDERM LOTION SSL International PLC PA0618/017/001 Cutaneous Solution - CARBARIL 12/07/2008
SULEO-M SSL International PLC PA0618/018/001 Cutaneous Solution - MALATHION 12/07/2008
DICLOMAX Galen Limited PA1329/001/001 Prolonged Release Capsules - DICLOFENAC SODIUM 10/07/2008

DICLOMAX RETARD Galen Limited PA1329/001/002 Prolonged Release Capsules - DICLOFENAC SODIUM 10/07/2008

SPECTRABAN 15 Stiefel Laboratories (U.K.) PA0144/007/001 Cutaneous Suspension - P-AMINOBENZOIC ACID 10/07/2008
Ltd. - PADIMATE O
HYPOVASE Pfizer Limited PA0019/023/002 Tablets - PRAZOSIN 01/07/2008
HYDROCHLORIDE
- PRAZOSIN
MITOMYCIN-C KYOWA 2 Kyowa Hakko Kirin UK Ltd PA0892/001/001 Pdr for Soln for Injection - MITOMYCIN 01/07/2008
MG, POWDER FOR
SOLUTION FOR IN
MITOMYCIN-C KYOWA 20 Kyowa Hakko Kirin UK Ltd PA0892/001/003 Pdr for Soln for Injection - MITOMYCIN 01/07/2008
MG, POWDER FOR
SOLUTION FOR I
PREPARATION H Pfizer Consumer Healthcare PA0172/011/001 Rectal Ointment - LIVE YEAST CELL 01/07/2008
Ltd DERIVATIVE
- SHARK-LIVER OIL
PROZAC WEEKLY Eli Lilly and Company Limite PA0047/077/005 Capsules Gastro-Resistant - FLUOXETINE 01/07/2008
HYDROCHLORIDE
SPORANOX PULSE Janssen-Cilag Ltd PA0748/009/003 Capsule - ITRACONAZOLE 01/07/2008
BENZAMYCIN SCHWARZ PHARMA Limite PA0271/012/001 Gel - BENZOYL PEROXIDE 30/06/2008
HYDROUS
- ERYTHROMYCIN
HUMAN ALBUMIN 20% Baxter Healthcare Limited PA0167/124/003 Solution for Injection - HUMAN ALBUMIN 30/06/2008
ROCALTROL 0.5 Roche Products Limited PA0050/047/002 Capsule - CALCITRIOL 30/06/2008
MICROGRAM CAPSULES
AMARYL PCO Manufacturing PPA0465/104/001A Tablets - GLIMEPIRIDE 29/06/2008

Human Medicines Withdrawn Products Page 248 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMARYL PCO Manufacturing PPA0465/104/002A Tablets - GLIMEPIRIDE 29/06/2008
AMARYL PCO Manufacturing PPA0465/104/003A Tablets - GLIMEPIRIDE 29/06/2008
CALCIUM GLUCONATE Mercury Pharmaceuticals PA0073/115/001 Solution for Injection - CALCIUM GLUCONATE 23/06/2008
(Ireland) Ltd
DOTAREM (VIAL) GUERBET PA0686/003/001 Solution for Injection - GADOTERIC ACID 23/06/2008
PARACETAMOL TABLETS The Wallis Laboratory Ltd PA0385/001/001 Tablets - PARACETAMOL 23/06/2008
BP 500 MG
THIOTEPA Mercury Pharmaceuticals Ltd PA0899/025/001 Pdr for Soln for Injection - THIOTEPA 23/06/2008

FLETCHERS' PHOSPATE Chemidex Pharma Limited PA1161/007/001 Enema - SODIUM ACID 22/06/2008
PHOSPHATE
- SODIUM PHOSPHATE
SLO-MORPH Ethypharm PA0549/013/001 Capsule - MORPHINE SULFATE 22/06/2008
SLO-MORPH Ethypharm PA0549/013/002 Capsule - MORPHINE SULFATE 22/06/2008
SLO-MORPH Ethypharm PA0549/013/003 Capsule - MORPHINE SULFATE 22/06/2008
SLO-MORPH Ethypharm PA0549/013/004 Capsule - MORPHINE SULFATE 22/06/2008
CLARITHROMYCIN Grünenthal Ltd PA1189/003/001 Granules for Oral - CLARITHROMYCIN 18/06/2008
GRUNENTHAL Suspension
CLARITHROMYCIN Grünenthal Ltd PA1189/003/002 Granules for Oral - CLARITHROMYCIN 18/06/2008
GRUNENTHAL Suspension
CLARITHROMYCIN Grünenthal Ltd PA1189/003/003 Granules for Oral - CLARITHROMYCIN 18/06/2008
GRUNENTHAL Suspension
ENDOXANA Asta Medica Ltd PA0705/001/001 Pdr for Soln for Injection - CYCLOPHOSPHAMIDE 16/06/2008
ENDOXANA Asta Medica Ltd PA0705/001/002 Pdr for Soln for Injection - CYCLOPHOSPHAMIDE 16/06/2008
MONOHYDRATE
CEFUROXIME Rowex Ltd PA0711/059/001 Tablets - CEFUROXIME AXETIL 13/06/2008
CEFUROXIME Rowex Ltd PA0711/059/002 Tablets - CEFUROXIME AXETIL 13/06/2008
DURAGLAN Jacobsen Pharma & PA1035/001/001 Tablet Prolonged Release - DOXAZOSIN MESILATE 13/06/2008
MedTech Advice A/S
PANTOZOL 40MG Rowex Ltd PA0711/109/001 Solution for Injection - PANTOPRAZOLE SODIUM 13/06/2008
POWDER FOR SOLUTION SESQUIHYDRATE
FOR INJECTION
DAY NURSE LIQUID GlaxoSmithKline Consumer PA0678/100/002 Unknown - PARACETAMOL 11/06/2008
Healthcare (Ireland) Limited - PSEUDOEPHEDRINE
HYDROCHLORIDE
- PHOLCODINE
SOLPADEINE COLD & FLU GlaxoSmithKline Consumer PA0678/101/002 Unknown - PARACETAMOL 11/06/2008
LIQUID Healthcare (Ireland) Limited - PSEUDOEPHEDRINE
HYDROCHLORIDE
- PHOLCODINE
PANADOL COLD AND FLU GlaxoSmithKline Consumer PA0678/039/004 Tablets - PARACETAMOL 10/06/2008
CITRUS 500MG SOLUBLE Healthcare (Ireland) Limited
TABLETS
PRURICALM Stiefel Laboratories (U.K.) PA0144/045/001 Cutaneous Solution - CAMPHOR 03/06/2008
Ltd. - MENTHOL
- BENZYL ALCOHOL
BLEOMYCIN SULPHATE Hospira UK Limited PA0437/038/001 Unknown - BLEOMYCIN SULFATE 01/06/2008
MINIMS GENTAMICIM Chauvin Pharmaceuticals PA0118/032/001 Eye Drops Solution - GENTAMICIN SULFATE 01/06/2008
SULPHATE Limited
MINIMS PILOCARPINE Chauvin Pharmaceuticals PA0118/017/004 Eye Drops Solution - PILOCARPINE NITRATE 01/06/2008
NITRATE Limited
LOPRESOR 50 MG FILM- Novartis Pharmaceuticals UK PA0013/083/001 Tablets - METOPROLOL TARTRATE 30/05/2008
COATED TABLETS Ltd
MODUCREN Merck Sharp and Dohme PA0035/055/001 Tablets - TIMOLOL MALEATE 30/05/2008
Limited - AMILORIDE
HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

SITAMIC BioAlliance Pharma PA1424/001/001 Buccal Tablet - MICONAZOLE 20/05/2008


SILKIS Galderma (UK) Ltd PA0590/016/001 Ointment - CALCITRIOL 19/05/2008

Human Medicines Withdrawn Products Page 249 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BAYER MULTIVITAMIN & Bayer PLC PA0021/061/002 Tablets Chewable - ASCORBIC ACID 16/05/2008
MINERAL FILM COATED - THIAMINE
TABLETS HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- FOLIC ACID
- BIOTIN
- CALCIUM CARBONATE
- MAGNESIUM
CARBONATE
- MAGNESIUM OXIDE
- ZINC CITRATE
TRIHYDRATE
ELANTAN LA Eurodrug Ltd DPR1392/010/001 Prolonged-release capsule, - ISOSORBIDE 13/05/2008
hard MONONITRATE
ACTOPRIL Stada Arzneimittel AG PA0593/011/002 Tablets - CAPTOPRIL 06/05/2008
ACTOPRIL TABLETS Stada Arzneimittel AG PA0593/011/001 Tablets - CAPTOPRIL 06/05/2008
12.5MG.
ACTOPRIL TABLETS 50MG Stada Arzneimittel AG PA0593/011/003 Tablets - CAPTOPRIL 06/05/2008

HENTOM Bentley Pharmaceuticals PA1284/008/001 Capsules Hard - OMEPRAZOLE 01/05/2008


Ireland Limited
HENTOM Bentley Pharmaceuticals PA1284/008/002 Capsules Hard - OMEPRAZOLE 01/05/2008
Ireland Limited
HENTOM Bentley Pharmaceuticals PA1284/008/003 Capsules Hard - OMEPRAZOLE 01/05/2008
Ireland Limited
SYMMETREL Novartis Pharmaceuticals UK PA0013/082/001 Capsule - AMANTADINE 01/05/2008
Ltd HYDROCHLORIDE
XANOMEL Clonmel Healthcare Ltd PA0126/097/001 Film Coated Tablet - RANITIDINE 28/04/2008
HYDROCHLORIDE
CALAMINE B.P. Ricesteele Manufacturing Ltd PA0095/021/001 Cutaneous Suspension - CALAMINE 27/04/2008
- ZINC OXIDE
MOBIC Boehringer Ingelheim PA0775/001/007 Solution for Injection - MELOXICAM 24/04/2008
International GmbH
MELOXICAM Clonmel Healthcare Ltd PA0126/139/001 Tablets - MELOXICAM 23/04/2008
MELOXICAM Clonmel Healthcare Ltd PA0126/139/002 Tablets - MELOXICAM 23/04/2008
Q.V. Bath Oil Bath Additive Ego Pharmaceuticals (UK) PA0863/005/001 Bath Additive - LIQUID PARAFFIN LIGHT 23/04/2008
Limited
RIMATIDINE Ranbaxy Ireland Limited PA0408/029/003 Tablets - CIMETIDINE 21/04/2008
CHIROCAINE Abbott Laboratories Ireland PA0038/071/001 Solution for injection/infusion - LEVOBUPIVACAINE 18/04/2008
Ltd
CHIROCAINE Abbott Laboratories Ireland PA0038/071/002 Solution for injection/infusion - LEVOBUPIVACAINE 18/04/2008
Ltd
CHIROCAINE Abbott Laboratories Ireland PA0038/071/003 Solution for injection/infusion - LEVOBUPIVACAINE 18/04/2008
Ltd
PRAVASTATIN SODIUM Bristol-Myers Squibb PA0002/077/001 Tablets - PRAVASTATIN SODIUM 18/04/2008
Pharmaceuticals uc
PRAVASTATIN SODIUM Bristol-Myers Squibb PA0002/077/002 Tablets - PRAVASTATIN SODIUM 18/04/2008
Pharmaceuticals uc
PRAVASTATIN SODIUM Bristol-Myers Squibb PA0002/077/003 Tablets - PRAVASTATIN SODIUM 18/04/2008
Pharmaceuticals uc
FULL MARKS MOUSSE SSL International PLC PA0618/015/002 Cutaneous Foam - PHENOTHRIN 16/04/2008
ACYCLOSTAD Stada Arzneimittel AG PA0593/015/001 Cream - ACICLOVIR 15/04/2008
MEROCET SSL International PLC PA0618/027/002 Mouth Wash - CETYLPYRIDINIUM 15/04/2008
CHLORIDE
- METHYL SALICYLATE
AMOXYCILLIN SACHET Athlone Laboratories Ltd PA0298/010/005 Powder for Oral Suspension - AMOXICILLIN 14/04/2008
SUGAR FREE TRIHYDRATE
OMNOPON Martindale Pharmaceuticals PA0361/009/001 Solution for Injection - MORPHINE 14/04/2008
Ltd HYDROCHLORIDE
- DIHYDROCODEINE
HYDROCHLORIDE
- PAPAVERINE
HYDROCHLORIDE
CUPLEX Smith & Nephew PA0710/002/001 Gel - SALICYLIC ACID 11/04/2008
Pharmaceuticals - LACTIC ACID
METHADONE CP Pharmaceuticals Ltd PA0409/019/001 Solution for Injection - METHADONE 07/04/2008
trading as Wockhardt UK HYDROCHLORIDE
RIMAPEN PENICILLIN VK Ranbaxy Ireland Limited PA0408/009/001 Tablets - 07/04/2008
PHENOXYMETHYLPENICI
LLIN POTASSIUM

Human Medicines Withdrawn Products Page 250 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DECADRON 500 Merck Sharp and Dohme PA0035/016/001 Tablets - DEXAMETHASONE 02/04/2008
MICROGRAM TABLETS Limited
CAPRILL Pinewood Laboratories Ltd, PA0281/099/002 Tablets - CAPTOPRIL 01/04/2008
CAPRILL Pinewood Laboratories Ltd, PA0281/099/003 Tablets - CAPTOPRIL 01/04/2008
CAPRILL Pinewood Laboratories Ltd, PA0281/099/004 Tablets - CAPTOPRIL 01/04/2008
EGODERM Ego Pharmaceuticals (UK) PA0863/003/001 Cream - ICHTHAMMOL 01/04/2008
Limited
EGODERM Ego Pharmaceuticals (UK) PA0863/003/002 Ointment - ICHTHAMMOL 01/04/2008
Limited - ZINC OXIDE
VAMIN 9 GLUCOSE, Fresenius Kabi Limited PA0566/012/001 Solution for Infusion - ALANINE 01/04/2008
SOLUTION FOR INFUSION - ARGININE
100MLS - ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- MAGNESIUM SULFATE
HEPTAHYDRATE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- GLUCOSE ANHYDROUS
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/009A Irrigation solution - CHLORHEXIDINE 31/03/2008
BP 0.02% W/V IRRIGATION DIACETATE
SOLU
COMBIVENT METERED PCO Manufacturing PPA0465/105/001A Pressurised Inhalation - IPRATROPIUM BROMIDE 31/03/2008
Suspension - SALBUTAMOL SULFATE
DIFFERIN CUTANEOUS Galderma (UK) Ltd PA0590/006/001 Cutaneous Solution - ADAPALENE 31/03/2008
SOLUTION 0.1% W/W
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/001A Solution for Infusion - GLUCOSE 31/03/2008
INFUSION BP 5% W/V. MONOHYDRATE
(VIAFLEX C
HALF STRENGTH Baxter Healthcare Limited PA0167/055/005A Solution for Infusion - SODIUM CHLORIDE 31/03/2008
COMPOUND SODIUM - SODIUM LACTATE
LACTATE IV INFUSION - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
HYDROCORTONE Merck Sharp and Dohme PA0035/021/002 Tablets - HYDROCORTISONE 31/03/2008
Limited
OROVITE Seton Healthcare Group PLC PA0696/009/002 Syrup - RIBOFLAVIN 31/03/2008
- PYRIDOXINE
- NICOTINAMIDE
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
PLASMA-LYTE M Baxter Healthcare Limited PA0167/039/001A Solution for Infusion - SODIUM ACETATE 31/03/2008
(ELECTROLYTE - SODIUM LACTATE
SOLUTION) WITH 5 % W/V - POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
POLYTAR PLUS Stiefel Laboratories (U.K.) PA0144/004/001 Shampoo - COAL TAR 31/03/2008
Ltd. - COAL TAR SOLUTION
- CADE OIL
- ARACHIS OIL
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/052/005A Solution for Infusion - POTASSIUM CHLORIDE 31/03/2008
AND SODIUM CHLORIDE - SODIUM CHLORIDE
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/051/007A Solution for Infusion - GLUCOSE 31/03/2008
GLUCOSE - POTASSIUM CHLORIDE
PROTAMINE SULPHATE Leo Laboratories Limited PA0046/033/001 Solution for Injection - PROTAMINE SULFATE 31/03/2008
LEO
PROZAC Eli Lilly and Company Limite PA0047/077/003 Capsule - FLUOXETINE 31/03/2008
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 251 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PYRALVEX OROMUCOSAL Norgine Limited PA0102/015/001 Oromucosal Solution - SALICYLIC ACID 31/03/2008
SOLUTION

RINGERS INTRAVENOUS Baxter Healthcare Limited PA0167/054/001A Solution for Infusion - SODIUM CHLORIDE 31/03/2008
INFUSION - CALCIUM CHLORIDE
DIHYDRATE
- POTASSIUM CHLORIDE
SODIUM CHLORIDE 0.18% Baxter Healthcare Limited PA0167/050/001A Solution for Infusion - SODIUM CHLORIDE 31/03/2008
W/V AND 4.0% W/V - GLUCOSE
GLUCOSE INT MONOHYDRATE
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/001 Solution for Infusion - SODIUM CHLORIDE 31/03/2008
INTRAVENOUS INFUSION
BP 0.9% W/V.
STERAX Galderma (UK) Ltd PA0590/013/003 Ointment - DESONIDE 31/03/2008
STERAX CREAM 0.05% Galderma (UK) Ltd PA0590/013/001 Cream - DESONIDE 31/03/2008
W/W
STERAX CUTANEOUS Galderma (UK) Ltd PA0590/013/002 Cutaneous Emulsion - DESONIDE 31/03/2008
EMULSION 0.05% W/W
TETRALYSAL Galderma (UK) Ltd PA0590/012/001 Capsules Hard - LYMECYCLINE 31/03/2008
NEUROBION Merck Serono Limited PA0654/009/001 Solution for Injection - THIAMINE 30/03/2008
HYDROCHLORIDE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
GELCOTAR Quinoderm Ltd PA0308/012/001 Shampoo - COAL TAR SOLUTION 28/03/2008
STRONG
- CADE OIL
HIOXYL Ferndale Pharmaceuticals PA1155/005/001 Cream - HYDROGEN PEROXIDE 28/03/2008
Ltd
BOESTROL Mercury Pharmaceuticals PA0073/039/001 Tablets - DIETHYLSTILBESTROL 27/03/2008
(Ireland) Ltd
BOESTROL Mercury Pharmaceuticals PA0073/039/002 Tablets - DIETHYLSTILBESTROL 27/03/2008
(Ireland) Ltd
COMPLEVEN Fresenius Kabi Limited PA0566/004/001 Solution for Infusion - ISOLEUCINE 27/03/2008
- LEUCINE
- LYSINE
- L-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- TYROSINE
- ARGININE
- HISTIDINE
- TAURINE
- AMINOACETIC ACID
- ALANINE
- PROLINE
- SERINE
- MALIC ACID
- GLYCEROL
- POTASSIUM HYDROXIDE
- SODIUM HYDROXIDE
- CALCIUM CHLORIDE
DIHYDRATE
- POTASSIUM CHLORIDE
- MANGANESE CHLORIDE
- ZINC CHLORIDE
- SOYA BEAN OIL
EPOXIDISED
- LECITHIN

PALFIUM Mercury Pharmaceuticals PA0073/019/001 Tablets - DEXTROMORAMIDE 27/03/2008


(Ireland) Ltd TARTRATE
CHLORPROMAZINE BP Mercury Pharmaceuticals PA0073/104/003 Tablets - CHLORPROMAZINE 24/03/2008
(Ireland) Ltd HYDROCHLORIDE
CHLORPROMAZINE BP Mercury Pharmaceuticals PA0073/104/004 Tablets - CHLORPROMAZINE 24/03/2008
(Ireland) Ltd HYDROCHLORIDE
CHLORPROMAZINE BP Mercury Pharmaceuticals PA0073/104/005 Tablets - CHLORPROMAZINE 24/03/2008
(Ireland) Ltd HYDROCHLORIDE
CLINICIDE LOTION E.C. De Witt & Company PA0299/010/001 Cutaneous Solution - CARBARIL 24/03/2008
Limited
CLINIMAL LOTION E.C. De Witt & Company PA0299/011/001 Cutaneous Solution - MALATHION 24/03/2008
Limited
TRAMEX Mercury Pharmaceuticals PA0073/150/001 Tablets - TRAMADOL 24/03/2008
(Ireland) Ltd HYDROCHLORIDE
PRAVITIN Rowex Ltd PA0711/058/003 Tablets - PRAVASTATIN SODIUM 14/03/2008

Human Medicines Withdrawn Products Page 252 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TETRACYCLINE Clonmel Healthcare Ltd PA0126/051/002 Capsule - TETRACYCLINE 13/03/2008
HYDROCHLORIDE
AMLODIPINE Rowex Ltd PA0711/078/001 Tablets - AMLODIPINE MALEATE 10/03/2008
AMLODIPINE Rowex Ltd PA0711/078/003 Tablets - AMLODIPINE MALEATE 10/03/2008
ISOTREXOL CREAM 0.05 % Stiefel Laboratories (U.K.) PA0144/042/001 Cream - ISOTRETINOIN 07/03/2008
Ltd.
ISOTREXOL CREAM 0.10 % Stiefel Laboratories (U.K.) PA0144/042/002 Cream - ISOTRETINOIN 07/03/2008
Ltd.
MOBIFLEX TABLETS 20 M Roche Products Limited PA0050/067/002 Tablets - TENOXICAM 04/03/2008

MOBIFLEX VIALS 20MG Roche Products Limited PA0050/067/005 Unknown - TENOXICAM 04/03/2008
POWDER AND SOLVENT
FOR SOLUTI
VALIUM Roche Products Limited PA0050/017/001 Tablets - DIAZEPAM 04/03/2008
ANDREWS ANTACID GlaxoSmithKline Consumer PA0678/048/001 Tablets Chewable - CALCIUM CARBONATE 03/03/2008
(ORANGE) Healthcare (Ireland) Limited - MAGNESIUM
CARBONATE
ANDREWS ANTACID FRUIT GlaxoSmithKline Consumer PA0678/048/002 Tablets Chewable - CALCIUM CARBONATE 03/03/2008
FLAVOURS Healthcare (Ireland) Limited - HEAVY MAGNESIUM
CARBONATE
TRENTAL Sanofi-Aventis Ireland PA0540/080/002 Solution for Injection - PENTOXIFYLLINE 01/03/2008
Limited T/A SANOFI
TAZAMEL Clonmel Healthcare Ltd PA0126/129/001 Tablets - MIRTAZAPINE 28/02/2008
TAZAMEL Clonmel Healthcare Ltd PA0126/129/003 Tablets - MIRTAZAPINE 28/02/2008
VOLOGEN Mercury Pharmaceuticals PA0073/133/002 Tablets - DICLOFENAC SODIUM 28/02/2008
(Ireland) Ltd
VOLOGEN RETARD Mercury Pharmaceuticals PA0073/133/004 Capsule - DICLOFENAC SODIUM 28/02/2008
(Ireland) Ltd
PHOLCOLIN Mercury Pharmaceuticals PA0073/018/001 Unknown - PHOLCODINE 25/02/2008
(Ireland) Ltd
DERBAC C SSL International PLC PA0618/013/001 Cutaneous Solution - CARBARIL 24/02/2008
DERBAC C SHAMPOO SSL International PLC PA0618/013/002 Shampoo - CARBARIL 24/02/2008
CANESTEN Bayer PLC PA0021/004/003 Cutaneous Solution - CLOTRIMAZOLE 22/02/2008
CANESTEN Bayer PLC PA0021/004/006 Cutaneous Powder - CLOTRIMAZOLE 22/02/2008
DERMATOLOGICAL
ORFIRIL Desitin Arzneimittel GmbH PA0815/003/001 Solution for Injection - VALPROATE SODIUM 22/02/2008
REDOXON Bayer PLC PA0021/074/004 Tablets Effervescent - ASCORBIC ACID 22/02/2008
SEROPHENE Serono Limited PA0285/003/001 Tablets - CLOMIFENE CITRATE 22/02/2008
SULPROMEL Clonmel Healthcare Ltd PA0126/155/001 Tablets - AMISULPRIDE 21/02/2008
SULPROMEL Clonmel Healthcare Ltd PA0126/155/002 Tablets - AMISULPRIDE 21/02/2008
SULPROMEL Clonmel Healthcare Ltd PA0126/155/003 Tablets - AMISULPRIDE 21/02/2008
SULPROMEL Clonmel Healthcare Ltd PA0126/155/004 Film Coated Tablet - AMISULPRIDE 21/02/2008
BUFIGEN Mercury Pharmaceuticals PA0073/063/001 Tablets - IBUPROFEN 20/02/2008
(Ireland) Ltd
BUFIGEN Mercury Pharmaceuticals PA0073/063/002 Tablets - IBUPROFEN 20/02/2008
(Ireland) Ltd
BUFIGEN Mercury Pharmaceuticals PA0073/063/003 Tablets - IBUPROFEN 20/02/2008
(Ireland) Ltd
ESTRADIOL TTS Merck Serono Limited PA0654/003/001 Transdermal Patch - ESTRADIOL 20/02/2008
HEMIHYDRATE
FORTIPINE LA Mercury Pharmaceuticals Ltd PA0899/018/001 Tablets - NIFEDIPINE 20/02/2008

DENOREX Pfizer Consumer Healthcare PA0172/023/001 Shampoo - COAL TAR SOLUTION 18/02/2008
Ltd - MENTHOL
ROBITUSSIN JUNIOR Pfizer Consumer Healthcare PA0172/033/001 Oral Solution - DEXTROMETHORPHAN 18/02/2008
Ltd HYDROBROMIDE
ROBITUSSIN SOFT Pfizer Consumer Healthcare PA0172/033/003 Unknown - DEXTROMETHORPHAN 18/02/2008
PASTILLES FOR DRY Ltd HYDROBROMIDE
COUGH
ISOPRINOSINE Newport Pharmaceuticals PA0336/001/002 Oral Solution - INOSINE ACEDOBEN 14/02/2008
Limited DIMEPRANOL
AZROMAX McDermott Laboratories Ltd PA0577/066/001 Coated Tablets - AZITHROMYCIN 06/02/2008
t/a Gerard Laboratories
AZROMAX McDermott Laboratories Ltd PA0577/066/002 Coated Tablets - AZITHROMYCIN 06/02/2008
t/a Gerard Laboratories
COMPLOMENT SSL International PLC PA0618/012/001 Tablets - PYRIDOXINE 05/02/2008
HYDROCHLORIDE
UBIT Otsuka Pharmaceutical PA0985/002/001 Tablets - 13C-UREA 05/02/2008
Europe Ltd
ANDROPATCH GlaxoSmithKline (Ireland) PA1077/018/001 Transdermal Patch - TESTOSTERONE 01/02/2008
Limited
ACICLOVIR Winthrop Pharmaceuticals PA1046/004/001 Tablets - ACICLOVIR 31/01/2008
UK Limited
ACICLOVIR DISPERSIBLE Winthrop Pharmaceuticals PA1046/004/003 Tablets - ACICLOVIR 31/01/2008
BP UK Limited

Human Medicines Withdrawn Products Page 253 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMIODARONE Winthrop Pharmaceuticals PA1046/003/001 Tablets - AMIODARONE 31/01/2008
UK Limited HYDROCHLORIDE
AMIODARONE Winthrop Pharmaceuticals PA1046/003/002 Tablets - AMIODARONE 31/01/2008
UK Limited HYDROCHLORIDE
AMISULPRIDE Winthrop Pharmaceuticals PA1046/013/001 Tablets - AMISULPRIDE 31/01/2008
UK Limited
AMISULPRIDE Winthrop Pharmaceuticals PA1046/013/002 Tablets - AMISULPRIDE 31/01/2008
UK Limited
AMISULPRIDE Winthrop Pharmaceuticals PA1046/013/003 Tablets - AMISULPRIDE 31/01/2008
UK Limited
AMISULPRIDE Winthrop Pharmaceuticals PA1046/013/004 Tablets - AMISULPRIDE 31/01/2008
UK Limited
CIMETIDINE Winthrop Pharmaceuticals PA1046/009/001 Coated Tablets - CIMETIDINE 31/01/2008
UK Limited
CIMETIDINE Winthrop Pharmaceuticals PA1046/009/002 Coated Tablets - CIMETIDINE 31/01/2008
UK Limited
CIMETIDINE Winthrop Pharmaceuticals PA1046/009/003 Coated Tablets - CIMETIDINE 31/01/2008
UK Limited
DICLOFENAC SODIUM Winthrop Pharmaceuticals PA1046/007/001 Tablets Gastro-Resistant - DICLOFENAC 31/01/2008
UK Limited
DICLOFENAC SODIUM Winthrop Pharmaceuticals PA1046/007/002 Tablets Gastro-Resistant - DICLOFENAC 31/01/2008
UK Limited
FANSIDAR Roche Products Limited PA0050/071/001 Tablets - SULFADOXINE 31/01/2008
- PYRIMETHAMINE
GLEPID Rowex Ltd PA0711/080/001 Tablets - GLIMEPIRIDE 31/01/2008
GLEPID Rowex Ltd PA0711/080/002 Tablets - GLIMEPIRIDE 31/01/2008
GLEPID Rowex Ltd PA0711/080/003 Tablets - GLIMEPIRIDE 31/01/2008
GLEPID Rowex Ltd PA0711/080/004 Tablets - GLIMEPIRIDE 31/01/2008
GLEPID Rowex Ltd PA0711/080/005 Tablets - GLIMEPIRIDE 31/01/2008
GLIMEPIRIDE Winthrop Pharmaceuticals PA1046/015/001 Tablets - GLIMEPIRIDE 31/01/2008
UK Limited
GLIMEPIRIDE Winthrop Pharmaceuticals PA1046/015/002 Tablets - GLIMEPIRIDE 31/01/2008
UK Limited
GLIMEPIRIDE Winthrop Pharmaceuticals PA1046/015/003 Tablets - GLIMEPIRIDE 31/01/2008
UK Limited
GLIMEPIRIDE Winthrop Pharmaceuticals PA1046/015/004 Tablets - GLIMEPIRIDE 31/01/2008
UK Limited
GLIMEPIRIDE Winthrop Pharmaceuticals PA1046/015/005 Tablets - GLIMEPIRIDE 31/01/2008
UK Limited
PARACETAMOL Winthrop Pharmaceuticals PA1046/011/001 Tablets - PARACETAMOL 31/01/2008
UK Limited
RANITIDINE Winthrop Pharmaceuticals PA1046/012/001 Tablets - RANITIDINE 31/01/2008
UK Limited HYDROCHLORIDE
RANITIDINE Winthrop Pharmaceuticals PA1046/012/002 Tablets - RANITIDINE 31/01/2008
UK Limited HYDROCHLORIDE
SODIUM VALPROATE Winthrop Pharmaceuticals PA1046/008/001 Oral Solution - VALPROATE SODIUM 31/01/2008
UK Limited
SODIUM VALPROATE Winthrop Pharmaceuticals PA1046/008/002 Tablets Gastro-Resistant - VALPROATE SODIUM 31/01/2008
UK Limited
SODIUM VALPROATE Winthrop Pharmaceuticals PA1046/008/003 Tablets Gastro-Resistant - VALPROATE SODIUM 31/01/2008
UK Limited
TRAMADOL Winthrop Pharmaceuticals PA1046/006/001 Capsule - TRAMADOL 31/01/2008
HYDROCHLORIDE UK Limited HYDROCHLORIDE
ECOSTATIN Bristol-Myers Squibb PA0002/024/001 Cream - ECONAZOLE NITRATE 30/01/2008
Pharmaceuticals uc
ECOSTATIN Bristol-Myers Squibb PA0002/024/002 Pessary - ECONAZOLE NITRATE 30/01/2008
Pharmaceuticals uc
ANTISEPTIC THROAT The Boots Company Plc PA0004/056/001 Lozenges - AMYLMETACRESOL 28/01/2008
DROPS MENTHOL AND
EUCALYPTUS
ORTHO-CREME Janssen-Cilag Ltd PA0748/035/001 Vaginal Cream - NONOXINOL 27/01/2008
CONTRACEPTIVE
SEMPREX GlaxoSmithKline Consumer PA0678/096/001 Capsule - ACRIVASTINE 25/01/2008
Healthcare (Ireland) Limited
FLOUROURACIL GLASS Hospira UK Limited PA0437/011/004A Solution for Inj/Inf - FLUOROURACIL 23/01/2008
VIAL
RADIAN B MUSCLE William Ransom & Son Plc PA0506/017/001 Cutaneous Solution - MENTHOL 22/01/2008
LOTION - CAMPHOR
- AMMONIUM SALICYLATE
- METHYL SALICYLATE

RADIAN B MUSCLE RUB William Ransom & Son Plc PA0506/015/001 Cream - MENTHOL 19/01/2008
CREAM - CAMPHOR
- METHYL SALICYLATE
- CAPSAICIN

Human Medicines Withdrawn Products Page 254 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DEXEMEL 4% Innovata plc PA0675/002/001 Solvent for Parenteral Use - ICODEXTRIN 18/01/2008
- SODIUM CHLORIDE
PH.EUR.
- S(+) SODIUM LACTATE
960%W/W SOLUTION
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
KEMADRIN GlaxoSmithKline (Ireland) PA1077/060/002 Solution for Injection - PROCYCLIDINE 14/01/2008
Limited HYDROCHLORIDE
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/001 Tablets - LAMOTRIGINE 14/01/2008
Limited
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/002 Tablets - LAMOTRIGINE 14/01/2008
Limited
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/003 Tablets - LAMOTRIGINE 14/01/2008
Limited
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/004 Tablets - LAMOTRIGINE 14/01/2008
Limited
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/005 Tablets - LAMOTRIGINE 14/01/2008
Limited
LAMOTRIGINE GlaxoSmithKline (Ireland) PA1077/110/006 Tablets - LAMOTRIGINE 14/01/2008
Limited
ONDANSETRON GlaxoSmithKline (Ireland) PA1077/109/001 Coated Tablets - ONDANSETRON 14/01/2008
Limited HYDROCHLORIDE
DIHYDRATE
ONDANSETRON GlaxoSmithKline (Ireland) PA1077/109/002 Coated Tablets - ONDANSETRON 14/01/2008
Limited HYDROCHLORIDE
DIHYDRATE
Q.V. SKIN Ego Pharmaceuticals (UK) PA0863/002/001 Cream - GLYCEROL 14/01/2008
Limited - LIQUID PARAFFIN LIGHT
- WHITE SOFT PARAFFIN
Q.V.SKIN Ego Pharmaceuticals (UK) PA0863/001/001 Cutaneous Solution - WHITE SOFT PARAFFIN 14/01/2008
Limited
VUNEXIN GlaxoSmithKline (Ireland) PA1077/107/001 Film Coated Tablet - ROPINIROLE 14/01/2008
Limited
VUNEXIN GlaxoSmithKline (Ireland) PA1077/107/002 Film Coated Tablet - ROPINIROLE 14/01/2008
Limited
VUNEXIN GlaxoSmithKline (Ireland) PA1077/107/003 Film Coated Tablet - ROPINIROLE 14/01/2008
Limited
VUNEXIN GlaxoSmithKline (Ireland) PA1077/107/004 Film Coated Tablet - ROPINIROLE 14/01/2008
Limited
PRESINEX Pliva Pharma Limited PA0585/012/001 Nasal Spray Solution - DESMOPRESSIN 11/01/2008
GABAPENTIN 600 MG FILM Winthrop Arzneimittel GmbH PA1300/001/001 Coated Tablets - GABAPENTIN 10/01/2008
COATED TABLETS
GABAPENTIN 800 MG FILM Winthrop Arzneimittel GmbH PA1300/001/002 Coated Tablets - GABAPENTIN 10/01/2008
COATED TABLETS
RADIAN B PAIN RELIEF William Ransom & Son Plc PA0506/016/001 Cutaneous Spray Solution - MENTHOL 08/01/2008
SPRAY - RACEMIC CAMPHOR
- AMMONIUM SALICYLATE
- METHYL SALICYLATE

TARMED Stiefel Laboratories (U.K.) PA0144/034/001 Shampoo - COAL TAR SOLUTION 08/01/2008
Ltd.
ELYZOL Colgate-Palmolive (U.K.) Ltd PA0320/009/001 Dental Gel - METRONIDAZOLE 07/01/2008
BENZOATE
MINIMS ROSE BENGAL Chauvin Pharmaceuticals PA0118/018/001 Eye Drops Solution - ROSE BENGAL 01/01/2008
Limited
AMOXIL PCO Manufacturing PPA0465/008/002C Capsule - AMOXICILLIN 31/12/2007
TRIHYDRATE
AULIN PCO Manufacturing PPA0465/110/001A Tablets - NIMESULIDE 31/12/2007
BECOTIDE INHALER 100 PCO Manufacturing PPA0465/041/002A Pressurised Inhalation - BECLOMETASONE 31/12/2007
MCG Suspension DIPROPIONATE
MONOHYDRATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001A Pressurised Inhalation - BECLOMETASONE 31/12/2007
50MCG Suspension DIPROPIONATE
CALCORT Shire Pharmaceuticals PA0535/005/002 Tablets - DEFLAZACORT 31/12/2007
Limited
CALPOL INFANT PCO Manufacturing PPA0465/029/001A Oral Suspension - PARACETAMOL 31/12/2007
ESTRADERM TTS PCO Manufacturing PPA0465/044/003B Transdermal Patch 31/12/2007
ESTRADERM TTS PCO Manufacturing PPA0465/044/003C Transdermal Patch 31/12/2007
ESTRADERM TTS PCO Manufacturing PPA0465/044/001B Transdermal Patch 31/12/2007
ESTRADERM TTS PCO Manufacturing PPA0465/044/001C Transdermal Patch 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/001A Tablets - SUMATRIPTAN 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/001B Tablets - SUMATRIPTAN 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/001C Tablets - SUMATRIPTAN 31/12/2007

Human Medicines Withdrawn Products Page 255 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IMIGRAN PCO Manufacturing PPA0465/070/001D Tablets - SUMATRIPTAN 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/002A Tablets - SUMATRIPTAN 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/002B Tablets - SUMATRIPTAN 31/12/2007
IMIGRAN PCO Manufacturing PPA0465/070/002C Tablets - SUMATRIPTAN 31/12/2007
LOSEC PCO Manufacturing PPA0465/039/001B Capsule - OMEPRAZOLE 31/12/2007
LOSEC PCO Manufacturing PPA0465/039/001C Capsules Gastro-Resistant - OMEPRAZOLE 31/12/2007
LOSEC PCO Manufacturing PPA0465/039/001D Capsules Gastro-Resistant 31/12/2007
LOSEC 20 MG GASTRO- PCO Manufacturing PPA0465/039/001A Capsules Gastro-Resistant - OMEPRAZOLE 31/12/2007
RESISTANT HARD
CAPSULES
OMNISCAN GE Healthcare AS PA0735/008/001 Solution for Injection - GADODIAMIDE 31/12/2007
OMNISCAN GE Healthcare AS PA0735/008/004 Solution for Injection - GADODIAMIDE 31/12/2007
OMNISCAN GE Healthcare AS PA0735/008/005 Solution for Injection - GADODIAMIDE 31/12/2007
REMINYL PCO Manufacturing PPA0465/166/001 Tablets - GALANTAMINE 31/12/2007
HYDROBROMIDE
ROGAINE REGULAR PCO Manufacturing PPA0465/150/001 Cutaneous Solution - MINOXIDIL 31/12/2007
STRENGTH
SEREVENT INHALER PCO Manufacturing PPA0465/127/001A Pressurised Inhalation - SALMETEROL 31/12/2007
Suspension XINAFOATE
SURMONTIL PCO Manufacturing PPA0465/170/001 Tablets - TRIMIPRAMINE MALEATE 31/12/2007

VIBRAMYCIN PCO Manufacturing PPA0465/015/002 Capsule - DOXYCYCLINE 31/12/2007


HYDROCHLORIDE
ZOPICALM Stada Arzneimittel AG PA0593/018/001 Tablets - ZOPICLONE 31/12/2007
ZOTON PCO Manufacturing PPA0465/058/002A Capsule - LANSOPRAZOLE 31/12/2007
ZOTON PCO Manufacturing PPA0465/058/002B Capsule - LANSOPRAZOLE 31/12/2007
ZOTON PCO Manufacturing PPA0465/058/002C Capsule - LANSOPRAZOLE 31/12/2007
CROOKES IBUPROFEN Crookes Healthcare Ltd PA0043/037/001 Capsule - IBUPROFEN 18/12/2007
LIQUID
DETTOL ANTISEPTIC PAIN Reckitt Benckiser Ireland Ltd PA0979/018/001 Cutaneous Spray Solution - BENZALKONIUM 18/12/2007
RELIEF SPRAY CHLORIDE
- LIDOCAINE
HYDROCHLORIDE
FLUTAMIDE PH & T S.p.A. PA0888/001/001 Tablets - FLUTAMIDE 18/12/2007
GAVISCON Reckitt Benckiser Ireland Ltd PA0979/011/002 Tablets Chewable - ALGINIC ACID 18/12/2007
- MAGNESIUM TRISILICATE
- ALUMINIUM HYDROXIDE
GEL, DRIED
- SODIUM BICARBONATE

PREMIQUE CYCLE John Wyeth & Brother PA0022/069/007 Tablets - ESTROGENS 18/12/2007
Limited CONJUGATED
- ESTROGENS
CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
STREPSILS INTENSIVE Crookes Healthcare Ltd PA0043/025/002 Lozenges - FLURBIPROFEN 18/12/2007
SUGAR FREE ORANGE
FEMIN-9 Seven Seas Health Care Ltd PA0416/009/001 Capsule - PYRIDOXINE 17/12/2007
HYDROCHLORIDE
- ASCORBIC ACID
- TOCOPHERYL ACETATE
- FERROUS SULFATE
- ZINC SULFATE
- CYANOCOBALAMIN
- FOLIC ACID
- POTASSIUM IODIDE
- EPANOIL
BARICOL E-Z-EM Nederland B.V. PA1037/001/001 Rectal Suspension - BARIUM SULFATE 16/12/2007
METOPROLOL TARTRATE Mercury Pharmaceuticals PA0073/098/001 Tablets - METOPROLOL TARTRATE 14/12/2007
(Ireland) Ltd
METOPROLOL TARTRATE Mercury Pharmaceuticals PA0073/098/002 Tablets - METOPROLOL TARTRATE 14/12/2007
(Ireland) Ltd
NOLGEN TABLETS 10 MG Mercury Pharmaceuticals PA0073/093/001 Tablets - TAMOXIFEN CITRATE 14/12/2007
(TAMOXIFEN TABLETS BP (Ireland) Ltd
10 MG)
HISTACLAR SYRUP McDermott Laboratories Ltd PA0577/046/003 Syrup - LORATADINE 05/12/2007
t/a Gerard Laboratories
SELEXIDIN INJECTION Leo Laboratories Limited PA0046/029/001 Pdr+Solv for Soln for Inj - MECILLINAM 01/12/2007
Xylocaine 1% With AstraZeneca UK Limited PA0970/053/002 Solution for injection - Adrenaline tartrate 01/12/2007
Adrenaline (Epinephrine) - LIDOCAINE
HYDROCHLORIDE
ACIC LYOPHILISATE Rowex Ltd PA0711/017/003 Unknown - ACICLOVIR 30/11/2007

Human Medicines Withdrawn Products Page 256 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EMCORETIC Merck Serono Limited PA0654/008/001 Tablets - BISOPROLOL FUMARATE 27/11/2007
- HYDROCHLOROTHIAZIDE

DICLOFENAC SODIUM Norton Waterford PA0436/009/001 Tablets - DICLOFENAC SODIUM 26/11/2007


DICLOFENAC SODIUM Norton Waterford PA0436/009/002 Tablets - DICLOFENAC SODIUM 26/11/2007
PROPINE STERILE Allergan Pharmaceuticals PA0148/002/001 Eye Drops Solution - DIPIVEFRINE 15/11/2007
OPHTHALMIC Ireland HYDROCHLORIDE
ROCEPHIN 1M Roche Products Limited PA0050/086/002 Solution for Injection - LIDOCAINE 15/11/2007
HYDROCHLORIDE
TRAMAKE Galen Limited PA0185/035/002 Powder for Oral Solution - TRAMADOL 15/11/2007
INSTS/TRAMADOL HYDROCHLORIDE
HYDROCHLORIDE
TRAMAKE Galen Limited PA0185/035/003 Powder for Oral Solution - TRAMADOL 15/11/2007
INSTS/TRAMADOL HYDROCHLORIDE
HYDROCHLORIDE
DAY COLD COMFORT The Boots Company Plc PA0004/026/001 Oral Solution - PARACETAMOL 12/11/2007
- PHOLCODINE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
DIMOTANE CO Pfizer Consumer Healthcare PA0172/032/001 Oral Solution - BROMPHENIRAMINE 12/11/2007
Ltd MALEATE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- CODEINE PHOSPHATE
DIMOTANE CO Pfizer Consumer Healthcare PA0172/032/002 Oral Solution - BROMPHENIRAMINE 12/11/2007
PAEDIATRIC Ltd MALEATE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- CODEINE PHOSPHATE
EZETIMIBE 10MG TABLETS MSD-SP Limited PA1091/002/001 Tablets - EZETIMIBE 12/11/2007

NIGHT COLD COMFORT The Boots Company Plc PA0004/027/001 Oral Solution - PARACETAMOL 12/11/2007
- DIPHENHYDRAMINE
HYDROCHLORIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- PHOLCODINE
- ETHANOL
PARACETAMOL CAPLETS The Boots Company Plc PA0004/058/001 Tablets - PARACETAMOL 12/11/2007
VYTORIN MSD-SP Limited PA1091/003/001 Tablets - EZETIMIBE 12/11/2007
- SIMVASTATIN
VYTORIN MSD-SP Limited PA1091/003/002 Tablets - EZETIMIBE 12/11/2007
- SIMVASTATIN
VYTORIN MSD-SP Limited PA1091/003/003 Tablets - EZETIMIBE 12/11/2007
- SIMVASTATIN
VYTORIN MSD-SP Limited PA1091/003/004 Tablets - EZETIMIBE 12/11/2007
- SIMVASTATIN
MYOCRISIN May & Baker Limited PA0040/068/005 Solution for Injection - SODIUM 07/11/2007
AUROTHIOMALATE
PERDAMEL Clonmel Healthcare Ltd PA0126/169/001 Film Coated Tablet - RISPERIDONE 06/11/2007
BENZOYL PEROXIDE Ferndale Pharmaceuticals PA1155/007/001 Cream - BENZOYL PEROXIDE 05/11/2007
Ltd
BENZOYL PEROXIDE Ferndale Pharmaceuticals PA1155/007/002 Cream - BENZOYL PEROXIDE 05/11/2007
Ltd
ONTON 2MG/ML SOLUTION Rowex Ltd PA0711/069/001 Solution for Inj/Inf - ONDANSETRON 02/11/2007
FOR INJECTION OR HYDROCHLORIDE
INFUSION
DETTOL FRESH Reckitt Benckiser Ireland Ltd PA0979/005/001 Cutaneous Solution - BENZALKONIUM 01/11/2007
CHLORIDE
EPHYNAL Bayer PLC PA0021/068/001 Tablets - TOCOPHERYL ACETATE 01/11/2007
EPHYNAL Bayer PLC PA0021/068/002 Tablets - TOCOPHERYL ACETATE 01/11/2007
KEFADOL Eli Lilly and Company Limite PA0047/038/001 Pdr for Soln for Injection - CEFAMANDOLE NAFATE 01/11/2007

KEFADOL Eli Lilly and Company Limite PA0047/038/003 Pdr for Soln for Injection - CEFAMANDOLE NAFATE 01/11/2007

KEFADOL Eli Lilly and Company Limite PA0047/038/004 Pdr for Soln for Injection - CEFAMANDOLE NAFATE 01/11/2007

POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/004/003A Solution for infusion - POTASSIUM CHLORIDE 01/11/2007
SODIUM CHLORIDE AND - SODIUM CHLORIDE
GLUCOSE - GLUCOSE
ANTAROL Mercury Pharmaceuticals PA0073/073/001 Tablets - PROPRANOLOL 31/10/2007
(Ireland) Ltd HYDROCHLORIDE
ANTAROL Mercury Pharmaceuticals PA0073/073/002 Tablets - PROPRANOLOL 31/10/2007
(Ireland) Ltd HYDROCHLORIDE

Human Medicines Withdrawn Products Page 257 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ANTAROL Mercury Pharmaceuticals PA0073/073/003 Tablets - PROPRANOLOL 31/10/2007
(Ireland) Ltd HYDROCHLORIDE
CALCORT Shire Pharmaceuticals PA0535/005/001 Tablets - DEFLAZACORT 31/10/2007
Limited
CALCORT Shire Pharmaceuticals PA0535/005/003 Tablets - DEFLAZACORT 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/001 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/002 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/003 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/004 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/005 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
MXL Napp Pharmaceuticals PA0913/017/006 Prolonged Release Capsules - MORPHINE SULFATE 31/10/2007
Limited
DEXAMETHASONE Organon (Ireland) Limited PA0061/010/001 Tablets - DEXAMETHASONE 30/10/2007
RIMADOL PARACETAMOL Ranbaxy Ireland Limited PA0408/004/002 Capsule - PARACETAMOL 26/10/2007
SOFRADEX EYE/EAR Roussel Laboratories Limited PA0006/010/002 Ointment - FRAMYCETIN SULFATE 22/10/2007
- DEXAMETHASONE
- GRAMICIDIN
LANEPA GR Lane Health Products Lt PA0257/034/001 Capsule - EICOSAPENTAENOIC 13/10/2007
ACID
- DOCOSAHEXANOIC ACID

SEREVENT ROTADISKS GlaxoSmithKline (Ireland) PA1077/047/002 Inhalation powder - SALMETEROL 13/10/2007


Limited XINAFOATE
SEREVENT INHALER GlaxoSmithKline (Ireland) PA1077/047/001 Pressurised Inhalation - SALMETEROL 12/10/2007
Limited Suspension XINAFOATE
ASILONE SSL International PLC PA0618/019/002 Oral Suspension - MAGNESIUM OXIDUM 11/10/2007
LEVE
- ALUMINIUM HYDROXIDE
- DIMETHICONE 350
ASILONE ANTACID SSL International PLC PA0618/019/003 Tablets - ALUMINIUM HYDROXIDE 11/10/2007
- DIMETHICONE 350
ASILONE ANTACID LIQUID SSL International PLC PA0618/019/001 Oral Suspension - MAGNESIUM OXIDUM 11/10/2007
LEVE
- ALUMINIUM HYDROXIDE
- DIMETHICONE 350
SEVEN SEAS CHERRY Seven Seas Ltd PA0417/002/001 Tablets Chewable - ASCORBIC ACID 08/10/2007
FLAVOUR VITAMIN C
CAPSULES
ZAMADOL Meda Health Sales Ireland PA1332/021/005 Capsules Hard - TRAMADOL 08/10/2007
Limited HYDROCHLORIDE
ZAMADOL SR 100 MG Meda Health Sales Ireland PA1332/021/002 Capsule - TRAMADOL 08/10/2007
PROLONGED-RELEASE Limited HYDROCHLORIDE
CAPSULES
ZAMADOL SR 150 MG Meda Health Sales Ireland PA1332/021/003 Capsule - TRAMADOL 08/10/2007
PROLONGED-RELEASE Limited HYDROCHLORIDE
CAPSULES
ZAMADOL SR 200MG Meda Health Sales Ireland PA1332/021/004 Capsule - TRAMADOL 08/10/2007
PROLONGED-RELEASE Limited HYDROCHLORIDE
CAPSULES
ZAMADOL SR 50MG Meda Health Sales Ireland PA1332/021/001 Capsule - TRAMADOL 08/10/2007
PROLONGED-RELEASE Limited HYDROCHLORIDE
CAPSULES
CATHATE John Wyeth & Brother PA0022/068/002 Tablets - ESTROGENS 05/10/2007
Limited CONJUGATED
PREMARIN John Wyeth & Brother PA0022/058/005 Tablets - ESTROGENS 05/10/2007
Limited CONJUGATED
PREMARIN VAGINAL John Wyeth & Brother PA0022/058/001 Vaginal Cream - ESTROGENS 05/10/2007
Limited CONJUGATED
DEXTRAN 40 Baxter Healthcare Limited PA0167/026/001A Solution for Infusion - DEXTRAN 40 04/10/2007
- GLUCOSE
DEXTRAN 70 Baxter Healthcare Limited PA0167/028/001A Solution for Infusion - DEXTRAN 70 04/10/2007
- GLUCOSE
GENTRAN 40 (DEXTRAN 40 Baxter Healthcare Limited PA0167/025/001A Solution for Infusion - DEXTRAN 40 04/10/2007
INTRAVENOUS INFUSION - SODIUM CHLORIDE
BP 10%
GENTRAN 70 (DEXTRAN 70 Baxter Healthcare Limited PA0167/027/001A Solution for Infusion - DEXTRAN 70 04/10/2007
INTRAVENOUS INFUSION - SODIUM CHLORIDE
BP 6.0
DICLOMEL 25 Clonmel Healthcare Ltd PA0126/082/001 Tablets - DICLOFENAC SODIUM 03/10/2007
DICLOMEL 50 Clonmel Healthcare Ltd PA0126/082/002 Tablets - DICLOFENAC SODIUM 03/10/2007

Human Medicines Withdrawn Products Page 258 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MYOCRISIN May & Baker Limited PA0040/068/003 Solution for Injection - SODIUM 01/10/2007
AUROTHIOMALATE
MYOCRISIN May & Baker Limited PA0040/068/004 Solution for Injection - SODIUM 01/10/2007
AUROTHIOMALATE
NOXYFLEX S Geistlich Sons Limited PA0143/011/001 Powder for Cutaneous Soln - NOXYTIOLIN 01/10/2007
VINCRISTINE SULPHATE Hospira UK Limited PA0437/008/006 Solution for Injection - VINCRISTINE SULFATE 01/10/2007
INJECTION
BREXIDOL Chiesi Limited PA0743/010/003 Tablets Effervescent - PIROXICAM BETADEX 29/09/2007
ISOPRENALINE International Medication PA0255/003/003 Solution for Inj/Inf - ISOPRENALINE 28/09/2007
HYDROCHLORIDE Systems (UK) Ltd HYDROCHLORIDE
BETAZOK 100 MG AstraZeneca UK Limited PA0970/034/001 Tablets - METOPROLOL 24/09/2007
PROLONGED-RELEASE SUCCINATE
FILM-COATED TABLE
KINIDIN DURULES AstraZeneca UK Limited PA0970/043/001 Tablets - QUINIDINE SULFATE 24/09/2007
DIHYDRATE
MERBENTYL Sanofi-Aventis Ireland PA0540/019/002 Tablets - DICYCLOMINE 17/09/2007
Limited T/A SANOFI HYDROCHLORIDE
FLUCIS CIS bio International PA0677/017/001 Solution for Injection - FLUDEOXYGLUCOSE 15/09/2007
(18F)
GLUCOSE Baxter Healthcare Limited PA0167/096/011 Solution for Infusion - GLUCOSE 06/09/2007
BENERVA Bayer PLC PA0021/060/001 Tablets - THIAMINE 05/09/2007
HYDROCHLORIDE
BENERVA Bayer PLC PA0021/060/002 Tablets - THIAMINE 05/09/2007
HYDROCHLORIDE
ASPRO Bayer PLC PA0021/058/001 Tablets - ACETYLSALICYLIC ACID 04/09/2007
BAYER ASPIRIN Bayer PLC PA0021/006/001 Tablets - ACETYLSALICYLIC ACID 04/09/2007
BAYTHROM Bayer PLC PA0021/038/001 Tablets - ACETYLSALICYLIC ACID 04/09/2007
- CITRIC ACID
- SODIUM BICARBONATE
BECOSYM FORTE Bayer PLC PA0021/059/001 Tablets - THIAMINE 04/09/2007
HYDROCHLORIDE
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- RIBOFLAVIN
LASONIL Bayer PLC PA0021/016/001 Ointment - HEPARINOID 04/09/2007
- HYALURONIDASE
PARACODOL Bayer PLC PA0021/071/001 Capsule - PARACETAMOL 04/09/2007
- CODEINE PHOSPHATE
PARACODOL Bayer PLC PA0021/071/002 Tablets - PARACETAMOL 04/09/2007
- CODEINE PHOSPHATE
REDOXON C Bayer PLC PA0021/072/001 Tablets - ASCORBIC ACID 04/09/2007
- SODIUM ASCORBATE
REDOXON C Bayer PLC PA0021/072/002 Tablets - ASCORBIC ACID 04/09/2007
- SODIUM ASCORBATE
REDOXON PLAIN Bayer PLC PA0021/074/001 Tablets Effervescent - ASCORBIC ACID 04/09/2007
EFFERVESCENT
TAZOCIN John Wyeth & Brother PA0022/090/003 Solution for Infusion - PIPERACILLIN SODIUM 03/09/2007
Limited - TAZOBACTAM SODIUM
FLUORIGARD GEL-KAM Colgate-Palmolive (U.K.) Ltd PA0320/004/001 Oromucosal Gel - STANNOUS FLUORIDE 31/08/2007

ZEROPAN Napp Pharmaceuticals PA0913/023/001 Tablets - OXYCODONE 28/08/2007


Limited
ZEROPAN Napp Pharmaceuticals PA0913/023/002 Tablets - OXYCODONE 28/08/2007
Limited
ZEROPAN Napp Pharmaceuticals PA0913/023/003 Tablets - OXYCODONE 28/08/2007
Limited
ZEROPAN Napp Pharmaceuticals PA0913/023/004 Tablets - OXYCODONE 28/08/2007
Limited
ZYTRAM-SR Napp Pharmaceuticals PA0913/021/005 Tablets - TRAMADOL 28/08/2007
Limited HYDROCHLORIDE
ZYTRAM-SR Napp Pharmaceuticals PA0913/021/006 Tablets - TRAMADOL 28/08/2007
Limited HYDROCHLORIDE
ZYTRAM-SR Napp Pharmaceuticals PA0913/021/007 Tablets - TRAMADOL 28/08/2007
Limited HYDROCHLORIDE
ZYTRAM-SR Napp Pharmaceuticals PA0913/021/008 Tablets - TRAMADOL 28/08/2007
Limited HYDROCHLORIDE
NOLVADEX AstraZeneca UK Limited PA0970/015/001 Tablets - TAMOXIFEN CITRATE 27/08/2007
SULEO-C SSL International PLC PA0618/010/002 Shampoo - CARBARIL 25/08/2007
DOBUTAMIN HIKMA 250 Hikma Farmaceutica PA1217/001/001 Solution for Infusion - DOBUTAMINE 23/08/2007
MG/ 50 ML AMPOULE (Portugal) SA HYDROCHLORIDE
DOBUTAMIN HIKMA 250 Hikma Farmaceutica PA1217/001/002 Solution for Infusion - DOBUTAMINE 23/08/2007
MG/50 ML VIAL (Portugal) SA HYDROCHLORIDE
DOBUTAMIN HIKMA 250/20 Hikma Farmaceutica PA1217/001/003 Concentrate for Soln for Inf - DOBUTAMINE 23/08/2007
ML AMPOULE (Portugal) SA HYDROCHLORIDE

Human Medicines Withdrawn Products Page 259 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MILK OF MAGNESIA (NEW GlaxoSmithKline Consumer PA0678/031/004 Tablets - MAGNESIUM HYDROXIDE 19/08/2007
FORMULA PEPPERMINT) Healthcare (Ireland) Limited
CLARITYN RAPIDE Schering-Plough Limited PA0277/053/003 Tablets - LORATADINE 18/08/2007
NUROFEN MICRO- Crookes Healthcare Ltd PA0043/006/003 Unknown - IBUPROFEN 15/08/2007
GRANULES
SIMVASTATIN Dumex Ltd PA1078/001/001 Coated Tablets - SIMVASTATIN 15/08/2007
SIMVASTATIN Dumex Ltd PA1078/001/002 Coated Tablets - SIMVASTATIN 15/08/2007
SIMVASTATIN Dumex Ltd PA1078/001/003 Coated Tablets - SIMVASTATIN 15/08/2007
SIMVASTATIN Accord-UK Ltd PA0176/071/001 Coated Tablets - SIMVASTATIN 15/08/2007
SIMVASTATIN Accord-UK Ltd PA0176/071/002 Coated Tablets - SIMVASTATIN 15/08/2007
SIMVASTATIN Accord-UK Ltd PA0176/071/003 Coated Tablets - SIMVASTATIN 15/08/2007
BREXIDOL TABLETS Chiesi Limited PA0743/010/002 Tablets - PIROXICAM BETADEX 13/08/2007
DOBUTREX Flynn Pharma Ltd PA1226/003/001 Concentrate for Soln for Inf - DOBUTAMINE 13/08/2007
HYDROCHLORIDE
DORYX Hospira UK Limited PA0437/037/001 Capsule - DOXYCYCLINE 13/08/2007
HYDROCHLORIDE
DORYX Hospira UK Limited PA0437/037/002 Capsule - DOXYCYCLINE 13/08/2007
HYDROCHLORIDE
LACTITOL Novartis Consumer Health PA0030/017/001 Oral Powder - LACTITOL 10/08/2007
UK Limited MONOHYDRATE
LIDOCAINE HCL/GLUCOSE Baxter Healthcare Limited PA0167/005/001 Solution for Infusion - LIDOCAINE 08/08/2007
HYDROCHLORIDE
- GLUCOSE
- GLUCOSE
MONOHYDRATE
LIDOCAINE HCL/GLUCOSE Baxter Healthcare Limited PA0167/005/002 Solution for Infusion - LIDOCAINE 08/08/2007
HYDROCHLORIDE
- GLUCOSE
- GLUCOSE
MONOHYDRATE
IBUPROFEN 200 Crookes Healthcare Ltd PA0043/036/001 Tablets - IBUPROFEN 07/08/2007
MG/CODEINE PHOSPHATE - CODEINE PHOSPHATE
12.8 MG TABLETS HEMIHYDRATE

MYCORTIN Crookes Healthcare Ltd PA0043/035/001 Cream - MICONAZOLE NITRATE 07/08/2007


- FLUPREDNIDENE
ACETATE
TRIPTAFEN Mercury Pharmaceuticals Ltd PA0899/027/001 Tablets - AMITRIPTYLINE 06/08/2007
HYDROCHLORIDE
- PERPHENAZINE
DOBUTAMIN HIKMA 250 Hikma Farmaceutica PA1217/001/004 Concentrate for Soln for Inf - DOBUTAMINE 03/08/2007
MG/ 5 ML AMPOULE (Portugal) SA HYDROCHLORIDE
PREMIQUE CYCLE 10 John Wyeth & Brother PA0022/069/004 Tablets - ESTROGENS 02/08/2007
SEPARATE Limited CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE
ZOTON 15MG GASTRO- John Wyeth & Brother PA0022/089/001 Capsules Gastro-Resistant - LANSOPRAZOLE 02/08/2007
RESISTANT CAPSULES Limited
ZOTON 30MG GASTRO- Cyanamid of Great Britain PA0037/069/003 Oral Suspension - LANSOPRAZOLE 30/07/2007
RESISTANT GRANULES
FOR ORAL SUSP
CEANEL CONCENTRATE Ferndale Pharmaceuticals PA1155/004/001 Shampoo - CETRIMONIUM BROMIDE 27/07/2007
Ltd - PHENYLETHYL ALCOHOL
- UNDECYLENIC ACID

Aspirin (Acetylsalicylic acid) Chanelle Medical PA0688/002/001 Tablet - Aspirin 23/07/2007


Tablets 300 mg
SURMONTIL Sanofi-Aventis Ireland PA0540/128/004 Tablets - TRIMIPRAMINE MALEATE 23/07/2007
Limited T/A SANOFI
Tantum verde eucalyptus Aziende Chimiche Riunite PA0959/001/004 Lozenge - BENZYDAMINE 23/07/2007
taste 3 mg lozenges Angelini Francesco HYDROCHLORIDE
Tantum Verde lemon taste 3 Aziende Chimiche Riunite PA0959/001/002 Lozenge - BENZYDAMINE 23/07/2007
mg lozenges Angelini Francesco HYDROCHLORIDE
MILDISON LIPOCREAM Astellas Pharma Europe BV PA1244/006/001 Cream - HYDROCORTISONE 17/07/2007
ASPIRIN MIGRAINE Bayer PLC PA0021/051/001 Tablets - ACETYLSALICYLIC ACID 16/07/2007
METOPROLOL 100 STADA Stada Arzneimittel AG PA0593/006/002 Tablets - METOPROLOL TARTRATE 12/07/2007

METOPROLOL 200 STADA Stada Arzneimittel AG PA0593/006/003 Tablet Prolonged Release - METOPROLOL TARTRATE 12/07/2007
RETARD PROLONGED
RELEASE TABL
METOPROLOL 50 STADA Stada Arzneimittel AG PA0593/006/001 Tablets - METOPROLOL TARTRATE 12/07/2007

NIFEDIPINE 10 STADA Stada Arzneimittel AG PA0593/003/002 Capsule - NIFEDIPINE 12/07/2007


NIFEDIPINE

Human Medicines Withdrawn Products Page 260 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NIFEDIPINE 5 STADA Stada Arzneimittel AG PA0593/003/001 Capsule - NIFEDIPINE 12/07/2007
NIFEDIPINE
NIFELEASE Stada Arzneimittel AG PA0593/010/002 Tablets - NIFEDIPINE 12/07/2007
NIFELEASE MR Stada Arzneimittel AG PA0593/010/001 Tablets - NIFEDIPINE 12/07/2007
MEFENAMIC ACID BP Winthrop Pharmaceuticals PA1046/002/001 Capsule - MEFENAMIC ACID 10/07/2007
UK Limited
MEFENAMIC ACID BP Winthrop Pharmaceuticals PA1046/002/002 Tablets - MEFENAMIC ACID 10/07/2007
UK Limited
NARCAN NEONATAL Bristol-Myers Squibb PA0002/071/001 Solution for Injection - NALOXONE 09/07/2007
Pharmaceuticals uc HYDROCHLORIDE
PINADONE METHADONE Pinewood Laboratories Ltd, PA0281/061/002 Syrup - METHADONE 07/07/2007
MIXTURE
ATIVAN John Wyeth & Brother PA0022/001/001 Tablets - LORAZEPAM 06/07/2007
Limited
ATIVAN John Wyeth & Brother PA0022/001/002 Tablets - LORAZEPAM 06/07/2007
Limited
GEREF 50 Serono Limited PA0285/006/001 Pdr+Solv for Soln for Inj - SERMORELIN ACETATE 06/07/2007
RIMACTANE Sandoz GmbH PA0111/002/001 Capsule - RIFAMPICIN 04/07/2007
CLINORIL Merck Sharp and Dohme PA0035/004/001 Tablets - SULINDAC 01/07/2007
Limited
CLINORIL Merck Sharp and Dohme PA0035/004/002 Tablets - SULINDAC 01/07/2007
Limited
PANCREASE Janssen-Cilag Ltd PA0748/014/001 Capsule - PROTEASE 01/07/2007
- AMYLASE
- LIPASE
RIMATASE Ranbaxy Ireland Limited PA0408/015/001 Tablets - CHLORPROPAMIDE 01/07/2007
CHLORPROPAMIDE
HEPARIN (MUCOUS) Leo Laboratories Limited PA0046/036/001 Solution for Injection - HEPARIN SODIUM 30/06/2007
INJECTION B.P. 1000
UNITS/ML
LIVIAL 1.25 MG CAPSULES Organon (Ireland) Limited PA0061/018/002 Capsules Hard - TIBOLONE 28/06/2007

BREVIBLOC Baxter Healthcare Limited PA0167/099/002 Solution for Injection - ESMOLOL 26/06/2007
CONCENTRATE HYDROCHLORIDE
SCHOLL ANTISEPTIC Scholl Consumer Products PA0455/005/001 Cream - MENTHOL 23/06/2007
FOOT BALM Limited - HALQUINOL
- METHYL SALICYLATE
CIMETIDINE 200 Stada Arzneimittel AG PA0593/007/001 Tablets - CIMETIDINE 22/06/2007
CIMETIDINE 400 Stada Arzneimittel AG PA0593/007/002 Tablets - CIMETIDINE 22/06/2007
CIMETIDINE 800 Stada Arzneimittel AG PA0593/007/003 Tablets - CIMETIDINE 22/06/2007
OPILON Archimedes Pharma UK PA0757/005/001 Tablets - MOXISYLYTE 21/06/2007
Limited HYDROCHLORIDE
HEPARIN (MUCOUS) Leo Laboratories Limited PA0046/036/003 Solution for Injection - HEPARIN SODIUM 18/06/2007
INJECTION B.P. 25000
UNITS/ML
HEPARIN (MUCOUS) Leo Laboratories Limited PA0046/036/002 Solution for Injection - HEPARIN SODIUM 18/06/2007
INJECTION B.P. 5000
UNITS/ML
OXYBUTYNIN Generics (UK) Limited PA0405/033/001 Tablets - OXYBUTYNIN CHLORIDE 17/06/2007
OXYBUTYNIN Generics (UK) Limited PA0405/033/002 Tablets - OXYBUTYNIN CHLORIDE 17/06/2007
ZEPHROL ADULT COUGH Pinewood Laboratories Ltd, PA0281/105/001 Oral Solution - PROMETHAZINE 11/06/2007
SUPPRESSANT HYDROCHLORIDE
- PHOLCODINE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
NARCAN Bristol-Myers Squibb PA0002/071/002 Solution for Injection - NALOXONE 09/06/2007
Pharmaceuticals uc HYDROCHLORIDE
NARCAN Bristol-Myers Squibb PA0002/071/003 Solution for Injection - NALOXONE 09/06/2007
Pharmaceuticals uc HYDROCHLORIDE
HUMAN ALBUMIN 4.5% Baxter Healthcare Limited PA0167/124/002 Solution for Infusion - PLASMA PROTEIN 08/06/2007
FRACTION (HUMAN)
SLOKET Eurand S.p.A. PA1315/001/001 Modified-release capsule, - KETOPROFEN 06/06/2007
hard
ACC Rowex Ltd PA0711/007/003 Tablets Effervescent - ACETYLCYSTEINE 31/05/2007
DIFLUCAN SOLUTION FOR Pfizer Limited PA0019/044/009 Solution for Infusion - FLUCONAZOLE 31/05/2007
INFUSION 2 MG/ML
(400MG/200M
SINEQUAN Pfizer Limited PA0019/015/001 Capsule - DOXEPIN 31/05/2007
HYDROCHLORIDE
SINEQUAN Pfizer Limited PA0019/015/002 Capsule - DOXEPIN 31/05/2007
HYDROCHLORIDE
SINEQUAN Pfizer Limited PA0019/015/003 Capsule - DOXEPIN 31/05/2007
HYDROCHLORIDE
SINEQUAN Pfizer Limited PA0019/015/004 Capsule - DOXEPIN 31/05/2007
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 261 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SULEO-C LOTION SSL International PLC PA0618/010/001 Cutaneous Solution - CARBARIL 31/05/2007
ZARONTIN Pfizer Healthcare Ireland PA0822/017/001 Capsule - ETHOSUXIMIDE 31/05/2007
EFEXOR John Wyeth & Brother PA0022/065/003 Tablets - VENLAFAXINE 22/05/2007
Limited HYDROCHLORIDE
EFEXOR John Wyeth & Brother PA0022/065/001 Tablets - VENLAFAXINE 22/05/2007
Limited HYDROCHLORIDE
JOLLET COATED TABLETS John Wyeth & Brother PA0022/088/001 Tablets - GESTODENE 22/05/2007
Limited - ETHINYLESTRADIOL
JOLLET ED COATED John Wyeth & Brother PA0022/088/002 Tablets - GESTODENE 22/05/2007
TABLETS Limited - ETHINYLESTRADIOL
VITRIMIX K.V. EMULSION Fresenius Kabi Limited PA0566/018/001 Emulsion for Infusion - ALANINE 22/05/2007
FOR INFUSION - ARGININE
- ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- GLUCOSE
MONOHYDRATE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM CHLORIDE
TAMNIC Norton Waterford PA0436/042/001 Modified-release capsule, - TAMSULOSIN 21/05/2007
hard HYDROCHLORIDE
UBIT Otsuka Pharma GmbH PA0975/001/001 Granules - 13C-UREA 21/05/2007
NORITATE Sanofi-Aventis Ireland PA0540/135/001 Cream - METRONIDAZOLE 19/05/2007
Limited T/A SANOFI
PROZATAN Stada Arzneimittel AG PA0593/013/001 Capsule - FLUOXETINE 16/05/2007
HYDROCHLORIDE
ACC Rowex Ltd PA0711/007/005 Granules - ACETYLCYSTEINE 15/05/2007
ACC Rowex Ltd PA0711/007/006 Granules - ACETYLCYSTEINE 15/05/2007
LANSOPRAZOLE Rowex Ltd PA0711/089/001 Capsules Gastro-Resistant - LANSOPRAZOLE 15/05/2007
LANSOPRAZOLE Rowex Ltd PA0711/089/002 Capsules Gastro-Resistant - LANSOPRAZOLE 15/05/2007
PRAVASTATIN Rowex Ltd PA0711/108/001 Tablets - PRAVASTATIN SODIUM 15/05/2007
PRAVASTATIN Rowex Ltd PA0711/108/002 Tablets - PRAVASTATIN SODIUM 15/05/2007
PRAVASTATIN Rowex Ltd PA0711/108/003 Tablets - PRAVASTATIN SODIUM 15/05/2007
RAMIPRIL Rowex Ltd PA0711/105/001 Tablets - RAMIPRIL 15/05/2007
RAMIPRIL Rowex Ltd PA0711/105/002 Tablets - RAMIPRIL 15/05/2007
RAMIPRIL Rowex Ltd PA0711/105/003 Tablets - RAMIPRIL 15/05/2007
RAMIPRIL Rowex Ltd PA0711/105/004 Tablets - RAMIPRIL 15/05/2007
SERTRALINE Rowex Ltd PA0711/084/001 Tablets - SERTRALINE 15/05/2007
HYDROCHLORIDE
SERTRALINE Rowex Ltd PA0711/084/002 Film Coated Tablet - SERTRALINE 15/05/2007
HYDROCHLORIDE
TAMSULOSIN Rowex Ltd PA0711/087/001 Modified-release capsule, - TAMSULOSIN 15/05/2007
hard HYDROCHLORIDE
VERAP Rowex Ltd PA0711/016/003 Tablets - VERAPAMIL 15/05/2007
HYDROCHLORIDE
GLUCOSE Baxter Healthcare Limited PA0167/096/007 Solution for Infusion - GLUCOSE 14/05/2007
GLUCOSE Baxter Healthcare Limited PA0167/096/001 Solution for Infusion - GLUCOSE 14/05/2007
BUPIVACAINE Baxter Healthcare Limited PA0167/112/001 Solution for Injection - BUPIVACAINE 04/05/2007
HYDROCHLORIDE HYDROCHLORIDE,
MONOHYDRATE
BUPIVACAINE Baxter Healthcare Limited PA0167/112/002 Solution for Injection - BUPIVACAINE 04/05/2007
HYDROCHLORIDE HYDROCHLORIDE,
MONOHYDRATE
METHOTREXATE Cyanamid of Great Britain PA0037/023/011 Solution for Injection - METHOTREXATE SODIUM 04/05/2007

METHOTREXATE Cyanamid of Great Britain PA0037/023/015 Solution for Injection - METHOTREXATE SODIUM 04/05/2007

Human Medicines Withdrawn Products Page 262 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALGIPAN RUB John Wyeth & Brother PA0022/014/001 Cream - GLYCOL SALICYLATE 02/05/2007
Limited - METHYL NICOTINATE
- CAPSAICIN
BRUFEN Abbott Laboratories Ireland PA0038/080/001 Film Coated Tablet - IBUPROFEN 01/05/2007
Ltd
DIFLUCAN SOLUTION FOR Pfizer Limited PA0019/044/007 Solution for Infusion - FLUCONAZOLE 30/04/2007
INFUSION 2 MG/ML
(100MG/50ML
AMPICILLIN Generics (UK) Limited PA0405/008/002 Capsule - AMPICILLIN TRIHYDRATE 27/04/2007

NUTRACEL 400 Baxter Healthcare Limited PA0167/094/001 Solution for Infusion - GLUCOSE 24/04/2007
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- ZINC ACETATE
- MANGANESE CHLORIDE
TETRAHYDRATE
NUTRACEL 800 Baxter Healthcare Limited PA0167/094/002 Solution for Infusion - GLUCOSE 24/04/2007
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- ZINC ACETATE
- MANGANESE CHLORIDE
TETRAHYDRATE
DIARREST RF Galen Limited PA0185/036/001 Oral Solution - LOPERAMIDE 23/04/2007
HYDROCHLORIDE
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- SODIUM CITRATE
GIVITOL Galen Limited PA0185/007/001 Capsule - FERROUS FUMARATE 23/04/2007
- SODIUM ASCORBATE
- NICOTINAMIDE
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- FOLIC ACID

MANUSEPT Medlock Medical Ltd PA1175/005/001 Cutaneous Solution - TRICLOSAN 23/04/2007


- ISOPROPANOL
TINADERM PLUS Schering-Plough Limited PA0277/062/001 Cutaneous Powder - TOLNAFTATE 22/04/2007
TINADERM PLUS Schering-Plough Limited PA0277/062/002 Cutaneous Spray Powder - TOLNAFTATE 22/04/2007
ANDROCUR 50 MG HE Clissmann PA0012/005/001 Tablets - CYPROTERONE 20/04/2007
TABLETS ACETATE
MINERVA HE Clissmann PA0012/080/001 Tablets - CYPROTERONE 20/04/2007
ACETATE
- ETHINYLESTRADIOL
HAEMATE P CSL Behring GmbH PA0800/002/002 Pdr+Solv for Soln for Inj - FACTOR VIII 18/04/2007
(ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
HAEMATE P CSL Behring GmbH PA0800/002/003 Solution for Infusion - FACTOR VIII 18/04/2007
(ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
LASIX PAEDIATRIC Hoechst Marion Roussel Irl PA0855/007/001 Unknown - POTASSIUM CHLORIDE 16/04/2007
Ltd - FUROSEMIDE
RYNACROM Fisons Limited PA0018/003/001 Nasal Drops Soln - CROMOGLICATE SODIUM 16/04/2007

RYNACROM Fisons Limited PA0018/003/005 Nasal Spray Solution - CROMOGLICATE SODIUM 16/04/2007

RYTHMODAN Hoechst Marion Roussel Irl PA0855/037/001 Capsule - DISOPYRAMIDE 16/04/2007


Ltd PHOSPHATE
SECTRAL Sanofi-Aventis Ireland PA0540/125/003 Tablets - ACEBUTOLOL 16/04/2007
Limited T/A SANOFI HYDROCHLORIDE
SURGAM Sanofi-Aventis Ireland PA0540/075/003 Tablets - TIAPROFENIC ACID 16/04/2007
Limited T/A SANOFI
TILAVIST Fisons Limited PA0018/050/001 Eye Drops Solution - NEDOCROMIL SODIUM 16/04/2007
TOPISOLON Sanofi-Aventis Ireland PA0540/079/001 Ointment - DESOXIMETASONE 16/04/2007
Limited T/A SANOFI
TRENTAL Sanofi-Aventis Ireland PA0540/080/001 Concentrate for Soln for Inf - PENTOXIFYLLINE 16/04/2007
Limited T/A SANOFI

Human Medicines Withdrawn Products Page 263 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GLYCOPYRROLATE U.S.P. Mercury Pharmaceuticals PA0073/126/001A Solution for Injection - GLYCOPYRRONIUM 13/04/2007
(Ireland) Ltd BROMIDE
BATRAFEN NAIL LACQUER Sanofi-Aventis Ireland PA0540/032/004 Unknown - CICLOPIROX 12/04/2007
Limited T/A SANOFI
CIFLOXAGER McDermott Laboratories Ltd PA0577/069/003 Coated Tablets - CIPROFLOXACIN 10/04/2007
t/a Gerard Laboratories
ASCAL Meda Health Sales Ireland PA1332/012/001 Oral Powder - CARBASALATE CALCIUM 09/04/2007
Limited - CALCIUM
- UREA

FEMODENE HE Clissmann PA0012/063/001 Tablets - ETHINYLESTRADIOL 04/04/2007


- GESTODENE
PENTASTARCH Baxter Healthcare Limited PA0167/110/001 Solution for Infusion - SODIUM CHLORIDE 04/04/2007
LOCOID CRELO Astellas Pharma Europe BV PA1244/005/001 Cutaneous Emulsion - HYDROCORTISONE 03/04/2007
BUTYRATE
ASCABIOL May & Baker Limited PA0040/062/001 Cutaneous Emulsion - BENZYL BENZOATE 01/04/2007
FLUTAMID STADA Stada Arzneimittel AG PA0593/016/001 Tablets - FLUTAMIDE 01/04/2007
HEPATECT Biotest Pharma GmbH PA0592/005/001 Solution for Injection - HUMAN PLASMA 01/04/2007
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
ANTIHEPATITIS B
IBUCAPS IBUPROFEN Banner Pharmacaps Europe PA1121/001/001 Capsules, Soft - IBUPROFEN 01/04/2007
B.V.
MISTAMINE MODIFIED Galderma (UK) Ltd PA0590/014/001 Tablets - MIZOLASTINE 01/04/2007
RELEASE
OXYBUTYNIN STADA Stada Arzneimittel AG PA0593/022/001 Tablets - OXYBUTYNIN 01/04/2007
HYDROCHLORIDE
PRAGMATAR Alliance Pharmaceuticals Ltd PA0943/001/001 Cream - COAL TAR 01/04/2007
- SULFUR
- SALICYLIC ACID
SOFRAMYCIN Roussel Laboratories Limited PA0006/011/001 Eye Drops Solution - FRAMYCETIN SULFATE 01/04/2007

SOFRAMYCIN EYE Roussel Laboratories Limited PA0006/011/002 Eye Ointment - FRAMYCETIN SULFATE 01/04/2007

SULTRIN TRIPLE SULFA Janssen-Cilag Ltd PA0748/038/001 Cream - SULFATHIAZOLE 01/04/2007


- SULFACETAMIDE
- SULFABENZAMIDE
BLEPHAMIDE LIQUIFILM Allergan Pharmaceuticals PA0148/021/001 Eye Drops Suspension - PREDNISOLONE 31/03/2007
Ireland ACETATE
- SULFACETAMIDE
SODIUM
- PHENYLEPHRINE
HYDROCHLORIDE
KELFIZINE W Farmitalia Carlo Erba Ltd PA0236/005/001 Tablets - SULFALENE 31/03/2007
RIMACTAZID Sandoz GmbH PA0111/003/001 Coated Tablets - RIFAMPICIN 31/03/2007
- ISONIAZID
STELAZINE SPANSULE Mercury Pharmaceuticals Ltd PA0899/003/003 Capsule - TRIFLUOPERAZINE 31/03/2007

STELAZINE SPANSULE Mercury Pharmaceuticals Ltd PA0899/003/004 Capsule - TRIFLUOPERAZINE 31/03/2007

STELAZINE SPANSULE Mercury Pharmaceuticals Ltd PA0899/003/005 Capsule - TRIFLUOPERAZINE 31/03/2007

STEMETIL Sanofi-Aventis Ireland PA0540/127/003 Suppositories - PROCHLORPERAZINE 31/03/2007


Limited T/A SANOFI MALEATE
STEMETIL Sanofi-Aventis Ireland PA0540/127/004 Suppositories - PROCHLORPERAZINE 31/03/2007
Limited T/A SANOFI MALEATE
SITOR UCB (Pharma) Ireland PA0891/007/001 Coated Tablets - LEVOCETIRIZINE 29/03/2007
Limited DIHYDROCHLORIDE
AMPICILLIN Generics (UK) Limited PA0405/008/001 Capsule - AMPICILLIN TRIHYDRATE 27/03/2007

MENGIVAC (A+C) SINGLE Sanofi Pasteur MSD Ltd PA0544/005/001 Pdr+Solv for Soln for Inj - NEISSERIA MENINGITIDIS 27/03/2007
DOSE A
- NEISSERIA MENINGITIDIS
C
ENTACT H. Lundbeck A/S PA0805/003/001 Film Coated Tablet - ESCITALOPRAM 23/03/2007
ENTACT H. Lundbeck A/S PA0805/003/002 Film Coated Tablet - ESCITALOPRAM 23/03/2007
ENTACT H. Lundbeck A/S PA0805/003/003 Film Coated Tablet - ESCITALOPRAM 23/03/2007
ENTACT H. Lundbeck A/S PA0805/003/004 Film Coated Tablet - ESCITALOPRAM 23/03/2007
ENTACT H. Lundbeck A/S PA0805/003/005 Oral Drops Solution - ESCITALOPRAM 23/03/2007
UROFLOX Stada Arzneimittel AG PA0593/017/001 Tablets - NORFLOXACIN 23/03/2007
FENTICONAZOLE NITRATE Recordati Industria Chimica e PA0812/003/001 Cream - FENTICONAZOLE 21/03/2007
VAGINAL Farmaceutica SpA NITRATE
HEMINEVRIN 0.8% AstraZeneca UK Limited PA0970/040/001 Solution for Infusion - CLOMETHIAZOLE 21/03/2007
INFUSION EDISILATE

Human Medicines Withdrawn Products Page 264 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BENPROTAN Clonmel Healthcare Ltd PA0126/160/001 Tablet Prolonged Release - ALFUZOSIN 20/03/2007
HYDROCHLORIDE
NOCUTIL Gebro Pharma GmbH PA1262/001/003 Nasal Spray Solution - DESMOPRESSIN 07/03/2007
ACETATE
MIGRANAT Rowa Pharmaceuticals PA0074/007/001 Tablets - ERGOTAMINE TARTRATE 05/03/2007
Limited - PIPOXOLAN
HYDROCHLORIDE
- CAFFEINE

VENTOLIN ROTACAP Allen and Hanburys Limited PA0024/001/003 Inhalation powder, hard - SALBUTAMOL SULFATE 02/03/2007
capsule
VENTOLIN ROTACAP Allen and Hanburys Limited PA0024/001/004 Inhalation powder, hard - SALBUTAMOL SULFATE 02/03/2007
capsule
ACTAL PASTILS Seven Seas Ltd PA0417/015/001 Tablets - HYDROTALCITE 01/03/2007
FUCIDIN FOR IV INFUSION Leo Laboratories Limited PA0046/004/015 Pdr+Solv for soln for Inf - FUSIDATE SODIUM 01/03/2007

STREPTASE Hoechst Marion Roussel Irl PA0855/014/001 Pdr for Soln for Injection - STREPTOKINASE 01/03/2007
Ltd
STREPTASE Hoechst Marion Roussel Irl PA0855/014/002 Pdr for Soln for Injection - STREPTOKINASE 01/03/2007
Ltd
STREPTASE Hoechst Marion Roussel Irl PA0855/014/003 Pdr for Soln for Injection - STREPTOKINASE 01/03/2007
Ltd
AMBROL Rowex Ltd PA0711/027/001 Tablets - AMBROXOL 28/02/2007
HYDROCHLORIDE
BURAM Leo Laboratories Limited PA0046/059/001 Tablets - BUMETANIDE 28/02/2007
- AMILORIDE
HYDROCHLORIDE
DIFTAVAX SYRINGE Sanofi Pasteur MSD Ltd PA0544/018/002 Solution for Injection - DIPHTHERIA TOXOID 28/02/2007
- TETANUS TOXOID
KLACID ADULT Abbott Laboratories Ireland PA0038/051/006 Granules for Oral - CLARITHROMYCIN 28/02/2007
Ltd Suspension
TAZAMEL 30MG FILM- Clonmel Healthcare Ltd PA0126/129/002 Tablets - MIRTAZAPINE 28/02/2007
COATED TABLETS
NAPROSYN Roche Products Limited PA0050/128/004 Tablets - NAPROXEN 27/02/2007
NAPROSYN 500MG Roche Products Limited PA0050/128/005 Tablets - NAPROXEN 27/02/2007
TABLETS
NAPROSYN EC Roche Products Limited PA0050/128/007 Tablets - NAPROXEN 27/02/2007
SYNFLEX TABLETS 275 M Roche Products Limited PA0050/129/001 Coated Tablets - NAPROXEN SODIUM 27/02/2007

PANCURONIUM Mercury Pharmaceuticals PA0073/130/001 Solution for Injection - PANCURONIUM BROMIDE 25/02/2007
(Ireland) Ltd
BENDROFLUAZIDE Ranbaxy Ireland Limited PA0408/030/001 Tablets - BENDROFLUMETHIAZIDE 24/02/2007

PIPORTIL DEPOT May & Baker Limited PA0040/063/001 Solution for Injection - PIPOTIAZINE PALMITATE 24/02/2007

PIPORTIL DEPOT May & Baker Limited PA0040/063/002 Solution for Injection - PIPOTIAZINE PALMITATE 24/02/2007

GAMMABULIN Baxter Healthcare Limited PA0167/116/002 Solution for Injection - HUMAN PLASMA 22/02/2007
PROTEIN >90% GAMMA
GLOBULIN
GAMMABULIN S/D 10ML Baxter Healthcare Limited PA0167/116/003 Solution for Injection - HUMAN PLASMA 22/02/2007
HUMAN NORMAL PROTEIN >90% GAMMA
IMMUNOGLOBULIN GLOBULIN
MOBIC Boehringer Ingelheim PA0775/001/008 Oral Suspension - MELOXICAM 22/02/2007
International GmbH
MOBIC Boehringer Ingelheim PA0775/001/001 Capsule - MELOXICAM 22/02/2007
International GmbH
MOBIC Boehringer Ingelheim PA0775/001/002 Capsule - MELOXICAM 22/02/2007
International GmbH
NAPROXEN Winthrop Pharmaceuticals PA1046/010/001 Tablets - NAPROXEN 22/02/2007
UK Limited
NAPROXEN Winthrop Pharmaceuticals PA1046/010/002 Tablets - NAPROXEN 22/02/2007
UK Limited
SALBUTAMOL CFC - FREE Norton Waterford PA0436/037/001 Pressurised Inhalation - SALBUTAMOL SULFATE 19/02/2007
INHALER Suspension
RESPRIN Ricesteele Manufacturing Ltd PA0095/006/001 Suppositories - ACETYLSALICYLIC ACID 16/02/2007
- ADEPS SOLIDUS
RESPRIN Ricesteele Manufacturing Ltd PA0095/006/002 Suppositories - ACETYLSALICYLIC ACID 16/02/2007

DICLOFENAC 25 Stada Arzneimittel AG PA0593/008/004 Tablets - DICLOFENAC SODIUM 15/02/2007


DICLOFENAC 50 Stada Arzneimittel AG PA0593/008/005 Tablets - DICLOFENAC SODIUM 15/02/2007
PAMIDRONATE DISODIUM Neomed Technology Ltd PA1064/001/001 Concentrate for Soln for Inf - PAMIDRONATE 15/02/2007
DISODIUM
PAMIDRONATE DISODIUM Neomed Technology Ltd PA1064/001/002 Concentrate for Soln for Inf - PAMIDRONATE 15/02/2007
DISODIUM

Human Medicines Withdrawn Products Page 265 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PREPARATION H Pfizer Consumer Healthcare PA0172/011/002 Suppositories - LIVE YEAST CELL 15/02/2007
Ltd DERIVATIVE
- SHARK-LIVER OIL
UNIMAX AstraZeneca UK Limited PA0970/052/001 Tablets - FELODIPINE 14/02/2007
- RAMIPRIL
UNIMAX AstraZeneca UK Limited PA0970/052/002 Tablets - FELODIPINE 14/02/2007
- RAMIPRIL
TOTELLE CYCLE John Wyeth & Brother PA0022/079/001 Tablets - ESTRADIOL 09/02/2007
Limited HEMIHYDRATE
- TRIMEGESTONE
- ESTRADIOL
HEMIHYDRATE
FORANS COUGH MIXTURE Foran Healthcare Limited PA0484/005/001 Syrup - LIQUORICE LIQUID 08/02/2007
EXTRACT
- IPECACUANHA FLUID
EXTRACT
- MARRUBIUM VULGARE
CALAMINE Rowa Pharmaceuticals PA0074/047/001 Cutaneous Suspension - CALAMINE 07/02/2007
Limited - ZINC OXIDE
KOLANTICON GEL Peckforton Pharmaceuticals PA0946/001/001 Oral Suspension - DICYCLOMINE 07/02/2007
Ltd HYDROCHLORIDE
- ALUMINIUM HYDROXIDE
GEL
- MAGNESIUM OXIDUM
LEVE
- DIMETICONE, ACTIVATED

COSALGESIC Accord-UK Ltd PA0176/034/001 Tablets - 06/02/2007


DEXTROPROPOXYPHENE
HYDROCHLORIDE
- PARACETAMOL
GLUCOSE 4.3% AND Bieffe Medital SpA PA0751/002/001 Solution for Infusion - SODIUM CHLORIDE 06/02/2007
SODIUM CHLORIDE 0.18% - GLUCOSE
MONOHYDRATE
GLUCOSE 4.3% AND Bieffe Medital SpA PA0751/002/002 Solution for Infusion - SODIUM CHLORIDE 06/02/2007
SODIUM CHLORIDE 0.18% - GLUCOSE
MONOHYDRATE
GLUCOSE 5% Bieffe Medital SpA PA0751/003/001 Solution for Infusion - GLUCOSE 06/02/2007
MONOHYDRATE
RINGER LACTATE Bieffe Medital SpA PA0751/004/001 Solution for Infusion - SODIUM CHLORIDE 06/02/2007
(HARTMANNS SOLUTION) - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- LACTIC ACID
- SODIUM HYDROXIDE
RINGER LACTATE Bieffe Medital SpA PA0751/004/002 Solution for Infusion - SODIUM CHLORIDE 06/02/2007
(HARTMANNS SOLUTION) - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- LACTIC ACID
- SODIUM HYDROXIDE
SIMVASTATIN PHARMA Takeda Danmark A/S PA0838/005/001 Coated Tablets - SIMVASTATIN 02/02/2007
SIMVASTATIN PHARMA Takeda Danmark A/S PA0838/005/002 Coated Tablets - SIMVASTATIN 02/02/2007
SIMVASTATIN PHARMA Takeda Danmark A/S PA0838/005/003 Coated Tablets - SIMVASTATIN 02/02/2007
Children’s Lemsip Cold & Flu Reckitt Benckiser Ireland Ltd PA0979/021/002 Powder for Oral Solution - PARACETAMOL 01/02/2007
Blackcurrant
INFUKOLL N Serumwerk Bernburg AG PA1136/001/002 Solution for Infusion - POLY(O-2- 01/02/2007
HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

NORDETTE COATED John Wyeth & Brother PA0022/066/001 Tablets - LEVONORGESTREL 01/02/2007
TABLETS Limited - ETHINYLESTRADIOL
RIMASAL SALBUTAMOL Ranbaxy Ireland Limited PA0408/018/001 Tablets - SALBUTAMOL SULFATE 01/02/2007
RIMASAL SALBUTAMOL Ranbaxy Ireland Limited PA0408/018/002 Tablets - SALBUTAMOL SULFATE 01/02/2007
OTEX Diomed Developments PA0727/002/001 Ear Drops Solution - UREA HYDROGEN 27/01/2007
PEROXIDE
MIOSTAT Alcon Laboratories (UK) Ltd PA0290/076/001 Solution for Injection - CARBACHOL 26/01/2007
GLUCOSE Baxter Healthcare Limited PA0167/009/026 Solution for Infusion - GLUCOSE 25/01/2007
GLUCOSE 0.3% Baxter Healthcare Limited PA0167/009/027 Solution for Infusion - GLUCOSE 25/01/2007
MOLIPAXIN Sanofi-Aventis Ireland PA0540/056/003 Oral Solution - TRAZODONE 19/01/2007
Limited T/A SANOFI HYDROCHLORIDE
LARGACTIL May & Baker Limited PA0040/018/009 Solution for Injection - CHLORPROMAZINE 10/01/2007
HYDROCHLORIDE
LARGACTIL Sanofi-Aventis Ireland PA0540/108/003 Tablets - CHLORPROMAZINE 10/01/2007
Limited T/A SANOFI HYDROCHLORIDE

Human Medicines Withdrawn Products Page 266 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LARGACTIL Sanofi-Aventis Ireland PA0540/108/004 Tablets - CHLORPROMAZINE 10/01/2007
Limited T/A SANOFI HYDROCHLORIDE
LARGACTIL Sanofi-Aventis Ireland PA0540/108/005 Tablets - CHLORPROMAZINE 10/01/2007
Limited T/A SANOFI HYDROCHLORIDE
RAMITACE Clonmel Healthcare Ltd PA0126/156/001 Capsules Hard - RAMIPRIL 08/01/2007
RAMITACE Clonmel Healthcare Ltd PA0126/156/002 Capsules Hard - RAMIPRIL 08/01/2007
RAMITACE Clonmel Healthcare Ltd PA0126/156/003 Capsules Hard - RAMIPRIL 08/01/2007
RAMITACE Clonmel Healthcare Ltd PA0126/156/004 Capsules Hard - RAMIPRIL 08/01/2007
MEGACE Bristol-Myers Squibb PA0048/027/001 Tablets - MEGESTROL ACETATE 04/01/2007
(Holdings) Limited
MINIMS NEOMYCIN Chauvin Pharmaceuticals PA0118/003/001 Eye Drops Solution - NEOMYCIN SULFATE 03/01/2007
SULPHATE Limited
NOCTAMID HE Clissmann PA0012/051/001 Tablets - LORMETAZEPAM 02/01/2007
SIMVASTATIN REAL Dolorgiet GmbH & Co. KG PA0848/002/001 Coated Tablets - SIMVASTATIN 02/01/2007
SIMVASTATIN REAL Dolorgiet GmbH & Co. KG PA0848/002/002 Coated Tablets - SIMVASTATIN 02/01/2007
SIMVASTATIN REAL Dolorgiet GmbH & Co. KG PA0848/002/003 Coated Tablets - SIMVASTATIN 02/01/2007
SIMVASTATIN REAL Dolorgiet GmbH & Co. KG PA0848/002/004 Coated Tablets - SIMVASTATIN 02/01/2007
DERMIDEX Thornton & Ross Limited PA0610/002/001 Cream - LIDOCAINE 01/01/2007
- CETRIMONIUM BROMIDE
- ALCLOXA
- CHLOROBUTANOL

GALPSEUD Thornton & Ross Limited PA0610/014/001 Tablets - PSEUDOEPHEDRINE 01/01/2007


HYDROCHLORIDE
CAPOTEN PCO Manufacturing PPA0465/002/003B Tablets 31/12/2006
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/001 Pdr for Soln for Injection - COLISTIN MESILATE 31/12/2006
SODIUM
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/005 Pdr for Soln for Injection - COLISTIN MESILATE 31/12/2006
SODIUM
LAMICTAL PCO Manufacturing PPA0465/092/004A Tablets - LAMOTRIGINE 31/12/2006
MINOCIN SA PCO Manufacturing PPA0465/162/001 Capsules Hard - MINOCYCLINE 31/12/2006
RESCULA Novartis Pharmaceuticals UK PA0013/112/001 Eye Drops Solution - UNOPROSTONE 31/12/2006
Ltd ISOPROPYL
SODIUM PHOSPHATE [32P GE Healthcare Limited PA0240/030/001 Solution for Injection - SODIUM PHOSPHATE (32 31/12/2006
P)
XENON GAS FOR GE Healthcare Limited PA0240/009/001 Inhalation vapour, liquid - XENON (133 XE) 31/12/2006
INHALATION
YTTRIUM [90Y] SILICATE GE Healthcare Limited PA0240/011/001 Suspension for Injection - YTTRIUM (90 Y) SILICATE 31/12/2006

ZOTON PCO Manufacturing PPA0465/058/001A Capsule - LANSOPRAZOLE 31/12/2006


TAGAMET GlaxoSmithKline (Ireland) PA1077/091/004 Tablets - CIMETIDINE 22/12/2006
Limited
TAGAMET GlaxoSmithKline (Ireland) PA1077/091/005 Tablets - CIMETIDINE 22/12/2006
Limited
INSULATARD FLEXPEN Novo Nordisk A/S PA0218/026/007 Solution for Injection - INSULIN HUMAN 21/12/2006
INSULATARD INNOLET Novo Nordisk A/S PA0218/026/006 Solution for Injection - INSULIN HUMAN 21/12/2006
MIXTARD 30 INNOLET Novo Nordisk A/S PA0218/029/006 Solution for Injection - INSULIN HUMAN 21/12/2006
TRISEQUENS Novo Nordisk A/S PA0218/008/002 Tablets - ESTRADIOL 21/12/2006
HEMIHYDRATE
- NORETHISTERONE
ACETATE
- ESTRADIOL
HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
BECOTIDE EVOHALER GlaxoSmithKline (Ireland) PA1077/042/008 Pressurised Inhalation Soln - BECLOMETASONE 20/12/2006
Limited DIPROPIONATE
CO-AMOXICLAV GlaxoSmithKline (Ireland) PA1077/021/004 Tablets - AMOXICILLIN 20/12/2006
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
CO-AMOXICLAV DUO 400 GlaxoSmithKline (Ireland) PA1077/022/002 Powder for Oral Suspension - AMOXICILLIN 20/12/2006
MG / 57 MG PER 5 ML Limited TRIHYDRATE
POWDER FO - CLAVULANATE
POTASSIUM
CO-AMOXICLAV DUO 500 GlaxoSmithKline (Ireland) PA1077/022/003 Film Coated Tablet - AMOXICILLIN 20/12/2006
MG / 125 MG FILM-COATED Limited TRIHYDRATE
TABLE - CLAVULANATE
POTASSIUM
CO-AMOXICLAV JUNIOR GlaxoSmithKline (Ireland) PA1077/021/002 Powder for Oral Suspension - AMOXICILLIN 20/12/2006
SUSPENSION Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM

Human Medicines Withdrawn Products Page 267 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CO-AMOXICLAV GlaxoSmithKline (Ireland) PA1077/021/001 Powder for Oral Suspension - AMOXICILLIN 20/12/2006
PAEDIATRIC Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
ENGERIX B VACCINE GlaxoSmithKline (Ireland) PA1077/023/003 Suspension for Injection - HEPATITIS B SURFACE 20/12/2006
Limited ANTIGEN (HBS AG)
FLIXONASE NASULE GlaxoSmithKline (Ireland) PA1077/043/002 Nasal drops, suspension - FLUTICASONE 20/12/2006
Limited PROPIONATE
FRAXIPARINE GlaxoSmithKline (Ireland) PA1077/112/001 Solution for injection - Nadroparin calcium 20/12/2006
Limited
Fraxiparine GlaxoSmithKline (Ireland) PA1077/112/002 Solution for injection - Nadroparin calcium 20/12/2006
Limited
Fraxiparine GlaxoSmithKline (Ireland) PA1077/112/003 Solution for injection - Nadroparin calcium 20/12/2006
Limited
Fraxiparine GlaxoSmithKline (Ireland) PA1077/112/004 Solution for injection - Nadroparin calcium 20/12/2006
Limited
Fraxiparine GlaxoSmithKline (Ireland) PA1077/112/005 Solution for injection - Nadroparin calcium 20/12/2006
Limited
Fraxiparine GlaxoSmithKline (Ireland) PA1077/112/006 Solution for injection - Nadroparin calcium 20/12/2006
Limited
HAVRIX MONODOSE GlaxoSmithKline (Ireland) PA1077/026/003 Suspension for Injection - HEPATIT A VIRUS 20/12/2006
VACCINE Limited ANTIGEN
- ALUMINIUM HYDROXIDE
IMIGRAN GlaxoSmithKline (Ireland) PA1077/008/005 Suppositories 20/12/2006
Limited
Infanrix IPV & Hib GlaxoSmithKline (Ireland) PA1077/029/001 Powder for suspension for - Pertussis vaccine 20/12/2006
Limited injection - Polio virus type 2
inactivated
- Diphtheria toxoid
- Polio virus type 1
inactivated
- Haemophilus influenzae
type b capsular
polysaccharide (prp) and
tetanus toxoid
- Tetanus toxoid
- Polio virus type 3
inactivated
- Filamentous haemagglutinin
(fha)
- Pertactin
PAROXETINE GlaxoSmithKline (Ireland) PA1077/034/001 Oral Suspension - PAROXETINE 20/12/2006
Limited HYDROCHLORIDE
PRIORIX GlaxoSmithKline (Ireland) PA1077/036/002 Pdr+Solv for Soln for Inj - MEASLES VIRUS - 20/12/2006
Limited SCHWARZ STRAIN LIVE
ATTENUATED
ROPINIROLE PAUCOURT GlaxoSmithKline (Ireland) PA1077/102/001 Tablets - ROPINIROLE 20/12/2006
Limited HYDROCHLORIDE
ROPINIROLE PAUCOURT GlaxoSmithKline (Ireland) PA1077/102/002 Tablets - ROPINIROLE 20/12/2006
Limited HYDROCHLORIDE
ROPINIROLE PAUCOURT GlaxoSmithKline (Ireland) PA1077/102/003 Tablets - ROPINIROLE 20/12/2006
Limited HYDROCHLORIDE
ROPINIROLE PAUCOURT GlaxoSmithKline (Ireland) PA1077/102/004 Tablets - ROPINIROLE 20/12/2006
Limited HYDROCHLORIDE
ROPINIROLE PAUCOURT GlaxoSmithKline (Ireland) PA1077/102/005 Tablets - ROPINIROLE 20/12/2006
Limited HYDROCHLORIDE
ROPINIROLE SAINT- GlaxoSmithKline (Ireland) PA1077/103/001 Coated Tablets - ROPINIROLE 20/12/2006
GERMAIN Limited HYDROCHLORIDE
ROPINIROLE SAINT- GlaxoSmithKline (Ireland) PA1077/103/002 Coated Tablets - ROPINIROLE 20/12/2006
GERMAIN Limited HYDROCHLORIDE
ROPINIROLE SAINT- GlaxoSmithKline (Ireland) PA1077/103/003 Coated Tablets - ROPINIROLE 20/12/2006
GERMAIN Limited HYDROCHLORIDE
ROPINIROLE SAINT- GlaxoSmithKline (Ireland) PA1077/103/004 Coated Tablets - ROPINIROLE 20/12/2006
GERMAIN Limited HYDROCHLORIDE
ROPINIROLE SAINT- GlaxoSmithKline (Ireland) PA1077/103/005 Coated Tablets - ROPINIROLE 20/12/2006
GERMAIN Limited HYDROCHLORIDE
SALMETEROL GlaxoSmithKline (Ireland) PA1077/113/001 Pressurised Inhalation - SALMETEROL 20/12/2006
Limited Suspension XINAFOATE
STERILE SALINE GlaxoSmithKline (Ireland) PA1077/031/001 Solution for injection - SODIUM CHLORIDE 20/12/2006
SOLUTION (0.9%) 1ML Limited
AMPOULE
STERILE SALINE GlaxoSmithKline (Ireland) PA1077/031/003 Solution for injection - SODIUM CHLORIDE 20/12/2006
SOLUTION (0.9%) 1ML Limited COMPOUND INJECTION
SYRINGE

Human Medicines Withdrawn Products Page 268 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STERILE SALINE GlaxoSmithKline (Ireland) PA1077/031/002 Solution for injection - SODIUM CHLORIDE 20/12/2006
SOLUTION (0.9%) 3ML VIAL Limited COMPOUND INJECTION

TIMENTIN 1.6 GlaxoSmithKline (Ireland) PA1077/098/001 Powder for solution for - TICARCILLIN DISODIUM 20/12/2006
Limited infusion - CLAVULANATE
POTASSIUM
TIMENTIN 3.2 GlaxoSmithKline (Ireland) PA1077/098/002 Powder for solution for - TICARCILLIN DISODIUM 20/12/2006
Limited infusion - CLAVULANATE
POTASSIUM
WATER FOR INJECTION GlaxoSmithKline (Ireland) PA1077/039/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 20/12/2006
Limited
WATER FOR INJECTION GlaxoSmithKline (Ireland) PA1077/039/002 Solvent for Parenteral Use - WATER FOR INJECTIONS 20/12/2006
Limited
WATER FOR INJECTION GlaxoSmithKline (Ireland) PA1077/039/003 Solvent for Parenteral Use - WATER FOR INJECTIONS 20/12/2006
Limited
ZANDINE GlaxoSmithKline (Ireland) PA1077/012/001 Coated Tablets - RANITIDINE 20/12/2006
Limited HYDROCHLORIDE
ZANDINE GlaxoSmithKline (Ireland) PA1077/012/002 Coated Tablets - RANITIDINE 20/12/2006
Limited HYDROCHLORIDE
ZANTAC GlaxoSmithKline (Ireland) PA1077/013/006 Tablets Effervescent - RANITIDINE 20/12/2006
Limited HYDROCHLORIDE
ZOVIRAX I.V. GlaxoSmithKline (Ireland) PA1077/084/004 Pdr for Soln for Injection - ACICLOVIR SODIUM 20/12/2006
Limited
ATENOLOL Norton Healthcare Limited PA0282/047/001 Tablets - ATENOLOL 15/12/2006
T/A IVAX Pharmaceuticals
UK
ATENOLOL Norton Healthcare Limited PA0282/047/002 Tablets - ATENOLOL 15/12/2006
T/A IVAX Pharmaceuticals
UK
GLIBENCLAMIDE Norton Healthcare Limited PA0282/038/001 Tablets - GLIBENCLAMIDE 15/12/2006
T/A IVAX Pharmaceuticals
UK
GLIBENCLAMIDE Norton Healthcare Limited PA0282/038/002 Tablets - GLIBENCLAMIDE 15/12/2006
T/A IVAX Pharmaceuticals
UK
Lignocaine Hydrochloride BP Mercury Pharmaceuticals PA0073/112/012 Solution for injection - Lignocaine hydrochloride 15/12/2006
(Ireland) Ltd
RANITIDINE BP Norton Healthcare Limited PA0282/071/001 Tablets - RANITIDINE 15/12/2006
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
RANITIDINE BP Norton Healthcare Limited PA0282/071/002 Tablets - RANITIDINE 15/12/2006
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
IBUPROFEN FROM THE Reckitt Benckiser Ireland Ltd PA0979/023/001 Tablets - IBUPROFEN 14/12/2006
MAKERS OF DISPRIN
TECHNESCAN HSA Mallinckrodt Medical B.V. PA0690/014/001 Pdr for Soln for Injection - ALBUMIN NORMAL 13/12/2006
HUMAN SERUM
TULPIN Clonmel Healthcare Ltd PA0126/157/001 Tablets - ONDANSETRON 12/12/2006
TULPIN Clonmel Healthcare Ltd PA0126/157/002 Tablets - ONDANSETRON 12/12/2006
TULPIN Clonmel Healthcare Ltd PA0126/157/003 Solution for Injection - ONDANSETRON 12/12/2006
ZOVIRAX GlaxoSmithKline (Ireland) PA1077/084/008 Coated Tablets - ACICLOVIR 12/12/2006
Limited
ISOSORBIDE DINITRATE Mercury Pharmaceuticals PA0073/123/001 Concentrate for Soln for Inf - ISOSORBIDE DINITRATE 11/12/2006
(Ireland) Ltd
HETASTARCH IN 0.9% W/V Baxter Healthcare Limited PA0167/089/001 Solution for Infusion - HETASTARCH 08/12/2006
SODIUM CHLORIDE - SODIUM CHLORIDE
INTRAVENOUS
TRANXENE Boehringer Ingelheim Limited PA0007/004/003 Capsule - CLORAZEPATE 28/11/2006
DIPOTASSIUM
CIDOMYCIN ADULT Sanofi-Aventis Ireland PA0540/036/001 Solution for Injection - GENTAMICIN SULFATE 27/11/2006
Limited T/A SANOFI
CIDOMYCIN ADULT Sanofi-Aventis Ireland PA0540/036/002 Solution for Injection - GENTAMICIN SULFATE 27/11/2006
Limited T/A SANOFI
DICLOMEL SR Clonmel Healthcare Ltd PA0126/082/003 Tablets - DICLOFENAC SODIUM 27/11/2006
FLAGYL May & Baker Limited PA0040/003/005 Suppositories - METRONIDAZOLE 27/11/2006
GLICLAZIDE Clonmel Healthcare Ltd PA0126/111/001 Tablets - GLICLAZIDE 27/11/2006
Cromogen Easi-Breathe Norton Waterford PA0436/022/003 Pressurised inhalation, - Sodium cromoglycate 24/11/2006
Inhaler suspension
Cromogen Inhaler Norton Waterford PA0436/022/002 Pressurised inhalation, - Sodium cromoglycate 24/11/2006
suspension
BRADOSOL PLUS Novartis Consumer Health PA0030/037/001 Lozenges - DOMIPHEN BROMIDE 22/11/2006
UK Limited - LIDOCAINE
HYDROCHLORIDE
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/001 Tablets - CALCIUM FOLINATE 22/11/2006

Human Medicines Withdrawn Products Page 269 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MU-CRON Novartis Consumer Health PA0030/024/001 Tablets - 22/11/2006
UK Limited PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PARACETAMOL
HAEMATE P CSL Behring GmbH PA0800/002/001 Pdr+Solv for Soln for Inj - FACTOR VIII 21/11/2006
(ANTIHAEMOPHILIC
FACTOR)
- VON WILLEBRAND
FACTOR
ZOCOR Merck Sharp and Dohme PA0035/073/001 Tablets - SIMVASTATIN 20/11/2006
Limited
PREMARIN PCO Manufacturing PPA0465/069/001A Tablets - ESTROGENS 15/11/2006
CONJUGATED
PREMARIN PCO Manufacturing PPA0465/069/002A Tablets - ESTROGENS 15/11/2006
CONJUGATED
PREMARIN PCO Manufacturing PPA0465/069/002B Tablets - ESTROGENS 15/11/2006
CONJUGATED
PREMARIN PCO Manufacturing PPA0465/069/002C Tablets - ESTROGENS 15/11/2006
CONJUGATED
DULAX (LACTULOSE Mercury Pharmaceuticals PA0073/132/001 Syrup - LACTULOSE 13/11/2006
SOLUTION B.P.) (Ireland) Ltd
PENBRITIN GlaxoSmithKline (Ireland) PA1077/096/004 Solution for Inj/Inf - AMPICILLIN SODIUM 10/11/2006
Limited
FROBEN Abbott Laboratories Ireland PA0038/083/004 Tablets - FLURBIPROFEN 09/11/2006
Ltd
FROBEN Abbott Laboratories Ireland PA0038/083/005 Tablets 09/11/2006
Ltd
FROBEN Abbott Laboratories Ireland PA0038/083/006 Tablets 09/11/2006
Ltd
FROBEN SR Abbott Laboratories Ireland PA0038/083/001 Capsule - FLURBIPROFEN 09/11/2006
Ltd
DOPAGEN Mercury Pharmaceuticals PA0073/051/001 Tablets - METHYLDOPA 04/11/2006
(Ireland) Ltd
DOPAGEN Mercury Pharmaceuticals PA0073/051/002 Tablets - METHYLDOPA 04/11/2006
(Ireland) Ltd
SIMVASTAD Stada Arzneimittel AG PA0593/036/001 Tablets - SIMVASTATIN 03/11/2006
SIMVASTAD Stada Arzneimittel AG PA0593/036/002 Tablets - SIMVASTATIN 03/11/2006
SIMVASTAD Stada Arzneimittel AG PA0593/036/003 Tablets - SIMVASTATIN 03/11/2006
SIMVASTAD Stada Arzneimittel AG PA0593/036/004 Tablets - SIMVASTATIN 03/11/2006
REDOXON DOUBLE Bayer PLC PA0021/073/002 Tablets Chewable - ASCORBIC ACID 02/11/2006
ACTION - ZINC CITRATE
TRIHYDRATE
AKNEMYCIN Crookes Healthcare Ltd PA0043/033/001 Ointment - ERYTHROMYCIN 01/11/2006
MYCOSTATIN Bristol-Myers Squibb PA0002/007/001 Ointment - NYSTATIN 01/11/2006
Pharmaceuticals uc
BOCATRIOL Leo Laboratories Limited PA0046/062/001 Capsule - CALCITRIOL 31/10/2006
BOCATRIOL Leo Laboratories Limited PA0046/062/002 Capsule - CALCITRIOL 31/10/2006
FLUCAZOL Norton Healthcare Limited PA0282/087/001 Capsule - FLUCONAZOLE 31/10/2006
T/A IVAX Pharmaceuticals
UK
FLUCAZOL Norton Healthcare Limited PA0282/087/002 Capsule - FLUCONAZOLE 31/10/2006
T/A IVAX Pharmaceuticals
UK
FLUCAZOL Norton Healthcare Limited PA0282/087/003 Capsule - FLUCONAZOLE 31/10/2006
T/A IVAX Pharmaceuticals
UK
HAY-RITE 10MG TABLETS Norton Healthcare Limited PA0282/086/001 Tablets - LORATADINE 31/10/2006
T/A IVAX Pharmaceuticals
UK
HEPARIN SODIUM Leo Laboratories Limited PA0046/063/001 Solution for Injection - HEPARIN SODIUM 31/10/2006
HEPARIN SODIUM Leo Laboratories Limited PA0046/063/002 Solution for Injection - HEPARIN SODIUM 31/10/2006
PRAVAGETTES Bristol-Myers Squibb PA0002/078/001 Tablets - PRAVASTATIN SODIUM 31/10/2006
Pharmaceuticals uc - ACETYLSALICYLIC ACID
RECOFOL Bayer Schering Pharma Oy PA0771/004/003 Emulsion for Infusion - PROPOFOL 31/10/2006
SURE-LAX SENNA Peter Black Healthcare Ltd PA0522/005/001 Tablets - SENNOSIDE B 31/10/2006
VIDEX Bristol-Myers Squibb PA0002/057/011 Tablets - DIDANOSINE 31/10/2006
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/012 Tablets - DIDANOSINE 31/10/2006
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/013 Tablets - DIDANOSINE 31/10/2006
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/014 Tablets - DIDANOSINE 31/10/2006
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/015 Tablets - DIDANOSINE 31/10/2006
Pharmaceuticals uc

Human Medicines Withdrawn Products Page 270 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SETLERS WIND-EZE GlaxoSmithKline Consumer PA0678/085/001 Tablets - DIMETICONE, ACTIVATED 29/10/2006
Healthcare (Ireland) Limited
ELECTROLADE Thornton & Ross Limited PA0610/015/003 Powder for Oral Solution - SODIUM CHLORIDE 27/10/2006
BLACKCURRANT - POTASSIUM CHLORIDE
- SODIUM BICARBONATE
ELECTROLADE MELON Thornton & Ross Limited PA0610/015/002 Powder for Oral Solution - SODIUM CHLORIDE 27/10/2006
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
ELECTROLADE ORANGE Thornton & Ross Limited PA0610/015/004 Powder for Oral Solution - SODIUM CHLORIDE 27/10/2006
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
FLUOXETINE Ratiopharm GmbH PA0819/001/001 Capsule - FLUOXETINE 26/10/2006
ACTIPROFEN GlaxoSmithKline Consumer PA0678/042/001 Capsule - IBUPROFEN 25/10/2006
Healthcare (Ireland) Limited
BALNEUM Crookes Healthcare Ltd PA0043/028/001 Bath Additive - SOYA OIL 24/10/2006
BALNEUM PLUS Crookes Healthcare Ltd PA0043/030/001 Bath Additive - SOYA OIL 24/10/2006
- MACROGOL FATTY
ACIDS ETHERS
BRICANYL AstraZeneca UK Limited PA0970/036/006 Syrup - TERBUTALINE SULFATE 24/10/2006
BRICANYL EXPECTORANT AstraZeneca UK Limited PA0970/035/001 Syrup - TERBUTALINE SULFATE 24/10/2006
- GUAIFENESIN
BRICANYL INHALER AstraZeneca UK Limited PA0970/036/001 Pressurised Inhalation - TERBUTALINE SULFATE 24/10/2006
Suspension
BRICANYL SA AstraZeneca UK Limited PA0970/037/001 Tablets - TERBUTALINE SULFATE 24/10/2006
UNGUENTUM M Crookes Healthcare Ltd PA0043/032/001 Cream - PARAFFIN, LIQUID 24/10/2006
ELECTROLADE BANANA Thornton & Ross Limited PA0610/015/001 Powder for Oral Solution - SODIUM CHLORIDE 22/10/2006
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- GLUCOSE
TYLEX SCHWARZ PHARMA Limite PA0271/010/002 Tablets - CODEINE PHOSPHATE 21/10/2006
- PARACETAMOL
NIOPAM 200 Bracco UK Limited PA1022/009/001 Solution for Injection - IOPAMIDOL 19/10/2006
NIOPAM 300 Bracco UK Limited PA1022/010/001 Solution for Injection - IOPAMIDOL 19/10/2006
NIOPAM 370 Bracco UK Limited PA1022/012/001 Solution for Injection - IOPAMIDOL 19/10/2006
PROFASI Serono Limited PA0285/002/005 Pdr+Solv for Soln for Inj - CHORIONIC 15/10/2006
GONADOTROPHIN
BETADINE Medlock Medical Ltd PA1175/002/013 Cream - POVIDONE-IODINE 11/10/2006
STERILE POTASSIUM Mercury Pharmaceuticals PA0073/106/002 Concentrate for Soln for Inf - POTASSIUM CHLORIDE 10/10/2006
CHLORIDE (Ireland) Ltd
BETADINE ANTISEPTIC Medlock Medical Ltd PA1175/002/016 Impregnated Dressing - POVIDONE-IODINE 06/10/2006
SWAB
BETADINE MISTETTE Medlock Medical Ltd PA1175/002/018 Cutaneous Spray Solution - POVIDONE-IODINE 06/10/2006
BETADINE SWABSTICKS Medlock Medical Ltd PA1175/002/017 Cutaneous Stick - POVIDONE-IODINE 06/10/2006
BETADINE VAGINAL Medlock Medical Ltd PA1175/002/009 Vaginal Gel - POVIDONE-IODINE 06/10/2006
EPADERM Medlock Medical Ltd PA1175/004/001 Ointment - EMULSIFYING WAX 06/10/2006
- PETROLATUM
STER-ZAC Medlock Medical Ltd PA1175/013/001 Cutaneous Powder - HEXACHLOROPHENE 06/10/2006
ELUDRIL Pierre Fabre Medicament PA0329/001/002 Oromucosal Spray, Soln - CHLORHEXIDINE 04/10/2006
GLUCONATE
- TETRACAINE
HYDROCHLORIDE
IDARAC Sanofi-Aventis Ireland PA0540/049/001 Tablets - FLOCTAFENINE 04/10/2006
Limited T/A SANOFI
CHLORHEXIDINE ACETAT Baxter Healthcare Limited PA0167/010/015 Cutaneous Solution - CHLORHEXIDINE 29/09/2006
DIACETATE
CHLORHEXIDINE ACETAT Baxter Healthcare Limited PA0167/010/016 Cutaneous Solution - CHLORHEXIDINE 29/09/2006
DIACETATE
MERBENTYL Sanofi-Aventis Ireland PA0540/019/003 Tablets - DICYCLOMINE 25/09/2006
Limited T/A SANOFI HYDROCHLORIDE
SKELID Sanofi-Synthelabo Ireland PA0077/127/001 Tablets - TILUDRONATE DISODIUM 25/09/2006
Ltd
SURGAM SA Sanofi-Aventis Ireland PA0540/075/001 Capsule - TIAPROFENIC ACID 25/09/2006
Limited T/A SANOFI
NORGALAX Norgine Limited PA0102/025/001 Rectal Suspension - DOCUSATE SODIUM 15/09/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/012 Solution for Injection - IOPENTOL 06/09/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/014 Solution for Injection - IOPENTOL 06/09/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/015 Solution for Injection - IOPENTOL 06/09/2006
NEULACTIL May & Baker Limited PA0040/021/003 Tablets - PERICIAZINE 05/09/2006
SENOKOT 7.5 MG/5ML Reckitt Benckiser Ireland Ltd PA0979/016/001 Syrup - SENNOSIDE B 04/09/2006
ORAL SOLUTION
INDERAL INJECTION AstraZeneca UK Limited PA0970/010/001 Solution for Inj/Inf - PROPRANOLOL 01/09/2006
HYDROCHLORIDE
INDERAL TABLETS AstraZeneca UK Limited PA0970/010/003 Tablets - PROPRANOLOL 01/09/2006
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 271 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INDERAL TABLETS AstraZeneca UK Limited PA0970/010/004 Tablets - PROPRANOLOL 01/09/2006
HYDROCHLORIDE
Seroquel 4-day starter pack AstraZeneca UK Limited PA0970/018/005 Tablet - Quetiapine fumarate 01/09/2006
CITALOPRAM Rowex Ltd PA0711/048/001 Coated Tablets - CITALOPRAM 31/08/2006
BETNOVATE N Glaxo Laboratories Limited PA0044/023/002 Ointment - BETAMETHASONE 30/08/2006
VALERATE
- NEOMYCIN SULFATE
CEPOREX Glaxo Laboratories Limited PA0044/009/004 Granules for Oral - CEFALEXIN 30/08/2006
Suspension
CEPOREX Glaxo Laboratories Limited PA0044/009/005 Granules for Oral - CEFALEXIN 30/08/2006
Suspension
TAGAMET SmithKline and French PA0060/006/002 Syrup - CIMETIDINE 30/08/2006
Laboratories Ltd HYDROCHLORIDE
TENORMIN INJECTION AstraZeneca UK Limited PA0970/019/001 Solution for Injection - ATENOLOL 30/08/2006
SMART DOSE Pro-Med AG PA0862/001/001 Solvent for Parenteral Use - SODIUM CHLORIDE 29/08/2006
SUPRAX Sanofi-Aventis Ireland PA0540/016/003 Tablets - CEFIXIME 29/08/2006
Limited T/A SANOFI
FREEZONE Pfizer Consumer Healthcare PA0172/014/001 Cutaneous Solution - SALICYLIC ACID 28/08/2006
Ltd
GEVRAL INSTANT Pfizer Consumer Healthcare PA0172/031/004 Granules for Oral - RETINOL PALMITATE 28/08/2006
PROTEIN CHOCOLATE Ltd Suspension - VITAMIN D SYNTHETIC
FLAVOUR CALCIFEROL
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- TOCOPHEROL
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CALCIUM PHOSPHATE
- PHOSPHORUS
- FERROUS FUMARATE
- MAGNESIUM OXIDE
- RIBOFLAVIN
- LYSINE
- CHOLINE
- COPPER
- IODINE
- INOSITOL
- POTASSIUM
- MILK POWDER
- SOYA PROTEIN
- ZINC OXIDE
- MANGANESE DIOXIDE

GEVRAL INSTANT Pfizer Consumer Healthcare PA0172/031/003 Granules for Oral - RETINOL PALMITATE 28/08/2006
PROTEIN CUSTARD Ltd Suspension - VITAMIN D SYNTHETIC
FLAVOUR CALCIFEROL
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- TOCOPHEROL
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CALCIUM PHOSPHATE
- PHOSPHORUS
- FERROUS FUMARATE
- MAGNESIUM OXIDE
- RIBOFLAVIN
- LYSINE
- CHOLINE
- COPPER
- IODINE
- INOSITOL
- POTASSIUM
- MILK POWDER
- SOYA PROTEIN
- ZINC OXIDE
- MANGANESE DIOXIDE

Human Medicines Withdrawn Products Page 272 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GEVRAL INSTANT Pfizer Consumer Healthcare PA0172/031/001 Granules for Oral - RETINOL PALMITATE 28/08/2006
PROTEIN ORANGE Ltd Suspension - VITAMIN D SYNTHETIC
FLAVOUR CALCIFEROL
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- TOCOPHEROL
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CALCIUM PHOSPHATE
- PHOSPHORUS
- FERROUS FUMARATE
- MAGNESIUM OXIDE
- RIBOFLAVIN
- LYSINE
- CHOLINE
- COPPER
- IODINE
- INOSITOL
- POTASSIUM
- MILK POWDER
- SOYA PROTEIN
- ZINC OXIDE
- MANGANESE DIOXIDE

GEVRAL INSTANT Pfizer Consumer Healthcare PA0172/031/002 Granules for Oral - RETINOL PALMITATE 28/08/2006
PROTEIN STRAWBERRY Ltd Suspension - VITAMIN D SYNTHETIC
FLAVOUR CALCIFEROL
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- TOCOPHEROL
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CALCIUM PHOSPHATE
- PHOSPHORUS
- FERROUS FUMARATE
- MAGNESIUM OXIDE
- RIBOFLAVIN
- LYSINE
- CHOLINE
- COPPER
- IODINE
- INOSITOL
- POTASSIUM
- MILK POWDER
- SOYA PROTEIN
- ZINC OXIDE
- MANGANESE DIOXIDE

JUNIOR PARACETAMOL Pfizer Consumer Healthcare PA0172/020/001 Unknown - PARACETAMOL 28/08/2006


Ltd
PROMETHAZINE Mercury Pharmaceuticals PA0073/053/002 Tablets - PROMETHAZINE 25/08/2006
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
EPAQ 3M Health Care Limited PA0057/069/001 Pressurised Inhalation - SALBUTAMOL SULFATE 24/08/2006
Suspension
PROMETHAZINE Mercury Pharmaceuticals PA0073/053/001 Tablets - PROMETHAZINE 24/08/2006
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
PRIMALAN Pierre Fabre Medicament PA0329/008/001 Tablets - MEQUITAZINE 23/08/2006
NIQUITIN GlaxoSmithKline Consumer PA0678/071/004 Transdermal Patch - NICOTINE 16/08/2006
Healthcare (Ireland) Limited
NIQUITIN GlaxoSmithKline Consumer PA0678/071/005 Transdermal Patch - NICOTINE 16/08/2006
Healthcare (Ireland) Limited
NIQUITIN GlaxoSmithKline Consumer PA0678/071/006 Transdermal Patch - NICOTINE 16/08/2006
Healthcare (Ireland) Limited
RETROVIR GlaxoSmithKline (Ireland) PA1077/078/002 Capsule - ZIDOVUDINE 15/08/2006
Limited

Human Medicines Withdrawn Products Page 273 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
R.B.C. Strides Shasun (UK) Ltd PA0894/002/001 Cream - ANTAZOLINE 11/08/2006
HYDROCHLORIDE
- CALAMINE
- CETRIMONIUM BROMIDE

SOLOL Rowex Ltd PA0711/034/001 Tablets - SOTALOL 10/08/2006


HYDROCHLORIDE
SOLOL Rowex Ltd PA0711/034/002 Tablets - SOTALOL 10/08/2006
HYDROCHLORIDE
ALLOPURINOL Roussel Laboratories Limited PA0006/038/001 Tablets - ALLOPURINOL 08/08/2006

ALLOPURINOL Roussel Laboratories Limited PA0006/038/002 Tablets - ALLOPURINOL 08/08/2006

IBUPROFEN Roussel Laboratories Limited PA0006/033/001 Tablets - IBUPROFEN 08/08/2006

IBUPROFEN Roussel Laboratories Limited PA0006/033/003 Tablets - IBUPROFEN 08/08/2006

LUBORANT SALIVA Mercury Pharmaceuticals PA0073/088/001 Oromucosal spray, solution - SODIUM FLUORIDE 08/08/2006
REPLACEMENT (Ireland) Ltd
MUCOGEN Mercury Pharmaceuticals PA0073/092/001 Syrup - CARBOCISTEINE 07/08/2006
(Ireland) Ltd
Solexa 100 mg capsules, Pharmacia Healthcare PA0936/031/001 Capsule - Celecoxib 07/08/2006
hard Ireland
Solexa 200 mg capsules, Pharmacia Healthcare PA0936/031/002 Capsule - Celecoxib 07/08/2006
hard Ireland
GENTAMICIN Hospira UK Limited PA0437/016/001A Solution for Injection - GENTAMICIN SULFATE 06/08/2006
PENBRITIN GlaxoSmithKline (Ireland) PA1077/096/005 Solution for Inj/Inf - AMPICILLIN SODIUM 04/08/2006
Limited
ATENOLOL Olinka (UK) Limited PA0476/005/002 Tablets - ATENOLOL 02/08/2006
ATENOLOL Olinka (UK) Limited PA0476/005/003 Tablets - ATENOLOL 02/08/2006
FAVINT Boehringer Ingelheim PA0775/003/001 Inhalation powder, hard - TIOTROPIUM BROMIDE 02/08/2006
International GmbH capsule
CURANDRON HE Clissmann PA0012/081/001 Tablets - CYPROTERONE 01/08/2006
ACETATE
SOLVAZINC Provalis Healthcare Limited PA0987/001/001 Tablets Effervescent - ZINC SULFATE 01/08/2006
VICKS COLDCARE Procter & Gamble (Health & PA0441/026/001 Capsule - DEXTROMETHORPHAN 01/08/2006
Beauty Care) Limited HYDROBROMIDE
- PARACETAMOL
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
DEPONIT 15 SCHWARZ PHARMA Limite PA0271/007/003 Transdermal Patch - GLYCERYL TRINITRATE 31/07/2006

ISOKET SCHWARZ PHARMA Limite PA0271/002/005 Tablets - ISOSORBIDE DINITRATE 31/07/2006

MINOCIN Cyanamid of Great Britain PA0037/007/004 Tablets - MINOCYCLINE 31/07/2006


HYDROCHLORIDE
IMAGOPAQUE GE Healthcare AS PA0735/007/001A Solution for Injection - IOPENTOL 26/07/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/003A Solution for Injection - IOPENTOL 26/07/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/005A Solution for Injection - IOPENTOL 26/07/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/007A Solution for Injection - IOPENTOL 26/07/2006
IMAGOPAQUE GE Healthcare AS PA0735/007/010A Solution for Injection - IOPENTOL 26/07/2006
PHYSEPTONE GlaxoSmithKline (Ireland) PA1077/075/001 Solution for Inj/Inf - METHADONE 21/07/2006
Limited HYDROCHLORIDE
MINOCIN Cyanamid of Great Britain PA0037/007/002 Tablets - MINOCYCLINE 14/07/2006
HYDROCHLORIDE
MINOCYCLINE Cyanamid of Great Britain PA0037/072/001 Tablets - MINOCYCLINE 14/07/2006
HYDROCHLORIDE
MINOCYCLINE Cyanamid of Great Britain PA0037/072/002 Tablets - MINOCYCLINE 14/07/2006
HYDROCHLORIDE
VARIDASE TOPICAL Cyanamid of Great Britain PA0037/018/001 Cutaneous Powder - STREPTOKINASE 14/07/2006
- STREPTODORNASE
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/003 Pdr for Soln Inj/Inf - CALCIUM FOLINATE 13/07/2006
CCNU Medac Gesellschaft fur PA0623/002/001 Capsule - Lomustine 13/07/2006
Klinische Spezialpraparate
mbH
Treosulfan Capsules 250 mg Medac Gesellschaft fur PA0623/001/001 Capsule - Treosulfan 13/07/2006
Klinische Spezialpraparate
mbH
PARACETAMOL Chanelle Medical PA0688/001/001 Tablets - PARACETAMOL 12/07/2006
VINCRISTINE SULPHATE Hospira UK Limited PA0437/008/004 Solution for Injection - VINCRISTINE SULFATE 11/07/2006
ORUDIS May & Baker Limited PA0040/033/003 Capsule - KETOPROFEN 09/07/2006
ORUDIS 50 May & Baker Limited PA0040/033/001 Capsule - KETOPROFEN 09/07/2006
MENTHOLAIR EXTRA The Mentholatum Company PA0076/004/001 Inhalation Vapour, Ointment - LEVOMENTHOL 08/07/2006
GENTLE VAPOUR RUB Ltd. - OIL OF EUCALIPTUS

Human Medicines Withdrawn Products Page 274 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BETADINE VAGINAL Seton Healthcare Group PLC PA0696/002/019 Pessary - POVIDONE-IODINE 07/07/2006

BETADINE VAGINAL Seton Healthcare Group PLC PA0696/002/020 Vaginal Solution - POVIDONE-IODINE 07/07/2006
CLEANSING KIT
BRUSH-OFF COLD SORE Seton Healthcare Group PLC PA0696/005/001 Cutaneous Solution - POVIDONE-IODINE 07/07/2006
TREATMENT
CALABAND Seton Healthcare Group PLC PA0696/004/001 Impregnated Dressing - ZINC OXIDE 07/07/2006
- CALAMINE
ESTRAMON Rowex Ltd PA0711/036/001 Transdermal Patch - ESTRADIOL 07/07/2006
ESTRAMON Rowex Ltd PA0711/036/002 Transdermal Patch - ESTRADIOL 07/07/2006
SEROTULLE Seton Healthcare Group PLC PA0696/001/001 Impregnated Dressing - CHLORHEXIDINE 07/07/2006
CHLORHEXIDINE GAUZE DIACETATE
PERSANTIN Boehringer Ingelheim Limited PA0007/008/001 Tablets - DIPYRIDAMOLE 03/07/2006

PERSANTIN Boehringer Ingelheim Limited PA0007/008/002 Tablets - DIPYRIDAMOLE 03/07/2006

BACLOPAR Generics (UK) Limited PA0405/029/002 Tablets - BACLOFEN 01/07/2006


GERICARB Generics (UK) Limited PA0405/016/003 Tablets - CARBAMAZEPINE 01/07/2006
GERINAP Generics (UK) Limited PA0405/011/001 Tablets - NAPROXEN 01/07/2006
GERINAP Generics (UK) Limited PA0405/011/002 Tablets - NAPROXEN 01/07/2006
TAMOXIFEN CITRATE Generics (UK) Limited PA0405/001/003 Tablets - TAMOXIFEN CITRATE 01/07/2006
TOLVON Organon Laboratories PA0261/001/001 Tablets - MIANSERIN 01/07/2006
Limited HYDROCHLORIDE
TOLVON Organon Laboratories PA0261/001/003 Tablets - MIANSERIN 01/07/2006
Limited HYDROCHLORIDE
ANGITIL SR Chiesi Limited PA0743/002/001 Capsule - DILTIAZEM 30/06/2006
HYDROCHLORIDE
DIUMIDE-K Napp Pharmaceuticals PA0913/004/001 Tablet - Potassium chloride 30/06/2006
Limited - Furosemide
Sno Tears Chauvin Pharmaceuticals PA0118/033/001 Eye drops, solution - Polyvinyl alcohol 30/06/2006
Limited
ONKOTRONE Asta Medica Ltd PA0705/013/001 Solution for Injection - MITOXANTRONE 28/06/2006
HYDROCHLORIDE
ZIAXEL Abbott Laboratories Ireland PA0038/091/001 Capsule 26/06/2006
Ltd
PROFLEX Novartis Consumer Health PA0030/020/002 Cream - IBUPROFEN 10/06/2006
UK Limited
PROFLEX PAIN RELIEF Novartis Consumer Health PA0030/020/001 Cream - IBUPROFEN 10/06/2006
UK Limited
SODIUM CHLORIDE Bieffe Medital SpA PA0751/001/001 Solution for Infusion - SODIUM CHLORIDE 10/06/2006
CIDOMYCIN INTRATHECAL Roussel Laboratories Limited PA0006/003/001 Solution for Injection - GENTAMICIN SULFATE 09/06/2006

DIPRIVAN 2% PRE-FILLED AstraZeneca UK Limited PA0970/005/006 Emulsion for Inj/Inf - PROPOFOL 09/06/2006
SYRINGE
DIPRIVAN 2% PRE-FILLED AstraZeneca UK Limited PA0970/005/007 Emulsion for Inj/Inf - PROPOFOL 09/06/2006
SYRINGE
TORBETOL ACNE Torbet Laboratories Limited PA0456/002/001 Cutaneous Solution - CETRIMONIUM BROMIDE 09/06/2006
- CHLORHEXIDINE
GLUCONATE

CALCIUM LEUCOVORIN Hospira UK Limited PA0437/010/002 Solution for Inj/Inf - CALCIUM FOLINATE 08/06/2006
TRAMAKE/TRAMADOL Galen Limited PA0185/035/001 Capsule - TRAMADOL 08/06/2006
HYDROCHLORIDE HYDROCHLORIDE
IBUPROFEN McDermott Laboratories Ltd PA0577/018/001 Tablets - IBUPROFEN 07/06/2006
t/a Gerard Laboratories
IBUPROFEN McDermott Laboratories Ltd PA0577/018/002 Tablets - IBUPROFEN 07/06/2006
t/a Gerard Laboratories
IBUPROFEN McDermott Laboratories Ltd PA0577/018/003 Tablets - IBUPROFEN 07/06/2006
t/a Gerard Laboratories
VIAZEM SR Biovail Technologies PA0993/001/001 Capsule - DILTIAZEM 06/06/2006
(Ireland) HYDROCHLORIDE
VIAZEM SR Biovail Technologies PA0993/001/002 Capsule - DILTIAZEM 06/06/2006
(Ireland) HYDROCHLORIDE
VIAZEM SR Biovail Technologies PA0993/001/003 Capsule - DILTIAZEM 06/06/2006
(Ireland) HYDROCHLORIDE
VIAZEM SR Biovail Technologies PA0993/001/004 Capsule - DILTIAZEM 06/06/2006
(Ireland) HYDROCHLORIDE
VIAZEM SR Biovail Technologies PA0993/001/005 Capsule - DILTIAZEM 06/06/2006
(Ireland) HYDROCHLORIDE
OMNICEF 300 MG Astellas Pharma GmbH PA0731/002/001 Capsule - CEFDINIR 01/06/2006
CAPSULE
OMNICEF SUSPENSION Astellas Pharma GmbH PA0731/002/002 Powder for Oral Suspension - CEFDINIR 01/06/2006
ZOSTRUM Galderma (UK) Ltd PA0590/017/001 Cutaneous Solution - IDOXURIDINE 01/06/2006
ACC HARD GELATIN Rowex Ltd PA0711/007/004 Capsule - ACETYLCYSTEINE 31/05/2006

Human Medicines Withdrawn Products Page 275 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BUTOVENT PULVINAL Chiesi Farmaceutici S.p.A. PA0584/002/001 Inhalation powder, hard - SALBUTAMOL 31/05/2006
capsule
KYTRIL PAEDIATRIC Roche Products Limited PA0050/149/001 Oral Solution - GRANISETRON 31/05/2006
HYDROCHLORIDE
GYNOL II CONTRACEPTIVE Janssen-Cilag Ltd PA0748/005/001 Vaginal Gel - NONOXINOL 28/05/2006
JELLY
UPRIMA Abbott Laboratories Limited EU/1/01/180/002 Tablet Sublingual - APOMORPHINE 28/05/2006
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/008 Tablet Sublingual - APOMORPHINE 28/05/2006
HYDROCHLORIDE
GERELAX McDermott Laboratories Ltd PA0577/002/001 - LACTULOSE 26/05/2006
t/a Gerard Laboratories
CAPRILL Pinewood Laboratories Ltd, PA0281/099/001 Tablets - CAPTOPRIL 24/05/2006
CAPRILL Pinewood Laboratories Ltd, PA0281/099/005 Tablets - CAPTOPRIL 24/05/2006
BETADINE EAR Seton Healthcare Group PLC PA0696/002/009 Ear Drops Solution - POVIDONE-IODINE 23/05/2006

HYPAQUE Intrapharm Laboratories PA0997/002/002 Solvent for Parenteral Use - SODIUM AMIDOTRIZOATE 23/05/2006
Limited
HYPAQUE Intrapharm Laboratories PA0997/002/003 Solvent for Parenteral Use - SODIUM AMIDOTRIZOATE 23/05/2006
Limited
HYPAQUE 25% Intrapharm Laboratories PA0997/002/001 Solvent for Parenteral Use - SODIUM AMIDOTRIZOATE 23/05/2006
Limited
HYPAQUE 45% Intrapharm Laboratories PA0997/003/001 Solvent for Parenteral Use - SODIUM AMIDOTRIZOATE 23/05/2006
Limited
MENOMUNE A/C/Y/W-135 Sanofi Pasteur MSD Ltd PA0544/016/001 Unknown - MENINGOCCAL 23/05/2006
POLYSACCHARIDE
GROUP A
- MENINGOCOCCAL
POLYSACCHARIDE
GROUP C
- MENINGOCOCCAL
POLYSACCHARIDE
GROUP Y
- MENINGOCOCCAL
POLYSACCHARIDE GROU
W-135
STERETS CHLORASOL Seton Prebbles Ltd PA0483/006/001 Cutaneous Solution - SODIUM HYPOCHLORITE 23/05/2006

INDOCOLLYRE Laboratoires Chauvin PA0448/001/001 Eye Drops Pdr & Solv for - INDOMETACIN 22/05/2006
Soln
PNEUMOVAX II PREFILLED Sanofi Pasteur MSD Ltd PA0544/021/002 Solution for Injection - PNEUMOCOCCAL 18/05/2006
SYRINGE VACCINE
QUINODERM LOTIO-GEL Ferndale Pharmaceuticals PA1155/003/001 Gel - BENZOYL PEROXIDE 18/05/2006
Ltd - POTASSIUM
HYDROXYQUINOLIN
SULFATE
RALGEX IBUPROFEN Seton Healthcare Group PLC PA0696/010/001 Gel - IBUPROFEN 18/05/2006

FOSAMAX Merck Sharp and Dohme PA0035/083/002 Tablets - ALENDRONATE SODIUM 17/05/2006
Limited
BETADINE ANTISEPTIC Seton Healthcare Group PLC PA0696/002/006 Impregnated Dressing - POVIDONE-IODINE 15/05/2006
WIPES
BETADINE SCALP & SKIN Seton Healthcare Group PLC PA0696/002/013 Cutaneous Solution - POVIDONE-IODINE 15/05/2006
CLEANSER
WOODWARDS TEETHING SSL International PLC PA0618/035/001 Gel - CHOLINE SALICYLATE 15/05/2006
- CETALKONIUM
CHLORIDE
ERYTHROMYCIN Athlone Laboratories Ltd PA0298/008/001 Powder for Oral Suspension - ERYTHROMYCIN 12/05/2006
ETHYLSUCCINATE
ERYTHROMYCIN Athlone Laboratories Ltd PA0298/008/002 Powder for Oral Suspension - ERYTHROMYCIN 12/05/2006
ETHYLSUCCINATE
CALCIFORTE Laboratoires Grimberg PA0345/002/001 Powder for Oral Solution - CALCIUM CHLORIDE 10/05/2006
DIHYDRATE
- CALCIUM GLUCONATE
- CALCIUM GLUCEPTATE
- CALCIUM LACTATE
- CALCIUM CARBONATE
- SACCHAROMYCES
CEREVISIAE MEYEN
INDOCID Merck Sharp and Dohme PA0035/003/001 Capsule - INDOMETACIN 10/05/2006
Limited
INDOCID Merck Sharp and Dohme PA0035/003/002 Capsule - INDOMETACIN 10/05/2006
Limited
INDOCID Merck Sharp and Dohme PA0035/003/004 Suppositories - INDOMETACIN 10/05/2006
Limited

Human Medicines Withdrawn Products Page 276 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INDOCID Merck Sharp and Dohme PA0035/003/005 Oral Suspension - INDOMETACIN 10/05/2006
Limited
INDOCID-R Merck Sharp and Dohme PA0035/003/006 Capsule - INDOMETACIN 10/05/2006
Limited
TOBREX Alcon Laboratories (UK) Ltd PA0290/034/001 Eye Drops Solution - TOBRAMYCIN 10/05/2006
BISODOL SPEARMINT Forest Laboratories UK Ltd PA0100/047/002 Tablets - CALCIUM CARBONATE 09/05/2006
- LIGHT MAGNESIUM
CARBONATE
- SODIUM BICARBONATE
CUNIL Helsinn Birex PA0294/005/002 Capsule - IBUPROFEN 08/05/2006
Pharmaceuticals Limited
VITAMIN C Quest Vitamins (UK) Ltd PA0466/004/001 Tablets - ASCORBIC ACID 07/05/2006
MULTI B COMPLEX PLUS Quest Vitamins (UK) Ltd PA0466/005/001 Tablets - ASCORBIC ACID 06/05/2006
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- FOLIC ACID
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRODOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- CHOLINE BITARTRATE
- INOSITOL
- P-AMINOBENZOIC ACID
- BIOTIN

LACTOLAX Olinka (UK) Limited PA0476/009/001 Oral Solution - LACTULOSE 05/05/2006


NAPROXEN EC Olinka (UK) Limited PA0476/007/005 Tablets - NAPROXEN 04/05/2006
NAPROXEN EC Olinka (UK) Limited PA0476/007/006 Tablets - NAPROXEN 04/05/2006
NAPROXEN EC Olinka (UK) Limited PA0476/007/007 Tablets - NAPROXEN 04/05/2006
PEPCID AC McNeil Limited PA0755/001/002 Tablets Chewable - FAMOTIDINE 04/05/2006
PRIPSEN WORM ELIXIR Cupal Limited PA0258/040/001 Oral Solution - PIPERAZINE HYDRATE 03/05/2006
JOY-RIDES GlaxoSmithKline Consumer PA0678/091/001 Tablets Chewable - HYOSCINE 02/05/2006
Healthcare (Ireland) Limited HYDROBROMIDE
Macleans Sensitive GlaxoSmithKline Consumer PA0678/059/001 Toothpaste - STRONTIUM ACETATE 02/05/2006
Healthcare (Ireland) Limited HEMIHYDRATE
- SODIUM FLUORIDE
QUELLADA APPLICATION GlaxoSmithKline Consumer PA0678/098/001 Shampoo - LINDANE 02/05/2006
PC Healthcare (Ireland) Limited
QUELLADA LOTION GlaxoSmithKline Consumer PA0678/097/001 Unknown - LINDANE 02/05/2006
Healthcare (Ireland) Limited
ALBUREX ZLB GmbH PA1112/002/002 Solution for Infusion - HUMAN ALBUMIN 01/05/2006
DOPAMINE 160 MG/ML Hospira UK Limited PA0437/003/003 Concentrate for Soln for Inf - DOPAMINE 01/05/2006
STERILE CONCENTRATE HYDROCHLORIDE
MORPHINE SULPHATE Hospira UK Limited PA0437/039/001 Solution for Injection - MORPHINE SULFATE 01/05/2006
MORPHINE SULPHATE Hospira UK Limited PA0437/039/002 Solution for Injection - MORPHINE SULFATE 01/05/2006
BICAFLAC BUFFER Edwards Lifesciences PA0992/001/001 Solution for Haemofiltration - SODIUM CHLORIDE 30/04/2006
SOLUTION Germany - SODIUM BICARBONATE
BICAFLAC ELECTROLYTE Edwards Lifesciences PA0992/003/001 Solution for Haemofiltration - SODIUM CHLORIDE 30/04/2006
SOLUTION WITH Germany - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
MONOHYDRATE
- GLUCOSE ANHYDROUS
BICAFLAC ELECTROLYTE Edwards Lifesciences PA0992/002/001 Unknown - SODIUM CHLORIDE 30/04/2006
SOLUTION WITHOUT Germany - CALCIUM CHLORIDE
POTASSIUM DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
MONOHYDRATE
ENTOCORT AstraZeneca UK Limited PA0970/039/003 Enema - BUDESONIDE 30/04/2006
PREMIQUE 2.5 John Wyeth & Brother PA0022/069/001 Tablets - ESTROGENS 30/04/2006
Limited CONJUGATED
-
MEDROXYPROGESTERO
NE ACETATE

Human Medicines Withdrawn Products Page 277 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALGICON Rorer Pharmaceuticals PA0468/003/001 Oral Suspension - MAGNESIUM ALGINATE 27/04/2006
Limited - ALUMINIUM HYDROXIDE-
MAGNESIUM CARBONATE
GEL
- MAGNESIUM
CARBONATE
- POTASSIUM
BICARBONATE
- CALCIUM CARBONATE
GAVISCON 250 Reckitt Benckiser Ireland Ltd PA0979/011/004 Tablets Chewable - ALGINIC ACID 25/04/2006
- SODIUM BICARBONATE
- ALUMINIUM HYDROXIDE
DRIED
- MAGNESIUM TRISILICATE

GAVISCON 250 - LEMON Reckitt Benckiser Ireland Ltd PA0979/011/005 Tablets Chewable - ALGINIC ACID 25/04/2006
FLAVOUR - SODIUM BICARBONATE
- ALUMINIUM HYDROXIDE
DRIED
- MAGNESIUM TRISILICATE

HUMAJECT I (ISOPHANE) Eli Lilly and Company Limite PA0047/082/001 Suspension for Injection - INSULIN HUMAN 25/04/2006

HUMAJECT M3 (MIXTURE Eli Lilly and Company Limite PA0047/083/001 Suspension for Injection - INSULIN HUMAN 25/04/2006
3)
HUMAJECT S (SOLUBLE) Eli Lilly and Company Limite PA0047/081/001 Solution for Injection - INSULIN HUMAN 25/04/2006

HUMULIN (MIXTURE 2) Eli Lilly and Company Limite PA0047/066/004 Suspension for Injection - INSULIN HUMAN 25/04/2006

HUMULIN LENTE Eli Lilly and Company Limite PA0047/075/001 Suspension for Injection - INSULIN HUMAN 25/04/2006

HUMULIN M2 PEN Eli Lilly and Company Limite PA0047/091/001 Solution for Injection - INSULIN HUMAN 25/04/2006

HUMULIN M5 (MIXTURE 5) Eli Lilly and Company Limite PA0047/074/001 Suspension for Injection - INSULIN HUMAN 25/04/2006

HUMULIN ZN (ZINC) Eli Lilly and Company Limite PA0047/061/001 Suspension for Injection - INSULIN HUMAN 25/04/2006

ORADEXON Organon Laboratories PA0261/048/001 Solution for Injection - DEXAMETHASONE 25/04/2006


Limited
ALBUMIN 20%W/V Baxter Healthcare Limited PA0167/001/001 Solution for Infusion - HUMAN ALBUMIN 21/04/2006
(BUMINATE 20%W/V)
METOCYL Rowa Pharmaceuticals PA0074/010/001 Syrup - METOCLOPRAMIDE 21/04/2006
Limited HYDROCHLORIDE
REGAINE TOPICAL Pharmacia Healthcare PA0936/003/002 Gel - MINOXIDIL 21/04/2006
Ireland
VASODUR Norton Healthcare Limited PA0282/080/001 Tablets - DOXAZOSIN 21/04/2006
T/A IVAX Pharmaceuticals
UK
VASODUR Norton Healthcare Limited PA0282/080/002 Tablets - DOXAZOSIN 21/04/2006
T/A IVAX Pharmaceuticals
UK
VASODUR Norton Healthcare Limited PA0282/080/003 Tablets - DOXAZOSIN 21/04/2006
T/A IVAX Pharmaceuticals
UK
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/015 Solution for Infusion - BUPIVACAINE 20/04/2006
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/016 Solution for Infusion - BUPIVACAINE 20/04/2006
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
NOVAPEN AMPICILLIN Pinewood Laboratories Ltd, PA0281/009/005 Oral Suspension - AMPICILLIN TRIHYDRATE 20/04/2006
SYRUP BP
REDOXON LEMON Bayer PLC PA0021/074/003 Tablets Effervescent - ASCORBIC ACID 19/04/2006
SLO-MORPH Ethypharm PA0549/013/005 Capsule - MORPHINE SULFATE 14/04/2006
VIRASORB Thornton & Ross Limited PA0610/017/001 Cream - ACICLOVIR 14/04/2006
DICLOFENAC 100 MG Olinka (UK) Limited PA0476/010/001 Tablets - DICLOFENAC SODIUM 12/04/2006
PROLONGED RELEASE
TABLETS
GLYCERINE LEMON & Colet Products Ltd PA1202/001/001 - GLYCEROL 11/04/2006
HONEY
LIQUID PARAFFIN PH EUR Colet Products Ltd PA1202/002/001 Oral Solution - PARAFFIN, LIQUID 11/04/2006

AMERSCAN DMSA AGENT GE Healthcare Limited PA0240/027/001 Unknown - SUCCIMER 07/04/2006


AMERSCAN PENTETATE II GE Healthcare Limited PA0240/028/001 Powder for suspension for - CALCIUM TRISODIUM 07/04/2006
AGENT injection PENTETATE
- STANNOUS CHLORIDE

Human Medicines Withdrawn Products Page 278 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MONONINE FREEZE DRIED Aventis Behring Limited PA0010/032/003 Unknown - FACTOR IX, HUMAN 06/04/2006
HUMAN COAG. FACTOR IX

MONONINE FREEZE DRIED Aventis Behring Limited PA0010/032/002 Unknown - FACTOR IX, HUMAN 06/04/2006
HUMAN COAG.FACTOR

RENAMEL Niche Generics Limited PA1063/006/001 Tablets - OXYBUTYNIN CHLORIDE 06/04/2006


RENAMEL Niche Generics Limited PA1063/006/002 Tablets - OXYBUTYNIN CHLORIDE 06/04/2006
VIVAGLOBIN CSL Behring GmbH PA0800/004/001 Solution for Injection - HUMAN 06/04/2006
IMMUMOGLOBULINS
BETIM Valeant Pharmaceuticals PA1096/002/001 Tablets - TIMOLOL MALEATE 05/04/2006
Limited
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/013 Solution for Injection - BUPIVACAINE 05/04/2006
HYDROCHLORIDE B.P. (Ireland) Ltd HYDROCHLORIDE
0.75% W/V
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/011 Solution for Injection - BUPIVACAINE 05/04/2006
HYDROCHLORIDE BP (Ireland) Ltd HYDROCHLORIDE
0.375%
SETLERS WIND-EZE SOFT GlaxoSmithKline Consumer PA0678/085/002 Capsule - DIMETICONE, ACTIVATED 05/04/2006
GEL Healthcare (Ireland) Limited
CHLORPROMAZINE 1 ML Mercury Pharmaceuticals PA0073/104/001A Solution for Injection - CHLORPROMAZINE 01/04/2006
(Ireland) Ltd HYDROCHLORIDE
HUMATROPE Eli Lilly and Company Limite PA0047/068/001 Pdr+Solv for Soln for Inj - SOMATROPIN 01/04/2006

HUMATROPE Eli Lilly and Company Limite PA0047/068/002 Pdr+Solv for Soln for Inj - SOMATROPIN 01/04/2006

HUMATROPE Eli Lilly and Company Limite PA0047/068/003 Pdr+Solv for Soln for Inj - SOMATROPIN 01/04/2006

HUMATROPE Eli Lilly and Company Limite PA0047/068/004 Pdr+Solv for Soln for Inj - SOMATROPIN 01/04/2006

HUMATROPE Eli Lilly and Company Limite PA0047/068/005 Pdr+Solv for Soln for Inj - SOMATROPIN 01/04/2006

INTRAGLOBIN F (FLUID) Biotest Pharma GmbH PA0592/001/003 Solution for Infusion - HUMAN PLASMA 01/04/2006
PROTEIN >95%
IMMUNOGLOBULINS
- GLUCOSE
- SODIUM CHLORIDE
- WATER FOR INJECTIONS

INTRAGLOBIN F (FLUID) Biotest Pharma GmbH PA0592/001/004A Solution for Infusion - HUMAN PLASMA 01/04/2006
PROTEIN >95%
IMMUNOGLOBULINS
- GLUCOSE
- SODIUM CHLORIDE
- WATER FOR INJECTIONS

ATGAM STERILE Pharmacia Limited PA0016/038/001 Solution for Injection - EQUINE GAMMA 31/03/2006
GLOBULIN
FELDENE 5 MG CAPSULES Pfizer Limited PA0019/024/001 Capsule - PIROXICAM 31/03/2006

HALOPERIDOL Rosemont Pharmaceuticals PA0312/003/001 Oral Solution - HALOPERIDOL 31/03/2006


Ltd
HALOPERIDOL Rosemont Pharmaceuticals PA0312/003/002 Oral Solution - HALOPERIDOL 31/03/2006
Ltd
LI-LIQUID/LITHIUM Rosemont Pharmaceuticals PA0312/004/001 Syrup - LITHIUM CITRATE 31/03/2006
CITRATE Ltd
LI-LIQUID/LITHIUM Rosemont Pharmaceuticals PA0312/004/002 Syrup - LITHIUM CITRATE 31/03/2006
CITRATE Ltd
RECOFOL Bayer Schering Pharma Oy PA0771/004/001 Emulsion for Injection - PROPOFOL 31/03/2006
RECOFOL Bayer Schering Pharma Oy PA0771/004/002 Emulsion for Injection - PROPOFOL 31/03/2006
RECOFOL Bayer Schering Pharma Oy PA0771/004/004 Emulsion for Injection - PROPOFOL 31/03/2006
REDOXON Bayer PLC PA0021/074/002 Tablets Effervescent - ASCORBIC ACID 31/03/2006
TOFRANIL Novartis Pharmaceuticals UK PA0013/086/002 Tablets - IMIPRAMINE 30/03/2006
Ltd HYDROCHLORIDE
ISOVORIN John Wyeth & Brother PA0022/076/001 Solution for Injection - CALCIUM FOLINATE 29/03/2006
Limited
Salofalk gastro-resistant Dr. Falk Pharma GmbH PA0573/003/003 Granules - Mesalazine 29/03/2006
prolonged release granules
in bottles
VUMON Bristol-Myers Squibb PA0048/023/001 Solution for Infusion - TENIPOSIDE 27/03/2006
(Holdings) Limited
IVELIP Baxter Healthcare Limited PA0167/095/001 Emulsion for Injection - SOYA OIL 16/03/2006
IVELIP Baxter Healthcare Limited PA0167/095/002 Emulsion for Injection - SOYA OIL 16/03/2006
MITOXANA LYOPHILISATE Asta Medica Ltd PA0705/005/003 Powder for concentrate for - IFOSFAMIDE 16/03/2006
solution for infusion

Human Medicines Withdrawn Products Page 279 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MITOXANA LYOPHILISATE Asta Medica Ltd PA0705/005/004 Powder for concentrate for - IFOSFAMIDE 16/03/2006
solution for infusion
MITOXANA LYOPHILISATE Asta Medica Ltd PA0705/005/005 Powder for concentrate for - IFOSFAMIDE 16/03/2006
solution for infusion
MITOXANA LYOPHILISATE Asta Medica Ltd PA0705/005/006 Powder for concentrate for - IFOSFAMIDE 16/03/2006
solution for infusion
QUINABAND Seton Healthcare Group PLC PA0696/003/001 Impregnated Dressing - ZINC OXIDE 16/03/2006
- CALAMINE
- CLIOQUINOL
CO-TENIDONE BP Norton Waterford PA0436/030/001 Tablets - ATENOLOL 15/03/2006
- CHLORTALIDONE
CO-TENIDONE BP Norton Waterford PA0436/030/002 Tablets - ATENOLOL 15/03/2006
- CHLORTALIDONE
THIOZINE Pinewood Laboratories Ltd, PA0281/011/001 Oral Solution - THIORIDAZINE 15/03/2006
HYDROCHLORIDE
ICODIAL Innovata plc PA0675/001/003 Solution for peritoneal - ICODEXTRIN 10/03/2006
dialysis
ICODIAL 7.5% Innovata plc PA0675/001/001 Solution for Infusion 10/03/2006
INTAL Fisons Limited PA0018/004/001 Nebuliser Solution - CROMOGLICATE SODIUM 10/03/2006

NEBCIN Eli Lilly and Company Limite PA0047/005/001 Solution for Injection - TOBRAMYCIN SULFATE 10/03/2006

NEBCIN Eli Lilly and Company Limite PA0047/005/002 Solution for Injection - TOBRAMYCIN SULFATE 10/03/2006

NEBCIN Eli Lilly and Company Limite PA0047/005/003 Solution for Injection - TOBRAMYCIN SULFATE 10/03/2006

NETILLIN AMPOULE Schering-Plough Limited PA0277/007/001 Solution for Injection - NETILMICIN SULFATE 09/03/2006
GALENAMOX Galen Limited PA0185/028/001 Oral Suspension - AMOXICILLIN 08/03/2006
TRIHYDRATE
GALENAMOX Galen Limited PA0185/028/002 Oral Suspension - AMOXICILLIN 08/03/2006
TRIHYDRATE
GALENAMOX Galen Limited PA0185/028/003 Capsule - AMOXICILLIN 08/03/2006
TRIHYDRATE
GALENAMOX Galen Limited PA0185/028/004 Capsule - AMOXICILLIN 08/03/2006
TRIHYDRATE
BUTENAFINE UCB (Pharma) Ireland PA0891/004/001 Cream - BUTENAFINE 03/03/2006
HYDROCHLORIDE 10 MG/ Limited

HEMOFIL M Baxter Healthcare Limited PA0167/080/001 Pdr for Soln for Injection - FACTOR VIII 03/03/2006
ANTIHAEMOPHILIC (ANTIHAEMOPHILIC
FACTOR)
HEMOFIL M Baxter Healthcare Limited PA0167/080/002 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 03/03/2006
ANTIHAEMOPHILIC
HEMOFIL M Baxter Healthcare Limited PA0167/080/003 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 03/03/2006
ANTIHAEMOPHILIC
LUVASED MONO Rowex Ltd PA0711/042/001 Tablets - VALERIANA OFFICINALIS 03/03/2006

PROSTIN E2 ORAL Pharmacia Limited PA0016/001/001 Tablets - DINOPROST 03/03/2006


SUPER VITAMIN C Peter Black Healthcare Ltd PA0522/007/001 Tablets - ASCORBIC ACID 02/03/2006
ALBUREX ZLB GmbH PA1112/002/001 Solution for Infusion - HUMAN ALBUMIN 01/03/2006
LIDOCAINE Baxter Healthcare Limited PA0167/108/001 Solution for Injection - LIDOCAINE 28/02/2006
HYDROCHLORIDE HYDROCHLORIDE
PANCREOLAURYL TEST McNeil Healthcare (Ireland) PA0823/039/001 Capsule - FLUORESCEIN 28/02/2006
Ltd DILAURATE
- FLUORESCEIN SODIUM
NETILLIN Schering-Plough Limited PA0277/007/004 Solution for Injection - NETILMICIN SULFATE 23/02/2006
NETILLIN Schering-Plough Limited PA0277/007/006 Solution for Injection - NETILMICIN SULFATE 23/02/2006
NETILLIN AMPOULE Schering-Plough Limited PA0277/007/003 Solution for Injection - NETILMICIN SULFATE 23/02/2006
NETILLIN VIAL Schering-Plough Limited PA0277/007/008 Solution for Injection - NETILMICIN SULFATE 23/02/2006
OPTIMINE Schering-Plough Limited PA0277/001/002 Unknown - AZATADINE MALEATE 23/02/2006
TINADERM-M Schering-Plough Limited PA0277/003/001 Cream - TOLNAFTATE 23/02/2006
- NYSTATIN
UNI-DUR SUSTAINED Schering-Plough Limited PA0277/069/001 Tablets - THEOPHYLLINE 23/02/2006
RELEASE
UNI-DUR SUSTAINED Schering-Plough Limited PA0277/069/002 Tablets - THEOPHYLLINE 23/02/2006
RELEASE
WATER FOR INJECTION Schering-Plough Limited PA0277/065/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 23/02/2006

Human Medicines Withdrawn Products Page 280 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KABIMIX 14 Fresenius Kabi Limited PA0566/008/002 Emulsion for Infusion - GLUCOSE ANHYDROUS 17/02/2006
- ALANINE
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- CALCIUM
GLYCEROPHOSPHATE
ANHYDROUS
- SODIUM
GLYCEROPHOSPHATE
ANHYDROUS
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM HYDROXIDE
- POTASSIUM HYDROXIDE
- SOYA OIL

KABIMIX 9 Fresenius Kabi Limited PA0566/008/001 Emulsion for Infusion - SOYA OIL 17/02/2006
- GLUCOSE
MONOHYDRATE
- ALANINE
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE ACETATE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- CALCIUM
GLYCEROPHOSPHATE
ANHYDROUS
- SODIUM
GLYCEROPHOSPHATE
ANHYDROUS
- MAGNESIUM CHLORIDE
HEXAHYDRATE
PAROXETINE Norton Healthcare Limited PA0282/077/001 Tablets - PAROXETINE 17/02/2006
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
PAROXETINE Norton Healthcare Limited PA0282/077/002 Tablets - PAROXETINE 17/02/2006
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
CIMAGEN Mercury Pharmaceuticals PA0073/128/001 Tablets - CIMETIDINE 16/02/2006
(Ireland) Ltd
CIMAGEN Mercury Pharmaceuticals PA0073/128/002 Tablets - CIMETIDINE 16/02/2006
(Ireland) Ltd
CIMAGEN Mercury Pharmaceuticals PA0073/128/003 Tablets - CIMETIDINE 16/02/2006
(Ireland) Ltd
DEXTROSE Mercury Pharmaceuticals PA0073/118/001 Solution for Infusion - GLUCOSE 16/02/2006
(Ireland) Ltd
FERROTAB Mercury Pharmaceuticals PA0073/114/001 Tablets - FERROUS SULFATE 16/02/2006
(Ireland) Ltd - COPPER SULFATE
- MANGANESE SULFATE

Human Medicines Withdrawn Products Page 281 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MORPHINE SULPHATE Mercury Pharmaceuticals PA0073/020/002 Solution for Injection - MORPHINE SULFATE 16/02/2006
(Ireland) Ltd
MORPHINE SULPHATE Mercury Pharmaceuticals PA0073/020/005 Solution for Injection - MORPHINE SULFATE 16/02/2006
(Ireland) Ltd
MORPHINE SULPHATE Mercury Pharmaceuticals PA0073/020/006 Solution for Injection - MORPHINE SULFATE 16/02/2006
(Ireland) Ltd
SODIUM CHLORIDE Mercury Pharmaceuticals PA0073/105/004 Solution for Injection - SODIUM CHLORIDE 16/02/2006
(Ireland) Ltd
WATER FOR INJECTIONS Mercury Pharmaceuticals PA0073/107/005 Solvent for Parenteral Use 16/02/2006
(Ireland) Ltd
RIMAPRIN ASPIRIN BP Ranbaxy Ireland Limited PA0408/024/001 Tablets - ACETYLSALICYLIC ACID 11/02/2006
ZISPIN PCO Manufacturing PPA0465/130/001A Tablets - MIRTAZAPINE 10/02/2006
PREGNYL 500 Organon Laboratories PA0261/012/001 Pdr+Solv for Susp for Inj - CHORIONIC 08/02/2006
Limited GONADOTROPHIN
RENNIE RELIEVE Bayer PLC PA0021/079/001 Tablets - CALCIUM CARBONATE 08/02/2006
- LIGHT MAGNESIUM
CARBONATE
- DIMETICONE, ACTIVATED

VALDERMA CARE Bayer PLC PA0021/081/001 Cream - CHLORHEXIDINE 08/02/2006


ANTISEPTIC SKIN HYDROCHLORIDE
SLOMON SR Chiesi Limited PA0743/004/001 Modified-release capsule, - ISOSORBIDE 06/02/2006
hard MONONITRATE
ZOLGEN Genthon GmbH PA0833/004/001 Tablets - ZOLPIDEM TARTRATE 01/02/2006
ZOLGEN Genthon GmbH PA0833/004/002 Tablets - ZOLPIDEM TARTRATE 01/02/2006
ATIVAN John Wyeth & Brother PA0022/001/004 Tablets - LORAZEPAM 31/01/2006
Limited
ATIVAN John Wyeth & Brother PA0022/001/005 Tablets - LORAZEPAM 31/01/2006
Limited
CARDENE Yamanouchi Pharma Ltd PA0062/037/001 Capsule - NICARDIPINE 31/01/2006
HYDROCHLORIDE
CARDENE Yamanouchi Pharma Ltd PA0062/037/002 Capsule - NICARDIPINE 31/01/2006
HYDROCHLORIDE
CARDENE SR Yamanouchi Pharma Ltd PA0062/037/003 Modified-release capsule, - NICARDIPINE 31/01/2006
hard HYDROCHLORIDE
CARDENE SR Yamanouchi Pharma Ltd PA0062/037/004 Modified-release capsule, - NICARDIPINE 31/01/2006
hard HYDROCHLORIDE
CORVERT Pharmacia Healthcare PA0936/088/001 Solution for Infusion - IBUTILIDE FUMARATE 31/01/2006
Ireland
ESTRACYT Pharmacia Healthcare PA0936/036/001 Capsule - ESTRAMUSTINE 31/01/2006
Ireland PHOSPHATE SODIUM
LIPOBASE Yamanouchi Pharma Ltd PA0062/029/001 Cream 31/01/2006
PARAKE Galen Limited PA0185/002/001 Tablets - PARACETAMOL 31/01/2006
- CODEINE PHOSPHATE
HEMIHYDRATE
TIMOLOL CHAUVIN Chauvin Pharmaceuticals PA0118/047/001 Eye Drops Solution - TIMOLOL MALEATE 31/01/2006
Limited
TIMOLOL CHAUVIN Chauvin Pharmaceuticals PA0118/047/002 Eye Drops Solution - TIMOLOL MALEATE 31/01/2006
Limited
CIMETIDINE Generics (UK) Limited PA0405/025/001 Tablets - CIMETIDINE 30/01/2006
CIMETIDINE Generics (UK) Limited PA0405/025/002 Tablets - CIMETIDINE 30/01/2006
CIMETIDINE Generics (UK) Limited PA0405/025/003 Coated Tablets - CIMETIDINE 30/01/2006
CYPROTERONE ACETATE Generics (UK) Limited PA0405/032/001 Tablets - CYPROTERONE 30/01/2006
ACETATE
DICLOFENAC McDermott Laboratories Ltd PA0577/019/001 Tablets - DICLOFENAC 30/01/2006
t/a Gerard Laboratories
DICLOFENAC McDermott Laboratories Ltd PA0577/019/002 Tablets - DICLOFENAC 30/01/2006
t/a Gerard Laboratories
GEROXICAM Generics (UK) Limited PA0405/026/001 Capsule - PIROXICAM 30/01/2006
GEROXICAM Generics (UK) Limited PA0405/026/002 Capsule - PIROXICAM 30/01/2006
GEROXICAM DISPERSIBLE McDermott Laboratories Ltd PA0577/012/001 Tablets - PIROXICAM 30/01/2006
t/a Gerard Laboratories
GEROXICAM DISPERSIBLE McDermott Laboratories Ltd PA0577/012/002 Tablets - PIROXICAM 30/01/2006
t/a Gerard Laboratories
GLIBENCLAMIDE McDermott Laboratories Ltd PA0577/015/001 Tablets - GLIBENCLAMIDE 30/01/2006
t/a Gerard Laboratories
IBUPROFEN Norton Healthcare Limited PA0282/010/001 Tablets - IBUPROFEN 30/01/2006
T/A IVAX Pharmaceuticals
UK
IBUPROFEN Norton Healthcare Limited PA0282/010/002 Tablets - IBUPROFEN 30/01/2006
T/A IVAX Pharmaceuticals
UK
IBUPROFEN Norton Healthcare Limited PA0282/010/003 Tablets - IBUPROFEN 30/01/2006
T/A IVAX Pharmaceuticals
UK

Human Medicines Withdrawn Products Page 282 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DISTALGESIC Napp Pharmaceuticals PA0913/020/001 Tablets - 29/01/2006
Limited DEXTROPROPOXYPHENE
HYDROCHLORIDE
- PARACETAMOL
RIMAZINE Ranbaxy Ireland Limited PA0408/021/001 Tablets - CHLORPROMAZINE 29/01/2006
CHLORPROMAZINE HYDROCHLORIDE
RIMAZINE Ranbaxy Ireland Limited PA0408/021/002 Tablets - CHLORPROMAZINE 29/01/2006
CHLORPROMAZINE HYDROCHLORIDE
RIMAZINE Ranbaxy Ireland Limited PA0408/021/003 Tablets - CHLORPROMAZINE 29/01/2006
CHLORPROMAZINE HYDROCHLORIDE
VALDERMA William Ransom & Son Plc PA0506/014/001 Cream - POTASSIUM 28/01/2006
HYDROXYQUINOLIN
SULFATE
- CHLOROCRESOL
GASTROBID CONTINUS Napp Pharmaceuticals PA0913/007/001 Tablets - METOCLOPRAMIDE 18/01/2006
Limited HYDROCHLORIDE
NITEDRI Galen Limited PA0185/034/001 Nasal Spray Solution - DESMOPRESSIN 18/01/2006
ACETATE
ACCURETIC Pfizer Healthcare Ireland PA0822/008/001 Tablets - QUINAPRIL 17/01/2006
HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

GAMMABULIN Baxter Healthcare Limited PA0167/116/001 Solution for Injection - HUMAN PLASMA 17/01/2006
PROTEIN >90% GAMMA
GLOBULIN
LORON 520 Roche Products Limited PA0050/148/002 Coated Tablets - CLODRONATE DISODIUM 17/01/2006
TETRAHYDRATE

AEROLIN AUTOHALER 3M Health Care Limited PA0057/054/006 Pressurised Inhalation - SALBUTAMOL SULFATE 16/01/2006
Suspension
EARCALM GlaxoSmithKline Consumer PA0678/083/001 Ear Spray Emulsion - ACETIC ACID 13/01/2006
Healthcare (Ireland) Limited
OTOMIZE GlaxoSmithKline Consumer PA0678/079/001 Ear Spray Emulsion - DEXAMETHASONE 11/01/2006
Healthcare (Ireland) Limited - NEOMYCIN SULFATE
- ACETIC ACID
LOWASA Mayne Pharma (Ireland) PA0422/006/001 Tablets - ACETYLSALICYLIC ACID 10/01/2006
Limited
CHENDOL CP Pharmaceuticals Ltd PA0409/004/001 Capsule - CHENODEOXYCHOLIC 09/01/2006
trading as Wockhardt UK ACID
CHENDOL CP Pharmaceuticals Ltd PA0409/004/002 Tablets - CHENODEOXYCHOLIC 09/01/2006
trading as Wockhardt UK ACID
GERIVENT Generics (UK) Limited PA0405/003/001 Pressurised Inhalation - SALBUTAMOL 09/01/2006
Suspension
BRICANYL AstraZeneca UK Limited PA0970/036/003 Solution for Injection - TERBUTALINE SULFATE 06/01/2006
INNOMEL Clonmel Healthcare Ltd PA0126/107/001 Tablets - ENALAPRIL MALEATE 06/01/2006
INNOMEL Clonmel Healthcare Ltd PA0126/107/002 Tablets - ENALAPRIL MALEATE 06/01/2006
INNOMEL Clonmel Healthcare Ltd PA0126/107/003 Tablets - ENALAPRIL MALEATE 06/01/2006
INNOMEL Clonmel Healthcare Ltd PA0126/107/004 Tablets - ENALAPRIL MALEATE 06/01/2006
OMEPRAZOLE- Ratiopharm GmbH PA0819/029/001 Capsules Gastro-Resistant - OMEPRAZOLE 06/01/2006
RATIOPHARM
OMEPRAZOLE- Ratiopharm GmbH PA0819/029/002 Capsules Gastro-Resistant - OMEPRAZOLE 06/01/2006
RATIOPHARM
ULCID Ratiopharm GmbH PA0819/021/001 Capsule - OMEPRAZOLE 06/01/2006
ANHYDROL Dermal Laboratories Ltd PA0278/007/002 Cutaneous Solution - ALUMINIUM CHLORIDE 04/01/2006
HEXAHYDRATE
DITHROGEL Dermal Laboratories Ltd PA0278/018/001 Gel - DITHRANOL 04/01/2006
DITHROGEL Dermal Laboratories Ltd PA0278/018/002 Gel - DITHRANOL 04/01/2006
DITHROGEL Dermal Laboratories Ltd PA0278/018/003 Gel - DITHRANOL 04/01/2006
DITHROGEL Dermal Laboratories Ltd PA0278/018/004 Gel - DITHRANOL 04/01/2006
DITHROGEL Dermal Laboratories Ltd PA0278/018/005 Gel - DITHRANOL 04/01/2006
DITHROGEL Dermal Laboratories Ltd PA0278/018/006 Gel - DITHRANOL 04/01/2006
ALBUTEIN 20% Instituto Grifols S.A. PA0849/005/002 Solution for Infusion - HUMAN ALBUMIN 03/01/2006
ALBUTEIN 25% Instituto Grifols S.A. PA0849/005/003 Solution for Infusion - HUMAN ALBUMIN 03/01/2006
ALBUTEIN 5% Instituto Grifols S.A. PA0849/005/001 Solution for Infusion - HUMAN ALBUMIN 03/01/2006
NUVELLE HE Clissmann PA0012/073/001 Tablets - ESTRADIOL VALERATE 03/01/2006
- ESTRADIOL VALERATE
- LEVONORGESTREL
RAPIFEN TM Janssen-Cilag Ltd PA0748/040/002 Solution for Inj/Inf - ALFENTANIL 03/01/2006
HYDROCHLORIDE
ASCAL MEDA Pharmaceuticals Ltd PA1058/001/001 Powder for Oral Solution - CARBASALATE CALCIUM 02/01/2006

CRYSTACIDE Bioglan Laboratories Ltd PA0469/016/001 Cream - HYDROGEN PEROXIDE 02/01/2006

Human Medicines Withdrawn Products Page 283 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHARMATON VIT-AL PLUS Boehringer Ingelheim Limited PA0007/059/001 Tablets - PANAX GINSENG 01/01/2006
- BETACAROTENE
- COLECALCIFEROL
- TOCOPHERYL ACETATE
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- BIOTIN
- NICOTINAMIDE
- ASCORBIC ACID
- FOLIC ACID
- COPPER SULFATE
- SODIUM SELENITE
- MANGANESE SULPHATE
MONOHYDRATE
- MAGNESIUM OXIDE
HEAVY
- FERROUS SULFATE
EXSICCATED
- ZINC SULFATE
- CALCIUM PHOSPHATE
DIBASIC

BONEFOS Boehringer Ingelheim Limited PA0007/047/001 Capsule - CLODRONATE DISODIUM 31/12/2005


TETRAHYDRATE

BONEFOS Boehringer Ingelheim Limited PA0007/047/002 Solution for Infusion - CLODRONATE DISODIUM 31/12/2005
TETRAHYDRATE

PHYLLOCONTIN Napp Pharmaceuticals PA0913/003/001 Tablets - AMINOPHYLLINE 31/12/2005


PAEDIATRIC CONTINUS Limited HYDRATE
TRANXENE Boehringer Ingelheim Limited PA0007/004/001 Capsule - CLORAZEPATE 31/12/2005
DIPOTASSIUM
ACTRAPID Novo Nordisk A/S PA0218/025/001 Solution for Injection - INSULIN HUMAN 28/12/2005
ACTRAPID NOVOLET Novo Nordisk A/S PA0218/025/005 Solution for Injection - INSULIN HUMAN 28/12/2005
ACTRAPID PENFILL Novo Nordisk A/S PA0218/025/004 Solution for Injection - INSULIN HUMAN 28/12/2005
INSULATARD 100IU Novo Nordisk A/S PA0218/026/001 Suspension for Injection - INSULIN HUMAN 28/12/2005
INSULATARD NOVOLET 3 Novo Nordisk A/S PA0218/026/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
ML
INSULATARD PENFILL Novo Nordisk A/S PA0218/026/004 Suspension for Injection - INSULIN HUMAN 28/12/2005
100IU
MIXTARD 10 NOVOLET Novo Nordisk A/S PA0218/033/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
3ML
MIXTARD 20 NOVOLET Novo Nordisk A/S PA0218/034/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
100IU/ML
MIXTARD 20 PENFILL 3ML Novo Nordisk A/S PA0218/034/004 Suspension for Injection - INSULIN HUMAN 28/12/2005
MIXTARD 30 NOVOLET Novo Nordisk A/S PA0218/029/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
100IU/ML
MIXTARD 30 PENFILL 3ML Novo Nordisk A/S PA0218/029/004 Suspension for Injection - INSULIN HUMAN 28/12/2005
MIXTARD 40 NOVOLET Novo Nordisk A/S PA0218/035/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
3ML
MIXTARD 40 PENFILL 3ML Novo Nordisk A/S PA0218/035/004 Suspension for Injection - INSULIN HUMAN 28/12/2005
MIXTARD 50 NOVOLET Novo Nordisk A/S PA0218/036/005 Suspension for Injection - INSULIN HUMAN 28/12/2005
3ML
MONOTARD INSULIN Novo Nordisk A/S PA0218/024/001 Suspension for Injection - INSULIN HUMAN 28/12/2005
ULTRATARD 100IU/ML Novo Nordisk A/S PA0218/027/001 Suspension for Injection - INSULIN HUMAN 28/12/2005
CITALOPRAM Clonmel Healthcare Ltd PA0126/145/001 Tablets - CITALOPRAM 21/12/2005
CITALOPRAM Clonmel Healthcare Ltd PA0126/145/002 Tablets - CITALOPRAM 21/12/2005
CITALOPRAM Clonmel Healthcare Ltd PA0126/145/003 Tablets - CITALOPRAM 21/12/2005
DICLOMEL 100 Clonmel Healthcare Ltd PA0126/082/005 Suppositories - DICLOFENAC SODIUM 21/12/2005
DICLOMEL 50 Clonmel Healthcare Ltd PA0126/082/004 Suppositories - DICLOFENAC SODIUM 21/12/2005
VIAZEM XL Clonmel Healthcare Ltd PA0126/109/001 Capsule - DILTIAZEM 21/12/2005
HYDROCHLORIDE
VIAZEM XL Clonmel Healthcare Ltd PA0126/109/002 Capsule - DILTIAZEM 21/12/2005
HYDROCHLORIDE
VIAZEM XL Clonmel Healthcare Ltd PA0126/109/003 Capsule - DILTIAZEM 21/12/2005
HYDROCHLORIDE
VIAZEM XL Clonmel Healthcare Ltd PA0126/109/004 Capsule - DILTIAZEM 21/12/2005
HYDROCHLORIDE
VIAZEM XL Clonmel Healthcare Ltd PA0126/109/005 Capsule - DILTIAZEM 21/12/2005
HYDROCHLORIDE
RANITIC Rowex Ltd PA0711/024/003 Solution for Injection - RANITIDINE 20/12/2005
RIMACILIN AMPICILLIN Ranbaxy Ireland Limited PA0408/001/003 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE 20/12/2005
MIXTURE BP

Human Medicines Withdrawn Products Page 284 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BECOTIDE 250 INHALER PCO Manufacturing PPA0465/041/004A Pressurised Inhalation - BECLOMETASONE 19/12/2005
Suspension
TAMOXIFEN Excella GmbH PA0282/057/001 Coated Tablets - TAMOXIFEN CITRATE 13/12/2005
TAMOXIFEN Norton Healthcare Limited PA0282/057/002 Coated Tablets - TAMOXIFEN CITRATE 13/12/2005
T/A IVAX Pharmaceuticals
UK
TAMOXIFEN Norton Healthcare Limited PA0282/057/003 Coated Tablets - TAMOXIFEN CITRATE 13/12/2005
T/A IVAX Pharmaceuticals
UK
AMOXYCILLIN Clonmel Healthcare Ltd PA0126/090/001 Oral Suspension - AMOXICILLIN 09/12/2005
TRIHYDRATE
AMOXYCILLIN Clonmel Healthcare Ltd PA0126/090/002 Oral Suspension - AMOXICILLIN 09/12/2005
TRIHYDRATE
CIDOMEL Clonmel Healthcare Ltd PA0126/029/001 Capsule - INDOMETACIN 09/12/2005
MELZINE Clonmel Healthcare Ltd PA0126/025/003 Tablets - THIORIDAZINE 09/12/2005
HYDROCHLORIDE
XANOMEL Clonmel Healthcare Ltd PA0126/097/002 Tablets - RANITIDINE 09/12/2005
HYDROCHLORIDE
INAMIDE McDermott Laboratories Ltd PA0577/009/001 Tablets - INDAPAMIDE 07/12/2005
t/a Gerard Laboratories
DOXORUBICIN Hospira UK Limited PA0437/026/001 Pdr for Soln for Injection - DOXORUBICIN 06/12/2005
HYDROCHLORIDE FOR HYDROCHLORIDE
INJECTION
TRITACE PCO Manufacturing PPA0465/163/001 Capsule - RAMIPRIL 05/12/2005
APRESOLINE Novartis Pharmaceuticals UK PA0013/064/001 Coated Tablets - HYDRALAZINE 01/12/2005
Ltd HYDROCHLORIDE
HIVID Roche Products Limited PA0050/089/001 Tablets - ZALCITABINE 30/11/2005
HIVID Roche Products Limited PA0050/089/002 Tablets - ZALCITABINE 30/11/2005
TICINAN SUSTAINED Lannacher Heilmittel PA0947/001/001 Tablets - MORPHINE 30/11/2005
RELEASE Ges.m.b.H HYDROCHLORIDE
TICINAN SUSTAINED Lannacher Heilmittel PA0947/001/002 Tablets - MORPHINE 30/11/2005
RELEASE Ges.m.b.H HYDROCHLORIDE
TICINAN SUSTAINED Lannacher Heilmittel PA0947/001/003 Tablets - MORPHINE 30/11/2005
RELEASE Ges.m.b.H HYDROCHLORIDE
TICINAN SUSTAINED Lannacher Heilmittel PA0947/001/004 Tablets - MORPHINE 30/11/2005
RELEASE Ges.m.b.H HYDROCHLORIDE
TICINAN SUSTAINED Lannacher Heilmittel PA0947/001/005 Tablets - MORPHINE 30/11/2005
RELEASE Ges.m.b.H HYDROCHLORIDE
NEULACTIL May & Baker Limited PA0040/021/004 Tablets - PERICIAZINE 22/11/2005
ARYTHMOL Abbott Laboratories Ireland PA0038/079/001 Solution for Injection - PROPAFENONE 21/11/2005
Ltd HYDROCHLORIDE
HEMOHES 10% B. Braun Melsungen AG PA0736/001/002 Solution for Infusion - HETASTARCH 21/11/2005
- SODIUM CHLORIDE
HEMOHES 6% B. Braun Melsungen AG PA0736/001/001 Solution for Infusion - POLY(O-2- 21/11/2005
HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

PREFERIN - A TOPICAL Allergan Pharmaceuticals PA0148/034/001 Eye Drops Solution - MEPYRAMINE MALEATE 21/11/2005
OPHTHALMIC Ireland - PHENYLEPHRINE
HYDROCHLORIDE
VOLOGEN Mercury Pharmaceuticals PA0073/133/005 Solution for Injection - DICLOFENAC SODIUM 12/11/2005
(Ireland) Ltd
SALOMOL INHALER Norton Waterford PA0436/007/001 Pressurised Inhalation - SALBUTAMOL 11/11/2005
Suspension
TETRACYCLINE Athlone Laboratories Ltd PA0298/004/001 Capsule - TETRACYCLINE 11/11/2005
HYDROCHLORIDE
AMOXIL GlaxoSmithKline (Ireland) PA1077/033/003 Pdr for Soln for Injection - AMOXICILLIN SODIUM 10/11/2005
Limited
NAPROXEN Norton Healthcare Limited PA0282/042/001 Tablets - NAPROXEN 10/11/2005
T/A IVAX Pharmaceuticals
UK
NAPROXEN Norton Healthcare Limited PA0282/042/002 Tablets - NAPROXEN 10/11/2005
T/A IVAX Pharmaceuticals
UK
OPTIMAX WITHOUT E. Merck Ltd PA0054/009/002 Tablets - TRYPTOPHAN, L- 10/11/2005
VITAMINS
ROBINUL A.H. Robins Company PA0086/008/005 Tablets - GLYCOPYRRONIUM 10/11/2005
Limited BROMIDE
ZINNAT GlaxoSmithKline (Ireland) PA1077/015/006 Granules for Oral - CEFUROXIME AXETIL 10/11/2005
Limited Suspension
CO-BETALOC Pharmacia Healthcare PA0936/021/001 Tablets - METOPROLOL TARTRATE 09/11/2005
Ireland - HYDROCHLOROTHIAZIDE

HAES STERIL Fresenius Kabi Limited PA0566/001/001 Solution for Infusion - PENTASTARCH 07/11/2005
- SODIUM CHLORIDE

Human Medicines Withdrawn Products Page 285 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HAES STERIL Fresenius Kabi Limited PA0566/001/002 Solution for Infusion - PENTASTARCH 07/11/2005
- SODIUM CHLORIDE
MINIHEP SODIUM Leo Laboratories Limited PA0046/035/002 Solution for Injection - HEPARIN SODIUM 07/11/2005
CONOTRANE Yamanouchi Pharma Ltd PA0062/038/001 Cream - BENZALKONIUM 04/11/2005
CHLORIDE
- DIMETICONE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/001 Coated Tablets - THIORIDAZINE 04/11/2005
Ltd HYDROCHLORIDE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/002 Coated Tablets - THIORIDAZINE 04/11/2005
Ltd HYDROCHLORIDE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/003 Coated Tablets - THIORIDAZINE 04/11/2005
Ltd HYDROCHLORIDE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/004 Coated Tablets - THIORIDAZINE 04/11/2005
Ltd HYDROCHLORIDE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/005 Syrup - THIORIDAZINE 04/11/2005
Ltd HYDROCHLORIDE
EPSOM SALTS PH. EUR East Wall Manufacturing PA0388/006/001 Powder for Oral Solution - MAGNESIUM SULFATE 03/11/2005
CUREA Foran Healthcare Limited PA0484/013/001 Cream - COAL TAR SOLUTION 02/11/2005
- UREA
TAR POMADE Foran Healthcare Limited PA0484/026/001 Ointment - COAL TAR SOLUTION 02/11/2005
- SALICYLIC ACID
TRIODENE HE Clissmann PA0012/065/001 Tablets - ETHINYLESTRADIOL 02/11/2005
- GESTODENE
- ETHINYLESTRADIOL
- GESTODENE
- ETHINYLESTRADIOL
- GESTODENE
MIXTARD 30 INSULIN Novo Nordisk A/S PA0218/029/001 Suspension for Injection - INSULIN HUMAN 31/10/2005
MODECATE Bristol-Myers Squibb PA0002/031/007 Concentrate for Soln for Inj - FLUPHENAZINE 28/10/2005
Pharmaceuticals uc DECANOATE
BIOVITAL Roche Products Limited PA0050/139/002 Tablets - FERRIC SODIUM 26/10/2005
CITRATE
- THIAMINE MONONITRATE
- ASCORBIC ACID
- RIBOFLAVIN
- MANGANESE CITRATE
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- CYANOCOBALAMIN

ETHRANE Abbott Laboratories Ireland PA0038/018/001 Inhalation vapour, liquid - ENFLURANE 18/10/2005
Ltd
ONE-ALPHA Leo Laboratories Limited PA0046/024/006A Solution for Injection - ALFACALCIDOL 18/10/2005
ORUVAIL-100 SR May & Baker Limited PA0040/070/001 Modified-release capsule, - KETOPROFEN 18/10/2005
hard
METROLYL Sandoz Ltd PA0372/001/001 Solution for infusion - Metronidazole 17/10/2005
METROLYL Sandoz Ltd PA0372/001/002 Solution for infusion - Metronidazole 17/10/2005
STUGERON FORTE Janssen-Cilag Ltd PA0748/023/003 Capsule - CINNARIZINE 15/10/2005
BECOTIDE 100 INHALER Primecrown Ltd. PPA1071/010/002A Pressurised Inhalation - BECLOMETASONE 13/10/2005
Suspension DIPROPIONATE
BECOTIDE 50 INHALER Primecrown Ltd. PPA1071/010/001A Pressurised Inhalation - BECLOMETASONE 13/10/2005
Suspension DIPROPIONATE
BRUFEN RETARD Primecrown Ltd. PPA1071/013/001A Tablets - IBUPROFEN 13/10/2005
PROTHIADEN Primecrown Ltd. PPA1071/008/001A Coated Tablets - DOSULEPIN 13/10/2005
HYDROCHLORIDE
PROTIUM Primecrown Ltd. PPA1071/006/001A Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM 13/10/2005
HYDRATE
PROTIUM Primecrown Ltd. PPA1071/006/002A Tablets - PANTOPRAZOLE SODIUM 13/10/2005
HYDRATE
TAGAMET Primecrown Ltd. PPA1071/012/001A Tablets - CIMETIDINE 13/10/2005
ACTILYSE Boehringer Ingelheim Limited PA0007/043/004 Pdr+Solv for Soln for Inj - ALTEPLASE 12/10/2005

NICOBREVIN Nicobrevin UK Limited PA0541/001/001 Capsule - QUININE 12/10/2005


- MENTHYL VALERATE
- CAMPHOR
- OIL OF EUCALIPTUS
OSMOFUNDIN B. Braun Medical Limited PA0179/008/004 Unknown - MANNITOL 12/10/2005
- SODIUM CHLORIDE
- SODIUM ACETATE
CEFZIL Bristol-Myers Squibb PA0002/065/001 Tablets - CEFPROZIL 07/10/2005
Pharmaceuticals uc
CEFZIL Bristol-Myers Squibb PA0002/065/002 Tablets - CEFPROZIL 07/10/2005
Pharmaceuticals uc
CEFZIL Bristol-Myers Squibb PA0002/065/003 Oral Suspension - CEFPROZIL 07/10/2005
Pharmaceuticals uc

Human Medicines Withdrawn Products Page 286 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CEFZIL Bristol-Myers Squibb PA0002/065/004 Oral Suspension - CEFPROZIL 07/10/2005
Pharmaceuticals uc
PHARMORUBICIN Pharmacia Healthcare PA0936/043/005 Solution for Infusion - EPIRUBICIN 07/10/2005
Ireland HYDROCHLORIDE
PHARMORUBICIN 10 Pharmacia Healthcare PA0936/043/001 Pdr for Soln for Injection - EPIRUBICIN 07/10/2005
Ireland HYDROCHLORIDE
PHARMORUBICIN 50 Pharmacia Healthcare PA0936/043/002 Pdr for Soln for Injection - EPIRUBICIN 07/10/2005
Ireland HYDROCHLORIDE
VERELAN Elan Pharma Ltd PA0516/007/001 Capsule - VERAPAMIL 07/10/2005
HYDROCHLORIDE
VERELAN Elan Pharma Ltd PA0516/007/002 Capsule - VERAPAMIL 07/10/2005
HYDROCHLORIDE
VERELAN Elan Pharma Ltd PA0516/007/003 Capsule - VERAPAMIL 07/10/2005
HYDROCHLORIDE
BOOSTRIX GlaxoSmithKline (Ireland) PA1077/020/002 Suspension for Injection - DIPHTHERIA TOXOID 05/10/2005
Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
BOOSTRIX POLIO (GLASS GlaxoSmithKline (Ireland) PA1077/101/002 Solution for Injection - DIPHTHERIA TOXOID 05/10/2005
VIALS) Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN (PRN, OR
69KDA OMP)
- POLIO VIRUS TYPE 1
INACTIVATED
- POLIO VIRUS TYPE 2
INACTIVATED
- POLIO VIRUS TYPE 3
INACTIVATED
INFANRIX SINGLE-DOSE GlaxoSmithKline (Ireland) PA1077/030/001 Suspension for Injection - DIPHTHERIA TOXOID 05/10/2005
VIAL Limited - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
INFANRIX-HIB GlaxoSmithKline (Ireland) PA1077/028/001 Pdr+Solv for Susp for Inj - PERTUSSIS TOXOID 05/10/2005
Limited - FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- DIPHTHERIA TOXOID
- TETANUS TOXOID
- HAEMOPHILUS
INFLUENZAE TYPE B,
CONJUGATE WITH
TETANUS PROTEIN
ZYDOL Grünenthal Ltd PA1189/001/003 Solution for Injection - TRAMADOL 01/10/2005
HYDROCHLORIDE
ZYDOL SOLUBLE Grünenthal Ltd PA1189/001/005 Tablets - TRAMADOL 01/10/2005
HYDROCHLORIDE
AVOMINE Manx Pharma Limited PA0903/002/001 Tablets - PROMETHAZINE 30/09/2005
TEOCLATE
BRULIDINE Manx Pharma Limited PA0903/001/001 Cream - DIBROMPROPAMIDINE 30/09/2005
ISETIONATE
CEPLAC Manx Pharma Limited PA0903/003/001 Tablets Chewable - ERYTHROSINE 30/09/2005
CODAFEN CONTINUS Napp Pharmaceuticals PA0913/009/001 Tablets - IBUPROFEN 30/09/2005
Limited - CODEINE PHOSPHATE
LOSEC AstraZeneca UK Limited PA0970/044/001 Capsules Gastro-Resistant - OMEPRAZOLE 30/09/2005
LOSEC AstraZeneca UK Limited PA0970/044/002 Capsules Gastro-Resistant - OMEPRAZOLE 30/09/2005
LOSEC AstraZeneca UK Limited PA0970/044/003 Capsules Gastro-Resistant - OMEPRAZOLE 30/09/2005
MELDOPA Clonmel Healthcare Ltd PA0126/022/001 Tablets - METHYLDOPA 29/09/2005
MELDOPA Clonmel Healthcare Ltd PA0126/022/002 Tablets - METHYLDOPA 29/09/2005
MORSTEL SR Clonmel Healthcare Ltd PA0126/106/001 Tablet Prolonged Release - MORPHINE SULFATE 29/09/2005
MORSTEL SR Clonmel Healthcare Ltd PA0126/106/002 Tablet Prolonged Release - MORPHINE SULFATE 29/09/2005
MORSTEL SR Clonmel Healthcare Ltd PA0126/106/003 Tablet Prolonged Release - MORPHINE SULFATE 29/09/2005
MORSTEL SR Clonmel Healthcare Ltd PA0126/106/004 Tablet Prolonged Release - MORPHINE SULFATE 29/09/2005
NAPMEL EC Clonmel Healthcare Ltd PA0126/044/003 Tablets - NAPROXEN 29/09/2005
NAPMEL EC Clonmel Healthcare Ltd PA0126/044/005 Tablets - NAPROXEN 29/09/2005
VERTAMEL Clonmel Healthcare Ltd PA0126/101/001 Tablets - BETAHISTINE 29/09/2005
HYDROCHLORIDE
VERTAMEL Clonmel Healthcare Ltd PA0126/101/002 Tablets - BETAHISTINE 29/09/2005
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 287 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DHC CONTINUS Napp Pharmaceuticals PA0913/008/002 Tablets - DIHYDROCODEINE 27/09/2005
Limited BITARTRATE
DHC CONTINUS Napp Pharmaceuticals PA0913/008/003 Tablets - DIHYDROCODEINE 27/09/2005
Limited BITARTRATE
SERDOLECT H. Lundbeck A/S PA0805/001/002 Tablets - SERTINDOLE 27/09/2005
SERDOLECT H. Lundbeck A/S PA0805/001/006 Tablets - SERTINDOLE 27/09/2005
ASCORBIC ACID Ranbaxy Ireland Limited PA0408/008/001 Tablets - ASCORBIC ACID 20/09/2005
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/007 Solution for Injection - BUPIVACAINE 20/09/2005
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/009 Solution for Injection - BUPIVACAINE 20/09/2005
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
VISIPAQUE GE Healthcare AS PA0735/009/001 Solution for Injection - IODIXANOL 19/09/2005
VISIPAQUE GE Healthcare AS PA0735/009/011 Solution for Injection - IODIXANOL 19/09/2005
RHEUMOX Mercury Pharmaceuticals Ltd PA0899/006/001 Capsule - AZAPROPAZONE 17/09/2005
DIHYDRATE
DOLOXENE Eli Lilly and Company Limite PA0047/028/001 Capsule - 16/09/2005
DEXTROPROPOXYPHENE
NAPSILATE
TRICLORYL Galen Limited PA0185/032/001 Syrup - TRICLOFOS SODIUM 12/09/2005
LORAMET John Wyeth & Brother PA0022/037/001 Tablets - LORMETAZEPAM 09/09/2005
Limited
SODIUM CROMOGLYCATE Pliva Pharma Limited PA0585/006/001 Eye Drops Solution - CROMOGLICATE SODIUM 06/09/2005

URIMIN Chiesi Limited PA0743/009/002 Tablets - OXYBUTYNIN 05/09/2005


HYDROCHLORIDE
MORCAP SR Hospira UK Limited PA0437/035/001 Capsule - MORPHINE SULFATE 01/09/2005
MORCAP SR Hospira UK Limited PA0437/035/002 Capsule - MORPHINE SULFATE 01/09/2005
MORCAP SR Hospira UK Limited PA0437/035/003 Capsule - MORPHINE SULFATE 01/09/2005
ACUPAN 3M Health Care Limited PA0057/061/001 Solution for Injection - NEFOPAM 24/08/2005
HYDROCHLORIDE
AMIKACIN Hospira UK Limited PA0437/032/001 Solvent for Parenteral Use - AMIKACIN SULFATE 15/08/2005
ETOPOSIDE Hospira UK Limited PA0437/047/001 Solution for Infusion - ETOPOSIDE 15/08/2005
DISPRIN EXTRA Reckitt Benckiser Ireland Ltd PA0979/019/001 Tablets - ACETYLSALICYLIC ACID 10/08/2005
- PARACETAMOL
NIFEDIPINE Teva Pharma B.V. PA0282/052/001 Capsule - NIFEDIPINE 10/08/2005
NIFEDIPINE Norton Healthcare Limited PA0282/052/002 Capsule - NIFEDIPINE 10/08/2005
T/A IVAX Pharmaceuticals
UK
DILZEM ONCE DAILY Elan Pharma Ltd PA0516/016/001 Capsule - DILTIAZEM 08/08/2005
HYDROCHLORIDE
SALAZOPYRIN Pharmacia Laboratories PA0187/051/005 Rectal Solution - SULFASALAZINE 26/07/2005
Limited
ACICLOVIR Winthrop Pharmaceuticals PA1046/004/002 Tablets - ACICLOVIR 25/07/2005
UK Limited
COLESTID Pharmacia Limited PA0016/004/001 Granules for Oral - COLESTIPOL 20/07/2005
Suspension HYDROCHLORIDE
PHENYTOIN Hospira UK Limited PA0437/034/001 Solution for Injection - PHENYTOIN SODIUM 12/07/2005
ALCODERM Galderma (UK) Ltd PA0590/001/001 Cream - PARAFFIN, LIQUID 04/07/2005
ALCODERM LOTION Galderma (UK) Ltd PA0590/001/002 Cutaneous Solution - PARAFFIN, LIQUID 04/07/2005
IONAX SCRUB Galderma (UK) Ltd PA0590/002/001 Cream - BENZALKONIUM 04/07/2005
CHLORIDE
- ETHANOL
- POLYETHYLENE
IONIL T Galderma (UK) Ltd PA0590/003/001 Shampoo - COAL TAR SOLUTION 04/07/2005
- POLYETHYLENE GLYCOL
4 LAURYL ETHA
- POLYETHYLENE GLYCOL
24 LAURYL ETHA
- SALICYLIC ACID
- BENZALKONIUM
CHLORIDE
PSORIGEL Galderma (UK) Ltd PA0590/005/001 Gel - COAL TAR SOLUTION 04/07/2005
FENTANYL CITRATE Hospira UK Limited PA0437/020/001 Solution for Injection - FENTANYL CITRATE 01/07/2005
FENTANYL CITRATE Hospira UK Limited PA0437/020/002 Solution for Injection - FENTANYL CITRATE 01/07/2005
MUCOLEX McNeil Healthcare (Ireland) PA0823/025/002 Syrup - CARBOCISTEINE 01/07/2005
Ltd
NEO-MEDRONE ACNE Pharmacia Limited PA0016/013/001 Cutaneous Suspension - METHYLPREDNISOLONE 01/07/2005
ACETATE
- NEOMYCIN SULFATE
- SULFUR
- ALUMINIUM
CHLORHYDROXIDE-
COMPLEX

Human Medicines Withdrawn Products Page 288 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BENADRYL McNeil Healthcare (Ireland) PA0823/015/001 Capsule - DIPHENHYDRAMINE 30/06/2005
Ltd HYDROCHLORIDE
GELCOTAR Ecolab Limited PA1110/007/001 Gel - COAL TAR SOLUTION 28/06/2005
STRONG
- COAL TAR
EXELDERM Bioglan Laboratories Ltd PA0469/034/001 Cream - SULCONAZOLE NITRATE 27/06/2005

DOLOBID Merck Sharp and Dohme PA0035/014/004 Tablets - DIFLUNISAL 24/06/2005


Limited
CLINIMYCIN Galen Limited PA0185/033/001 Tablets - OXYTETRACYCLINE 13/06/2005
DIHYDRATE
DF 118 Galen Limited PA0185/030/001 Solution for Injection - DIHYDROCODEINE 13/06/2005
BITARTRATE
DYNESE ANTACID Galen Limited PA0185/015/001 Oral Suspension - MAGALDRATE 13/06/2005
EXPULIN DRY COUGH Galen Limited PA0185/021/002 Oral Suspension - PHOLCODINE 13/06/2005
EXPULIN DRY COUGH Galen Limited PA0185/021/001 Oral Suspension - PHOLCODINE 13/06/2005
PAEDIATRIC
GALENAMET Galen Limited PA0185/023/001 Tablets - CIMETIDINE 13/06/2005
GALENAMET Galen Limited PA0185/023/002 Tablets - CIMETIDINE 13/06/2005
GALENAMET Galen Limited PA0185/023/003 Tablets - CIMETIDINE 13/06/2005
MINOGAL Galen Limited PA0185/029/001 Tablets - MINOCYCLINE 13/06/2005
HYDROCHLORIDE
MINOGAL Galen Limited PA0185/029/002 Tablets - MINOCYCLINE 13/06/2005
HYDROCHLORIDE
VERUCASEP Galen Limited PA0185/013/001 Gel - GLUTARAL 13/06/2005
RHEUMOX Mercury Pharmaceuticals Ltd PA0899/006/002 Coated Tablets - AZAPROPAZONE 04/06/2005
DIHYDRATE
PENTACARINAT May & Baker Limited PA0040/086/001 Tablets - PENTAMIDINE 29/05/2005
ISETHIONATE
FENOFIBRATE Ethypharm PA0549/010/001 Capsule - FENOFIBRATE 23/05/2005
ETHYPHARM
TETABULIN Immuno Limited PA0212/008/001 Unknown - GAMMA GLOBULIN 19/05/2005
- TETANUS ANTIBODIES
PINALGESIC Pinewood Laboratories Ltd, PA0281/044/002 Tablets - MEFENAMIC ACID 10/05/2005
PINAMET Pinewood Laboratories Ltd, PA0281/092/001 Tablets - CIMETIDINE 10/05/2005
AILAX Galen Limited PA0185/037/001 Oral Suspension - DANTRON 09/05/2005
- POLOXALCOL
AILAX FORTE Galen Limited PA0185/037/002 Oral Suspension - DANTRON 09/05/2005
- POLOXAMER
BAXTER PROPOFOL Baxter Healthcare Limited PA0167/111/001 Emulsion for Inj/Inf - PROPOFOL 09/05/2005
BAXTER PROPOFOL Baxter Healthcare Limited PA0167/111/002 Emulsion for Infusion - PROPOFOL 09/05/2005
FIBERCON Pfizer Consumer Healthcare PA0172/030/001 Tablets - POLYCARBOPHIL 09/05/2005
Ltd CALCIUM
GYNO TROSYL VAGINAL Pfizer Limited PA0019/033/004 Vaginal capsule, soft - TIOCONAZOLE 06/05/2005
OVULES
GYNO-TROSYL VAGINAL Pfizer Limited PA0019/033/005 Vaginal capsule, soft - TIOCONAZOLE 06/05/2005
OVULES
PACLITAXEL INJECTION Bristol-Myers Squibb PA0002/076/001 Concentrate for Soln for Inf - PACLITAXEL 06/05/2005
CONCENTRATE Pharmaceuticals uc
PERICAM 10 Clonmel Healthcare Ltd PA0126/080/001 Capsule - PIROXICAM 03/05/2005
PERICAM 20 Clonmel Healthcare Ltd PA0126/080/002 Capsule - PIROXICAM 03/05/2005
TRIMOPAN (SUSPENSION) Pinewood Laboratories Ltd, PA0281/094/001 Oral Suspension - TRIMETHOPRIM 03/05/2005

NALOXONE Hospira UK Limited PA0437/024/001 Solution for Injection - NALOXONE 23/04/2005


HYDROCHLORIDE HYDROCHLORIDE
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/001 Tablet Prolonged Release - GLYCERYL TRINITRATE 21/04/2005
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/004 Tablet Prolonged Release - GLYCERYL TRINITRATE 21/04/2005
FLEXIN CONTINUS Napp Pharmaceuticals PA0913/010/001 Tablets - INDOMETACIN 20/04/2005
Limited
FLEXIN CONTINUS Napp Pharmaceuticals PA0913/010/002 Tablets - INDOMETACIN 20/04/2005
Limited
FLEXIN CONTINUS Napp Pharmaceuticals PA0913/010/003 Tablets - INDOMETACIN 20/04/2005
Limited
ALPHARUBICIN Ebewe Pharma Ges.m.b.H PA0789/008/001 Solution for Infusion - DOXORUBICIN 13/04/2005
Nfg. KG HYDROCHLORIDE
BETARUBICIN Ebewe Pharma Ges.m.b.H PA0789/009/001 Solution for Infusion - DOXORUBICIN 13/04/2005
Nfg. KG HYDROCHLORIDE
EBEDOX Ebewe Pharma Ges.m.b.H PA0789/010/001 Solution for Infusion - DOXORUBICIN 13/04/2005
Nfg. KG HYDROCHLORIDE
STARIL Bristol-Myers Squibb PA0002/056/002 Tablets - FOSINOPRIL SODIUM 13/04/2005
Pharmaceuticals uc
STARIL Bristol-Myers Squibb PA0002/056/003 Tablets - FOSINOPRIL SODIUM 13/04/2005
Pharmaceuticals uc
GALLIUM CITRATE CIS bio International PA0677/012/001 Solution for Injection - GALLIUM (67 GA) 12/04/2005
CITRATE

Human Medicines Withdrawn Products Page 289 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STADOL Bristol-Myers Squibb PA0002/066/001 Nasal Spray Solution - BUTORPHANOL 12/04/2005
Pharmaceuticals uc TARTRATE
FOLEX-350 Rybar Laboratories Ltd PA0003/004/001 Tablets - FERROUS FUMARATE 01/04/2005
- FOLIC ACID
PLESMET Archimedes Pharma UK PA0757/002/001 Syrup - FERROUS GLYCINE 01/04/2005
Limited SULFATE
PRONESTYL Bristol-Myers Squibb PA0002/034/001 Tablets - PROCAINAMIDE 01/04/2005
Pharmaceuticals uc HYDROCHLORIDE
CREMALGIN BALM Strides Shasun (UK) Ltd PA0894/001/001 Ointment - METHYL NICOTINATE 31/03/2005
- CAPSICUM FRUTESCENS
- GLYCOL
MONOSALICYLATE

DIGOXIN Mercury Pharmaceuticals PA0073/056/001 Tablets - DIGOXIN 31/03/2005


(Ireland) Ltd
NUTRIZYM E. Merck Ltd PA0054/064/001 Capsule - PANCREATIN 31/03/2005
WINRHO SDF Cangene Europe Limited PA1027/001/001 Pdr+Solv for soln for inf/inj - ANTI-D 31/03/2005
IMMUNOGLOBULIN
WINRHO SDF Cangene Europe Limited PA1027/001/002 Pdr+Solv for soln for inf/inj - ANTI-D 31/03/2005
IMMUNOGLOBULIN
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/004 Solution for Injection - BUPIVACAINE 26/03/2005
HYDROCHLOIDE (Ireland) Ltd HYDROCHLORIDE
BUPIVACAINE Mercury Pharmaceuticals PA0073/091/003 Solution for Injection - BUPIVACAINE 26/03/2005
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
SINUTAB McNeil Healthcare (Ireland) PA0823/028/001 Tablets - PARACETAMOL 26/03/2005
Ltd -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
VEGANIN McNeil Healthcare (Ireland) PA0823/027/001 Tablets - ACETYLSALICYLIC ACID 26/03/2005
Ltd - PARACETAMOL
- CODEINE PHOSPHATE
SERENACE AMPOULES Norton Healthcare Limited PA0282/063/002 Solution for Injection - HALOPERIDOL 23/03/2005
T/A IVAX Pharmaceuticals
UK
AMINOPLASMAL B. Braun Medical Limited PA0179/039/001 Solution for Infusion - ISOLEUCINE 20/03/2005
- LEUCINE
- LYSINE
HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- ALANINE
- PROLINE
- ASPARTIC ACID
- ASPARAGINE
- ACETYLCYSTEINE
- GLUTAMIC ACID
- ORNITHINE
HYDROCHLORIDE
- SERINE
- TYROSINE
- AMINOACETIC ACID
- ACETYLTYROSINE

Human Medicines Withdrawn Products Page 290 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMINOPLASMAL - E B. Braun Medical Limited PA0179/040/001 Solution for Infusion - ISOLEUCINE 20/03/2005
- LEUCINE
- LYSINE
HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- ALANINE
- PROLINE
- ASPARTIC ACID
- ASPARAGINE
- ACETYLCYSTEINE
- GLUTAMIC ACID
- ORNITHINE
HYDROCHLORIDE
- SERINE
- TYROSINE
- AMINOACETIC ACID
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM ACETATE
- MAGNESIUM ACETATE
TETRAHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- SODIUM HYDROXIDE
- MALIC ACID
EUHYPNOS ELIXIR Pharmacia Healthcare PA0936/054/001 Oral Solution - TEMAZEPAM 18/03/2005
Ireland
FUCIDIN Leo Laboratories Limited PA0046/004/004 Gel - FUSIDIC ACID 16/03/2005
BECODISKS Allen and Hanburys Limited PA0024/019/003 Inhalation powder - BECLOMETASONE 14/03/2005
DIPROPIONATE
MONOHYDRATE
AUDICORT EAR Cyanamid of Great Britain PA0037/062/001 Ear Drops Solution - TRIAMCINOLONE 11/03/2005
ACETONIDE
- NEOMYCIN UNDECYLATE

BONEFOS Boehringer Ingelheim Limited PA0007/047/003 Tablets - CLODRONATE DISODIUM 11/03/2005


TETRAHYDRATE

ALPHOSYL HC GlaxoSmithKline Consumer PA0678/087/001 Cream - HYDROCORTISONE 10/03/2005


Healthcare (Ireland) Limited - COAL TAR
CO-BRUFEN Abbott Laboratories Ireland PA0038/078/001 Tablets - IBUPROFEN 10/03/2005
Ltd - CODEINE PHOSPHATE
HEMIHYDRATE
GASTROCOTE Thornton & Ross Limited PA0610/010/001 Tablets - ALGINIC ACID 07/03/2005
- ALUMINIUM HYDROXIDE
- MAGNESIUM TRISILICATE
- SODIUM BICARBONATE

FLIXOTIDE ROTADISKS Allen and Hanburys Limited PA0024/023/005 Inhalation powder - FLUTICASONE 03/03/2005
PROPIONATE
FLIXOTIDE ROTADISKS Allen and Hanburys Limited PA0024/023/006 Inhalation powder - FLUTICASONE 03/03/2005
PROPIONATE
FLIXOTIDE ROTADISKS Allen and Hanburys Limited PA0024/023/007 Inhalation powder - FLUTICASONE 03/03/2005
PROPIONATE
FLIXOTIDE ROTADISKS Allen and Hanburys Limited PA0024/023/008 Inhalation powder - FLUTICASONE 03/03/2005
PROPIONATE
HACKS BLACKCURRANT Trebor Ireland Limited PA0692/001/002 Lozenges - LEVOMENTHOL 02/03/2005
HACKS HONEY & LEMON Trebor Ireland Limited PA0692/001/003 Lozenges - LEVOMENTHOL 02/03/2005
HACKS ORIGINAL Trebor Ireland Limited PA0692/001/001 Lozenges - LEVOMENTHOL 02/03/2005
ACCOLATE AstraZeneca UK Limited PA0970/001/002 Tablets - ZAFIRLUKAST 01/03/2005
AREDIA DRY POWDER Novartis Pharmaceuticals UK PA0013/090/001 Concentrate for Soln for Inf - PAMIDRONATE 01/03/2005
Ltd DISODIUM
FLUORO-URACIL ROCHE Lifehealth Limited PA0809/001/001 Solution for Injection - FLUOROURACIL SODIUM 01/03/2005
AMPOULES
OCTONATIV M Pharmacia Laboratories PA0187/055/002 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 01/03/2005
Limited
OCTONATIV-M Pharmacia Laboratories PA0187/055/001 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 01/03/2005
Limited
SANDOSTATIN MULTI- Novartis Pharmaceuticals UK PA0013/043/004 Solution for Injection - OCTREOTIDE 01/03/2005
DOSE Ltd

Human Medicines Withdrawn Products Page 291 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ULTRACEF Bristol-Myers Squibb PA0048/014/002 Capsule - CEFADROXIL 01/03/2005
(Holdings) Limited MONOHYDRATE
AMOXICILLIN Pinewood Laboratories Ltd, PA0281/081/002 Oral Suspension - AMOXICILLIN 28/02/2005
TRIHYDRATE
AMOXICILLIN MIXTURE Pinewood Laboratories Ltd, PA0281/081/001 Oral Suspension - AMOXICILLIN 28/02/2005
TRIHYDRATE
ATROVENT METERED Boehringer Ingelheim Limited PA0007/002/001 Pressurised Inhalation - IPRATROPIUM BROMIDE 28/02/2005
DOSE INHALER Suspension
NUELIN 3M Health Care Limited PA0057/005/003 Oral Solution - THEOPHYLLINE SODIUM 28/02/2005
AMINOACETATE
VASOFED RETARD Mercury Pharmaceuticals PA0073/121/003 Capsule - NIFEDIPINE 27/02/2005
(Ireland) Ltd
RIMACTANE Sandoz GmbH PA0111/002/003 Pdr+Solv for Soln for Inj - RIFAMPICIN 25/02/2005
VISTALBALON Allergan Pharmaceuticals PA0148/044/001 Eye Drops Solution - ANTAZOLINE 25/02/2005
Ireland PHOSPHATE
- NAPHAZOLINE
HYDROCHLORIDE
PINAMET CIMETIDINE Pinewood Laboratories Ltd, PA0281/054/001 Tablets - CIMETIDINE 23/02/2005
MEASLES RUBELLA Sanofi Pasteur MSD Ltd PA0544/020/003 Pdr+Solv for Soln for Inj - MEASLES VIRUS - 22/02/2005
VACCINE LIVE - SYRINGE SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
MERBENTYL SYRUP Sanofi-Aventis Ireland PA0540/019/001 Oral Solution - DICYCLOMINE 22/02/2005
Limited T/A SANOFI HYDROCHLORIDE
SULPIRIDE Norton Healthcare Limited PA0282/066/001 Tablets - SULPIRIDE 16/02/2005
T/A IVAX Pharmaceuticals
UK
HIGH POTENCY VITAMIN C Peter Black Healthcare Ltd PA0522/009/001 Tablets - ASCORBIC ACID 15/02/2005
- CITRUS BIOFLAVANOIDS

METHOTREXATE INJ Teva Pharma B.V. PA0749/003/001 Unknown - METHOTREXATE 15/02/2005


AMPOULES
METHOTREXATE INJ VIAL Teva Pharma B.V. PA0749/003/004 Unknown - METHOTREXATE 15/02/2005

ANTEPSIN Chugai Pharma UK Ltd PA0950/001/002 Tablets - SUCRALFATE 14/02/2005


ULTRAPROCT HE Clissmann PA0012/032/002 Suppositories - FLUOCORTOLONE 14/02/2005
PIVALATE
- FLUOCORTOLONE
CAPROATE
- CINCHOCAINE
HYDROCHLORIDE
FABROL Novartis Consumer Health PA0030/013/001 Powder for Oral Solution - ACETYLCYSTEINE 12/02/2005
UK Limited
REBOXETINE Pharmacia Healthcare PA0936/090/001 Tablets - REBOXETINE MESYLATE 11/02/2005
Ireland
REBOXETINE Pharmacia Healthcare PA0936/090/002 Tablets - REBOXETINE MESYLATE 11/02/2005
Ireland
FENOR Rowex Ltd PA0711/041/001 Capsule - FENOFIBRATE 09/02/2005
Fenor Rowex Ltd PA0711/041/002 Capsule - Fenofibrate 09/02/2005
EXARTIN Olinka (UK) Limited PA0476/001/001 Capsule - INDOMETACIN 07/02/2005
BECLAZONE EASI- Norton Waterford PA0436/021/006 Pressurised Inhalation - BECLOMETASONE 01/02/2005
BREATHE INHALER Suspension DIPROPIONATE
BECLAZONE EASI- Norton Waterford PA0436/021/007 Pressurised Inhalation - BECLOMETASONE 01/02/2005
BREATHE INHALER Suspension DIPROPIONATE
BECLAZONE EASI- Norton Waterford PA0436/021/008 Pressurised Inhalation - BECLOMETASONE 01/02/2005
BREATHE INHALER Suspension DIPROPIONATE
BECOTIDE 100 Allen and Hanburys Limited PA0024/005/005 Pressurised Inhalation - BECLOMETASONE 31/01/2005
Suspension DIPROPIONATE
BECOTIDE 250 Allen and Hanburys Limited PA0024/005/004 Pressurised Inhalation - BECLOMETASONE 31/01/2005
Suspension DIPROPIONATE
BECOTIDE INHALER Allen and Hanburys Limited PA0024/005/001 Pressurised Inhalation - BECLOMETASONE 31/01/2005
Suspension DIPROPIONATE
ORABET Rowex Ltd PA0711/045/001 Tablets - METFORMIN 31/01/2005
HYDROCHLORIDE
ORABET Rowex Ltd PA0711/045/002 Tablets - METFORMIN 31/01/2005
HYDROCHLORIDE
SMECTA Beaufour Ipsen Pharma PA1003/001/001 Powder for Oral Suspension - SMECTITE 31/01/2005
- ALUMINIUM HYDROXIDE-
MAGNESIUM CARBONATE

GUAREM Rybar Laboratories Ltd PA0003/006/001 Powder for Oral Suspension - GUAR GUM 28/01/2005
SOFRA - TULLE Roussel Laboratories Limited PA0006/009/001 Impregnated Dressing - FRAMYCETIN SULFATE 26/01/2005

ADULT KAO-C DIARRHOEA Cupal Limited PA0258/017/002 Oral Suspension - KAOLIN, LIGHT 24/01/2005
- CALCIUM CARBONATE

Human Medicines Withdrawn Products Page 292 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COLD SORE LOTION Cupal Limited PA0258/036/001 Cutaneous Solution - POVIDONE-IODINE 24/01/2005
CYSTOLEVE SACHETS Cupal Limited PA0258/034/001 Powder for Oral Solution - SODIUM CITRATE 24/01/2005
GLUCO-LYTE Cupal Limited PA0258/031/001 Powder for Oral Solution - SODIUM CHLORIDE 24/01/2005
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- GLUCOSE
MONOHYDRATE
GLYCERIN LEMON & Cupal Limited PA0258/043/001 Syrup - GUAIFENESIN 24/01/2005
HONEY
JUNIOR KAO-C Cupal Limited PA0258/017/001 Oral Suspension - KAOLIN, LIGHT 24/01/2005
DIARRHOEA - CALCIUM CARBONATE
NOVASIL PLUS ANTACID Cupal Limited PA0258/042/001 Oral Suspension - ALUMINIUM HYDROXIDE 24/01/2005
DRIED
- MAGNESIUM HYDROXIDE
- DIMETICONE, ACTIVATED

OCTEGRA Bayer AG PA0669/004/001 Tablets - MOXIFLOXACIN 24/01/2005


HYDROCHLORIDE
OCTEGRA Bayer AG PA0669/004/002 Solution for Infusion - MOXIFLOXACIN 24/01/2005
HYDROCHLORIDE
OCTEGRA Bayer AG PA0669/004/003 Solution for Infusion - MOXIFLOXACIN 24/01/2005
HYDROCHLORIDE
PARACETAMOL B.P. Cupal Limited PA0258/005/001 Tablets - PARACETAMOL 24/01/2005
TYROCANE JUNIOR Cupal Limited PA0258/033/001 Lozenges - CETYLPYRIDINIUM 24/01/2005
ANTISEPTIC CHLORIDE
TYROCANE THROAT Cupal Limited PA0258/004/001 Lozenges - CETYLPYRIDINIUM 24/01/2005
CHLORIDE
- TYROTHRICIN
- BENZOCAINE
ULC-AID MOUTH ULCER Cupal Limited PA0258/001/001 Oromucosal Gel - LIDOCAINE 24/01/2005
HYDROCHLORIDE
- CETYLPYRIDINIUM
CHLORIDE
ULC-AID MOUTH ULCER Cupal Limited PA0258/003/001 Lozenges - CETYLPYRIDINIUM 24/01/2005
THROAT CHLORIDE
- TYROTHRICIN
- BENZOCAINE
VERRUCA TREATMENT Cupal Limited PA0258/013/001 Cutaneous Paste - SALICYLIC ACID 24/01/2005
WAPEZE INSECT BITE Cupal Limited PA0258/035/001 Ointment - ANTAZOLINE 24/01/2005
HYDROCHLORIDE
GANDA (3+0.5) Chauvin Pharmaceuticals PA0118/010/003 Eye Drops Solution - GUANETHIDINE SULFATE 23/01/2005
Limited - EPINEPHRINE

NUTRIFLEX SPECIAL B. Braun Melsungen AG PA0736/010/001 Solution for Infusion - ISOLEUCINE 21/01/2005
WITHOUT ELECTROLYTES - LEUCINE
- LYSINE ACETATE
- L-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE GLUTAMATE
- ALANINE
- ASPARAGINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- PROLINE
- SERINE
- HISTIDINE
- GLUCOSE
MONOHYDRATE
VASOFED RETARD Mercury Pharmaceuticals PA0073/121/005 Capsule - NIFEDIPINE 20/01/2005
(Ireland) Ltd
SALAMOL EASI-BREATHE Norton Waterford PA0436/029/001 Pressurised Inhalation - SALBUTAMOL 19/01/2005
INHALER Suspension
PREPULSID Janssen-Cilag Ltd PA0748/011/005 Oral Suspension - CISAPRIDE 15/01/2005
MONOHYDRATE
PREPULSID Janssen-Cilag Ltd PA0748/011/007 Tablets - CISAPRIDE 15/01/2005
MONOHYDRATE
PREPULSID Janssen-Cilag Ltd PA0748/011/008 Tablets - CISAPRIDE 15/01/2005
MONOHYDRATE
PREPULSID PAEDIATRIC Janssen-Cilag Ltd PA0748/011/006 Oral Suspension - CISAPRIDE 15/01/2005
MONOHYDRATE
TAGAMET SmithKline and French PA0060/006/005 Tablets - CIMETIDINE 08/01/2005
Laboratories Ltd

Human Medicines Withdrawn Products Page 293 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NUTRIFLEX PLUS B. Braun Melsungen AG PA0736/009/001 Solution for Infusion - ISOLEUCINE 07/01/2005
WITHOUT ELECTROLYTES - LEUCINE
- LYSINE ACETATE
- L-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE GLUTAMATE
- ALANINE
- HISTIDINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- PROLINE
- SERINE
- GLUCOSE
MONOHYDRATE
- ASPARAGINE
ALGITEC SmithKline and French PA0060/046/002 Oral Suspension - CIMETIDINE 03/01/2005
Laboratories Ltd - SODIUM ALGINATE
ZEPHOLIN S.R. Fujisawa Deutschland GmbH PA0473/003/004 Modified-release capsule, - THEOPHYLLINE 31/12/2004
hard
VIVIOPTAL Pharma-Global Limited PA0141/020/001 Capsule - RETINOL PALMITATE 23/12/2004
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- TOCOPHERYL ACETATE
- RUTOSIDE
- DEXPANTHENOL
- NICOTINAMIDE
- CALCIUM ASCORBATE
- BIOTIN
- FOLIC ACID
- ETHYL LINOLEATE
- INOSITOL
- OROTIC ACID
- SODIUM MOLYBDATE
ANHYDROUS
- COLECALCIFEROL
- CHOLINE BITARTRATE
- ADENOSINE
- MAGNESIUM
GLYCEROPHOSPHATE
- POTASSIUM SULFATE
- COPPER SULPHATE
MONOHYDRATE
- COBALT SULPHATE
MONOHYDRATE
- MANGANESE SULPHATE
MONOHYDRATE
- FERROUS SULFATE
EXSICCATED
- ZINC OXIDE
- LECITHIN
- CALCIUM PHOSPHATE
DIBASIC
- LYSINE
HYDROCHLORIDE

NEGRAM Sanofi-Synthelabo Ireland PA0077/010/002 Oral Suspension - NALIDIXIC ACID 21/12/2004


Ltd
PERSANTIN - AMPOULES Boehringer Ingelheim Limited PA0007/008/003 Solution for Injection - DIPYRIDAMOLE 21/12/2004

DAKTACORT PCO Manufacturing PPA0465/004/001A Cream - MICONAZOLE NITRATE 20/12/2004


- HYDROCORTISONE
IMODIUM PCO Manufacturing PPA0465/001/001A Capsule - LOPERAMIDE 20/12/2004
HYDROCHLORIDE
JUNIOR MELTUS Cupal Limited PA0258/026/002 Oral Solution - GUAIFENESIN 20/12/2004
- CETYLPYRIDINIUM
CHLORIDE
- SUCROSE
- HONEY
MIRELLE HE Clissmann PA0012/088/001 Tablets - GESTODENE 20/12/2004
- ETHINYLESTRADIOL
NIFED Rowex Ltd PA0711/011/010 Capsule - NIFEDIPINE 20/12/2004

Human Medicines Withdrawn Products Page 294 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NOVAPEN Pinewood Laboratories Ltd, PA0281/009/001 Capsule - AMPICILLIN TRIHYDRATE 20/12/2004

NOVAPEN Pinewood Laboratories Ltd, PA0281/009/003 Oral Suspension - AMPICILLIN TRIHYDRATE 20/12/2004

NOVAPEN AMPICILLIN BP Pinewood Laboratories Ltd, PA0281/009/002 Capsule 20/12/2004


PENTOFYL Hoechst Marion Roussel PA0711/012/001 Solution for Infusion - PENTOXIFYLLINE 20/12/2004
(PENTOXIFYLLINE)
PENTOFYL Rowex Ltd PA0711/012/002 Tablets - PENTOXIFYLLINE 20/12/2004
(PENTOXIFYLLINE)
PINAMET CIMETIDINE Pinewood Laboratories Ltd, PA0281/054/002 Tablets - CIMETIDINE 20/12/2004
VITAMIN C & B Quest Vitamins (UK) Ltd PA0466/003/001 Tablets - ASCORBIC ACID 20/12/2004
BIOFLAVONOIDS - CITRUS BIOFLAVANOIDS

ISOPTO CARPINE 1.0% Alcon Laboratories (UK) Ltd PA0290/058/002 Eye Drops Solution - PILOCARPINE 16/12/2004
HYDROCHLORIDE
ISOPTO CARPINE 2.0% Alcon Laboratories (UK) Ltd PA0290/058/003 Eye Drops Solution - PILOCARPINE 16/12/2004
HYDROCHLORIDE
ISOPTO CARPINE 4.0% Alcon Laboratories (UK) Ltd PA0290/058/005 Eye Drops Solution - PILOCARPINE 16/12/2004
HYDROCHLORIDE
TAMOFEN Bayer Schering Pharma Oy PA0771/006/001 Tablets - TAMOXIFEN 16/12/2004
TAMOFEN Bayer Schering Pharma Oy PA0771/006/002 Tablets - TAMOXIFEN CITRATE 16/12/2004
TARKA Abbott Laboratories Ireland PA0038/089/001 Unknown - VERAPAMIL 14/12/2004
Ltd HYDROCHLORIDE
- TRANDOLAPRIL
PARACETAMOL INFANT Olinka (UK) Limited PA0476/006/001 Oral Drops Solution - PARACETAMOL 11/12/2004
OSMOFUNDIN B. Braun Medical Limited PA0179/008/003 Unknown - MANNITOL 10/12/2004
- SODIUM CHLORIDE
- SODIUM ACETATE
- WATER FOR INJECTIONS

CYKLOKAPRON Pharmacia Healthcare PA0936/008/003 Syrup - TRANEXAMIC ACID 07/12/2004


Ireland
DRAMAMINE Pharmacia Healthcare PA0936/005/001 Tablets - DIMENHYDRINATE 07/12/2004
Ireland
EVOREL PATCH Janssen-Cilag Ltd PA0748/004/001 Transdermal Patch - ESTRADIOL 07/12/2004
EVOREL PATCH Janssen-Cilag Ltd PA0748/004/002 Transdermal Patch 07/12/2004
EVOREL PATCH Janssen-Cilag Ltd PA0748/004/003 Transdermal Patch - ESTRADIOL 07/12/2004
MENORING 50 Galen Limited PA0185/041/001 Vaginal delivery system - ESTRADIOL 07/12/2004
MICRONOR HRT Janssen-Cilag Ltd PA0748/010/001 Tablet - Norethisterone 07/12/2004
RETIN A Janssen-Cilag Ltd PA0748/033/002 Gel - TRETINOIN 07/12/2004
RETIN-A Janssen-Cilag Ltd PA0748/033/001 Gel - TRETINOIN 07/12/2004
SPASMONAL FIBRE Norgine Limited PA0102/014/001 Granules - ALVERINE CITRATE 07/12/2004
- STERCULIA
WHITE HAEMORRHOIDAL Pfizer Consumer Healthcare PA0172/025/001 Ointment - LIDOCAINE 07/12/2004
Ltd HYDROCHLORIDE
- ZINC OXIDE
WHITE HAEMORRHOIDAL Pfizer Consumer Healthcare PA0172/025/002 Suppositories - LIDOCAINE 07/12/2004
Ltd HYDROCHLORIDE
- ZINC OXIDE
LENTIZOL Warner Lambert (UK) Limite PA0856/008/001 Capsule - AMITRIPTYLINE 03/12/2004
HYDROCHLORIDE
LENTIZOL Warner Lambert (UK) Limite PA0856/008/002 Capsule - AMITRIPTYLINE 03/12/2004
HYDROCHLORIDE
MONONINE FREEZE DRIED Aventis Behring Limited PA0010/032/001 Unknown - FACTOR IX, HUMAN 01/12/2004
HUMAN COAG. FACTOR IX

DTP VACCINE BEHRING GSK Vaccines GmbH PA0877/002/001 Suspension for Injection - DIPHTHERIA TOXOID 30/11/2004
SINGLE DOSE AMPOULE - PERTUSSIS VACCINE
- TETANUS TOXOID
- ALUMINIUM HYDROXIDE
- SODIUM TIMERFONATE
- ALUMINIUM PHOSPHATE

DTP VACCINE BEHRING GSK Vaccines GmbH PA0877/002/002 Suspension for Injection - DIPHTHERIA TOXOID 30/11/2004
VIAL - PERTUSSIS VACCINE
- TETANUS TOXOID
- ALUMINIUM HYDROXIDE
- SODIUM TIMERFONATE
- ALUMINIUM PHOSPHATE

Human Medicines Withdrawn Products Page 295 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DTP VACCINE BEHRING GSK Vaccines GmbH PA0877/002/003 Suspension for Injection - DIPHTHERIA TOXOID 30/11/2004
VIAL - PERTUSSIS VACCINE
- TETANUS TOXOID
- ALUMINIUM HYDROXIDE
- SODIUM TIMERFONATE
- ALUMINIUM PHOSPHATE

DOLOBID Merck Sharp and Dohme PA0035/014/002 Tablets - DIFLUNISAL 29/11/2004


Limited
SEVREDOL Napp Pharmaceuticals PA0913/011/007 Oral Solution - MORPHINE SULFATE 26/11/2004
Limited
SEVREDOL Napp Pharmaceuticals PA0913/011/008 Oral Solution - MORPHINE SULFATE 26/11/2004
CONCENTRATED Limited
PRIPSEN Thornton & Ross Limited PA0610/007/001 Powder for Oral Suspension - PIPERAZINE PHOSPHATE 22/11/2004
- SENNOSIDE B

CUPAL DECONGESTANT Cupal Limited PA0258/039/001 Inhalation Vapour, Capsule - CAMPHOR 20/11/2004
INHALENT - MENTHOL
- TURPENTINE OIL
FLETCHERS ENEMETTE Forest Laboratories UK Ltd PA0100/037/001 Rectal Solution - DOCUSATE SODIUM 15/11/2004
- GLYCEROL
DARROWS Baxter Healthcare Limited PA0167/053/001 Solution for Injection - SODIUM LACTATE 12/11/2004
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
ALLEREZE Novartis Consumer Health PA0030/035/001 Tablets - CLEMASTINE 11/11/2004
UK Limited
DILTAM Rowex Ltd PA0711/004/001 Tablets - DILTIAZEM 10/11/2004
HYDROCHLORIDE
JECTOFER AstraZeneca UK Limited PA0970/042/001 Solution for Injection - IRON SORBITEX 08/11/2004
XYLOCAINE 0.5% WITH AstraZeneca UK Limited PA0970/053/001 Solution for Injection - LIDOCAINE 08/11/2004
ADRENALINE HYDROCHLORIDE
- EPINEPHRINE
BITARTRATE
XYLOCAINE PLAIN AstraZeneca UK Limited PA0970/054/003 Unknown - LIDOCAINE 08/11/2004
HYDROCHLORIDE
INNOVACE Merck Sharp and Dohme PA0035/067/004 Tablets - ENALAPRIL MALEATE 04/11/2004
Limited
TERFENADINE Norton Healthcare Limited PA0282/064/001 Tablets - TERFENADINE 04/11/2004
T/A IVAX Pharmaceuticals
UK
ZOLPIDEM-RATIOPHARM Ratiopharm GmbH PA0819/017/001 Tablets - ZOLPIDEM TARTRATE 04/11/2004
ZOLPIDEM-RATIOPHARM Ratiopharm GmbH PA0819/017/002 Tablets - ZOLPIDEM TARTRATE 04/11/2004
EDNYT Medimpex France S.A. PA0969/001/001 Tablets - ENALAPRIL MALEATE 03/11/2004
EDNYT Medimpex France S.A. PA0969/001/002 Tablets - ENALAPRIL MALEATE 03/11/2004
EDNYT Medimpex France S.A. PA0969/001/003 Tablets - ENALAPRIL MALEATE 03/11/2004
EDNYT Medimpex France S.A. PA0969/001/004 Tablets - ENALAPRIL MALEATE 03/11/2004
NYRACTA SmithKline Beecham Plc EU/1/00/139/012 Tablets - ROSIGLITAZONE 01/11/2004
NYRACTA SmithKline Beecham Pharm EU/1/00/138/001 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/003 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/004 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/005 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/006 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/007 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/008 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/009 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/010 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/011 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
NYRACTA SmithKline Beecham Pharm EU/1/00/138/012 Tablets - ROSIGLITAZONE 01/11/2004
Ltd
VENVIA SmithKline Beecham Plc EU/1/00/139/002 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/003 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/004 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/005 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/006 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/007 Tablets - ROSIGLITAZONE 01/11/2004

Human Medicines Withdrawn Products Page 296 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VENVIA SmithKline Beecham Plc EU/1/00/139/008 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/009 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/010 Tablets - ROSIGLITAZONE 01/11/2004
VENVIA SmithKline Beecham Plc EU/1/00/139/011 Tablets - ROSIGLITAZONE 01/11/2004
VIOXX PCO Manufacturing PPA0465/084/001A Tablets - ROFECOXIB 29/10/2004
VIOXX PCO Manufacturing PPA0465/084/001B Tablets - ROFECOXIB 29/10/2004
VIOXX PCO Manufacturing PPA0465/084/002A Tablets - ROFECOXIB 29/10/2004
VIOXX PCO Manufacturing PPA0465/084/002B Tablets - ROFECOXIB 29/10/2004
LIGNOCAINE Mercury Pharmaceuticals PA0073/112/014 Solution for Injection - LIDOCAINE 28/10/2004
HYDROCHLORIDE 2.0% (Ireland) Ltd HYDROCHLORIDE
PYLORID GlaxoSmithKline (Ireland) PA1077/092/001 Coated Tablets - RANITIDINE BISMUTREX 28/10/2004
Limited
BENORILATE Winthrop Pharmaceuticals PA1046/005/001 Tablets - BENORILATE 27/10/2004
UK Limited
BENORILATE MIXTURE Winthrop Pharmaceuticals PA1046/005/002 Oral Suspension - BENORILATE 27/10/2004
UK Limited
PLASMA-LYTE 148/WATER Baxter Healthcare Limited PA0167/041/001 Solution for Infusion - SODIUM CHLORIDE 27/10/2004
- GLUCONATE SODIUM
- SODIUM ACETATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
PLASMA-LYTE 50/30 Baxter Healthcare Limited PA0167/035/001 Solution for Infusion - GLUCOSE 26/10/2004
- POTASSIUM CHLORIDE
- SODIUM ACETATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
TAGAMET INFUSION GlaxoSmithKline (Ireland) PA1077/091/001 Solution for Infusion - CIMETIDINE 22/10/2004
Limited
DAY NURSE GlaxoSmithKline Consumer PA0678/013/001 Capsule - PARACETAMOL 21/10/2004
Healthcare (Ireland) Limited -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROCHLORIDE
PRIMENE 5% Baxter Healthcare Limited PA0167/090/001 Solution for Infusion - ISOLEUCINE 20/10/2004
- LEUCINE
- VALINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- ARGININE
- HISTIDINE
- ALANINE
- ASPARTIC ACID
- CYSTEINE
HYDROCHLORIDE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- ORNITHINE
- TAURINE
AMPICLOX SmithKline Beecham Pharm PA0049/007/001 Capsule - AMPICILLIN TRIHYDRATE 18/10/2004
Ltd - CLOXACILLIN SODIUM

AMPICLOX SmithKline Beecham Pharm PA0049/007/003 Pdr for Soln for Injection - AMPICILLIN SODIUM 18/10/2004
Ltd - CLOXACILLIN SODIUM
AMPICLOX NEONATAL SmithKline Beecham Pharm PA0049/007/005 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE 18/10/2004
Ltd - CLOXACILLIN SODIUM

AMPLICOX SmithKline Beecham Pharm PA0049/007/006 Syrup - AMPICILLIN TRIHYDRATE 18/10/2004


Ltd - CLOXACILLIN SODIUM

MICROGYNON 30 HE Clissmann PA0012/011/001 Tablets - LEVONORGESTREL 18/10/2004


- ETHINYLESTRADIOL
NAPMEL 250 Clonmel Healthcare Ltd PA0126/044/002 Tablets - NAPROXEN 18/10/2004
NAPMEL 250 (500) Clonmel Healthcare Ltd PA0126/044/001 Tablets - NAPROXEN 18/10/2004

Human Medicines Withdrawn Products Page 297 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLINOMEL N4-550 Baxter Healthcare Limited PA0167/100/001 Solution for Infusion - ALANINE 11/10/2004
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
TRIHYDRATE
- SODIUM CHLORIDE
- GLUCOSE
MONOHYDRATE
- CALCIUM CHLORIDE
DIHYDRATE
- SOYBEAN OIL
- LEUCINE
CLINOMEL N5-800 Baxter Healthcare Limited PA0167/100/002 Solution for Infusion - ALANINE 11/10/2004
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
TRIHYDRATE
- SODIUM CHLORIDE
- GLUCOSE
MONOHYDRATE
- CALCIUM CHLORIDE
DIHYDRATE
- SOYBEAN OIL
- LEUCINE
- POTASSIUM PHOSPHATE
DIBASIC
- MAGNESIUM CHLORIDE
HEXAHYDRATE

Human Medicines Withdrawn Products Page 298 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLINOMEL N6-900 Baxter Healthcare Limited PA0167/100/003 Solution for Infusion - ALANINE 11/10/2004
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
TRIHYDRATE
- SODIUM CHLORIDE
- GLUCOSE
MONOHYDRATE
- CALCIUM CHLORIDE
DIHYDRATE
- SOYBEAN OIL
- LEUCINE
- POTASSIUM PHOSPHATE
DIBASIC
- MAGNESIUM CHLORIDE
HEXAHYDRATE
CLINOMEL N7-1000 Baxter Healthcare Limited PA0167/100/004 Solution for Infusion - ALANINE 11/10/2004
- ARGININE
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- SODIUM ACETATE
TRIHYDRATE
- SODIUM CHLORIDE
- GLUCOSE
MONOHYDRATE
- CALCIUM CHLORIDE
DIHYDRATE
- SOYBEAN OIL
- LEUCINE
- POTASSIUM PHOSPHATE
DIBASIC
- MAGNESIUM CHLORIDE
HEXAHYDRATE
GLUCOSE Baxter Healthcare Limited PA0167/096/005 Solution for Infusion - GLUCOSE 11/10/2004
TERFENOR Norton Healthcare Limited PA0282/065/001 Tablets - TERFENADINE 11/10/2004
T/A IVAX Pharmaceuticals
UK
ACTRAPID FLEXPEN Novo Nordisk A/S PA0218/025/007 Solution for Injection - INSULIN HUMAN 06/10/2004
ACTRAPID INNOLET Novo Nordisk A/S PA0218/025/006 Solution for Injection - INSULIN HUMAN 06/10/2004
MIXTARD 30 FLEXPEN Novo Nordisk A/S PA0218/029/007 Solution for Injection - INSULIN HUMAN 06/10/2004
CEOXX Merck Sharp and Dohme PA0035/092/001 Tablets - ROFECOXIB 04/10/2004
Limited
CEOXX Merck Sharp and Dohme PA0035/092/002 Tablets - ROFECOXIB 04/10/2004
Limited
VIOXX Merck Sharp and Dohme PA0035/091/001 Tablets - ROFECOXIB 04/10/2004
Limited
VIOXX Merck Sharp and Dohme PA0035/091/002 Tablets - ROFECOXIB 04/10/2004
Limited
VIOXX Merck Sharp and Dohme PA0035/091/003 Oral Suspension - ROFECOXIB 04/10/2004
Limited
VIOXX Merck Sharp and Dohme PA0035/091/004 Oral Suspension - ROFECOXIB 04/10/2004
Limited
HEXOGEN Mercury Pharmaceuticals PA0073/083/001 Tablets - INOSITOL NICOTINATE 03/10/2004
(Ireland) Ltd

Human Medicines Withdrawn Products Page 299 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZESTRIL AstraZeneca UK Limited PA0970/023/005 Tablets - LISINOPRIL DIHYDRATE 01/10/2004
DICYNENE Sanofi-Synthelabo Ireland PA0077/148/002 Tablets - ETAMSILATE 29/09/2004
Ltd
BISOPROLOL Ratiopharm GmbH PA0819/007/001 Tablets - BISOPROLOL FUMARATE 28/09/2004

BISOPROLOL Ratiopharm GmbH PA0819/007/002 Tablets - BISOPROLOL FUMARATE 28/09/2004

CAPTOHCT-RATIOPHARM Ratiopharm GmbH PA0819/006/001 Tablets - CAPTOPRIL 28/09/2004


- HYDROCHLOROTHIAZIDE

CAPTOHCT-RATIOPHARM Ratiopharm GmbH PA0819/006/002 Tablets - CAPTOPRIL 28/09/2004


- HYDROCHLOROTHIAZIDE

CAPTOPRIL Ratiopharm GmbH PA0819/010/001 Tablets - CAPTOPRIL 28/09/2004


CAPTOPRIL Ratiopharm GmbH PA0819/010/002 Tablets - CAPTOPRIL 28/09/2004
CAPTOPRIL Ratiopharm GmbH PA0819/010/003 Tablets - CAPTOPRIL 28/09/2004
CAPTOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/011/001 Tablets - CAPTOPRIL 28/09/2004

CAPTOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/011/002 Tablets - CAPTOPRIL 28/09/2004

CAPTOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/011/003 Tablets - CAPTOPRIL 28/09/2004

CETIRIZINE Ratiopharm GmbH PA0819/018/001 Tablets - CETIRIZINE 28/09/2004


HYDROCHLORIDE
DOXAZIN Ratiopharm GmbH PA0819/003/001 Tablets - DOXAZOSIN MESILATE 28/09/2004
DOXAZIN Ratiopharm GmbH PA0819/003/002 Tablets - DOXAZOSIN MESILATE 28/09/2004
DOXAZIN Ratiopharm GmbH PA0819/003/003 Tablets - DOXAZOSIN MESILATE 28/09/2004
DOXAZOSIN-RATIOPHARM Ratiopharm GmbH PA0819/002/001 Tablets - DOXAZOSIN MESILATE 28/09/2004

DOXAZOSIN-RATIOPHARM Ratiopharm GmbH PA0819/002/002 Tablets - DOXAZOSIN MESILATE 28/09/2004

DOXAZOSIN-RATIOPHARM Ratiopharm GmbH PA0819/002/003 Tablets - DOXAZOSIN MESILATE 28/09/2004

ENALAPRIL Ratiopharm GmbH PA0819/005/001 Tablets - ENALAPRIL MALEATE 28/09/2004


ENALAPRIL Ratiopharm GmbH PA0819/005/002 Tablets - ENALAPRIL MALEATE 28/09/2004
ENALAPRIL Ratiopharm GmbH PA0819/005/003 Tablets - ENALAPRIL MALEATE 28/09/2004
ENALAPRIL HCT Ratiopharm GmbH PA0819/013/001 Tablets - ENALAPRIL MALEATE 28/09/2004
- HYDROCHLOROTHIAZIDE

ENALAPRIL HCT- Ratiopharm GmbH PA0819/012/001 Tablets - ENALAPRIL MALEATE 28/09/2004


RATIOPHARM - HYDROCHLOROTHIAZIDE

ENALAPRIL-RATIOPHARM Ratiopharm GmbH PA0819/004/001 Tablets - ENALAPRIL MALEATE 28/09/2004


ENALAPRIL-RATIOPHARM Ratiopharm GmbH PA0819/004/002 Tablets - ENALAPRIL MALEATE 28/09/2004
ENALAPRIL-RATIOPHARM Ratiopharm GmbH PA0819/004/003 Tablets - ENALAPRIL MALEATE 28/09/2004
ENALAPRIL-RATIOPHARM Ratiopharm GmbH PA0819/004/004 Tablets - ENALAPRIL MALEATE 28/09/2004
FELODIPINE XL Ratiopharm GmbH PA0819/019/002 Tablets - FELODIPINE 28/09/2004
FELODIPINE XL Ratiopharm GmbH PA0819/019/003 Tablets - FELODIPINE 28/09/2004
LISINOPRIL Ratiopharm GmbH PA0819/027/001 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE
10 MG/12.5 MG
LISINOPRIL Ratiopharm GmbH PA0819/027/002 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE
20 MG/12.5 MG
LISINOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/008/001 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
LISINOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/008/002 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
LISINOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/008/003 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
LISINOPRIL-RATIOPHARM Ratiopharm GmbH PA0819/008/004 Tablets - LISINOPRIL DIHYDRATE 28/09/2004
MENGIVAC (A+C) 10 DOSE Sanofi Pasteur MSD Ltd PA0544/005/002 Pdr+Solv for Soln for Inj - NEISSERIA MENINGITIDIS 28/09/2004
A
- NEISSERIA MENINGITIDIS
C
RANITIDINE-RATIOPHARM Ratiopharm GmbH PA0819/014/001 Tablets - RANITIDINE 28/09/2004
HYDROCHLORIDE
RANITIDINE-RATIOPHARM Ratiopharm GmbH PA0819/014/002 Tablets - RANITIDINE 28/09/2004
HYDROCHLORIDE
EXPULIN CHILDRENS Monmouth Pharmaceuticals PA0488/010/001 Oral Suspension - CHLORPHENAMINE 23/09/2004
COUGH LINCTUS-SUGAR Ltd MALEATE
FREE - PHOLCODINE
EXPULIN COUGH LINCTUS Monmouth Pharmaceuticals PA0488/013/001 Oromucosal Gel - PHOLCODINE 23/09/2004
Ltd - PSEUDOEPHEDRINE
HYDROCHLORIDE
- CHLORPHENAMINE
MALEATE

Human Medicines Withdrawn Products Page 300 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EXPULIN DECONGESTANT Monmouth Pharmaceuticals PA0488/012/001 Oral Suspension - PSEUDOEPHEDRINE 23/09/2004
SUGAR FREE Ltd

EXPULIN DRY COUGH Monmouth Pharmaceuticals PA0488/011/001 Oral Suspension - PHOLCODINE 23/09/2004
STRONG Ltd
ADSORBED DIPHTHERIA & Sanofi Pasteur MSD Ltd PA0544/004/001 Solution for Injection - DIPHTHERIA TOXOID 20/09/2004
TETANUS VACCINE BP - TETANUS TOXOID
AMPOULE
GAMBROSOL 40 H WITH Gambro Lundia AB PA0785/001/003 Solution for Infusion - GLUCOSE 09/09/2004
GLUCOSE 4% MONOHYDRATE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
GAMBROSOL 40L WITH Gambro Lundia AB PA0785/001/001 Solution for Infusion - GLUCOSE 09/09/2004
GLUCOSE 1.5% MONOHYDRATE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
GAMBROSOL 40M WITH Gambro Lundia AB PA0785/001/002 Solution for Infusion - GLUCOSE 09/09/2004
GLUCOSE 2.5% MONOHYDRATE
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
NEOSPORIN Wellcome (Ireland) Limited PA0017/005/001 Eye Drops Solution - POLYMYXIN B SULFATE 09/09/2004
- NEOMYCIN SULFATE
- GRAMICIDIN
GLYCERIN LEMON & Foran Healthcare Limited PA0484/025/001 Syrup - GLYCEROL 08/09/2004
HONEY - HONEY
- CITRIC ACID
MONOHYDRATE
KABIMIX 11 Fresenius Kabi Limited PA0566/008/003 Emulsion for Infusion - SOYA OIL 06/09/2004
- GLUCOSE
MONOHYDRATE
- ALANINE
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYCINE ACETATE
- DL-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- CALCIUM
GLYCEROPHOSPHATE
ANHYDROUS
- SODIUM
GLYCEROPHOSPHATE
ANHYDROUS
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM HYDROXIDE
- POTASSIUM HYDROXIDE

MEFENAMIC ACID Norton Healthcare Limited PA0282/048/001 Capsule - MEFENAMIC ACID 03/09/2004
T/A IVAX Pharmaceuticals
UK

Human Medicines Withdrawn Products Page 301 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COMPOUND SODIUM Galen Research Laboratories PA0295/006/001 Solution for Infusion - SODIUM LACTATE 30/08/2004
LACTATE Ltd - SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
GLUCOSE 10% Galen Research Laboratories PA0295/003/005 Solution for Infusion - GLUCOSE 30/08/2004
Ltd
GLUCOSE 5% Galen Research Laboratories PA0295/003/001 Solution for Infusion - GLUCOSE 30/08/2004
Ltd
SODIUM CHLORIDE Ivex Pharmaceuticals Limited PA0423/002/001A Irrigation solution - SODIUM CHLORIDE 30/08/2004

SODIUM CHLORIDE Galen Research Laboratories PA0295/007/001 Solution for Infusion - SODIUM CHLORIDE 30/08/2004
0.18%/DEXTROSE 4.0% Ltd - GLUCOSE
SODIUM CHLORIDE 0.45% Galen Research Laboratories PA0295/002/005 Solution for Infusion - SODIUM CHLORIDE 30/08/2004
Ltd
SODIUM CHLORIDE 0.9% Galen Research Laboratories PA0295/002/001 Solution for Infusion - SODIUM CHLORIDE 30/08/2004
Ltd
SODIUM CHLORIDE Galen Research Laboratories PA0295/007/003 Solution for Infusion - SODIUM CHLORIDE 30/08/2004
0.9%/DEXTROSE 5.0% Ltd - GLUCOSE
SODIUM LACTATE Galen Research Laboratories PA0295/005/001A Solution for Infusion - SODIUM LACTATE 30/08/2004
Ltd
STERILE WATER Galen Research Laboratories PA0295/004/001 Irrigation solution - WATER FOR INJECTIONS 30/08/2004
Ltd
STERILE WATER FOR Ivex Pharmaceuticals Limited PA0423/001/001A Irrigation solution - WATER FOR INJECTIONS 30/08/2004
IRRIGATION
ALPRAZOLAM Pharmacia Limited PA0016/055/001 Tablets - ALPRAZOLAM 27/08/2004
ALPRAZOLAM Pharmacia Limited PA0016/055/002 Tablets - ALPRAZOLAM 27/08/2004
ALPRAZOLAM Pharmacia Limited PA0016/055/003 Tablets - ALPRAZOLAM 27/08/2004
CALCIPARINE Sanofi-Synthelabo Ireland PA0077/115/001 Solution for Injection - HEPARIN CALCIUM 27/08/2004
Ltd
CAVERJECT DUAL Pharmacia Healthcare PA0936/009/001 Solution for Injection - ALPROSTADIL 27/08/2004
CHAMBER Ireland
CAVERJECT DUAL Pharmacia Healthcare PA0936/009/002 Solution for Injection - ALPROSTADIL 27/08/2004
CHAMBER Ireland
DOXORUBICIN Pharmacia Healthcare PA0936/034/002 Solution for Injection - DOXORUBICIN 27/08/2004
Ireland HYDROCHLORIDE
DOXORUBICIN Pharmacia Healthcare PA0936/034/003 Solution for Injection - DOXORUBICIN 27/08/2004
Ireland HYDROCHLORIDE
DOXORUBICIN Pharmacia Healthcare PA0936/034/004 Solution for Injection - DOXORUBICIN 27/08/2004
Ireland HYDROCHLORIDE
EPOGAM Pharmacia Healthcare PA0936/014/003 Capsule - OENOTHERA BIENNIS 27/08/2004
Ireland
EPOGAM Pharmacia Healthcare PA0936/014/001 Capsule - OENOTHERA BIENNIS 27/08/2004
Ireland
GADOVIST HE Clissmann PA0012/089/001 Solution for Injection - GADOBUTROL 27/08/2004
GADOVIST HE Clissmann PA0012/089/002 Solution for Injection - GADOBUTROL 27/08/2004
GADOVIST HE Clissmann PA0012/089/003 Solution for Injection - GADOBUTROL 27/08/2004
FSME-IMMUN Baxter Vaccine AG PA0935/001/001 Suspension for injection - Tbe virus antigen 23/08/2004
SOLU-MEDRONE Pharmacia Healthcare PA0936/071/005 Pdr+Solv for Soln for Inj - METHYLPREDNISOLONE 17/08/2004
Ireland SODIUM SUCCINATE

SYNPHASE Monsanto PLC PA0778/014/001 Tablets - NORETHISTERONE 17/08/2004


- ETHINYLESTRADIOL
- NORETHISTERONE
- ETHINYLESTRADIOL
CALPOL SIX PLUS McNeil Healthcare (Ireland) PA0823/010/001 Granules for Oral - PARACETAMOL 16/08/2004
Ltd Suspension
CYCLOPHOSPHAMIDE Farmitalia Carlo Erba Ltd PA0236/010/001 Tablets - CYCLOPHOSPHAMIDE 16/08/2004
EPOGAM PAEDIATRIC Pharmacia Healthcare PA0936/014/002 Capsule - OENOTHERA BIENNIS 13/08/2004
Ireland
UTINOR Merck Sharp and Dohme PA0035/065/003 Tablets - NORFLOXACIN 13/08/2004
Limited
VENTODISKS GlaxoSmithKline (Ireland) PA1077/048/001 Inhalation powder - SALBUTAMOL SULFATE 10/08/2004
Limited
VENTODISKS GlaxoSmithKline (Ireland) PA1077/048/002 Unknown - SALBUTAMOL SULFATE 10/08/2004
Limited
PERGONAL Serono Limited PA0285/001/001 Pdr+Solv for Soln for Inj - FOLLICLE-STIMULATING 09/08/2004
HORMONE, HUMAN
- LUTEINISING HORMONE
SEROQUEL AstraZeneca UK Limited PA0970/018/004 Tablets - QUETIAPINE FUMARATE 09/08/2004
BECODISKS GlaxoSmithKline (Ireland) PA1077/040/001 Inhalation powder 08/08/2004
Limited
BECODISKS GlaxoSmithKline (Ireland) PA1077/040/002 Inhalation powder - BECLOMETASONE 08/08/2004
Limited DIPROPIONATE

Human Medicines Withdrawn Products Page 302 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOXORUBICIN Pharmacia Healthcare PA0936/034/001 Solution for Injection - DOXORUBICIN 04/08/2004
Ireland HYDROCHLORIDE
DOXORUBICIN Pharmacia Healthcare PA0936/034/007 Solution for Injection - DOXORUBICIN 04/08/2004
Ireland HYDROCHLORIDE
DOXORUBICIN Pharmacia Healthcare PA0936/034/008 Solution for Injection - DOXORUBICIN 04/08/2004
Ireland HYDROCHLORIDE
DOXORUBICIN RAPID Pharmacia Healthcare PA0936/034/005 Pdr for Soln for Injection - DOXORUBICIN 04/08/2004
DISSOLUTION Ireland HYDROCHLORIDE
DOXORUBICIN RAPID Pharmacia Healthcare PA0936/034/006 Pdr for Soln for Injection - DOXORUBICIN 04/08/2004
DISSOLUTION Ireland HYDROCHLORIDE
LONITEN Pharmacia Healthcare PA0936/076/001 Tablets - MINOXIDIL 04/08/2004
Ireland
LONITEN Pharmacia Healthcare PA0936/076/003 Tablets - MINOXIDIL 04/08/2004
Ireland
ZAVEDOS Pharmacia Healthcare PA0936/058/003 Capsule - IDARUBICIN 04/08/2004
Ireland HYDROCHLORIDE
DETSEL SR Pharmacia Healthcare PA0936/013/001 Modified-release capsule, - TOLTERODINE L- 03/08/2004
Ireland hard TARTRATE
DETSEL SR Pharmacia Healthcare PA0936/013/002 Modified-release capsule, - TOLTERODINE L- 03/08/2004
Ireland hard TARTRATE
FELDENE Pfizer Limited PA0019/024/005 Suppositories - PIROXICAM 03/08/2004
GENOTROPIN Pharmacia Laboratories PA0187/032/024 Pdr+Solv for Soln for Inj - GROWTH HORMONE 03/08/2004
Limited
GENOTROPIN 1.3 MG Pharmacia Laboratories PA0187/032/001 Pdr+Solv for Soln for Inj - SOMATROPIN 03/08/2004
Limited
GENOTROPIN KABI VIAL Pharmacia Laboratories PA0187/032/025 Pdr+Solv for Soln for Inj - GROWTH HORMONE 03/08/2004
Limited
MONOCLATE P Aventis Behring Limited PA0010/031/001 Unknown - FACTOR VIII, HUMAN 01/08/2004
MONOCLATE P Aventis Behring Limited PA0010/031/002 Unknown - FACTOR VIII, HUMAN 01/08/2004
MONOCLATE P Aventis Behring Limited PA0010/031/003 Unknown - FACTOR VIII, HUMAN 01/08/2004
EXOSURF NEONATAL Wellcome (Ireland) Limited PA0017/101/001 Pdr+Solv/Susp/EPulmInst - COLFOSCERIL 27/07/2004
PALMITATE
VENTOLIN INHALER Allen and Hanburys Limited PA0024/001/012 Pressurised Inhalation - SALBUTAMOL 27/07/2004
Suspension
KAPAKE INSTS 30/500 Galen Limited PA0185/025/002 Powder for Oral Solution - PARACETAMOL 26/07/2004
- CODEINE PHOSPHATE
KAPAKE INSTS 60/1000 Galen Limited PA0185/025/003 Powder for Oral Solution - PARACETAMOL 26/07/2004
- CODEINE PHOSPHATE
VITATHONE CHILBLAIN Thornton & Ross Limited PA0610/009/001 Ointment - METHYL NICOTINATE 24/07/2004
BETAGAN OPHTHALMIC Allergan Pharmaceuticals PA0148/040/003 Eye Drops Solution - LEVOBUNOLOL 22/07/2004
Ireland HYDROCHLORIDE
PREFRIN Allergan Pharmaceuticals PA0148/015/001 Eye Drops Solution - PHENYLEPHRINE 22/07/2004
Ireland HYDROCHLORIDE
ACIDOPINE Pinewood Laboratories Ltd, PA0281/112/001 Tablets - FAMOTIDINE 19/07/2004
CYMEVENE Roche Products Limited PA0050/125/001 Capsule - GANCICLOVIR 19/07/2004
TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/018 Cutaneous Solution - CHLORHEXIDINE 19/07/2004
DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 15 Baxter Healthcare Limited PA0167/032/016 Cutaneous Solution - CHLORHEXIDINE 19/07/2004


DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 30 Baxter Healthcare Limited PA0167/032/017 Cutaneous Solution - CHLORHEXIDINE 19/07/2004


DIACETATE
- CETRIMONIUM BROMIDE

TROSYL DERMAL Pfizer Limited PA0019/030/001 Cream - TIOCONAZOLE 18/07/2004


TROSYL DERMAL LOTION Pfizer Limited PA0019/030/004 Cutaneous Emulsion - TIOCONAZOLE 18/07/2004
TROSYL DERMAL PUMP Pfizer Limited PA0019/030/005 Cutaneous Spray Solution - TIOCONAZOLE 18/07/2004
SPRAY
TROSYL DUSTING POWER Pfizer Limited PA0019/030/003 Cutaneous Powder - TIOCONAZOLE 18/07/2004

CORTOPIN Pinewood Laboratories Ltd, PA0281/071/001 Cream - HYDROCORTISONE 17/07/2004


HYDROCORTISONE B.P.
LEUCOMAX Schering-Plough Limited PA0277/063/002 Pdr for Soln for Injection - GRANULOCYTE 16/07/2004
MACROPHAGE COLONY
STIMULATING FACTOR
LEUCOMAX Schering-Plough Limited PA0277/063/003 Pdr for Soln for Injection - GRANULOCYTE 16/07/2004
MACROPHAGE COLONY
STIMULATING FACTOR
LEUCOMAX Schering-Plough Limited PA0277/063/006 Pdr for Soln for Injection - GRANULOCYTE 16/07/2004
MACROPHAGE COLONY
STIMULATING FACTOR

Human Medicines Withdrawn Products Page 303 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALLBEE WITH C 300 A.H. Robins Company PA0086/001/003 Capsule - THIAMINE MONONITRATE 12/07/2004
Limited - RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- ASCORBIC ACID

OXYBASE Rowex Ltd PA0711/035/001 Tablets - OXYBUTYNIN 07/07/2004


HYDROCHLORIDE
OXYBASE Rowex Ltd PA0711/035/002 Tablets - OXYBUTYNIN 07/07/2004
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 304 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PNEUMO 23 Sanofi Pasteur MSD Ltd PA0544/030/001 Solution for Injection - PNEUMOCOCCAL 07/07/2004
POLYSACCHARIDE TYPE 1
(1)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 2
(2)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 3
(3)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 4
(4)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 5
(5)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
26 (6B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
51 (7F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 8
(8)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
9N
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
9V
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
34 (10A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
43 (11A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
12 (12F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
14 (14)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
54 (15B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
17 (17F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
56 (18C)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
57 (19A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
19 (19F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
20 (20)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
22 (22F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
23 (23F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
70 (33F)
CLAVAMEL PAEDIATRIC Clonmel Healthcare Ltd PA0126/103/004 Powder for Oral Suspension - AMOXICILLIN 06/07/2004
SACHETS TRIHYDRATE
- CLAVULANATE
POTASSIUM
CO-AMOXICLAV DUO GlaxoSmithKline (Ireland) PA1077/022/001 Powder for Oral Suspension - AMOXICILLIN 06/07/2004
SACHETS Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM

Human Medicines Withdrawn Products Page 305 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CO-AMOXICLAV GlaxoSmithKline (Ireland) PA1077/021/003 Powder for Oral Suspension - AMOXICILLIN 06/07/2004
PAEDIATRIC SACHET Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
INTRAVAL SODIUM May & Baker Limited PA0040/017/001 Pdr for Soln for Injection - THIOPENTAL SODIUM 02/07/2004
SECTRAL May & Baker Limited PA0040/001/002 Capsule - ACEBUTOLOL 02/07/2004
HYDROCHLORIDE
SECTRAL May & Baker Limited PA0040/001/003 Capsule - ACEBUTOLOL 02/07/2004
HYDROCHLORIDE
POLIOMYELITIS VACCINE SmithKline and French PA0060/023/002 Oral Suspension - POLIOVIRUS, TYPE 1 01/07/2004
LIVE (ORAL) Laboratories Ltd - POLIOVIRUS, TYPE 2
- POLIOVIRUS, TYPE 3
TAMOFEN Bayer Schering Pharma Oy PA0771/006/003 Tablets - TAMOXIFEN CITRATE 01/07/2004
TAMOFEN Bayer Schering Pharma Oy PA0771/006/004 Tablets - TAMOXIFEN CITRATE 01/07/2004
IBUPROFEN Pinewood Laboratories Ltd, PA0281/015/001 Tablets - IBUPROFEN 29/06/2004
IBUPROFEN Pinewood Laboratories Ltd, PA0281/015/002 Tablets - IBUPROFEN 29/06/2004
MANNITOL Baxter Healthcare Limited PA0167/037/005 Solution for Infusion - MANNITOL 29/06/2004
RIMAFEN Ranbaxy Ireland Limited PA0408/032/001 Tablets - IBUPROFEN 29/06/2004
RIMAFEN Ranbaxy Ireland Limited PA0408/032/002 Tablets - IBUPROFEN 29/06/2004
RIMAFLOX Ranbaxy Ireland Limited PA0408/037/001 Capsule - FLUCLOXACILLIN 29/06/2004
SODIUM
RIMAFLOX Ranbaxy Ireland Limited PA0408/037/002 Capsule - FLUCLOXACILLIN 29/06/2004
SODIUM
MANNITOL Baxter Healthcare Limited PA0167/037/001 Solution for Infusion - MANNITOL 28/06/2004
BONFIELDS Foran Healthcare Limited PA0484/001/001 Cream - HYDROCORTISONE 27/06/2004
HYDROCORTISONE
STERETS CHLORHEXIDIN Seton Prebbles Ltd PA0483/004/001 Unknown - ISOPROPANOL 25/06/2004
- CHLORHEXIDINE
DIACETATE
TOPAMAX Janssen-Cilag Ltd PA0748/012/005 Tablet - Topiramate 22/06/2004
TOPAMAX Janssen-Cilag Ltd PA0748/012/006 Tablet - Topiramate 22/06/2004
CALCIJEX Abbott Laboratories Ireland PA0038/058/001 Solution for Injection - CALCITRIOL 13/06/2004
Ltd
CALCIJEX Abbott Laboratories Ireland PA0038/058/002 Solution for Injection - CALCITRIOL 13/06/2004
Ltd
ADSORBED TETANUS Sanofi Pasteur MSD Ltd PA0544/001/001 Suspension for Injection - TETANUS TOXOID 12/06/2004
- ALUMINIUM HYDROXIDE
AMILCO Norton Healthcare Limited PA0282/027/001 Tablets - AMILORIDE 12/06/2004
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK - HYDROCHLOROTHIAZIDE

MAALOX TC Rorer Pharmaceuticals PA0468/016/003 Tablets - ALUMINIUM HYDROXIDE 12/06/2004


Limited GEL, DRIED
- MAGNESIUM HYDROXIDE

ADSORBED TETANUS Sanofi Pasteur MSD Ltd PA0544/001/002 Suspension for Injection - TETANUS TOXOID 11/06/2004
SYRINGE - ALUMINIUM HYDROXIDE
EPSOM SALTS Foran Healthcare Limited PA0484/022/001 Powder for Oral Solution - MAGNESIUM SULFATE 11/06/2004
ZOFRAN GlaxoSmithKline (Ireland) PA1077/016/007 Coated Tablets - ONDANSETRON 11/06/2004
Limited HYDROCHLORIDE
DIHYDRATE
DIMOTANE A.H. Robins Company PA0086/013/001 Tablets - BROMPHENIRAMINE 08/06/2004
Limited MALEATE
DIMOTANE A.H. Robins Company PA0086/013/002 Syrup - BROMPHENIRAMINE 08/06/2004
Limited MALEATE
HEPARIN SODIUM BP Baxter Healthcare Limited PA0167/067/009 Solution for Infusion - HEPARIN SODIUM 06/06/2004
20000 - SODIUM CHLORIDE
- SODIUM PHOSPHATE
- CITRIC ACID
MONOHYDRATE
HEPARIN SODIUM BP 2500 Baxter Healthcare Limited PA0167/067/005 Solution for Injection - HEPARIN SODIUM 06/06/2004
- SODIUM CHLORIDE
- SODIUM PHOSPHATE
- CITRIC ACID
MONOHYDRATE
HEPARIN SODIUM BP Baxter Healthcare Limited PA0167/067/011 Solution for Infusion - HEPARIN SODIUM 06/06/2004
25000 - SODIUM CHLORIDE
- SODIUM PHOSPHATE
- CITRIC ACID
MONOHYDRATE
HEPARIN SODIUM BP Baxter Healthcare Limited PA0167/067/013 Solution for Injection - HEPARIN SODIUM 06/06/2004
75000 - SODIUM CHLORIDE
- SODIUM PHOSPHATE
- CITRIC ACID
MONOHYDRATE

Human Medicines Withdrawn Products Page 306 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HEPARIN SODIUM BP 5000 Baxter Healthcare Limited PA0167/067/007 Solution for Infusion - HEPARIN SODIUM 05/06/2004
- SODIUM CHLORIDE
- SODIUM PHOSPHATE
- CITRIC ACID
MONOHYDRATE
CALSYNAR Sanofi-Aventis Ireland PA0540/095/001 Solution for Injection - CALCITONIN, SALMON 25/05/2004
Limited T/A SANOFI
CALSYNAR Sanofi-Aventis Ireland PA0540/095/002 Solution for Injection - CALCITONIN, SALMON 25/05/2004
Limited T/A SANOFI
CETIPRIN NOVUM Pharmacia Laboratories PA0187/014/002 Tablets - EMEPRONIUM 25/05/2004
Limited CARRAGEENATE
PILOCARPINE Schering-Plough Limited PA0277/018/005 Eye Drops Solution - PILOCARPINE 25/05/2004
HYDROCHLORIDE
PROVERA Pharmacia Healthcare PA0936/072/006 Tablets - 25/05/2004
Ireland MEDROXYPROGESTERO
NE ACETATE
RELEFACT LH-RH Sanofi-Aventis Ireland PA0540/065/001 Solution for Infusion - GONADORELIN 25/05/2004
Limited T/A SANOFI
RETIN-A LOTION Janssen-Cilag Ltd PA0748/033/003 Cutaneous Solution - TRETINOIN 24/05/2004
BECOTIDE ROTACAPS Allen and Hanburys Limited PA0024/005/002 Inhalation powder, hard - BECLOMETASONE 21/05/2004
capsule DIPROPIONATE
BECOTIDE ROTACAPS Allen and Hanburys Limited PA0024/005/003 Inhalation powder, hard - BECLOMETASONE 21/05/2004
capsule DIPROPIONATE
COLESTID Pharmacia Limited PA0016/004/003 Tablets 20/05/2004
COLESTID ORANGE Pharmacia Limited PA0016/004/002 Powder for Oral Suspension - COLESTIPOL 20/05/2004
HYDROCHLORIDE
NIFED RETARD Rowex Ltd PA0711/011/007 Tablet Prolonged Release - NIFEDIPINE 20/05/2004
FRUMIL DOUBLE Rorer Pharmaceuticals PA0468/004/003 Tablets - FUROSEMIDE 17/05/2004
STRENGTH Limited - AMILORIDE
HYDROCHLORIDE
ORUVAIL 150 May & Baker Limited PA0040/070/006 Capsule - KETOPROFEN 17/05/2004
GYNOFLOR E Medinova GmbH PA0178/006/001 Pessary - ESTRIOL 16/05/2004
- LACTOBACILLUS
ACIDOPHILUS
HYDROCAL Bioglan Laboratories Ltd PA0469/002/001 Cream - HYDROCORTISONE 16/05/2004
ACETATE
TAGAMET GlaxoSmithKline (Ireland) PA1077/091/002 Solution for Injection - CIMETIDINE 10/05/2004
Limited
CAL-D-VITA CHEWABLE Roche Products Limited PA0050/137/002 Tablets - CALCIUM 05/05/2004
- COLECALCIFEROL
CAL-D-VITA Roche Products Limited PA0050/137/001 Tablets - CALCIUM 05/05/2004
EFFERVESCENT - COLECALCIFEROL
MINITRAN 10 3M Health Care Limited PA0057/062/002 Transdermal Patch - GLYCERYL TRINITRATE 03/05/2004
MINITRAN 15 3M Health Care Limited PA0057/062/003 Transdermal Patch - GLYCERYL TRINITRATE 03/05/2004
MINITRAN 5 3M Health Care Limited PA0057/062/001 Transdermal Patch - GLYCERYL TRINITRATE 03/05/2004
MIDAZOLAM INJECTION Hospira UK Limited PA0437/046/001 Solution for Injection - MIDAZOLAM 29/04/2004
MIDAZOLAM INJECTION Hospira UK Limited PA0437/046/002 Solution for Injection - MIDAZOLAM 29/04/2004
MIDAZOLAM INJECTION Hospira UK Limited PA0437/046/003 Solution for Injection - MIDAZOLAM 29/04/2004
INTRALIPID 30% Fresenius Kabi Limited PA0566/019/006 Emulsion for Infusion - SOYA OIL 27/04/2004
INTRALIPID 30% Fresenius Kabi Limited PA0566/019/008 Emulsion for Infusion - SOYA OIL 27/04/2004
INTRALIPID 30% Fresenius Kabi Limited PA0566/019/009 Emulsion for Infusion - SOYA OIL 27/04/2004
NALTREXIN AOP Orphan PA0934/001/001 Tablets - NALTREXONE 27/04/2004
Pharmaceuticals AG HYDROCHLORIDE
INFRA-RUB Pfizer Consumer Healthcare PA0172/036/002 Gel - FELBINAC 26/04/2004
Ltd
SOLUBLE ANADIN Pfizer Consumer Healthcare PA0172/004/004 Tablets - ACETYLSALICYLIC ACID 26/04/2004
Ltd - CAFFEINE CITRATE
TIPERAL Clonmel Healthcare Ltd PA0126/028/001 Tablets - PROPRANOLOL 26/04/2004
HYDROCHLORIDE
DYSPAMET Mercury Pharmaceuticals Ltd PA0899/010/001 Oral Suspension - CIMETIDINE 24/04/2004

HEXOPAL FORTE Sanofi-Synthelabo Ireland PA0077/003/002 Tablets - INOSITOL NICOTINATE 23/04/2004


Ltd
DIFLUCAN Pfizer Limited PA0019/044/003 Capsule - FLUCONAZOLE 21/04/2004
FELDENE DISPERSIBLE Pfizer Limited PA0019/024/006 Tablets - PIROXICAM 21/04/2004
FELDENE DISPERSIBLE Pfizer Limited PA0019/024/007 Tablets - PIROXICAM 21/04/2004
FELDENE IM Pfizer Limited PA0019/024/009 Solution for Injection - PIROXICAM 21/04/2004
FELDENE MELT Pfizer Limited PA0019/024/011 Tablets - PIROXICAM 21/04/2004
FELDENE MELT Pfizer Limited PA0019/024/012 Tablets - PIROXICAM 21/04/2004
LUSTRAL Pfizer Healthcare Ireland PA0822/001/007 Oral Solution - SERTRALINE 21/04/2004
VIBRAMYCIN Pfizer Limited PA0019/013/008 Tablets - DOXYCYCLINE HYCLATE 21/04/2004

VIBRAMYCIN Pfizer Limited PA0019/013/009 Tablets - DOXYCYCLINE HYCLATE 21/04/2004

Human Medicines Withdrawn Products Page 307 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METHYLPREDNISOLONE Hospira UK Limited PA0437/018/001 Pdr for Soln for Injection - METHYLPREDNISOLONE 20/04/2004
SODIUM SUCCINATE SODIUM SUCCINATE

METHYLPREDNISOLONE Hospira UK Limited PA0437/018/002 Pdr for Soln for Injection - METHYLPREDNISOLONE 20/04/2004
SODIUM SUCCINATE SODIUM SUCCINATE

CYTOSAR Pharmacia Limited PA0016/025/003 Pdr for Soln for Injection - CYTARABINE 17/04/2004
CAVERJECT Pharmacia Healthcare PA0936/009/006 Pdr+Solv for Soln for Inj - ALPROSTADIL 16/04/2004
Ireland
PINAMOX Pinewood Laboratories Ltd, PA0281/036/003 Powder for Oral Suspension - AMOXICILLIN 15/04/2004
TRIHYDRATE
BEROCCA Roche Products Limited PA0050/143/001 Tablets Effervescent - ASCORBIC ACID 12/04/2004
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- BIOTIN
- CALCIUM CARBONATE
- MAGNESIUM
CARBONATE
- MAGNESIUM SULFATE
COMPOUND MAGNESIUM Ranbaxy Ireland Limited PA0408/023/001 Tablets - MAGNESIUM TRISILICATE 11/04/2004
TRISILICATE - ALUMINIUM HYDROXIDE
GEL, DRIED

CYTOTEC Monsanto PLC PA0778/004/003 Tablets - MISOPROSTOL 11/04/2004


RIAMET Novartis Pharmaceuticals UK PA0013/098/001 Tablets - ARTEMETHER 08/04/2004
Ltd - LUMEFANTRINE
ALKERAN GlaxoSmithKline (Ireland) PA1077/051/003 Tablets - MELPHALAN 07/04/2004
Limited
IOPAMIDOL IODINE/ML Chiesi Limited PA0743/008/001 Solution for Injection - IOPAMIDOL 03/04/2004
IOPAMIDOL IODINE/ML Chiesi Limited PA0743/008/002 Solution for Injection - IOPAMIDOL 03/04/2004
IOPAMIDOL IODINE/ML Chiesi Limited PA0743/008/003 Solution for Injection - IOPAMIDOL 03/04/2004
IOPAMIDOL IODINE/ML Chiesi Limited PA0743/008/004 Solution for Injection - IOPAMIDOL 03/04/2004
VIBRAMYCIN-D Pfizer Limited PA0019/013/005 Tablet - Doxycycline 02/04/2004
ALDOMET Merck Sharp and Dohme PA0035/051/001 Coated Tablets - METHYLDOPA 01/04/2004
Limited
ALKERAN GlaxoSmithKline (Ireland) PA1077/051/001 Pdr+Solv for Soln for Inj - MELPHALAN 01/04/2004
Limited
ARTANE Cyanamid of Great Britain PA0037/050/001 Tablets - TRIHEXYPHENIDYL 01/04/2004
HYDROCHLORIDE
ARTANE Cyanamid of Great Britain PA0037/050/002 Tablets - TRIHEXYPHENIDYL 01/04/2004
HYDROCHLORIDE
BLOCADREN Merck Sharp and Dohme PA0035/044/005 Tablets - TIMOLOL MALEATE 01/04/2004
Limited
BRICANYL AstraZeneca UK Limited PA0970/036/007 Tablets - TERBUTALINE SULFATE 01/04/2004
BRICANYL SPACER AstraZeneca UK Limited PA0970/036/005 Pressurised Inhalation - TERBUTALINE SULFATE 01/04/2004
INHALER Suspension
COGENTIN Merck Sharp and Dohme PA0035/046/001 Tablets - BENZATROPINE 01/04/2004
Limited MESILATE
CYTOSAR Pharmacia Limited PA0016/025/001 Pdr for Soln for Injection - CYTARABINE 01/04/2004
DEBRISOQUINE Lifehealth Limited PA0809/002/001 Tablets - DEBRISOQUINE SULFATE 01/04/2004

DRISTAN NASAL SPRAY Pfizer Consumer Healthcare PA0172/007/001 Nasal Spray Solution - OXYMETAZOLINE 01/04/2004
Ltd HYDROCHLORIDE
- LEVOMENTHOL
- CINEOLE
- CAMPHOR
ISOPTO ATROPINE Alcon Laboratories (UK) Ltd PA0290/004/001 Eye Drops Solution - ATROPINE SULFATE 01/04/2004
ISOPTO CARBACHOL Alcon Laboratories (UK) Ltd PA0290/003/001 Eye Drops Solution - CARBACHOL 01/04/2004
ISOPTO FRIN Alcon Laboratories (UK) Ltd PA0290/001/001 Eye Drops Solution - PHENYLEPHRINE 01/04/2004
HYDROCHLORIDE
LEUKERAN GlaxoSmithKline (Ireland) PA1077/065/002 Tablets - CHLORAMBUCIL 01/04/2004
Limited
MINIMS HOMATROPINE Chauvin Pharmaceuticals PA0118/014/002 Eye Drops Solution - HOMATROPINE 01/04/2004
HYDROBROMIDE Limited HYDROBROMIDE
MINIMS PILOCARPINE Chauvin Pharmaceuticals PA0118/017/001 Eye Drops Solution - PILOCARPINE NITRATE 01/04/2004
NITRATE Limited
MUCAINE John Wyeth & Brother PA0022/020/001 Oral Suspension - OXETACAINE 01/04/2004
Limited - ALUMINIUM HYDROXIDE
- MAGNESIUM HYDROXIDE

Human Medicines Withdrawn Products Page 308 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MYLERAN GlaxoSmithKline (Ireland) PA1077/070/001 Tablets - BUSULFAN 01/04/2004
Limited
PROSTIN E2 Pharmacia Healthcare PA0936/062/004 Solution for Infusion - DINOPROSTONE 01/04/2004
Ireland
VASOXINE Wellcome (Ireland) Limited PA0017/055/001 Solution for Injection - METHOXAMINE 01/04/2004
HYDROCHLORIDE
ANAPOLON Cambridge Laboratories PA0844/003/001 Tablets - OXYMETHOLONE 31/03/2004
Limited
CHORAGON 5000 U AND Ferring Ireland Ltd PA1009/011/002 Pdr+Solv for Soln for Inj - CHORIONIC 31/03/2004
CHORAGON SOLVENT GONADOTROPHIN
ENTOCORT CR AstraZeneca UK Limited PA0970/039/001 Capsule - BUDESONIDE 29/03/2004
IOMERON 250 Bracco UK Limited PA1022/003/002 Solution for Injection - IOMEPROL 28/03/2004
IOMERON 300 Bracco UK Limited PA1022/007/001 Solution for Injection - IOMEPROL 27/03/2004
NAPREX ENTERIC Pinewood Laboratories Ltd, PA0281/028/003 Tablets Gastro-Resistant - NAPROXEN 26/03/2004
COATED
NAPREX ENTERIC Pinewood Laboratories Ltd, PA0281/028/004 Tablets Gastro-Resistant - NAPROXEN 26/03/2004
COATED
PINAMET Pinewood Laboratories Ltd, PA0281/092/003 Tablets - CIMETIDINE 26/03/2004
PINAMOX Pinewood Laboratories Ltd, PA0281/036/001 Capsule - AMOXICILLIN 26/03/2004
TRIHYDRATE
PINAMOX Pinewood Laboratories Ltd, PA0281/036/002 Capsule - AMOXICILLIN 26/03/2004
TRIHYDRATE
TEMAZINE Pinewood Laboratories Ltd, PA0281/060/001 Tablets - TEMAZEPAM 26/03/2004
TEMAZINE Pinewood Laboratories Ltd, PA0281/060/002 Tablets - TEMAZEPAM 26/03/2004
TENCHLOR Pinewood Laboratories Ltd, PA0281/084/001 Tablets - ATENOLOL 26/03/2004
- CHLORTALIDONE
TENCHLOR Pinewood Laboratories Ltd, PA0281/084/002 Tablets - ATENOLOL 26/03/2004
- CHLORTALIDONE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/011 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/012 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/013 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/014 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/015 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
FLEMOXIN SOLUTABS Yamanouchi Pharma Ltd PA0062/026/016 Tablets - AMOXICILLIN 25/03/2004
TRIHYDRATE
MINIHEP SYRINGES Leo Laboratories Limited PA0046/035/001 Solution for Injection - HEPARIN SODIUM 25/03/2004
DANOL Sanofi-Synthelabo Ireland PA0077/002/001 Capsule - DANAZOL 24/03/2004
Ltd
DANOL Sanofi-Synthelabo Ireland PA0077/002/002 Capsule - DANAZOL 24/03/2004
Ltd
TOP C GR Lane Health Products Lt PA0257/012/001 Tablets - ASCORBIC ACID 22/03/2004

VOLTAROL OPHTHA Novartis Pharmaceuticals UK PA0013/087/009 Eye Drops Solution - DICLOFENAC SODIUM 21/03/2004
Ltd
AUGMENTIN DUO GlaxoSmithKline (Ireland) PA1077/019/001 Powder for Oral Suspension - AMOXICILLIN 19/03/2004
SACHETS Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
CEC Rowex Ltd PA0711/021/001 Oral Suspension - CEFACLOR 19/03/2004
MONOHYDRATE
CEC Rowex Ltd PA0711/021/002 Oral Suspension - CEFACLOR 19/03/2004
MONOHYDRATE
HEMATOCIS KIT FOR CIS bio International PA0677/004/001 Unknown - SODIUM 19/03/2004
LABELLING RED BLOOD PYROPHOSPHATE
CELLS DECAHYDRATE
PHYTACIS CIS bio International PA0677/014/001 Pdr for Soln for Injection - SODIUM PHYTATE 19/03/2004
- STANNOUS CHLORIDE
DIHYDRATE
RESPIRONTIN NEBULES GlaxoSmithKline (Ireland) PA1077/045/001 Inhalation solution - IPRATROPIUM BROMIDE 19/03/2004
Limited
THALLIUM CHLORIDE CIS bio International PA0677/011/001 Solution for Injection - THALLOUS CHLORIDE 19/03/2004
(201 TL)
DIANEAL WITH GLUCOSE Baxter Healthcare Limited PA0167/042/001 Solution for peritoneal - GLUCOSE 16/03/2004
1.36 % dialysis - SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS

Human Medicines Withdrawn Products Page 309 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VAMIN 9 Fresenius Kabi Limited PA0566/011/001 Solution for Infusion - ALANINE 16/03/2004
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- MAGNESIUM SULFATE
HEPTAHYDRATE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
GAMMABULIN Immuno Limited PA0212/003/004 Solution for Injection - HUMAN PLASMA 12/03/2004
LYOPHILISED PROTEIN >90% GAMMA
GLOBULIN
PROVERA Pharmacia Healthcare PA0936/072/005 Tablets - 05/03/2004
Ireland MEDROXYPROGESTERO
NE ACETATE
AXID AP Pfizer Consumer Healthcare PA0172/027/001 Tablets - NIZATIDINE 04/03/2004
Ltd
ROSUVASTATIN AstraZeneca UK Limited PA0970/058/001 Tablets - ROSUVASTATIN 03/03/2004
ASTRAZENECA
ROSUVASTATIN AstraZeneca UK Limited PA0970/058/002 Tablets - ROSUVASTATIN 03/03/2004
ASTRAZENECA
ROSUVASTATIN AstraZeneca UK Limited PA0970/058/003 Tablets - ROSUVASTATIN 03/03/2004
ASTRAZENECA
LISINOPRIL-RATIO Ratiopharm GmbH PA0819/009/001 Tablets - LISINOPRIL DIHYDRATE 01/03/2004
LISINOPRIL-RATIO Ratiopharm GmbH PA0819/009/002 Tablets - LISINOPRIL DIHYDRATE 01/03/2004
LISINOPRIL-RATIO Ratiopharm GmbH PA0819/009/003 Tablets - LISINOPRIL DIHYDRATE 01/03/2004
LISINOPRIL-RATIO Ratiopharm GmbH PA0819/009/004 Tablet - Lisinopril dihydrate 01/03/2004
XYLOCARD AstraZeneca UK Limited PA0970/055/001 Solution for Injection - LIDOCAINE 25/02/2004
HYDROCHLORIDE
FLUPHENAZINE Mercury Pharmaceuticals PA0073/109/001 Solution for Injection - FLUPHENAZINE 23/02/2004
DECANOATE (Ireland) Ltd DECANOATE
FLUPHENAZINE Mercury Pharmaceuticals PA0073/109/002 Solution for Injection - FLUPHENAZINE 23/02/2004
DECANOATE (Ireland) Ltd DECANOATE
PRIMACINE Pinewood Laboratories Ltd, PA0281/026/001 Capsule - ERYTHROMYCIN 22/02/2004
STEARATE
PENBRITIN GlaxoSmithKline (Ireland) PA1077/096/003 Solution for Inj/Inf - AMPICILLIN SODIUM 20/02/2004
Limited
DIOVAN Novartis Pharmaceuticals UK PA0013/079/001 Capsule - VALSARTAN 19/02/2004
Ltd
DIOVAN Novartis Pharmaceuticals UK PA0013/079/002 Capsule - VALSARTAN 19/02/2004
Ltd
ESTRADERM MX Novartis Pharmaceuticals UK PA0013/070/004 Transdermal Patch - ESTRADIOL 19/02/2004
Ltd
ESTRADERM MX Novartis Pharmaceuticals UK PA0013/070/005 Transdermal Patch - ESTRADIOL 19/02/2004
Ltd
ESTRADERM MX Novartis Pharmaceuticals UK PA0013/070/006 Transdermal Patch - ESTRADIOL 19/02/2004
Ltd
PRIMEDOL PARACETAMO Murphy Healthcare Ireland PA0904/001/001 Tablets - PARACETAMOL 19/02/2004
Ltd.,
NOROXIN Merck Sharp and Dohme PA0035/077/001 Eye Drops Solution - NORFLOXACIN 15/02/2004
Limited
NOZINAN May & Baker Limited PA0040/071/002 Tablets - METHOTRIMEPRAZINE 14/02/2004
MALEATE
PENBRITIN GlaxoSmithKline (Ireland) PA1077/096/001 Capsule - AMPICILLIN TRIHYDRATE 12/02/2004
Limited
PENBRITIN GlaxoSmithKline (Ireland) PA1077/096/002 Capsule - AMPICILLIN TRIHYDRATE 12/02/2004
Limited
EMZOL Crookes Healthcare Ltd PA0043/034/001 Cream - MICONAZOLE NITRATE 11/02/2004
ERVEVAX SmithKline and French PA0060/042/001 Pdr+Solv for Soln for Inj - RUBELLA VIRUS (RA 27/3 10/02/2004
Laboratories Ltd STRAIN)
ERYACNE 2 Galderma (UK) Ltd PA0590/011/001 Gel - ERYTHROMYCIN 10/02/2004
ERYACNE 4 Galderma (UK) Ltd PA0590/011/002 Gel - ERYTHROMYCIN 10/02/2004

Human Medicines Withdrawn Products Page 310 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SUPREFACT DEPOT 3 Sanofi-Aventis Ireland PA0540/074/003 Implant - BUSERELIN ACETATE 07/02/2004
MONTHS Limited T/A SANOFI
CORLOPAM Elan Pharma International PA0872/003/001 Concentrate for Soln for Inf - FENOLDOPAM 05/02/2004
Ltd MESYLATE
BSS (BALANCED SALT Alcon Laboratories (UK) Ltd PA0290/005/001 Irrigation solution - SODIUM CHLORIDE 02/02/2004
SOLUTION) - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM ACETATE
- SODIUM CITRATE
GAMBROSOL 10H/4.0% Gambro Lundia AB PA0785/003/003 Solution for Infusion - GLUCOSE ANHYDROUS 02/02/2004
GLUCOSE - SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
GAMBROSOL 10L/1.5% Gambro Lundia AB PA0785/003/001 Soln for Peritoneal Dialysis - GLUCOSE ANHYDROUS 02/02/2004
GLUCOSE - SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
GAMBROSOL 10M/2.5% Gambro Lundia AB PA0785/003/002 Soln for Peritoneal Dialysis - GLUCOSE ANHYDROUS 02/02/2004
GLUCOSE - SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM LACTATE
ACTRAPID NOVOLET Novo Nordisk A/S PA0218/025/003 Solution for Injection - INSULIN HUMAN 01/02/2004
ACTRAPID PENFILL Novo Nordisk A/S PA0218/025/002 Solution for Injection - INSULIN HUMAN 01/02/2004
INSULATARD NOVOLET Novo Nordisk A/S PA0218/026/003 Suspension for Injection - INSULIN HUMAN 01/02/2004
INSULATARD PENFILL Novo Nordisk A/S PA0218/026/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
MIXTARD 10 PENFILL Novo Nordisk A/S PA0218/033/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
MIXTARD 20 PENFILL 1.5 Novo Nordisk A/S PA0218/034/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
ML
MIXTARD 30 NOVOLET 1.5 Novo Nordisk A/S PA0218/029/003 Suspension for Injection - INSULIN HUMAN 01/02/2004
ML
MIXTARD 30 PENFILL 1.5 Novo Nordisk A/S PA0218/029/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
ML
MIXTARD 40 PENFILL Novo Nordisk A/S PA0218/035/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
1.5ML
MIXTARD 50 Novo Nordisk A/S PA0218/036/001 Suspension for Injection - INSULIN HUMAN 01/02/2004
MIXTARD 50 PENFILL Novo Nordisk A/S PA0218/036/002 Suspension for Injection - INSULIN HUMAN 01/02/2004
1.5ML
ZYLORIC PCO Manufacturing PPA0465/017/002A Tablets - ALLOPURINOL 01/02/2004
CIMETIDINE Norton Waterford PA0436/012/001 Tablets - CIMETIDINE 28/01/2004
CIMETIDINE Norton Waterford PA0436/012/002 Tablets - CIMETIDINE 28/01/2004
CIMETIDINE Norton Waterford PA0436/012/003 Tablets - CIMETIDINE 28/01/2004
HARMOGEN Abbott Laboratories Ireland PA0038/016/001 Tablets - ESTROPIPATE 28/01/2004
Ltd
NIAR Abbott Laboratories Ireland PA0038/086/001 Tablets - SELEGILINE 28/01/2004
Ltd HYDROCHLORIDE
MEXITIL PL PERLONGETS Boehringer Ingelheim Limited PA0007/001/005 Capsule - MEXILETINE 20/01/2004
HYDROCHLORIDE
VOLOGEN RETARD Mercury Pharmaceuticals PA0073/133/003 Capsule - DICLOFENAC SODIUM 20/01/2004
(Ireland) Ltd
BUPIVACAINE & Mercury Pharmaceuticals PA0073/103/001 Solution for Injection - EPINEPHRINE 19/01/2004
ADRENALINE (Ireland) Ltd BITARTRATE
- BUPIVACAINE
HYDROCHLORIDE,
MONOHYDRATE
PYROGASTRONE Sanofi-Synthelabo Ireland PA0077/046/001 Tablets - CARBENOXOLONE 17/01/2004
Ltd SODIUM
- ALUMINIUM HYDROXIDE
GEL, DRIED
- MAGNESIUM TRISILICATE

AMOXIL PCO Manufacturing PPA0465/008/001B Capsule 16/01/2004


CIPRAMIL PCO Manufacturing PPA0465/068/003A Tablets - CITALOPRAM 16/01/2004
CIPRAMIL PCO Manufacturing PPA0465/068/003B Tablets - CITALOPRAM 16/01/2004
LAMICTAL PCO Manufacturing PPA0465/092/001A Tablets - LAMOTRIGINE 16/01/2004

Human Medicines Withdrawn Products Page 311 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LAMICTAL PCO Manufacturing PPA0465/092/002A Tablets - LAMOTRIGINE 16/01/2004
LAMICTAL PCO Manufacturing PPA0465/092/003A Tablets - LAMOTRIGINE 16/01/2004
VALDYN Pharmacia Enterprises S.A. EU/1/02/242/1-24 - VALDECOXIB 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/001 Pdr for Soln for Injection - PARECOXIB SODIUM 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/002 Pdr+Solv for Soln for Inj 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/003 Pdr+Solv for Soln for Inj 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/004 Pdr+Solv for Soln for Inj 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/005 Pdr for Soln for Injection 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/006 Pdr+Solv for Soln for Inj 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/007 Pdr+Solv for Soln for Inj 16/01/2004
XAPIT Pharmacia Europe EEIG EU/1/02/208/008 Pdr+Solv for Soln for Inj 16/01/2004
MELZINE Teva Pharma B.V. PA0126/025/002 Tablets - THIORIDAZINE 14/01/2004
HYDROCHLORIDE
MELZINE Clonmel Healthcare Ltd PA0126/025/004 Tablets - THIORIDAZINE 14/01/2004
HYDROCHLORIDE
FEMPLAN - MA . Mercury Pharmaceuticals PA0073/138/001 Tablets - ESTRADIOL 08/01/2004
(Ireland) Ltd - ESTRADIOL
-
MEDROXYPROGESTERO
NE ACETATE
INFRA-RUB PAIN Pfizer Consumer Healthcare PA0172/036/001 Cutaneous Foam - FELBINAC 08/01/2004
RELIEVING Ltd
OPTIMINE Schering-Plough Limited PA0277/001/001 Tablets - AZATADINE MALEATE 08/01/2004
URIMIN Chiesi Limited PA0743/009/001 Tablets - OXYBUTYNIN 07/01/2004
HYDROCHLORIDE
ETIPROFEN SR Ethypharm PA0549/008/001 Capsule - IBUPROFEN 05/01/2004
OSPEXIN Biochem Ltd PA0454/001/001 Capsule - CEFALEXIN 31/12/2003
OSPEXIN Forum Products Limited PA0454/001/004 Tablets - CEFALEXIN 31/12/2003
OSPEXIN Forum Products Limited PA0454/001/005 Capsule - CEFALEXIN 31/12/2003
OSPEXIN GRANULES FOR Forum Products Limited PA0454/001/002 Granules for Oral - CEFALEXIN 31/12/2003
CEPHALEXIN MIXTURE Suspension

OSPEXIN GRANULES FOR Forum Products Limited PA0454/001/003 Granules for Oral - CEFALEXIN 31/12/2003
CEPHALEXIN MIXTURE Suspension

BECLOMET EASYHALER Orion Corporation PA0795/001/001 Inhalation powder - BECLOMETASONE 22/12/2003


DIPROPIONATE
BECLOMET EASYHALER Orion Corporation PA0795/001/002 Inhalation powder - BECLOMETASONE 22/12/2003
DIPROPIONATE
BECLOMET EASYHALER Orion Corporation PA0795/001/003 Inhalation powder - BECLOMETASONE 22/12/2003
DIPROPIONATE
CLONILIX Clonmel Healthcare Ltd PA0126/088/001 - INDAPAMIDE 22/12/2003
HEMIHYDRATE
FLAREX Alcon Laboratories (UK) Ltd PA0290/062/001 Eye Drops Suspension - FLUOROMETHOLONE 22/12/2003
ACETATE
MAXIPIME Bristol-Myers Squibb PA0002/062/001 Pdr for Soln for Injection - CEFEPIME 22/12/2003
Pharmaceuticals uc DIHYDROCHLORIDE
MONOHYDRATE
MAXIPIME Bristol-Myers Squibb PA0002/062/002 Pdr for Soln for Injection - CEFEPIME 22/12/2003
Pharmaceuticals uc DIHYDROCHLORIDE
MONOHYDRATE
MAXIPIME Bristol-Myers Squibb PA0002/062/003 Pdr for Soln for Injection - CEFEPIME 22/12/2003
Pharmaceuticals uc DIHYDROCHLORIDE
MONOHYDRATE
IBUTOP Dolorgiet GmbH & Co. KG PA0848/001/001 Gel - IBUPROFEN 21/12/2003
BRETYLATE GlaxoSmithKline (Ireland) PA1077/053/001 Solution for Injection - BRETYLIUM TOSILATE 20/12/2003
Limited
ALPROX Orion Pharma A/s PA0303/025/002 Tablets - ALPRAZOLAM 19/12/2003
BUVENTOL EASYHALER Orion Pharma A/s PA0303/032/001 Inhalation powder - SALBUTAMOL SULFATE 19/12/2003
BUVENTOL EASYHALER Orion Pharma A/s PA0303/032/002 Inhalation powder - SALBUTAMOL SULFATE 19/12/2003
MRS CULLENS Cullen and Davison Limited PA0184/007/001 Powder for Oral Solution - ACETYLSALICYLIC ACID 19/12/2003
- CAFFEINE
DIVISEQ Orion Corporation PA0795/003/001 Tablets - ESTRADIOL VALERATE 15/12/2003
- ESTRADIOL VALERATE
-
MEDROXYPROGESTERO
NE ACETATE
- ESTRADIOL VALERATE
METHOTREXATE Cyanamid of Great Britain PA0037/023/010 Solution for Injection - METHOTREXATE SODIUM 13/12/2003

ULTRACEF Bristol-Myers Squibb PA0048/014/003 Powder for Oral Suspension - CEFADROXIL 11/12/2003
(Holdings) Limited MONOHYDRATE
ULTRACEF Bristol-Myers Squibb PA0048/014/004 Powder for Oral Suspension - CEFADROXIL 11/12/2003
(Holdings) Limited MONOHYDRATE

Human Medicines Withdrawn Products Page 312 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PENCICLOVIR Novartis Pharmaceuticals UK PA0013/108/001 Powder for solution for - PENCICLOVIR 10/12/2003
INTRAVENOUS Ltd infusion
PENCICLOVIR Novartis Pharmaceuticals UK PA0013/108/002 Powder for solution for - PENCICLOVIR 10/12/2003
INTRAVENOUS Ltd infusion
METRODIN HIGH PURITY Serono Limited PA0285/004/002 Pdr+Solv for Soln for Inj - UROFOLLITROPIN 30/11/2003
/0.9% NACL - FOLLICLE-STIMULATING
HORMONE, HUMAN
METRODIN HIGH Serono Limited PA0285/004/003 Pdr+Solv for Soln for Inj - UROFOLLITROPIN 30/11/2003
PURITY/0.9% NACL - FOLLICLE-STIMULATING
HORMONE, HUMAN
PARACETAMOL Abdine Ltd. PA0551/002/002 Tablets - PARACETAMOL 28/11/2003
SOMNITE Norgine Limited PA0102/004/002 Oral Suspension - NITRAZEPAM 28/11/2003
ALBUMINAR-5 Aventis Behring Limited PA0010/022/010 Solution for Infusion - HUMAN ALBUMIN 27/11/2003
ELDEPRYL Orion Pharma A/s PA0303/028/002 Tablets - SELEGILINE 27/11/2003
HYDROCHLORIDE
Evorel Sequi Janssen-Cilag Ltd PA0748/008/002 Transdermal patch - Norethisterone acetate 27/11/2003
- Estradiol hemihydrate
ONDEVA Sanofi-Aventis Ireland PA0540/022/001 Coated Tablets - ESTRADIOL 27/11/2003
Limited T/A SANOFI HEMIHYDRATE
- TRIMEGESTONE
SIMVASTATIN Pinewood Laboratories Ltd, PA0281/113/001 Tablets - SIMVASTATIN 27/11/2003
SIMVASTATIN Pinewood Laboratories Ltd, PA0281/113/002 Tablets - SIMVASTATIN 27/11/2003
SIMVASTATIN Pinewood Laboratories Ltd, PA0281/113/003 Tablets - SIMVASTATIN 27/11/2003
ZANTAC PCO Manufacturing PPA0465/033/002B Tablets - RANITIDINE 27/11/2003
HYDROCHLORIDE
ZANTAC PCO Manufacturing PPA0465/033/002C Tablets - RANITIDINE 27/11/2003
HYDROCHLORIDE
ZANTAC PCO Manufacturing PPA0465/033/002E Tablets - RANITIDINE 27/11/2003
HYDROCHLORIDE
ZIMOVANE PCO Manufacturing PPA0465/053/001C Coated Tablets 27/11/2003
ZIMOVANE PCO Manufacturing PPA0465/053/001E Coated Tablets 27/11/2003
Alphosyl ConditioningGlaxoSmithKline Consumer PA0678/078/001 Shampoo - ALCOHOLIC COAL TAR 18/11/2003
Shampoo Healthcare (Ireland) Limited EXTRACT
ALPHOSYL LOTION GlaxoSmithKline Consumer PA0678/081/002 Cutaneous Emulsion - ALCOHOLIC COAL TAR 18/11/2003
Healthcare (Ireland) Limited EXTRACT
BRONALIN EXPECTORANT Cupal Limited PA0258/020/001 Oral Solution - AMMONIUM CHLORIDE 18/11/2003
- SODIUM CITRATE
- DIPHENHYDRAMINE
HYDROCHLORIDE
CEPOREX Glaxo Laboratories Limited PA0044/009/002 Tablets - CEFALEXIN 18/11/2003
CEPOREX Glaxo Laboratories Limited PA0044/009/003 Tablets - CEFALEXIN 18/11/2003
LIGNOCAINE Baxter Healthcare Limited PA0167/005/005 Solution for Infusion - LIDOCAINE 18/11/2003
HCL/GLUCOSE HYDROCHLORIDE
- GLUCOSE
LIGNOCAINE Baxter Healthcare Limited PA0167/005/006 Solution for Infusion - LIDOCAINE 18/11/2003
HCL/GLUCOSE HYDROCHLORIDE
- GLUCOSE
LIGNOCAINE Baxter Healthcare Limited PA0167/005/007 Solution for Infusion - LIDOCAINE 18/11/2003
HCL/GLUCOSE HYDROCHLORIDE
- GLUCOSE
CALCIFORTE Laboratoires Grimberg PA0345/002/002 Tablets - CALCIUM CHLORIDE 17/11/2003
DIHYDRATE
- CALCIUM GLUCONATE
- CALCIUM GLUCEPTATE
- CALCIUM LACTATE
- CALCIUM CARBONATE
- SACCHAROMYCES
CEREVISIAE MEYEN
CALMURID Galderma (UK) Ltd PA0590/008/002 Cutaneous Solution - UREA 16/11/2003
- LACTIC ACID
FLIXOTIDE GlaxoSmithKline (Ireland) PA1077/044/001 Pressurised Inhalation - FLUTICASONE 16/11/2003
Limited Suspension PROPIONATE
FLIXOTIDE GlaxoSmithKline (Ireland) PA1077/044/003 Pressurised Inhalation Soln - FLUTICASONE 16/11/2003
Limited PROPIONATE
FLIXOTIDE GlaxoSmithKline (Ireland) PA1077/044/004 Pressurised Inhalation - FLUTICASONE 16/11/2003
Limited Suspension PROPIONATE
FLIXOTIDE Allen and Hanburys Limited PA0024/023/002 Pressurised Inhalation - FLUTICASONE 16/11/2003
Suspension PROPIONATE
HIPREX 3M Health Care Limited PA0057/009/001 Tablets - METHENAMINE 16/11/2003
HIPPURATE
LAXOL McDermott Laboratories Ltd PA0577/025/001 Oral Solution - LACTULOSE 13/11/2003
t/a Gerard Laboratories
OSTEOCUR Merck Serono Limited PA0654/006/001 Powder for Oral Suspension - COLECALCIFEROL 13/11/2003
- CALCIUM PHOSPHATE
OSTRAM D3 Merck Serono Limited PA0654/005/001 Powder for Oral Suspension - COLECALCIFEROL 13/11/2003
- CALCIUM PHOSPHATE

Human Medicines Withdrawn Products Page 313 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VOLTAROL RETARD PCO Manufacturing PPA0465/013/004C Tablets 13/11/2003
VOLTAROL RETARD PCO Manufacturing PPA0465/013/004D Tablets 13/11/2003
VOLTROL RETARD PCO Manufacturing PPA0465/013/004B Tablets - DICLOFENAC SODIUM 13/11/2003
DILZEM SR 180 Elan Pharma Ltd PA0516/012/004 Capsule - DILTIAZEM 29/10/2003
HYDROCHLORIDE
FLAGYL May & Baker Limited PA0040/003/009 Solution for Injection - METRONIDAZOLE 27/10/2003
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/001 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD 55 - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/002 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD 55 - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/003 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD AA - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/004 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD AA - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/005 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD AC - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
PERITONEAL DIALYSIS Bieffe Medital SpA PA0751/005/006 Soln for Peritoneal Dialysis - SODIUM CHLORIDE 26/10/2003
COD AC - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- GLUCOSE
ANTIMET Mercury Pharmaceuticals PA0073/060/002 Syrup - METOCLOPRAMIDE 25/10/2003
(Ireland) Ltd HYDROCHLORIDE
DIACARDYNE SR Ethypharm PA0549/001/005 Capsule - DILTIAZEM 22/10/2003
HYDROCHLORIDE
FEMHRT Warner Lambert (UK) Limite PA0856/021/001 Tablets - NORETHISTERONE 22/10/2003
ACETATE
- ETHINYLESTRADIOL
MINODIAB Pharmacia Healthcare PA0936/056/001 Tablets - GLIPIZIDE 21/10/2003
Ireland
DUTONIN Bristol-Myers Squibb PA0002/060/001 Tablets - NEFAZODONE 20/10/2003
Pharmaceuticals uc HYDROCHLORIDE
DUTONIN Bristol-Myers Squibb PA0002/060/002 Tablets - NEFAZODONE 20/10/2003
Pharmaceuticals uc HYDROCHLORIDE
DUTONIN Bristol-Myers Squibb PA0002/060/003 Tablets - NEFAZODONE 20/10/2003
Pharmaceuticals uc HYDROCHLORIDE
DUTONIN Bristol-Myers Squibb PA0002/060/004 Tablets - NEFAZODONE 20/10/2003
Pharmaceuticals uc HYDROCHLORIDE
MEFOXIN Merck Sharp and Dohme PA0035/042/001 Pdr for Soln for Injection - CEFOXITIN SODIUM 19/10/2003
Limited
MEFOXIN Merck Sharp and Dohme PA0035/042/002 Pdr for Soln for Injection - CEFOXITIN SODIUM 19/10/2003
Limited
ALPHOSYL GlaxoSmithKline Consumer PA0678/081/001 Cream - COAL TAR EXTRACT 18/10/2003
Healthcare (Ireland) Limited

Human Medicines Withdrawn Products Page 314 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VITAN Mercury Pharmaceuticals PA0073/081/001 Syrup - RETINOL 18/10/2003
(Ireland) Ltd - ERGOCALCIFEROL
- RIBOFLAVIN SODIUM
PHOSPHATE
- NICOTINAMIDE
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
- CYANOCOBALAMIN
VITAN Mercury Pharmaceuticals PA0073/081/002 Tablets - RETINOL 18/10/2003
(Ireland) Ltd - ERGOCALCIFEROL
- RIBOFLAVIN SODIUM
PHOSPHATE
- NICOTINAMIDE
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
- CYANOCOBALAMIN
- PYRIDOXINE
HYDROCHLORIDE
- CALCIUM
PANTOTHENATE
- FOLIC ACID
- INOSITOL
- TOCOPHERYL ACETATE
- FERROUS SULFATE
- POTASSIUM IODIDE
- CALCIUM PHOSPHATE
- COPPER SULFATE
ZITHROMAX Pfizer Limited PA0019/047/003 Powder for Oral Suspension - AZITHROMYCIN 18/10/2003
DIHYDRATE
ZITHROMAX Pfizer Limited PA0019/047/004 Powder for Oral Suspension - AZITHROMYCIN 18/10/2003
DIHYDRATE
ZITHROMAX Pfizer Limited PA0019/047/005 Powder for Oral Suspension - AZITHROMYCIN 18/10/2003
DIHYDRATE
ZITHROMAX Pfizer Limited PA0019/047/006 Powder for Oral Suspension - AZITHROMYCIN 18/10/2003
DIHYDRATE
ZITHROMAX Pfizer Limited PA0019/047/007 Powder for Oral Suspension - AZITHROMYCIN 18/10/2003
DIHYDRATE
ATENOLOL Mercury Pharmaceuticals PA0073/152/001 Coated Tablets - ATENOLOL 17/10/2003
(Ireland) Ltd
ATENOLOL Mercury Pharmaceuticals PA0073/152/002 Coated Tablets - ATENOLOL 17/10/2003
(Ireland) Ltd
GLYCOPYRROLATE & Mercury Pharmaceuticals PA0073/134/001 Solution for Injection - GLYCOPYRRONIUM 17/10/2003
NEOSTIGMINE (Ireland) Ltd BROMIDE
- NEOSTIGMINE
METILSULFATE
TIENAM I.V. 13ML Merck Sharp and Dohme PA0035/070/003 Powder for solution for - IMIPENEM 16/10/2003
Limited infusion - CILASTATIN SODIUM
SYNTARIS NASAL SPRAY Norton Healthcare Limited PA0282/088/001 Nasal Spray Solution - FLUNISOLIDE 14/10/2003
T/A IVAX Pharmaceuticals
UK
IPRAL Bristol-Myers Squibb PA0002/036/003 Tablets - TRIMETHOPRIM 13/10/2003
Pharmaceuticals uc
IPRAL Bristol-Myers Squibb PA0002/036/001 Tablets - TRIMETHOPRIM 13/10/2003
Pharmaceuticals uc
LEDERFOLIN Cyanamid of Great Britain PA0037/063/001 Pdr for Soln for Injection - CALCIUM FOLINATE 08/10/2003
NEUPOGEN Amgen Europe B.V. PA1026/001/003 Solution for Injection - FILGRASTIM 08/10/2003
NEUPOGEN Amgen Europe B.V. PA1026/001/004 Solution for Injection - FILGRASTIM 08/10/2003
NEUPOGEN Amgen Europe B.V. PA1026/001/005 Solution for Injection - FILGRASTIM 08/10/2003
NEUPOGEN Amgen Europe B.V. PA1026/001/006 Solution for Injection - FILGRASTIM 08/10/2003
SYSTEPIN Fujisawa Deutschland GmbH PA0473/002/001 Capsule - NIFEDIPINE 28/09/2003

SYSTEPIN Fujisawa Deutschland GmbH PA0473/002/002 Capsule - NIFEDIPINE 28/09/2003

SYSTEPIN RETARD Fujisawa Deutschland GmbH PA0473/002/003 Capsule - NIFEDIPINE 28/09/2003

DOBUTREX Eli Lilly and Company Limite PA0047/014/002 Powder for solution for - DOBUTAMINE 22/09/2003
infusion HYDROCHLORIDE
HUMASPECT KS Biomedix Limited EU/1/98/083/001 Pdr+Solv for Soln for Inj - VOTUMUMAB 22/09/2003
ADULT MELTUS Cupal Limited PA0258/026/001 Oral Solution - GUAIFENESIN 18/09/2003
- CETYLPYRIDINIUM
CHLORIDE
- SUCROSE
- HONEY

Human Medicines Withdrawn Products Page 315 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LANSINOH FOR Egnell Ameda Limited PA0907/001/001 Ointment - WOOL FAT 18/09/2003
BREASTFEEDING
MOTHERS
BURINEX Leo Laboratories Limited PA0046/016/010 Tablets - BUMETANIDE 11/09/2003
KERLONE Sanofi-Synthelabo Ireland PA0077/154/001 Tablets - BETAXOLOL 11/09/2003
Ltd HYDROCHLORIDE
ROFERON A Roche Products Limited PA0050/068/019 Solution for Injection - INTERFERON ALFA-2A 11/09/2003
FRANOL EXPECTORANT Sanofi-Synthelabo Ireland PA0077/017/004 Oral Solution - THEOPHYLLINE 09/09/2003
Ltd MONOHYDRATE
- GUAIFENESIN
LOMEXIN Pharmacia Limited PA0016/050/001 Pessary - FENTICONAZOLE 05/09/2003
NITRATE
MOXYDAR Laboratoires Grimberg PA0345/003/001 Tablets - ALUMINIUM OXIDE 05/09/2003
- MAGNESIUM HYDROXIDE
- ALUMINIUM PHOSPHATE
- GUAR GUM

MYOVIEW GE Healthcare Limited PA0240/007/001 Pdr for Soln for Injection - TETROFOSMIN 04/09/2003
NOLGEN Mercury Pharmaceuticals PA0073/093/002 Tablets - TAMOXIFEN CITRATE 04/09/2003
(Ireland) Ltd
CALCIUM PLUS D3 Hermes Arzneimittel GmbH PA0952/004/001 Tablets Effervescent - CALCIUM CARBONATE 03/09/2003
HERMES - COLECALCIFEROL
CALCIUM PLUS VITAMIN Hermes Arzneimittel GmbH PA0952/003/001 Tablets Effervescent - CALCIUM CARBONATE 03/09/2003
D3 HERMES - COLECALCIFEROL
CALCIUM VITAMIN D3 Hermes Arzneimittel GmbH PA0952/001/001 Tablets Effervescent - CALCIUM CARBONATE 03/09/2003
HERMES - COLECALCIFEROL
DUOVENT MDI Boehringer Ingelheim Limited PA0007/034/001 Pressurised Inhalation - IPRATROPIUM BROMIDE 03/09/2003
Suspension - FENOTEROL
HYDROBROMIDE
OXIVENT AUTOHALER Boehringer Ingelheim Limited PA0007/048/002 Pressurised Inhalation - OXITROPIUM BROMIDE 03/09/2003
Suspension
OXIVENT INHALER Boehringer Ingelheim Limited PA0007/048/001 Pressurised Inhalation - OXITROPIUM BROMIDE 03/09/2003
Suspension
VENTAMOL SALBUTAMOL Pinewood Laboratories Ltd, PA0281/030/003 Pressurised Inhalation Soln - SALBUTAMOL 03/09/2003
DUMICOAT DENTURE Alpharma ApS PA0363/007/001 Dental Solution - MICONAZOLE 01/09/2003
LACQUER
ZINC & CASTOR OIL Foran Healthcare Limited PA0484/006/001 Cream - ZINC OXIDE 01/09/2003
- CASTOR OIL
- CETOSTEARYL ALCOHOL
- BEESWAX
- ARACHIS OIL

MEDICOAL CHARCOAL Concord Pharmaceuticals Lt PA0828/001/001 Granules - CHARCOAL, ACTIVATED 28/08/2003

RETINOVA Janssen-Cilag Ltd PA0748/039/001 - TRETINOIN 28/08/2003


DILOSPIR Boehringer Ingelheim Limited PA0007/058/001 Nebuliser Solution - CROMOGLICATE SODIUM 26/08/2003

EMLA PATCH Astra Pharmaceuticals Ltd PA0009/035/002 Transdermal Patch - LIDOCAINE 26/08/2003
- PRILOCAINE
STAFOXIL Yamanouchi Pharma Ltd PA0062/024/001 Capsule - FLUCLOXACILLIN 25/08/2003
SODIUM
STAFOXIL Yamanouchi Pharma Ltd PA0062/024/002 Capsule - FLUCLOXACILLIN 25/08/2003
SODIUM
STEMETIL E.F.F. May & Baker Limited PA0040/026/008 Effervescent powder - PROCHLORPERAZINE 22/08/2003
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
- PROCHLORPERAZINE
MESILATE
DIABINESE Pfizer Limited PA0019/025/001 Tablets - CHLORPROPAMIDE 21/08/2003
DIABINESE Pfizer Limited PA0019/025/002 Tablets - CHLORPROPAMIDE 21/08/2003
HYPOVASE Pfizer Limited PA0019/023/003 Tablets - PRAZOSIN 21/08/2003
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 316 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALEXAN Pfizer Limited PA0019/036/001 Solution for Injection - CYTARABINE 20/08/2003
ALEXAN Pfizer Limited PA0019/036/002 Solution for Injection - CYTARABINE 20/08/2003
ALEXAN Pfizer Limited PA0019/036/003 Solution for Injection - CYTARABINE 20/08/2003
ALEXAN Pfizer Limited PA0019/036/004 Solution for Injection - CYTARABINE 20/08/2003
CLIMAVAL Novartis Pharmaceuticals UK PA0013/049/001 Coated Tablets - ESTRADIOL VALERATE 19/08/2003
Ltd
CLIMAVAL Novartis Pharmaceuticals UK PA0013/049/002 Coated Tablets - ESTRADIOL VALERATE 19/08/2003
Ltd
ISOTRATE Niche Generics Limited PA1063/004/001 Tablets - ISOSORBIDE 19/08/2003
MONONITRATE
ISOTRATE Niche Generics Limited PA1063/004/002 Tablets - ISOSORBIDE 19/08/2003
MONONITRATE
ISOTRATE Niche Generics Limited PA1063/004/003 Tablets - ISOSORBIDE 19/08/2003
MONONITRATE
PROZAC DISPERSIBLE Dista Products Limited PA0447/005/006 Tablets - FLUOXETINE 19/08/2003
HYDROCHLORIDE
SELEGILINE Niche Generics Limited PA1063/005/001 Tablets - SELEGILINE 19/08/2003
HYDROCHLORIDE
SELEGILINE Niche Generics Limited PA1063/005/002 Tablets - SELEGILINE 19/08/2003
HYDROCHLORIDE
TAVEGIL Novartis Pharmaceuticals UK PA0013/021/001 Tablets - CLEMASTINE FUMARATE 19/08/2003
Ltd
TRAMADOL Niche Generics Limited PA1063/007/001 Tablets - TRAMADOL 19/08/2003
HYDROCHLORIDE HYDROCHLORIDE
XYLOCAINE Astra Pharmaceuticals Ltd PA0009/016/022 Gel - LIDOCAINE 19/08/2003
HYDROCHLORIDE
NYCOPREN Takeda Danmark A/S PA0838/003/001 Tablets Gastro-Resistant - NAPROXEN 13/08/2003
NYCOPREN Takeda Danmark A/S PA0838/003/002 Tablets Gastro-Resistant - NAPROXEN 13/08/2003
WATER FOR INJECTION Novartis Pharmaceuticals UK PA0013/047/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 10/08/2003
PH.EUR. Ltd
FAMOTIDINE Niche Generics Limited PA1063/010/001 Tablets - FAMOTIDINE 07/08/2003
FAMOTIDINE Niche Generics Limited PA1063/010/002 Tablets - FAMOTIDINE 07/08/2003
VENTOLIN INHALER Allen and Hanburys Limited PA0024/001/009 Pressurised Inhalation - SALBUTAMOL 05/08/2003
Suspension
GYNO-TROSYL Pfizer Limited PA0019/033/002 Vaginal Cream - TIOCONAZOLE 02/08/2003
GYNO-TROSYL Pfizer Limited PA0019/033/003 Vaginal Ointment - TIOCONAZOLE 02/08/2003
OXYTETRACYCLINE Norton Healthcare Limited PA0282/015/001 Coated Tablets - OXYTETRACYCLINE 02/08/2003
T/A IVAX Pharmaceuticals DIHYDRATE
UK
STROMBA Sanofi-Synthelabo Ireland PA0077/045/001 Tablets - STANOZOLOL 29/07/2003
Ltd
AUGMENTIN JUNIOR GlaxoSmithKline (Ireland) PA1077/093/003 Powder for Oral Suspension - AMOXICILLIN 28/07/2003
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
AUGMENTIN PAEDIATRIC GlaxoSmithKline (Ireland) PA1077/093/005 Powder for Oral Suspension - AMOXICILLIN 28/07/2003
Limited TRIHYDRATE
- CLAVULANATE
POTASSIUM
HYPERBARIC Mercury Pharmaceuticals PA0073/142/001 Solution for Injection - BUPIVACAINE 27/07/2003
BUPIVACAINE (Ireland) Ltd HYDROCHLORIDE
HYDROCHLORIDE
LIPOVENOS Fresenius AG PA0697/003/003 Emulsion for Infusion - SOYBEAN OIL 27/07/2003
- GLYCEROL
- PHOSPHOLIPIDS
SAVENTRINE I.V. Forest Laboratories UK Ltd PA0100/016/002 Concentrate for Soln for Inf - ISOPRENALINE 27/07/2003
HYDROCHLORIDE
DECAVIT Rowa Pharmaceuticals PA0074/014/001 Capsule - RETINOL PALMITATE 25/07/2003
Limited - COLECALCIFEROL
- DL-ALFA-TOCOPHERYL
ACETATE
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- RIBOFLAVIN
- CALCIUM
PANTOTHENATE
- FOLIC ACID
- NICOTINAMIDE
- ASCORBIC ACID

LOMEXIN Recordati Industria Chimica e PA0812/002/002 Gel - FENTICONAZOLE 25/07/2003


Farmaceutica SpA NITRATE
LOMEXIN Recordati Industria Chimica e PA0812/002/003 Cutaneous Solution - FENTICONAZOLE 25/07/2003
Farmaceutica SpA NITRATE

Human Medicines Withdrawn Products Page 317 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PENTOXIFYLLINE 600 MG Fujisawa Deutschland GmbH PA0473/009/003 Capsule - PENTOXIFYLLINE 17/07/2003
SR
PENTOXIFYLLINE Fujisawa Deutschland GmbH PA0473/009/001 Solution for Injection - PENTOXIFYLLINE 17/07/2003
AMPOULES
PENTOXIFYLLINE S.R. Fujisawa Deutschland GmbH PA0473/009/002 Capsule - PENTOXIFYLLINE 17/07/2003

PRED G LIQUIFILM Allergan Pharmaceuticals PA0148/043/002 Eye Drops Suspension - PREDNISOLONE 17/07/2003
STERILE OPHTHALMIC Ireland ACETATE
- GENTAMICIN SULFATE
TRIFYBA Sanofi-Synthelabo Ireland PA0077/116/001 Oral Powder - TESTA TRITICUM TRICUM 17/07/2003
Ltd
ZEPHOLIN AMPOULE Fujisawa Deutschland GmbH PA0473/003/009 Solution for Injection - THEOPHYLLINE SODIUM 17/07/2003
AMINOACETATE
TOBRAMYCIN Hospira UK Limited PA0437/030/001 Solution for Injection - TOBRAMYCIN 14/07/2003
ZOLERIM Sanofi-Aventis Ireland PA0540/007/002 Tablets - ZOPICLONE 13/07/2003
Limited T/A SANOFI
ORUDIS Sanofi-Aventis Ireland PA0540/117/003 Tablets - KETOPROFEN 12/07/2003
Limited T/A SANOFI
SEPTOPAL E. Merck Ltd PA0054/041/001 Implant - GENTAMICIN SULFATE 11/07/2003
SEPTOPAL E. Merck Ltd PA0054/041/002 Implantation Chain - GENTAMICIN SULFATE 11/07/2003
CLINITAR Cambridge Healthcare PA0980/001/001 Cream - COAL TAR EXTRACT 07/07/2003
Supplies Limited
CLINITAR Cambridge Healthcare PA0980/001/002 Shampoo - COAL TAR EXTRACT 07/07/2003
Supplies Limited
BURINEX Leo Laboratories Limited PA0046/016/007 Solution for Injection - BUMETANIDE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/001 Coated Tablets - LOXAPINE SUCCINATE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/002 Coated Tablets - LOXAPINE SUCCINATE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/003 Tablets - LOXAPINE SUCCINATE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/006 Capsule - LOXAPINE SUCCINATE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/007 Capsule - LOXAPINE SUCCINATE 04/07/2003
LOXAPAC Cyanamid of Great Britain PA0037/004/008 Capsule - LOXAPINE SUCCINATE 04/07/2003
CLAFORAN Sanofi-Aventis Ireland PA0540/037/001 Powder for solution for - CEFOTAXIME SODIUM 03/07/2003
Limited T/A SANOFI infusion
ACTIRA Bayer AG PA0669/005/001 Tablets - MOXIFLOXACIN 30/06/2003
HYDROCHLORIDE
DELFEN CONTRACEPTIVE Janssen-Cilag Ltd PA0748/006/001 Vaginal Foam - NONOXINOL 30/06/2003

DANAZANT Mercury Pharmaceuticals PA0073/096/001 Capsule 27/06/2003


(Ireland) Ltd
DANAZANT Mercury Pharmaceuticals PA0073/096/002 Capsule - DANAZOL 27/06/2003
(Ireland) Ltd
MENTHOL AND Thornton & Ross Limited PA0610/003/001 Cream - MUSTARD OIL 27/06/2003
WINTERGREEN HEAT RUB - CAMPHOR
- MENTHOL
- METHYL SALICYLATE
ZACTOLINE Niche Generics Limited PA1063/008/001 Tablets - SELEGILINE 26/06/2003
HYDROCHLORIDE
ZACTOLINE Niche Generics Limited PA1063/008/002 Tablets - SELEGILINE 26/06/2003
HYDROCHLORIDE
FLETCHERS ARACHIS OIL Forest Laboratories UK Ltd PA0100/027/001 Rectal Solution - ARACHIS OIL 23/06/2003
RETENTION
BOCATRIOL Leo Laboratories Limited PA0046/062/003 Oral Drops Solution - CALCITRIOL 17/06/2003
ONE-ALPHA Leo Laboratories Limited PA0046/024/008 Capsule - ALFACALCIDOL 17/06/2003
CLARITYN PCO Manufacturing PPA0465/049/001A Tablets - LORATADINE 15/06/2003
CLARITYN PCO Manufacturing PPA0465/049/001C Tablets 15/06/2003
CLARITYN PCO Manufacturing PPA0465/049/001E Tablets - LORATADINE 15/06/2003
QUINOCORT Ecolab Limited PA1110/008/001 Cream - POTASSIUM 02/06/2003
HYDROXYQUINOLIN
SULFATE
- HYDROCORTISONE
OXAZEPAM John Wyeth & Brother PA0022/043/002 Tablets - OXAZEPAM 01/06/2003
Limited
OXAZEPAM John Wyeth & Brother PA0022/043/003 Tablets - OXAZEPAM 01/06/2003
Limited
ESTRAPAK Novartis Pharmaceuticals UK PA0013/071/002 Transdermal Patch+Tablets - NORETHISTERONE 31/05/2003
Ltd ACETATE
- ESTRADIOL
DOPAGEN Mercury Pharmaceuticals PA0073/051/003 Tablets - METHYLDOPA 30/05/2003
(Ireland) Ltd
H-B VAX II PREFILLED Sanofi Pasteur MSD Ltd PA0544/023/004 Solution for Injection - HEPATITIS B SURFACE 30/05/2003
ANTIGEN, RECOMINANT
H-B VAX II PREFILLED Sanofi Pasteur MSD Ltd PA0544/023/005 Solution for Injection - HEPATITIS B SURFACE 30/05/2003
ANTIGEN, RECOMINANT
HB-VAX II Sanofi Pasteur MSD Ltd PA0544/023/003 Suspension for Injection - HEPATITIS B SURFACE 30/05/2003
ANTIGEN, RECOMINANT

Human Medicines Withdrawn Products Page 318 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METROLYL Sandoz Ltd PA0372/001/003 Suppositories - METRONIDAZOLE 30/05/2003
METROLYL Sandoz Ltd PA0372/001/004 Suppositories - METRONIDAZOLE 30/05/2003
DUACT Wellcome (Ireland) Limited PA0017/097/001 Capsule - ACRIVASTINE 28/05/2003
- PSEUDOEPHEDRINE
HYDROCHLORIDE
DUACT LA Wellcome (Ireland) Limited PA0017/097/002 Capsule - PSEUDOEPHEDRINE 28/05/2003
HYDROCHLORIDE
- ACRIVASTINE
HALIBUT LIVER OIL GR Lane Health Products Lt PA0257/041/001 Capsule - RETINOL 26/05/2003
- COLECALCIFEROL
HEXOPAL Sanofi-Synthelabo Ireland PA0077/003/001 Oral Suspension - INOSITOL NICOTINATE 26/05/2003
Ltd
PRAXILENE Lipha Pharmaceuticals PA0289/008/002 Capsule - NAFTIDROFURYL 26/05/2003
Limited OXALATE
FEMULEN Pharmacia Healthcare PA0936/024/001 Tablets - ETYNODIOL DIACETATE 24/05/2003
Ireland
ANTEPSIN John Wyeth & Brother PA0022/053/001 Tablets - SUCRALFATE 23/05/2003
Limited
ANTEPSIN John Wyeth & Brother PA0022/053/002 Tablets - SUCRALFATE 23/05/2003
Limited
ANTEPSIN John Wyeth & Brother PA0022/053/003 Oral Suspension - SUCRALFATE 23/05/2003
Limited
BC 500 John Wyeth & Brother PA0022/055/001 Coated Tablets - THIAMINE MONONITRATE 23/05/2003
Limited - RIBOFLAVIN
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- CALCIUM
PANTOTHENATE
- SODIUM ASCORBATE
- CYANOCOBALAMIN

ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/011 Solution for Infusion - GENTAMICIN SULFATE 21/05/2003
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/014 Solution for Infusion - GENTAMICIN SULFATE 21/05/2003
XYLOCAINE Astra Pharmaceuticals Ltd PA0009/016/006 Ointment - LIDOCAINE 21/05/2003
XYLOCAINE PLAIN Astra Pharmaceuticals Ltd PA0009/016/009 Solution for Injection - LIDOCAINE 21/05/2003
HYDROCHLORIDE
XYLOCAINE PLAIN Astra Pharmaceuticals Ltd PA0009/016/013 Solution for Injection - LIDOCAINE 21/05/2003
HYDROCHLORIDE
ZAFIRLUKAST ZENECA AstraZeneca UK Limited PA0970/002/001 Coated Tablets - ZAFIRLUKAST 21/05/2003
ZAFIRLUKAST ZENECA AstraZeneca UK Limited PA0970/002/002 Coated Tablets - ZAFIRLUKAST 21/05/2003
DALACIN C PAEDIATRIC Pharmacia Limited PA0016/002/001 Granules for Oral - CLINDAMYCIN 06/05/2003
Suspension PALMITATE
HYDROCHLORIDE
GENOTROPIN 0.7MG Pharmacia Laboratories PA0187/032/004 Pdr+Solv for Soln for Inj - SOMATROPIN 06/05/2003
KABIQUICK Limited
GENOTROPIN 1.3MG Pharmacia Laboratories PA0187/032/006 Pdr+Solv for Soln for Inj - SOMATROPIN 06/05/2003
KABIQUICK Limited
GENOTROPIN 1MG Pharmacia Laboratories PA0187/032/005 Pdr+Solv for Soln for Inj - SOMATROPIN 06/05/2003
KABIQUICK Limited
MAXAQUIN Monsanto PLC PA0778/008/001 Tablets - LOMEFLOXACIN 06/05/2003
HYDROCHLORIDE
MENOPHASE Monsanto PLC PA0778/016/001 Tablets - MESTRANOL 06/05/2003
- MESTRANOL
- MESTRANOL
- MESTRANOL
- NORETHISTERONE
- MESTRANOL
- NORETHISTERONE
- NORETHISTERONE
PREPIDIL Pharmacia Limited PA0016/043/001 Gel - DINOPROSTONE 06/05/2003
MICTRAL Sanofi-Synthelabo Ireland PA0077/051/001 Granules Effervescent - NALIDIXIC ACID 02/05/2003
Ltd - SODIUM CITRATE
- CITRIC ACID
- SODIUM BICARBONATE
KLACID PCO Manufacturing PPA0465/051/001C Tablets 01/05/2003
KLACID PCO Manufacturing PPA0465/051/001F Tablets 01/05/2003
PAVULON NV Organon PA0964/003/001 Solution for Injection - PANCURONIUM BROMIDE 30/04/2003

PILOCARPINE Schering-Plough Limited PA0277/018/001 Eye Drops Solution - PILOCARPINE 25/04/2003


HYDROCHLORIDE
PILOCARPINE Schering-Plough Limited PA0277/018/002 Eye Drops Solution - PILOCARPINE 25/04/2003
HYDROCHLORIDE
PILOCARPINE Schering-Plough Limited PA0277/018/003 Eye Drops Solution - PILOCARPINE 25/04/2003
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 319 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PILOCARPINE Schering-Plough Limited PA0277/018/004 Eye Drops Solution - PILOCARPINE 25/04/2003
HYDROCHLORIDE
CHLORAMPHENICOL Schering-Plough Limited PA0277/011/001 Eye Drops Solution - CHLORAMPHENICOL 24/04/2003
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/004 Pdr for Soln Inj/Inf - CALCIUM FOLINATE 23/04/2003
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/005 Solution for Injection - CALCIUM FOLINATE 23/04/2003
LORAZEPAM John Wyeth & Brother PA0022/044/001 Tablets - LORAZEPAM 21/04/2003
Limited
LORAZEPAM John Wyeth & Brother PA0022/044/002 Tablets - LORAZEPAM 21/04/2003
Limited
HOMATROPINE Schering-Plough Limited PA0277/012/001 Eye Drops Solution - HOMATROPINE 20/04/2003
HOMATROPINE Schering-Plough Limited PA0277/012/002 Eye Drops Solution - HOMATROPINE 20/04/2003
ATROPINE SULPHATE Schering-Plough Limited PA0277/010/001 Eye Drops Solution - ATROPINE SULFATE 19/04/2003
MAALOX Rorer Pharmaceuticals PA0468/016/001 Tablets - ALUMINIUM HYDROXIDE 19/04/2003
Limited DRIED
- MAGNESIUM HYDROXIDE

FEMATRIX 7 DAY 80 Elan Pharma International PA0872/005/003 Transdermal Patch - ESTRADIOL 17/04/2003
Ltd
AZOPINE Pinewood Laboratories Ltd, PA0281/047/001 Tablets - AZATHIOPRINE 15/04/2003
FUROSEMIDE Pinewood Laboratories Ltd, PA0281/006/002 Tablets - FUROSEMIDE 15/04/2003
PERDIX SCHWARZ PHARMA Limite PA0271/008/001 Tablets - MOEXIPRIL 15/04/2003
HYDROCHLORIDE
PERDIX SCHWARZ PHARMA Limite PA0271/008/002 Tablets - MOEXIPRIL 15/04/2003
HYDROCHLORIDE
PINAMET CIMETIDINE Pinewood Laboratories Ltd, PA0281/054/003 Tablets - CIMETIDINE 15/04/2003
PINAMOX Pinewood Laboratories Ltd, PA0281/036/004 Powder for Oral Suspension - AMOXICILLIN 15/04/2003
TRIHYDRATE
CARBOPLATIN Hospira UK Limited PA0437/017/001 Powder for solution for - CARBOPLATIN 13/04/2003
infusion
GOLYTELY Golytely Limited name PA0439/001/001 Powder for Oral Solution - MACROGOL 3350 13/04/2003
changed - SODIUM SULFATE
ANHYDROUS
- SODIUM BICARBONATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
ASENDIS Cyanamid of Great Britain PA0037/039/001 Tablets - AMOXAPINE 10/04/2003
ASENDIS Cyanamid of Great Britain PA0037/039/002 Tablets - AMOXAPINE 10/04/2003
ASENDIS Cyanamid of Great Britain PA0037/039/003 Tablets - AMOXAPINE 10/04/2003
HYPROMELLOSE Schering-Plough Limited PA0277/014/001 Eye Drops Solution - HYPROMELLOSE 08/04/2003
STERINEB SODIUM Steripak Ltd PA0621/002/001 Nebuliser Solution - CROMOGLICATE SODIUM 07/04/2003
CROMOGLYCATE
ASTRIX Hospira UK Limited PA0437/041/001 Capsule - ACETYLSALICYLIC ACID 04/04/2003
TRAMADOL Winthrop Pharmaceuticals PA1046/006/002 Solution for Injection - TRAMADOL 03/04/2003
HYDROCHLORIDE UK Limited HYDROCHLORIDE
ABIDEC McNeil Healthcare (Ireland) PA0823/030/001 Oral Drops Solution - RETINOL 01/04/2003
Ltd - THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- ASCORBIC ACID
- ERGOCALCIFEROL
- NICOTINAMIDE
ACTHAR GEL Rorer Pharmaceuticals PA0468/021/003 Solution for Injection - CORTICOTROPHIN 01/04/2003
Limited
ASPIRIN Mercury Pharmaceuticals PA0073/025/001 Tablets - ACETYLSALICYLIC ACID 01/04/2003
(Ireland) Ltd
ATTENUVAX VACCINE Sanofi Pasteur MSD Ltd PA0544/022/001 Pdr+Solv for Soln for Inj - MEASLES VIRUS - 01/04/2003
ENDERS EDMONSTON
STRAIN
BELLADONNA POROUS Ovelle Limited PA0206/011/001 Impregnated Dressing - BELLADONNA 01/04/2003
PLASTER ON RED ALKALOIDS
FLANNELETTE
BENEMID Merck Sharp and Dohme PA0035/012/001 Tablets - PROBENECID 01/04/2003
Limited
BILOPTIN HE Clissmann PA0012/035/001 Capsule - SODIUM IOPODATE 01/04/2003
BOOTS HEALTHCARE HOT The Boots Company Plc PA0004/025/001 Granules for Oral - PARACETAMOL 01/04/2003
LEMON COLD RELIEF Suspension - ASCORBIC ACID

BRADOSOL Novartis Consumer Health PA0030/031/001 Lozenges - DOMIPHEN BROMIDE 01/04/2003


UK Limited
BURINEX K Leo Laboratories Limited PA0046/017/001 Tablets - BUMETANIDE 01/04/2003
- POTASSIUM CHLORIDE
BURNAID Cupal Limited PA0258/009/001 Cream - AMINOACRIDINE 01/04/2003
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 320 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALPOL McNeil Healthcare (Ireland) PA0823/010/007 Tablets - PARACETAMOL 01/04/2003
Ltd
CONCORDIN Merck Sharp and Dohme PA0035/041/001 Tablets - PROTRIPTYLINE 01/04/2003
Limited HYDROCHLORIDE
CONCORDIN Merck Sharp and Dohme PA0035/041/002 Tablets - PROTRIPTYLINE 01/04/2003
Limited HYDROCHLORIDE
CUPAL Cupal Limited PA0258/007/001 Tablets - PARACETAMOL 01/04/2003
- CAFFEINE
- PHENYLEPHRINE
HYDROCHLORIDE
CUPAL COLD/FLU WITH Cupal Limited PA0258/011/001 Capsule - PARACETAMOL 01/04/2003
COUGH SUPPRESSANT - DEXTROMETHORPHAN
HYDROBROMIDE
- PHENYLEPHRINE
HYDROCHLORIDE
DECADRON Merck Sharp and Dohme PA0035/016/003 Solution for Injection - DEXAMETHASONE 01/04/2003
Limited SODIUM PHOSPHATE
DECADRON SHOCK PAK Merck Sharp and Dohme PA0035/016/004 Solution for Injection - DEXAMETHASONE 01/04/2003
Limited SODIUM PHOSPHATE
DIANEAL 130/GLUCOSE Baxter Healthcare Limited PA0167/043/001 Solution for peritoneal - GLUCOSE 01/04/2003
1.36 % W/V/13.6 MG/ML dialysis - SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
DIANEAL 130/GLUCOSE Baxter Healthcare Limited PA0167/045/001 Solution for peritoneal - GLUCOSE 01/04/2003
1.36%/POTASSIUM dialysis - SODIUM ACETATE
2.5MMOL/L - SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
DIANEAL/GLUCOSE 3.86% Baxter Healthcare Limited PA0167/044/001 Solution for peritoneal - GLUCOSE 01/04/2003
dialysis - SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
DICONAL Wellcome (Ireland) Limited PA0017/017/001 Tablets - DIPIPANONE 01/04/2003
HYDROCHLORIDE
- CYCLIZINE
HYDROCHLORIDE
EDECRIN Merck Sharp and Dohme PA0035/024/001 Pdr for Soln for Injection - ETACRYNATE SODIUM 01/04/2003
Limited
ERGOMETRINE Mercury Pharmaceuticals PA0073/100/001 Solution for Injection - ERGOMETRINE MALEATE 01/04/2003
(Ireland) Ltd
FLAGYL May & Baker Limited PA0040/003/006 Solution for Injection - METRONIDAZOLE 01/04/2003
HYDROSALURIC Merck Sharp and Dohme PA0035/026/001 Tablets - HYDROCHLOROTHIAZIDE 01/04/2003
Limited
ISONIAZID Mercury Pharmaceuticals PA0073/034/001 Tablets - ISONIAZID 01/04/2003
(Ireland) Ltd
ISONIAZID Mercury Pharmaceuticals PA0073/034/002 Tablets - ISONIAZID 01/04/2003
(Ireland) Ltd
METANIUM William Ransom & Son Plc PA0506/018/001 Ointment - TITANIUM DIOXIDE 01/04/2003
- TITANIUM PEROXIDE
- TITANIUM SALICYLATE
MIDAMOR Merck Sharp and Dohme PA0035/028/001 Tablets - AMILORIDE 01/04/2003
Limited HYDROCHLORIDE
MINTEZOL Merck Sharp and Dohme PA0035/057/001 Tablets Chewable - TIABENDAZOLE 01/04/2003
Limited
MULTIBIONTA E. Merck Ltd PA0054/053/001 Solution for Infusion - RETINOL 01/04/2003
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN SODIUM
PHOSPHATE
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- DEXPANTHENOL
- ASCORBIC ACID
- TOCOPHERYL ACETATE
MUMPSVAX VACCINE Sanofi Pasteur MSD Ltd PA0544/026/001 Solution for Injection - MUMPS VIRUS - 01/04/2003
JERYLYNN STRAIN

Human Medicines Withdrawn Products Page 321 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEUROBION Merck Serono Limited PA0654/009/002 Tablets - THIAMINE MONONITRATE 01/04/2003
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN

NORGESIC 3M Health Care Limited PA0057/012/001 Tablets - ORPHENADRINE 01/04/2003


CITRATE
- PARACETAMOL
- GELATINE
HYDROLYSATE
OROVITE Thornton & Ross Limited PA0610/005/001 Tablets - RIBOFLAVIN 01/04/2003
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
PAPAVERETUM B.P. Mercury Pharmaceuticals PA0073/031/001 Solution for Injection - PAPAVERETUM 01/04/2003
(Ireland) Ltd
PREDNISOLONE Mercury Pharmaceuticals PA0073/033/001 Tablets - PREDNISOLONE 01/04/2003
(Ireland) Ltd
PREDNISOLONE Mercury Pharmaceuticals PA0073/033/002 Tablets - PREDNISOLONE 01/04/2003
(Ireland) Ltd
RESONIUM A Sanofi-Synthelabo Ireland PA0077/077/001 Powder for Oral Suspension - SODIUM POLYSTYRENE 01/04/2003
Ltd SULFONATE
SODIUM Baxter Healthcare Limited PA0167/050/013A Solution for Infusion - SODIUM CHLORIDE 01/04/2003
CHLORIDE/GLUCOSE - GLUCOSE
TERRACORTRIL NYSTATIN Pfizer Limited PA0019/021/001 Cream - OXYTETRACYCLINE 01/04/2003
- HYDROCORTISONE
- NYSTATIN
TRAVASEPT 15 Baxter Healthcare Limited PA0167/032/019A Cutaneous Solution - CHLORHEXIDINE 01/04/2003
DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 30 Baxter Healthcare Limited PA0167/032/022A Cutaneous Solution - CHLORHEXIDINE 01/04/2003


DIACETATE
- CETRIMONIUM BROMIDE

TRYPTIZOL Merck Sharp and Dohme PA0035/002/002 Tablets - AMITRIPTYLINE 01/04/2003


Limited HYDROCHLORIDE
TRYPTIZOL Merck Sharp and Dohme PA0035/002/003 Tablets - AMITRIPTYLINE 01/04/2003
Limited HYDROCHLORIDE
TRYPTIZOL Merck Sharp and Dohme PA0035/002/004 Tablets - AMITRIPTYLINE 01/04/2003
Limited HYDROCHLORIDE
TRYPTIZOL Merck Sharp and Dohme PA0035/002/006 Solution for Injection - AMITRIPTYLINE 01/04/2003
Limited HYDROCHLORIDE
WATER May & Baker Limited PA0040/074/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 01/04/2003

WATER May & Baker Limited PA0040/074/002 Solvent for Parenteral Use - WATER FOR INJECTIONS 01/04/2003

WATER May & Baker Limited PA0040/074/003 Solvent for Parenteral Use - WATER FOR INJECTIONS 01/04/2003

XYLOPROCT Astra Pharmaceuticals Ltd PA0009/007/002 Suppositories - LIDOCAINE 01/04/2003


- HYDROCORTISONE
ACETATE
ZAROXOLYN UCB Pharma Limited PA0365/080/001 Tablets - METOLAZONE 01/04/2003
ZAROXOLYN UCB Pharma Limited PA0365/080/002 Tablets - METOLAZONE 01/04/2003
CETAVLEX ANTISEPTIC Bioglan Laboratories Ltd PA0469/030/001 Cream - CETRIMONIUM BROMIDE 31/03/2003

HIBITANE OBSTETRIC Bioglan Laboratories Ltd PA0469/031/001 Cream - CHLORHEXIDINE 31/03/2003


GLUCONATE
METOSYN Bioglan Laboratories Ltd PA0469/029/001 Cutaneous Paste - FLUOCINONIDE 31/03/2003
SIOPEL Bioglan Laboratories Ltd PA0469/033/001 Cream - CETRIMONIUM BROMIDE 31/03/2003
- DIMETHICONE 350

SODIUM Baxter Healthcare Limited PA0167/050/015A Solution for Infusion - SODIUM CHLORIDE 31/03/2003
CHLORIDE/GLUCOSE - GLUCOSE
SYNALAR Bioglan Laboratories Ltd PA0469/026/001 Cream - FLUOCINOLONE 31/03/2003
ACETONIDE
SYNALAR Bioglan Laboratories Ltd PA0469/026/003 Ointment - FLUOCINOLONE 31/03/2003
ACETONIDE
SYNALAR C Bioglan Laboratories Ltd PA0469/028/001 Cream - FLUOCINOLONE 31/03/2003
ACETONIDE
- CLIOQUINOL

Human Medicines Withdrawn Products Page 322 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SYNALAR C Bioglan Laboratories Ltd PA0469/028/002 Ointment - FLUOCINOLONE 31/03/2003
ACETONIDE
- CLIOQUINOL
SYNALAR N Bioglan Laboratories Ltd PA0469/027/002 Ointment - FLUOCINOLONE 31/03/2003
ACETONIDE
- NEOMYCIN SULFATE
SYNLAR N Bioglan Laboratories Ltd PA0469/027/001 Cream - FLUOCINOLONE 31/03/2003
ACETONIDE
- NEOMYCIN SULFATE
LORON FOR INFUSION Roche Products Limited PA0050/148/001 Concentrate for Soln for Inf - CLODRONATE DISODIUM 30/03/2003

BENZYL BENZOATE Foran Healthcare Limited PA0484/002/001 Cutaneous Emulsion - BENZYL BENZOATE 29/03/2003
ETHYL CHLORIDE BP Roche Products Limited PA0050/135/001 Cutaneous Spray Solution - ETHYL CHLORIDE 27/03/2003
TRANTALOL ATENOLOL Pinewood Laboratories Ltd, PA0281/045/001 Coated Tablets - ATENOLOL 23/03/2003
TRANTALOL ATENOLOL Pinewood Laboratories Ltd, PA0281/045/002 Coated Tablets - ATENOLOL 23/03/2003
AREDIA DRY POWDER Novartis Pharmaceuticals UK PA0013/090/003 Concentrate for Soln for Inf - PAMIDRONATE 21/03/2003
Ltd DISODIUM
CIBACEN Novartis Pharmaceuticals UK PA0013/078/003 Tablets - BENAZEPRIL 21/03/2003
Ltd HYDROCHLORIDE
DILAUDID Knoll Limited PA0769/009/001 Solution for Injection - HYDROMORPHONE 21/03/2003
HYDROCHLORIDE
FAMVIR Novartis Pharmaceuticals UK PA0013/106/003 Coated Tablets - FAMCICLOVIR 21/03/2003
Ltd
FERRIC CITRATE GE Healthcare Limited PA0240/015/001 Solution for Injection - FERRIC (59 FE) CITRATE 21/03/2003
INJECTION
LAMISIL Novartis Pharmaceuticals UK PA0013/045/002 Tablets - TERBINAFINE 21/03/2003
Ltd HYDROCHLORIDE
NEORAL Novartis Pharmaceuticals UK PA0013/054/005 Capsule - CICLOSPORIN 21/03/2003
Ltd
OSTRAM Laboratoires Merck-Clevenot PA0656/001/001 Powder for Oral Solution - CALCIUM PHOSPHATE 21/03/2003

SANDIMMUN Novartis Pharmaceuticals UK PA0013/033/002 Concentrate for Soln for Inf - CICLOSPORIN 21/03/2003
Ltd
SYNTOPRESSIN Novartis Pharmaceuticals UK PA0013/019/001 Nasal Spray Solution - LYPRESSIN 21/03/2003
Ltd
TAMOX Rowex Ltd PA0711/022/003 Tablets - TAMOXIFEN CITRATE 21/03/2003
ZADITEN Novartis Pharmaceuticals UK PA0013/013/001 Capsule - KETOTIFEN FUMARATE 21/03/2003
Ltd
NORDITROPIN Novo Nordisk A/S PA0218/040/003 Pdr+Solv for Soln for Inj - SOMATROPIN 19/03/2003
NORDITROPIN Novo Nordisk A/S PA0218/040/004 Pdr+Solv for Soln for Inj - SOMATROPIN 19/03/2003
NORDITROPIN PENSET Novo Nordisk A/S PA0218/040/001 Pdr+Solv for Soln for Inj - SOMATROPIN 19/03/2003
- R-DNA (E.COLI
EXPRESSION SYSTEM)
NORDITROPIN PENSET Novo Nordisk A/S PA0218/040/002 Pdr+Solv for Soln for Inj - SOMATROPIN 19/03/2003
TAREG Novartis Pharmaceuticals UK PA0013/109/001 Tablets - VALSARTAN 18/03/2003
Ltd
TAREG Novartis Pharmaceuticals UK PA0013/109/002 Tablets - VALSARTAN 18/03/2003
Ltd
OLANSEK Eli Lilly and Company Limite EU/1/96/021/001 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/002 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/003 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/004 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/005 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/006 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/007 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/008 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/009 Tablets - OLANZAPINE 17/03/2003

OLANSEK Eli Lilly and Company Limite EU/1/96/021/010 Tablets - OLANZAPINE 17/03/2003

CHYMODIACTIN Knoll Limited PA0769/001/001 Pdr for Soln for Injection - CHYMOPAPAIN 10/03/2003
NAPROSYN Roche Products Limited PA0050/128/002 Suppositories - NAPROXEN 10/03/2003
NAPROSYN Roche Products Limited PA0050/128/003 Oral Suspension - NAPROXEN 10/03/2003
MALOPRIM Wellcome (Ireland) Limited PA0017/084/001 Tablets - PYRIMETHAMINE 07/03/2003
- DAPSONE
PLASMATEIN Alpha Therapeutic Europe PA1047/002/001 Solution for Infusion - HUMAN PLASMA 04/03/2003
Limited PROTEIN

Human Medicines Withdrawn Products Page 323 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MIOCHOL Dispersa (UK) Ltd PA0582/014/001 Eye Drops Pdr & Solv for - ACETYLCHOLINE 28/02/2003
Soln CHLORIDE
VOLOGEN Mercury Pharmaceuticals PA0073/133/001 Tablets - DICLOFENAC SODIUM 28/02/2003
(Ireland) Ltd
IBUPROFEN Pinewood Laboratories Ltd, PA0281/015/003 Coated Tablets - IBUPROFEN 25/02/2003
PSORIN LPC Medical (UK) Ltd PA1056/002/001 Ointment - DITHRANOL 25/02/2003
- COAL TAR
- SALICYLIC ACID
- ZINC OXIDE
PSORIN SCALP LPC Medical (UK) Ltd PA1056/001/001 Gel - DITHRANOL 25/02/2003
- SALICYLIC ACID
TIMOLOL EYE DROPS Pliva Pharma Limited PA0585/004/001 Eye Drops Solution - TIMOLOL MALEATE 25/02/2003
- BENZALKONIUM
CHLORIDE
TIMOLOL EYE DROPS Pliva Pharma Limited PA0585/004/002 Eye Drops Solution - TIMOLOL MALEATE 25/02/2003
- BENZALKONIUM
CHLORIDE
HRF (GONADORELIN) Intrapharm Laboratories PA0997/005/002 Pdr+Solv for Soln for Inj - GONADORELIN 24/02/2003
Limited
IMTACK Astra Pharmaceuticals Ltd PA0009/050/001 Sublingual spray, solution - ISOSORBIDE DINITRATE 23/02/2003
FLOUROURACIL ONCO- Hospira UK Limited PA0437/011/008 Solution for Injection - FLUOROURACIL 20/02/2003
VIAL
VIVOTIF UCB Pharma Limited PA0365/055/001 Capsule - VIABLE SALMONELLA 18/02/2003
TYPHI TY21A BERNA
CELLS
- SALMONELLA TYPHI
TY21A BERNA CELLS
INACTIVATED
VAMIN 9 Fresenius Kabi Limited PA0566/011/002 Solution for Infusion - ALANINE 16/02/2003
- ARGININE
- CYSTEINE
- L-GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- L-LYSINE
- L-METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
- MAGNESIUM SULFATE
HEPTAHYDRATE
- POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
HMS LIQUIFILM Allergan Pharmaceuticals PA0148/010/001 Eye Drops Suspension - MEDRYSONE 14/02/2003
Ireland
ESTRADERM TTS PCO Manufacturing PPA0465/044/003A Transdermal Patch - ESTRADIOL 12/02/2003
ESTRADERM TTS PCO Manufacturing PPA0465/044/001A Transdermal Patch - ESTRADIOL 12/02/2003
ESTRADERM TTS PCO Manufacturing PPA0465/044/002A Transdermal Patch 12/02/2003
ELLESTE DUET Monsanto PLC PA0778/018/004 Tablets - ESTRADIOL 11/02/2003
HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
- NORETHISTERONE
ACETATE
ELLESTE DUET CONTI Monsanto PLC PA0778/018/005 Tablets - ESTRADIOL 11/02/2003
HEMIHYDRATE
- NORETHISTERONE
ACETATE
ELLESTE-DUET Monsanto PLC PA0778/018/003 Tablets - ESTRADIOL 11/02/2003
HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
- NORETHISTERONE
ACETATE
ELLESTE-SOLO Monsanto PLC PA0778/018/001 Tablets - ESTRADIOL 11/02/2003
HEMIHYDRATE
ELLESTE-SOLO Monsanto PLC PA0778/018/002 Tablets - ESTRADIOL 11/02/2003
HEMIHYDRATE
ZADSTAT Cyanamid of Great Britain PA0037/020/001 Tablets - METRONIDAZOLE 11/02/2003

Human Medicines Withdrawn Products Page 324 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZADSTAT Cyanamid of Great Britain PA0037/020/005 Solution for Infusion - METRONIDAZOLE 11/02/2003
MENOGON Ferring Ireland Ltd PA1009/009/001 Pdr+Solv for Soln for Inj - FOLLICLE-STIMULATING 27/01/2003
HORMONE, HUMAN
- LUTEINISING HORMONE
BEECHAMS COLD RELIEF GlaxoSmithKline Consumer PA0678/060/001 Capsule - PARACETAMOL 23/01/2003
Healthcare (Ireland) Limited - CAFFEINE
- PHENYLEPHRINE
HYDROCHLORIDE
BEECHAMS HOT LEMON GlaxoSmithKline Consumer PA0678/053/001 Powder for Oral Solution - PARACETAMOL 23/01/2003
DECONGESTANT Healthcare (Ireland) Limited - ASCORBIC ACID
- PHENYLEPHRINE
HYDROCHLORIDE
HAVRIX JUNIOR SmithKline Beecham Plc PA0620/001/003 Suspension for Injection - HEPATIT A VIRUS 23/01/2003
ANTIGEN
- ALUMINIUM HYDROXIDE
HAVRIX JUNIOR SmithKline Beecham Plc PA0620/001/004 Suspension for Injection - HEPATIT A VIRUS 23/01/2003
ANTIGEN
- ALUMINIUM HYDROXIDE
ISOKET SCHWARZ PHARMA Limite PA0271/002/003 Concentrate for Soln for Inf - ISOSORBIDE DINITRATE 23/01/2003

ISOKET SCHWARZ PHARMA Limite PA0271/002/004 Tablets - ISOSORBIDE DINITRATE 23/01/2003

ISOKET SCHWARZ PHARMA Limite PA0271/002/006 Tablets - ISOSORBIDE DINITRATE 23/01/2003

ISORDIL Monmouth Pharmaceuticals PA0488/007/003 Tablets - ISOSORBIDE DINITRATE 23/01/2003


Ltd
TUMS ASSORTED GlaxoSmithKline Consumer PA0678/057/001 Tablets - CALCIUM CARBONATE 23/01/2003
FLAVOUR Healthcare (Ireland) Limited
VALDA PASTILLES GlaxoSmithKline Consumer PA0678/046/001 - MENTHOL 23/01/2003
Healthcare (Ireland) Limited - CINEOLE
- THYMOL
- EXTRACT OF PINEWOOD,
COMPOUND
- GUAIACOL
VIRIDAL SCHWARZ PHARMA Limite PA0271/009/001 Pdr+Solv for Soln for Inj - ALPROSTADIL 23/01/2003

VIRIDAL SCHWARZ PHARMA Limite PA0271/009/002 Pdr+Solv for Soln for Inj - ALPROSTADIL 23/01/2003

VIRIDAL SCHWARZ PHARMA Limite PA0271/009/003 Pdr+Solv for Soln for Inj - ALPROSTADIL 23/01/2003

CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/014 Irrigation solution - CHLORHEXIDINE 20/01/2003
ANTISEPTIC DIACETATE
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/012 Irrigation solution - CHLORHEXIDINE 20/01/2003
ANTISEPTIC SOLUTION DIACETATE
PNU-IMUNE VACCINE Cyanamid of Great Britain PA0037/074/001 Solution for Injection - A/BAYERN/7/95 (HINI) - 20/01/2003
LIKE STRAIN

Human Medicines Withdrawn Products Page 325 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PNU-IMUNE VACCINE Cyanamid of Great Britain PA0037/074/002 Solution for Injection - PNEUMOCOCCAL 20/01/2003
POLYSACCHARIDE TYPE 1
(1)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 2
(2)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 3
(3)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 4
(4)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 5
(5)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
26 (6B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
51 (7F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 8
(8)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
9N
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
9V
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
34 (10A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
43 (11A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
12 (12F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
14 (14)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
54 (15B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
17 (17F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
56 (18C)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
57 (19A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
19 (19F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
20 (20)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
22 (22F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
23 (23F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
70 (33F)
DIAZEPAM Pinewood Laboratories Ltd, PA0281/007/001 Tablets - DIAZEPAM 14/01/2003
DIAZEPAM Pinewood Laboratories Ltd, PA0281/007/003 Tablets - DIAZEPAM 14/01/2003
RETIN-A Janssen-Cilag Ltd PA0748/033/005 Cream - TRETINOIN 12/01/2003
PROFASI Serono Limited PA0285/002/001 Pdr+Solv for Soln for Inj - CHORIONIC 10/01/2003
GONADOTROPHIN
PROFASI Serono Limited PA0285/002/002 Pdr+Solv for Soln for Inj - CHORIONIC 10/01/2003
GONADOTROPHIN

Human Medicines Withdrawn Products Page 326 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROFASI Serono Limited PA0285/002/003 Pdr+Solv for Soln for Inj - CHORIONIC 10/01/2003
GONADOTROPHIN
PROFASI Serono Limited PA0285/002/004 Pdr+Solv for Soln for Inj - CHORIONIC 10/01/2003
GONADOTROPHIN
REHIDRAT Pharmacia Healthcare PA0936/030/001 Powder for Oral Suspension - SODIUM CHLORIDE 10/01/2003
Ireland - POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- CITRIC ACID
- GLUCOSE
- SUCROSE
- FRUCTOSE
CLIMESSE Novartis Pharmaceuticals UK PA0013/055/001 Tablets - ESTRADIOL VALERATE 09/01/2003
Ltd - NORETHISTERONE
OESCLIM Fournier Pharmaceuticals PA0810/002/001 Transdermal Patch - ESTRADIOL 08/01/2003
Limited HEMIHYDRATE
OESCLIM Fournier Pharmaceuticals PA0810/002/002 Transdermal Patch - ESTRADIOL 08/01/2003
Limited HEMIHYDRATE
OESCLIM Fournier Pharmaceuticals PA0810/002/003 Transdermal Patch - ESTRADIOL 08/01/2003
Limited HEMIHYDRATE
OESCLIM Fournier Pharmaceuticals PA0810/002/004 Transdermal Patch - OESTRADIOL 08/01/2003
Limited HEMIHYDRATE
OESCLIM Fournier Pharmaceuticals PA0810/002/005 Transdermal Patch - OESTRADIOL 08/01/2003
Limited HEMIHYDRATE
EPPY MULTIDOSE Chauvin Pharmaceuticals PA0118/029/001 Eye Drops Solution - EPINEPHRINE 01/01/2003
Limited
REPLENS Columbia Laboratories (UK) PA0667/001/001 Vaginal Gel - PURIFIED WATER 01/01/2003
Ltd
HELIXATE 1000 Bayer AG PA0669/002/003 Pdr+Solv for Soln for Inj - FACTOR VIII 23/12/2002
(ANTIHAEMOPHILIC
FACTOR)
HELIXATE 250 Bayer AG PA0669/002/001 Pdr+Solv for Soln for Inj - FACTOR VIII 23/12/2002
(ANTIHAEMOPHILIC
FACTOR)
HELIXATE 500 Bayer AG PA0669/002/002 Pdr+Solv for Soln for Inj - FACTOR VIII 23/12/2002
(ANTIHAEMOPHILIC
FACTOR)
KOGENATE 1000 Bayer PLC PA0021/041/003 Pdr for Soln for Injection - FACTOR VIII, HUMAN 23/12/2002
RECOMBINANT
KOGENATE 250 Bayer PLC PA0021/041/001 - FACTOR VIII, HUMAN 23/12/2002
RECOMBINANT
KOGENATE 500 Bayer PLC PA0021/041/002 Pdr for Soln for Injection - FACTOR VIII, HUMAN 23/12/2002
RECOMBINANT
PERDIX PLUS SCHWARZ PHARMA Limite PA0271/008/003 Tablets - MOEXIPRIL 23/12/2002
HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

PERDIX PLUS SCHWARZ PHARMA Limite PA0271/008/004 Tablets - MOEXIPRIL 23/12/2002


HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

TABCIN Bayer PLC PA0021/039/001 Tablets - ACETYLSALICYLIC ACID 22/12/2002


- ASCORBIC ACID
- PHENYLEPHRINE
HYDROCHLORIDE
- PHENYLEPHRINE
BITARTRATE
- CHLORPHENAMINE
MALEATE
CARDURA Pfizer Limited PA0019/043/003 Tablets - DOXAZOSIN MESILATE 21/12/2002
CARDURA Pfizer Limited PA0019/043/004 Tablets - DOXAZOSIN MESILATE 21/12/2002
RAXAR Otsuka Pharma GmbH PA0975/002/001 Tablets - GREPAFLOXACIN 19/12/2002
HYDROCHLORIDE
SESQUIHYDRATE
RAXAR Otsuka Pharma GmbH PA0975/002/002 Tablets - GREPAFLOXACIN 19/12/2002
HYDROCHLORIDE
SESQUIHYDRATE
MINOXIDIL BIOGLAN Bioglan Laboratories Ltd PA0469/005/001 Cutaneous Solution - MINOXIDIL 18/12/2002
ISOKET 0.05% I.C. 10ML SCHWARZ PHARMA Limite PA0271/002/011 Solution for Injection - ISOSORBIDE DINITRATE 17/12/2002
PREFILLED SYRINGE
WATER FOR INJECTION Grifols UK Limited PA0415/008/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 17/12/2002

PHASONIT 10 SCHWARZ PHARMA Limite PA0271/004/002 - GLYCERYL TRINITRATE 16/12/2002

PHASONIT 5 SCHWARZ PHARMA Limite PA0271/004/001 Transdermal Patch - GLYCERYL TRINITRATE 16/12/2002

Human Medicines Withdrawn Products Page 327 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARBEX Ferring Ireland Ltd PA1009/002/001 Powder for Oral Solution - SODIUM BICARBONATE 13/12/2002
- DIMETICONE, ACTIVATED
- CITRIC ACID

KIDDI PHARMATON United Pharmacists CoOp PA0337/006/001 Syrup - CALCIUM 13/12/2002


Ltd GLYCEROPHOSPHATE
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- COLECALCIFEROL
- TOCOPHERYL ACETATE
- NICOTINAMIDE
- PANTHENOL
- LYSINE
HYDROCHLORIDE
MENOREST Novartis Pharmaceuticals UK PA0013/097/001 Transdermal Patch - ESTRADIOL 13/12/2002
Ltd
MENOREST Novartis Pharmaceuticals UK PA0013/097/002 Transdermal Patch - ESTRADIOL 13/12/2002
Ltd
MENOREST Novartis Pharmaceuticals UK PA0013/097/003 Transdermal Patch - ESTRADIOL 13/12/2002
Ltd
MENOREST Novartis Pharmaceuticals UK PA0013/097/004 Transdermal Patch - ESTRADIOL 13/12/2002
Ltd
TECHNESCAN Q12 Mallinckrodt Medical B.V. PA0690/019/001 Pdr for Soln for Injection - TRIFOSMIN 13/12/2002
- FUROMINE
FERRISELTZ Bracco SPA PA0729/001/001 Granules Effervescent - FERRIC AMMONIUM 11/12/2002
CITRATE
ADALAT RETARD PCO Manufacturing PPA0465/012/004B Tablets - NIFEDIPINE 10/12/2002
ALDOMET PCO Manufacturing PPA0465/011/001A Tablets - METHYLDOPA 10/12/2002
ALDOMET PCO Manufacturing PPA0465/011/001B Tablets - METHYLDOPA 10/12/2002
ALDOMET PCO Manufacturing PPA0465/011/002A Tablets - METHYLDOPA 10/12/2002
ALDOMET PCO Manufacturing PPA0465/011/002B Tablets 10/12/2002
BECOTIDE ROTACAPS PCO Manufacturing PPA0465/041/003A - BECLOMETASONE 10/12/2002
BECOTIDE ROTACAPS PCO Manufacturing PPA0465/041/003B 10/12/2002
BECOTIDE ROTACAPS PCO Manufacturing PPA0465/041/003C 10/12/2002
CALPOL SIX PLUS PCO Manufacturing PPA0465/029/002A Oral Suspension - PARACETAMOL 10/12/2002
CARDURA PCO Manufacturing PPA0465/063/001A Tablets - DOXAZOSIN 10/12/2002
CARDURA PCO Manufacturing PPA0465/063/003A Tablets - DOXAZOSIN 10/12/2002
CARDURA PCO Manufacturing PPA0465/063/003B Tablets - DOXAZOSIN 10/12/2002
CARDURA PCO Manufacturing PPA0465/063/003C Tablets - DOXAZOSIN 10/12/2002
CARDURA PCO Manufacturing PPA0465/063/003D Tablets - DOXAZOSIN 10/12/2002
FELDENDE DISPERSIBLE PCO Manufacturing PPA0465/037/002B Tablets 10/12/2002
FELDENE DISPERSIBLE PCO Manufacturing PPA0465/037/002C Tablets 10/12/2002
FELDENE DISPERSIBLE PCO Manufacturing PPA0465/037/002D Tablets 10/12/2002
FELDENE DISPERSIBLE PCO Manufacturing PPA0465/037/001A Tablets - PIROXICAM 10/12/2002
FELDENE DISPERSIBLE PCO Manufacturing PPA0465/037/001B Tablets 10/12/2002
FELDENE DISPERSIBLE PCO Manufacturing PPA0465/037/002A Tablets - PIROXICAM 10/12/2002
LOSEC PCO Manufacturing PPA0465/039/002A Capsules Gastro-Resistant - OMEPRAZOLE 10/12/2002
LOSEC PCO Manufacturing PPA0465/039/002B Capsule - OMEPRAZOLE 10/12/2002
OPTICROM PCO Manufacturing PPA0465/036/001A Eye Drops Solution - CROMOGLICATE SODIUM 10/12/2002

OPTICROM PCO Manufacturing PPA0465/036/001B Eye Drops Solution 10/12/2002


KAOPECTATE Pharmacia Healthcare PA0936/007/001 Oral Suspension - KAOLIN, LIGHT 09/12/2002
Ireland
FENTANYL B. BRAUN B. Braun Melsungen AG PA0736/012/001 Solution for Injection - FENTANYL CITRATE 04/12/2002
FENTANYL B. BRAUN B. Braun Melsungen AG PA0736/012/002 Solution for Injection - FENTANYL CITRATE 04/12/2002
FENTANYL B. BRAUN B. Braun Melsungen AG PA0736/012/003 Solution for Injection - FENTANYL CITRATE 04/12/2002
CYKLO Q Pharmacia Healthcare PA0936/001/002 Coated Tablets - TRANEXAMIC ACID 02/12/2002
Ireland
KABIKINASE IV MI Pharmacia Laboratories PA0187/013/004 Powder for solution for - STREPTOKINASE 02/12/2002
Limited infusion
KABIKINASE IV MI Pharmacia Laboratories PA0187/013/005 Powder for solution for - STREPTOKINASE 02/12/2002
Limited infusion
CHLOROPTIC Allergan Pharmaceuticals PA0148/023/001 Eye Drops Solution - CHLORAMPHENICOL 29/11/2002
Ireland
VASOFED RETARD Mercury Pharmaceuticals PA0073/121/004 Capsule - NIFEDIPINE 28/11/2002
(Ireland) Ltd
CISPLATIN Farmitalia Carlo Erba Ltd PA0236/013/003 Powder for solution for - CISPLATIN 27/11/2002
infusion
CISPLATIN Farmitalia Carlo Erba Ltd PA0236/013/001 Powder for solution for - CISPLATIN 27/11/2002
infusion

Human Medicines Withdrawn Products Page 328 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CISPLATIN VIALS Farmitalia Carlo Erba Ltd PA0236/013/002 Powder for solution for - CISPLATIN 27/11/2002
infusion
CYTARABINE Pharmacia Limited PA0016/047/001 Solution for Injection - CYTARABINE 27/11/2002
CYTARABINE Pharmacia Limited PA0016/047/003 Solution for Injection - CYTARABINE 27/11/2002
MEDRONE Pharmacia Limited PA0016/020/002 Tablets - METHYLPREDNISOLONE 27/11/2002

MELFEN Clonmel Healthcare Ltd PA0126/012/003 Tablets - IBUPROFEN 27/11/2002


OLBETAM Farmitalia Carlo Erba Ltd PA0236/020/001 Capsule - ACIPIMOX 27/11/2002
VERYL Pharmacia Limited PA0016/054/001 Tablets - OXYBUTYNIN 27/11/2002
HYDROCHLORIDE
VERYL Pharmacia Limited PA0016/054/003 Tablets - OXYBUTYNIN 27/11/2002
HYDROCHLORIDE
BURINEX Leo Laboratories Limited PA0046/016/008 Oral Solution - BUMETANIDE 26/11/2002
METHOTREXATE Cyanamid of Great Britain PA0037/023/001 Solution for Injection - METHOTREXATE 26/11/2002
METHOTREXATE Cyanamid of Great Britain PA0037/023/002 Pdr for Soln for Injection - METHOTREXATE 26/11/2002
METHOTREXATE Cyanamid of Great Britain PA0037/023/004 Pdr for Soln for Injection - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/005 Pdr for Soln Inj/Inf - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/006 Solution for Inj/Inf - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/007 Solution for Inj/Inf - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/008 Tablets - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/009 Solution for Injection - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/012 Solution for Injection - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/013 Solution for Injection - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/014 Solution for Injection - METHOTREXATE SODIUM 26/11/2002

METHOTREXATE Cyanamid of Great Britain PA0037/023/016 Solution for Injection - METHOTREXATE SODIUM 26/11/2002

NAPRELAN Elan Pharma Ltd PA0516/010/002 Tablets - NAPROXEN SODIUM 26/11/2002


UNIHEP LEO Leo Laboratories Limited PA0046/039/004 Solution for Injection - HEPARIN SODIUM 26/11/2002
UNIHEP LEO 1000 Leo Laboratories Limited PA0046/039/001 Solution for Injection - HEPARIN SODIUM 26/11/2002
UNIHEP LEO 10000 Leo Laboratories Limited PA0046/039/003 Solution for Injection - HEPARIN SODIUM 26/11/2002
UNIHEP LEO 5000 Leo Laboratories Limited PA0046/039/002 Solution for Injection - HEPARIN SODIUM 26/11/2002
MEDRONE Pharmacia Limited PA0016/020/003 Tablets - METHYLPREDNISOLONE 22/11/2002

VINCRISOL Pharmacia Limited PA0016/052/001 Solution for Inj/Inf - VINCRISTINE SULFATE 22/11/2002
OCUFEN LIQUIFILM Allergan Pharmaceuticals PA0148/042/001 Eye Drops Solution - FLURBIPROFEN SODIUM 19/11/2002
OPHTHALMIC Ireland DIHYDRATE
TRASYLOL Bayer PLC PA0021/001/001 Solution for Injection - APROTININ 19/11/2002
TRASYLOL Bayer PLC PA0021/001/002 Solution for Injection - APROTININ 19/11/2002
TUBERCULIN PPD Chiron Vaccines Limited PA1001/006/001 Suspension for Injection - TUBERCULIN PPD 19/11/2002
CHENOFALK Mercury Pharmaceuticals PA0073/007/001 Capsule - CHENODEOXYCHOLIC 18/11/2002
(Ireland) Ltd ACID
DE-NOLTAB Yamanouchi Pharma Ltd PA0062/022/002 Tablets - TRIPOTASSIUM 18/11/2002
DICITRATO BISMUTHATE
LUGACIN Sandoz Ltd PA0372/003/001 Solution for Injection - GENTAMICIN SULFATE 17/11/2002
LUGACIN PAEDIATRIC Sandoz Ltd PA0372/003/002 Solution for Injection - GENTAMICIN SULFATE 17/11/2002
BENPERIDOL Concord Pharmaceuticals Lt PA0828/006/001 Tablets - BENPERIDOL 15/11/2002

DUVADILAN RETARD Abbott Healthcare Products PA0108/012/001 Capsule - ISOXSUPRINE 15/11/2002


Ltd HYDROCHLORIDE
GASTRON Sanofi-Synthelabo Ireland PA0077/092/001 Tablets Chewable - ALGINIC ACID 15/11/2002
Ltd - ALUMINIUM HYDROXIDE
DRIED
- SODIUM BICARBONATE
- MAGNESIUM TRISILICATE

LEDERFEN Cyanamid of Great Britain PA0037/026/001 Capsule - FENBUFEN 15/11/2002


LEDERFEN Cyanamid of Great Britain PA0037/026/002 Capsule - FENBUFEN 15/11/2002
YUTOPAR Abbott Healthcare Products PA0108/013/003 Solution for Inj/Inf - RITODRINE 15/11/2002
Ltd HYDROCHLORIDE
DELSYM Fisons Pharmaceuticals PA0072/006/001 Oral Suspension - DEXTROMETHORPHAN 11/11/2002
(Ireland) HYDROBROMIDE
OVRAN 30 John Wyeth & Brother PA0022/013/001 Tablets - LEVONORGESTREL 08/11/2002
Limited - ETHINYLESTRADIOL
ATE-NIFE Rowex Ltd PA0711/026/001 Capsule - ATENOLOL 05/11/2002
- NIFEDIPINE

Human Medicines Withdrawn Products Page 329 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BROMOX Rowex Ltd PA0711/018/001 Capsule - BROMOCRIPTINE 05/11/2002
MESILATE
BROMOX Rowex Ltd PA0711/018/002 Capsule - BROMOCRIPTINE 05/11/2002
MESILATE
BROMOX Rowex Ltd PA0711/018/003 Tablets - BROMOCRIPTINE 05/11/2002
MESILATE
CAPTOR Rowex Ltd PA0711/002/005 Tablets - CAPTOPRIL 05/11/2002
CARACE Bristol-Myers Squibb PA0002/072/004 Tablets - LISINOPRIL DIHYDRATE 05/11/2002
Pharmaceuticals uc
CARACE Bristol-Myers Squibb PA0002/072/005 Tablets - LISINOPRIL DIHYDRATE 05/11/2002
Pharmaceuticals uc
CEDINE Rowex Ltd PA0711/044/003 Coated Tablets - CIMETIDINE 05/11/2002
FRUDEX Rowex Ltd PA0711/006/001 Tablets - FUROSEMIDE 05/11/2002
SUPER PLENAMINS 3M Health Care Limited PA0057/051/001 Tablets - RETINOL ACETATE 05/11/2002
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- DEXPANTHENOL
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- ERGOCALCIFEROL
- NICOTINAMIDE
- FERROUS SULFATE
EXSICCATED
- CALCIUM PHOSPHATE
DIBASIC
- POTASSIUM IODIDE
- COPPER SULFATE
PENTAHYDRATE
- MAGNESIUM SULFATE
- POTASSIUM CHLORIDE
- ZINC SULFATE
- TOCOPHERYL ACETATE
- MAGNESIUM SULFATE
DRIED
TERFEN Rowex Ltd PA0711/015/001 Tablets - TERFENADINE 05/11/2002
TIMOLOL MALEATE Rowex Ltd PA0711/019/001 Eye Drops Solution - TIMOLOL MALEATE 05/11/2002
OPHTHALMIC
TIMOLOL MALEATE Rowex Ltd PA0711/019/002 Eye Drops Solution - TIMOLOL MALEATE 05/11/2002
OPHTHALMIC - BENZALKONIUM
CHLORIDE
TIMOLOL MALEATE Rowex Ltd PA0711/019/003 Eye Drops Solution - TIMOLOL MALEATE 05/11/2002
OPHTHALMIC - BENZALKONIUM
CHLORIDE
TOPFEN Ethypharm PA0549/012/001 Capsule - KETOPROFEN 03/11/2002
TOPFEN CR Ethypharm PA0549/012/002 Capsule - KETOPROFEN 03/11/2002
TOPFEN CR Ethypharm PA0549/012/003 Capsule - KETOPROFEN 03/11/2002
FASIGYN Pfizer Limited PA0019/037/001 Tablets - TINIDAZOLE 01/11/2002
GYNO-TROSYL Pfizer Limited PA0019/033/001 Vaginal Tablets - TIOCONAZOLE 01/11/2002
ADSORBED DIPHTHERIA & Chiron Vaccines Limited PA1001/001/001 Suspension for Injection - DIPHTHERIA TOXOID 31/10/2002
TETANUS VACCINE - TETANUS TOXOID
ADSORBED DIPHTHERIA & Chiron Vaccines Limited PA1001/001/002 Suspension for Injection - DIPHTHERIA TOXOID 31/10/2002
TETANUS VACCINE - TETANUS TOXOID
ADSORBED DIPHTHERIA Chiron Vaccines Limited PA1001/003/001 Suspension for Injection - DIPHTHERIA TOXOID 31/10/2002
VACCINE BP (CHILD) - ALUMINIUM
ADSORBED TETANUS Chiron Vaccines Limited PA1001/002/002 Suspension for Injection - TETANUS TOXOID 31/10/2002
VACCINE
ADSORBED TETANUS Chiron Vaccines Limited PA1001/002/001 Suspension for Injection - TETANUS TOXOID 31/10/2002
VACCINE BP
ARILVAX YELLOW FEVER Chiron Vaccines Limited PA1001/004/001 Pdr+Solv for Susp for Inj - YELLOW FEVER VIRUS 31/10/2002
VACCINE LIVE B.P. STRAIN 17D
BCG VACCINE Chiron Vaccines Limited PA1001/007/001 Suspension for Injection - BCG VACCINE 31/10/2002
INTRADERMAL
BUSORIL Orion Pharma A/s PA0303/027/001 Tablets - BUSPIRONE 31/10/2002
HYDROCHLORIDE
BUSORIL Orion Pharma A/s PA0303/027/002 Tablets - BUSPIRONE 31/10/2002
HYDROCHLORIDE
FEMOSTON 2/20 Abbott Healthcare Products PA0108/021/002 Tablets - ESTRADIOL 31/10/2002
Ltd HEMIHYDRATE
- DYDROGESTERONE
LASORIDE Hoechst Marion Roussel Irl PA0855/018/001 Tablets - FUROSEMIDE 28/10/2002
Ltd - AMILORIDE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 330 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FEMATRIX 80 Elan Pharma International PA0872/005/002 Transdermal Patch - ESTRADIOL 25/10/2002
Ltd
MEFENAMIC ACID McDermott Laboratories Ltd PA0577/027/001 Tablets - MEFENAMIC ACID 24/10/2002
t/a Gerard Laboratories
CONRAY 325 Mallinckrodt UK Limited PA0199/004/002 Solution for Injection - IOTALAMATE SODIUM 21/10/2002
ASPEGIC 100 Sanofi-Synthelabo Ireland PA0077/142/001 Powder for Oral Solution - ACETYLSALICYLATE 17/10/2002
Ltd LYSINE
ASPEGIC 1000 Sanofi-Synthelabo Ireland PA0077/142/003 Powder for Oral Solution - ACETYLSALICYLATE 17/10/2002
Ltd LYSINE
ASPEGIC 500 Sanofi-Synthelabo Ireland PA0077/142/002 Powder for Oral Solution - ACETYLSALICYLATE 17/10/2002
Ltd LYSINE
BARATOL Monmouth Pharmaceuticals PA0488/005/001 Tablets - INDORAMIN 17/10/2002
Ltd HYDROCHLORIDE
BARATOL Monmouth Pharmaceuticals PA0488/005/002 Tablets - INDORAMIN 17/10/2002
Ltd HYDROCHLORIDE
ERYMIN Elan Pharma Ltd PA0516/022/001 Oral Suspension - ERYTHROMYCIN 17/10/2002
ETHYLSUCCINATE
FERGON Sanofi-Synthelabo Ireland PA0077/050/001 Tablets 17/10/2002
Ltd
ISORDIL Monmouth Pharmaceuticals PA0488/007/001 Tablets - ISOSORBIDE DINITRATE 17/10/2002
Ltd
ISORDIL Monmouth Pharmaceuticals PA0488/007/002 Tablets - ISOSORBIDE DINITRATE 17/10/2002
Ltd
METRONIDAZOLE B. Braun Medical Limited PA0179/032/002 Solution for Infusion - METRONIDAZOLE 17/10/2002
UNIVER Elan Pharma Ltd PA0516/023/001 Modified-release capsule, - VERAPAMIL 17/10/2002
hard HYDROCHLORIDE
UNIVER Elan Pharma Ltd PA0516/023/002 Modified-release capsule, - VERAPAMIL 17/10/2002
hard HYDROCHLORIDE
WATER FOR INJECTION B. Braun Medical Limited PA0179/009/008 Solvent for Parenteral Use - WATER FOR INJECTIONS 17/10/2002

EOLARIX VACCINE GlaxoSmithKline Consumer PA0678/006/001 Solution for Injection - MEASLES VIRUS - 16/10/2002
Healthcare (Ireland) Limited SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
PENTASA Ferring Ireland Ltd PA1009/006/004 Tablet Prolonged Release - MESALAZINE 16/10/2002
RIMEVAX SmithKline and French PA0060/036/001 Pdr+Solv for Soln for Inj - MEASLES VIRUS - 16/10/2002
Laboratories Ltd SCHWARZ STRAIN LIVE
ATTENUATED
HESPAN Fresenius Kabi Austria PA0773/001/001 Solution for Infusion - HETASTARCH 08/10/2002
GmbH
METAZEM Bioglan Laboratories Ltd PA0469/004/001 Tablets - DILTIAZEM 08/10/2002
HYDROCHLORIDE
PANCREASE HI LIPASE Janssen-Cilag Ltd PA0748/014/002 Capsule - PANCREATIN 08/10/2002
FLUPHENAZINE Mercury Pharmaceuticals PA0073/109/003 Solution for Injection - FLUPHENAZINE 07/10/2002
DECANOATE (Ireland) Ltd DECANOATE
FLUPHENAZINE Mercury Pharmaceuticals PA0073/109/004 Solution for Injection - FLUPHENAZINE 07/10/2002
DECANOATE (Ireland) Ltd DECANOATE
FLUPHENAZINE Mercury Pharmaceuticals PA0073/109/005 Solution for Injection - FLUPHENAZINE 07/10/2002
DECANOATE (Ireland) Ltd DECANOATE
EXPULIN CHESTY COUGH Monmouth Pharmaceuticals PA0488/009/001 Oral Suspension - GUAIFENESIN 03/10/2002
LINCTUS Ltd
ANTABUSE Alpharma ApS PA0363/008/001 Tablets - DISULFIRAM 30/09/2002
EFFERVESCENT
PURINOL - ALLOPURINOL Pinewood Laboratories Ltd, PA0281/024/001 Tablets - ALLOPURINOL 29/09/2002
PURINOL - ALLOPURINOL Pinewood Laboratories Ltd, PA0281/024/002 Tablets - ALLOPURINOL 29/09/2002
ISOPTO CARPINE 0.5% Alcon Laboratories (UK) Ltd PA0290/058/001 Eye Drops Solution - PILOCARPINE 26/09/2002
HYDROCHLORIDE
ISOPTO CARPINE 3.0% Alcon Laboratories (UK) Ltd PA0290/058/004 Eye Drops Solution - PILOCARPINE 26/09/2002
HYDROCHLORIDE
ENFLURANE Fresenius AG PA0697/005/001 Inhalation Vapour Liquid - ENFLURANE 19/09/2002
FUCIDIN INTERTULLE Leo Laboratories Limited PA0046/004/006 Impregnated Dressing - FUSIDATE SODIUM 19/09/2002
ISOFLURANE MEDEVA Celltech Pharma Europe PA0793/001/001 Inhalation Vapour Liquid - ISOFLURANE 19/09/2002
EUROPE Limited
METHOTREXATE Hospira UK Limited PA0437/005/011 Solution for Injection - METHOTREXATE 19/09/2002
METHOTREXATE Hospira UK Limited PA0437/005/012 Solution for Injection - METHOTREXATE 19/09/2002
METHOTREXATE Hospira UK Limited PA0437/005/013 Solution for Injection - METHOTREXATE 19/09/2002
PROLEUKIN Chiron B.V. PA0499/001/002 Pdr for Soln for Injection - ALDESLEUKIN 19/09/2002
SURGICAL SPIRIT Foran Healthcare Limited PA0484/011/001 - METHYL SALICYLATE 19/09/2002
- ETHYL PHTHALATE
VERYL Pharmacia Limited PA0016/054/002 Tablets - OXYBUTYNIN 19/09/2002
HYDROCHLORIDE
SUPRECUR DEPOT Sanofi-Aventis Ireland PA0540/073/001 Pdr+Solv for Soln for Inj - BUSERELIN ACETATE 06/09/2002
Limited T/A SANOFI

Human Medicines Withdrawn Products Page 331 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LOMEXIN PESSARY Pharmacia Limited PA0016/050/002 Pessary - FENTICONAZOLE 05/09/2002
NITRATE
LOMEXIN VAGINAL CREAM Pharmacia Limited PA0016/050/003 Vaginal Cream - FENTICONAZOLE 05/09/2002
NITRATE
ELDOPAR Orion Pharma A/s PA0303/034/001 Tablets - LEVODOPA 02/09/2002
- CARBIDOPA
ELDOPAR Orion Pharma A/s PA0303/034/002 Tablets - LEVODOPA 02/09/2002
- CARBIDOPA
OPHTHETIC STERILE Allergan Pharmaceuticals PA0148/030/001 Eye Drops Solution - PROPARACAINE 01/09/2002
OPTHALMIC Ireland HYDROCHLORIDE
PINALGESIC Pinewood Laboratories Ltd, PA0281/044/001 Capsule - MEFENAMIC ACID 01/09/2002
RAPAMUNE Wyeth Europa Limited EU/1/01/171/003 Oral Solution - SIROLIMUS 30/08/2002
RAPAMUNE Wyeth Europa Limited EU/1/01/171/004 Oral Solution - SIROLIMUS 30/08/2002
CONTAC 400 GlaxoSmithKline Consumer PA0678/047/001 Capsule - CHLORPHENAMINE 22/08/2002
Healthcare (Ireland) Limited MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
FEMATRIX 40 Elan Pharma International PA0872/005/001 Transdermal Patch - ESTRADIOL 20/08/2002
Ltd
PABRINEX IMHP Archimedes Pharma UK PA0757/007/002 Solution for Infusion - THIAMINE 20/08/2002
Limited HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- ASCORBIC ACID
ENOS FRUIT SALTS GlaxoSmithKline Consumer PA0678/041/001 Powder for Oral Solution - SODIUM BICARBONATE 18/08/2002
Healthcare (Ireland) Limited - TARTARIC ACID
- CITRIC ACID
- SODIUM CARBONATE
ANHYDROUS
BREXIDOL SACHETS Chiesi Limited PA0743/010/001 Powder for Oral Solution - PIROXICAM BETADEX 15/08/2002
CORACTEN SPANSULE SmithKline and French PA0060/048/002 Capsule - NIFEDIPINE 15/08/2002
Laboratories Ltd
TAGAMET PCO Manufacturing PPA0465/020/001A Tablets - CIMETIDINE 13/08/2002
TAGAMET PCO Manufacturing PPA0465/020/001B Tablets 13/08/2002
TAGAMET PCO Manufacturing PPA0465/020/002A Tablets - CIMETIDINE 13/08/2002
TAGAMET PCO Manufacturing PPA0465/020/002B Tablets 13/08/2002
TAGAMET PCO Manufacturing PPA0465/020/003A Tablets - CIMETIDINE 13/08/2002
WATER Bayer PLC PA0021/013/001 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/002 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/003 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/004 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/005 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/006 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

WATER Bayer PLC PA0021/013/007 Solvent for Parenteral Use - WATER FOR INJECTIONS 13/08/2002

ADALAT RETARD PCO Manufacturing PPA0465/012/003A Tablets - NIFEDIPINE 12/08/2002


ADALAT RETARD PCO Manufacturing PPA0465/012/003B Tablets 12/08/2002
ADALAT RETARD PCO Manufacturing PPA0465/012/003C Tablets 12/08/2002
ADALAT RETARD PCO Manufacturing PPA0465/012/003D Tablets 12/08/2002
AMOXIL PCO Manufacturing PPA0465/008/001A Capsule - AMOXICILLIN 12/08/2002
AMOXIL PCO Manufacturing PPA0465/008/002A Capsule - AMOXICILLIN 12/08/2002
GYNO-PEVARYL 150 Janssen-Cilag Ltd PA0748/017/001 - ECONAZOLE NITRATE 12/08/2002
COMBIPACK - ECONAZOLE NITRATE

Human Medicines Withdrawn Products Page 332 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PNEUMOVAX II Sanofi Pasteur MSD Ltd PA0544/021/001 Solution for Injection - PNEUMOCOCCAL 12/08/2002
POLYSACCHARIDE TYPE 1
(1)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 2
(2)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 3
(3)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 4
(4)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 5
(5)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 8
(8)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE 9
(9)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
12 (12F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
14 (14)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
17 (17F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
19 (19F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
20 (20)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
22 (22F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
23 (23F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
26 (6B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
34 (10A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
43 (11A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
51 (7F)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
54 (15B)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
56 (18C)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
57 (19A)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
68 (9L)
- PNEUMOCOCCAL
POLYSACCHARIDE TYPE
70 (33F)
FLUORO-URACIL ROCHE Lifehealth Limited PA0809/001/002 Capsule - FLUOROURACIL 30/07/2002
VITRAVENE Novartis Ophthalmics Europe EU/1/99/115/001 Solution for Injection - FOMIVIRSEN SODIUM 30/07/2002
Ltd
ANTI-HIST Clonmel Healthcare Ltd PA0126/034/001 Tablets - CHLORPHENAMINE 26/07/2002
MALEATE
CAPOTEN PCO Manufacturing PPA0465/002/003A Tablets - CAPTOPRIL 25/07/2002
ETHYPHARM Ethypharm PA0549/006/001 Capsule - PARACETAMOL 25/07/2002
PARACETAMOL

Human Medicines Withdrawn Products Page 333 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ETHYPHARM Ethypharm PA0549/006/002 Capsule - PARACETAMOL 25/07/2002
PARACETAMOL
ETHYPHARM Ethypharm PA0549/006/003 Capsule - PARACETAMOL 25/07/2002
PARACETAMOL
TENORETIC PCO Manufacturing PPA0465/046/001B Tablets 25/07/2002
TENORETIC PCO Manufacturing PPA0465/046/001C Tablets 25/07/2002
TENORETIC PCO Manufacturing PPA0465/046/001D Tablets 25/07/2002
DIUREXAN MEDA Pharmaceuticals Ltd PA1058/003/001 Tablets - XIPAMIDE 24/07/2002
KEFEXIN Orion Pharma A/s PA0303/017/001 Tablets - CEFALEXIN 24/07/2002
MONOHYDRATE
KEFEXIN Orion Pharma A/s PA0303/017/002 Tablets - CEFALEXIN 24/07/2002
MONOHYDRATE
SECADREX May & Baker Limited PA0040/069/001 Tablets - ACEBUTOLOL 24/07/2002
HYDROCHLORIDE
- HYDROCHLORTHIAZIDE
VENALE
BENORAL Sanofi-Synthelabo Ireland PA0077/008/002 Oral Suspension - BENORILATE 18/07/2002
Ltd
HYCAMTIN Novartis Europharm Limited EU/1/96/027/002 Powder for solution for - TOPOTECAN 18/07/2002
infusion HYDROCHLORIDE
REHIDRAT ORANGE Pharmacia Healthcare PA0936/030/002 Powder for Oral Suspension - SODIUM CHLORIDE 08/07/2002
Ireland - POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- GLUCOSE
- SUCROSE
- CITRIC ACID
ALORA Procter & Gamble PA0170/019/001 Transdermal Patch - ESTRADIOL 05/07/2002
Pharmaceuticals UK Limited
ALORA Procter & Gamble PA0170/019/002 Transdermal Patch - ESTRADIOL 05/07/2002
Pharmaceuticals UK Limited
ALORA Procter & Gamble PA0170/019/003 Transdermal Patch - ESTRADIOL 05/07/2002
Pharmaceuticals UK Limited
CALSALETTES Torbet Laboratories Limited PA0456/001/001 Tablets - ALOIN 05/07/2002
RIMACTANE Sandoz GmbH PA0111/002/004 Syrup - RIFAMPICIN 05/07/2002
MAALOX TC Rorer Pharmaceuticals PA0468/016/002 Oral Suspension - ALUMINIUM HYDROXIDE 03/07/2002
Limited GEL, DRIED
- MAGNESIUM HYDROXIDE
GEL 30 %
REGULETT Cupal Limited PA0258/029/001 Tablets Chewable - PHENOLPHTHALEIN 03/07/2002
YELLOW
STERILE CO- Hospira UK Limited PA0437/001/001 Concentrate for Soln for Inf - SULFAMETHOXAZOLE 03/07/2002
TRIMOXAZOLE - TRIMETHOPRIM
CONCENTRATE BP
ATRACURIUM BESYLATE Abbott Laboratories Ireland PA0038/064/001 Solution for Injection - ATRACURIUM BESILATE 28/06/2002
2.5ML Ltd
ATRACURIUM BESYLATE Abbott Laboratories Ireland PA0038/064/002 - ATRACURIUM BESILATE 28/06/2002
5.0ML Ltd
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/006 Tablets - CALCIUM FOLINATE 28/06/2002
CLIMARA DUO HE Clissmann PA0012/087/001 - ESTRADIOL 28/06/2002
HEMIHYDRATE
- ESTRADIOL
HEMIHYDRATE
- LEVONORGESTREL
ISORDIL TEMBIDS Monmouth Pharmaceuticals PA0488/007/004 Capsule - ISOSORBIDE DINITRATE 19/06/2002
Ltd
RAMODAR Monmouth Pharmaceuticals PA0488/020/001 Capsule - ETODOLAC 19/06/2002
Ltd
RAMODAR Monmouth Pharmaceuticals PA0488/020/002 Capsule - ETODOLAC 19/06/2002
Ltd
RAMODAR Monmouth Pharmaceuticals PA0488/020/003 Tablets - ETODOLAC 19/06/2002
Ltd
KOLANTICON Marion Merrell Limited PA0041/016/001 Oral Suspension - DICYCLOMINE 18/06/2002
HYDROCHLORIDE
- ALUMINIUM HYDROXIDE
GEL, DRIED
- MAGNESIUM OXIDE
LIGHT
- DIMETICONE, ACTIVATED

ZOLERIM Sanofi-Aventis Ireland PA0540/007/001 Tablets - ZOPICLONE 18/06/2002


Limited T/A SANOFI
ZOPICLONE Sanofi-Aventis Ireland PA0540/012/002 Tablets - ZOPICLONE 18/06/2002
Limited T/A SANOFI
ALBUMINAR 20 Aventis Behring Limited PA0010/022/005A Solution for Infusion - HUMAN ALBUMIN 11/06/2002
ALBUMINAR 25 Aventis Behring Limited PA0010/022/008A Solution for Infusion - HUMAN ALBUMIN 11/06/2002
ALBUMINAR 5 Aventis Behring Limited PA0010/022/002A Solution for Injection - HUMAN ALBUMIN 11/06/2002

Human Medicines Withdrawn Products Page 334 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ORLAAM Sipaco Internacional LDA EU/1/97/41/001 Oral Solution - LEVACETYL METHADOL 11/06/2002
HYDROCHLORIDE
ZARTRA Laboratories 3M Sante EU/1/98/079/001 Cream - IMIQUIMOD 11/06/2002
NICONIL 11 Elan Pharma Ltd PA0516/018/002 Transdermal Patch - NICOTINE 09/06/2002
THIOPENTONE SODIUM Archimedes Pharma UK PA0757/004/002 Pdr for Soln for Injection - THIOPENTAL SODIUM 09/06/2002
Limited
BERKMYCEN Pinewood Laboratories Ltd, PA0281/091/001 Tablets - OXYTETRACYCLINE 30/05/2002
IMBRILON Pinewood Laboratories Ltd, PA0281/089/001 Capsule - INDOMETACIN 30/05/2002
TETRACHEL Pinewood Laboratories Ltd, PA0281/090/001 Capsule - TETRACYCLINE 30/05/2002
HYDROCHLORIDE
TRIMOPAN Pinewood Laboratories Ltd, PA0281/094/002 Tablets - TRIMETHOPRIM 30/05/2002
TRIMOPAN Pinewood Laboratories Ltd, PA0281/094/003 Tablets - TRIMETHOPRIM 30/05/2002
TERFENADINE Sanofi-Synthelabo Ireland PA0077/132/001 Tablets - TERFENADINE 28/05/2002
Ltd
NOVORAPID NOVOLET Novo Nordisk A/S EU/1/99/119/004 Solution for Injection - INSULIN ASPART 24/05/2002
NOVORAPID PENFILL Novo Nordisk A/S EU/1/99/119/002 Solution for Injection - INSULIN ASPART 24/05/2002
DERMAMIST Yamanouchi Pharma Ltd PA0062/035/001 - WHITE SOFT PARAFFIN 19/05/2002
SALOMOL Norton Waterford PA0436/007/002 Syrup - SALBUTAMOL SULFATE 14/05/2002
ERYTHROPED ADULT Abbott Laboratories Ireland PA0038/009/005 Granules for Oral - ERYTHROMYCIN 13/05/2002
SINGLE DOSE Ltd Suspension ETHYLSUCCINATE
ALUDROX LIQUID Unicliffe Limited PA0231/008/001 Oral Suspension - ALUMINIUM HYDROXIDE 09/05/2002
ALUDROX MH Unicliffe Limited PA0231/006/001 Tablets - ALUMINIUM HYDROXIDE 09/05/2002
MAGNESIUM CARBONATE
CO-DRIED GEL
- MAGNESIUM HYDROXIDE

DICLO (ENTERIC-COATED) Pinewood Laboratories Ltd, PA0281/085/001 Tablets - DICLOFENAC SODIUM 09/05/2002

ISOGEL Unicliffe Limited PA0231/007/001 Granules for Oral - ISPAGHULA HUSKS 09/05/2002
Suspension
PULMOCLASE UCB S.A. PA0230/006/002 Capsule - CARBOCISTEINE 09/05/2002
PULMOCLASE ADULT UCB S.A. PA0230/006/004 Syrup - CARBOCISTEINE 09/05/2002
SEHCAT GE Healthcare Limited PA0240/003/001 Capsule 09/05/2002
TCP BLACKCURRANT Unicliffe Limited PA0231/003/002 Lozenges - PHENOL 09/05/2002
- HALOGENATED
PHENOLS
- SODIUM SALICYLATE
TCP HONEY & MENTHOL Unicliffe Limited PA0231/003/004 Lozenges - PHENOL 09/05/2002
- HALOGENATED
PHENOLS
- SODIUM SALICYLATE
TCP ORANGE Unicliffe Limited PA0231/003/005 Lozenges - PHENOL 09/05/2002
- SODIUM SALICYLATE
- HALOGENATED
PHENOLS
TCP THROAT PASTILLES - Unicliffe Limited PA0231/003/003 Lozenges - PHENOL 09/05/2002
LEMON - HALOGENATED
PHENOLS
- SODIUM SALICYLATE
MANNITOL Baxter Healthcare Limited PA0167/037/013 Solution for Infusion - MANNITOL 07/05/2002
MANNITOL Baxter Healthcare Limited PA0167/037/014 Solution for Infusion - MANNITOL 07/05/2002
MIACALCIC MULTIDOSE Novartis Pharmaceuticals UK PA0013/040/003 Solution for Injection - CALCITONIN, SALMON 07/05/2002
VIALS Ltd
SURGAM Roussel Laboratories Limited PA0006/023/003 Tablets - TIAPROFENIC ACID 29/04/2002
- TALC
ETHYPHARM IBUPROFEN Ethypharm PA0549/002/001 Powder for Oral Suspension - IBUPROFEN 23/04/2002
SPARKLETS
ETHYPHARM IBUPROFEN Ethypharm PA0549/002/002 Powder for Oral Suspension - IBUPROFEN 23/04/2002
SPARKLETS
HAVRIX VACCINE SmithKline Beecham Plc PA0620/001/002 Suspension for Injection - HEPATIT A VIRUS 22/04/2002
ANTIGEN
- ALUMINIUM HYDROXIDE
HAVRIX VACCINE SmithKline Beecham Plc PA0620/001/001 Suspension for Injection - HEPATIT A VIRUS 17/04/2002
ANTIGEN
- ALUMINIUM HYDROXIDE
SEVREDOL Napp Laboratories Limited PA0114/057/003 Suppositories - MORPHINE SULFATE 16/04/2002
SEVREDOL Napp Laboratories Limited PA0114/057/004 Suppositories - MORPHINE SULFATE 16/04/2002
SEVREDOL Napp Laboratories Limited PA0114/057/005 Suppositories - MORPHINE SULFATE 16/04/2002
CISPLATIN Farmitalia Carlo Erba Ltd PA0236/013/004 Solution for Injection - CISPLATIN 09/04/2002
CISPLATIN Farmitalia Carlo Erba Ltd PA0236/013/006 Solution for Injection - CISPLATIN 09/04/2002
IBUPROFEN Roussel Laboratories Limited PA0006/033/002 Tablets - IBUPROFEN 08/04/2002

PROPRANOLOL Roussel Laboratories Limited PA0006/036/001 Tablets - PROPRANOLOL 08/04/2002


HYDROCHLORIDE

Human Medicines Withdrawn Products Page 335 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROPRANOLOL Roussel Laboratories Limited PA0006/036/002 Tablets - PROPRANOLOL 08/04/2002
HYDROCHLORIDE
PROPRANOLOL Roussel Laboratories Limited PA0006/036/003 Tablets - PROPRANOLOL 08/04/2002
HYDROCHLORIDE
THROMBOSTAT 10000 IU Warner Lambert (UK) Limite PA0856/004/002 - THROMBIN 08/04/2002

THROMBOSTAT 20000 IU Warner Lambert (UK) Limite PA0856/004/003 - THROMBIN 08/04/2002

THROMBOSTAT 5000 IU Warner Lambert (UK) Limite PA0856/004/001 - THROMBIN 08/04/2002

ALGITEC CHEWTAB SmithKline and French PA0060/046/001 Tablets - CIMETIDINE 07/04/2002


Laboratories Ltd - ALGINIC ACID
ONE-ALPHA Leo Laboratories Limited PA0046/024/005 Oral Solution - ALFACALCIDOL 07/04/2002
GLUCOSE 5% Abbott Laboratories Ireland PA0038/050/001 Solution for Infusion - GLUCOSE 05/04/2002
Ltd
GLUCOSE 5% Abbott Laboratories Ireland PA0038/050/002 Solution for Infusion - GLUCOSE 05/04/2002
Ltd
GLUCOSE 5% Abbott Laboratories Ireland PA0038/050/003 Solution for Infusion - GLUCOSE 05/04/2002
Ltd
SODIUM CHLORIDE Abbott Laboratories Ireland PA0038/044/003 Solution for Infusion - SODIUM CHLORIDE 05/04/2002
Ltd
NEPHRIL Pfizer Limited PA0019/017/001 Tablets - POLYTHIAZIDE 04/04/2002
AMOXIL SmithKline Beecham Pharm PA0049/006/004 Powder for Syrup - AMOXICILLIN 02/04/2002
Ltd TRIHYDRATE
VITRASERT IMPLANT Dr. Gerhard Mann, Chem.- EU/1/97/034/001 Implant - GANCICLOVIR 02/04/2002
Pharm,
ACHROMYCIN Cyanamid of Great Britain PA0037/010/001 Capsule - TETRACYCLINE 01/04/2002
HYDROCHLORIDE
ACHROMYCIN Cyanamid of Great Britain PA0037/010/006 Ointment 01/04/2002
ACHROMYCIN IV Cyanamid of Great Britain PA0037/010/008 Powder for solution for - TETRACYCLINE 01/04/2002
infusion HYDROCHLORIDE
ATARAX Pfizer Limited PA0019/003/001 Syrup - HYDROXYZINE 01/04/2002
HYDROCHLORIDE
ATARAX Pfizer Limited PA0019/003/002 Tablets - HYDROXYZINE 01/04/2002
HYDROCHLORIDE
AUREOMYCIN Cyanamid of Great Britain PA0037/012/001 Ointment - CHLORTETRACYCLINE 01/04/2002
HYDROCHLORIDE
AUREOMYCIN Cyanamid of Great Britain PA0037/012/002 Eye Ointment - CHLORTETRACYCLINE 01/04/2002
HYDROCHLORIDE
DETECLO Cyanamid of Great Britain PA0037/006/001 Tablets - TETRACYCLINE 01/04/2002
HYDROCHLORIDE
- CHLORTETRACYCLINE
HYDROCHLORIDE
- DEMECLOCYCLINE
HYDROCHLORIDE
FUCIDIN H Leo Laboratories Limited PA0046/005/001 Gel - FUSIDIC ACID 01/04/2002
- HYDROCORTISONE
ACETATE
FURADANTIN Mercury Pharmaceuticals Ltd PA0899/013/003 Oral Suspension - NITROFURANTOIN 01/04/2002

INTRAVAL SODIUM May & Baker Limited PA0040/017/003 Pdr for Soln for Injection - THIOPENTAL SODIUM 01/04/2002
INTRAVAL SODIUM May & Baker Limited PA0040/017/004 Pdr for Soln for Injection - THIOPENTAL SODIUM 01/04/2002
INTRAVAL SODIUM May & Baker Limited PA0040/017/005 Pdr for Soln for Injection - THIOPENTAL SODIUM 01/04/2002
INTRAVAL SODIUM May & Baker Limited PA0040/017/007 Pdr for Soln for Injection - THIOPENTAL SODIUM 01/04/2002
LEDERMYCIN Cyanamid of Great Britain PA0037/013/006 Capsule - DEMECLOCYCLINE 01/04/2002
HYDROCHLORIDE
MODECATE INJECTION Bristol-Myers Squibb PA0002/031/006 Concentrate for Soln for Inj - FLUPHENAZINE 01/04/2002
Pharmaceuticals uc DECANOATE
MYCIFRADIN SULPHATE Pharmacia Limited PA0016/010/002 Tablets - NEOMYCIN SULFATE 01/04/2002
NEO-CORTEF Pharmacia Limited PA0016/012/001 Ear/Eye Drops, Suspension - HYDROCORTISONE 01/04/2002
ACETATE
- NEOMYCIN SULFATE
NEO-CORTEF Pharmacia Limited PA0016/012/002 Eye Ointment - HYDROCORTISONE 01/04/2002
ACETATE
- NEOMYCIN SULFATE
ORBENIN SmithKline Beecham Pharm PA0049/009/001 Capsule - CLOXACILLIN SODIUM 01/04/2002
Ltd
ORBENIN SmithKline Beecham Pharm PA0049/009/003 Capsule - CLOXACILLIN SODIUM 01/04/2002
Ltd
ORBENIN SmithKline Beecham Pharm PA0049/009/006 Pdr for Soln for Injection - CLOXACILLIN SODIUM 01/04/2002
Ltd
ORBENIN SmithKline Beecham Pharm PA0049/009/007 Pdr for Soln for Injection - CLOXACILLIN SODIUM 01/04/2002
Ltd
ORBENIN SmithKline Beecham Pharm PA0049/009/008 Powder for Oral Solution - CLOXACILLIN SODIUM 01/04/2002
Ltd

Human Medicines Withdrawn Products Page 336 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PENBRITIN SmithKline Beecham Pharm PA0049/010/018 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE 01/04/2002
Ltd
PENBRITIN FORTE SmithKline Beecham Pharm PA0049/010/020 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE 01/04/2002
Ltd
QUINIDINE SULPHATE Regent Laboratories Limited PA0493/001/001 Tablets - QUINIDINE SULFATE 01/04/2002
QUINIDINE SULPHATE Regent Laboratories Limited PA0493/001/002 Tablets - QUINIDINE SULFATE 01/04/2002
RIMACTAZID Sandoz GmbH PA0111/003/002 Tablets - RIFAMPICIN 01/04/2002
- ISONIAZID
SPARINE John Wyeth & Brother PA0022/010/001 Solution for Injection - PROMAZINE 01/04/2002
Limited HYDROCHLORIDE
SPARINE John Wyeth & Brother PA0022/010/006 Solution for Injection - PROMAZINE 01/04/2002
Limited HYDROCHLORIDE
STEMETIL May & Baker Limited PA0040/026/006 Tablets - PROCHLORPERAZINE 01/04/2002
MALEATE
TERRACORTRIL Pfizer Limited PA0019/007/001 Ointment - OXYTETRACYCLINE 01/04/2002
HYDROCHLORIDE
- HYDROCORTISONE
TERRACORTRIL Pfizer Limited PA0019/008/001 Ear Drops Suspension - OXYTETRACYCLINE 01/04/2002
HYDROCHLORIDE
- HYDROCORTISONE
ACETATE
- POLYMYXIN B SULFATE
TERRAMYCIN Pfizer Limited PA0019/009/001 Capsule - OXYTETRACYCLINE 01/04/2002
HYDROCHLORIDE
TERRAMYCIN Pfizer Limited PA0019/009/007 Tablets - OXYTETRACYCLINE 01/04/2002
DIHYDRATE
ZINAMIDE Merck Sharp and Dohme PA0035/060/001 Tablets - PYRAZINAMIDE 01/04/2002
Limited
ERYTHROPED Abbott Laboratories Ireland PA0038/009/009 Granules for Oral - ERYTHROMYCIN 26/03/2002
Ltd Suspension ETHYLSUCCINATE
ERYTHROPED Abbott Laboratories Ireland PA0038/009/010 Granules for Oral - ERYTHROMYCIN 26/03/2002
Ltd Suspension ETHYLSUCCINATE
ERYTHROPED FORTE Abbott Laboratories Ireland PA0038/009/001 Granules for Oral - ERYTHROMYCIN 26/03/2002
Ltd Suspension ETHYLSUCCINATE
ERYTHROPED P.I. SINGLE Abbott Laboratories Ireland PA0038/009/011 Granules for Oral - ERYTHROMYCIN 26/03/2002
DOSE Ltd Suspension ETHYLSUCCINATE
ERYTHROPED SINGLE Abbott Laboratories Ireland PA0038/009/012 Granules for Oral - ERYTHROMYCIN 26/03/2002
DOSE Ltd Suspension ETHYLSUCCINATE
CHLORAMPHENICOL Roussel Laboratories Limited PA0006/031/002 Eye Ointment - CHLORAMPHENICOL 25/03/2002

LUSTRAL Pfizer Healthcare Ireland PA0822/001/001 Capsule - SERTRALINE 25/03/2002


HYDROCHLORIDE
LUSTRAL Pfizer Healthcare Ireland PA0822/001/002 Capsule - SERTRALINE 25/03/2002
HYDROCHLORIDE
LUSTRAL Pfizer Healthcare Ireland PA0822/001/003 Capsule - SERTRALINE 25/03/2002
HYDROCHLORIDE
LUSTRAL Pfizer Healthcare Ireland PA0822/001/006 Tablets - SERTRALINE 25/03/2002
HYDROCHLORIDE
SODIUM CHLORIDE Organon (Ireland) Limited PA0061/005/001 Solution for Injection - SODIUM CHLORIDE 25/03/2002
OMEPRAZOLE- Ratiopharm Espana S.A. PA0965/001/001 Capsules Gastro-Resistant - OMEPRAZOLE 20/03/2002
RATIOPHARM
FEMAPAK 40 (PATCH AND Elan Pharma International PA0872/006/001 Transdermal Patch+Tablets - ESTRADIOL 19/03/2002
TABLETS) Ltd - DYDROGESTERONE
GHRH FERRING Ferring Ireland Ltd PA1009/010/001 Pdr+Solv for Soln for Inj - SOMATORELIN ACETATE 18/03/2002

ERYTHROCIN Abbott Laboratories Ireland PA0038/002/007 Pdr for Soln for Injection - ERYTHROMYCIN 16/03/2002
Ltd LACTOBIONATE
ERYTHROCIN Abbott Laboratories Ireland PA0038/002/008 Pdr for Soln for Injection - ERYTHROMYCIN 16/03/2002
Ltd LACTOBIONATE
PINIFED Pinewood Laboratories Ltd, PA0281/038/002 Capsule - NIFEDIPINE 15/03/2002
ATROVENT FORTE Boehringer Ingelheim Limited PA0007/002/003 Pressurised Inhalation - IPRATROPIUM BROMIDE 13/03/2002
Suspension
SALBUTAMOL EASI- Norton Waterford PA0436/008/001 Pressurised Inhalation - SALBUTAMOL 13/03/2002
BREATHE INHALER Suspension
SODIUM CHLORIDE Abbott Laboratories Ireland PA0038/044/001 Solution for Infusion - SODIUM CHLORIDE 13/03/2002
Ltd
SODIUM CHLORIDE Abbott Laboratories Ireland PA0038/044/002 Solution for Infusion - SODIUM CHLORIDE 13/03/2002
Ltd
NEORECORMON Roche Registration GmbH EU/1/97/031/018 Pdr+Solv for Soln for Inj - EPOETIN BETA 12/03/2002
NEORECORMON WITH Roche Registration Limited EU/1/97/031/014 Pdr+Solv for Soln for Inj - EPOETIN BETA 12/03/2002
SYRINGE
NEORECORMON WITH Roche Registration Limited EU/1/97/031/015 Pdr+Solv for Soln for Inj - EPOETIN BETA 12/03/2002
SYRINGE
NEORECORMON WITH Roche Registration Limited EU/1/97/031/016 Pdr+Solv for Soln for Inj - EPOETIN BETA 12/03/2002
SYRINGE

Human Medicines Withdrawn Products Page 337 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEORECORMON WITH Roche Registration Limited EU/1/97/031/017 Pdr+Solv for Soln for Inj - EPOETIN BETA 12/03/2002
SYRINGE
OXYPERTINE Sanofi-Synthelabo Ireland PA0077/009/001 Capsule - OXYPERTINE 08/03/2002
Ltd
DEPIXOL Lundbeck Limited PA0115/001/004 Tablets - FLUPENTIXOL 06/03/2002
DIHYDROCHLORIDE
TRYPTIZOL Merck Sharp and Dohme PA0035/002/005 Oral Suspension - AMITRIPTYLINE 06/03/2002
Limited PAMOATE
EPIESTROL Rottapharm B.V. PA0591/001/001 Transdermal Patch - ESTRADIOL 28/02/2002
HEMIHYDRATE
EPIESTROL Rottapharm B.V. PA0591/001/002 Transdermal Patch - ESTRADIOL 28/02/2002
HEMIHYDRATE
EPIESTROL Rottapharm B.V. PA0591/001/003 Transdermal Patch - ESTRADIOL 28/02/2002
HEMIHYDRATE
PENTASPAN Fresenius Kabi Austria PA0773/002/001 Solution for Infusion - PENTASTARCH 25/02/2002
GmbH
TAMOX Rowex Ltd PA0711/022/004 Tablets - TAMOXIFEN CITRATE 25/02/2002
GYNOXIN Organon Laboratories PA0261/030/001 Vaginal Cream 24/02/2002
Limited
PINIFED Pinewood Laboratories Ltd, PA0281/038/001 Capsule - NIFEDIPINE 24/02/2002
VALDISPERT Abbott Products GmbH PA0410/002/001 Tablets 24/02/2002
VALDISPERT FORTE Abbott Products GmbH PA0410/002/002 Tablets 24/02/2002
BLEOMYCIN LUNDBECK Lundbeck Limited PA0115/004/002 Pdr for Soln Inj/Inf - BLEOMYCIN SULFATE 23/02/2002
INJECTION
DICLO-DICLOFENAC Pinewood Laboratories Ltd, PA0281/058/001 Tablets - DICLOFENAC SODIUM 22/02/2002
ENTERIC COATED
DICLO-DICLOFENAC Pinewood Laboratories Ltd, PA0281/058/002 Tablets - DICLOFENAC SODIUM 22/02/2002
ENTERIC COATED
EPIMAZ Norton Waterford PA0436/027/001 Tablets - CARBAMAZEPINE 22/02/2002
EPIMAZ Norton Waterford PA0436/027/002 Tablets - CARBAMAZEPINE 22/02/2002
EPIMAZ Norton Waterford PA0436/027/003 Tablets - CARBAMAZEPINE 22/02/2002
ALDOMET Merck Sharp and Dohme PA0035/051/005 Oral Suspension - METHYLDOPA 19/02/2002
Limited
ZOVIRAX PCO Manufacturing PPA0465/038/001D Cream - ACICLOVIR 19/02/2002
ZOVIRAX PCO Manufacturing PPA0465/038/001E Cream - ACICLOVIR 19/02/2002
ZOVIRAX PCO Manufacturing PPA0465/038/001F Cream - ACICLOVIR 19/02/2002
ZOVIRAX PCO Manufacturing PPA0465/038/001G Cream - ACICLOVIR 19/02/2002
ZOVIRAX PCO Manufacturing PPA0465/038/001H Cream - ACICLOVIR 19/02/2002
MIGRAMAX Sanofi-Synthelabo Ireland PA0077/144/001 Powder for Oral Solution - ACETYLSALICYLATE 18/02/2002
Ltd LYSINE
- METOCLOPRAMIDE
HYDROCHLORIDE
PREDNISOLONE B.P. Pinewood Laboratories Ltd, PA0281/013/001 Tablets - PREDNISOLONE 18/02/2002
DROLEPTAN Janssen-Cilag Ltd PA0748/018/001 Solution for Injection - DROPERIDOL 15/02/2002
SAIZEN Serono Limited PA0285/005/003 Pdr+Solv for Soln for Inj - SOMATROPIN 12/02/2002
NORIMIN Monsanto PLC PA0778/013/001 Tablets - NORETHISTERONE 07/02/2002
- ETHINYLESTRADIOL
NORINYL - 1 Monsanto PLC PA0778/015/001 Tablets - NORETHISTERONE 07/02/2002
- MESTRANOL
TELFAST Marion Merrell Limited PA0041/051/002 Tablets - FEXOFENADINE 07/02/2002
HYDROCHLORIDE
VIDEX Bristol-Myers Squibb PA0002/057/001 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/002 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/003 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/004 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/005 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/006 Powder for Oral Solution - DIDANOSINE 06/02/2002
Pharmaceuticals uc
OLBETAM Farmitalia Carlo Erba Ltd PA0236/020/002 Capsule - ACIPIMOX 31/01/2002
LYRELLE 50 John Wyeth & Brother PA0022/074/001 Transdermal Patch - ESTRADIOL 28/01/2002
Limited
LYRELLE 80 John Wyeth & Brother PA0022/074/002 Transdermal Patch - ESTRADIOL 28/01/2002
Limited
DOLMATIL Sanofi-Synthelabo Ireland PA0077/155/001 Capsule - SULPIRIDE 22/01/2002
Ltd
DOLMATIL Sanofi-Synthelabo Ireland PA0077/155/002 Solution for Injection - SULPIRIDE 22/01/2002
Ltd
CLIVARINE Knoll Limited PA0769/014/001 Solution for Injection - REVIPARIN SODIUM 15/01/2002
DARAPRIM Wellcome (Ireland) Limited PA0017/004/001 Tablets - PYRIMETHAMINE 15/01/2002

Human Medicines Withdrawn Products Page 338 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STEMETIL May & Baker Limited PA0040/026/007 Solution for Injection - PROCHLORPERAZINE 15/01/2002
MESILATE
PIPRIL Cyanamid of Great Britain PA0037/053/001 Pdr for Soln for Injection - PIPERACILLIN SODIUM 11/01/2002
PIPRIL Cyanamid of Great Britain PA0037/053/002 - PIPERACILLIN SODIUM 11/01/2002
PIPRIL Cyanamid of Great Britain PA0037/053/003 - PIPERACILLIN SODIUM 11/01/2002
PIPRIL Cyanamid of Great Britain PA0037/053/004 - PIPERACILLIN SODIUM 11/01/2002
PIPRIL Cyanamid of Great Britain PA0037/053/005 - PIPERACILLIN SODIUM 11/01/2002
PIPRIL Cyanamid of Great Britain PA0037/053/006 Powder for solution for - PIPERACILLIN SODIUM 11/01/2002
infusion
PIPRIL Cyanamid of Great Britain PA0037/053/007 Powder for solution for - PIPERACILLIN SODIUM 11/01/2002
infusion
PIPRIL Cyanamid of Great Britain PA0037/053/008 Powder for solution for - PIPERACILLIN SODIUM 11/01/2002
infusion
CROMOGEN STERI-NEB Norton Healthcare Limited PA0282/059/001 Nebuliser Solution - CROMOGLICATE SODIUM 08/01/2002
T/A IVAX Pharmaceuticals
UK
CO-TENOMEL Clonmel Healthcare Ltd PA0126/098/001 Tablets - ATENOLOL 07/01/2002
- CHLORTALIDONE
CO-TENOMEL Clonmel Healthcare Ltd PA0126/098/002 Tablets - ATENOLOL 07/01/2002
- CHLORTALIDONE
FORTAGESIC Sanofi-Synthelabo Ireland PA0077/004/001 Tablets - PENTAZOCINE 07/01/2002
Ltd HYDROCHLORIDE
- PARACETAMOL
FRANOL SR Sanofi-Synthelabo Ireland PA0077/122/001 Capsule - THEOPHYLLINE 07/01/2002
Ltd
FRANOL SR Sanofi-Synthelabo Ireland PA0077/122/002 Capsule - THEOPHYLLINE 07/01/2002
Ltd
FRANOL SR Sanofi-Synthelabo Ireland PA0077/122/003 Capsule - THEOPHYLLINE 07/01/2002
Ltd
PREVILEX Les Laboratoires Servier PA0568/006/001 Tablets - INDAPAMIDE 07/01/2002
HEMIHYDRATE
TILDIEM INJECTABLE Sanofi-Synthelabo Ireland PA0077/153/003 Pdr+Solv for Soln for Inj - DILTIAZEM 07/01/2002
Ltd HYDROCHLORIDE
TILDIEM INJECTABLE Sanofi-Synthelabo Ireland PA0077/153/004 Pdr+Solv for Soln for Inj - DILTIAZEM 07/01/2002
Ltd HYDROCHLORIDE
TIPERAL Clonmel Healthcare Ltd PA0126/028/002 Tablets - PROPRANOLOL 07/01/2002
HYDROCHLORIDE
TIPROCIN Clonmel Healthcare Ltd PA0126/037/001 Tablets Gastro-Resistant - ERYTHROMYCIN 07/01/2002
TIPROCIN Clonmel Healthcare Ltd PA0126/042/001 Granules for Oral - ERYTHROMYCIN 07/01/2002
Suspension ETHYLSUCCINATE
LIPOBAY Bayer PLC PA0021/045/001 Tablets - CERIVASTATIN 04/01/2002
LIPOBAY Bayer PLC PA0021/045/002 Tablets - CERIVASTATIN 04/01/2002
LIPOBAY Bayer PLC PA0021/045/003 Tablets - CERIVASTATIN 04/01/2002
LIPOBAY Bayer PLC PA0021/045/004 Tablets - CERIVASTATIN 04/01/2002
NORCURON NV Organon PA0964/002/001 Pdr+Solv for Soln for Inj - VECURONIUM BROMIDE 02/01/2002
NEUTREXIN Ipsen Biotech PA0646/002/001 Concentrate for Soln for Inf - TRIMETREXATE 28/12/2001
ALLEREZE PLUS Novartis Consumer Health PA0030/036/001 Tablets - CLEMASTINE 20/12/2001
UK Limited -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
TRIOGESIC Novartis Consumer Health PA0030/033/002 Tablets - 20/12/2001
UK Limited PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PARACETAMOL
TRIOGESIC ELIXIR Novartis Consumer Health PA0030/033/001 Oral Solution - 20/12/2001
UK Limited PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PARACETAMOL
TRIOMINIC Novartis Consumer Health PA0030/034/001 Syrup - 20/12/2001
UK Limited PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PHENIRAMINE MALEATE
TRIOMINIC Novartis Consumer Health PA0030/034/002 Tablets - 20/12/2001
UK Limited PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PHENIRAMINE MALEATE
CHLORAMPHENICOL Roussel Laboratories Limited PA0006/031/001 Eye Drops Solution - CHLORAMPHENICOL 18/12/2001

THEODUR Astra Pharmaceuticals Ltd PA0009/041/001 Tablets - THEOPHYLLINE 17/12/2001


THEODUR Astra Pharmaceuticals Ltd PA0009/041/002 Tablets - THEOPHYLLINE 17/12/2001
ZOMACTON Ferring Ireland Ltd PA1009/008/001 Pdr+Solv for soln for Inf - SOMATROPIN 16/12/2001
AAA MOUTH & THROAT Rorer Pharmaceuticals PA0468/019/001 Oromucosal spray, solution - BENZOCAINE 14/12/2001
Limited
ATROPINE Roussel Laboratories Limited PA0006/032/001 Eye Drops Solution - ATROPINE SULFATE 14/12/2001

Human Medicines Withdrawn Products Page 339 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FEMAPAK 80 (PATCH AND Elan Pharma International PA0872/006/002 Transdermal Patch+Tablets - ESTRADIOL 13/12/2001
TABLETS) Ltd - DYDROGESTERONE
DANERAL SA Hoechst Marion Roussel Irl PA0855/011/001 Coated Tablets - PHENIRAMINE MALEATE 12/12/2001
Ltd
MELZINE Clonmel Healthcare Ltd PA0126/025/001 Syrup - THIORIDAZINE 12/12/2001
HYDROCHLORIDE
PRECORTISYL Roussel Laboratories Limited PA0006/017/002 Tablets - PREDNISOLONE 12/12/2001

RASTINON Hoechst Marion Roussel Irl PA0855/009/001 Tablets - TOLBUTAMIDE 12/12/2001


Ltd
STELABID SmithKline and French PA0060/014/001 Tablets - ISOPROPAMIDE IODIDE 12/12/2001
Laboratories Ltd - TRIFLUOPERAZINE
HYDROCHLORIDE
TOPISOLON Hoechst Marion Roussel Irl PA0855/004/002 - DESOXIMETASONE 12/12/2001
Ltd - SALICYLIC ACID
TOPISOLON Hoechst Marion Roussel Irl PA0855/004/003 - DESOXIMETASONE 12/12/2001
Ltd - SALICYLIC ACID
HYPROMELLOSE Roussel Laboratories Limited PA0006/041/001 Eye Drops Solution - HYPROMELLOSE 11/12/2001

LASIKAL Hoechst Marion Roussel Irl PA0855/006/001 Tablets - FUROSEMIDE 11/12/2001


Ltd - POTASSIUM CHLORIDE
LASIX Hoechst Marion Roussel Irl PA0855/003/004 Tablets - FUROSEMIDE 11/12/2001
Ltd
LURSELLE Marion Merrell Limited PA0041/031/001 Tablets - PROBUCOL 11/12/2001
STEMETIL May & Baker Limited PA0040/026/004 Syrup - PROCHLORPERAZINE 11/12/2001
MESILATE
TESTOSTERONE FERRING Ferring Ireland Ltd PA1009/013/001 Transdermal Patch - TESTOSTERONE 11/12/2001

TESTOTOP 10 Ferring Ireland Ltd PA1009/012/001 Transdermal Patch - TESTOSTERONE 11/12/2001


TESTOTOP 15 Ferring Ireland Ltd PA1009/012/002 Transdermal Patch - TESTOSTERONE 11/12/2001
TUBERCULIN PPD RT23 Statens Serum Institute PA0798/001/001 Suspension for Injection - TUBERCULIN PPD 11/12/2001
SSI
TUBERCULIN PPD RT23 Statens Serum Institute PA0798/001/003 Suspension for Injection - TUBERCULIN PPD 11/12/2001
SSI
CYKLO-F Pharmacia Healthcare PA0936/001/001 Tablets - TRANEXAMIC ACID 04/12/2001
Ireland
DERMAZOLE Ego Pharmaceuticals (UK) PA0863/004/001 Cream - ECONAZOLE NITRATE 03/12/2001
Limited
CROMOGEN INHALER Norton Waterford PA0436/022/001 Pressurised Inhalation - CROMOGLICATE SODIUM 26/11/2001
Suspension
DEPO-PROVERA Pharmacia Limited PA0016/024/004 Suspension for Injection - 26/11/2001
MEDROXYPROGESTERO
NE ACETATE
NARDIL Archimedes Pharma UK PA0757/006/001 Tablets - PHENELZINE SULFATE 26/11/2001
Limited
TIMONIL RETARD Desitin Arzneimittel GmbH PA0815/002/001 Tablets - CARBAMAZEPINE 26/11/2001
TIMONIL RETARD Desitin Arzneimittel GmbH PA0815/002/002 Tablets - CARBAMAZEPINE 26/11/2001
ARELIX Hoechst Marion Roussel Irl PA0855/015/001 Capsule - PIRETANIDE 23/11/2001
Ltd
ARELIX Hoechst Marion Roussel Irl PA0855/015/002 Tablets - PIRETANIDE 23/11/2001
Ltd
DECORTISYL Roussel Laboratories Limited PA0006/014/001 Tablets - PREDNISONE 23/11/2001

DECORTISYL Roussel Laboratories Limited PA0006/014/002 Tablets - PREDNISONE 23/11/2001

HOSTACYCLINE Hoechst Marion Roussel Irl PA0855/005/001 Tablets - TETRACYCLINE 23/11/2001


Ltd HYDROCHLORIDE

Human Medicines Withdrawn Products Page 340 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NUTRINEAL PD2 1.1% Baxter Healthcare Limited PA0167/085/001A Solution for Injection - TYROSINE 23/11/2001
- TRYPTOPHAN, L-
- PHENYLALANINE
- THREONINE
- SERINE
- PROLINE
- AMINOACETIC ACID
- ALANINE
- VALINE
- L-METHIONINE
- ISOLEUCINE
- LEUCINE
- LYSINE
HYDROCHLORIDE
- HISTIDINE
- ARGININE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- SODIUM LACTATE
- SODIUM CHLORIDE
TARIVID Hoechst Marion Roussel Irl PA0855/019/004 Tablets - OFLOXACIN 23/11/2001
Ltd
TARIVID IV INFUSION Hoechst Marion Roussel Irl PA0855/019/001 Solution for Infusion - OFLOXACIN 23/11/2001
Ltd HYDROCHLORIDE
NIFEDIPINE McDermott Laboratories Ltd PA0577/017/001 Capsule - NIFEDIPINE 20/11/2001
t/a Gerard Laboratories
NIFEDIPINE McDermott Laboratories Ltd PA0577/017/002 Capsule - NIFEDIPINE 20/11/2001
t/a Gerard Laboratories
ADALAT PCO Manufacturing PPA0465/012/002 Capsule - NIFEDIPINE 14/11/2001
ALDACTONE PCO Manufacturing PPA0465/014/002A Tablets - SPIRONOLACTONE 14/11/2001
ALDACTONE P.B.S Sales Limited PPA0465/014/002B Tablets - SPIRONOLACTONE 14/11/2001
ALDACTONE TABLETS 25 PCO Manufacturing PPA0465/014/001A Tablets - SPIRONOLACTONE 14/11/2001
MG
ALDACTONE TABLETS 25 PCO Manufacturing PPA0465/014/001B Tablets 14/11/2001
MG
INDOCID PCO Manufacturing PPA0465/007/001A Capsule - INDOMETACIN 14/11/2001
INDOCID PCO Manufacturing PPA0465/007/001B Capsule 14/11/2001
INDOCID PCO Manufacturing PPA0465/007/001C Capsule 14/11/2001
INDOCID PCO Manufacturing PPA0465/007/002A Capsule - INDOMETACIN 14/11/2001
INDOCID PCO Manufacturing PPA0465/007/002B Capsule 14/11/2001
INDOCID PCO Manufacturing PPA0465/007/002C Capsule 14/11/2001
INDOCID R PCO Manufacturing PPA0465/007/003A Capsule - INDOMETACIN 14/11/2001
LOSEC PCO Manufacturing PPA0465/039/003A Capsule - OMEPRAZOLE 14/11/2001
LOSEC PCO Manufacturing PPA0465/039/003B Capsule - OMEPRAZOLE 14/11/2001
MINOCIN PCO Manufacturing PPA0465/035/001 Tablets - MINOCYCLINE 14/11/2001
MINOCIN PCO Manufacturing PPA0465/035/002 Tablets - MINOCYCLINE 14/11/2001
NATRILIX PCO Manufacturing PPA0465/016/001 Tablets - INDAPAMIDE 14/11/2001
HEMIHYDRATE
PERSANTIN PCO Manufacturing PPA0465/034/001A Tablets - DIPYRIDAMOLE 14/11/2001
PERSANTIN PCO Manufacturing PPA0465/034/002A Tablets - DIPYRIDAMOLE 14/11/2001
VENTOLIN INHALER PCO Manufacturing PPA0465/019/001 Pressurised Inhalation - SALBUTAMOL 14/11/2001
Suspension
VOLTAROL PCO Manufacturing PPA0465/013/001 Tablets - DICLOFENAC SODIUM 14/11/2001
VOLTAROL PCO Manufacturing PPA0465/013/002 Tablets 14/11/2001
ACTINAC Peckforton Pharmaceuticals PA0946/002/001 Cutaneous Solution - CHLORAMPHENICOL 13/11/2001
Ltd - HYDROCORTISONE
ACETATE
- BUTOXYETHYL
NICOTINATE
- ALLANTOIN
- SULFUR
LARGACTIL May & Baker Limited PA0040/018/004 Syrup - CHLORPROMAZINE 12/11/2001
HYDROCHLORIDE
LARGACTIL May & Baker Limited PA0040/018/005 Tablets - CHLORPROMAZINE 12/11/2001
HYDROCHLORIDE
OXPRENOLOL Roussel Laboratories Limited PA0006/037/001 Tablets - OXPRENOLOL 12/11/2001
HYDROCHLORIDE
OXPRENOLOL Roussel Laboratories Limited PA0006/037/002 Tablets 12/11/2001

OXPRENOLOL Roussel Laboratories Limited PA0006/037/003 Tablets - OXPRENOLOL 12/11/2001


HYDROCHLORIDE
OXPRENOLOL Roussel Laboratories Limited PA0006/037/004 Tablets - OXPRENOLOL 12/11/2001
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 341 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PRECORTISYL Roussel Laboratories Limited PA0006/017/001 Tablets - PREDNISOLONE 12/11/2001

DIAZEPAM Roussel Laboratories Limited PA0006/034/001 Tablets - DIAZEPAM 05/11/2001

DIAZEPAM Roussel Laboratories Limited PA0006/034/002 Tablets - DIAZEPAM 05/11/2001

DIAZEPAM Roussel Laboratories Limited PA0006/034/003 Tablets - DIAZEPAM 05/11/2001

LASIX Hoechst Ireland Limited PA0023/008/007 Oral Solution - FUROSEMIDE 05/11/2001


ATROVENT AUTOHALER Boehringer Ingelheim Limited PA0007/002/006 Pressurised Inhalation - IPRATROPIUM BROMIDE 30/10/2001
Suspension
DUOVENT AUTOHALER Boehringer Ingelheim Limited PA0007/034/005 Pressurised Inhalation - IPRATROPIUM BROMIDE 30/10/2001
Suspension - FENOTEROL
HYDROBROMIDE
RHINOCORT AQUA Astra Pharmaceuticals Ltd PA0009/034/002 Nasal Spray Suspension - BUDESONIDE 30/10/2001
CORDIUM Organon Laboratories PA0261/024/001 Tablets - BEPRIDIL 26/10/2001
Limited HYDROCHLORIDE
MONOHYDRATE
CORDIUM Organon Laboratories PA0261/024/002 Tablets - BEPRIDIL 26/10/2001
Limited HYDROCHLORIDE
MONOHYDRATE
CORDIUM Organon Laboratories PA0261/024/003 Tablets - BEPRIDIL 26/10/2001
Limited HYDROCHLORIDE
MONOHYDRATE
RIMEXEL Organon Laboratories PA0261/041/001 Powder for suspension for - RIMEXOLONE 26/10/2001
Limited injection
CEFROM Hoechst Ireland Limited PA0006/045/001 Powder for suspension for - CEFPIROME SULFATE 25/10/2001
injection
CEFROM Hoechst Ireland Limited PA0006/045/002 Powder for suspension for - CEFPIROME SULFATE 25/10/2001
injection
CEFROM Hoechst Ireland Limited PA0006/045/003 Powder for suspension for - CEFPIROME SULFATE 25/10/2001
injection
CEFROM Hoechst Ireland Limited PA0006/045/004 Pdr for Soln for Injection - CEFPIROME SULFATE 25/10/2001
CEFROM POWDER Hoechst Ireland Limited PA0006/045/005 Powder for solution for - CEFPIROME 25/10/2001
infusion
CEFROM POWDER Hoechst Ireland Limited PA0006/045/006 Powder for solution for - CEFPIROME SULFATE 25/10/2001
infusion
HUMEGON Organon Laboratories PA0261/002/002 Pdr+Solv for Soln for Inj - FOLLICLE-STIMULATING 21/10/2001
Limited HORMONE, HUMAN
- LUTEINISING HORMONE
MENTADENT P MINT Elida Faberge Ireland PA0581/001/001 Toothpaste - TRICLOSAN 21/10/2001
FLAVOUR - SODIUM MONOFLUORO
PHOSPHATE
- ZINC CITRATE
TRIHYDRATE
TIMOLOL CIBA VISION Novartis Ophthalmics Europe PA0914/001/001 Eye Drops Solution - TIMOLOL MALEATE 17/10/2001
Ltd
TIMOLOL CIBA VISION Novartis Ophthalmics Europe PA0914/001/002 Eye Drops Solution - TIMOLOL MALEATE 17/10/2001
Ltd
ANGISED Wellcome (Ireland) Limited PA0017/067/001 Tablets - GLYCERYL TRINITRATE 12/10/2001
DIVINA Orion Pharma A/s PA0303/033/001 Tablets - ESTRADIOL VALERATE 12/10/2001
- ESTRADIOL VALERATE
-
MEDROXYPROGESTERO
NE ACETATE
LASMA SUSTAINED Forest Laboratories UK Ltd PA0100/034/001 Tablets - THEOPHYLLINE 12/10/2001
RELEASE
LINGRAINE Sanofi-Synthelabo Ireland PA0077/039/001 Tablets - ERGOTAMINE TARTRATE 12/10/2001
Ltd
HUMEGON Organon Laboratories PA0261/002/001 Pdr+Solv for Soln for Inj - FOLLICLE-STIMULATING 11/10/2001
Limited HORMONE, HUMAN
- LUTEINISING HORMONE
MENTADENT P Elida Faberge Ireland PA0581/001/002 Toothpaste - TRICLOSAN 11/10/2001
TOOTHPASTE ORIGINAL - SODIUM MONOFLUORO
FLAVOUR PHOSPHATE
- ZINC CITRATE
TRIHYDRATE
COTENT 100 Pinewood Laboratories Ltd, PA0281/065/002 Tablets - ATENOLOL 10/10/2001
- CHLORTALIDONE
COTENT 50 Pinewood Laboratories Ltd, PA0281/065/001 Tablets - ATENOLOL 10/10/2001
- CHLORTALIDONE
PROZAC PCO Manufacturing PPA0465/040/001C Capsule - FLUOXETINE 18/09/2001
HYDROCHLORIDE
PROZAC PCO Manufacturing PPA0465/040/001F Capsule - FLUOXETINE 18/09/2001
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 342 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROZAC PCO Manufacturing PPA0465/040/001G Capsule - FLUOXETINE 18/09/2001
HYDROCHLORIDE
ZOVIRAX PCO Manufacturing PPA0465/038/001A Cream - ACICLOVIR 18/09/2001
ZOVIRAX PCO Manufacturing PPA0465/038/001B Cream - ACICLOVIR 18/09/2001
ZOVIRAX PCO Manufacturing PPA0465/038/001C Cream - ACICLOVIR 18/09/2001
DIMOTAPP A.H. Robins Company PA0086/011/001 Syrup - BROMPHENIRAMINE 13/09/2001
Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
DIMOTAPP L.A. A.H. Robins Company PA0086/012/001 Tablets - PHENYLEPHRINE 13/09/2001
Limited HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- BROMPHENIRAMINE
MALEATE
PANCREX Paines and Byrne Limited PA0090/009/005 Granules - PANCREATIN 07/09/2001
PANCREX V Paines and Byrne Limited PA0090/009/001 Tablets - PANCREATIN 07/09/2001
PANCREX V Paines and Byrne Limited PA0090/009/003 Capsule - PANCREATIN 07/09/2001
PANCREX V Paines and Byrne Limited PA0090/009/004 Oral Powder - PANCREATIN 07/09/2001
PANCREX V FORTE Paines and Byrne Limited PA0090/009/002 Tablets - PANCREATIN 07/09/2001
SURMONTIL May & Baker Limited PA0040/027/004 Capsule - TRIMIPRAMINE MALEATE 06/09/2001

SURMONTIL May & Baker Limited PA0040/027/005 Capsule - TRIMIPRAMINE MALEATE 06/09/2001

TRILUDAN Marion Merrell Limited PA0041/026/002 Oral Suspension - TERFENADINE 06/09/2001


CIPRAMIL Lundbeck ( Ireland ) Limited PA0776/001/003 Tablets - CITALOPRAM 03/09/2001
INDOMETHACIN Pinewood Laboratories Ltd, PA0281/018/001 Capsule - INDOMETACIN 25/08/2001
INDOMETHACIN Pinewood Laboratories Ltd, PA0281/018/002 Capsule - INDOMETACIN 25/08/2001
BISOLVON Boehringer Ingelheim Limited PA0007/025/001 Tablets - BROMHEXINE 20/08/2001
HYDROCHLORIDE
VAQTA ADULT Sanofi Pasteur MSD Ltd PA0544/028/003 Solution for Injection - HEPATITIS A VACCINE 15/08/2001
VAQTA PAEDIATRIC Sanofi Pasteur MSD Ltd PA0544/028/001 Suspension for Injection - HEPATITIS A VACCINE 15/08/2001
DOBUTAMINE Abbott Laboratories Ireland PA0038/061/002 Solution for Injection - DOBUTAMINE 14/08/2001
Ltd HYDROCHLORIDE
DOBUTAMINE Abbott Laboratories Ireland PA0038/061/003 Solution for Injection - DOBUTAMINE 14/08/2001
Ltd HYDROCHLORIDE
DOBUTAMINE Abbott Laboratories Ireland PA0038/061/004 Solution for Injection - DOBUTAMINE 14/08/2001
Ltd HYDROCHLORIDE
STERILE DOBUTAMINE Abbott Laboratories Ireland PA0038/061/001 Concentrate for Soln for Inf - DOBUTAMINE 14/08/2001
Ltd HYDROCHLORIDE
PEVARYL Janssen-Cilag Ltd PA0748/037/002 Cutaneous Solution - ECONAZOLE NITRATE 13/08/2001
ZOFRAN PLASTIC Glaxo Laboratories Limited PA0044/090/005 Solution for Injection - ONDANSETRON 07/08/2001
AMPOULES HYDROCHLORIDE
ZOFRAN PLASTIC Glaxo Laboratories Limited PA0044/090/006 Solution for Injection - ONDANSETRON 07/08/2001
AMPOULES HYDROCHLORIDE
STERILE WATER Baxter Healthcare Limited PA0167/065/002 Solution for Infusion - WATER FOR INJECTIONS 06/08/2001

WATER Baxter Healthcare Limited PA0167/065/003 Solution for Infusion - WATER FOR INJECTIONS 06/08/2001

STERETS NORMASOL Seton Prebbles Ltd PA0483/007/001 Irrigation solution - SODIUM CHLORIDE 03/08/2001
MERONEM Zeneca Limited PA0051/063/002 Pdr for Soln for Injection - MEROPENEM 02/08/2001
DEXAMETHASONE Hospira UK Limited PA0437/014/001 Solution for Injection - DEXAMETHASONE 28/07/2001
SODIUM PHOSPHATE SODIUM PHOSPHATE
DEXAMETHASONE Hospira UK Limited PA0437/014/003 Solution for Injection - DEXAMETHASONE 28/07/2001
SODIUM PHOSPHATE SODIUM PHOSPHATE
HUMULIN M 20/80 Eli Lilly and Company Limite PA0047/066/001 Suspension for Injection - INSULIN HUMAN 28/07/2001

HUMULIN M4 Eli Lilly and Company Limite PA0047/070/002 Suspension for Injection - INSULIN HUMAN 28/07/2001

BECLAZONE INHALER Norton Waterford PA0436/021/001 Pressurised Inhalation - BECLOMETASONE 26/07/2001


Suspension DIPROPIONATE
BECLAZONE INHALER Norton Waterford PA0436/021/002 Pressurised Inhalation - BECLOMETASONE 26/07/2001
Suspension DIPROPIONATE
BECLAZONE INHALER Norton Waterford PA0436/021/003 Pressurised Inhalation - BECLOMETASONE 26/07/2001
Suspension DIPROPIONATE
BECLOMETHASONE Norton Waterford PA0436/024/001 Pressurised Inhalation - BECLOMETASONE 26/07/2001
DIPROPIONATE INHALER Suspension DIPROPIONATE
BECLOMETHASONE Norton Waterford PA0436/024/002 Pressurised Inhalation - BECLOMETASONE 26/07/2001
DIPROPIONATE INHALER Suspension DIPROPIONATE
BECLOMETHASONE Norton Waterford PA0436/024/003 Pressurised Inhalation - BECLOMETASONE 26/07/2001
DIPROPIONATE INHALER Suspension DIPROPIONATE

Human Medicines Withdrawn Products Page 343 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZAGAM Rhone DPC Europe PA0703/001/002 Tablets - SPARFLOXACIN 24/07/2001
NAPROSYN Roche Products Limited PA0050/128/001 Gel - NAPROXEN 17/07/2001
BRICANYL RESPIRATOR Astra Pharmaceuticals Ltd PA0009/004/001 Nebuliser Solution - TERBUTALINE SULFATE 14/07/2001
BEROTEC Boehringer Ingelheim Limited PA0007/033/002 Nebuliser Solution - FENOTEROL 10/07/2001
HYDROBROMIDE
BEROTEC Boehringer Ingelheim Limited PA0007/033/003 Nebuliser Solution - FENOTEROL 10/07/2001
HYDROBROMIDE
RINATEC NASAL Boehringer Ingelheim Limited PA0007/027/003 Nasal Spray Solution - IPRATROPIUM BROMIDE 10/07/2001
MONOHYDRATE
CYSTRIN CR Sanofi-Synthelabo Ireland PA0077/156/003 Tablets - OXYBUTYNIN 09/07/2001
Ltd HYDROCHLORIDE
ATROVENT AEROCAPS Boehringer Ingelheim Limited PA0007/002/005 Inhalation powder, hard - IPRATROPIUM BROMIDE 06/07/2001
capsule MONOHYDRATE
IMIPRAMINE Clonmel Healthcare Ltd PA0126/052/001 Tablets - IMIPRAMINE 29/06/2001
HYDROCHLORIDE
LANSOYL JELLY Parke-Davis PA0470/002/001 Oral Gel - PARAFFIN, LIQUID 29/06/2001
LEDERSPAN Cyanamid of Great Britain PA0037/031/001 Suspension for Injection - TRIAMCINOLONE 29/06/2001
HEXACETONIDE
LEDERSPAN Cyanamid of Great Britain PA0037/031/002 Suspension for Injection - TRIAMCINOLONE 29/06/2001
HEXACETONIDE
TOREM Boehringer Mannheim PA0130/020/003 Solution for Injection - TORASEMIDE SODIUM 29/06/2001
VALDERMA Roche Products Limited PA0050/080/001 Soap - TRICLOCARBAN 29/06/2001
PARACETAMOL Blackhall Pharmaceutical PA0490/001/001 Tablets - PARACETAMOL 26/06/2001
ELYZOL Alpharma ApS PA0363/004/001 Cream - METRONIDAZOLE 10/06/2001
SOTACOR Bristol-Myers Squibb PA0048/001/009 Solution for Injection - SOTALOL 24/05/2001
(Holdings) Limited HYDROCHLORIDE
XYLOCAINE 5% HEAVY Astra Pharmaceuticals Ltd PA0009/016/021 Solution for Injection - LIDOCAINE 24/05/2001
(INTRATHECAL) HYDROCHLORIDE
- GLUCOSE
HYPAQUE 45% Sanofi-Synthelabo Ireland PA0077/069/002 Solution for Injection - SODIUM AMIDOTRIZOATE 23/05/2001
Ltd
CISPLATIN Hospira UK Limited PA0437/004/001 Powder for solution for - CISPLATIN 21/05/2001
infusion
CISPLATIN Hospira UK Limited PA0437/004/003 Powder for solution for - CISPLATIN 21/05/2001
infusion
NIZORAL PCO Manufacturing PPA0465/042/001B Shampoo - KETOCONAZOLE 20/05/2001
NIZORAL PCO Manufacturing PPA0465/042/001C Shampoo - KETOCONAZOLE 20/05/2001
CATAPRES PL Boehringer Ingelheim Limited PA0007/014/004 Capsule - CLONIDINE 19/05/2001
PERLONGETS HYDROCHLORIDE
STERILE WATER Baxter Healthcare Limited PA0167/065/001 Solution for Infusion - WATER FOR INJECTIONS 11/05/2001

ACTIDOSE-AQUA Paddock Laboratories Inc. PA0645/001/001 Oral Suspension - CHARCOAL, ACTIVATED 10/05/2001
Ltd
HEXABRIX 200 GUERBET PA0686/005/001 Solution for Injection - IOXAGLATE MEGLUMINE 09/05/2001
- IOXAGLATE SODIUM

CONRAY 280 Mallinckrodt UK Limited PA0199/003/001 Solution for Injection - IOTALAMATE 08/05/2001
MEGLUMINE
CONRAY 325 Mallinckrodt UK Limited PA0199/004/001 Solution for Injection - IOTALAMATE SODIUM 08/05/2001
CALAMINE Rowa Pharmaceuticals PA0074/047/002 Cream - CALAMINE 07/05/2001
Limited - ZINC OXIDE
CONRAY 420 Mallinckrodt UK Limited PA0199/005/001 Solution for Injection - IOTALAMATE SODIUM 07/05/2001
CONRAY 420 Mallinckrodt UK Limited PA0199/005/002 Solution for Injection - IOTALAMATE SODIUM 07/05/2001
BIOCLATE 1000 CSL Behring GmbH PA0800/001/003 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 01/05/2001
RECOMBINANT
BIOCLATE 250 CSL Behring GmbH PA0800/001/001 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 01/05/2001
RECOMBINANT
BIOCLATE 500 CSL Behring GmbH PA0800/001/002 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 01/05/2001
RECOMBINANT
TETRACYCLINE Pinewood Laboratories Ltd, PA0281/010/001 Capsule - TETRACYCLINE 01/05/2001
HYDROCHLORIDE
AKINETON Knoll Limited PA0769/018/001 Solution for Injection - SODIUM LACTATE 30/04/2001
- BIPERIDEN LACTATE
BRUFEN GRANULES Knoll Limited PA0769/002/001 Powder for Oral Solution - IBUPROFEN 30/04/2001
FROBEN Knoll Limited PA0769/004/001 Suppositories - FLURBIPROFEN 30/04/2001
MELLERIL Novartis Pharmaceuticals UK PA0013/004/006 Oral Suspension - THIORIDAZINE 30/04/2001
Ltd HYDROCHLORIDE
MELLERIL Novartis Pharmaceuticals UK PA0013/004/007 Oral Suspension - THIORIDAZINE 30/04/2001
Ltd HYDROCHLORIDE
SPARINE John Wyeth & Brother PA0022/010/002 Oral Suspension - PROMAZINE 30/04/2001
Limited HYDROCHLORIDE
- PAMOIC ACID
ERYTHROMYCIN McDermott Laboratories Ltd PA0577/014/001 Tablets - ERYTHROMYCIN 27/04/2001
t/a Gerard Laboratories
FULCIN Zeneca Limited PA0051/009/003 Oral Suspension - GRISEOFULVIN 27/04/2001

Human Medicines Withdrawn Products Page 344 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KETRAX Zeneca Limited PA0051/037/001 Tablets - LEVAMISOLE 27/04/2001
HYDROCHLORIDE
UPSANOL Laboratoires UPSA PA0514/001/001 Powder for Oral Solution - PARACETAMOL 27/04/2001
UPSANOL Laboratoires UPSA PA0514/001/003 Tablets Effervescent - PARACETAMOL 27/04/2001
UPSARIN Laboratoires UPSA PA0514/002/001 Tablets Effervescent - ACETYLSALICYLIC ACID 27/04/2001
UPSARIN Laboratoires UPSA PA0514/002/002 Tablets Effervescent - ACETYLSALICYLIC ACID 27/04/2001
ORTHO GYNE-T 380 Cilag Limited PA0059/039/001 Intrauterine delivery system - COPPER 26/04/2001
ORTHO GYNE-T Cilag Limited PA0059/038/001 Intrauterine delivery system - COPPER 26/04/2001
INTRAUTERINE
ORPHENADRINE Rosemont Pharmaceuticals PA0312/005/001 Oral Solution - ORPHENADRINE 25/04/2001
Ltd
AEROBEC 100 3M Health Care Limited PA0057/056/003 Pressurised Inhalation - BECLOMETASONE 22/04/2001
AUTOHALER Suspension DIPROPIONATE
AEROBEC 250 INHALER 3M Health Care Limited PA0057/056/004 Pressurised Inhalation - BECLOMETASONE 22/04/2001
Suspension DIPROPIONATE
AEROBEC 50 AUTOHALER 3M Health Care Limited PA0057/056/001 Pressurised Inhalation - BECLOMETASONE 22/04/2001
Suspension DIPROPIONATE
DIAZEPAM WPR Healthcare Limited PA0565/001/001 Tablets - DIAZEPAM 18/04/2001
DIAZEPAM WPR Healthcare Limited PA0565/001/002 Tablets - DIAZEPAM 18/04/2001
DIAZEPAM WPR Healthcare Limited PA0565/001/003 Tablets - DIAZEPAM 18/04/2001
NITRAZEPAM WPR Healthcare Limited PA0565/002/001 Tablets - NITRAZEPAM 18/04/2001
AKFEN (GUANFACINE HCLA.H. Robins Company PA0086/028/002 Tablets - GUANFACINE 12/04/2001
Limited HYDROCHLORIDE
BEROTEC METERED DOSE Boehringer Ingelheim Limited PA0007/033/001 Pressurised Inhalation - FENOTEROL 10/04/2001
INHALER Suspension HYDROBROMIDE
CLONOFILIN SR Clonmel Healthcare Ltd PA0126/072/001 Tablets - AMINOPHYLLINE 09/04/2001
HYDRATE
NITROFURANTOIN Clonmel Healthcare Ltd PA0126/018/001 Tablets - NITROFURANTOIN 09/04/2001
PREDNISONE Clonmel Healthcare Ltd PA0126/059/002 Tablets - PREDNISONE 09/04/2001
ADIZEM PLUS Napp Laboratories Limited PA0114/077/001 Capsule - DILTIAZEM 05/04/2001
HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

HYDOL Napp Laboratories Limited PA0114/074/004 Tablets Effervescent - DIHYDROCODEINE 05/04/2001


BITARTRATE
HYDROMORPHONE Napp Laboratories Limited PA0114/059/001 Tablets - HYDROMORPHONE 05/04/2001
HYDROCHLORIDE HYDROCHLORIDE
HYDROMORPHONE Napp Laboratories Limited PA0114/059/002 Tablets - HYDROMORPHONE 05/04/2001
HYDROCHLORIDE HYDROCHLORIDE
UNILAR XL Napp Laboratories Limited PA0114/078/001 Tablets - THEOPHYLLINE 05/04/2001
UNILAR XL Napp Laboratories Limited PA0114/078/002 Tablets - THEOPHYLLINE 05/04/2001
ANTRIMOX Mercury Pharmaceuticals PA0073/086/001 Tablets - TRIMETHOPRIM 02/04/2001
(Ireland) Ltd - SULFAMETHOXAZOLE
TRILUDAN Marion Merrell Limited PA0041/026/001 Tablets 02/04/2001
SANOMIGRAN ELIXIR Novartis Pharmaceuticals UK PA0013/039/003 Syrup - PIZOTIFEN MALEATE 31/03/2001
Ltd
MYAMBUTOL Cyanamid of Great Britain PA0037/008/003 Syrup - ETHAMBUTOL 27/03/2001
DIHYDROCHLORIDE
QUINODERM LOTIO-GEL Quinoderm Ltd PA0308/007/001 Gel - BENZOYL PEROXIDE 26/03/2001
- POTASSIUM
HYDROXYQUINOLIN
SULFATE
CLIMACTOL Novartis Pharmaceuticals UK PA0013/052/001 Tablets - ESTRADIOL VALERATE 23/03/2001
Ltd - ESTRADIOL VALERATE
- NORETHISTERONE
CLIMACTOL Novartis Pharmaceuticals UK PA0013/052/002 Tablets - ESTRADIOL VALERATE 23/03/2001
Ltd - ESTRADIOL VALERATE
- NORETHISTERONE
TROVAN Pfizer Limited EU/1/98/059/001 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/002 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/003 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/004 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/005 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/006 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/007 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/008 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/009 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/010 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/011 Tablets 20/03/2001
TROVAN Pfizer Limited EU/1/98/059/012 Tablets 20/03/2001
TROVAN IV Pfizer Limited EU/1/98/060/001 Solution for Infusion 20/03/2001
TROVAN IV Pfizer Limited EU/1/98/060/002 20/03/2001
TROVAN IV Pfizer Limited EU/1/98/060/003 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/001 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/002 Tablets 20/03/2001

Human Medicines Withdrawn Products Page 345 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/003 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/004 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/005 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/006 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/007 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/008 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/009 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/010 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/011 Tablets 20/03/2001
TURVEL Roerig Farmaceutici Italiana EU/1/98/061/012 Tablets 20/03/2001
TURVEL IV Roerig Farmaceutici Italiana EU/1/98/062/001 Solution for Infusion 20/03/2001
TURVEL IV Roerig Farmaceutici Italiana EU/1/98/062/002 20/03/2001
TURVEL IV Roerig Farmaceutici Italiana EU/1/98/062/003 Solution for Infusion 20/03/2001
ISMO RETARD Boehringer Mannheim PA0130/015/004 Tablets - ISOSORBIDE 16/03/2001
MONONITRATE
ALVEOLEX Fujisawa Deutschland GmbH PA0473/004/002 Powder for Oral Solution - ACETYLCYSTEINE 15/03/2001

ALVEOLEX GRANULES Fujisawa Deutschland GmbH PA0473/004/001 - ACETYLCYSTEINE 15/03/2001

LIPROLOG Eli Lilly and Company Limite EU/1/97/038/001 Solution for Injection - INSULIN LISPRO 13/03/2001

LIPROLOG Eli Lilly and Company Limite EU/1/97/038/002 Solution for Injection - INSULIN LISPRO 13/03/2001

LIPROLOG Eli Lilly and Company Limite EU/1/97/038/003 Solution for Injection - INSULIN LISPRO 13/03/2001

RISPERDAL Janssen-Cilag Ltd PA0748/003/003 Tablets - RISPERIDONE 12/03/2001


UBRETID Rorer Pharmaceuticals PA0468/009/002 Tablets - DISTIGMINE 12/03/2001
Limited HYDROCHLORIDE
ALRHEUMAT Bayer PLC PA0021/002/001 Capsule - KETOPROFEN 06/03/2001
GANDA (1+0.2) Chauvin Pharmaceuticals PA0118/010/004 Eye Drops Solution - GUANETHIDINE 02/03/2001
Limited MONOSULFATE
- EPINEPHRINE
CISPLATIN Cyanamid of Great Britain PA0037/021/001 Powder for solution for - CISPLATIN 28/02/2001
infusion
CISPLATIN Cyanamid of Great Britain PA0037/021/002 Powder for solution for - CISPLATIN 28/02/2001
infusion
ANDROSTAT Orion Pharma A/s PA0303/030/001 Tablets - FLUTAMIDE 27/02/2001
HUMULIN TM I Eli Lilly and Company Limite PA0047/059/004 Suspension for Injection - INSULIN HUMAN 27/02/2001

HUMULIN TM M3 Eli Lilly and Company Limite PA0047/069/001 Suspension for Injection - INSULIN HUMAN 27/02/2001

LORON Boehringer Mannheim PA0130/019/001 Capsule - CLODRONATE DISODIUM 27/02/2001


TETRAHYDRATE

MANERIX Roche Products Limited PA0050/081/003 Tablets - MOCLOBEMIDE 27/02/2001


INNOHEP Leo Laboratories Limited PA0046/060/001 Solution for Injection - TINZAPARIN 21/02/2001
MINIHEP CALCIUM Leo Laboratories Limited PA0046/025/001 Solution for Injection - HEPARIN CALCIUM 21/02/2001
MINIHEP CALCIUM Leo Laboratories Limited PA0046/025/003 Solution for Injection - HEPARIN CALCIUM 21/02/2001
PUMP-HEP Leo Laboratories Limited PA0046/044/001 Solution for Infusion - HEPARIN SODIUM 21/02/2001
SCINTADREN GE Healthcare Limited PA0240/001/001 Solution for Injection - 16/02/2001
SELENONORCHOLESTER
OL (75 SE)
ALTACITE Roussel Laboratories Limited PA0006/026/002 Oral Suspension - HYDROTALCITE 12/02/2001

ALTACITE PLUS Roussel Laboratories Limited PA0006/004/001 Tablets - HYDROTALCITE 12/02/2001


- DIMETICONE, ACTIVATED

ALTACITE PLUS Roussel Laboratories Limited PA0006/004/002 Oral Suspension - HYDROTALCITE 12/02/2001
- DIMETICONE, ACTIVATED

CREON 20000 Abbott Healthcare Products PA0108/025/003 Granules Gastro-Resistant - PANCREATIN 08/02/2001
Ltd
INDAPAMIDE Sanofi-Synthelabo Ireland PA0077/129/001 Tablets - INDAPAMIDE 07/02/2001
Ltd HEMIHYDRATE
ALUPENT Boehringer Ingelheim Limited PA0007/015/003 Tablets - ORCIPRENALINE 06/02/2001
SULFATE
ALUPENT METERED Boehringer Ingelheim Ltd PA0007/015/005 Pressurised Inhalation - ORCIPRENALINE 06/02/2001
AEROSOL Suspension SULFATE
FULCIN Zeneca Limited PA0051/009/001 Tablets - GRISEOFULVIN 05/02/2001
FULCIN Zeneca Limited PA0051/009/002 Tablets - GRISEOFULVIN 05/02/2001
LASIX Hoechst Ireland Limited PA0023/008/006 Solution for Injection - FUROSEMIDE 05/02/2001
MYSOLINE Zeneca Limited PA0051/025/002 Oral Suspension - PRIMIDONE 05/02/2001
ORTHOFORMS Janssen-Cilag Ltd PA0748/007/001 Pessary - NONOXINOL 05/02/2001
CONTRACEPTIVE

Human Medicines Withdrawn Products Page 346 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TRINOVUM Cilag Limited PA0059/021/001 Tablets - NORETHISTERONE 05/02/2001
- ETHINYLESTRADIOL
- NORETHISTERONE
- ETHINYLESTRADIOL
- NORETHISTERONE
- ETHINYLESTRADIOL
BECOTIDE 100 EASI Allen and Hanburys Limited PA0024/005/010 Pressurised Inhalation - BECLOMETASONE 01/02/2001
BREATHE INHALER Suspension
BECOTIDE 250 EASI- Allen and Hanburys Limited PA0024/005/011 Pressurised Inhalation - BECLOMETASONE 01/02/2001
BREATHE INHALER Suspension
BECOTIDE 50 EASI- Allen and Hanburys Limited PA0024/005/009 Pressurised Inhalation - BECLOMETASONE 01/02/2001
BREATHE INHALER Suspension
VENTOLIN EASI-BREATHE Allen and Hanburys Limited PA0024/001/015 Pressurised Inhalation - SALBUTAMOL 01/02/2001
INHALER Suspension
AMOLIN Helsinn Birex PA0294/013/001 Tablets - ATENOLOL 31/01/2001
Pharmaceuticals Limited
AMOLIN Helsinn Birex PA0294/013/002 Tablets - ATENOLOL 31/01/2001
Pharmaceuticals Limited
DUPHALAC Abbott Healthcare Products PA0108/015/002 Oral Powder - LACTULOSE 31/01/2001
Ltd
KONAKION Roche Products Limited PA0050/051/002 Solution for Injection - PHYTOMENADIONE 31/01/2001
TOILAX Landen PharmaChem NV PA0303/004/002 Tablets Gastro-Resistant - BISACODYL 21/01/2001
VERAMIL Orion Pharma A/s PA0303/001/003 Solution for Injection - VERAPAMIL 20/01/2001
HYDROCHLORIDE
AMOLIN Helsinn Birex PA0294/013/003 Tablets - ATENOLOL 19/01/2001
Pharmaceuticals Limited
KABIKINASE Pharmacia Laboratories PA0187/013/002 Powder for solution for - STREPTOKINASE 17/01/2001
Limited infusion
NIFEDIPINE WPR Healthcare Limited PA0565/003/001 Capsule - NIFEDIPINE 14/01/2001
Nifedipine WPR Healthcare Limited PA0565/003/002 Capsule - Nifedipine 14/01/2001
NIFEDIPINE WPR Healthcare Limited PPA0565/003/002 Capsule - NIFEDIPINE 14/01/2001
MERUVAX II VACCINE Sanofi Pasteur MSD Ltd PA0544/025/001 Suspension for Injection - RUBELLA VIRUS 13/01/2001
VACCINE LIVE
ATTENUATED
GLAUPAX Orion Pharma A/s PA0303/005/001 Tablets - ACETAZOLAMIDE 12/01/2001
GLAUPAX RETARD Orion Pharma A/s PA0303/005/002 Capsule - ACETAZOLAMIDE 12/01/2001
FLUPHENAZINE Hospira UK Limited PA0437/022/002 Solution for Injection - FLUPHENAZINE 02/01/2001
DECANOATE DECANOATE
FLUPHENAZINE Hospira UK Limited PA0437/022/004 Solution for Injection - FLUPHENAZINE 02/01/2001
DECANOATE DECANOATE
BUPIVACAINE & Mercury Pharmaceuticals PA0073/103/002 Solution for Injection - EPINEPHRINE 01/01/2001
ADRENALINE (Ireland) Ltd BITARTRATE
- BUPIVACAINE
HYDROCHLORIDE,
MONOHYDRATE
SOMAGARD (TM Monmouth Pharmaceuticals PA0488/002/001 Solution for Injection - DELORELIN 01/01/2001
DESLORELIN) Ltd
HUMAJECT M1 PEN Eli Lilly and Company Limite PA0047/084/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMAJECT M2 PEN Eli Lilly and Company Limite PA0047/085/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMAJECT M4 PEN Eli Lilly and Company Limite PA0047/086/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMAJECT M5 PEN Eli Lilly and Company Limite PA0047/087/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M 10/90 Eli Lilly and Company Limite PA0047/065/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M1 CARTRIDGE Eli Lilly and Company Limite PA0047/065/004 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M1 PEN Eli Lilly and Company Limite PA0047/090/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M2 Eli Lilly and Company Limite PA0047/066/002 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M4 CARTRIDGE Eli Lilly and Company Limite PA0047/070/004 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M4 PEN Eli Lilly and Company Limite PA0047/093/001 Solution for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M5 CARTRIDGE Eli Lilly and Company Limite PA0047/074/002 - INSULIN HUMAN 31/12/2000

HUMULIN M5 CARTRIDGE Eli Lilly and Company Limite PA0047/074/003 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN M5 PEN Eli Lilly and Company Limite PA0047/094/001 Solution for Injection - INSULIN HUMAN 31/12/2000

HUMULIN TM M1 Eli Lilly and Company Limite PA0047/065/002 Suspension for Injection - INSULIN HUMAN 31/12/2000

Human Medicines Withdrawn Products Page 347 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HUMULIN TM M4 Eli Lilly and Company Limite PA0047/070/001 Suspension for Injection - INSULIN HUMAN 31/12/2000

HUMULIN TM S Eli Lilly and Company Limite PA0047/058/004 Solution for Injection - INSULIN HUMAN 31/12/2000

HYDERGINE Novartis Pharmaceuticals UK PA0013/024/001 Tablets - DIHYDROERGOTOXINE 29/12/2000


Ltd MESILATE
HYDERGINE Novartis Pharmaceuticals UK PA0013/024/002 Tablets - DIHYDROERGOTOXINE 29/12/2000
Ltd MESILATE
TRIDIL 5 MG/ML Bristol-Myers Squibb Pharma PA0700/009/002 Solution for Infusion - GLYCERYL TRINITRATE 23/12/2000

TRIDIL 500 MCG/ML Bristol-Myers Squibb Pharma PA0700/009/001 Solution for Infusion - GLYCERYL TRINITRATE 23/12/2000

ASPRO CLEAR Nicholas Laboratories PA0032/003/002 Tablets - ACETYLSALICYLIC ACID 19/12/2000


BECOSYM Roche Products Limited PA0050/054/001 Tablets - THIAMINE 19/12/2000
HYDROCHLORIDE
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- RIBOFLAVIN
BENADON Roche Products Limited PA0050/055/001 Tablets - PYRIDOXINE 19/12/2000
HYDROCHLORIDE
BENADON Roche Products Limited PA0050/055/002 Tablets - PYRIDOXINE 19/12/2000
HYDROCHLORIDE
BENERVA Roche Products Limited PA0050/056/003 Tablets - THIAMINE 19/12/2000
HYDROCHLORIDE
BENERVA Roche Products Limited PA0050/056/006 Tablets - THIAMINE 19/12/2000
HYDROCHLORIDE
BIOVITAL Roche Products Limited PA0050/139/001 Oral Solution - FERRIC SODIUM 19/12/2000
CITRATE
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
- RIBOFLAVIN SODIUM
PHOSPHATE
- MANGANESE CITRATE
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- CYANOCOBALAMIN
REDOXON Roche Products Limited PA0050/007/009 Tablets Effervescent - ASCORBIC ACID 19/12/2000
REDOXON Roche Products Limited PA0050/007/007 Tablets - ASCORBIC ACID 19/12/2000
REDOXON 200 MG Roche Products Limited PA0050/007/008 Tablets - ASCORBIC ACID 19/12/2000
SECADERM SALVE Roche Products Limited PA0050/102/001 Ointment - PINUS PALUSTRIS 19/12/2000
- TURPENTINE OIL
- MELALEUCA OIL
- TEREBENE
- PHENOL
STAYCEPT Syntex Pharmaceuticals PA0033/020/001 Vaginal Gel - OCTOXINOL 19/12/2000
Limited
STAYCEPT Syntex Pharmaceuticals PA0033/020/002 Pessary - NONOXINOL 19/12/2000
Limited
SYNTARIS HAYFEVER Roche Products Limited PA0050/133/001 Nasal Spray Solution - FLUNISOLIDE 19/12/2000
NASAL
ZAM BUK Roche Products Limited PA0050/104/001 Ointment - CAMPHOR 19/12/2000
- PINUS PALUSTRIS
DIPIVEFRIN Alcon Laboratories (UK) Ltd PA0290/071/001 Eye Drops Solution - DIPIVEFRINE 14/12/2000
HYDROCHLORIDE HYDROCHLORIDE
OPHTHALMIC
NEOCON 1/35 Janssen-Cilag Ltd PA0748/046/001 Tablets - NORETHISTERONE 14/12/2000
- ETHINYLESTRADIOL
PEVARYL Cilag Limited PA0059/009/007 Shampoo - ECONAZOLE 14/12/2000
TOLECTIN Cilag Limited PA0059/003/004 Capsule - TOLMETIN SODIUM 14/12/2000
DIHYDRATE
VICKS VAPORUB Procter & Gamble (Health & PA0441/002/001 Inhalation Vapour, Ointment - MENTHOL 14/12/2000
Beauty Care) Limited - CAMPHOR
- TURPENTINE OIL
INSUM BASAL FOR Hoechst Ireland Limited PA0023/060/002 Suspension for Injection - HUMAN INSULIN 12/12/2000
OPTIPEN CARTRIDGE RECOMBINANT
INSUMAN 25/75 FOR Hoechst Ireland Limited PA0023/061/004 Suspension for Injection - INSULIN HUMAN 12/12/2000
OPTIPEN CARTRIDGE

Human Medicines Withdrawn Products Page 348 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROTASHIELD Wyeth-Lederle Vaccines S.A EU/1/99/105/001 Powder for Oral Suspension - ROTAVIRUS 08/12/2000
REASSORTANT
SEROTYPE 1
- ROTAVIRUS
REASSORTANT
SEROTYPE 2
- ROTAVIRUS
REASSORTANT
SEROTYPE 4
VIDAYLIN Abbott Laboratories Ireland PA0038/031/001 Oral Solution - RETINOL PALMITATE 04/12/2000
Ltd - ERGOCALCIFEROL
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- ASCORBIC ACID
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
TEMPOROL Orion Pharma A/s PA0303/016/001 Tablets - CARBAMAZEPINE 02/12/2000
ANANASE FORTE Rorer Pharmaceuticals PA0468/012/002 Tablets - BROMELAINS 01/12/2000
Limited
BENZYL BENZOATE Ricesteele Manufacturing Ltd PA0095/018/001 Cutaneous Emulsion - BENZYL BENZOATE 01/12/2000
APPLICATION B.P.
BURINEX Leo Laboratories Limited PA0046/016/009 Tablets - BUMETANIDE 01/12/2000
CLONDEPRYL Clonmel Healthcare Ltd PA0126/093/001 Tablets - SELEGILINE 01/12/2000
HYDROCHLORIDE
PONDOCILLIN Leo Laboratories Limited PA0046/009/005 Powder for Oral Suspension - PIVAMPICILLIN 01/12/2000
ALGICON Rorer Pharmaceuticals PA0468/003/002 Tablets - MAGNESIUM ALGINATE 30/11/2000
Limited - ALUMINIUM HYDROXIDE-
MAGNESIUM CARBONATE
GEL
- MAGNESIUM
CARBONATE
- POTASSIUM
BICARBONATE
CORSYM Roche Products Limited PA0050/112/001 Oral Suspension - 30/11/2000
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- CHLORPHENAMINE
MALEATE
NAVOBAN Novartis Pharmaceuticals UK PA0013/048/002 Capsule - TROPISETRON 30/11/2000
Ltd HYDROCHLORIDE
NAVOBAN Novartis Pharmaceuticals UK PA0013/048/003 Solution for Injection - TROPISETRON 30/11/2000
Ltd HYDROCHLORIDE
NAVOBAN AMPOULES Novartis Pharmaceuticals UK PA0013/048/001 Solution for Injection - TROPISETRON 30/11/2000
Ltd HYDROCHLORIDE
BAYCARON Bayer PLC PA0021/005/001 Tablets - MEFRUSIDE 29/11/2000
CLONTERIC Dallas Burston Healthcare PA0732/001/001 Tablets - ACETYLSALICYLIC ACID 29/11/2000
Ltd
BINOVUM ORAL Janssen-Cilag Ltd PA0748/028/001 Tablets - NORETHISTERONE 28/11/2000
CONTRACEPTIVE - ETHINYLESTRADIOL
- NORETHISTERONE
NIZORAL Janssen-Cilag Ltd PA0748/015/005 Tablets - KETOCONAZOLE 28/11/2000
ORAP Janssen-Cilag Ltd PA0748/024/001 Tablets - PIMOZIDE 28/11/2000
PEVARYL Janssen-Cilag Ltd PA0748/037/001 Cream - ECONAZOLE NITRATE 28/11/2000
ECHOGEN Sonus Pharmaceuticals Ltd EU/1/98/072/001 Emulsion for Injection - 27/11/2000
DODECAFLUOROPENTAN
E
VALIUM Roche Products Limited PA0050/017/007 Solution for Injection - DIAZEPAM 20/11/2000
INTROPIN Bristol-Myers Squibb Pharma PA0700/005/001 Solution for Injection - DOPAMINE 16/11/2000
HYDROCHLORIDE
RIMADOPA Ranbaxy Ireland Limited PA0408/035/001 Tablets - METHYLDOPA 16/11/2000
RIMADOPA Ranbaxy Ireland Limited PA0408/035/002 Tablets - METHYLDOPA 16/11/2000
RIMAFLOX Ranbaxy Ireland Limited PA0408/037/003 Powder for Oral Suspension - FLUCLOXACILLIN 16/11/2000
SODIUM
CHLORDIAZEPOXIDE Clonmel Healthcare Ltd PA0126/048/001 Capsule - CHLORDIAZEPOXIDE 15/11/2000
HYDROCHLORIDE
ORTHO-DIENOESTROL Janssen-Cilag Ltd PA0748/036/001 Vaginal Cream - DIENESTROL 15/11/2000
TRIDESTRA Orion Pharma A/s PA0303/026/001 Tablets - ESTRADIOL VALERATE 15/11/2000
- LACTOSE ANHYDROUS
- ESTRADIOL VALERATE
-
MEDROXYPROGESTERO
NE ACETATE
ERYCAPS Chiesi Limited PA0743/001/001 Capsule - ERYTHROMYCIN 13/11/2000
ERYTHROMYCIN

Human Medicines Withdrawn Products Page 349 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/003 Solution for Injection - GENTAMICIN SULFATE 13/11/2000
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/006 Solution for Injection - GENTAMICIN SULFATE 13/11/2000
GAMIMUNE Bayer PLC PA0021/043/001 Solution for Infusion - HUMAN 06/11/2000
IMMUMOGLOBULINS
TEVETEN Abbott Healthcare Products PA0108/023/001 Tablets - EPROSARTAN 06/11/2000
Ltd MESGLATE DIHYDRATE
NARCAN SYRINGE Bristol-Myers Squibb Pharma PA0700/008/004 Solution for Injection - NALOXONE 02/11/2000
HYDROCHLORIDE
XURET Galen Limited PA0185/020/001 Tablets - METOLAZONE 02/11/2000
RIMACID Ranbaxy Ireland Limited PA0408/033/001 Capsule - INDOMETACIN 01/11/2000
RIMACID Ranbaxy Ireland Limited PA0408/033/002 Capsule - INDOMETACIN 01/11/2000
RIMATHROCIN Ranbaxy Ireland Limited PA0408/034/001 Tablets - ERYTHROMYCIN 01/11/2000
RIMAZOLE CO- Ranbaxy Ireland Limited PA0408/036/001 Tablets - SULFAMETHOXAZOLE 01/11/2000
TRIMOXAZOLE - TRIMETHOPRIM
ROFERON A Roche Products Limited PA0050/068/009 Solution for Injection - INTERFERON ALFA-2A 31/10/2000
ROFERON A Roche Products Limited PA0050/068/010 Solution for Injection - INTERFERON ALFA-2A 31/10/2000
ROFERON A Roche Products Limited PA0050/068/011 Solution for Injection - INTERFERON ALFA-2A 31/10/2000
ROFERON A Roche Products Limited PA0050/068/012 Solution for Injection - INTERFERON ALFA-2A 31/10/2000
ROFERON A Roche Products Limited PA0050/068/013 Solution for Injection - INTERFERON ALFA-2A 31/10/2000
ROFERON-A Roche Products Limited PA0050/068/007 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2A 31/10/2000
ROFERON-A Roche Products Limited PA0050/068/001 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2A 31/10/2000
ROFERON-A Roche Products Limited PA0050/068/002 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2A 31/10/2000
ROFERON-A Roche Products Limited PA0050/068/003 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2A 31/10/2000
STERETS AQUASOL Seton Prebbles Ltd PA0483/005/001 Cutaneous Solution - PURIFIED WATER 30/10/2000
NOVOMIX 30 Novo Nordisk A/S EU/1/00/142/001 Suspension for Injection 27/10/2000
NOVOMIX 30 Novo Nordisk A/S EU/1/00/142/002 Suspension for Injection 27/10/2000
HUMAN ALBUMIN Biotest Pharma GmbH PA0592/002/003 Solution for Infusion - HUMAN ALBUMIN 25/10/2000
INTRAGLOBIN F (FLUID) Biotest Pharma GmbH PA0592/001/001 Solution for Infusion - HUMAN PLASMA 16/10/2000
PROTEIN >95%
IMMUNOGLOBULINS
- GLUCOSE
- SODIUM CHLORIDE
- WATER FOR INJECTIONS

INTRAGLOBIN F (FLUID) Biotest Pharma GmbH PA0592/001/002 Solution for Infusion - HUMAN PLASMA 16/10/2000
PROTEIN >95%
IMMUNOGLOBULINS
- GLUCOSE
- SODIUM CHLORIDE
- WATER FOR INJECTIONS

AMOXIL PCO Manufacturing PPA0465/008/003 Syrup - AMOXICILLIN 15/10/2000


AMOXIL FORTE PCO Manufacturing PPA0465/008/004 Syrup - AMOXICILLIN 15/10/2000
BELCLOMETHASONE 3M Health Care Limited PA0057/064/003 Pressurised Inhalation - BECLOMETASONE 11/10/2000
Suspension DIPROPIONATE
BECLOMETHASONE 50UG 3M Health Care Limited PA0057/064/001 Pressurised Inhalation - BECLOMETASONE 10/10/2000
Suspension DIPROPIONATE
BELCLOMETHASONE 100 3M Health Care Limited PA0057/064/002 Pressurised Inhalation - BECLOMETASONE 10/10/2000
UG Suspension DIPROPIONATE
FLAGYL COMPAK May & Baker Limited PA0040/004/002 - METRONIDAZOLE 10/10/2000
- NYSTATIN
TYLEX Janssen-Cilag Ltd PA0748/001/002 Tablets Effervescent - PARACETAMOL 10/10/2000
- CODEINE PHOSPHATE
STERI-DROP Steripak Ltd PA0621/005/001 Eye Drops Solution - HYPROMELLOSE 09/10/2000
HYPROMELLOSE
AZATHIOPRINE Pinewood Laboratories Ltd, PA0281/104/001 Tablets - AZATHIOPRINE 06/10/2000
INTRON A Schering-Plough Limited PA0277/050/013 Solution for Injection - INTERFERON ALFA-2B 03/10/2000
INTRON A Schering-Plough Limited PA0277/050/014 Solution for Injection - INTERFERON ALFA-2B 03/10/2000
PARSTELIN SmithKline and French PA0060/012/001 Coated Tablets - TRANYLCYPROMINE 03/10/2000
Laboratories Ltd SULFATE
- TRIFLUOPERAZINE
HYDROCHLORIDE
VIRAFERON Schering-Plough Limited PA0277/073/008 Solution for Injection - INTERFERON ALFA-2B 03/10/2000
NAVISPARE Novartis Pharmaceuticals UK PA0013/073/001 Tablets - CYCLOPENTHIAZIDE 29/09/2000
Ltd - AMILORIDE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 350 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FERYBAR ELIXIR Pinewood Laboratories Ltd, PA0281/053/001 Oral Suspension - LIVER EXTRACT 27/09/2000
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- SODIUM
GLYCEROPHOSPHATE
- MANGANESE SULFATE
- FERRIC AMMONIUM
CITRATE
- CITRIC ACID
- POTASSIUM
GLYCEROPHOSPHATE
- ETHANOL
NIZORAL Janssen-Cilag Ltd PA0748/015/004 Oral Suspension - KETOCONAZOLE 27/09/2000
TYLEX Janssen-Cilag Ltd PA0748/001/003 Capsule - PARACETAMOL 27/09/2000
- CODEINE PHOSPHATE
TYLEX FORTE Janssen-Cilag Ltd PA0748/001/004 Capsule - PARACETAMOL 27/09/2000
- CODEINE PHOSPHATE
HUMAN ALBUMIN 20% Immuno Limited PA0212/005/001 Solution for Injection - HUMAN ALBUMIN 22/09/2000
AMOXYCILLIN Rowex Ltd PA0711/014/001 Powder for Oral Suspension - AMOXICILLIN 21/09/2000
TRIHYDRATE
IDOMED Rowex Ltd PA0711/001/001 Capsule - INDOMETACIN 21/09/2000
IDOMED Rowex Ltd PA0711/001/002 Capsule - INDOMETACIN 21/09/2000
MINOX Rowex Ltd PA0711/013/002 Tablets - MINOCYCLINE 21/09/2000
HYDROCHLORIDE
ROXILLIN Rowex Ltd PA0711/005/005 Capsule - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN Rowex Ltd PA0711/005/006 Capsule - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN Rowex Ltd PA0711/005/007 Powder for Oral Suspension - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN Rowex Ltd PA0711/005/008 Powder for Oral Suspension - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN Rowex Ltd PA0711/005/009 Powder for Oral Suspension - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN 1000 Rowex Ltd PA0711/005/003 Tablets - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN 500 Rowex Ltd PA0711/005/001 Tablets - AMOXICILLIN 21/09/2000
TRIHYDRATE
ROXILLIN 750 Rowex Ltd PA0711/005/002 Tablets - AMOXICILLIN 21/09/2000
TRIHYDRATE
OPV POLIOMYELITIS UCB Pharma Limited PA0365/065/001 Oral Solution - POLIOVIRUS, TYPE 1 20/09/2000
VACINE/LIVE - POLIOVIRUS, TYPE 2
BP/TRIVALENT - POLIOVIRUS, TYPE 3
PARACLEAR Nicholas Laboratories PA0032/031/002 Tablets - PARACETAMOL 20/09/2000
COLGATE FLUORIGARD Colgate-Palmolive (U.K.) Ltd PA0320/001/001 Tablets - SODIUM FLUORIDE 19/09/2000
(GRAPE)
COLGATE FLUORIGARD Colgate-Palmolive (U.K.) Ltd PA0320/001/002 Tablets - SODIUM FLUORIDE 19/09/2000
(ORANGE)
ACT-HIB DTP Sanofi Pasteur MSD Ltd PA0544/015/001 Pdr for Soln for Injection - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
- BORDETELLA
PERTUSSIS
- HAEMOPHILUS
INFLUENZAE TYPE B
POLYSACCHARIDE
ACT-HIB DTP Sanofi Pasteur MSD Ltd PA0544/015/002 Pdr for Soln for Injection - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
- BORDETELLA
PERTUSSIS
- HAEMOPHILUS
INFLUENZAE TYPE B
POLYSACCHARIDE
ACT-HIB DTP D.C. Sanofi Pasteur MSD Ltd PA0544/015/003 - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
- BORDETELLA
PERTUSSIS
- HAEMOPHILUS
INFLUENZAE TYPE B
POLYSACCHARIDE

Human Medicines Withdrawn Products Page 351 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ADSORBED DIPHTHERIA & Sanofi Pasteur MSD Ltd PA0544/004/003 - DIPHTHERIA TOXOID 18/09/2000
TETANUS VACCINE BP 10 - TETANUS TOXOID
DOSE
ADSORBED TETANUS 10 Sanofi Pasteur MSD Ltd PA0544/001/003 Suspension for Injection - TETANUS TOXOID 18/09/2000
DOSE - ALUMINIUM HYDROXIDE
BRUFEN Knoll Limited PA0769/002/007 Tablets - IBUPROFEN 18/09/2000
DIFTAVAX Sanofi Pasteur MSD Ltd PA0544/018/001 Suspension for Injection - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
- ALUMINIUM PHOSPHATE

DIFTAVAX Sanofi Pasteur MSD Ltd PA0544/018/003 Suspension for Injection - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
- ALUMINIUM PHOSPHATE

DIMOTAPP PAEDIATRIC A.H. Robins Company PA0086/011/003 Syrup - PHENYLEPHRINE 18/09/2000


Limited HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- BROMPHENIRAMINE
MALEATE
DIPHTHERIA TETANUS Sanofi Pasteur MSD Ltd PA0544/013/003 Solution for Injection - DIPHTHERIA TOXOID 18/09/2000
PERTUSSIS 10 DOSE - TETANUS TOXOID
- BORDETELLA
PERTUSSIS
DIPHTHERIA TETANUS Sanofi Pasteur MSD Ltd PA0544/013/001 Solution for Injection - DIPHTHERIA TOXOID 18/09/2000
PERTUSSIS SINGLE DOSE - TETANUS TOXOID
- BORDETELLA
PERTUSSIS
DIPHTHERIA TETANUS Sanofi Pasteur MSD Ltd PA0544/013/002 Solution for Injection - DIPHTHERIA TOXOID 18/09/2000
PERTUSSIS SINGLE DOSE - TETANUS TOXOID
SYRINGE - BORDETELLA
PERTUSSIS
DIP-TET VAX 20 DOSE Sanofi Pasteur MSD Ltd PA0544/004/004 Solution for Injection - DIPHTHERIA TOXOID 18/09/2000
- TETANUS TOXOID
MEASAVAX 10 DOSE Sanofi Pasteur MSD Ltd PA0544/003/002 Solution for Injection - MEASLES VIRUS - 18/09/2000
SCHWARZ STRAIN LIVE
ATTENUATED
MEASLES RUBELLA Sanofi Pasteur MSD Ltd PA0544/020/002 Solution for Injection - MEASLES VIRUS - 18/09/2000
VACCINE LIVE SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
MEASLES RUBELLA Sanofi Pasteur MSD Ltd PA0544/020/001 Pdr+Solv for Soln for Inj - MEASLES VIRUS - 18/09/2000
VACCINE LIVE - VIAL SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
RUBAVAX 10 DOSE Sanofi Pasteur MSD Ltd PA0544/002/002 Pdr+Solv for Soln for Inj - RUBELLA VIRUS 18/09/2000
VACCINE LIVE
ATTENUATED
TYPHIM VI 20 DOSE Sanofi Pasteur MSD Ltd PA0544/007/002 Solution for Injection - SALMONELLA TYPHI, VI 18/09/2000
ANTIGEN
CISPLATIN Cyanamid of Great Britain PA0037/021/003 Concentrate for Soln for Inf - CISPLATIN 16/09/2000
CEFIZOX Wellcome (Ireland) Limited PA0017/087/003 Pdr for Soln for Injection - CEFTIZOXIME SODIUM 15/09/2000
LIVOSTIN EYE DROPS Janssen Pharmaceutica PA0045/030/001 Eye Drops Suspension - LEVOCABASTINE 11/09/2000
LIVOSTIN NASAL SPRAY Janssen Pharmaceutica PA0045/030/002 Nasal Spray Suspension - LEVOCABASTINE 11/09/2000
ASCRIPTIN Rorer Pharmaceuticals PA0468/024/001 Tablets - ACETYLSALICYLIC ACID 05/09/2000
Limited - MAGNESIUM HYDROXIDE
- ALUMINIUM HYDROXIDE
DRIED

CEDAX Schering-Plough Limited PA0277/066/001 Capsule - CEFTIBUTEN 05/09/2000


CEDAX Schering-Plough Limited PA0277/066/002 Capsule - CEFTIBUTEN 05/09/2000
CEDAX Schering-Plough Limited PA0277/066/003 Oral Suspension - CEFTIBUTEN 05/09/2000
CEDAX Schering-Plough Limited PA0277/066/004 Oral Suspension - CEFTIBUTEN 05/09/2000
NOLVADEX FORTE Zeneca Limited PA0051/024/003 Tablets - TAMOXIFEN CITRATE 05/09/2000
HALOTHANE Concord Pharmaceuticals Lt PA0828/003/001 - HALOTHANE 01/09/2000

OZIDIA CONTROLLED Pfizer Limited PA0019/051/001 Tablets - GLIPIZIDE 01/09/2000


RELEASE
OZIDIA CONTROLLED Pfizer Limited PA0019/051/002 Tablets - GLIPIZIDE 01/09/2000
RELEASE
OZIDIA CONTROLLED Pfizer Limited PA0019/051/003 Tablets - GLIPIZIDE 01/09/2000
RELEASE
ZIMOVANE May & Baker Limited PA0040/078/002 Capsule - ZOPICLONE 30/08/2000

Human Medicines Withdrawn Products Page 352 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ZIMOVANE May & Baker Limited PA0040/078/003 Capsule - ZOPICLONE 30/08/2000
CYCROMATE 20 B.V. Pharbita PA0508/004/001 Inhalation powder, hard - CROMOGLICATE SODIUM 25/08/2000
capsule
SAVARINE Zeneca Limited PA0051/070/001 Tablets - PROGUANIL 23/08/2000
HYDROCHLORIDE
- CHLOROQUINE
PHOSPHATE
SEPTRIN DISPERSIBLE Wellcome (Ireland) Limited PA0017/002/005 Tablets - SULFAMETHOXAZOLE 23/08/2000
DUBLIN COUGH MIXTURE Hayes, Conyngham & PA0430/001/001 Oral Solution - LIQUORICE LIQUID 10/08/2000
Robinson Ltd EXTRACT
- IPECACUANHA FLUID
EXTRACT
TRANXENE Boehringer Ingelheim Limited PA0007/004/002 Tablets - CLORAZEPATE 10/08/2000
DIPOTASSIUM
COMTREX Bristol-Myers Squibb PA0048/037/002 Oral Solution - PARACETAMOL 02/08/2000
(Holdings) Limited -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- CHLORPHENAMINE
MALEATE
DETTOL BABY Reckitt's (Ireland) Limited PA0027/035/001 Cream - DIMETHICONE 350 01/08/2000
- BENZALKONIUM
CHLORIDE
DETTOL CLEAR Reckitt's (Ireland) Limited PA0027/042/001 Cutaneous Solution - CHLOROXYLENOL 01/08/2000
- EDETATE DISODIUM
- BENZALKONIUM
CHLORIDE
DETTOL ORAL ANTISEPTI Reckitt's (Ireland) Limited PA0027/014/003 Mouth Wash - CHLOROXYLENOL 01/08/2000

DISPROL PAEDIATRIC Reckitt's (Ireland) Limited PA0027/036/003 Oral Suspension - PARACETAMOL 01/08/2000
SENOKOT Reckitt's (Ireland) Limited PA0027/024/001 Granules - SENNOSIDE B 01/08/2000
EPIVAL Abbott Laboratories Ireland PA0038/036/003 Tablets - VALPROATE 24/07/2000
Ltd SEMISODIUM
INDERECTIC Zeneca Limited PA0051/029/001 Capsule - PROPRANOLOL 23/07/2000
HYDROCHLORIDE
- BENDROFLUMETHIAZIDE

FUCIDIN Leo Laboratories Limited PA0046/004/016 Cutaneous Solution - FUSIDIC ACID 18/07/2000
PONDOCILLIN Leo Laboratories Limited PA0046/009/006 Tablets 18/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/001 Solution for Injection - IOPAMIDOL 17/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/002 Solution for Injection - IOPAMIDOL 17/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/003 Solution for Injection - IOPAMIDOL 17/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/004 Solution for Injection - IOPAMIDOL 17/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/005 Solution for Injection - IOPAMIDOL 17/07/2000
IOPAMIDOL 370 Generics (UK) Limited PA0405/041/006 Solution for Injection - IOPAMIDOL 17/07/2000
PROSTAP SR Cyanamid of Great Britain PA0037/059/003 Powder for suspension for - LEUPRORELIN ACETATE 17/07/2000
injection
PROSTAP SR Cyanamid of Great Britain PA0037/059/004 Powder for suspension for - LEUPRORELIN ACETATE 17/07/2000
injection
BOTOX Allergan Pharmaceuticals PA0148/055/001 Pdr for Soln for Injection - CLOSTRIDIUM 14/07/2000
Ireland BOTULINUM TYP A-
ANTITOXIN
ANEXATE Roche Products Limited PA0050/072/002 Solution for Inj/Inf - FLUMAZENIL 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/001 - INTERFERON ALFA-2B 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/002 - INTERFERON ALFA-2B 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/003 - INTERFERON ALFA-2B 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/004 Powder for suspension for - INTERFERON ALFA-2B 10/07/2000
injection
INTRON A Schering-Plough Limited PA0277/050/015 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/016 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INTRON A Schering-Plough Limited PA0277/050/017 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INTRON A MULTIDOSE Schering-Plough Limited PA0277/050/018 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INJECTION PEN
INTRON A MULTIDOSE Schering-Plough Limited PA0277/050/019 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INJECTION PEN
INTRON A MULTIDOSE Schering-Plough Limited PA0277/050/020 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INJECTION PEN
VIRAFERON Schering-Plough Limited PA0277/073/009 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON Schering-Plough Limited PA0277/073/010 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON Schering-Plough Limited PA0277/073/011 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON Schering-Plough Limited PA0277/073/012 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON 10 MILLION IU Schering-Plough Limited PA0277/073/006 Solution for Injection - INTERFERON ALFA-2B 10/07/2000

Human Medicines Withdrawn Products Page 353 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VIRAFERON 25 MILLION IU Schering-Plough Limited PA0277/073/007 Solution for Injection - INTERFERON ALFA-2B 10/07/2000

VIRAFERON MULTIDOSE Schering-Plough Limited PA0277/073/013 - INTERFERON ALFA-2B 10/07/2000


INJECTION PEN
VIRAFERON MULTIDOSE Schering-Plough Limited PA0277/073/014 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
INJECTION PEN
VIRAFERON MULTIDOSE Schering-Plough Limited PA0277/073/015 - INTERFERON ALFA-2B 10/07/2000
INJECTION PEN
VIRAFERON VIAL Schering-Plough Limited PA0277/073/001 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON VIAL Schering-Plough Limited PA0277/073/002 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON VIAL Schering-Plough Limited PA0277/073/003 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON VIAL Schering-Plough Limited PA0277/073/004 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
VIRAFERON VIAL Schering-Plough Limited PA0277/073/005 Solution for Injection - INTERFERON ALFA-2B 10/07/2000
ADSORBED DIPHTHERIA UCB Pharma Limited PA0365/058/002 Solution for Injection - DIPHTHERIA TOXOID 07/07/2000
TETANUS & PERTUSSIS - TETANUS TOXOID
- PERTUSSIS VACCINE
DIFENE SUSTAINED Fujisawa Deutschland GmbH PA0473/001/004 Capsule - DICLOFENAC SODIUM 05/07/2000

GLUCAGEN Novo Nordisk A/S PA0218/031/001 Pdr+Solv for Soln for Inj - GLUCAGON 03/07/2000
LENTARON IM DEPOT Novartis Pharmaceuticals UK PA0013/077/001 Powder for suspension for - FORMESTANE 03/07/2000
Ltd injection
ORIMETEN Novartis Pharmaceuticals UK PA0013/068/001 Tablets - AMINOGLUTETHIMIDE 03/07/2000
Ltd
PARLODEL Novartis Pharmaceuticals UK PA0013/002/002 Capsule - BROMOCRIPTINE 03/07/2000
Ltd MESILATE
SLOW TRASICOR Novartis Pharmaceuticals UK PA0013/060/001 Tablets - OXPRENOLOL 03/07/2000
Ltd HYDROCHLORIDE
TAVEGIL Novartis Pharmaceuticals UK PA0013/021/002 Syrup - CLEMASTINE FUMARATE 03/07/2000
Ltd
TRASICOR Novartis Pharmaceuticals UK PA0013/057/001 Tablets - OXPRENOLOL 03/07/2000
Ltd HYDROCHLORIDE
TRASICOR Novartis Pharmaceuticals UK PA0013/057/002 Tablets - OXPRENOLOL 03/07/2000
Ltd HYDROCHLORIDE
TRASICOR Novartis Pharmaceuticals UK PA0013/057/003 Tablets - OXPRENOLOL 03/07/2000
Ltd HYDROCHLORIDE
TRASIDREX Novartis Pharmaceuticals UK PA0013/062/001 Tablets - OXPRENOLOL 03/07/2000
Ltd HYDROCHLORIDE
- CYCLOPENTHIAZIDE
PYLORI-CHEK C-UREA Alimenterics B.V. EU/1/98/068/001 Powder for Oral Solution - 13C-UREA 30/06/2000
BREATH TEST
FLAGYL May & Baker Limited PA0040/003/007 Solution for Injection - METRONIDAZOLE 28/06/2000
TOFRANIL Novartis Pharmaceuticals UK PA0013/086/003 Syrup - IMIPRAMINE 28/06/2000
Ltd HYDROCHLORIDE
INSUMAN 15/85 VIAL Hoechst Marion Roussel Irl PA0855/024/002 Suspension for Injection - INSULIN HUMAN 25/06/2000
Ltd
INSUMAN 25/75 - VIAL Hoechst Marion Roussel Irl PA0855/024/003 Suspension for Injection - INSULIN HUMAN 25/06/2000
Ltd
INSUMAN 50/50 - VIAL Hoechst Marion Roussel Irl PA0855/024/004 Suspension for Injection - INSULIN HUMAN 25/06/2000
Ltd
INSUMAN RAPID - VIAL Hoechst Marion Roussel Irl PA0855/021/002 Solution for Injection - INSULIN HUMAN 25/06/2000
Ltd
INSUMAN RAPID FOR Hoechst Marion Roussel Irl PA0855/021/001 Solution for Injection - INSULIN HUMAN 25/06/2000
OPTIPEN - CARTRIDGE Ltd
TOREM Boehringer Mannheim PA0130/020/001 Solution for Injection - TORASEMIDE SODIUM 25/06/2000
TOREM Boehringer Mannheim PA0130/020/002 Solution for Injection - TORASEMIDE SODIUM 25/06/2000
TOREM Boehringer Mannheim PA0130/020/004 Tablets - TORASEMIDE 25/06/2000
TOREM Boehringer Mannheim PA0130/020/005 Tablets - TORASEMIDE 25/06/2000
TOREM Boehringer Mannheim PA0130/020/006 Tablets - TORASEMIDE 25/06/2000
TOREM Boehringer Mannheim PA0130/020/007 Tablets - TORASEMIDE 25/06/2000
METHYLDOPA Norton Healthcare Limited PA0282/008/001 Tablets - METHYLDOPA 24/06/2000
T/A IVAX Pharmaceuticals
UK
ECHOVIST 200 HE Clissmann PA0012/075/001 Solution for Injection - GALACTOSE 22/06/2000
- GALACTOSE
INNOVACE MELT Merck Sharp and Dohme PA0035/067/006 Buccal Tablet - ENALAPRIL MALEATE 22/06/2000
Limited
INNOVACE MELT Merck Sharp and Dohme PA0035/067/007 Buccal Tablet - ENALAPRIL MALEATE 22/06/2000
Limited
INNOVACE MELT Merck Sharp and Dohme PA0035/067/008 Buccal Tablet - ENALAPRIL MALEATE 22/06/2000
Limited
INNOVACE MELT Merck Sharp and Dohme PA0035/067/009 Buccal Tablet - ENALAPRIL MALEATE 22/06/2000
Limited
INSUMAN BASAL Hoechst Ireland Limited PA0023/060/003 Suspension for Injection - INSULIN HUMAN 22/06/2000
ISOVIST HE Clissmann PA0012/068/005 Solution for Injection - IOTROLAN 22/06/2000

Human Medicines Withdrawn Products Page 354 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TYLEX Janssen-Cilag Ltd PA0748/001/001 Tablets - PARACETAMOL 15/06/2000
- CODEINE PHOSPHATE
ZOMACTON Ferring Pharmaceuticals PA0224/014/003 Pdr+Solv for Soln for Inj - SOMATROPIN 15/06/2000
Limited
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/001 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/002 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/003 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/004 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/005 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 200 Generics (UK) Limited PA0405/038/006 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/001 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/002 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/003 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/004 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/005 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 300 Generics (UK) Limited PA0405/039/006 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/001 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/002 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/003 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/004 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/005 Solution for Injection - IOPAMIDOL 14/06/2000
IOPAMIDOL 340 Generics (UK) Limited PA0405/040/006 Solution for Injection - IOPAMIDOL 14/06/2000
FRUPIN Pinewood Laboratories Ltd, PA0281/059/001 Tablets - FUROSEMIDE 13/06/2000
- AMILORIDE
HYDROCHLORIDE
ONCOSCINT CR 103 CIS bio International PA0677/016/001 Solution for Injection - SATUMOMAB PENDETIDE 13/06/2000

TRYPTIZOL - 75 Merck Sharp and Dohme PA0035/002/001 Capsule - AMITRIPTYLINE 12/06/2000


Limited HYDROCHLORIDE
COLGATE SENSITIVE Colgate-Palmolive (U.K.) Ltd PA0320/003/001 Toothpaste - SODIUM MONOFLUORO 06/06/2000
CARE PHOSPHATE
- POTASSIUM CITRATE
FORTRAL Sanofi-Synthelabo Ireland PA0077/035/003 Tablets - PENTAZOCINE 25/05/2000
Ltd HYDROCHLORIDE
FORTRAL Sanofi-Synthelabo Ireland PA0077/035/004 Capsule - PENTAZOCINE 25/05/2000
Ltd HYDROCHLORIDE
FORTRAL Sanofi-Synthelabo Ireland PA0077/035/001 Solution for Injection - PENTAZOCINE LACTATE 24/05/2000
Ltd
FORTRAL Sanofi-Synthelabo Ireland PA0077/035/002 Solution for Injection - PENTAZOCINE LACTATE 24/05/2000
Ltd
CREMALGIN BALM May & Baker Limited PA0040/092/001 Ointment - METHYL NICOTINATE 22/05/2000
- GLYCOL
MONOSALICYLATE
BETANETA Shire Pharmaceutical PA0689/001/001 Tablets - ESTRADIOL 17/05/2000
Contracts Limited - NORETHISTERONE
ACETATE
AUREOCORT Cyanamid of Great Britain PA0037/028/001 Ointment - CHLORTETRACYCLINE 11/05/2000
HYDROCHLORIDE
- TRIAMCINOLONE
ACETONIDE
NIVAQUINE May & Baker Limited PA0040/006/001 Syrup - CHLOROQUINE SULFATE 27/04/2000

NIVAQUINE May & Baker Limited PA0040/006/002 Tablets - CHLOROQUINE SULFATE 27/04/2000

CLONIFED SR Clonmel Healthcare Ltd PA0126/087/001 Tablets - NIFEDIPINE 26/04/2000


CLONORAX COLD SORE Clonmel Healthcare Ltd PA0126/091/004 Cream - ACICLOVIR 26/04/2000
ASASANTIN Boehringer Ingelheim Limited PA0007/013/001 Capsule - ACETYLSALICYLIC ACID 13/04/2000
- DIPYRIDAMOLE
DIHYDERGOT NASAL Novartis Pharmaceuticals UK PA0013/015/002 Nasal Spray Solution - DIHYDROERGOTAMINE 13/04/2000
Ltd MESILATE
VANCOMYCIN Abbott GmbH & Co KG PA0073/135/001 Pdr for Soln for Injection - VANCOMYCIN 10/04/2000
HYDROCHLORIDE
LABOSEPT Laboratories for Applied PA0300/005/001 Lozenges - DEQUALINIUM CHLORIDE 04/04/2000
Biology
FLUOTHANE Zeneca Limited PA0051/032/001 Inhalation Vapour Liquid - HALOTHANE 01/04/2000
LANOXIN - 125 Wellcome (Ireland) Limited PA0017/069/002 Tablets - DIGOXIN 01/04/2000
ABDOSCAN GE Healthcare AS PA0735/004/001 Granules for Oral - FERRISTENE 31/03/2000
Suspension
PRAGMATAR Bioglan Laboratories Ltd PA0469/008/001 Cream - COAL TAR 31/03/2000
- SULFUR
- SALICYLIC ACID
MUCOLEX McNeil Healthcare (Ireland) PA0823/025/001 Capsule - CARBOCISTEINE 30/03/2000
Ltd

Human Medicines Withdrawn Products Page 355 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COLAVAGE Stafford Miller Limited PA0069/013/001 Ointment - MACROGOL 3350 28/03/2000
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- SODIUM SULFATE
ANHYDROUS
VASOFED 10 Mercury Pharmaceuticals PA0073/121/002 Capsule - NIFEDIPINE 27/03/2000
(Ireland) Ltd
VASOFED 5 Mercury Pharmaceuticals PA0073/121/001 Capsule - NIFEDIPINE 27/03/2000
(Ireland) Ltd
NUROFEN SOLUBLE Crookes Healthcare Ltd PA0043/006/002 Tablets - IBUPROFEN 26/03/2000
LEVOVIST HE Clissmann PA0012/078/001 Powder for suspension for - D-GALACTOSE 24/03/2000
injection - PALMITIC ACID
LEVOVIST HE Clissmann PA0012/078/002 Powder for suspension for - D-GALACTOSE 24/03/2000
injection - PALMITIC ACID
NORVIR Abbott Laboratories Ireland EU/1/96/016/002 Capsule - RITONAVIR 24/03/2000
Ltd
DEMSER Merck Sharp and Dohme PA0035/043/001 Capsule - METIROSINE 21/03/2000
Limited
DUOVENT 100 AEROCAPS Boehringer Ingelheim Limited PA0007/034/002 Capsule - IPRATROPIUM BROMIDE 21/03/2000
- FENOTEROL
HYDROBROMIDE
DUOVENT 200 AEROCAPS Boehringer Ingelheim Limited PA0007/034/003 Capsule - IPRATROPIUM BROMIDE 21/03/2000
- FENOTEROL
HYDROBROMIDE
OVYSMEN ORAL Janssen-Cilag Ltd PA0748/027/001 Tablets - NORETHISTERONE 16/03/2000
CONTRACEPTIVE - ETHINYLESTRADIOL
NICONIL 22 Elan Pharma Ltd PA0516/018/001 Transdermal Patch - NICOTINE 15/03/2000
UROGRAFIN HE Clissmann PA0012/039/006 Solution for Injection - AMIDOTRIZOATE 14/03/2000
MEGLUMINE
- SODIUM AMIDOTRIZOATE

HYPNOVEL Roche Products Limited PA0050/061/004 Solution for Injection - MIDAZOLAM 10/03/2000
HYDROCHLORIDE
LEXOTAN ROCHE Roche Products Limited PA0050/049/003 Tablets - BROMAZEPAM 10/03/2000
TOLVON Organon Laboratories PA0261/001/002 Coated Tablets - MIANSERIN 09/03/2000
Limited HYDROCHLORIDE
BRULIDINE May & Baker Limited PA0040/065/001 Cream - DIBROMPROPAMIDINE 08/03/2000
ISETIONATE
MEGALOTECT Biotest Pharma GmbH PA0592/004/001 Solution for Injection - HUMAN PLASMA 07/03/2000
PROTEIN >95%
IMMUNOGLOBULINS
- IMMUNOGLOBULIN
CYTOMEGALOVIRUS
ORUDIS May & Baker Limited PA0040/033/002 Suppositories - KETOPROFEN 06/03/2000
CREON Abbott Products GmbH PA0410/001/001 Capsule - PANCREATIN 02/03/2000
ULTRALIEF ANALGESIC Wallace, Cameron & PA0402/002/001 Tablets - PARACETAMOL 02/03/2000
Company (Ire) - CAFFEINE
M & B 693 Concord Pharmaceuticals Lt PA0828/002/001 Tablets - SULFAPYRIDINE 01/03/2000

VALIUM Roche Products Limited PA0050/017/006 Syrup - DIAZEPAM 25/02/2000


ZOVIRAX PCO Manufacturing PPA0465/038/002 Tablets - ACICLOVIR 25/02/2000
ZOVIRAX TABLETS PCO Manufacturing PPA0465/038/003 Tablets - ACICLOVIR 25/02/2000
CALDESENE Fisons Pharmaceuticals PA0072/002/001 Cutaneous Powder - CALCIUM UNDECYLEN 22/02/2000
(Ireland)
DESENEX OINTMENT Fisons Pharmaceuticals PA0072/008/001 Ointment - ZINC UNDECYLENATE 22/02/2000
(Ireland) - UNDECYLENIC ACID
DESENEX POWDER Fisons Pharmaceuticals PA0072/008/002 Cutaneous Powder - ZINC UNDECYLENATE 22/02/2000
(Ireland)
RADIAN B HEAT Fisons Limited PA0018/045/001 Cutaneous Spray Solution - MENTHOL 22/02/2000
- CAMPHOR
- AMMONIUM SALICYLATE
- SALICYLIC ACID

Radian B Muscle Rub Fisons Limited PA0018/044/001 Cutaneous Spray Solution - MENTHOL 22/02/2000
- CAMPHOR
- METHYL SALICYLATE
- CAMPHOR OIL
- CAPSAICIN
GENESA Gensia Europe Ltd PA0614/003/001 Solution for Infusion - ARBUTAMINE 20/02/2000
PROSTIN F2 ALPHA Pharmacia Limited PA0016/031/001 Solution for Injection - DINOPROST 19/02/2000
STERILE TROMETAMOL

Human Medicines Withdrawn Products Page 356 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EOLARIX VACCINE GlaxoSmithKline Consumer PA0678/006/002 Solution for Injection - MEASLES VIRUS - 16/02/2000
Healthcare (Ireland) Limited SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
METHYLDOPA Norton Healthcare Limited PA0282/008/002 Tablets - METHYLDOPA 15/02/2000
T/A IVAX Pharmaceuticals
UK
PRONETA Ciba Geigy Plc PA0028/074/001 Tablets - NORETHISTERONE 15/02/2000
ACETATE
DISPERSIBLE ASPIRIN Accord-UK Ltd PA0176/015/001 Tablets - ACETYLSALICYLIC ACID 11/02/2000
INDOMETHACIN Accord-UK Ltd PA0176/017/001 Capsule - INDOMETACIN 11/02/2000
INDOMETHACIN Accord-UK Ltd PA0176/017/002 Capsule - INDOMETACIN 11/02/2000
SALBUTAMOL 200 B.V. Pharbita PA0508/003/001 Inhalation powder, hard - SALBUTAMOL SULFATE 11/02/2000
CYCLOCAPS capsule
SALBUTAMOL 400 B.V. Pharbita PA0508/003/002 Inhalation powder, hard - SALBUTAMOL SULFATE 11/02/2000
CYCLOCAPS capsule
OCUCOAT INJECTABLE Cyanamid of Great Britain PA0037/067/001 Suspension for Injection - HYPROLOSE 08/02/2000
CARPINE Pinewood Laboratories Ltd, PA0281/064/001 Tablets - CARBAMAZEPINE 07/02/2000
CARPINE Pinewood Laboratories Ltd, PA0281/064/002 Tablets - CARBAMAZEPINE 07/02/2000
CARPINE Pinewood Laboratories Ltd, PA0281/064/003 Tablets - CARBAMAZEPINE 07/02/2000
DTIC DOME Bayer PLC PA0021/025/002 Pdr for Soln for Injection - DACARBAZINE 07/02/2000
BALNEUM WITH TAR Crookes Healthcare Ltd PA0043/029/001 Bath Additive - SOYA OIL 06/02/2000
- COAL TAR
PREFIL Pierre Fabre Sante PA0826/001/001 Granules for Oral - STERCULIA 05/02/2000
Suspension
NUELIN 3M Health Care Limited PA0057/005/001 Tablets - THEOPHYLLINE 03/02/2000
TECNEMAB-K-1 Amersham Sorin S.r.l. EU/1/96/019/001 Pdr for Soln for Injection - ANTI-MELANOMA MAB 31/01/2000
FRAGMENTS
MIGRAVESS Bayer PLC PA0021/024/001 Tablets - METOCLOPRAMIDE 28/01/2000
HYDROCHLORIDE
- ACETYLSALICYLIC ACID
MIGRAVESS FORTE Bayer PLC PA0021/024/002 Tablets - METOCLOPRAMIDE 28/01/2000
HYDROCHLORIDE
- ACETYLSALICYLIC ACID
SECUROPEN Bayer PLC PA0021/011/001 Powder for suspension for - AZLOCILLIN SODIUM 28/01/2000
injection
SECUROPEN Bayer PLC PA0021/011/002 Powder for suspension for - AZLOCILLIN SODIUM 28/01/2000
injection
SECUROPEN Bayer PLC PA0021/011/003 Powder for suspension for - AZLOCILLIN SODIUM 28/01/2000
injection
SECUROPEN Bayer PLC PA0021/011/004 Powder for suspension for - AZLOCILLIN SODIUM 28/01/2000
injection
SECUROPEN Bayer PLC PA0021/011/005 Powder for suspension for - AZLOCILLIN SODIUM 28/01/2000
injection
GELOX Beaufour Schwabe PA0353/003/001 Oral Suspension - SMECTITE 27/01/2000
- ALUMINIUM HYDROXIDE
- MAGNESIUM HYDROXIDE

ANTIBIOTIC SIMPLEX Howmedica International IRL PA0723/001/001 - ERYTHROMYCIN 24/01/2000


BONE CEMENT GLUCEPTATE
- COLISTIN
SULFOMETHATE
FLAXEDIL Concord Pharmaceuticals Lt PA0828/005/001 Solution for Injection - GALLAMINE 24/01/2000
TRIETHIODIDE
EVOTOPIN Beecham Group Plc EU/1/96/028/001 Powder for solution for - TOPOTECAN 20/01/2000
infusion HYDROCHLORIDE
EVOTOPIN Beecham Group Plc EU/1/96/028/002 Powder for solution for - TOPOTECAN 20/01/2000
infusion HYDROCHLORIDE
PREFERID Yamanouchi Pharma Ltd PA0062/027/001 Cream - BUDESONIDE 19/01/2000
PREFERID Yamanouchi Pharma Ltd PA0062/027/002 Ointment - BUDESONIDE 19/01/2000
CITRAZINE Mercury Pharmaceuticals PA0073/064/001 Syrup - PIPERAZINE CITRATE 18/01/2000
(Ireland) Ltd
EUPHYLONG 250 Byk Gulden Lomberg PA0492/001/001 Capsule - THEOPHYLLINE 17/01/2000
Chemische
EUPHYLONG 375 Byk Gulden Lomberg PA0492/001/002 Capsule - THEOPHYLLINE 17/01/2000
Chemische
BRIETAL SODIUM Eli Lilly and Company Limite PA0047/062/001 Pdr for Soln for Injection - METHOHEXITAL SODIUM 13/01/2000
- SODIUM CARBONATE
ANHYDROUS

BRIETAL SODIUM Eli Lilly and Company Limite PA0047/062/002 Pdr for Soln for Injection 13/01/2000

DISTACLOR Dista Products Limited PA0447/007/001 Capsule - CEFACLOR 13/01/2000


DISTACLOR GRANULES Dista Products Limited PA0447/007/008 Granules for Oral - CEFACLOR 13/01/2000
Suspension MONOHYDRATE

Human Medicines Withdrawn Products Page 357 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DISTACLOR GRANULES Dista Products Limited PA0447/007/009 Granules for Oral - CEFACLOR 13/01/2000
Suspension MONOHYDRATE
DISTACLOR LA Eli Lilly and Company Limite PA0047/078/003 Tablets - CEFACLOR 13/01/2000
MONOHYDRATE
ONCOVIN (VINCRISTINE Eli Lilly and Company Limite PA0047/046/004 Solution for Injection - VINCRISTINE SULFATE 13/01/2000
SULPHATE)
ONCOVIN (VINCRISTINE Eli Lilly and Company Limite PA0047/046/005 Solution for Injection - VINCRISTINE SULFATE 13/01/2000
SULPHATE)
PROGESIC Dista Products Limited PA0447/002/001 Tablets - FENOPROFEN CALCIUM 13/01/2000
IRON SUPPLEMENT GR Lane Health Products Lt PA0257/040/001 Capsule - FERROUS GLUCONATE 11/01/2000
- SOYA OIL
ALYRANE INHALATION Pharmacia Laboratories PA0187/060/001 Inhalation Vapour Liquid - ENFLURANE 10/01/2000
ANAESTHETIC Limited
CYCLOPHOSPHAMIDE Farmitalia Carlo Erba Ltd PA0236/010/002 Powder for solution for - CYCLOPHOSPHAMIDE 10/01/2000
infusion
CYCLOPHOSPHAMIDE Farmitalia Carlo Erba Ltd PA0236/010/003 Powder for solution for - CYCLOPHOSPHAMIDE 10/01/2000
infusion
CYCLOPHOSPHAMIDE Farmitalia Carlo Erba Ltd PA0236/010/004 Powder for solution for - CYCLOPHOSPHAMIDE 10/01/2000
infusion
CYCLOPHOSPHAMIDE Farmitalia Carlo Erba Ltd PA0236/010/005 Powder for solution for - CYCLOPHOSPHAMIDE 10/01/2000
infusion
MEDRONE Pharmacia Limited PA0016/020/004 Tablets - METHYLPREDNISOLONE 10/01/2000

MEDRONE Pharmacia Limited PA0016/020/005 Tablets - METHYLPREDNISOLONE 10/01/2000

MOTRIN Pharmacia Limited PA0016/039/001 Tablets - IBUPROFEN 10/01/2000


MOTRIN Pharmacia Limited PA0016/039/002 Tablets - IBUPROFEN 10/01/2000
MOTRIN Pharmacia Limited PA0016/039/003 Tablets - IBUPROFEN 10/01/2000
PROSTIN F2 ALPHA Pharmacia Limited PA0016/031/002 Solution for Injection - DINOPROST 10/01/2000
STERILE TROMETAMOL
PROVERA Pharmacia Limited PA0016/023/007 Tablets - 10/01/2000
MEDROXYPROGESTERO
NE ACETATE
CORGARD Bristol-Myers Squibb PA0002/025/001 Tablets - NADOLOL 07/01/2000
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/002 Tablets - NADOLOL 07/01/2000
Pharmaceuticals uc
OPHTHAINE Bristol-Myers Squibb PA0002/035/001 Eye Drops Solution - PROXYMETACAINE 07/01/2000
Pharmaceuticals uc HYDROCHLORIDE
DOXY KOMB Karl Engelhard PA0425/002/001 Tablets - DOXYCYCLINE HYCLATE 06/01/2000
- DOXYCYCLINE HYCLATE

ALSUCRAL Orion Pharma A/s PA0303/024/4 - SUCRALFATE 31/12/1999


CLONOXIFEN Clonmel Healthcare Ltd PA0126/092/001 Tablets - TAMOXIFEN CITRATE 22/12/1999
CLONOXIFEN Clonmel Healthcare Ltd PA0126/092/002 Tablets - TAMOXIFEN CITRATE 22/12/1999
NITROFURANTOIN Clonmel Healthcare Ltd PA0126/018/002 Tablets - NITROFURANTOIN 22/12/1999
VERAPAMIL Clonmel Healthcare Ltd PA0126/071/001 Tablets - VERAPAMIL 22/12/1999
HYDROCHLORIDE HYDROCHLORIDE
VERAPAMIL Clonmel Healthcare Ltd PA0126/071/002 Tablets - VERAPAMIL 22/12/1999
HYDROCHLORIDE HYDROCHLORIDE
VERAPAMIL Clonmel Healthcare Ltd PA0126/071/003 Tablets - VERAPAMIL 22/12/1999
HYDROCHLORIDE HYDROCHLORIDE
METHADONE ORAL DTF Rosemont Pharmaceuticals PA0312/007/001 Oral Solution - METHADONE 15/12/1999
Ltd HYDROCHLORIDE
BENGUES BALSAM Bengue & Company Limited PA0096/008/001 Ointment 13/12/1999
LIMBITROL Roche Products Limited PA0050/015/001 Capsule - CHLORDIAZEPOXIDE 13/12/1999
- AMITRIPTYLINE
HYDROCHLORIDE
LIMBITROL Roche Products Limited PA0050/015/002 Capsule - CHLORDIAZEPOXIDE 13/12/1999
- AMITRIPTYLINE
HYDROCHLORIDE
PIXOL Thames Laboratories Limited PA0391/004/001 Bath Additive - COAL TAR SOLUTION 13/12/1999
- COAL TAR
- CADE OIL
RINSTEAD Schering-Plough Limited PA0277/056/001 Lozenges - MENTHOL 10/12/1999
- CHLOROXYLENOL
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/007 Tablets - PRAMIPEXOLE 08/12/1999
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/008 Tablets - PRAMIPEXOLE 08/12/1999
DIHYDROXHLORIDE
ADSORBED DIPHTHERIA UCB Pharma Limited PA0365/058/001 Solution for Injection - DIPHTHERIA TOXOID 02/12/1999
TETANUS & PERTUSSIS - TETANUS TOXOID
VACCINE BP - PERTUSSIS VACCINE
ALMODAN Teva UK Limited PA0237/043/001 Capsule 02/12/1999

Human Medicines Withdrawn Products Page 358 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALMODAN Teva UK Limited PA0237/043/002 Capsule 02/12/1999
ALMODAN Teva UK Limited PA0237/043/003 Pdr for Soln for Injection - AMOXICILLIN SODIUM 02/12/1999
ALMODAN Teva UK Limited PA0237/043/004 Pdr for Soln for Injection - AMOXICILLIN SODIUM 02/12/1999
ALMODAN Teva UK Limited PA0237/043/005 Pdr for Soln for Injection - AMOXICILLIN SODIUM 02/12/1999
AMPIBERK Teva UK Limited PA0237/046/001 Capsule - AMPICILLIN TRIHYDRATE 02/12/1999

AMPIBERK Teva UK Limited PA0237/046/002 Capsule - AMPICILLIN TRIHYDRATE 02/12/1999

AMPIBERK Teva UK Limited PA0237/046/003 Pdr for Soln for Injection - AMPICILLIN SODIUM 02/12/1999
AMPIBERK Teva UK Limited PA0237/046/004 Pdr for Soln for Injection - AMPICILLIN SODIUM 02/12/1999
AMPIBERK Teva UK Limited PA0237/046/005 Pdr for Soln for Injection - AMPICILLIN SODIUM 02/12/1999
AMPIBERK Teva UK Limited PA0237/046/006 Syrup - AMPICILLIN TRIHYDRATE 02/12/1999

AMPIBERK Teva UK Limited PA0237/046/007 Syrup - AMPICILLIN TRIHYDRATE 02/12/1999

APS DIPYRIDAMOLE Teva UK Limited PA0237/025/002 Tablets - DIPYRIDAMOLE 02/12/1999


ARBRALENE Teva UK Limited PA0237/056/001 Tablets - METOPROLOL TARTRATE 02/12/1999

ARBRALENE Teva UK Limited PA0237/056/002 Tablets - METOPROLOL TARTRATE 02/12/1999

BERKAMIL Teva UK Limited PA0237/051/001 Tablets - AMILORIDE 02/12/1999


HYDROCHLORIDE
BERKOLOL Teva UK Limited PA0237/038/001 - PROPRANOLOL 02/12/1999
HYDROCHLORIDE
BERKOLOL Teva UK Limited PA0237/038/002 - PROPRANOLOL 02/12/1999
HYDROCHLORIDE
BERKOLOL Teva UK Limited PA0237/038/003 Tablets - PROPRANOLOL 02/12/1999
HYDROCHLORIDE
BERKOLOL Teva UK Limited PA0237/038/004 Tablets - PROPRANOLOL 02/12/1999
HYDROCHLORIDE
CALANIF Teva UK Limited PA0237/054/001 Capsule - NIFEDIPINE 02/12/1999
CALANIF Teva UK Limited PA0237/054/002 Capsule - NIFEDIPINE 02/12/1999
CHLORPROPAMIDE Teva UK Limited PA0237/030/001 Tablets - CHLORPROPAMIDE 02/12/1999
CHLORPROPAMIDE Teva UK Limited PA0237/030/002 Tablets - CHLORPROPAMIDE 02/12/1999
DOMICAL Teva UK Limited PA0237/033/001 Coated Tablets - AMITRIPTYLINE 02/12/1999
HYDROCHLORIDE
DOMICAL Teva UK Limited PA0237/033/002 Coated Tablets - AMITRIPTYLINE 02/12/1999
HYDROCHLORIDE
DOMICAL Teva UK Limited PA0237/033/003 Coated Tablets - AMITRIPTYLINE 02/12/1999
HYDROCHLORIDE
DRYPTAL Teva UK Limited PA0237/034/002 Tablets - FUROSEMIDE 02/12/1999
DRYPTAL Teva UK Limited PA0237/034/003 Solution for Injection - FUROSEMIDE 02/12/1999
DRYPTAL Teva UK Limited PA0237/034/004 Solution for Injection - FUROSEMIDE 02/12/1999
DRYPTAL Teva UK Limited PA0237/034/005 Solution for Injection - FUROSEMIDE 02/12/1999
ERYCEN Teva UK Limited PA0237/047/001 Syrup - ERYTHROMYCIN 02/12/1999
ETHYLSUCCINATE
ERYCEN Teva UK Limited PA0237/047/002 Syrup - ERYTHROMYCIN 02/12/1999
ETHYLSUCCINATE
FLOXABERK Teva UK Limited PA0237/049/003 Tablets - FLUCLOXACILLIN 02/12/1999
SODIUM
FLOXABERK Teva UK Limited PA0237/049/004 Tablets - FLUCLOXACILLIN 02/12/1999
SODIUM
FLOXABERK Teva UK Limited PA0237/049/005 Tablets - FLUCLOXACILLIN 02/12/1999
SODIUM
IMBRILON Teva UK Limited PA0237/036/002 Capsule - INDOMETACIN 02/12/1999
IMBRILON Teva UK Limited PA0237/036/003 Suppositories 02/12/1999
MODAPLATE Teva UK Limited PA0237/052/001 Tablets - DIPYRIDAMOLE 02/12/1999
PRIMPERAN Teva UK Limited PA0237/035/001 Solution for Injection - METOCLOPRAMIDE 02/12/1999
HYDROCHLORIDE
PRIMPERAN Teva UK Limited PA0237/035/002 Syrup - METOCLOPRAMIDE 02/12/1999
HYDROCHLORIDE
PRIMPERAN Teva UK Limited PA0237/035/003 Tablets - METOCLOPRAMIDE 02/12/1999
HYDROCHLORIDE
TIMPRON Teva UK Limited PA0237/055/001 Tablets - NAPROXEN 02/12/1999
TIMPRON Teva UK Limited PA0237/055/002 Tablets - NAPROXEN 02/12/1999
VICK SINEX Procter & Gamble (Health & PA0441/024/001 Nasal Spray Solution - OXYMETAZOLINE 29/11/1999
Beauty Care) Limited HYDROCHLORIDE
- MENTHOL
- CAMPHOR
- CINEOLE
BERKATENS Teva UK Limited PA0237/048/001 Tablets - VERAPAMIL 25/11/1999
HYDROCHLORIDE
BERKATENS Teva UK Limited PA0237/048/002 Tablets - VERAPAMIL 25/11/1999
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 359 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BERKATENS Teva UK Limited PA0237/048/003 Tablets - VERAPAMIL 25/11/1999
HYDROCHLORIDE
BERKATENS Teva UK Limited PA0237/048/004 Tablets - VERAPAMIL 25/11/1999
HYDROCHLORIDE
VISDERM H Cyanamid of Great Britain PA0037/038/002 Cream - AMCINONIDE 23/11/1999
ACETARD A/S Alfred Benzon PA0317/001/001 Tablets - ACETYLSALICYLIC ACID 22/11/1999
ACETARD A/S Alfred Benzon PA0317/001/002 Tablets - ACETYLSALICYLIC ACID 22/11/1999
FURIX RETARD A/S Alfred Benzon PA0317/007/001 Capsule - FUROSEMIDE 22/11/1999
FURIX RETARD A/S Alfred Benzon PA0317/007/002 Capsule - FUROSEMIDE 22/11/1999
FURIX RETARD A/S Alfred Benzon PA0317/007/003 Capsule - FUROSEMIDE 22/11/1999
INDOMOD A/S Alfred Benzon PA0317/005/001 Modified-release capsule, - INDOMETACIN 22/11/1999
hard
INDOMOD A/S Alfred Benzon PA0317/005/002 Modified-release capsule, - INDOMETACIN 22/11/1999
hard
FANSIMEF Roche Products Limited PA0050/074/001 Tablets - MEFLOQUINE 21/11/1999
HYDROCHLORIDE
- SULFADOXINE
- PYRIMETHAMINE
KALINORM MODIFIED A/S Alfred Benzon PA0317/002/001 Tablets - POTASSIUM CHLORIDE 18/11/1999
RELEASE
KREDEX GlaxoSmithKline Consumer PA0678/029/001 Tablets - CARVEDILOL 18/11/1999
Healthcare (Ireland) Limited
KREDEX GlaxoSmithKline Consumer PA0678/029/002 Tablets - CARVEDILOL 18/11/1999
Healthcare (Ireland) Limited
KREDEX GlaxoSmithKline Consumer PA0678/029/003 Tablets - CARVEDILOL 18/11/1999
Healthcare (Ireland) Limited
ASPRIN Sanofi-Synthelabo Ireland PA0077/091/002 Tablets - ACETYLSALICYLIC ACID 15/11/1999
Ltd
ASPRIN Sanofi-Synthelabo Ireland PA0077/091/003 Tablets - ACETYLSALICYLIC ACID 15/11/1999
Ltd
DISPERSIBLE ASPRIN Sanofi-Synthelabo Ireland PA0077/091/001 Tablets - ACETYLSALICYLIC ACID 15/11/1999
Ltd
NIVAQUINE May & Baker Limited PA0040/006/003 Solution for Injection - CHLOROQUINE SULFATE 14/11/1999

RESPIJET Fujisawa Deutschland GmbH PA0473/005/001 Pressurised Inhalation - SALBUTAMOL 11/11/1999


Suspension
RONICOL Tillomed Laboratories Limite PA0644/002/001 Tablets - NICOTINYL TARTRATE 10/11/1999

INTRON A WITH Schering-Plough Limited PA0277/050/011 Solution for Injection - INTERFERON ALFA-2B 08/11/1999
PRESERVATIVE
INTRON A WITH Schering-Plough Limited PA0277/050/012 - INTERFERON ALFA-2B 08/11/1999
PRESERVATIVE
DRISTAN DECONGESTANT Pfizer Consumer Healthcare PA0172/005/002 Tablets - ACETYLSALICYLIC ACID 01/11/1999
Ltd - PHENYLEPHRINE
HYDROCHLORIDE
- CAFFEINE
- CHLORPHENAMINE
MALEATE
MEROCAINE SOLUTION Marion Merrell Limited PA0041/020/004 Mouth Wash - BENZOCAINE 01/11/1999
- BENZYL ALCOHOL
- ETHANOL
- CETYLPYRIDINIUM
CHLORIDE
MEROVIT Marion Merrell Limited PA0041/042/001 Lozenges - ASCORBIC ACID 01/11/1999
- SODIUM ASCORBATE
INSIDON Geigy Pharmaceuticals PA0011/010/001 Tablets - OPIPRAMOL 31/10/1999
DIHYDROCHLORIDE
CO-VASCACE Roche Products Limited PA0050/090/001 Tablets - CILAZAPRIL 29/10/1999
DIARREST Galen Limited PA0185/010/001 Syrup - CODEINE PHOSPHATE 28/10/1999
- DICYCLOVERINE
HYDROCHLORIDE
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- SODIUM CITRATE
SODIUM CHLORIDE 0.9% Bieffe Medital SpA PA0751/001/006 Irrigation solution - SODIUM CHLORIDE 27/10/1999
SODIUM CHLORIDE 0.9% Bieffe Medital SpA PA0751/001/007 Irrigation solution - SODIUM CHLORIDE 27/10/1999
SODIUM CHLORIDE 0.9% Bieffe Medital SpA PA0751/001/008 Irrigation solution - SODIUM CHLORIDE 27/10/1999
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/001 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/002 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/003 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE

Human Medicines Withdrawn Products Page 360 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/004 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/005 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE
GLUCOSE/ELECTROLYTE B. Braun Medical Limited PA0179/033/006 Solution for Infusion - GLUCOSE 24/10/1999
MONOHYDRATE
- SODIUM CHLORIDE
MYCARDOL Sanofi-Synthelabo Ireland PA0077/049/001 Tablets - PENTAERITHRITYL 22/10/1999
Ltd TETRANITRATE
ALBUMIN HUMAN 20% Octapharma Limited PA0521/002/005 Solution for Injection - HUMAN ALBUMIN 18/10/1999
ERECNOS Fournier Pharmaceuticals PA0810/003/001 Pdr+Solv for Soln for Inj - MOXISYLYTE 18/10/1999
Limited HYDROCHLORIDE
ERECNOS Fournier Pharmaceuticals PA0810/003/002 Pdr+Solv for Soln for Inj - MOXISYLYTE 18/10/1999
Limited HYDROCHLORIDE
RETROVIR Wellcome (Ireland) Limited PA0017/092/006 Tablets - ZIDOVUDINE 18/10/1999
ACCUSITE INJECTABLE Matrix Pharmaceuticals PA0813/001/001 Solution for Injection - FLUOROURACIL 15/10/1999
GEL Limited
INFLUVAC INACTIVATED Abbott Healthcare Products PA0108/017/002 Suspension for Injection - A/SYDNEY /5/97 (H3N2)- 15/10/1999
INFLUENZA Ltd LIKE STRAIN
- A/BEIJING /262/95 (H1N1)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
- INFLUENZA VIRUS
INACTIVATED STRAIN
A/EQUI-2/MIAMI/63
TOLECTIN Cilag Limited PA0059/003/002 Capsule - TOLMETIN SODIUM 15/10/1999
DIHYDRATE
HYDOL Napp Laboratories Limited PA0114/074/001 Tablets - DIHYDROCODEINE 13/10/1999
BITARTRATE
PARMID Sandoz Ltd PA0372/004/001 Solution for Injection - METOCLOPRAMIDE 11/10/1999
HYDROCHLORIDE
PARMID Sandoz Ltd PA0372/004/002 Solution for Injection - METOCLOPRAMIDE 11/10/1999
HYDROCHLORIDE
SIFROL Boehringer Ingelheim EU/1/97/050/007 Tablets - PRAMIPEXOLE 11/10/1999
International GmbH DIHYDROXHLORIDE
SIFROL Boehringer Ingelheim EU/1/97/050/008 Tablets - PRAMIPEXOLE 11/10/1999
International GmbH DIHYDROXHLORIDE
FLUCILLIN Pinewood Laboratories Ltd, PA0281/031/001 Capsule - FLUCLOXACILLIN 09/10/1999
SODIUM MONOHYDRATE
FLUCILLIN Pinewood Laboratories Ltd, PA0281/031/002 Capsule - FLUCLOXACILLIN 09/10/1999
SODIUM
VALIUM Roche Products Limited PA0050/017/003 Tablets - DIAZEPAM 08/10/1999
GENOTROPIN (WITH Pharmacia Laboratories PA0187/032/013 Pdr+Solv for Soln for Inj - SOMATROPIN 04/10/1999
PRESERVATIVE) Limited
GENOTROPIN (WITH Pharmacia Laboratories PA0187/032/009 Pdr+Solv for Soln for Inj - SOMATROPIN 04/10/1999
PRESERVATIVE) KABIVIAL Limited

GENOTROPIN KABIVIAL Pharmacia Laboratories PA0187/032/007 Pdr+Solv for Soln for Inj - SOMATROPIN 04/10/1999
Limited
GENOTROPIN KABIVIAL Pharmacia Laboratories PA0187/032/008 Pdr+Solv for Soln for Inj - SOMATROPIN 04/10/1999
Limited
ROCEPHIN Roche Products Limited PA0050/062/001 Pdr for Soln for Injection - CEFTRIAXONE SODIUM 04/10/1999
BECLOMETHASONE 100 B.V. Pharbita PA0508/001/001 Capsule - BECLOMETASONE 01/10/1999
PHARBITA DIPROPIONATE
BECLOMETHASONE 200 B.V. Pharbita PA0508/001/002 Capsule - BECLOMETASONE 01/10/1999
PHARBITA DIPROPIONATE
BECLOMETHASONE 400 B.V. Pharbita PA0508/001/003 Capsule - BECLOMETASONE 01/10/1999
PHARBITA DIPROPIONATE
MIRAPEXIN Boehringer Ingelheim EU/1/97/051/008 Tablets - PRAMIPEXOLE 01/10/1999
International GmbH DIHYDROXHLORIDE
CALSYNAR Rorer Pharmaceuticals PA0468/022/003 Solution for Injection - CALCITONIN, SALMON 30/09/1999
Limited
LIBRIUM Roche Products Limited PA0050/018/003 Tablets - CHLORDIAZEPOXIDE 30/09/1999
LIBRIUM Roche Products Limited PA0050/018/004 Tablets - CHLORDIAZEPOXIDE 30/09/1999
LIBRIUM Roche Products Limited PA0050/018/005 Tablets - CHLORDIAZEPOXIDE 30/09/1999
IBUMETIN A/S Alfred Benzon PA0317/004/001 Tablets - IBUPROFEN 29/09/1999
IBUMETIN A/S Alfred Benzon PA0317/004/002 Tablets - IBUPROFEN 29/09/1999
IBUMETIN A/S Alfred Benzon PA0317/004/003 Tablets - IBUPROFEN 29/09/1999
NORMORIX A/S Alfred Benzon PA0317/006/001 Tablets - HYDROCHLOROTHIAZIDE 29/09/1999
- AMILORIDE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 361 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NORMORIX A/S Alfred Benzon PA0317/006/002 Tablets - HYDROCHLOROTHIAZIDE 29/09/1999
- AMILORIDE
HYDROCHLORIDE

ACID CITRATE DEXTROSE Baxter Healthcare Limited PA0167/013/001 - GLUCOSE 27/09/1999


- SODIUM CITRATE
- CITRIC ACID
MONOHYDRATE
ACID CITRATE DEXTROSE Baxter Healthcare Limited PA0167/021/001 - GLUCOSE 27/09/1999
BP FORMULA A - SODIUM CITRATE
- CITRIC ACID
ACID CITRATE DEXTROSE Baxter Healthcare Limited PA0167/021/002 - GLUCOSE 27/09/1999
FORMULA A - SODIUM CITRATE
- CITRIC ACID
ACID CITRATE Baxter Healthcare Limited PA0167/066/001 - GLUCOSE 27/09/1999
DEXTROSE/ADENINE- - SODIUM CITRATE
ANTICOAGULANT - CITRIC ACID
MONOHYDRATE
- ADENINE
ADSOL RED CELL Baxter Healthcare Limited PA0167/077/001 Unknown - GLUCOSE 27/09/1999
PRESERVATION - SODIUM CHLORIDE
- MANNITOL
- ADENINE
CITRATE PHOSPHATE Baxter Healthcare Limited PA0167/082/001 Unknown - GLUCOSE 27/09/1999
DEXTROSE MONOHYDRATE
- SODIUM CITRATE
- CITRIC ACID
MONOHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
CITRATE PHOSPHATE Baxter Healthcare Limited PA0167/083/001 Unknown - GLUCOSE 27/09/1999
DEXTROSE MONOHYDRATE
- SODIUM CITRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- CITRIC ACID
MONOHYDRATE
- ADENINE
CITRATE PHOSPHATE Baxter Healthcare Limited PA0167/014/001 - SODIUM CITRATE 27/09/1999
DEXTROSE - GLUCOSE
- CITRIC ACID
MONOHYDRATE
- SODIUM ACID
PHOSPHATE
FENWAL-CPD ADENINE Baxter Healthcare Limited PA0167/030/001 - SODIUM CITRATE 27/09/1999
BLOOD PACK UNIT - GLUCOSE
- CITRIC ACID
MONOHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- ADENINE
FENWAL-CPD ADENINE I Baxter Healthcare Limited PA0167/031/001 - SODIUM CITRATE 27/09/1999
BLOOD PACK UNIT - GLUCOSE
- CITRIC ACID
MONOHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- ADENINE
HEPARIN Baxter Healthcare Limited PA0167/023/001 - HEPARIN SODIUM 27/09/1999
ANTICOAGULANT
OPTIMAL ADDITIVE BLOO Baxter Healthcare Limited PA0167/048/001 - SODIUM CITRATE 27/09/1999
- GLUCOSE
- CITRIC ACID
MONOHYDRATE
- SODIUM ACID
PHOSPHATE
- SODIUM CHLORIDE
- MANNITOL
- ADENINE
OPTIMAL ADDITIVE BLOOD Baxter Healthcare Limited PA0167/048/002 - GLUCOSE 27/09/1999
COLLECTION SYSTEM - SODIUM CHLORIDE
- MANNITOL
- ADENINE
ERYTHROPED Abbott Laboratories Ireland PA0038/009/003 Powder for Oral Suspension - ERYTHROMYCIN 26/09/1999
Ltd ETHYLSUCCINATE
H-B-VAX II Sanofi Pasteur MSD Ltd PA0544/023/002 Suspension for Injection - HEPATITIS B SURFACE 26/09/1999
ANTIGEN, RECOMINANT

Human Medicines Withdrawn Products Page 362 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
H-B-VAX II PAEDIATRIC Sanofi Pasteur MSD Ltd PA0544/023/001 Suspension for Injection - HEPATITIS B SURFACE 26/09/1999
ANTIGEN, RECOMINANT
OTOSPORIN PCO Manufacturing PPA0465/018/001 Ear Drops Suspension - NEOMYCIN SULFATE 22/09/1999
- HYDROCORTISONE
ERYTHROPED SUGAR Abbott Laboratories Ireland PA0038/009/013 20/09/1999
FREE SINGLE DOSE Ltd
INDIMACIS 125 CIS bio International EU/1/96/025/001 Solution for Infusion - IGOVOMAB 14/09/1999
PARACETAMOL Abdine Ltd. PA0551/002/001 Capsule - PARACETAMOL 09/09/1999
SENSODYNE Stafford Miller Limited PA0069/019/001 Gel - POTASSIUM CHLORIDE 09/09/1999
- SODIUM FLUORIDE
LACTULOSE Rowa Pharmaceuticals PA0074/039/001 Oral Solution 08/09/1999
Limited
NORPROLAC Novartis Pharmaceuticals UK PA0013/051/001 Tablets - QUINAGOLIDE 07/09/1999
Ltd HYDROCHLORIDE
- QUINAGOLIDE
HYDROCHLORIDE
NORPROLAC 150 Novartis Pharmaceuticals UK PA0013/051/003 Tablets - QUINAGOLIDE 07/09/1999
Ltd
NORPROLAC 75 Novartis Pharmaceuticals UK PA0013/051/002 Tablets - QUINAGOLIDE 07/09/1999
Ltd HYDROCHLORIDE
EPIVAL Abbott Laboratories Ireland PA0038/036/001 Tablets 03/09/1999
Ltd
EPIVAL Abbott Laboratories Ireland PA0038/036/002 Tablets 03/09/1999
Ltd
ARDUAN Medimpex (UK) Limited PA0818/002/001 Pdr for Soln for Injection - PIPECURONIUM 31/08/1999
BROMIDE
COSAL S Foran Healthcare Limited PA0484/012/001 Ointment - COAL TAR SOLUTION 30/08/1999
- SALICYLIC ACID
- SULFUR
SECTRAL May & Baker Limited PA0040/001/005 Solution for Injection - ACEBUTOLOL 30/08/1999
HYDROCHLORIDE
ALSUCRAL Orion Pharma A/s PA0303/024/002 - SUCRALFATE 23/08/1999
ALSUCRAL Orion Pharma A/s PA0303/024/003 Tablets - SUCRALFATE 23/08/1999
ALSUCRAL Orion Pharma A/s PA0303/024/004 - SUCRALFATE 23/08/1999
ISMO 10 Boehringer Mannheim PA0130/015/003 Tablets - ISOSORBIDE 23/08/1999
MONONITRATE
DIFLUCAN Pfizer Limited PA0019/044/005 Syrup - FLUCONAZOLE 22/08/1999
ESTRAMON Rowex Ltd PA0711/032/001 - ESTRADIOL 20/08/1999
MODIVID Hoechst Marion Roussel Irl PA0855/025/001 - CEFODIZIME DISODIUM 20/08/1999
Ltd
MODIVID Hoechst Marion Roussel Irl PA0855/025/002 - CEFODIZIME DISODIUM 20/08/1999
Ltd
MODIVID Hoechst Marion Roussel Irl PA0855/025/003 - CEFODIZIME DISODIUM 20/08/1999
Ltd
MODIVID Hoechst Marion Roussel Irl PA0855/025/004 - CEFODIZIME DISODIUM 20/08/1999
Ltd
MODIVID Hoechst Marion Roussel Irl PA0855/025/005 - CEFODIZIME DISODIUM 20/08/1999
Ltd
MONPHYTOL PAINT Laboratories for Applied PA0300/006/001 - CHLOROBUTANOL 19/08/1999
Biology - SALICYLIC ACID
- METHYL SALICYLATE
- PROPYL SALICYLATE
- PROPYL UNDECENOATE
- METHYL UNDECENOATE

ZETAR Rorer Pharmaceuticals PA0468/030/001 Shampoo - COAL TAR 17/08/1999


Limited
INTAL INHALER Fisons Limited PA0018/018/002 - CROMOGLICATE SODIUM 16/08/1999

HEPARIN 5000 Immuno Limited PA0212/006/001 Solution for Injection - HEPARIN SODIUM 15/08/1999
RYNACROM Fisons Limited PA0018/003/003 Nasal Powder - CROMOGLICATE SODIUM 15/08/1999

JUNIOR LEMSIP WITH Reckitt's (Ireland) Limited PA0027/006/003 Powder for Oral Solution - PARACETAMOL 09/08/1999
PHENYLEPHRINE - PHENYLEPHRINE
HYDROCHLORIDE
- SODIUM CITRATE
- ASCORBIC ACID

Human Medicines Withdrawn Products Page 363 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ETHYPHARM Ethypharm PA0549/005/003 Capsule - DOXYCYCLINE HYCLATE 04/08/1999
DOXYCYCLINE - DOXYCYCLINE HYCLATE
- DOXYCYCLINE HYCLATE
- DOXYCYCLINE HYCLATE
- DOXYCYCLINE HYCLATE
- DOXYCYCLINE HYCLATE

ROTERSEPT SPRAY Crookes Healthcare B.V. PA0342/001/001 Pressurised Inhalation - CHLORHEXIDINE 03/08/1999
Suspension GLUCONATE
DE-NOL Yamanouchi Pharma Ltd PA0062/023/001 Oral Solution - BISMUTH SUBCITRATE 30/07/1999
ECOKINASE Galenus Mannheim GmbH EU/1/96/017/001 - RETEPLASE 30/07/1999
HUMALOG MIX50 Eli Lilly and Company Limite EU/1/96/007/009 Suspension for Injection - INSULIN LISPRO 30/07/1999

TORECAN Novartis Pharmaceuticals UK PA0013/006/001 Coated Tablets - THIETHYLPERAZINE 28/07/1999


Ltd MALEATE
TORECAN Novartis Pharmaceuticals UK PA0013/006/002 Suppositories - THIETHYLPERAZINE 28/07/1999
Ltd MALEATE
TORECAN Novartis Pharmaceuticals UK PA0013/006/003 Solution for Injection - THIETHYLPERAZINE 28/07/1999
Ltd MALEATE
HISMANAL Janssen-Cilag Ltd PA0748/030/001 Tablets - ASTEMIZOLE 27/07/1999
IMB TRAINING DRUG Company Liquidated M123 PA0999/001/003 Capsule - ALUMINIUM MAGNESIUM 27/07/1999
SILICATE
- ALUMINIUM MAGNESIUM
STEARATE
- ALUMINIUM MAGNESIUM
SILICATE
- SODIUM FLUORIDE
FURAMIDE Knoll Limited PA0769/005/001 Tablets - DILOXANIDE FUROATE 26/07/1999
GLUCOSE (DEXTROSE Rusco Pharmaceuticals PA0392/018/001 Oral Powder - GLUCOSE 25/07/1999
MONOHYDRATE)
GLYCERIN Rusco Pharmaceuticals PA0392/019/001 Oral Solution - GLYCEROL 25/07/1999
CARDENE I.V. Syntex Pharmaceuticals PA0033/025/003 Solution for Infusion - NICARDIPINE 21/07/1999
Limited HYDROCHLORIDE
CARDENE I.V. Syntex Pharmaceuticals PA0033/025/004 Solution for Infusion - NICARDIPINE 21/07/1999
Limited HYDROCHLORIDE
CARDENE I.V. Syntex Pharmaceuticals PA0033/025/005 Solution for Infusion - NICARDIPINE 21/07/1999
Limited HYDROCHLORIDE
CARDENE I.V. Syntex Pharmaceuticals PA0033/025/006 Solution for Infusion - NICARDIPINE 21/07/1999
Limited HYDROCHLORIDE
OESTROGEL Hoechst Marion Roussel Irl PA0855/027/001 Gel - ESTRADIOL 21/07/1999
Ltd
DENTOMYCIN Cyanamid of Great Britain PA0037/071/001 Gel - MINOCYCLINE 19/07/1999
HYDROCHLORIDE
TOPEX Procter & Gamble (Health & PA0441/012/001 Cutaneous Solution - BENZOYL PEROXIDE 13/07/1999
Beauty Care) Limited
NAPREX Pinewood Laboratories Ltd, PA0281/028/001 Tablets - NAPROXEN 09/07/1999
NAPREX Pinewood Laboratories Ltd, PA0281/028/002 Tablets - NAPROXEN 09/07/1999
AUREOMYCIN Cyanamid of Great Britain PA0037/012/003 Cream - CHLORTETRACYCLINE 24/06/1999
HYDROCHLORIDE
TOPROMEL B.V. Pharbita PA0508/002/001 Tablets - METOPROLOL TARTRATE 23/06/1999

TOPROMEL B.V. Pharbita PA0508/002/002 Tablets - METOPROLOL TARTRATE 23/06/1999

LEDERCORT Cyanamid of Great Britain PA0037/030/006 Cream - TRIAMCINOLONE 17/06/1999


ACETONIDE
LEDERCORT Cyanamid of Great Britain PA0037/030/007 Cream - TRIAMCINOLONE 17/06/1999
ACETONIDE
BEGRIVAC - F (PREFILLED Hoechst Ireland Limited PA0023/043/001 Solution for Injection - A/WUHAN\359\95 - LIKE 14/06/1999
SYRINGE) STRAIN - (H3N2)
- B/BEIJING /184/93-LIKE
STRAIN
- B/YAMAGATA 16/88
BEGRIVAC - F AMPOULE Hoechst Ireland Limited PA0023/043/003 Solution for Injection - A/WUHAN\359\95 - LIKE 14/06/1999
STRAIN - (H3N2)
- B/BEIJING /184/93-LIKE
STRAIN
DOPACARD Ipsen Limited PA0583/003/002 - DOPEXAMINE 14/06/1999
HYDROCHLORIDE
DOPACARD Ipsen Limited PA0583/003/003 - DOPEXAMINE 14/06/1999
HYDROCHLORIDE
DOPACARD Ipsen Limited PA0583/008/002 Withdrawn Form 14/06/1999

Human Medicines Withdrawn Products Page 364 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TALOXA Schering-Plough Limited PA0277/072/001 Tablets - FELBAMATE 13/06/1999
TALOXA Schering-Plough Limited PA0277/072/002 Tablets - FELBAMATE 13/06/1999
TALOXA Schering-Plough Limited PA0277/072/003 Oral Suspension - FELBAMATE 13/06/1999
PHYLLOCONTIN Napp Laboratories Limited PA0114/007/002 Tablets - AMINOPHYLLINE 12/06/1999
CONTINUS
PAEDIATRIC CODEINE Pinewood Laboratories Ltd, PA0281/005/002 Oral Solution 08/06/1999
LINCTUS B.P.
PROCOL Menley & James PA0159/005/001 Capsule - 07/06/1999
Laboratories PHENYLPROPANOLAMINE
HYDROCHLORIDE
PRIMALAN May & Baker Limited PA0040/077/001 Tablets - MEQUITAZINE 27/05/1999
UNIDOX 50 SOLUTAB Yamanouchi Pharma Ltd PA0062/025/006 Tablets - DOXYCYCLINE 25/05/1999
MONOHYDRATE
LARGACTIL May & Baker Limited PA0040/018/002 Solution for Injection - CHLORPROMAZINE 24/05/1999
HYDROCHLORIDE
NEULACTIL May & Baker Limited PA0040/021/005 Tablets - PERICIAZINE 24/05/1999
MINOCIN Cyanamid of Great Britain PA0037/007/001 Syrup - MINOCYCLINE 22/05/1999
HYDROCHLORIDE
MINOCIN Cyanamid of Great Britain PA0037/007/003 - MINOCYCLINE 22/05/1999
HYDROCHLORIDE
KETOVAIL Sanofi-Aventis Ireland PA0540/009/003 Gel - KETOPROFEN 19/05/1999
Limited T/A SANOFI
LOMEXIN May & Baker Limited PA0040/079/004 Cutaneous Powder - FENTICONAZOLE 19/05/1999
NITRATE
CALCIUM A.C. & D GR Lane Health Products Lt PA0257/043/001 Tablets - RETINOL ACETATE 18/05/1999
- ASCORBIC ACID
- COLECALCIFEROL
- CALCIUM PHOSPHATE
NORMISON John Wyeth & Brother PA0022/026/001 Capsule - TEMAZEPAM 17/05/1999
Limited
NORMISON John Wyeth & Brother PA0022/026/002 Capsule - TEMAZEPAM 17/05/1999
Limited
ISOFLURANE Rhodia Limited PA0668/001/001 Inhalation vapour, liquid - ISOFLURANE 16/05/1999
LOXAPAC IM (AMPOULE) Cyanamid of Great Britain PA0037/004/010 Suspension for Injection - LOXAPINE 11/05/1999
LOXAPAC IM (VIAL) Cyanamid of Great Britain PA0037/004/011 Suspension for Injection - LOXAPINE 11/05/1999
PHENERGAN May & Baker Limited PA0040/042/001 Tablets - PROMETHAZINE 11/05/1999
HYDROCHLORIDE
HALDOL Janssen Pharmaceuticals Lt PA0545/005/004 Tablets - HALOPERIDOL 10/05/1999

SYNTOCINON Novartis Pharmaceuticals UK PA0013/018/001 Solution for Injection - OXYTOCIN 05/05/1999


Ltd
SYNTOCINON Novartis Pharmaceuticals UK PA0013/018/004 Solution for Injection - OXYTOCIN 05/05/1999
Ltd
ALPHA KERI BATH Bristol-Myers Squibb PA0048/035/001 Bath Additive - PARAFFIN, LIQUID 04/05/1999
(Holdings) Limited - LANOLIN OIL
FLAGYL May & Baker Limited PA0040/003/010 Pessary - METRONIDAZOLE 03/05/1999
ORUVAIL May & Baker Limited PA0040/070/003 Powder for Oral Suspension - KETOPROFEN 03/05/1999
ORUVAIL May & Baker Limited PA0040/070/004 - KETOPROFEN 03/05/1999
CALDEASE MEDICATED Fisons Pharmaceuticals PA0072/007/001 Ointment - ZINC OXIDE 30/04/1999
(Ireland)
SUDAFED EXPECTORANT McNeil Healthcare (Ireland) PA0823/009/002 Syrup - PSEUDOEPHEDRINE 30/04/1999
Ltd HYDROCHLORIDE
- GUAIFENESIN
GLYCERIN LEMON AND Rusco Pharmaceuticals PA0392/020/001 - HONEY 29/04/1999
HONEY - CITRUS LIMON
METRODIN Serono Limited PA0285/004/001 Pdr+Solv for Soln for Inj - FOLLICLE-STIMULATING 29/04/1999
HORMONE, HUMAN
PROPRANOLOL Pinewood Laboratories Ltd, PA0281/016/001 Tablets - PROPRANOLOL 28/04/1999
HYDROCHLORIDE
PROPRANOLOL Pinewood Laboratories Ltd, PA0281/016/002 Tablets - PROPRANOLOL 28/04/1999
HYDROCHLORIDE
PROPRANOLOL Pinewood Laboratories Ltd, PA0281/016/003 Tablets - PROPRANOLOL 28/04/1999
HYDROCHLORIDE
SULCOSYN Syntex Pharmaceuticals PA0033/021/001 Cream - SULCONAZOLE NITRATE 26/04/1999
Limited
SULCOSYN Syntex Pharmaceuticals PA0033/021/002 Cutaneous Powder - SULCONAZOLE NITRATE 26/04/1999
Limited
SULCOSYN Syntex Pharmaceuticals PA0033/021/003 Cutaneous Solution - SULCONAZOLE NITRATE 26/04/1999
Limited
LARGACTIL May & Baker Limited PA0040/018/003 Suppositories - CHLORPROMAZINE 23/04/1999
ADALAT BIPHASIC Bayer PLC PA0021/003/006 Tablets - NIFEDIPINE 21/04/1999
ADALAT SA Bayer PLC PA0021/003/010 Tablets - NIFEDIPINE 21/04/1999
ADALAT SA Bayer PLC PA0021/003/011 Tablets - NIFEDIPINE 21/04/1999
ADALAT SA Bayer PLC PA0021/003/012 Tablets - NIFEDIPINE 21/04/1999
BALTAR Crookes Healthcare Ltd PA0043/031/001 Shampoo - COAL TAR 21/04/1999

Human Medicines Withdrawn Products Page 365 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DTIC DOME Bayer PLC PA0021/025/001 Pdr for Soln for Injection - DACARBAZINE 21/04/1999
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/002 Eye Drops Solution - PILOCARPINE NITRATE 21/04/1999
Ireland
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/003 - PILOCARPINE NITRATE 21/04/1999
Ireland
HYDOL Napp Laboratories Limited PA0114/074/002 Withdrawn Form - DIHYDROCODEINE 20/04/1999
BITARTRATE
HYDOL Napp Laboratories Limited PA0114/074/003 Unknown - DIHYDROCODEINE 20/04/1999
BITARTRATE
CROMAIR Fisons Pharmaceuticals PA0072/027/001 Pressurised Inhalation - CROMOGLICATE SODIUM 19/04/1999
(Ireland) Suspension
WELLFERON Wellcome (Ireland) Limited PA0017/093/001 Solution for Injection - INTERFERON ALFA - N1 18/04/1999
WELLFERON Wellcome (Ireland) Limited PA0017/093/002 Solution for Injection - INTERFERON ALFA - N1 18/04/1999
ERYTHROMYCIN Norton Healthcare Limited PA0282/019/001 Tablets Gastro-Resistant - ERYTHROMYCIN 16/04/1999
T/A IVAX Pharmaceuticals
UK
CARBIDOPA Merck Sharp and Dohme PA0035/048/002 Tablets - CARBIDOPA 13/04/1999
Limited
EMINASE Monmouth Pharmaceuticals PA0488/019/001 Pdr for Soln for Injection - ANISTREPLASE 05/04/1999
Ltd
OPTICROM S.R. Fisons Limited PA0018/002/003 - CROMOGLICATE SODIUM 04/04/1999

OPTICROM Fisons Limited PA0018/002/002 Eye Ointment - CROMOGLICATE SODIUM 03/04/1999

ATROMID-S Zeneca Limited PA0051/022/001 Capsule - CLOFIBRATE 01/04/1999


BROCADOPA Yamanouchi Pharma Ltd PA0062/011/001 Capsule - LEVODOPA 01/04/1999
BROCADOPA Yamanouchi Pharma Ltd PA0062/011/002 Capsule - LEVODOPA 01/04/1999
BROCADOPA Yamanouchi Pharma Ltd PA0062/011/003 Capsule - LEVODOPA 01/04/1999
CALCITARE Rorer Pharmaceuticals PA0468/011/001 Pdr+Solv for Soln for Inj - CALCITONIN, PORCINE 01/04/1999
Limited
DEXA-RHINASPRAY Boehringer Ingelheim Limited PA0007/006/001 Nasal Spray Suspension - DEXAMETHASONE 01/04/1999
ISONICOTINATE
- TRAMAZOLINE
HYDROCHLORIDE
- NEOMYCIN SULFATE
DICOPAC (TWO CAPSULES GE Healthcare Limited PA0240/002/001 Capsule - CYANOCOBALAMIN (57 01/04/1999
+ ONE SOL. FOR INJ.) CO)
- CYANOCOBALAMIN (58
CO)
DISIPAL Yamanouchi Pharma Ltd PA0062/010/001 Tablets - ORPHENADRINE 01/04/1999
HYDROCHLORIDE
EPSOM SALTS Rusco Pharmaceuticals PA0392/024/001 Powder for Oral Solution - MAGNESIUM SULFATE 01/04/1999
GONADOTRAPHON LH Ferring Pharmaceuticals PA0224/018/001 Solution for Injection - CHORIONIC 01/04/1999
Limited GONADOTROPHIN
MICROX Fisons Pharmaceuticals PA0072/012/001 Tablets - METOLAZONE 01/04/1999
(Ireland)
MITHRACIN Pfizer Limited PA0019/029/001 Pdr for Soln for Injection - PLICAMYCIN 01/04/1999
- MANNITOL
PERIACTIN Merck Sharp and Dohme PA0035/045/002 Syrup - CYPROHEPTADINE 01/04/1999
Limited HYDROCHLORIDE
TESTOVIRON DEPOT HE Clissmann PA0012/029/002 Solution for Injection - TESTOSTERONE 01/04/1999
ENANTHATE
CLARITHROMYCIN Abbott Laboratories Ireland PA0038/062/001 Pdr for Soln for Injection - CLARITHROMYCIN 30/03/1999
GRANULES Ltd
DIMOTANE L.A. A.H. Robins Company PA0086/015/001 Tablets - BROMPHENIRAMINE 25/03/1999
Limited MALEATE
HYDROSALURIC Merck Sharp and Dohme PA0035/026/002 Tablets - HYDROCHLOROTHIAZIDE 23/03/1999
Limited
SENOSEC Rosemont Pharmaceuticals PA0312/006/001 Tablets - OXYBUTYNIN 16/03/1999
Ltd HYDROCHLORIDE
ALLOPURINOL Abbott Laboratories Ireland PA0038/028/001 Tablets - ALLOPURINOL 15/03/1999
Ltd
ALLOPURINOL Abbott Laboratories Ireland PA0038/028/002 Tablets - ALLOPURINOL 15/03/1999
Ltd
CEFIZOX Wellcome (Ireland) Limited PA0017/087/002 Pdr for Soln for Injection - CEFTIZOXIME SODIUM 15/03/1999
CLEXANE May & Baker Limited PA0040/081/001 Withdrawn Form - ENOXAPARIN SODIUM 15/03/1999
CLEXANE May & Baker Limited PA0040/081/002 Solution for Injection - ENOXAPARIN SODIUM 15/03/1999
COMTREX Bristol-Myers Squibb PA0048/037/001 Capsule - PARACETAMOL 15/03/1999
(Holdings) Limited -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- CHLORPHENAMINE
MALEATE

Human Medicines Withdrawn Products Page 366 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COMTREX Bristol-Myers Squibb PA0048/037/003 Tablets - PARACETAMOL 15/03/1999
(Holdings) Limited -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- CHLORPHENAMINE
MALEATE
TAGAMET 400 Parallel Lines Ltd PPA0384/003/002 Tablets - CIMETIDINE 13/03/1999
CIMETIDINE RHONE Sanofi-Aventis Ireland PA0540/006/001 Tablets - CIMETIDINE 10/03/1999
POULENC RORER Limited T/A SANOFI
CIMETIDINE RHONE Sanofi-Aventis Ireland PA0540/006/002 Tablets - CIMETIDINE 10/03/1999
POULENC RORER Limited T/A SANOFI
FRUSEMEK Sanofi-Aventis Ireland PA0540/008/001 Tablets - FUROSEMIDE 10/03/1999
Limited T/A SANOFI - AMILORIDE
HYDROCHLORIDE
FRUSENE Fisons Limited PA0018/046/001 Tablets - FUROSEMIDE 10/03/1999
- TRIAMTERENE
TILARIN Fisons Limited PA0018/051/001 Nasal Spray Solution - NEDOCROMIL SODIUM 10/03/1999
VISICROM EYE Fisons Pharmaceuticals PA0072/028/001 - CROMOGLICATE SODIUM 10/03/1999
(Ireland)
DESERIL Novartis Pharmaceuticals UK PA0013/014/001 Tablets - METHYSERGIDE 05/03/1999
Ltd MALEATE
GLYCINE & ETHANOL Baxter Healthcare Limited PA0167/087/001 Irrigation solution - AMINOACETIC ACID 04/03/1999
- ETHANOL
GLYCINE & ETHANOL Baxter Healthcare Limited PA0167/087/002 Irrigation solution - AMINOACETIC ACID 04/03/1999
- ETHANOL
GLYCINE & ETHANOL Baxter Healthcare Limited PA0167/087/003 Irrigation solution - AMINOACETIC ACID 04/03/1999
- ETHANOL
GLYCINE UROLOGICAL Baxter Healthcare Limited PA0167/046/001 Irrigation solution - AMINOACETIC ACID 04/03/1999
GLYCINE UROLOGICAL Baxter Healthcare Limited PA0167/046/002 Irrigation solution - AMINOACETIC ACID 04/03/1999
IRRIGATION
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/012/011 Solution for Bladder & - SODIUM CHLORIDE 04/03/1999
Topical Irrigation
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/012/004 Irrigation solution - SODIUM CHLORIDE 04/03/1999
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/012/007 Solution for Bladder & - SODIUM CHLORIDE 04/03/1999
Topical Irrigation
SODIUM CHLORIDE 3L Baxter Healthcare Limited PA0167/012/008 Irrigation solution - SODIUM CHLORIDE 04/03/1999
UROMATIC
SODIUM CHLORIDE FOR Baxter Healthcare Limited PA0167/012/005 Irrigation solution - SODIUM CHLORIDE 04/03/1999
IRRIGATION
SODIUM CHLORIDE FOR Baxter Healthcare Limited PA0167/012/006 Irrigation solution - SODIUM CHLORIDE 04/03/1999
IRRIGATION
STERILE WATER Baxter Healthcare Limited PA0167/011/004 Solution for Bladder Irrigation - WATER FOR INJECTIONS 04/03/1999

STERILE WATER Baxter Healthcare Limited PA0167/011/005 Solution for Bladder Irrigation - WATER FOR INJECTIONS 04/03/1999

STERILE WATER Baxter Healthcare Limited PA0167/011/006 Solution for Bladder Irrigation - WATER FOR INJECTIONS 04/03/1999

STERILE WATER Baxter Healthcare Limited PA0167/011/007 Solution for Bladder Irrigation - WATER FOR INJECTIONS 04/03/1999

STERILE WATER Baxter Healthcare Limited PA0167/011/008 Solution for Bladder Irrigation - WATER FOR INJECTIONS 04/03/1999

LIPOSTAT Bristol-Myers Squibb PA0002/055/001 Tablets - PRAVASTATIN SODIUM 02/03/1999


Pharmaceuticals uc
LIPOSTAT Bristol-Myers Squibb PA0002/055/002 Tablets - PRAVASTATIN SODIUM 02/03/1999
Pharmaceuticals uc
LIPOSTAT Bristol-Myers Squibb PA0002/055/003 Tablets - PRAVASTATIN SODIUM 02/03/1999
Pharmaceuticals uc
CEFIZOX Wellcome (Ireland) Limited PA0017/087/001 Pdr for Soln for Injection - CEFTIZOXIME SODIUM 01/03/1999
PALACOS R BONE Schering-Plough Limited PA0277/005/001 - 01/03/1999
CEMENT POLYMETHYLMETHACRY
LATE
- METHYLMETHACRYLATE

PALACOS R WITH Schering-Plough Limited PA0277/005/002 - 01/03/1999


GENTAMICIN POLYMETHYLMETHACRY
LATE
- GENTAMICIN SULFATE
- METHYLMETHACRYLATE

Human Medicines Withdrawn Products Page 367 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PALACOS R-20 WITH Schering-Plough Limited PA0277/005/003 - 01/03/1999
GENTAMICIN POLYMETHYLMETHACRY
LATE
- GENTAMICIN SULFATE
- METHYLMETHACRYLATE

INTRON A Schering-Plough Limited PA0277/050/005 - INTERFERON ALFA-2B 28/02/1999


INTRON A Schering-Plough Limited PA0277/050/006 - INTERFERON ALFA-2B 28/02/1999
RADIAN B LINIMENT Radiol Chemicals Ltd PA0355/001/001 Cutaneous Solution - MENTHOL 28/02/1999
- ACETYLSALICYLIC ACID
- CAMPHOR
- METHYL SALICYLATE
HUMAN ALBUMIN Biotest Pharma GmbH PA0592/002/002 Solution for Infusion - HUMAN ALBUMIN 24/02/1999
FLUZONE Sanofi Pasteur MSD Ltd PA0544/010/001 Solution for Injection - A/SINGAPORE /6/86 17/02/1999
(H1N1)-LIKE STRAIN
- A/WUHAN /359/95 (H3N2)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
MUSTINE Knoll Limited PA0769/008/001 - CHLORMETHINE 10/02/1999
HYDROCHLORIDE BP HYDROCHLORIDE
MASSE Cilag Limited PA0059/028/001 Cream - GLYCERYL 08/02/1999
MONOSTEARATE
- STEARIC ACID
- SORBITAN STEARATE
MICRONOR Cilag Limited PA0059/011/001 Tablets - NORETHISTERONE 08/02/1999
ORTHO-NOVIN 1/50 Cilag Limited PA0059/012/001 Tablets - NORETHISTERONE 08/02/1999
- MESTRANOL
ZINC SULPHATE Penn Pharmaceuticals Ltd PA0650/010/001 Solution for Injection - ZINC SULFATE 08/02/1999
- WATER FOR INJECTIONS

CALSYNAR Aventis Behring Limited PA0010/001/003 Solution for Injection - CALCITONIN, SALMON 02/02/1999
METHADONE MIXTURE Martindale Pharmaceuticals PA0361/007/005 Oral Suspension - METHADONE 02/02/1999
DTF Ltd HYDROCHLORIDE
ORTHO-NOVIN 1/50 Janssen-Cilag Ltd PA0748/045/001 Tablets - NORETHISTERONE 31/01/1999
- MESTRANOL
MICRONOR Janssen-Cilag Ltd PA0748/010/002 Tablets - NORETHISTERONE 30/01/1999
LENS REFRESHER Allergan Pharmaceuticals PA0148/054/001 - MYRJ 52 25/01/1999
Ireland - MACROGOL 300
PIROXICAM Sanofi-Synthelabo Ireland PA0077/112/001 Capsule - PIROXICAM 24/01/1999
Ltd
PIROXICAM Sanofi-Synthelabo Ireland PA0077/112/002 Capsule - PIROXICAM 24/01/1999
Ltd
FLUARIX VACCINE SmithKline Beecham Plc PA0620/002/002 - A/SINGAPORE 6/86 21/01/1999
- B/BEYING /1/87
- B/PANAMA/45/90
NORFLEX 3M Health Care Limited PA0057/023/001 Tablets - ORPHENADRINE 21/01/1999
CITRATE
DOPAMET Teva UK Limited PA0237/040/001 Tablets - METHYLDOPA 20/01/1999
DOPAMET Teva UK Limited PA0237/040/002 Tablets - METHYLDOPA 20/01/1999
DOPAMET Teva UK Limited PA0237/040/003 Tablets - METHYLDOPA 20/01/1999
BONOMINT Intercare Products Ltd PA0398/007/001 Tablets Chewable - YELLOW 19/01/1999
PHENOLPHTHALEIN
BROOKLAX Intercare Products Ltd PA0398/008/001 Tablets - YELLOW 19/01/1999
PHENOLPHTHALEIN
KEFLEX PCO Manufacturing PPA0465/010/001 Tablets - CEFALEXIN 19/01/1999
CALCIUM RESONIUM Sanofi-Synthelabo Ireland PA0077/076/002 Oral Powder - CALCIUM POLYSTYRENE 18/01/1999
Ltd SULFONATE

CALCIUM RESONIUM Sanofi-Synthelabo Ireland PA0077/076/003 Oral Powder - CALCIUM POLYSTYRENE 18/01/1999
Ltd SULFONATE

SOLCO ALBURES Solco Basle (UK) Limited PA0461/001/001 - HUMAN ALBUMIN 18/01/1999
SOLCO NANOCOLL Solco Basle (UK) Limited PA0461/002/001 - HUMAN ALBUMIN 18/01/1999
GYNO-PEVARYL VAGINAL Cilag Limited PA0059/010/002 Pessary - ECONAZOLE NITRATE 06/01/1999
OVULES
PEVARYL Cilag Limited PA0059/009/001 - ECONAZOLE NITRATE 06/01/1999
PEVARYL Cilag Limited PA0059/009/004 Cutaneous Powder - ECONAZOLE NITRATE 06/01/1999
PEVARYL SPRAY Cilag Limited PA0059/009/002 - ECONAZOLE NITRATE 06/01/1999
PEVISONE Cilag Limited PA0059/015/001 Cream - ECONAZOLE NITRATE 06/01/1999
- TRIAMCINOLONE
ACETONIDE
MULTILOAD CU 250 - MINI Organon Laboratories PA0261/036/003 Intrauterine delivery system - COPPER 05/01/1999
Limited
MULTILOAD CU 250 - Organon Laboratories PA0261/036/002 Intrauterine delivery system - COPPER 05/01/1999
SHORT Limited

Human Medicines Withdrawn Products Page 368 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MULTILOAD CU 250 Organon Laboratories PA0261/036/001 Intrauterine delivery system - COPPER 05/01/1999
STANDARD Limited
MULTILOAD CU 375 - Organon Laboratories PA0261/037/002 Intrauterine delivery system - COPPER 05/01/1999
SHORT LOOP Limited
MULTILOAD CU 375 - Organon Laboratories PA0261/037/001 Intrauterine delivery system - COPPER 05/01/1999
STANDARD Limited
EPHEDRINE Penn Pharmaceuticals Ltd PA0650/016/001 Solution for Injection - EPHEDRINE 04/01/1999
HYDROCHLORIDE HYDROCHLORIDE
- WATER FOR INJECTIONS

RIMEVAX SmithKline and French PA0060/036/002 Withdrawn Form - MEASLES VIRUS - 04/01/1999
Laboratories Ltd SCHWARZ STRAIN LIVE
ATTENUATED
RIMEVAX SmithKline and French PA0060/036/003 Withdrawn Form - MEASLES VIRUS - 04/01/1999
Laboratories Ltd SCHWARZ STRAIN LIVE
ATTENUATED
PINDAC Leo Laboratories Limited PA0046/054/001 Capsule - PINACIDIL 31/12/1998
CIPROXIN Bayer PLC PA0021/036/003 Solution for Infusion - CIPROFLOXACIN 20/12/1998
LACTATE
QUININE SULPHATE Norton Healthcare Limited PA0282/003/001 Tablets - QUININE SULFATE 19/12/1998
T/A IVAX Pharmaceuticals
UK
MYOSCINT Janssen Biologics B.V. PA0502/001/001 - IMCIROMAB PENTETATE 18/12/1998
KELOCYANOR Lipha Pharmaceuticals PA0289/006/001 Solution for Injection - DICOBALT EDETATE 15/12/1998
Limited
KLYX ENEMA Ferring Pharmaceuticals PA0224/004/001 - DOCUSATE SODIUM 14/12/1998
Limited
OPULETS 0.4% Alcon Laboratories (UK) Ltd PA0290/047/001 - OXYBUPROCAINE 14/12/1998
BENOXINATE HYDROCHLORIDE
OPULETS 0.5% Alcon Laboratories (UK) Ltd PA0290/052/001 Eye Drops Solution - CHLORAMPHENICOL 14/12/1998
CHLORAMPHENICOL
OPULETS 0.5% Alcon Laboratories (UK) Ltd PA0290/049/001 Eye Drops Solution - CYCLOPENTOLATE 14/12/1998
CYCLOPENTOLATE HYDROCHLORIDE
OPULETS 0.9% SALINE Alcon Laboratories (UK) Ltd PA0290/048/001 Eye Drops Solution - SODIUM CHLORIDE 14/12/1998
EYE
OPULETS 1% ATROPINE Alcon Laboratories (UK) Ltd PA0290/046/001 Eye Drops Solution - ATROPINE SULFATE 14/12/1998
OPULETS 1% Alcon Laboratories (UK) Ltd PA0290/049/002 Eye Drops Solution - CYCLOPENTOLATE 14/12/1998
CYCLOPENTOLATE HYDROCHLORIDE
OPULETS 1% Alcon Laboratories (UK) Ltd PA0290/051/001 Eye Drops Solution - FLUORESCEIN SODIUM 14/12/1998
FLOURESCEIN
OPULETS 1% Alcon Laboratories (UK) Ltd PA0290/050/001 Eye Drops Solution - PILOCARPINE 14/12/1998
PILOCARPINE HYDROCHLORIDE
OPULETS 2% Alcon Laboratories (UK) Ltd PA0290/050/002 Eye Drops Solution - PILOCARPINE 14/12/1998
PILOCARPINE HYDROCHLORIDE
OPULETS 4% Alcon Laboratories (UK) Ltd PA0290/050/003 Eye Drops Solution - PILOCARPINE 14/12/1998
PILOCARPINE HYDROCHLORIDE
UNIPHYLLIN CONTINUS Napp Laboratories Limited PA0114/042/010 Tablets - THEOPHYLLINE 14/12/1998
UNIPHYLLIN SPRINKLE Napp Laboratories Limited PA0114/042/005 Capsule - THEOPHYLLINE 14/12/1998
UNIPHYLLIN SPRINKLE Napp Laboratories Limited PA0114/042/006 Capsule - THEOPHYLLINE 14/12/1998
UNIPHYLLIN SPRINKLE Napp Laboratories Limited PA0114/042/007 Capsule - THEOPHYLLINE 14/12/1998
UNIPHYLLIN SPRINKLE Napp Laboratories Limited PA0114/042/008 Capsule - THEOPHYLLINE 14/12/1998
UNIPHYLLIN SPRINKLE Napp Laboratories Limited PA0114/042/009 Capsule - THEOPHYLLINE 14/12/1998
PEPCID IV Merck Sharp and Dohme PA0035/069/004 - FAMOTIDINE 07/12/1998
Limited
DIDRONEL I.V. Procter & Gamble PA0170/014/002 Solution for Injection - ETIDRONATE DISODIUM 03/12/1998
Pharmaceuticals UK Limited
EPIFOAM Stafford Miller Limited PA0069/009/001 Cutaneous Foam - HYDROCORTISONE 01/12/1998
ACETATE
- PRAMOCAINE
HYDROCHLORIDE
PROSTAP Cyanamid of Great Britain PA0037/059/002 Withdrawn Form - LEUPRORELIN ACETATE 28/11/1998
PROSTIGMIN Roche Products Limited PA0050/041/003 Solution for Injection - NEOSTIGMINE 27/11/1998
METILSULFATE
METOPROLOL TARTRATE Norton Waterford PA0436/020/001 Tablets - METOPROLOL TARTRATE 25/11/1998

METOPROLOL TARTRATE Norton Waterford PA0436/020/002 Tablets - METOPROLOL TARTRATE 25/11/1998

PIROXICAM Norton Waterford PA0436/016/001 Capsule - PIROXICAM 25/11/1998


PIROXICAM Norton Waterford PA0436/016/002 Capsule - PIROXICAM 25/11/1998
SALBUTAMOL NEBULISER Norton Waterford PA0436/008/007 Nebuliser Solution - SALBUTAMOL SULFATE 25/11/1998

HYMECEL Dispersa (UK) Ltd PA0582/011/001 Solution for Injection - HYPROMELLOSE 19/11/1998
ORUGESIC I.M. May & Baker Limited PA0040/084/001 Solution for Injection - KETOPROFEN 19/11/1998

Human Medicines Withdrawn Products Page 369 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHOSPHOLINE IODIDE Pliva Pharma Limited PA0585/003/001 Eye Drops Pdr & Solv for - ECOTHIOPATE IODIDE 17/11/1998
Soln - POTASSIUM ACETATE
- CHLOROBUTANOL
PHOSPHOLINE IODIDE Pliva Pharma Limited PA0585/003/002 Eye Drops Pdr & Solv for - ECOTHIOPATE IODIDE 17/11/1998
Soln - POTASSIUM ACETATE
- CHLOROBUTANOL
PHOSPHOLINE IODIDE Pliva Pharma Limited PA0585/003/003 Eye Drops Pdr & Solv for - ECOTHIOPATE IODIDE 17/11/1998
Soln - POTASSIUM ACETATE
PHOSPHOLINE IODIDE Pliva Pharma Limited PA0585/003/004 Eye Drops Pdr & Solv for - ECOTHIOPATE IODIDE 17/11/1998
Soln - POTASSIUM ACETATE
- CHLOROBUTANOL
CUTIVATE Glaxo Laboratories Limited PA0044/094/001 Cream - FLUTICASONE 16/11/1998
PROPIONATE
CUTIVATE Glaxo Laboratories Limited PA0044/094/002 Ointment - FLUTICASONE 16/11/1998
PROPIONATE
MONOCORD John Wyeth & Brother PA0022/059/001 Tablets - ISOSORBIDE 16/11/1998
Limited MONONITRATE
DANERAL ELIXIR Hoechst Ireland Limited PA0023/022/001 Oral Solution - PHENIRAMINE MALEATE 11/11/1998
TOPEX TINTED Procter & Gamble (Health & PA0441/012/003 Cream - BENZOYL PEROXIDE 11/11/1998
Beauty Care) Limited
TOPEX UNTINTED Procter & Gamble (Health & PA0441/012/002 Cream - BENZOYL PEROXIDE 11/11/1998
Beauty Care) Limited
VIPRINEX Knoll AG H/C/208/00/0/0 Unknown - ANCROD 11/11/1998
APS DIPYRIDAMOLE Teva UK Limited PA0237/025/001 Tablets - DIPYRIDAMOLE 09/11/1998
ISMO Boehringer Mannheim PA0130/015/001 Tablets - ISOSORBIDE 05/11/1998
MONONITRATE
ISMO Boehringer Mannheim PA0130/015/002 Tablets - ISOSORBIDE 05/11/1998
MONONITRATE
GASTROZEPIN Knoll Limited PA0769/006/001 Tablets - PIRENZEPINE 04/11/1998
DIHYDROCHLORIDE
DILTIAZEM Norton Waterford PA0436/017/001 Tablets - DILTIAZEM 30/10/1998
HYDROCHLORIDE HYDROCHLORIDE
MEFENAMIC ACID Norton Waterford PA0436/015/002 Tablets - MEFENAMIC ACID 30/10/1998
NIFEDIPINE Norton Waterford PA0436/019/001 Capsule - NIFEDIPINE 30/10/1998
NIFEDIPINE Norton Waterford PA0436/019/002 Capsule - NIFEDIPINE 30/10/1998
DIMERCAPROL BP (BAL) Knoll Limited PA0769/007/001 Solution for Injection - DIMERCAPROL 29/10/1998
SOLABAN Stiefel Laboratories (U.K.) PA0144/013/001 Cream - OXYBENZONE 28/10/1998
Ltd. - ETHYLHEXYL P-
METHOXYCINNAMATE
BILISCOPIN HE Clissmann PA0012/074/001 Solution for Infusion - IOTROXATE MEGLUMINE 25/10/1998

TRILUDAN Marion Merrell Limited PA0041/026/003 Tablets - TERFENADINE 22/10/1998


DEBRISAN Pharmacia Biosystems PA0107/007/003 - DEXTRANOMER 21/10/1998
Limited
DEBRISAN Pharmacia Laboratories PA0187/049/002 Cutaneous Powder - DEXTRANOMER 21/10/1998
Limited
HALF-PRODUR LA Forest Laboratories UK Ltd PA0100/042/001 Tablets - PROPRANOLOL 21/10/1998
HYDROCHLORIDE
HEALONID CARTRIDGES Pharmacia Laboratories PA0187/040/001 Solution for Injection - HYALURONATE SODIUM 21/10/1998
Limited
HEALONID GV Pharmacia Laboratories PA0187/040/003 Solution for Injection - HYALURONATE SODIUM 21/10/1998
Limited
HEALONID GV Pharmacia Laboratories PA0187/040/004 Solution for Injection - HYALURONATE SODIUM 21/10/1998
Limited
PRODUR LA Forest Laboratories UK Ltd PA0100/042/002 Tablets - PROPRANOLOL 21/10/1998
HYDROCHLORIDE
DARANIDE Merck Sharp and Dohme PA0035/062/001 Tablets - DICLOFENAMIDE 19/10/1998
Limited
ETHMOZINE Monmouth Pharmaceuticals PA0488/016/001 Tablets - MORACIZINE 19/10/1998
Ltd HYDROCHLORIDE
ETHMOZINE Monmouth Pharmaceuticals PA0488/016/002 Tablets - MORACIZINE 19/10/1998
Ltd HYDROCHLORIDE
ETHMOZINE Monmouth Pharmaceuticals PA0488/016/003 Tablets - MORACIZINE 19/10/1998
Ltd HYDROCHLORIDE
FENOMEL 100 Clonmel Healthcare Ltd PA0126/084/002 Tablets - FLURBIPROFEN 18/10/1998
FENOMEL 50 Clonmel Healthcare Ltd PA0126/084/001 Tablets - FLURBIPROFEN 18/10/1998
GYNO-PEVARYL Cilag Limited PA0059/010/001 Vaginal Cream - ECONAZOLE NITRATE 16/10/1998
MACRODEX/DEXTROSE Pharmacia Biosystems PA0107/008/001 Solution for Infusion - DEXTRAN 70 16/10/1998
Limited
MACRODEX/SALINE Pharmacia Biosystems PA0107/008/002 Solution for Infusion - DEXTRAN 70 16/10/1998
Limited
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/007 Tablets - METHOTREXATE 16/10/1998
MEDICOAL CHARCOAL Torbet Laboratories Limited PA0456/003/001 Granules for Oral - CHARCOAL, ACTIVATED 16/10/1998
GRANULES Suspension

Human Medicines Withdrawn Products Page 370 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHYSEPTONE LINCTUS Wellcome (Ireland) Limited PA0017/020/003 - METHADONE 16/10/1998
HYDROCHLORIDE
PRIMACINE Pinewood Laboratories Ltd, PA0281/026/005 Oral Suspension - ERYTHROMYCIN 08/10/1998
ETHYLSUCCINATE
PRIMACINE Pinewood Laboratories Ltd, PA0281/026/006 Oral Suspension - ERYTHROMYCIN 08/10/1998
ETHYLSUCCINATE
NITRAZEPAM Clonmel Healthcare Ltd PA0126/007/001 Tablets - NITRAZEPAM 29/09/1998
CDP - 50 ANTICOAGULANT Parkfields Pharmaceuticals PA0764/001/001 Unknown - SODIUM CITRATE 22/09/1998
Ltd - CITRIC ACID
CAFERGOT Novartis Pharmaceuticals UK PA0013/005/001 Tablets - ERGOTAMINE TARTRATE 17/09/1998
Ltd - CAFFEINE

CAFERGOT Novartis Pharmaceuticals UK PA0013/005/002 Suppositories - ERGOTAMINE TARTRATE 17/09/1998


Ltd - CAFFEINE

DIMETRIOSE Roussel Laboratories Limited PA0006/039/001 Capsule - GESTRINONE 17/09/1998

EUGLUCON Roussel Laboratories Limited PA0006/019/001 Tablets - GLIBENCLAMIDE 17/09/1998

EUGLUCON Roussel Laboratories Limited PA0006/019/002 Tablets - GLIBENCLAMIDE 17/09/1998

MOLIPAXIN Roussel Laboratories Limited PA0006/012/004 Coated Tablets - TRAZODONE 17/09/1998


HYDROCHLORIDE
MOLIPAXIN Roussel Laboratories Limited PA0006/012/005 Coated Tablets - TRAZODONE 17/09/1998
HYDROCHLORIDE
MOLIPAXIN Roussel Laboratories Limited PA0006/012/006 Coated Tablets - TRAZODONE 17/09/1998
HYDROCHLORIDE
MOLIPAXIN CR Roussel Laboratories Limited PA0006/012/009 Tablets - TRAZODONE 17/09/1998
HYDROCHLORIDE
NORPLANT Roussel Laboratories Limited PA0006/046/001 Implant - LEVONORGESTREL 17/09/1998

RINATEC Boehringer Ingelheim Limited PA0007/027/001 Nasal Spray Suspension - IPRATROPIUM BROMIDE 17/09/1998
MONOHYDRATE
SABRIL Marion Merrell Limited PA0041/043/002 Powder for Oral Solution - VIGABATRIN 17/09/1998
SABRIL Marion Merrell Limited PA0041/043/003 Powder for Oral Solution - VIGABATRIN 17/09/1998
SABRIL Marion Merrell Limited PA0041/043/004 Powder for Oral Solution - VIGABATRIN 17/09/1998
SLOW SODIUM Novartis Pharmaceuticals UK PA0013/074/001 Tablets - SODIUM CHLORIDE 17/09/1998
Ltd
SURGAM Roussel Laboratories Limited PA0006/023/005 Powder for Oral Solution - TIAPROFENIC ACID 17/09/1998

SURGAM SA Roussel Laboratories Limited PA0006/023/009 Tablets - TIAPROFENIC ACID 17/09/1998

SURGAM SA Roussel Laboratories Limited PA0006/023/008 Tablets - TIAPROFENIC ACID 17/09/1998

ISOPAQUE CYSTO 100 MG Nycomed (UK) Limited PA0235/008/003 - SODIUM METRIZOATE 15/09/1998
- CALCIUM METRIZOATE
- MAGNESIUM
METRIZOATE
- MEGLUMINE
METRIZOATE
AMIPAQUE Nycomed (UK) Limited PA0235/001/003 Withdrawn Form - METRIZAMIDE 07/09/1998
- SODIUM CALCIUM
EDETATE
CALCIUM LACTATE Mercury Pharmaceuticals PA0073/116/001 Tablets - CALCIUM LACTATE 01/09/1998
(Ireland) Ltd PENTAHYDRATE
DORMONOCT Roussel Laboratories Limited PA0006/027/001 Tablets - LOPRAZOLAM MESILATE 01/09/1998

FLUVIRIN INACTIVATED UCB Pharma Limited PA0365/024/004 - A/SYDNEY /5/97 (H3N2)- 31/08/1998
INFLUENZA VACCINE LIKE STRAIN
AMPOULE - A/BEIJING /262/95 (H1N1)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
AMYLINE Mercury Pharmaceuticals PA0073/049/003 Tablets - AMITRIPTYLINE 30/08/1998
(Ireland) Ltd
AGAROL Parke Davis & Company PA0056/050/001 - PHENOLPHTHALEIN 27/08/1998
- PARAFFIN, LIQUID
- GELIDIUM AMANSII
ALOPHEN Parke Davis & Company PA0056/031/001 - ALOIN 27/08/1998
- PHENOLPHTHALEIN

Human Medicines Withdrawn Products Page 371 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IMMRAVAX MUMPS, Merieux UK Limited PA0504/009/001 Pdr+Solv for Soln for Inj - MUMPS VIRUS (URABE 23/08/1998
MEASLES AND RUBELLA AM9 STRAIN)
VACCINE - MEASLES VIRUS -
SCHWARZ STRAIN LIVE
ATTENUATED
- RUBELLA VIRUS (RA 27/3
STRAIN)
CORTISYL Roussel Laboratories Limited PA0006/013/001 Tablets - CORTISONE ACETATE 20/08/1998

NIFELAN Elan Pharma Ltd PA0516/014/001 Tablets - NIFEDIPINE 20/08/1998


NIFELAN Elan Pharma Ltd PA0516/014/002 Tablets - NIFEDIPINE 20/08/1998
RECORMON 10,000 N Boehringer Mannheim PA0130/017/007 - EPOETIN BETA 17/08/1998
RECORMON 1000 Boehringer Mannheim PA0130/017/001 Solution for Injection - EPOETIN BETA 17/08/1998
RECORMON 2000 Boehringer Mannheim PA0130/017/002 Solution for Injection - EPOETIN BETA 17/08/1998
RECORMON 5000 N Boehringer Mannheim PA0130/017/006 - EPOETIN BETA 17/08/1998
RECORMON S 1000 Boehringer Mannheim PA0130/017/004 - EPOETIN BETA 17/08/1998
RECORMON S 10000 Boehringer Mannheim PA0130/017/009 - EPOETIN BETA 17/08/1998
RECORMON S 2000 Boehringer Mannheim PA0130/017/005 - EPOETIN BETA 17/08/1998
RECORMON S 5000 Boehringer Mannheim PA0130/017/008 - EPOETIN BETA 17/08/1998
MORPHGESIC May & Baker Limited PA0040/080/001 Granules Effervescent - MORPHINE SULFATE 12/08/1998
MORPHGESIC May & Baker Limited PA0040/080/002 Granules Effervescent - MORPHINE SULFATE 12/08/1998
MORPHGESIC May & Baker Limited PA0040/080/003 Granules Effervescent - MORPHINE SULFATE 12/08/1998
AMILORIDE Norton Healthcare Limited PA0282/043/001 Tablets - AMILORIDE 05/08/1998
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
AMOXYCILLIN Norton Healthcare Limited PA0282/039/003 - AMOXICILLIN 05/08/1998
T/A IVAX Pharmaceuticals TRIHYDRATE
UK
AMOXYCILLIN Norton Healthcare Limited PA0282/039/004 - AMOXICILLIN 05/08/1998
T/A IVAX Pharmaceuticals TRIHYDRATE
UK
AMOXYCILLIN BP Norton Healthcare Limited PA0282/039/001 Capsule - AMOXICILLIN 05/08/1998
T/A IVAX Pharmaceuticals TRIHYDRATE
UK
AMOXYCILLIN BP Norton Healthcare Limited PA0282/039/002 Capsule - AMOXICILLIN 05/08/1998
T/A IVAX Pharmaceuticals TRIHYDRATE
UK
ATENOLOL BP Norton Healthcare Limited PA0282/047/003 Tablets - ATENOLOL 05/08/1998
T/A IVAX Pharmaceuticals
UK
CEPHALEXIN Norton Healthcare Limited PA0282/056/001 Capsule - CEFALEXIN 05/08/1998
T/A IVAX Pharmaceuticals
UK
CEPHALEXIN Norton Healthcare Limited PA0282/056/002 Capsule - CEFALEXIN 05/08/1998
T/A IVAX Pharmaceuticals
UK
CIDOMYCIN Roussel Laboratories Limited PA0006/003/006 - GENTAMICIN SULFATE 05/08/1998

ERYTHROMYCIN Norton Healthcare Limited PA0282/019/002 - ERYTHROMYCIN 05/08/1998


(SUSPENSION) T/A IVAX Pharmaceuticals
UK
ERYTHROMYCIN Norton Healthcare Limited PA0282/019/003 - ERYTHROMYCIN 05/08/1998
(SUSPENSION) T/A IVAX Pharmaceuticals
UK
ERYTHROMYCIN Norton Healthcare Limited PA0282/019/004 - ERYTHROMYCIN 05/08/1998
(SUSPENSION) T/A IVAX Pharmaceuticals
UK
HALOPERIDOL Norton Healthcare Limited PA0282/029/001 Tablets - HALOPERIDOL 05/08/1998
T/A IVAX Pharmaceuticals
UK
HALOPERIDOL Norton Healthcare Limited PA0282/029/002 Tablets - HALOPERIDOL 05/08/1998
T/A IVAX Pharmaceuticals
UK
HALOPERIDOL Norton Healthcare Limited PA0282/029/003 Tablets - HALOPERIDOL 05/08/1998
T/A IVAX Pharmaceuticals
UK
HALOPERIDOL Norton Healthcare Limited PA0282/029/004 Tablets - HALOPERIDOL 05/08/1998
T/A IVAX Pharmaceuticals
UK
INDOMETHACIN Norton Healthcare Limited PA0282/009/001 Capsule - INDOMETACIN 05/08/1998
T/A IVAX Pharmaceuticals
UK
INDOMETHACIN Norton Healthcare Limited PA0282/009/002 Capsule - INDOMETACIN 05/08/1998
T/A IVAX Pharmaceuticals
UK

Human Medicines Withdrawn Products Page 372 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ISOSORBIDE DINITRATE Norton Healthcare Limited PA0282/068/001 Tablets - ISOSORBIDE DINITRATE 05/08/1998
T/A IVAX Pharmaceuticals
UK
LORAZEPAM Norton Healthcare Limited PA0282/023/001 Tablets - LORAZEPAM 05/08/1998
T/A IVAX Pharmaceuticals
UK
LORAZEPAM Norton Healthcare Limited PA0282/023/002 Tablets - LORAZEPAM 05/08/1998
T/A IVAX Pharmaceuticals
UK
METFORMIN Norton Healthcare Limited PA0282/034/001 Tablets - METFORMIN 05/08/1998
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
METFORMIN Norton Healthcare Limited PA0282/034/002 Tablets - METFORMIN 05/08/1998
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
METOCLOPRAMIDE Norton Healthcare Limited PA0282/025/001 Tablets 05/08/1998
T/A IVAX Pharmaceuticals
UK
METOPROLOL TARTRATE Norton Healthcare Limited PA0282/053/001 Tablets - METOPROLOL TARTRATE 05/08/1998
T/A IVAX Pharmaceuticals
UK
METOPROLOL TARTRATE Norton Healthcare Limited PA0282/053/002 Tablets - METOPROLOL TARTRATE 05/08/1998
T/A IVAX Pharmaceuticals
UK
PIROXICAM Norton Healthcare Limited PA0282/051/002 Capsule - PIROXICAM 05/08/1998
T/A IVAX Pharmaceuticals
UK
PROXICAM USP Norton Healthcare Limited PA0282/051/001 - PIROXICAM 05/08/1998
T/A IVAX Pharmaceuticals
UK
TIMOLOL EYE H.N. Norton & Company Ltd PA0382/005/001 - TIMOLOL MALEATE 05/08/1998
TIMOLOL EYE DROPS H.N. Norton & Company Ltd PA0382/005/002 - TIMOLOL MALEATE 05/08/1998
UROMIRO 340 E. Merck Ltd PA0054/016/001 Solution for Injection - IODAMIDE 05/08/1998
UROMIRO 340 E. Merck Ltd PA0054/016/002 Solution for Injection - IODAMIDE 05/08/1998
VENTOLIN Allen and Hanburys Limited PA0024/001/006 Tablets - SALBUTAMOL 05/08/1998
ACCURETIC Parke Davis & Company PA0056/066/003 Tablets 04/08/1998
MEXITIL Boehringer Ingelheim Limited PA0007/001/002 Capsule - MEXILETINE 01/08/1998
HYDROCHLORIDE
PANZYTRAT Knoll A.G. (Clissmann) PA0058/019/001 Capsule - PANCREATIN 31/07/1998
ORTHO-GYNOL Cilag Limited PA0059/026/001 Lubricant Jelly - P- 28/07/1998
DIISOBUTYLPHENOXYPO
LYETHOXYETHANOL
SENSODYNE F Stafford Miller Limited PA0069/011/001 Unknown - SODIUM MONOFLUORO 28/07/1998
PHOSPHATE
- TRICLOSAN
MELACTONE Clonmel Healthcare Ltd PA0126/039/001 Tablets - SPIRONOLACTONE 27/07/1998
FARLUTAL 100 Farmitalia Carlo Erba Ltd PA0236/011/003 Tablets - 25/07/1998
MEDROXYPROGESTERO
NE ACETATE
FARLUTAL 250 Farmitalia Carlo Erba Ltd PA0236/011/005 Tablets - 25/07/1998
MEDROXYPROGESTERO
NE ACETATE
FINALGON Boehringer Ingelheim Limited PA0007/024/001 Ointment - BUTOXYETHYL 25/07/1998
NICOTINATE
- NONIVAMIDE
PROCYCLIDINE Norton Healthcare Limited PA0282/046/001 Tablets - PROCYCLIDINE 25/07/1998
T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
SENSODYNE MINT Stafford Miller Limited PA0069/010/001 Toothpaste - STRONTIUM CHLORIDE 25/07/1998
HEXAHYDRATE
SENSODYNE REG Stafford Miller Limited PA0069/010/002 Unknown - STRONTIUM CHLORIDE 25/07/1998
HEXAHYDRATE
DOLOXENE COMPOUND Eli Lilly and Company Limite PA0047/029/001 Capsule - 24/07/1998
DEXTROPROPOXYPHENE
NAPSILATE
- ACETYLSALICYLIC ACID
- CAFFEINE
AQUATAIN Cyanamid of Great Britain PA0037/016/001 Cream - ETHOXYLATED STEARYL 22/07/1998
ALCOHOL
- GLYCEROL
- SORBITOL SOLUTION 70
%
- ISOPROPYL PALMITATE
CORACTEN SPANSULE SmithKline and French PA0060/048/001 Capsule - NIFEDIPINE 20/07/1998
Laboratories Ltd

Human Medicines Withdrawn Products Page 373 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RYNACROM CO AEROSOL Fisons Limited PA0018/038/001 - CROMOGLICATE SODIUM 20/07/1998
- XYLOMETAZOLINE
HYDROCHLORIDE

TINADERM Schering-Plough Limited PA0277/002/003 - TOLNAFTATE 19/07/1998


TINADERM Schering-Plough Limited PA0277/002/004 - TOLNAFTATE 19/07/1998
AMBAXIN Pharmacia Limited PA0016/033/001 Tablets - BACAMPICILLIN 16/07/1998
HYDROCHLORIDE
DALACIN C Pharmacia Limited PA0016/002/002 Capsule - CLINDAMYCIN 16/07/1998
HYDROCHLORIDE
DEPO PROVERA Pharmacia Limited PA0016/024/007 Suspension for Injection - 16/07/1998
MEDROXYPROGESTERO
NE ACETATE
DEPO-PROVERA Pharmacia Limited PA0016/024/002 Suspension for Injection - 16/07/1998
MEDROXYPROGESTERO
NE ACETATE
DEPO-PROVERA Pharmacia Limited PA0016/024/005 Suspension for Injection - 16/07/1998
MEDROXYPROGESTERO
NE ACETATE
DOXORUBICIN RAPID Farmitalia Carlo Erba Ltd PA0236/023/010 - DOXORUBICIN 16/07/1998
DISSOLUTION HYDROCHLORIDE
DOXORUBICIN SOLUTION Farmitalia Carlo Erba Ltd PA0236/023/011 Solution for Injection - DOXORUBICIN 16/07/1998
HYDROCHLORIDE
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/008 Tablets - METHOTREXATE 16/07/1998
NAXOGIN Farmitalia Carlo Erba Ltd PA0236/002/001 Tablets - NIMORAZOLE 16/07/1998
OCTONATIV-M- Pharmacia Laboratories PA0187/055/003 Pdr+Solv for Soln for Inj - FACTOR VIII, HUMAN 16/07/1998
Limited
PHARMORUBICIN 150 Farmitalia Carlo Erba Ltd PA0236/016/007 - EPIRUBICIN 16/07/1998
HYDROCHLORIDE
PROMEDROL STERILE Pharmacia Limited PA0016/045/001 Solution for Injection - METHYLPREDNISOLONE 16/07/1998
SULEPTANATE

PROMEDROL STERILE Pharmacia Limited PA0016/045/002 - METHYLPREDNISOLONE 16/07/1998


SULEPTANATE

SALCATONIN 100 Farmitalia Carlo Erba Ltd PA0236/022/002 - CALCITONIN, SALMON 16/07/1998
SALCATONIN 50 Farmitalia Carlo Erba Ltd PA0236/022/001 - CALCITONIN, SALMON 16/07/1998
TOLANASE Pharmacia Limited PA0016/028/001 Tablets - TOLAZAMIDE 16/07/1998
TOLANASE Pharmacia Limited PA0016/028/002 Tablets - TOLAZAMIDE 16/07/1998
ZAVEDOS Farmitalia Carlo Erba Ltd PA0236/024/003 Pdr for Soln for Injection - IDARUBICIN 16/07/1998
HYDROCHLORIDE
ALBUMIN HUMAN 20% Octapharma Limited PA0521/002/006 - HUMAN ALBUMIN 14/07/1998
SALAZOPYRIN Pharmacia Biosystems PA0107/005/006 Oral Suspension - SULFASALAZINE 13/07/1998
Limited
NALCROM Fisons Limited PA0018/016/002 - CROMOGLICATE SODIUM 12/07/1998

NALCROM Fisons Limited PA0018/016/003 - CROMOGLICATE SODIUM 12/07/1998

FARLUTAL 500 Farmitalia Carlo Erba Ltd PA0236/011/006 Tablets - 09/07/1998


MEDROXYPROGESTERO
NE ACETATE
CITRATE PHOSPHATE Baxter Healthcare Limited PA0167/022/001 - SODIUM CITRATE 08/07/1998
DEXTROSE - GLUCOSE
ANTICOAGULANT - CITRIC ACID
- SODIUM ACID
PHOSPHATE
ELTROXIN UCB Pharma Limited PA0365/051/001 Tablets - LEVOTHYROXINE 07/07/1998
SODIUM
LOXAPAC Cyanamid of Great Britain PA0037/004/005 Unknown - LOXAPINE 04/07/1998
LOXAPAC ORAL Cyanamid of Great Britain PA0037/004/004 - LOXAPINE 04/07/1998
(SUSPENSION)
UROMIRO 300 E. Merck Ltd PA0054/044/001 Withdrawn Form - IODAMIDE 04/07/1998
UROMIRO 300 E. Merck Ltd PA0054/044/002 Withdrawn Form - IODAMIDE 04/07/1998
LIGNOCAINE International Medication PA0255/019/001 28/06/1998
HYDROCHLORIDE Systems (UK) Ltd
STERILE SOLUTION
CESAMET Eli Lilly and Company Limite PA0047/056/001 Capsule - NABILONE 23/06/1998

INTERBERIN Hoechst Ireland Limited PA0023/066/001 Powder for solution for - SARGRAMOSTIM 22/06/1998
infusion
INTERBERIN Hoechst Ireland Limited PA0023/066/002 Powder for solution for - SARGRAMOSTIM 22/06/1998
infusion
PERSANTIN Boehringer Ingelheim Limited PA0007/008/006 - DIPYRIDAMOLE 22/06/1998
(SUSPENSION)
METHYLDOPA Pinewood Laboratories Ltd, PA0281/017/002 Tablets - METHYLDOPA 15/06/1998

Human Medicines Withdrawn Products Page 374 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEPHRO LYTE Pinewood Laboratories Ltd, PA0281/035/002 Unknown - SODIUM 14/06/1998
- CALCIUM
- MAGNESIUM
- POTASSIUM
- CHLORINE
- GLUCOSE
NEPHRO LYTE 160 Pinewood Laboratories Ltd, PA0281/035/011 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHRO LYTE 49 Pinewood Laboratories Ltd, PA0281/035/003 - SODIUM CHLORIDE 14/06/1998
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
- GLUCOSE
NEPHRO LYTE 53 Pinewood Laboratories Ltd, PA0281/035/005 - SODIUM 14/06/1998
- CALCIUM
- MAGNESIUM
- POTASSIUM
- CHLORINE
NEPHRO LYTE 61 Pinewood Laboratories Ltd, PA0281/035/006 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHRO LYTE 62 Pinewood Laboratories Ltd, PA0281/035/001 Unknown - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
NEPHRO LYTE 77 Pinewood Laboratories Ltd, PA0281/035/007 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHRO LYTE 81 Pinewood Laboratories Ltd, PA0281/035/008 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHRO-LYTE Pinewood Laboratories Ltd, PA0281/035/004 - SODIUM 14/06/1998
- CALCIUM
- MAGNESIUM
- POTASSIUM
- CHLORINE
NEPHROLYTE 319/B Pinewood Laboratories Ltd, PA0281/046/016 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHRO-LYTE 115 Pinewood Laboratories Ltd, PA0281/035/009 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE

Human Medicines Withdrawn Products Page 375 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEPHRO-LYTE 154 Pinewood Laboratories Ltd, PA0281/035/010 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHROLYTE 183 Pinewood Laboratories Ltd, PA0281/035/012 Unknown - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHROLYTE 186 Pinewood Laboratories Ltd, PA0281/035/013 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
NEPHROLYTE 205 Pinewood Laboratories Ltd, PA0281/035/014 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
NEPHROLYTE 210/B Pinewood Laboratories Ltd, PA0281/046/014 - SODIUM BICARBONATE 14/06/1998
- PURIFIED WATER
- SODIUM CHLORIDE
NEPHROLYTE 211/A Pinewood Laboratories Ltd, PA0281/046/001 - ACETIC ACID 14/06/1998
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- WATER
NEPHROLYTE 221 Pinewood Laboratories Ltd, PA0281/035/015 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
- GLUCOSE
NEPHROLYTE 227 Pinewood Laboratories Ltd, PA0281/035/016 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
NEPHROLYTE 228/A Pinewood Laboratories Ltd, PA0281/046/002 - ACETIC ACID 14/06/1998
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- WATER
NEPHROLYTE 239/A Pinewood Laboratories Ltd, PA0281/046/003 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 241/A Pinewood Laboratories Ltd, PA0281/046/004 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID

Human Medicines Withdrawn Products Page 376 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEPHROLYTE 242/B Pinewood Laboratories Ltd, PA0281/046/015 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 244 Pinewood Laboratories Ltd, PA0281/035/017 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- POTASSIUM CHLORIDE
NEPHROLYTE 246/A Pinewood Laboratories Ltd, PA0281/046/005 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 303/A Pinewood Laboratories Ltd, PA0281/046/006 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 318/A Pinewood Laboratories Ltd, PA0281/046/007 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 330/A Pinewood Laboratories Ltd, PA0281/046/008 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 331/A Pinewood Laboratories Ltd, PA0281/046/009 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 332/A Pinewood Laboratories Ltd, PA0281/046/010 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 357 Pinewood Laboratories Ltd, PA0281/035/018 - SODIUM CHLORIDE 14/06/1998
- SODIUM ACETATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
- GLUCOSE
NEPHROLYTE 358/A Pinewood Laboratories Ltd, PA0281/046/011 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID

Human Medicines Withdrawn Products Page 377 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEPHROLYTE 366/A Pinewood Laboratories Ltd, PA0281/046/012 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
NEPHROLYTE 370/A Pinewood Laboratories Ltd, PA0281/046/013 - SODIUM CHLORIDE 14/06/1998
- POTASSIUM CHLORIDE
- MAGNESIUM CHLORIDE
ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- PURIFIED WATER
- ACETIC ACID
BICART SODIUM Pinewood Laboratories Ltd, PA0281/048/001 PDR for Soln for - SODIUM BICARBONATE 13/06/1998
BICARBONATE Haemodialysis
BICART, SODIUM Gambro UK Limited PA0479/002/001 Concentrate for solution for - SODIUM BICARBONATE 13/06/1998
BICARBONATE COLUMN haemodialysis
CORSYM (SUSPENSION) Fisons Pharmaceuticals PA0072/010/001 - 09/06/1998
(Ireland) PHENYLPROPANOLAMINE
HYDROCHLORIDE
- CHLORPHENAMINE
PARACODOL Fisons Limited PA0018/014/002 Capsule - PARACETAMOL 09/06/1998
- CODEINE PHOSPHATE
PINAMOX - SUGAR FREE Pinewood Laboratories Ltd, PA0281/036/005 - AMOXICILLIN 09/06/1998
REDEPTIN SmithKline and French PA0060/002/001 09/06/1998
Laboratories Ltd
REDEPTIN SmithKline and French PA0060/002/002 09/06/1998
Laboratories Ltd
ZAM BUK Fisons Limited PA0018/033/001 Ointment - CAMPHENE 09/06/1998
POSICOR Roche Registration Limited PA0796/002/001 Tablets - MIBEFRADIL 08/06/1998
DIHYDROCHLORIDE
POSICOR Roche Registration Limited PA0796/002/002 Tablets 08/06/1998
PSORADRATE Procter & Gamble PA0170/010/002 - DITHRANOL 08/06/1998
Pharmaceuticals UK Limited - UREA
PSORADRATE Procter & Gamble PA0170/010/003 Cream - DITHRANOL 08/06/1998
Pharmaceuticals UK Limited - UREA
ESTRAPAK Novartis Pharmaceuticals UK PA0013/071/001 - NORETHISTERONE 31/05/1998
Ltd ACETATE
- ESTRADIOL
ESTRAPAK Novartis Pharmaceuticals UK PA0013/071/003 - NORETHISTERONE 31/05/1998
Ltd ACETATE
- ESTRADIOL
ARPICOLIN Rosemont Pharmaceuticals PA0312/002/001 Syrup - PROCYCLIDINE 27/05/1998
Ltd HYDROCHLORIDE
FARLUTAL (SUSPENSION) Farmitalia Carlo Erba Ltd PA0236/011/007 - 26/05/1998
MEDROXYPROGESTERO
NE ACETATE
ARPICOLIN SYRUP Rosemont Pharmaceuticals PA0312/002/002 Syrup - PROCYCLIDINE 25/05/1998
Ltd HYDROCHLORIDE
BC 500 WITH IRON John Wyeth & Brother PA0022/056/001 Tablets - THIAMINE MONONITRATE 23/05/1998
Limited - RIBOFLAVIN
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
- CALCIUM
PANTOTHENATE
- FERROUS FUMARATE
- ASCORBIC ACID

RUBEX BLACKCURRANT Ricesteele Manufacturing Ltd PA0095/008/007 Tablets 18/05/1998

PSORADRATE Procter & Gamble PA0170/010/001 Cream - DITHRANOL 17/05/1998


Pharmaceuticals UK Limited - UREA
FLUARIX VACCINE SmithKline Beecham Plc PA0620/002/001 - A/SINGAPORE 6/86 15/05/1998
- B/BEYING /1/87
- B/PANAMA/45/90
FLUARIX VACCINE SmithKline Beecham Plc PA0620/002/003 - A/SINGAPORE 6/86 15/05/1998
SYRINGE - B/BEYING /1/87
- B/PANAMA/45/90
INACTIVATED INFLUENZA Sanofi Pasteur MSD Ltd PA0544/012/001 13/05/1998
VACCINE BP
MELBETESE 2.5 Clonmel Healthcare Ltd PA0126/070/002 10/05/1998
MELBETESE 5 Clonmel Healthcare Ltd PA0126/070/001 10/05/1998

Human Medicines Withdrawn Products Page 378 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VISDERM H Cyanamid of Great Britain PA0037/038/001 Cream 09/05/1998
ERYTHROMYCIN Abbott Laboratories Ireland PA0038/029/002 Tablets 08/05/1998
Ltd
NITROLINGUAL SPRAY Lipha Pharmaceuticals PA0289/001/001 Sublingual spray, solution - GLYCERYL TRINITRATE 04/05/1998
Limited
NIFENSAR Rorer Pharmaceuticals PA0468/025/001 Tablets - NIFEDIPINE 27/04/1998
Limited
NIFENSAR Rorer Pharmaceuticals PA0468/025/002 Tablets - NIFEDIPINE 27/04/1998
Limited
KETOVAIL 100 Sanofi-Aventis Ireland PA0540/009/001 Capsule - KETOPROFEN 26/04/1998
CONTROLLED RELEASE Limited T/A SANOFI
KETOVAIL 200 Sanofi-Aventis Ireland PA0540/009/002 Capsule - KETOPROFEN 26/04/1998
CONTROLLED RELEASE Limited T/A SANOFI
DIPROSONE Lambert Chemicals Co. Ltd PA0377/034/003 Cream - BETAMETHASONE 25/04/1998
DIPROPIONATE
RECTOVALONE Parke-Davis PA0470/001/001 - TIXOCORTOL PIVALATE 23/04/1998
(SUSPENSION)
TINCTURE OF IODINE Foran Healthcare Limited PA0484/009/001 - IODINE 23/04/1998
OPTIRAY 240 Mallinckrodt UK Limited PA0199/001/004 Solution for Injection - IOVERSOL 22/04/1998
VENOGLOBULIN Grifols UK Limited PA0415/003/001 22/04/1998
VENOGLOBULIN Grifols UK Limited PA0415/003/002 Withdrawn Form - IMMUNOGLOBULIN 22/04/1998
HUMAN NORMAL
VENOGLOBULIN Grifols UK Limited PA0415/003/003 Withdrawn Form - IMMUNOGLOBULIN 22/04/1998
HUMAN NORMAL
VENOGLOBULIN Grifols UK Limited PA0415/003/004 Withdrawn Form - IMMUNOGLOBULIN 22/04/1998
HUMAN NORMAL
MAGNEVIST ENTERAL HE Clissmann PA0012/067/004 Oral Solution - GADOPENTETATE 21/04/1998
DIMEGLUMINE
ATENOLOL Norton Waterford PA0436/010/001 Tablets - ATENOLOL 19/04/1998
ATENOLOL Norton Waterford PA0436/010/002 Tablets - ATENOLOL 19/04/1998
ROACCUTANE Roche Products Limited PA0050/053/003 Capsule - ISOTRETINOIN 19/04/1998
NALOXONE International Medication PA0255/036/002 Withdrawn Form 18/04/1998
HYDROCHLORIDE Systems (UK) Ltd
NALOXONE International Medication PA0255/036/003 Withdrawn Form 18/04/1998
HYDROCHLORIDE Systems (UK) Ltd
MERONEM Zeneca Limited PA0051/063/001 Solution for Injection - MEROPENEM 16/04/1998
BACTRIM ROCHE Roche Products Limited PA0050/003/001 Tablets - SULFAMETHOXAZOLE 15/04/1998
DRAPSULES - TRIMETHOPRIM
BACTRIM ROCHE Roche Products Limited PA0050/003/004 Syrup - SULFAMETHOXAZOLE 15/04/1998
PAEDIATRIC - TRIMETHOPRIM
ERGAMISOL Janssen Pharmaceuticals Lt PA0545/025/001 Tablets 08/04/1998

ALUDROX PLUS John Wyeth & Brother PA0022/039/002 Tablets - MAGNESIUM HYDROXIDE 01/04/1998
Limited - DIMETICONE, ACTIVATED
- ALUMINIUM HYDROXIDE

ANAFRANIL Novartis Pharmaceuticals UK PA0013/084/004 Syrup - CLOMIPRAMINE 01/04/1998


Ltd
ANAFRANIL AMPOULES Novartis Pharmaceuticals UK PA0013/084/005 - CLOMIPRAMINE 01/04/1998
Ltd HYDROCHLORIDE
AUREOCORT Cyanamid of Great Britain PA0037/028/002 Cream 01/04/1998
AVENTYL Eli Lilly and Company Limite PA0047/025/001 Capsule - NORTRIPTYLINE 01/04/1998
HYDROCHLORIDE
AVENTYL Eli Lilly and Company Limite PA0047/025/002 Capsule - NORTRIPTYLINE 01/04/1998
HYDROCHLORIDE
CALCIUM-SANDOZ Novartis Pharmaceuticals UK PA0013/029/002 Withdrawn Form - CALCIUM GLUBIONATE 01/04/1998
Ltd - CALCIUM LACTOBIONATE

CETAMOL Mercury Pharmaceuticals PA0073/016/001 Tablets - PARACETAMOL 01/04/1998


(Ireland) Ltd
CETAMOL Mercury Pharmaceuticals PA0073/016/002 - PARACETAMOL 01/04/1998
(Ireland) Ltd
CLONALIN Clonmel Healthcare Ltd PA0126/024/001 01/04/1998
COMPOUND SODIUM B. Braun Medical Limited PA0179/004/001 Withdrawn Form 01/04/1998
LACTATE
COMPOUND SODIUM B. Braun Medical Limited PA0179/004/002 Withdrawn Form 01/04/1998
LACTATE
CONRAY 280 May & Baker Limited PA0040/051/001 Solution for Injection - IOTALAMATE 01/04/1998
MEGLUMINE
CONRAY 280 May & Baker Limited PA0040/051/002 Solution for Injection - IOTALAMATE 01/04/1998
MEGLUMINE
CONRAY 325 May & Baker Limited PA0040/054/001 Solution for Injection - IOTALAMATE SODIUM 01/04/1998
CONRAY 325 May & Baker Limited PA0040/054/002 Solution for Injection - IOTALAMATE SODIUM 01/04/1998
CONRAY 420 May & Baker Limited PA0040/053/001 Solution for Injection - IOTALAMATE SODIUM 01/04/1998

Human Medicines Withdrawn Products Page 379 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CONRAY 420 May & Baker Limited PA0040/053/002 Solution for Injection - IOTALAMATE SODIUM 01/04/1998
CYCLO PROGYNOVA HE Clissmann PA0012/023/001 Tablets - ESTRADIOL VALERATE 01/04/1998
- NORGESTREL
DIAMOX SUSTETS Cyanamid of Great Britain PA0037/029/002 Capsule 01/04/1998
EDECRIN Merck Sharp and Dohme PA0035/024/002 Tablets - ETACRYNIC ACID 01/04/1998
Limited
HAELAN Dista Products Limited PA0447/009/001 Cream - FLUDROXYCORTIDE 01/04/1998
HAELAN Dista Products Limited PA0447/009/002 Ointment - FLUDROXYCORTIDE 01/04/1998
HIBITANE Zeneca Limited PA0051/046/004 - CHLORHEXIDINE 01/04/1998
GLUCONATE
IPESIL Mercury Pharmaceuticals PA0073/075/001 Syrup - SQUILL TINCTURE 01/04/1998
(Ireland) Ltd - IPECACUANHA
TINCTURE
KOLANTYL Marion Merrell Limited PA0041/014/001 Gel - DICYCLOMINE 01/04/1998
HYDROCHLORIDE
- ALUMINIUM HYDROXIDE
GEL, DRIED
- MAGNESIUM OXIDE
LIGHT
KONAKION Roche Products Limited PA0050/051/003 Withdrawn Form - PHYTOMENADIONE 01/04/1998
LAROXYL Roche Products Limited PA0050/021/002 Tablets - AMITRIPTYLINE 01/04/1998
HYDROCHLORIDE
LEDERCORT Cyanamid of Great Britain PA0037/030/002 Ointment 01/04/1998
LEDERCORT Cyanamid of Great Britain PA0037/030/004 Tablets 01/04/1998
LEDERCORT Cyanamid of Great Britain PA0037/030/005 Tablets 01/04/1998
LEVIUS Farmitalia Carlo Erba Ltd PA0236/006/001 Tablets 01/04/1998
LIPIODOL May & Baker Limited PA0040/059/001 Solution for Injection - POPPY SEED OIL 01/04/1998
IODISED FATTY ACID
ETHYLESTERS
MICROLUT HE Clissmann PA0012/012/001 Tablets - LEVONORGESTREL 01/04/1998
OPERIDINE Janssen Pharmaceuticals Lt PA0545/014/001 Withdrawn Form 01/04/1998

PAEDAVIT Mercury Pharmaceuticals PA0073/080/001 - MULTIVITAMINS 01/04/1998


(Ireland) Ltd
PARACODOL Fisons Limited PA0018/014/001 Tablets - PARACETAMOL 01/04/1998
- CODEINE PHOSPHATE
PARFENAC Cyanamid of Great Britain PA0037/032/001 Cream 01/04/1998
PETROLAGAR John Wyeth & Brother PA0022/027/001 Emulsion for Infusion - PHENOLPHTHALEIN 01/04/1998
Limited - PARAFFIN, LIQUID
PHOSPHATE-SANDOZ Novartis Pharmaceuticals UK PA0013/030/001 Tablets - SODIUM PHOSPHATE 01/04/1998
Ltd DIBASIC
- SODIUM BICARBONATE
- POTASSIUM
BICARBONATE
PROGYNOVA HE Clissmann PA0012/024/001 Tablets - ESTRADIOL VALERATE 01/04/1998
RHEOMACRODEX/DEXTR Pharmacia Biosystems PA0107/009/001 Solution for Infusion - DEXTRAN 40 01/04/1998
OSE Limited
RHEOMACRODEX/SALINE Pharmacia Biosystems PA0107/009/002 Solution for Infusion - DEXTRAN 40 01/04/1998
Limited
ROBAXISAL A.H. Robins Company PA0086/007/001 Tablets - ACETYLSALICYLIC ACID 01/04/1998
Limited - METHOCARBAMOL
SANDO-K Novartis Pharmaceuticals UK PA0013/031/001 Tablets - POTASSIUM CHLORIDE 01/04/1998
Ltd - POTASSIUM
BICARBONATE
SINTISONE Farmitalia Carlo Erba Ltd PA0236/007/001 Tablets 01/04/1998
SOLPRIN Reckitt's (Ireland) Limited PA0027/007/001 Tablets - ACETYLSALICYLIC ACID 01/04/1998
ULTRADIL HE Clissmann PA0012/030/001 Cream - FLUOCORTOLONE 01/04/1998
CAPROATE
- FLUOCORTOLONE
PIVALATE
TEMPOROL Orion Pharma A/s PA0303/016/002 Tablets - CARBAMAZEPINE 31/03/1998
METOCLOPRAMIDE Ethical Pharmaceuticals UK PA0467/003/001 Tablets - METOCLOPRAMIDE 29/03/1998
Ltd. HYDROCHLORIDE
PYRIDOXINE Ethical Pharmaceuticals UK PA0467/001/001 Tablets - PYRIDOXINE 29/03/1998
HYDROCHLORIDE Ltd. HYDROCHLORIDE
LOCERYL Roche Products Limited PA0050/082/001 Cream - AMOROLFINE 25/03/1998
HYDROCHLORIDE
VISKEN Novartis Pharmaceuticals UK PA0013/001/004 Tablets - PINDOLOL 22/03/1998
Ltd
THEO NOVA Elan Pharma Ltd PA0516/009/005 Capsule 16/03/1998
THEO NOVA Elan Pharma Ltd PA0516/009/006 Capsule 16/03/1998
THEOPHYLLINE Elan Pharma Ltd PA0516/009/004 Capsule 16/03/1998

Human Medicines Withdrawn Products Page 380 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
REDELAN Roche Products Limited PA0050/029/001 Tablets Effervescent - RETINOL PALMITATE 15/03/1998
- THIAMINE MONONITRATE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CYANOCOBALAMIN
- ASCORBIC ACID
- ERGOCALCIFEROL
- TOCOPHERYL ACETATE

GRISEODERM Ethical Pharmaceuticals UK PA0467/002/001 - GRISEOFULVIN 14/03/1998


Ltd.
DELFEN Cilag Limited PA0059/023/001 Cream - NONOXINOL 13/03/1998
GRANOCYTE Chugai Sanofi-Aventis PA0639/001/002 Withdrawn Form - LENOGRASTIM 13/03/1998
HALDOL Janssen Pharmaceuticals Lt PA0545/005/002 Tablets - HALOPERIDOL 13/03/1998

MOTILIUM Janssen Pharmaceuticals Lt PA0545/018/006 Granules Effervescent 13/03/1998

ORTHO-GYNEST Cilag Limited PA0059/017/002 Cream - ESTRIOL 13/03/1998


FRIARS BALSAM Foran Healthcare Limited PA0484/015/001 - ETHANOL 09/03/1998
BAUSCH & LOMB Bausch & Lomb UK Limited PA0555/004/001 - SODIUM CHLORIDE 25/02/1998
AEROSOL SALINE
BAUSCH & LOMB DAILY Bausch & Lomb UK Limited PA0555/002/001 - SORBIC ACID 25/02/1998
CLEANER - EDETATE DISODIUM
- SODIUM CHLORIDE
- SODIUM BORATE
- HYPROMELLOSE
- PURIFIED WATER
BAUSCH & LOMB Bausch & Lomb UK Limited PA0555/003/001 Tablets 25/02/1998
FIZZICLEAN CLEANING
BAUSCH & LOMB SALINE Bausch & Lomb UK Limited PA0555/001/001 - SORBIC ACID 25/02/1998
- EDETATE DISODIUM
- SODIUM CHLORIDE
- BORIC ACID
- SODIUM BORATE
BEKUNIS HERBAL Roha Arzneimittel GmbH & PA0434/001/003 Tablets 25/02/1998
Co. K.G
INTRON A Schering-Plough Limited PA0277/050/007 - INTERFERON ALFA-2B 24/02/1998
INTRON A Schering-Plough Limited PA0277/050/008 - INTERFERON ALFA-2B 24/02/1998
INTRON A Schering-Plough Limited PA0277/050/009 - INTERFERON ALFA-2B 24/02/1998
INTRON A Schering-Plough Limited PA0277/050/010 - INTERFERON ALFA-2B 24/02/1998
LIGNOCAINE International Medication PA0255/004/001 Withdrawn Form 24/02/1998
HYDROCHLORIDE Systems (UK) Ltd
METHYLENE BLUE Penn Pharmaceuticals Ltd PA0650/009/001 Withdrawn Form - METHYLTHIONINIUM 24/02/1998
CHLORIDE
- WATER FOR INJECTIONS

SODIUM BICARBONATE Penn Pharmaceuticals Ltd PA0650/001/001 - SODIUM BICARBONATE 24/02/1998


INFUSION - EDETATE DISODIUM
- WATER FOR INJECTIONS

DAKTARIN Janssen Pharmaceuticals Lt PA0545/008/004 Solution for Injection 20/02/1998

DAKTARIN Janssen Pharmaceuticals Lt PA0545/008/005 Tablets 20/02/1998

TINSET Janssen Pharmaceuticals Lt PA0545/021/001 Tablets - OXATOMIDE 20/02/1998

NOVOFILINE Medical & Pharmaceutical PA0309/006/001 Tablets - THEOPHYLLINE 19/02/1998


Sales C - PROXYPHYLLINE
- DIPROPHYLLINE
HALDOL Janssen Pharmaceuticals Lt PA0545/005/001 Tablets - HALOPERIDOL 16/02/1998

PHARCETIL SUGAR-FREE B.V. Pharbita PA0508/005/001 16/02/1998


ZADSTAT Cyanamid of Great Britain PA0037/020/002 Pessary - METRONIDAZOLE 11/02/1998
ZADSTAT Cyanamid of Great Britain PA0037/020/003 Suppositories - METRONIDAZOLE 11/02/1998
ZADSTAT Cyanamid of Great Britain PA0037/020/004 Suppositories - METRONIDAZOLE 11/02/1998
SAVLODIL Zeneca Limited PA0051/040/001 - CHLORHEXIDINE 08/02/1998
GLUCONATE
- CETRIMONIUM BROMIDE

Human Medicines Withdrawn Products Page 381 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SAVLODIL Zeneca Limited PA0051/040/002 - CHLORHEXIDINE 08/02/1998
GLUCONATE
- CETRIMONIUM BROMIDE

ALOMIDE OPHTHALMIC Galen Limited PA0185/022/001 - LODOXAMIDE 02/02/1998


MODURETIC Merck Sharp and Dohme PA0035/029/001 Tablets - AMILORIDE 29/01/1998
Limited HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

TESTOVIRON DEPOT HE Clissmann PA0012/029/001 Solution for Injection - TESTOSTERONE 29/01/1998


ENANTATE
CAM MIXTURE Rybar Laboratories Ltd PA0003/002/001 - EPHEDRINE 28/01/1998
HYDROCHLORIDE
CYFOL Rybar Laboratories Ltd PA0003/003/001 Tablets - FERROUS GLUCONATE 28/01/1998
- FOLIC ACID
- CYANOCOBALAMIN
FORTUM St. Jamess Hospital PA0681/001/001 Withdrawn Form - CEFTAZIDIME 28/01/1998
PENTAHYDRATE
FORTUM St. Jamess Hospital PA0681/001/002 Withdrawn Form - CEFTAZIDIME 28/01/1998
PENTAHYDRATE
APSOLOX Teva UK Limited PA0237/021/001 Tablets 27/01/1998
APSOLOX Teva UK Limited PA0237/021/002 Tablets 27/01/1998
APSOLOX Teva UK Limited PA0237/021/003 Tablets 27/01/1998
APSOLOX Teva UK Limited PA0237/021/004 Tablets 27/01/1998
EN-DE-KAY Stafford Miller Limited PA0069/016/002 Tablets 26/01/1998
EN-DE-KAY Stafford Miller Limited PA0069/016/003 Tablets 26/01/1998
IODINE LINIMENT Pinewood Laboratories Ltd, PA0281/050/001 - IODINE 26/01/1998
IODINE TINCTURE BP Pinewood Laboratories Ltd, PA0281/050/002 - IODINE 26/01/1998
PIPERAZINE CITRATE Pinewood Laboratories Ltd, PA0281/001/001 - PIPERAZINE CITRATE 26/01/1998
SYRUP CODEINE Pinewood Laboratories Ltd, PA0281/005/003 Oral Solution - CODEINE PHOSPHATE 26/01/1998
PHOSPHATE B.P.C. HEMIHYDRATE
TRICOMOX PAEDIATRIC Pinewood Laboratories Ltd, PA0281/022/002 - TRIMETHOPRIM 26/01/1998
(SUSPENSION) - SULFAMETHOXAZOLE
ADRENALINE International Medication PA0255/002/001 Withdrawn Form 25/01/1998
Systems (UK) Ltd
MEDIJEL D.D.D. Limited PA0302/001/002 Lozenges - LIDOCAINE 23/01/1998
- AMINOACRIDINE
HYDROCHLORIDE
TOFRANIL Novartis Pharmaceuticals UK PA0013/086/001 Tablets - IMIPRAMINE 23/01/1998
Ltd HYDROCHLORIDE
CO TRIMOXAZOLE Teva UK Limited PA0237/019/001 Tablets 20/01/1998
CO-TRIMOXAZOLE Teva UK Limited PA0237/019/002 Tablets 20/01/1998
CO-TRIMOXAZOLE Teva UK Limited PA0237/019/003 Tablets 20/01/1998
CIDOMEL 50 Clonmel Healthcare Ltd PA0126/029/002 20/01/1998
EPIFRIN Allergan Pharmaceuticals PA0148/008/002 - EPINEPHRINE 20/01/1998
Ireland
EPIFRIN Allergan Pharmaceuticals PA0148/008/003 - EPINEPHRINE 20/01/1998
Ireland
DESMOTABS Ferring Pharmaceuticals PA0224/013/001 19/01/1998
Limited
ENTEROSAN Windsor Healthcare Ltd PA0429/001/001 Tablets - KAOLIN, LIGHT 19/01/1998
- MORPHINE
HYDROCHLORIDE
- ATROPA BELLADONNA
DIAZEPAM Accord-UK Ltd PA0176/001/001 Tablets - DIAZEPAM 18/01/1998
DIAZEPAM Accord-UK Ltd PA0176/001/002 Tablets - DIAZEPAM 18/01/1998
DIAZEPAM Accord-UK Ltd PA0176/001/003 Tablets - DIAZEPAM 18/01/1998
NITRAZEPAM Accord-UK Ltd PA0176/002/001 Tablets - NITRAZEPAM 18/01/1998
SURELAX LAXATIVE Peter Black Healthcare Ltd PA0522/002/001 Tablets - YELLOW 16/01/1998
PHENOLPHTHALEIN
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/004 - COLISTIN SULFATE 13/01/1998
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/007 Withdrawn Form - GENTAMICIN 13/01/1998
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/008 Withdrawn Form - GENTAMICIN 13/01/1998
BUTORPHANOL Bristol-Myers Squibb PA0048/010/001 Withdrawn Form - BUTORPHANOL 12/01/1998
TARTRATE (Holdings) Limited
BUTORPHANOL Bristol-Myers Squibb PA0048/010/002 Withdrawn Form - BUTORPHANOL 12/01/1998
TARTRATE (Holdings) Limited
BENYLIN PAEDIATRIC Parke Davis & Company PA0056/010/001 Syrup - DIPHENHYDRAMINE 08/01/1998
HYDROCHLORIDE
- SODIUM CITRATE
- MENTHOL
CHOLEDYL Parke Davis & Company PA0056/062/001 Syrup - CHOLINE 08/01/1998
THEOPHYLLINATE
CHOLEDYL Warner Lambert (UK) Limite PA0856/013/002 Tablets - CHOLINE 08/01/1998
THEOPHYLLINATE

Human Medicines Withdrawn Products Page 382 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CHOLEDYL Warner Lambert (UK) Limite PA0856/013/003 Tablets - CHOLINE 08/01/1998
THEOPHYLLINATE
AMYLINE Mercury Pharmaceuticals PA0073/049/001 Tablets - AMITRIPTYLINE 07/01/1998
(Ireland) Ltd
AMYLINE Mercury Pharmaceuticals PA0073/049/002 Tablets - AMITRIPTYLINE 07/01/1998
(Ireland) Ltd
DIORALYTE Rorer Pharmaceuticals PA0468/002/001 Tablets Effervescent - GLUCOSE 07/01/1998
EFFERVESCENT Limited - SODIUM BICARBONATE
- POTASSIUM CHLORIDE
- CITRIC ACID
- SODIUM CHLORIDE
DIORALYTE Rorer Pharmaceuticals PA0468/002/003 Tablets Effervescent - GLUCOSE 07/01/1998
EFFERVESCENT Limited - POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- CITRIC ACID
- SODIUM BICARBONATE
MODITEN Bristol-Myers Squibb PA0002/041/001 Tablets - FLUPHENAZINE 07/01/1998
Pharmaceuticals uc HYDROCHLORIDE
MODITEN Bristol-Myers Squibb PA0002/041/002 Tablets - FLUPHENAZINE 07/01/1998
Pharmaceuticals uc HYDROCHLORIDE
MODITEN Bristol-Myers Squibb PA0002/041/003 Tablets - FLUPHENAZINE 07/01/1998
Pharmaceuticals uc HYDROCHLORIDE
METHYLDOPA Accord-UK Ltd PA0176/022/001 Tablets - METHYLDOPA 02/01/1998
10.10 CLEANING & Ciba Vision (UK) Ltd PA0628/002/001 - HYDROGEN PEROXIDE 31/12/1997
DISINFECTING
10.10 RINSING & Ciba Vision (UK) Ltd PA0628/003/001 - SODIUM PYRUVATE 31/12/1997
NEUTRALISING - SODIUM CHLORIDE
- EDETATE DISODIUM
- BORIC ACID
- SODIUM BORATE
- PURIFIED WATER
CO-CODAPRIN Clonmel Healthcare Ltd PA0126/046/001 Tablets 30/12/1997
HALOPERIDOL Clonmel Healthcare Ltd PA0126/055/001 Tablets 30/12/1997
PAEDIATRIC Clonmel Healthcare Ltd PA0126/065/002 30/12/1997
PARACETAMOL ELIXIR
PREDNISONE Clonmel Healthcare Ltd PA0126/059/001 Tablets 30/12/1997
SALBUTAMOL Norton Waterford PA0436/008/003 Tablets - SALBUTAMOL 30/12/1997
SALBUTAMOL Norton Waterford PA0436/008/004 Tablets - SALBUTAMOL 30/12/1997
SODIUM FLORIDE Clonmel Healthcare Ltd PA0126/050/001 Tablets 30/12/1997
SODIUM FLORIDE Clonmel Healthcare Ltd PA0126/050/002 Tablets 30/12/1997
VITAMIN B6 Clonmel Healthcare Ltd PA0126/074/001 Tablets 30/12/1997
VITAMIN C Clonmel Healthcare Ltd PA0126/068/001 Tablets 30/12/1997
COTRIMEL Clonmel Healthcare Ltd PA0126/033/001 Tablets 23/12/1997
COTRIMEL FORTE Clonmel Healthcare Ltd PA0126/033/003 Tablets - SULFAMETHOXAZOLE 23/12/1997
- TRIMETHOPRIM
SALBUTAMOL Clonmel Healthcare Ltd PA0126/040/002 Tablets 23/12/1997
SALBUTAMOL Clonmel Healthcare Ltd PA0126/040/003 Tablets 23/12/1997
BUTORPHANOL Bristol-Myers Squibb PA0048/010/004 Withdrawn Form - BUTORPHANOL 22/12/1997
TARTRATE (Holdings) Limited TARTRATE
NAPROXEN McDermott Laboratories Ltd PA0577/003/001 - NAPROXEN 22/12/1997
t/a Gerard Laboratories
NAPROXEN McDermott Laboratories Ltd PA0577/003/002 Tablets - NAPROXEN 22/12/1997
t/a Gerard Laboratories
BUTORPHANOL Bristol-Myers Squibb PA0048/010/003 Withdrawn Form - BUTORPHANOL 20/12/1997
TARTRATE (Holdings) Limited TARTRATE
EN-DE-KAY Stafford Miller Limited PA0069/016/001 Tablets 17/12/1997
HUMAN VELOSULIN Novo Nordisk A/S PA0218/037/001 17/12/1997
HUMAN VELOSULIN Novo Nordisk A/S PA0218/037/003 17/12/1997
HYDROCORTISONE Daniels Pharmaceutical Ltd PA0396/003/002 Ointment 17/12/1997
PETOLAGAR/PHENOLPHT John Wyeth & Brother PA0022/023/001 - PHENOLPHTHALEIN 16/12/1997
HALEIN Limited - PARAFFIN, LIQUID
DUOBACT Orion Pharma A/s PA0303/015/003 Tablets - SULFAMETHOXAZOLE 10/12/1997
- TRIMETHOPRIM
EMULSIFYING Ricesteele Manufacturing Ltd PA0095/017/001 Ointment 08/12/1997

HYDROGEN PEROXIDE 20 Ricesteele Manufacturing Ltd PA0095/019/001 08/12/1997


VOLUMES
SULTRIN Cilag Limited PA0059/005/002 Tablets - SULFACETAMIDE 08/12/1997
- SULPHOAMINOBENZOIC
ACID
- SULFATHIAZOLE
GYNO TRAVOGEN OVULE HE Clissmann PA0012/046/004 - ISOCONAZOLE NITRATE 04/12/1997
SWARM J. Pickles & Sons PA0495/009/001 Cream - CALAMINE 30/11/1997
- DIBROMPROPAMIDINE
ISETIONATE

Human Medicines Withdrawn Products Page 383 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FRUSEMIDE May & Baker Limited PA0040/093/001 Solution for Injection - FUROSEMIDE 27/11/1997
HEALONID Pharmacia Laboratories PA0187/040/002 - HYALURONATE SODIUM 25/11/1997
Limited
SUGAR FREE SUDAFED Wellcome (Ireland) Limited PA0017/054/005 Syrup - PSEUDOEPHEDRINE 25/11/1997
ELIXIR HYDROCHLORIDE
BRETYLATE Wellcome (Ireland) Limited PA0017/068/001 Withdrawn Form - BRETYLIUM TOSILATE 24/11/1997
ELANTAN SCHWARZ PHARMA Limite PA0271/001/004 - ISOSORBIDE 24/11/1997
MONONITRATE
ELANTAN SCHWARZ PHARMA Limite PA0271/001/005 - ISOSORBIDE 24/11/1997
MONONITRATE
ELANTAN 0.1% SCHWARZ PHARMA Limite PA0271/001/006 - ISOSORBIDE 24/11/1997
MONONITRATE
ELANTAN 0.1% SCHWARZ PHARMA Limite PA0271/001/007 - ISOSORBIDE 24/11/1997
MONONITRATE
PRO-ACTIDIL T Wellcome (Ireland) Limited PA0017/048/001 Tablets - TRIPROLIDINE 24/11/1997
HYDROCHLORIDE
SONI SLO Helsinn Birex PA0294/021/001 Capsule - ISOSORBIDE DINITRATE 24/11/1997
Pharmaceuticals Limited
SONI SLO Helsinn Birex PA0294/021/002 Capsule - ISOSORBIDE DINITRATE 24/11/1997
Pharmaceuticals Limited
HEALONID YELLOW Pharmacia Laboratories PA0187/040/005 - HYALURONATE SODIUM 18/11/1997
Limited - FLUORESCEIN SODIUM
HEALONID YELLOW Pharmacia Laboratories PA0187/040/006 - HYALURONATE SODIUM 18/11/1997
Limited - FLUORESCEIN SODIUM
ATENOLOL McDermott Laboratories Ltd PA0577/004/001 Tablets - ATENOLOL 17/11/1997
t/a Gerard Laboratories
ATENOLOL McDermott Laboratories Ltd PA0577/004/002 Tablets - ATENOLOL 17/11/1997
t/a Gerard Laboratories
MANNS SUPER GARLIC Pharma-Global Limited PA0141/025/001 Capsule - LACTOSE 17/11/1997
PILLS MONOHYDRATE
- STARCH MAIZE
NORGOTIN Helsinn Birex PA0294/011/001 - TETRACAINE 17/11/1997
Pharmaceuticals Limited HYDROCHLORIDE
- EPHEDRINE
HYDROCHLORIDE
- CHLORHEXIDINE
DIACETATE
- PROPYLENE GLYCOL
ROCEPHIN 1M Roche Products Limited PA0050/086/001 Withdrawn Form - LIDOCAINE 16/11/1997
HYDROCHLORIDE
ROCEPHIN 1V Roche Products Limited PA0050/087/001 Withdrawn Form - WATER FOR INJECTIONS 16/11/1997

ROCEPHIN 1V Roche Products Limited PA0050/087/002 Withdrawn Form - WATER FOR INJECTIONS 16/11/1997

EPREX Cilag Limited PA0059/042/001 Withdrawn Form - ERYTHROPOIETIN 12/11/1997


HUMAN
EPREX Cilag Limited PA0059/042/002 Withdrawn Form - ERYTHROPOIETIN 12/11/1997
HUMAN
EPREX Cilag Limited PA0059/042/003 Withdrawn Form - ERYTHROPOIETIN 12/11/1997
HUMAN
EPREX Cilag Limited PA0059/042/009 Withdrawn Form - ERYTHROPOIETIN 12/11/1997
HUMAN
NAPROSYN Syntex Pharmaceuticals PA0033/005/006 Granules for Oral - NAPROXEN 11/11/1997
Limited Suspension
THEOPHORIN Sinclair Pharmaceuticals PA0251/007/001 Tablets 11/11/1997
Limited
DOPAMINE International Medication PA0255/011/002 Withdrawn Form 10/11/1997
HYDROCHLORIDE Systems (UK) Ltd
DOPAMINE International Medication PA0255/011/003 Withdrawn Form 10/11/1997
HYDROCHLORIDE Systems (UK) Ltd
UBRETID AMPOULES Rorer Pharmaceuticals PA0468/009/001 - DISTIGMINE BROMIDE 09/11/1997
Limited - SODIUM CHLORIDE
CIMETIDINE A/S GEA Farmaceutisk PA0310/002/001 Tablets - CIMETIDINE 06/11/1997
Fabrik
CIMETIDINE A/S GEA Farmaceutisk PA0310/002/002 Tablets - CIMETIDINE 06/11/1997
Fabrik
CIMETIDINE A/S GEA Farmaceutisk PA0310/002/004 Tablets - CIMETIDINE 06/11/1997
Fabrik
ISOVIST HE Clissmann PA0012/068/003 Withdrawn Form - IOTROLAN 04/11/1997
RUBEX CHEWABLE Ricesteele Manufacturing Ltd PA0095/008/008 Tablets 01/11/1997
BLACKCURRANT
SAVENTRINE Forest Laboratories UK Ltd PA0100/016/001 Tablets - ISOPRENALINE 31/10/1997
HYDROCHLORIDE
SYNTHAMIX 14/1200X Clintec Nutrition Limited (UK) PA0708/004/003 - AMINO ACIDS 28/10/1997
- GLUCOSE
- ELECTROLYTES NOS

Human Medicines Withdrawn Products Page 384 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SYNTHAMIX 14/2200X Clintec Nutrition Limited (UK) PA0708/004/004 - AMINO ACIDS 28/10/1997
- GLUCOSE
- ELECTROLYTES NOS
SYNTHAMIX 9/1800X Clintec Nutrition Limited (UK) PA0708/004/002 - AMINO ACIDS 28/10/1997
- GLUCOSE
- ELECTROLYTES NOS
MORSEP Napp Laboratories Limited PA0114/037/001 Cream - CETRIMONIUM BROMIDE 21/10/1997
- RETINOL

GEVRAL Cyanamid of Great Britain PA0037/022/006 Tablets 20/10/1997


MODURETIC Merck Sharp and Dohme PA0035/029/002 - AMILORIDE 19/10/1997
Limited HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

MODURETIC Merck Sharp and Dohme PA0035/029/003 - AMILORIDE 19/10/1997


Limited HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

BACTIGRAS T.J. Smith & Nephew PA0518/004/001 16/10/1997


AMINOPHYLLINE International Medication PA0255/013/002 Withdrawn Form 10/10/1997
Systems (UK) Ltd
DIPHENHYDRAMINE International Medication PA0255/014/001 Withdrawn Form 10/10/1997
Systems (UK) Ltd
PURITAN COD LIVER OIL Ricesteele Manufacturing Ltd PA0095/015/001 09/10/1997

STELAZINE AMPOULE SmithKline and French PA0060/016/008 Withdrawn Form 02/10/1997


Laboratories Ltd
STELAZINE SmithKline and French PA0060/016/007 Oral Solution 02/10/1997
CONCENTRATE Laboratories Ltd
CO-TRIMOXAZOLE Norton Healthcare Limited PA0282/020/001 Tablets 01/10/1997
T/A IVAX Pharmaceuticals
UK
ALUDROX PLUS John Wyeth & Brother PA0022/039/001 Gel - ALUMINIUM HYDROXIDE 30/09/1997
Limited - MAGNESIUM HYDROXIDE
- DIMETICONE, ACTIVATED

TRICOMOX Pinewood Laboratories Ltd, PA0281/022/001 Tablets - TRIMETHOPRIM 29/09/1997


- SULFAMETHOXAZOLE
HIBIDIL Zeneca Limited PA0051/039/002 - CHLORHEXIDINE 27/09/1997
GLUCONATE
APRESOLINE Novartis Pharmaceuticals UK PA0013/064/002 Tablets - HYDRALAZINE 26/09/1997
Ltd HYDROCHLORIDE
AMINESS Pharmacia Laboratories PA0187/008/001 Tablets - AMINO ACIDS 25/09/1997
Limited
STERLING HEALTHS Sterling Health Limited PA0622/012/001 - PARACETAMOL 22/09/1997
ANSWER - CAFFEINE
- SODIUM BICARBONATE
TYPHOID VACCINE B.P. UCB Pharma Limited PA0365/056/001 - TYPHOID VACCINE 22/09/1997
MONOVALENT
TELFAST Marion Merrell Limited PA0041/051/001 Capsule 15/09/1997
ALUMINIUM HYDROXIDE Sterling Health Limited PA0622/021/001 Tablets - ALGINIC ACID 12/09/1997
- ALUMINIUM HYDROXIDE
GEL, DRIED
- SODIUM BICARBONATE
- MAGNESIUM TRISILICATE

BEECHAMS POWDERS IN SmithKlineBeecham PA0379/004/003 - ACETYLSALICYLIC ACID 12/09/1997


TABLET FORM Consumer Brand - CAFFEINE
LEMON ENO Beecham Group Plc PA0449/005/001 - SODIUM BICARBONATE 12/09/1997
- TARTARIC ACID
- CITRIC ACID
- SODIUM CARBONATE
ANHYDROUS
ORANGE ENO FRUIT SALT Beecham Group Plc PA0449/005/002 - SODIUM BICARBONATE 12/09/1997
- TARTARIC ACID
- CITRIC ACID
- SODIUM CARBONATE
ANHYDROUS
AMINOPHYLLINE INJ International Medication PA0255/013/001 10/09/1997
Systems (UK) Ltd
POLIOMYELITIS VACCINE SmithKline and French PA0060/023/001 Oral Suspension - POLIOMYELITIS VACCINE 09/09/1997
LIVE (ORAL) Laboratories Ltd
ASENDIS Cyanamid of Great Britain PA0037/039/004 Tablets 08/09/1997
DEXTROSE International Medication PA0255/008/001 Withdrawn Form 08/09/1997
Systems (UK) Ltd

Human Medicines Withdrawn Products Page 385 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOPAMINE International Medication PA0255/011/001 Withdrawn Form 08/09/1997
HYDROCHLORIDE Systems (UK) Ltd
HEXABRIX May & Baker Limited PA0040/064/001 Solution for Injection - IOXAGLATE SODIUM 08/09/1997
- IOXAGLATE MEGLUMINE

HEXABRIX May & Baker Limited PA0040/064/002 Solution for Injection - IOXAGLATE SODIUM 08/09/1997
- IOXAGLATE MEGLUMINE

MANNITOL International Medication PA0255/009/001 Solution for Infusion 08/09/1997


Systems (UK) Ltd
SODIUM BICARBONATE International Medication PA0255/001/002 08/09/1997
INJ Systems (UK) Ltd
VILLESCON Boehringer Ingelheim Limited PA0007/019/002 - PYRIDOXINE 02/09/1997
HYDROCHLORIDE
- NICOTINAMIDE
- PROLINTANE
HYDROCHLORIDE
- THIAMINE
HYDROCHLORIDE
ALUDROX S A John Wyeth & Brother PA0022/002/002 - AMBUTONIUM BROMIDE 01/09/1997
(SUSPENSION) Limited - MAGNESIUM HYDROXIDE
- ALUMINIUM HYDROXIDE
GEL

DIARPHEN Norgine Limited PA0102/009/001 Tablets - DIPHENOXYLATE 01/09/1997


HYDROCHLORIDE
- ATROPINE SULFATE
IDURIDIN Ferring Pharmaceuticals PA0224/006/001 01/09/1997
Limited
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/001 - PILOCARPINE NITRATE 01/09/1997
Ireland
PREFRIN - Z LIQUIFILM Allergan Pharmaceuticals PA0148/029/001 - ZINC SULFATE 01/09/1997
Ireland - PHENYLEPHRINE
UNASYN Pfizer Limited PA0019/041/001 - SULBACTAM SODIUM 27/08/1997
UNASYN INFUSION Pfizer Limited PA0019/041/006 - SULBACTAM SODIUM 27/08/1997
UNASYN INFUSION Pfizer Limited PA0019/041/007 - SULBACTAM SODIUM 27/08/1997
UNASYN INFUSION 750 Pfizer Limited PA0019/041/002 - SULBACTAM SODIUM 27/08/1997
UNASYN INJECTION Pfizer Limited PA0019/041/004 - SULBACTAM SODIUM 27/08/1997
UNASYN INJECTION Pfizer Limited PA0019/041/005 - SULBACTAM SODIUM 27/08/1997
UNASYN INJECTION 1500 Pfizer Limited PA0019/041/003 - SULBACTAM SODIUM 27/08/1997
4% BRANCHED CHAIN Clintec Nutrition Limited (UK) PA0708/005/002 Solution for Infusion - LEUCINE 21/08/1997
- ISOLEUCINE
- VALINE
OPTIM EYES CONTACT Core Technologies Limited PA0638/001/001 Unknown - CHLORHEXIDINE 20/08/1997
LENS GLUCONATE
OPTIM EYES TM CONTACT Core Technologies Limited PA0638/001/002 Unknown - CHLORHEXIDINE 20/08/1997
LENS DISINFECTING GLUCONATE

PHILLIPS MILK OF Sterling Health Limited PA0622/010/001 Oral Solution - MAGNESIUM 20/08/1997
MAGNESIA LIQUID
SALETTE Alcon Laboratories (UK) Ltd PA0290/067/001 - SODIUM CHLORIDE 18/08/1997
SALETTE Alcon Laboratories (UK) Ltd PA0290/067/002 - SODIUM CHLORIDE 18/08/1997
SOACLENS Alcon Laboratories (UK) Ltd PA0290/068/001 - BENZALKONIUM 18/08/1997
CHLORIDE
- EDETATE DISODIUM
STERILE WATER B. Braun Medical Limited PA0179/036/003 Irrigation solution - WATER FOR IRRIGATION 17/08/1997

STERILE WATER B. Braun Medical Limited PA0179/036/004 Solution for Injection - WATER FOR IRRIGATION 17/08/1997

CHLORHEXIDINE ACETAT Baxter Healthcare Limited PA0167/010/005 - CHLORHEXIDINE 14/08/1997


DIACETATE
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/020 Solution for Infusion - GLUCOSE 14/08/1997
10%
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/021 Solution for Infusion - GLUCOSE 14/08/1997
10%
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/024 Solution for Infusion - GLUCOSE 14/08/1997
5%
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/025 Solution for Infusion - GLUCOSE 14/08/1997
5%
INTAL AUTOHALER Fisons Limited PA0018/040/002 Pressurised Inhalation - CROMOGLICATE SODIUM 14/08/1997
Suspension
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/001 Withdrawn Form - GENTAMICIN 14/08/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/002 Withdrawn Form - GENTAMICIN 14/08/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/004 Withdrawn Form - GENTAMICIN 14/08/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/005 Withdrawn Form - GENTAMICIN 14/08/1997
MANNITOL Baxter Healthcare Limited PA0167/037/003 Solution for Infusion 14/08/1997

Human Medicines Withdrawn Products Page 386 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MANNITOL Baxter Healthcare Limited PA0167/037/004 Solution for Infusion 14/08/1997
MANNITOL Baxter Healthcare Limited PA0167/037/007 Solution for Infusion 14/08/1997
MANNITOL Baxter Healthcare Limited PA0167/037/008 Solution for Infusion 14/08/1997
MANNITOL Baxter Healthcare Limited PA0167/037/011 Solution for Infusion 14/08/1997
MANNITOL Baxter Healthcare Limited PA0167/037/012 Solution for Infusion 14/08/1997
NUELIN 3M Health Care Limited PA0057/005/007 Capsule - THEOPHYLLINE 14/08/1997
NUELIN 3M Health Care Limited PA0057/005/008 Capsule - THEOPHYLLINE 14/08/1997
NUELIN 3M Health Care Limited PA0057/005/009 Capsule - THEOPHYLLINE 14/08/1997
SODIUM Baxter Healthcare Limited PA0167/050/019 Solution for Infusion - SODIUM CHLORIDE 14/08/1997
CHLORIDE/DEXTROSE - GLUCOSE
BETAZOK Astra Pharmaceuticals Ltd PA0009/044/002 Tablets - METOPROLOL 05/08/1997
SUCCINATE
BETAZOK Astra Pharmaceuticals Ltd PA0009/044/003 Tablets - METOPROLOL TARTRATE 05/08/1997

DIRYTHMIN SA Astra Pharmaceuticals Ltd PA0009/025/001 Tablets - DISOPYRAMIDE 05/08/1997


AMINOPHYLLINE Abbott Laboratories Ireland PA0038/039/001 Withdrawn Form 29/07/1997
Ltd
AMINOPHYLLINE Abbott Laboratories Ireland PA0038/039/002 Withdrawn Form 29/07/1997
Ltd
AMINOPHYLLINE Abbott Laboratories Ireland PA0038/039/003 Withdrawn Form 29/07/1997
Ltd
CHYMAR ZON Rorer Pharmaceuticals PA0468/033/001 - CHYMOTRYPSIN 24/07/1997
Limited
LEDERFEN Cyanamid of Great Britain PA0037/026/003 Tablets 18/07/1997
LEDERFEN F Cyanamid of Great Britain PA0037/026/006 Tablets 18/07/1997
SUCRAT Rowa Pharmaceuticals PA0074/025/001 Granules Effervescent - SUCRALFATE 16/07/1997
Limited
SUCRAT Rowa Pharmaceuticals PA0074/025/002 Tablets - SUCRALFATE 16/07/1997
Limited
4% BRANCHED CHAIN Clintec Nutrition Limited (UK) PA0708/005/001 Solution for Infusion - LEUCINE 09/07/1997
- ISOLEUCINE
- VALINE
LOTUSSIN COUGH G.D. Searle & Company PA0001/010/002 Syrup - DIPHENHYDRAMINE 08/07/1997
Limited HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
OSMOFUNDIN 10% B. Braun Medical Limited PA0179/008/001 23/06/1997
GASTRESE A.H. Robins Company PA0086/026/003 Tablets - METOCLOPRAMIDE 17/06/1997
Limited
GASTRESE LA A.H. Robins Company PA0086/026/004 Tablets - METOCLOPRAMIDE 17/06/1997
Limited
GASTRESE PAEDIATRIC A.H. Robins Company PA0086/026/002 - METOCLOPRAMIDE 17/06/1997
Limited
SERENID-D EXPIDET John Wyeth & Brother PA0022/035/004 Tablets - OXAZEPAM 17/06/1997
Limited
SERENID-D EXPIDET John Wyeth & Brother PA0022/035/005 Tablets - OXAZEPAM 17/06/1997
Limited
STAPHLIPEN Cyanamid of Great Britain PA0037/057/001 Withdrawn Form 17/06/1997
STAPHLIPEN Cyanamid of Great Britain PA0037/057/002 17/06/1997
STAPHLIPEN Cyanamid of Great Britain PA0037/057/003 17/06/1997
WYDORA John Wyeth & Brother PA0022/031/001 Tablets - INDORAMIN 17/06/1997
Limited HYDROCHLORIDE
WYDORA John Wyeth & Brother PA0022/031/002 Tablets - INDORAMIN 17/06/1997
Limited HYDROCHLORIDE
INTRAFUSIN 7.5E E. Merck Ltd PA0054/068/001 Solution for Infusion - AMINO ACIDS 16/06/1997
- ELECTROLYTES NOS
INTRAFUSIN 7.5E E. Merck Ltd PA0054/068/002 Solution for Infusion - AMINO ACIDS 16/06/1997
- ELECTROLYTES NOS
PERIFUSIN E. Merck Ltd PA0054/040/001 - AMINO ACIDS 16/06/1997
ALGIPAN (SPRAY) John Wyeth & Brother PA0022/041/001 - ETHYLENE GLYCOL 12/06/1997
Limited MONOSTEARATE
- METHYL NICOTINATE
DELPRAL Delagrange Limited PA0387/003/001 Withdrawn Form - TIAPRIDE 12/06/1997
DELPRAL Delagrange Limited PA0387/003/002 Tablets - TIAPRIDE 12/06/1997
SALBUTAMOL/MICROHAL Norton Waterford PA0436/008/005 Capsule - SALBUTAMOL 10/06/1997
ER
SALBUTAMOL/MICROHAL Norton Waterford PA0436/008/006 Capsule - SALBUTAMOL 10/06/1997
ER
CERVIPROST Organon Laboratories PA0261/027/001 - DINOPROSTONE 05/06/1997
Limited
COTRIMEL (SUSPENSION) Clonmel Healthcare Ltd PA0126/033/002 03/06/1997

EUROMEL Clonmel Healthcare Ltd PA0126/049/001 Tablets 03/06/1997


FERRUM HAUSMANN Clonmel Healthcare Ltd PA0126/030/004 03/06/1997
KEMELEX Clonmel Healthcare Ltd PA0126/067/001 Capsule 03/06/1997

Human Medicines Withdrawn Products Page 387 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KEMELEX Clonmel Healthcare Ltd PA0126/067/002 Capsule 03/06/1997
NAPMEL E.C. Clonmel Healthcare Ltd PA0126/044/004 Tablets 03/06/1997
SPIRONOLACTONE Clonmel Healthcare Ltd PA0126/039/002 Tablets 03/06/1997
TETRACYCLINE Clonmel Healthcare Ltd PA0126/051/001 Tablets 03/06/1997
TIPERAL Clonmel Healthcare Ltd PA0126/028/003 Tablets 03/06/1997
VERAPAMIL Clonmel Healthcare Ltd PA0126/071/004 Tablets 03/06/1997
HYDROCHLORIDE
SORMODREN Knoll A.G. (Clissmann) PA0058/007/001 Tablets - BORNAPRINE 02/06/1997
HYDROCHLORIDE
FLUVIRIN UCB Pharma Limited PA0365/024/002 - A/SYDNEY /5/97 (H3N2)- 29/05/1997
LIKE STRAIN
- A/BEIJING /262/95 (H1N1)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
FLUVIRIN PRE-FILLED UCB Pharma Limited PA0365/024/001 - A/SYDNEY /5/97 (H3N2)- 29/05/1997
SYRINGE LIKE STRAIN
- A/BEIJING /262/95 (H1N1)-
LIKE STRAIN
- B/BEIJING /184/93-LIKE
STRAIN
CHLORHEXIDINE ACETAT Baxter Healthcare Limited PA0167/010/008 - CHLORHEXIDINE 27/05/1997
DIACETATE
COMPOUND SODIUM Baxter Healthcare Limited PA0167/055/003 Withdrawn Form - SODIUM LACTATE 27/05/1997
LACTATE COMPOUND INJECTION
COMPOUND SODIUM Baxter Healthcare Limited PA0167/055/004 Withdrawn Form - SODIUM LACTATE 27/05/1997
LACTATE COMPOUND INJECTION
COMPOUND Baxter Healthcare Limited PA0167/063/003 Withdrawn Form - SODIUM LACTATE 27/05/1997
SODIUM/LACTATE/DEXTR COMPOUND INJECTION
OSE
COMPOUND Baxter Healthcare Limited PA0167/063/004 Withdrawn Form - SODIUM LACTATE 27/05/1997
SODIUM/LACTATE/DEXTR COMPOUND INJECTION
OSE
DEBRISAN Pharmacia Biosystems PA0107/007/002 - DEXTRANOMER 27/05/1997
Limited
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/009 Withdrawn Form - GENTAMICIN 27/05/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/010 Withdrawn Form - GENTAMICIN 27/05/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/012 Withdrawn Form - GENTAMICIN 27/05/1997
ISOTONIC GENTAMICIN Baxter Healthcare Limited PA0167/068/013 Withdrawn Form - GENTAMICIN 27/05/1997
PLASMALYTE Baxter Healthcare Limited PA0167/039/004 - ELECTROLYTES NOS 27/05/1997
M/DEXTROSE - GLUCOSE
PLASMALYTE M/GLUCOSE Baxter Healthcare Limited PA0167/039/003 - ELECTROLYTES NOS 27/05/1997
- GLUCOSE
POTASSIUM/SODIUM Baxter Healthcare Limited PA0167/052/003 Withdrawn Form - POTASSIUM CHLORIDE 27/05/1997
CHLORIDE - SODIUM CHLORIDE
POTASSIUM/SODIUM Baxter Healthcare Limited PA0167/052/004 Withdrawn Form - POTASSIUM CHLORIDE 27/05/1997
CHLORIDE - SODIUM CHLORIDE
POTASSIUM/SODIUM Baxter Healthcare Limited PA0167/052/007 - POTASSIUM CHLORIDE 27/05/1997
CHLORIDE - SODIUM CHLORIDE
POTASSIUM/SODIUM Baxter Healthcare Limited PA0167/052/008 Withdrawn Form - POTASSIUM CHLORIDE 27/05/1997
CHLORIDE - SODIUM CHLORIDE
RINGERS/CHLORIDE Baxter Healthcare Limited PA0167/054/003 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
RINGERS/CHLORIDE Baxter Healthcare Limited PA0167/054/004 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/007 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/008 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/011 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/012 Withdrawn Form - SODIUM CHLORIDE 27/05/1997
SODIUM Baxter Healthcare Limited PA0167/050/008 Withdrawn Form 27/05/1997
CHLORIDE/DEXTROSE
SODIUM Baxter Healthcare Limited PA0167/050/011 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/012 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/017 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/018 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/007 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/003 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
SODIUM Baxter Healthcare Limited PA0167/050/004 Withdrawn Form 27/05/1997
CHLORIDE/GLUCOSE
OSTEOFLOUR Sanofi-Synthelabo Ireland PA0077/119/001 Tablets - SODIUM FLUORIDE 19/05/1997
Ltd

Human Medicines Withdrawn Products Page 388 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CHLOROMYCETIN Parke Davis & Company PA0056/015/008 - CHLORAMPHENICOL 13/05/1997
SODIUM SUCCINATE
CHLOROMYCETIN Parke Davis & Company PA0056/015/007 - CHLORAMPHENICOL 13/05/1997
OPHTHALMIC SODIUM SUCCINATE
FEFOL-VIT SPANSULE UCB Pharma Limited PA0365/071/001 Capsule - FERROUS SULFATE 13/05/1997
- FOLIC ACID
- VITAMIN B NOS
- ASCORBIC ACID
- THIAMINE MONONITRATE
- RIBOFLAVIN
- NICOTINAMIDE

FESOVIT SPANSULE UCB Pharma Limited PA0365/072/001 Capsule - FERROUS SULFATE 13/05/1997
- VITAMIN B NOS
- ASCORBIC ACID
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE

NYSTATIN-DOME Bayer Diagnostics PA0079/002/003 Ointment 08/05/1997


Manufacturing
PAVACOL-D Boehringer Ingelheim Ltd PA0007/031/001 Syrup - PAPAVERINE 07/05/1997
- PHOLCODINE
PONSTAN FORTE Parke Davis & Company PA0056/001/002 - MEFENAMIC ACID 07/05/1997
VINBLASTINE Cyanamid of Great Britain PA0037/051/001 Withdrawn Form 06/05/1997
TETRABID ORGANON Organon Laboratories PA0261/004/001 - TETRACYCLINE 01/05/1997
Limited HYDROCHLORIDE
DETTOL Reckitt's (Ireland) Limited PA0027/014/002 - CHLOROXYLENOL 30/04/1997
EUHYPNOS GELTHIX Farmitalia Carlo Erba Ltd PA0236/009/001 Capsule - TEMAZEPAM 30/04/1997
EUHYPNOS GELTHIX Farmitalia Carlo Erba Ltd PA0236/009/002 Capsule - TEMAZEPAM 30/04/1997
PAROVEN Novartis Consumer Health PA0030/004/001 Capsule - OXYBUTYNIN 30/04/1997
UK Limited
PAROVEN 500 Novartis Consumer Health PA0030/004/002 Tablets - OXYBUTYNIN 30/04/1997
UK Limited
SPILAC Pinewood Laboratories Ltd, PA0281/021/001 Tablets - SPIRONOLACTONE 30/04/1997
SALOCAPS INHALER Norton Waterford PA0436/014/001 Capsule - SALBUTAMOL 29/04/1997
SALOCAPS INHALER Norton Waterford PA0436/014/002 Capsule - SALBUTAMOL 29/04/1997
FLURAZEPAM Pinewood Laboratories Ltd, PA0281/027/001 Capsule - FLURAZEPAM 28/04/1997
FLURAZEPAM Pinewood Laboratories Ltd, PA0281/027/002 Capsule - FLURAZEPAM 28/04/1997
ALU-CAPS 3M Health Care Limited PA0057/001/001 Capsule - ALUMINIUM HYDROXIDE 23/04/1997
GEL
SILCOCKS BASE Superpac Products Limited PA0552/011/001 23/04/1997
TERRACORTRIL Pfizer Limited PA0019/007/002 Cutaneous Spray Solution - OXYTETRACYCLINE 17/04/1997
HYDROCHLORIDE
- HYDROCORTISONE
VIVIMED Pharma-Global Limited PA0141/023/001 Tablets - PARACETAMOL 15/04/1997
- CAFFEINE
PROPESS Controlled Therapeutics PA0503/002/001 11/04/1997
(Scotland) Ltd
PRESCAL Ciba Geigy Plc PA0028/061/001 Tablets - ISRADIPINE 10/04/1997
THROMBOSTAT Parke Davis & Company PA0056/041/001 - THROMBIN 10/04/1997
LASIX Hoechst Ireland Limited PA0023/008/005 Withdrawn Form - FUROSEMIDE 04/04/1997
DERMONISTAT Cilag Limited PA0059/006/001 Cream - MICONAZOLE NITRATE 01/04/1997
PENIDURAL John Wyeth & Brother PA0022/009/004 Oral Suspension - BENZATHINE 01/04/1997
Limited BENZYLPENICILLIN
CARDENE SR Roche Products Limited PA0050/127/005 Capsule - NICARDIPINE 27/03/1997
HYDROCHLORIDE
FLAGYL COMPAK May & Baker Limited PA0040/004/001 Tablets 27/03/1997
ILOSONE Dista Products Limited PA0447/004/001 Capsule - ERYTHROMYCIN 27/03/1997
ESTOLATE
KANNASYN Sanofi-Synthelabo Ireland PA0077/015/001 - KANAMYCIN 27/03/1997
Ltd
ALLURINOL 300 Lipha Pharmaceuticals PA0289/007/001 26/03/1997
Limited
OMNOPON Roche Products Limited PA0050/024/004 - MORPHINE 26/03/1997
HYDROCHLORIDE
- PAPAVERINE
HYDROCHLORIDE
- DIHYDROCODEINE
HYDROCHLORIDE
PHENOBARBITONE SmithKline and French PA0060/013/001 Capsule - PHENOBARBITAL 26/03/1997
SPANSULE Laboratories Ltd
PHENOBARITONE SmithKline and French PA0060/013/002 Capsule 26/03/1997
SPANSULE Laboratories Ltd

Human Medicines Withdrawn Products Page 389 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BONFIELDS SILCOCKS Foran Healthcare Limited PA0484/007/001 - EMULSIFYING WAX 25/03/1997
BASE - PARAFFIN SOFT
IMPERACIN Zeneca Limited PA0051/011/003 Tablets - OXYTETRACYCLINE 25/03/1997
DIHYDRATE
LOGIPARIN 2500 Novo Nordisk A/S PA0218/032/003 25/03/1997
LOGIPARIN 4500 Novo Nordisk A/S PA0218/032/004 25/03/1997
PRESCAL Ciba Geigy Plc PA0028/061/006 Solution for Infusion - ISRADIPINE 25/03/1997
PRESCAL RETARD Ciba Geigy Plc PA0028/061/004 Capsule - ISRADIPINE 25/03/1997
PRESCAL RETARD Ciba Geigy Plc PA0028/061/005 Capsule - ISRADIPINE 25/03/1997
ULSO Ulso Laboratories Limited PA0228/001/001 Oral Solution - BISMUTH CITRATE 25/03/1997
- STRONG AMMONIA
SOLUTION
VICKS CHLORASEPTIC Procter & Gamble (Health & PA0441/032/001 - PHENOL 25/03/1997
Beauty Care) Limited
0.18% SODIUM B. Braun Medical Limited PA0179/003/002 Withdrawn Form 24/03/1997
CHLORIDE/DEXTROSE
0.18% SODIUM B. Braun Medical Limited PA0179/003/014 Withdrawn Form 24/03/1997
CHLORIDE/GLUCOSE
0.9% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/003 Withdrawn Form 24/03/1997
0.9% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/004 Withdrawn Form 24/03/1997
0.9% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/005 Withdrawn Form 24/03/1997
0.9% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/006 Withdrawn Form 24/03/1997
ACHROMYCIN Cyanamid of Great Britain PA0037/010/002 Withdrawn Form - TETRACYCLINE 24/03/1997
HYDROCHLORIDE
ACHROMYCIN Cyanamid of Great Britain PA0037/010/007 Withdrawn Form 24/03/1997
ACHROMYCIN V Cyanamid of Great Britain PA0037/025/003 Capsule 24/03/1997
ACHROMYCIN 1% Cyanamid of Great Britain PA0037/010/004 Ointment 24/03/1997
ACHROMYCIN Cyanamid of Great Britain PA0037/010/005 24/03/1997
OPHTHALMIC OIL
(SUSPENSION)
AMINOPLASMAL L-10 B. Braun Medical Limited PA0179/017/001 24/03/1997
AMINOPLASMAL L-5 B. Braun Medical Limited PA0179/016/001 - AMINO ACIDS 24/03/1997
- SORBITOL
AMINOPLASMAL PED B. Braun Medical Limited PA0179/018/001 24/03/1997
AMINOPLASMAL PED B. Braun Medical Limited PA0179/018/002 24/03/1997
C P D ANTICOAGULANT NPBI B.V. PA0617/002/001 - SODIUM CITRATE 24/03/1997
- CITRIC ACID
- GLUCOSE
- SODIUM ACID
PHOSPHATE
COMPOUND SODIUM B. Braun Medical Limited PA0179/004/006 Withdrawn Form 24/03/1997
LACTATE
COMPOUND SODIUM B. Braun Medical Limited PA0179/004/007 Withdrawn Form 24/03/1997
LACTATE
DEXTROSE 5% B. Braun Medical Limited PA0179/001/001 Withdrawn Form - GLUCOSE 24/03/1997
DEXTROSE 5% B. Braun Medical Limited PA0179/001/002 Withdrawn Form - GLUCOSE 24/03/1997
EQUAGESIC John Wyeth & Brother PA0022/004/001 Tablets - ACETYLSALICYLIC ACID 24/03/1997
Limited - MEPROBAMATE
- ETHOHEPTAZINE
CITRATE
EQUANIL John Wyeth & Brother PA0022/005/001 Tablets 24/03/1997
Limited
EQUANIL John Wyeth & Brother PA0022/005/002 Tablets - MEPROBAMATE 24/03/1997
Limited
GLUCOSE 20% B. Braun Medical Limited PA0179/001/031 Withdrawn Form 24/03/1997
GLUCOSE 25% B. Braun Medical Limited PA0179/001/032 Withdrawn Form 24/03/1997
GLUCOSE 25% B. Braun Medical Limited PA0179/001/033 Withdrawn Form 24/03/1997
GLUCOSE 40% B. Braun Medical Limited PA0179/001/034 Withdrawn Form 24/03/1997
GLUCOSE 40% B. Braun Medical Limited PA0179/001/035 Withdrawn Form 24/03/1997
GLUCOSE 5% B. Braun Medical Limited PA0179/001/025 Withdrawn Form 24/03/1997
GLUCOSE 5% B. Braun Medical Limited PA0179/001/026 Withdrawn Form 24/03/1997
GLUCOSE 50% B. Braun Medical Limited PA0179/001/037 Withdrawn Form 24/03/1997
HEMINEVRIN 0.8% Astra Pharmaceuticals Ltd PA0009/005/004 Solution for Infusion - CLOMETHIAZOLE 24/03/1997
EDISILATE
LEDERMYCIN Cyanamid of Great Britain PA0037/013/002 Tablets 24/03/1997
LEUCOMAX Schering-Plough Limited PA0277/063/001 - GRANULOCYTE 24/03/1997
MACROPHAGE COLONY
STIMULATING FACTOR
- MOLGRAMOSTIM
LEUCOMAX Schering-Plough Limited PA0277/063/004 - GRANULOCYTE 24/03/1997
MACROPHAGE COLONY
STIMULATING FACTOR
- MOLGRAMOSTIM

Human Medicines Withdrawn Products Page 390 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LEUCOMAX Schering-Plough Limited PA0277/063/005 - GRANULOCYTE 24/03/1997
MACROPHAGE COLONY
STIMULATING FACTOR
- MOLGRAMOSTIM
PYOPEN SmithKline Beecham Pharm PA0049/011/001 Withdrawn Form - CARBENICILLIN 24/03/1997
Ltd DISODIUM
PYOPEN SmithKline Beecham Pharm PA0049/011/002 Withdrawn Form - CARBENICILLIN 24/03/1997
Ltd DISODIUM
RELIFEX DISPERSIBLE SmithKline Beecham Pharm PA0049/046/003 Tablets - NABUMETONE 24/03/1997
Ltd
RELIFEX DISPERSIBLE SmithKline Beecham Pharm PA0049/046/004 Tablets - NABUMETONE 24/03/1997
Ltd
S A G M RED CELL NPBI B.V. PA0617/001/001 - SODIUM CHLORIDE 24/03/1997
PRESERVATION - MANNITOL
- GLUCOSE
- ADENINE
- GLUCOSE
MONOHYDRATE
- WATER FOR INJECTIONS

SCHOLL WART REMOVER Scholl Consumer Products PA0455/002/001 - SALICYLIC ACID 24/03/1997
KIT Limited
SODIUM CHLORIDE B. Braun Medical Limited PA0179/003/013 Withdrawn Form 24/03/1997
0.18%/GLUCOSE 4%
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/017 Solution for Infusion 24/03/1997
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/018 Solution for Infusion 24/03/1997
TIGASON Roche Products Limited PA0050/052/001 Capsule - ETRETINATE 24/03/1997
TIGASON Roche Products Limited PA0050/052/002 Capsule - ETRETINATE 24/03/1997
VERTIGON SPANSULE SmithKline and French PA0060/017/001 Capsule - PROCHLORPERAZINE 24/03/1997
Laboratories Ltd MALEATE
VERTIGON SPANSULE SmithKline and French PA0060/017/002 Capsule - PROCHLORPERAZINE 24/03/1997
Laboratories Ltd MALEATE
WATER B. Braun Medical Limited PA0179/009/005 Withdrawn Form 24/03/1997
WATER B. Braun Medical Limited PA0179/009/006 Withdrawn Form 24/03/1997
VICKS THROAT LOZENGE Procter & Gamble (Health & PA0441/029/001 - MENTHOL 21/03/1997
Beauty Care) Limited - CAMPHOR
VICKS THROAT LOZENGE Procter & Gamble (Health & PA0441/029/002 - MENTHOL 21/03/1997
Beauty Care) Limited - CAMPHOR
CCNU LUNDBECK Lundbeck Limited PA0115/006/002 Capsule - LOMUSTINE 14/03/1997
CAPSULES
DIMOTANE EXPECTORAN A.H. Robins Company PA0086/013/007 Syrup - GUAIFENESIN 12/03/1997
Limited - BROMPHENIRAMINE
MALEATE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
0.18% SODIUM B. Braun Medical Limited PA0179/003/001 Withdrawn Form 01/03/1997
CHLORIDE/DEXTROSE
ACID CITRATE DEXTROSE Baxter Healthcare Limited PA0167/013/003 28/02/1997

AKFEN (GUANFACINE HCL A.H. Robins Company PA0086/028/001 Tablets 28/02/1997


Limited
AKFEN (GUANFACINE HCL A.H. Robins Company PA0086/028/003 Tablets 28/02/1997
Limited
AKFEN (GUANFACINE HCL A.H. Robins Company PA0086/028/004 Tablets 28/02/1997
Limited
BACTERIOSTATIC Hospira UK Limited PA0437/015/001 - BENZYL ALCOHOL 28/02/1997
DILUENT - SODIUM CHLORIDE
- WATER FOR INJECTIONS

BIOGASTRONE Sanofi-Synthelabo Ireland PA0077/079/001 Tablets - CARBENOXOLONE 28/02/1997


Ltd SODIUM
BURONIL Knoll A.G. (Clissmann) PA0058/016/002 - MELPERONE 28/02/1997
HYDROCHLORIDE
BURONIL Knoll A.G. (Clissmann) PA0058/016/003 Tablets - MELPERONE 28/02/1997
HYDROCHLORIDE
BURONIL Knoll A.G. (Clissmann) PA0058/016/004 Tablets - MELPERONE 28/02/1997
HYDROCHLORIDE
BURONIL Knoll A.G. (Clissmann) PA0058/016/005 Tablets - MELPERONE 28/02/1997
HYDROCHLORIDE
BURONIL Knoll A.G. (Clissmann) PA0058/016/006 Tablets - MELPERONE 28/02/1997
HYDROCHLORIDE
CALCIPARINE Sanofi-Synthelabo Ireland PA0077/115/003 Withdrawn Form - HEPARIN CALCIUM 28/02/1997
Ltd
CRYSTAPEN INJECTION Glaxo Laboratories Limited PA0044/017/002 Withdrawn Form - GRISEOFULVIN 28/02/1997

Human Medicines Withdrawn Products Page 391 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIOCALM (II) SmithKlineBeecham PA0379/006/002 Tablets - MORPHINE SULFATE 28/02/1997
Consumer Brand - ATTAPULGITE
- ACTIVATED
ATTAPULGITE
DUOGASTRONE Sanofi-Synthelabo Ireland PA0077/078/001 Capsule - CARBENOXOLONE 28/02/1997
Ltd SODIUM
EPILIM Sanofi-Synthelabo Ireland PA0077/113/003 Tablets - VALPROATE SODIUM 28/02/1997
Ltd
ERADACIN Sanofi-Synthelabo Ireland PA0077/052/001 Capsule - ROSOXACIN 28/02/1997
Ltd
KEMELEX Clonmel Healthcare Ltd PA0126/067/003 28/02/1997
KEMELEX Clonmel Healthcare Ltd PA0126/067/004 28/02/1997
METOCLOPRAMIDE Clonmel Healthcare Ltd PA0126/073/001 Tablets 28/02/1997
PHISO-MED Sanofi-Synthelabo Ireland PA0077/064/001 - CHLORHEXIDINE 28/02/1997
Ltd GLUCONATE
PROHIBIT SINGLE DOSE Sanofi Pasteur MSD Ltd PA0544/009/001 Solution for Injection 28/02/1997
RETROLYTE-ORAL Sanofi-Synthelabo Ireland PA0077/118/001 - SODIUM CHLORIDE 28/02/1997
REHYDRATION Ltd - POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- GLUCOSE
SALBUTAMOL Norton Waterford PA0436/008/002 Syrup - SALBUTAMOL 28/02/1997
TELEPAQUE Sanofi-Synthelabo Ireland PA0077/080/001 Tablets - IOPANOIC ACID 28/02/1997
Ltd
VINBLASTINE SULPHATE Hospira UK Limited PA0437/009/001 Withdrawn Form - VINBLASTINE SULFATE 28/02/1997
VINCRISTINE SULPHATE Hospira UK Limited PA0437/008/001 Solution for Injection - VINCRISTINE SULFATE 28/02/1997
- LACTOSE ANHYDROUS
VINCRISTINE SULPHATE Hospira UK Limited PA0437/008/002 Solution for Injection - VINCRISTINE SULFATE 28/02/1997
- LACTOSE ANHYDROUS
VINCRISTINE SULPHATE Hospira UK Limited PA0437/008/003 Solution for Injection - VINCRISTINE SULFATE 28/02/1997
- LACTOSE ANHYDROUS
EPSOM SALTS Superpac Products Limited PA0552/010/001 Powder for Oral Solution - MAGNESIUM SULFATE 24/02/1997
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/001 Solution for Injection - SODIUM CHLORIDE 22/02/1997
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/002 Solution for Injection - SODIUM CHLORIDE 22/02/1997
AMOXIL SmithKline Beecham Pharm PA0049/006/008 Withdrawn Form - AMOXICILLIN 31/01/1997
Ltd
ANGETTES 75 Bristol-Myers Squibb PA0048/013/001 Tablets - ACETYLSALICYLIC ACID 31/01/1997
(Holdings) Limited
ANGIERS PARACETAMOL Bristol-Myers Squibb PA0048/039/002 Syrup 31/01/1997
ELIXIR (Holdings) Limited
ANTRIMOX (SUSPENSION) Mercury Pharmaceuticals PA0073/086/002 - SULFAMETHOXAZOLE 31/01/1997
(Ireland) Ltd - TRIMETHOPRIM
AZACTAM Bristol-Myers Squibb PA0002/052/004 Solution for Infusion - AZTREONAM 31/01/1997
Pharmaceuticals uc - ARGININE
AZACTAM Bristol-Myers Squibb PA0002/052/005 Withdrawn Form - AZTREONAM 31/01/1997
Pharmaceuticals uc - ARGININE
AZACTAM Bristol-Myers Squibb PA0002/052/006 Solution for Infusion - AZTREONAM 31/01/1997
Pharmaceuticals uc - ARGININE
CAPOTEN Bristol-Myers Squibb PA0002/039/003 Tablets - CAPTOPRIL 31/01/1997
Pharmaceuticals uc
CEDOCARD RETARD 20 J B Tillotts Limited PA0360/021/007 Tablets - ISOSORBIDE DINITRATE 31/01/1997
CMW 1 - G GENTAMICIN DePuy International Ltd PA0715/001/001 - GENTAMICIN 31/01/1997
BONE CEMENT
CMW 3 - G GENTAMICIN DePuy International Ltd PA0715/001/002 31/01/1997
BONE CEMENT
COJENE Fisons Limited PA0018/036/001 Tablets - CAFFEINE CITRATE 31/01/1997
- CODEINE PHOSPHATE
CORGARETIC Bristol-Myers Squibb PA0002/047/001 Tablets - NADOLOL 31/01/1997
Pharmaceuticals uc - BENDROFLUMETHIAZIDE

CORGARETIC Bristol-Myers Squibb PA0002/047/002 Tablets - NADOLOL 31/01/1997


Pharmaceuticals uc - BENDROFLUMETHIAZIDE

CYSTOGARD Boehringer Ingelheim Limited PA0007/045/004 Solution for Injection - MESNA 31/01/1997

DE WITT THROAT E.C. De Witt & Company PA0299/003/001 Lozenges - TYROTHRICIN 31/01/1997
Limited - BENZOCAINE
- CETYLPYRIDINIUM
CHLORIDE
DEQUACETS Crookes Healthcare Ltd PA0043/014/001 Lozenges - DEQUALINIUM CHLORIDE 31/01/1997
- MENTHOL

DEQUACETS Crookes Healthcare Ltd PA0043/014/002 - DEQUALINIUM CHLORIDE 31/01/1997


- MENTHOL

Human Medicines Withdrawn Products Page 392 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DEQUACETS Crookes Healthcare Ltd PA0043/014/003 Lozenges - DEQUALINIUM CHLORIDE 31/01/1997
- MENTHOL

DIJEX (SUSPENSION) Crookes Healthcare Ltd PA0043/008/001 - ALUMINIUM HYDROXIDE 31/01/1997


GEL
- MAGNESIUM HYDROXIDE

DOXORUBICIN SOLUTION Farmitalia Carlo Erba Ltd PA0236/023/008 Solution for Injection - DOXORUBICIN 31/01/1997
HYDROCHLORIDE
ECOSTATIN 1 Bristol-Myers Squibb PA0002/024/007 Pessary - ECONAZOLE NITRATE 31/01/1997
Pharmaceuticals uc
ECOSTATIN LOTION Bristol-Myers Squibb PA0002/024/006 Cutaneous Solution - ECONAZOLE NITRATE 31/01/1997
Pharmaceuticals uc
ECOSTATIN POWDER Bristol-Myers Squibb PA0002/024/003 - ECONAZOLE NITRATE 31/01/1997
Pharmaceuticals uc
ENGRAN-HP Bristol-Myers Squibb PA0002/051/001 Tablets - RETINOL 31/01/1997
Pharmaceuticals uc - VITAMIN D SYNTHETIC
CALCIFEROL
- THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- SODIUM ASCORBATE
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- FOLIC ACID
- CALCIUM CARBONATE
- FERROUS CARBONATE
- IODINE
- MANGANESE SULFATE
- ZINC SULFATE
- COPPER

FEM IRON Fisons Limited PA0018/005/001 Tablets - FERROUS FUMARATE 31/01/1997


FUNGILIN Bristol-Myers Squibb PA0002/005/001 Cream - AMPHOTERICIN B 31/01/1997
Pharmaceuticals uc
FUNGILIN Bristol-Myers Squibb PA0002/005/002 Pessary - AMPHOTERICIN B 31/01/1997
Pharmaceuticals uc
FUNGILIN Bristol-Myers Squibb PA0002/005/003 Tablets - AMPHOTERICIN B 31/01/1997
Pharmaceuticals uc
FUNGILIN Bristol-Myers Squibb PA0002/005/004 Lozenges - AMPHOTERICIN B 31/01/1997
Pharmaceuticals uc
HALCIDERM TOPICAL Bristol-Myers Squibb PA0002/020/001 Cream - HALCINONIDE 31/01/1997
Pharmaceuticals uc
HALIBUT LIVER OIL Mercury Pharmaceuticals PA0073/124/001 Capsule - HALIBUT-LIVER OIL 31/01/1997
(Ireland) Ltd
HUMAN ALBUMIN Immuno Limited PA0212/004/006 31/01/1997
INCREMIN Cyanamid of Great Britain PA0037/003/001 - CYANOCOBALAMIN 31/01/1997
- THIAMINE
HYDROCHLORIDE
- PYRIDOXINE
HYDROCHLORIDE
- LYSINE ACETATE
INCREMIN Cyanamid of Great Britain PA0037/003/002 Syrup - FERRIC 31/01/1997
PYROPHOSPHATE
- THIAMINE
HYDROCHLORIDE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
K.P.N. (SUSPENSION) Mercury Pharmaceuticals PA0073/012/001 - NEOMYCIN SULFATE 31/01/1997
(Ireland) Ltd - PECTIN
- KAOLIN, LIGHT
KENACORT Bristol-Myers Squibb PA0002/022/002 Tablets - TRIAMCINOLONE 31/01/1997
Pharmaceuticals uc
KENACORT-A Bristol-Myers Squibb PA0002/021/001 Cream - TRIAMCINOLONE 31/01/1997
Pharmaceuticals uc ACETONIDE
KENACORT-A Bristol-Myers Squibb PA0002/021/002 Ointment - TRIAMCINOLONE 31/01/1997
Pharmaceuticals uc ACETONIDE
KENALOG INJECTION Bristol-Myers Squibb PA0002/023/003 - TRIAMCINOLONE 31/01/1997
Pharmaceuticals uc ACETONIDE
LASMA Forest Laboratories UK Ltd PA0100/034/002 Tablets - THEOPHYLLINE 31/01/1997
LASMA Forest Laboratories UK Ltd PA0100/034/003 Tablets - THEOPHYLLINE 31/01/1997

Human Medicines Withdrawn Products Page 393 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MODECATE Bristol-Myers Squibb PA0002/031/002 Unknown - FLUPHENAZINE 31/01/1997
Pharmaceuticals uc DECANOATE
MODECATE Bristol-Myers Squibb PA0002/031/003 Unknown - FLUPHENAZINE 31/01/1997
Pharmaceuticals uc DECANOATE
MODECATE Bristol-Myers Squibb PA0002/031/004 Solution for Injection - FLUPHENAZINE 31/01/1997
Pharmaceuticals uc DECANOATE
MODITEN ENANTHATE Bristol-Myers Squibb PA0002/040/001 Withdrawn Form - FLUPHENAZINE 31/01/1997
Pharmaceuticals uc ENANTATE
MOGADON Roche Products Limited PA0050/019/002 Capsule - NITRAZEPAM 31/01/1997
MOTIPRESS Bristol-Myers Squibb PA0002/004/001 Tablets - FLUPHENAZINE 31/01/1997
Pharmaceuticals uc HYDROCHLORIDE
- NORTRIPTYLINE
MYCOSTATIN Bristol-Myers Squibb PA0002/007/003 Tablets - NYSTATIN 31/01/1997
Pharmaceuticals uc
MYCOSTATIN - VAGINAL Bristol-Myers Squibb PA0002/007/004 Tablets - NYSTATIN 31/01/1997
Pharmaceuticals uc
MYSTECLIN F. Bristol-Myers Squibb PA0002/012/001 Capsule - TETRACYCLINE 31/01/1997
Pharmaceuticals uc HYDROCHLORIDE
- AMPHOTERICIN B
NITROGLYCERIN Mercury Pharmaceuticals PA0073/131/001 31/01/1997
(Ireland) Ltd
NITROGLYCERIN 0.1% Mercury Pharmaceuticals PA0073/131/002 Withdrawn Form 31/01/1997
(Ireland) Ltd
NITROGLYCERIN 0.5% Mercury Pharmaceuticals PA0073/131/003 Withdrawn Form 31/01/1997
(Ireland) Ltd
NOBRIUM Roche Products Limited PA0050/013/002 Capsule - MEDAZEPAM 31/01/1997
PENTOTHAL RECTAL Abbott Laboratories Ireland PA0038/008/001 31/01/1997
(SUSPENSION) Ltd
PHARMORUBICIN Farmitalia Carlo Erba Ltd PA0236/016/005 Solution for Injection 31/01/1997
PIROXICAM 10 PHARBITA B.V. Pharbita PA0508/007/001 Suppositories 31/01/1997
PIROXICAM 20 PHARBITA B.V. Pharbita PA0508/007/002 Suppositories 31/01/1997
QUESTRAN LIGHT Bristol-Myers Squibb PA0048/020/002 - COLESTYRAMINE 31/01/1997
(Holdings) Limited
RAUTRAX Bristol-Myers Squibb PA0002/029/001 Tablets - RAUWOLFIA 31/01/1997
Pharmaceuticals uc SERPENTINA
- HYDROFLUMETHIAZIDE
- POTASSIUM CHLORIDE
SALBUL Rowa Pharmaceuticals PA0074/022/001 Tablets - SALBUTAMOL 31/01/1997
Limited
SALBUL RETARD Rowa Pharmaceuticals PA0074/022/002 Tablets - SALBUTAMOL 31/01/1997
Limited
SCHOLL S I Wynlit Laboratories Limited PA0283/001/001 31/01/1997
SCHOLL S.2 Wynlit Laboratories Limited PA0283/001/002 31/01/1997
SOTACOR Bristol-Myers Squibb PA0048/001/001 Tablets - SOTALOL 31/01/1997
(Holdings) Limited HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/002 Tablets - SOTALOL 31/01/1997
(Holdings) Limited HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/003 Tablets - SOTALOL 31/01/1997
(Holdings) Limited HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/005 Tablets - SOTALOL 31/01/1997
(Holdings) Limited
SOTACOR Bristol-Myers Squibb PA0048/001/008 Withdrawn Form - SOTALOL 31/01/1997
(Holdings) Limited HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/010 Withdrawn Form - SOTALOL 31/01/1997
(Holdings) Limited HYDROCHLORIDE
STERILE WATER Baxter Healthcare Limited PA0167/011/011 - WATER FOR IRRIGATION 31/01/1997

ULTRACEF Bristol-Myers Squibb PA0048/014/006 Tablets - CEFADROXIL 31/01/1997


(Holdings) Limited
ULTRACEF Bristol-Myers Squibb PA0048/014/001 Capsule - CEFADROXIL 31/01/1997
(Holdings) Limited
VELOSEF INJECTION Bristol-Myers Squibb PA0002/014/011 - ARGININE 31/01/1997
Pharmaceuticals uc - CEFRADINE
VEPESID Bristol-Myers Squibb PA0048/022/002 Withdrawn Form - ETOPOSIDE 31/01/1997
(Holdings) Limited
VEPESID Bristol-Myers Squibb PA0048/022/004 Withdrawn Form 31/01/1997
(Holdings) Limited
NOBRIUM Roche Products Limited PA0050/013/001 Capsule - MEDAZEPAM 30/01/1997
GLUCOSE Clintec Nutrition Limited (UK) PA0708/008/009 Solution for Infusion - GLUCOSE 26/01/1997

GLUCOSE Clintec Nutrition Limited (UK) PA0708/008/010 Solution for Infusion - GLUCOSE 26/01/1997

Human Medicines Withdrawn Products Page 394 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROWACYLAT Rowa Pharmaceuticals PA0074/005/001 Tablets - PARACETAMOL 01/01/1997
Limited - CODEINE PHOSPHATE
- PIPOXOLAN
HYDROCHLORIDE
- CHLORMEZANONE
ACRIFLEX Crookes Healthcare Ltd PA0043/015/001 Cream - CHLORHEXIDINE 31/12/1996
GLUCONATE
ACTHAR Rorer Pharmaceuticals PA0468/021/001 Gel - CORTICOTROPHIN 31/12/1996
Limited
ACTHAR Rorer Pharmaceuticals PA0468/021/002 Gel - CORTICOTROPHIN 31/12/1996
Limited
AMINOFUSIN Clonmel Healthcare Ltd PA0126/002/001 31/12/1996
AMINOFUSIN Clonmel Healthcare Ltd PA0126/002/002 31/12/1996
AMINOFUSIN Clonmel Healthcare Ltd PA0126/002/003 31/12/1996
AMOXIL SmithKline Beecham Pharm PA0049/006/014 - AMOXICILLIN 31/12/1996
Ltd TRIHYDRATE
AMPICILLIN Norton Healthcare Limited PA0282/004/001 Capsule - AMPICILLIN TRIHYDRATE 31/12/1996
T/A IVAX Pharmaceuticals
UK
AMPICILLIN Norton Healthcare Limited PA0282/004/002 Capsule - AMPICILLIN TRIHYDRATE 31/12/1996
T/A IVAX Pharmaceuticals
UK
AMPICLOX SmithKline Beecham Pharm PA0049/007/004 Withdrawn Form - AMPICILLIN SODIUM 31/12/1996
Ltd - CLOXACILLIN SODIUM
ASCRIPTIN A/D May & Baker Limited PA0040/091/001 Tablets 31/12/1996
BACTICLENS T.J. Smith & Nephew PA0518/001/001 31/12/1996
BENDROFLUAZIDE Norton Healthcare Limited PA0282/018/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
BREVIDIL M May & Baker Limited PA0040/049/002 31/12/1996
CAMALOX Rorer Pharmaceuticals PA0468/013/002 Tablets - MAGNESIUM HYDROXIDE 31/12/1996
Limited - ALUMINIUM HYDROXIDE
- CALCIUM CARBONATE

CAMALOX (SUSPENSION) Rorer Pharmaceuticals PA0468/013/001 - MAGNESIUM HYDROXIDE 31/12/1996


Limited - ALUMINIUM HYDROXIDE
- CALCIUM CARBONATE

CETRICLENS T.J. Smith & Nephew PA0518/003/001 31/12/1996


CETRICLENS FORTE T.J. Smith & Nephew PA0518/003/002 31/12/1996
CHLORDIAZEPOXIDE Athlone Laboratories Ltd PA0298/005/001 Capsule - CHLORDIAZEPOXIDE 31/12/1996
CHYMAR Rorer Pharmaceuticals PA0468/010/001 Withdrawn Form - CHYMOTRYPSIN 31/12/1996
Limited
CHYMORAL Rorer Pharmaceuticals PA0468/026/001 Tablets 31/12/1996
Limited
CHYMORAL FORTE Rorer Pharmaceuticals PA0468/026/002 Tablets - TRYPSIN 31/12/1996
Limited
CIMETIDINE Norton Healthcare Limited PA0282/050/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
CIMETIDINE Norton Healthcare Limited PA0282/050/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
CIMETIDINE Norton Healthcare Limited PA0282/050/003 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
CITANEST Astra Pharmaceuticals Ltd PA0009/021/007 Solution for Injection - PRILOCAINE 31/12/1996
HYDROCHLORIDE
CITANEST 3% WITH Astra Pharmaceuticals Ltd PA0009/022/001 - PRILOCAINE 31/12/1996
ADRENALINE - EPINEPHRINE
BITARTRATE
CLOXACILLIN Norton Healthcare Limited PA0282/040/001 Capsule - CLOXACILLIN SODIUM 31/12/1996
T/A IVAX Pharmaceuticals
UK
CLOXACILLIN Norton Healthcare Limited PA0282/040/002 Capsule 31/12/1996
T/A IVAX Pharmaceuticals
UK
CLOXACILLIN Norton Healthcare Limited PA0282/040/003 31/12/1996
T/A IVAX Pharmaceuticals
UK
CO-TRIMOXAZOLE Norton Healthcare Limited PA0282/020/002 31/12/1996
PAEDIATRIC B.P.C. T/A IVAX Pharmaceuticals
UK
DIAZEPAM Norton Healthcare Limited PA0282/001/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK

Human Medicines Withdrawn Products Page 395 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIAZEPAM Norton Healthcare Limited PA0282/001/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
DIAZEPAM Norton Healthcare Limited PA0282/001/003 Tablets - DIAZEPAM 31/12/1996
T/A IVAX Pharmaceuticals
UK
DIORALYTE CHERRY Rorer Pharmaceuticals PA0468/001/002 31/12/1996
Limited
DIORALYTE PINEAPPLE Rorer Pharmaceuticals PA0468/001/003 31/12/1996
Limited
DIRYTHMIN Astra Pharmaceuticals Ltd PA0009/033/001 Capsule - DISOPYRAMIDE 31/12/1996
PHOSPHATE
DIRYTHMIN Astra Pharmaceuticals Ltd PA0009/033/002 Capsule - DISOPYRAMIDE 31/12/1996
PHOSPHATE
DIRYTHMIN I.V. Astra Pharmaceuticals Ltd PA0009/033/003 Solution for Injection - DISOPYRAMIDE 31/12/1996
PHOSPHATE
DIRYTHMIN I.V. Astra Pharmaceuticals Ltd PA0009/033/004 Solution for Injection - DISOPYRAMIDE 31/12/1996
PHOSPHATE
EPHYNAL Roche Products Limited PA0050/057/002 Tablets - TOCOPHERYL ACETATE 31/12/1996
ESKACEF DRY MIX SmithKline and French PA0060/009/004 31/12/1996
(SUSPENSION) Laboratories Ltd
ESODERM Napp Laboratories Limited PA0114/006/001 - LINDANE 31/12/1996
ESODERM Napp Laboratories Limited PA0114/006/002 - LINDANE 31/12/1996
EXPANSYL SPANSULE SmithKline and French PA0060/011/001 Capsule 31/12/1996
Laboratories Ltd
FENBUFEN Norton Healthcare Limited PA0282/058/001 Capsule 31/12/1996
T/A IVAX Pharmaceuticals
UK
FENBUFEN Norton Healthcare Limited PA0282/058/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
FENBUFEN Norton Healthcare Limited PA0282/058/003 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
FRUSEMIDE Norton Healthcare Limited PA0282/002/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
GARDENAL May & Baker Limited PA0040/015/001 Withdrawn Form 31/12/1996
GAROIN May & Baker Limited PA0040/016/001 Tablets 31/12/1996
HEDAMOL Nicholas Laboratories PA0032/030/001 Capsule - CODEINE PHOSPHATE 31/12/1996
- PARACETAMOL
HEXABRIX 250 May & Baker Limited PA0040/064/005 31/12/1996
HISTRYL PAEDIATRIC SmithKline and French PA0060/024/002 Capsule 31/12/1996
SPANSULE Laboratories Ltd
HISTRYL SPANSULE SmithKline and French PA0060/024/001 Capsule 31/12/1996
Laboratories Ltd
HYDROCARE PROTEIN Allergan Pharmaceuticals PA0148/004/001 Tablets - PAPAIN 31/12/1996
REMOVER Ireland
HYDROCORTISONE H.N. Norton & Company Ltd PA0382/004/002 Ointment - HYDROCORTISONE 31/12/1996
HYDROCORTISONE H.N. Norton & Company Ltd PA0382/004/001 - HYDROCORTISONE 31/12/1996
CREAM
JUNIOR PARACLEAR Nicholas Laboratories PA0032/031/001 Tablets - PARACETAMOL 31/12/1996
LIBRIUM Roche Products Limited PA0050/018/006 Withdrawn Form - CHLORDIAZEPOXIDE 31/12/1996
HYDROCHLORIDE
LITHOFALK Dr. Falk Pharma GmbH PA0573/001/001 Tablets - URSODEOXYCHOLIC 31/12/1996
ACID
- CHENODEOXYCHOLIC
ACID
LOGIPARIN 20,000 Novo Nordisk A/S PA0218/032/002 31/12/1996
LOGIPARIN 3,500 Novo Nordisk A/S PA0218/032/001 31/12/1996
MADOPAR 250 Roche Products Limited PA0050/043/004 Tablets - LEVODOPA 31/12/1996
- BENSERAZIDE
HYDROCHLORIDE
NAPROXEN Norton Waterford PA0436/011/001 Tablets - NAPROXEN 31/12/1996
NAPROXEN Norton Waterford PA0436/011/002 Tablets - NAPROXEN 31/12/1996
NASOFLU MONODOSE SmithKline and French PA0060/003/001 Withdrawn Form 31/12/1996
VIAL Laboratories Ltd
NASOFLU MULTIDOSE 10 SmithKline and French PA0060/003/002 Withdrawn Form 31/12/1996
Laboratories Ltd
NASOFLU MULTIDOSE 50 SmithKline and French PA0060/003/003 Withdrawn Form 31/12/1996
Laboratories Ltd
OMNOPON Roche Products Limited PA0050/024/002 Withdrawn Form 31/12/1996
OMNOPON Roche Products Limited PA0050/024/003 Withdrawn Form 31/12/1996

Human Medicines Withdrawn Products Page 396 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OMNOPON-SCOPOLAMINE Roche Products Limited PA0050/025/001 Withdrawn Form - PAPAVERINE 31/12/1996
- HYOSCINE
HYDROBROMIDE
OXAZEPAM Norton Healthcare Limited PA0282/011/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
OXAZEPAM Norton Healthcare Limited PA0282/011/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
OXAZEPAM Norton Healthcare Limited PA0282/011/003 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
OXPRENOLOL Norton Healthcare Limited PA0282/022/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
OXPRENOLOL Norton Healthcare Limited PA0282/022/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
OXPRENOLOL Norton Healthcare Limited PA0282/022/003 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PALAPRIN FORTE Nicholas Laboratories PA0032/008/001 Tablets - ACETYLSALICYLIC ACID 31/12/1996
- ALUMINIUM OXIDE
PENBRITIN SmithKline Beecham Pharm PA0049/010/005 - AMPICILLIN TRIHYDRATE 31/12/1996
Ltd
PENBRITIN SmithKline Beecham Pharm PA0049/010/012 Withdrawn Form - AMPICILLIN SODIUM 31/12/1996
Ltd
PENBRITIN PAEDIATRIC SmithKline Beecham Pharm PA0049/010/006 Tablets - AMPICILLIN TRIHYDRATE 31/12/1996
Ltd
PENBRITIN SYRUP SmithKline Beecham Pharm PA0049/010/007 Syrup - AMPICILLIN TRIHYDRATE 31/12/1996
Ltd
PENBRITIN SYRUP SmithKline Beecham Pharm PA0049/010/008 - AMPICILLIN TRIHYDRATE 31/12/1996
Ltd
PENBRITIN SYRUP SmithKline Beecham Pharm PA0049/010/010 - AMPICILLIN TRIHYDRATE 31/12/1996
Ltd
POSTURE Napp Laboratories Limited PA0114/053/001 Tablets - CALCIUM CARBONATE 31/12/1996
POSTURE Napp Laboratories Limited PA0114/053/002 Tablets - CALCIUM CARBONATE 31/12/1996
PREDNISOLONE Norton Healthcare Limited PA0282/015//00 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PREDNISOLONE Norton Healthcare Limited PA0282/028/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PREDNISOLONE Norton Healthcare Limited PA0282/028/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PROPINE-PTM Allergan Pharmaceuticals PA0148/037/001 - DIPIVEFRINE 31/12/1996
Ireland HYDROCHLORIDE
- PILOCARPINE
HYDROCHLORIDE
PROPRANOLOL Norton Healthcare Limited PA0282/013/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PROPRANOLOL Norton Healthcare Limited PA0282/013/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PROPRANOLOL Norton Healthcare Limited PA0282/013/003 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PROPRANOLOL Norton Healthcare Limited PA0282/013/004 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
PULMO BAILLY Bengue & Company Limited PA0096/007/001 31/12/1996
REDOXON Roche Products Limited PA0050/007/006 Tablets - ASCORBIC ACID 31/12/1996
ROCEPHIN Roche Products Limited PA0050/062/003 Withdrawn Form - CEFTRIAXONE 31/12/1996
- LIDOCAINE
SALBUTAMOL Norton Healthcare Limited PA0282/031/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
SALBUTAMOL Norton Healthcare Limited PA0282/031/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
SALOMOL Norton Waterford PA0436/007/003 Tablets - SALBUTAMOL 31/12/1996
SALOMOL Norton Waterford PA0436/007/004 Tablets - SALBUTAMOL 31/12/1996
SOFLENS CLEANING Allergan Pharmaceuticals PA0148/005/001 Tablets - PAPAIN 31/12/1996
Ireland

Human Medicines Withdrawn Products Page 397 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SONERYL May & Baker Limited PA0040/025/001 Tablets 31/12/1996
SPIRIDON Orion Pharma A/s PA0303/009/001 Tablets - SPIRONOLACTONE 31/12/1996
SPIRIDON Orion Pharma A/s PA0303/009/002 Tablets - SPIRONOLACTONE 31/12/1996
SPIRONOLACTONE Norton Healthcare Limited PA0282/014/001 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
SPIRONOLACTONE Norton Healthcare Limited PA0282/014/002 Tablets 31/12/1996
T/A IVAX Pharmaceuticals
UK
STREPTOTRIAD May & Baker Limited PA0040/008/001 Tablets 31/12/1996
SULPHADIAZINE May & Baker Limited PA0040/009/001 Withdrawn Form 31/12/1996
SULPHATRIAD May & Baker Limited PA0040/010/002 Tablets 31/12/1996
TANDERIL EYE Dispersa (UK) Ltd PA0582/008/001 Ointment - OXYPHENBUTAZONE 31/12/1996
- ETHANOL
TIMENTIN SmithKline Beecham Pharm PA0049/048/001 - TICARCILLIN DISODIUM 31/12/1996
Ltd - CLAVULANATE
POTASSIUM
TIMENTIN SmithKline Beecham Pharm PA0049/048/004 Solution for Infusion - TICARCILLIN DISODIUM 31/12/1996
Ltd - CLAVULANATE
POTASSIUM
TOPICLENS T.J. Smith & Nephew PA0518/002/001 31/12/1996
TRH ROCHE Roche Products Limited PA0050/044/002 Withdrawn Form - PROTIRELIN 31/12/1996
TRIGLOBE Astra Pharmaceuticals Ltd PA0009/009/002 Tablets - SULFADIAZINE 31/12/1996
- TRIMETHOPRIM LACTATE

TRIGLOBE (SUSPENSION) Astra Pharmaceuticals Ltd PA0009/009/001 - SULFADIAZINE 31/12/1996


- TRIMETHOPRIM
TRIODENE ED HE Clissmann PA0012/066/001 Tablets - GESTODENE 31/12/1996
- ETHINYLESTRADIOL
VERACTIL May & Baker Limited PA0040/030/001 Withdrawn Form 31/12/1996
VINCRISTINE Cyanamid of Great Britain PA0037/052/001 Withdrawn Form 31/12/1996
VINCRISTINE Cyanamid of Great Britain PA0037/052/002 Withdrawn Form 31/12/1996
VINCRISTINE Cyanamid of Great Britain PA0037/052/003 Withdrawn Form 31/12/1996
XYLOCAINE Astra Pharmaceuticals Ltd PA0009/016/020 - LIDOCAINE 31/12/1996
HYDROCHLORIDE
ALSUCRAL Orion Pharma A/s PA0303/024/001 - SUCRALFATE 30/12/1996
PENBRITIN SYRUP SmithKline Beecham Pharm PA0049/010/009 Syrup - AMPICILLIN TRIHYDRATE 30/12/1996
Ltd
HIBIDIL Zeneca Limited PA0051/039/001 - CHLORHEXIDINE 23/12/1996
GLUCONATE
FERROCAP Consolidated Chemicals PA0132/004/001 Capsule - FERROUS FUMARATE 20/12/1996
Limited
FERROCAP F 350 Consolidated Chemicals PA0132/006/001 Capsule - FERROUS FUMARATE 20/12/1996
Limited - FOLIC ACID
ACTIFED EXPECTORANT Wellcome (Ireland) Limited PA0017/013/004 Syrup - TRIPROLIDINE 29/11/1996
HYDROCHLORIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- GUAIFENESIN
ADALAT PCO Manufacturing PPA0465/012/001 Capsule - NIFEDIPINE 29/11/1996
ALREDASE John Wyeth & Brother PA0022/051/001 Capsule - TOLRESTAT 29/11/1996
Limited
ALTACITE Roussel Laboratories Limited PA0006/026/001 Tablets - HYDROTALCITE 29/11/1996

AMFIPEN Yamanouchi Pharma Ltd PA0062/004/005 Withdrawn Form 29/11/1996


AMFIPEN Yamanouchi Pharma Ltd PA0062/004/006 Withdrawn Form 29/11/1996
AMFIPEN Yamanouchi Pharma Ltd PA0062/004/007 Withdrawn Form 29/11/1996
AMFIPEN Yamanouchi Pharma Ltd PA0062/004/008 Withdrawn Form 29/11/1996
AMFIPEN Yamanouchi Pharma Ltd PA0062/004/009 29/11/1996
AMFIPEN Yamanouchi Pharma Ltd PA0062/004/001 Capsule 29/11/1996
AMFIPEN Yamanouchi Pharma Ltd PA0062/004/002 Capsule 29/11/1996
AMFIPEN 250 Yamanouchi Pharma Ltd PA0062/004/004 Syrup 29/11/1996
AMFIPEN SYRUP Yamanouchi Pharma Ltd PA0062/004/003 Syrup 29/11/1996
AMFIPEN SYRUP Yamanouchi Pharma Ltd PA0062/004/010 Syrup 29/11/1996
AMFIPEN SYRUP FORTE Yamanouchi Pharma Ltd PA0062/004/011 Syrup 29/11/1996
ARELIX-K Hoechst Ireland Limited PA0023/045/001 Tablets - PIRETANIDE 29/11/1996
- POTASSIUM CHLORIDE
CEPASTAT Marion Merrell Limited PA0041/021/001 - PHENOL 29/11/1996
CIDOMYCIN EAR Roussel Laboratories Limited PA0006/003/015 Ointment - GENTAMICIN 29/11/1996

CIDOMYCIN EYE Roussel Laboratories Limited PA0006/003/014 - GENTAMICIN 29/11/1996

CITRUCEL Marion Merrell Limited PA0041/039/001 - METHYLCELLULOSE 29/11/1996


COLOCLER Ricesteele Manufacturing Ltd PA0095/014/001 Powder for Oral Solution 29/11/1996

Human Medicines Withdrawn Products Page 398 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/001/002 Tablets 29/11/1996
DELPHYLLINE Delandale Laboratories PA0080/007/001 Syrup - THEOPHYLLINE SODIUM 29/11/1996
Limited AMINOACETATE
FELDENE Parallel Lines Ltd PA0384/012/002 Capsule - PIROXICAM 29/11/1996
FRISIUM Hoechst Ireland Limited PA0023/018/001 Capsule - CLOBAZAM 29/11/1996
FRISIUM Hoechst Ireland Limited PA0023/018/002 Capsule - CLOBAZAM 29/11/1996
FRISIUM Hoechst Ireland Limited PA0023/018/003 Capsule - CLOBAZAM 29/11/1996
FYBRANTA Norgine Limited PA0102/001/001 - BRAN 29/11/1996
- CALCIUM
HEXOPAL PCO Manufacturing PPA0465/006/001 Tablets 29/11/1996
ILOSONE (SUSPENSION) Dista Products Limited PA0447/004/002 - ERYTHROMYCIN 29/11/1996
ESTOLATE
ILOSONE (SUSPENSION) Dista Products Limited PA0447/004/003 - ERYTHROMYCIN 29/11/1996
ESTOLATE
MERASYN Marion Merrell Limited PA0041/004/001 Gel - ALUMINIUM HYDROXIDE 29/11/1996
GEL
- MAGNESIUM HYDROXIDE

MERBENTYL DOSPAN Marion Merrell Limited PA0041/006/001 Tablets - DICYCLOVERINE 29/11/1996


MFV-JECT MERIEUX Merieux UK Limited PA0504/001/001 29/11/1996
MONO DOSE
MUCODYNE Berk Pharmaceuticals PA0082/002/004 - CARBOCISTEINE 29/11/1996
Limited
NATRILIX Parallel Lines Ltd PA0384/016/001 Tablets - INDAPAMIDE 29/11/1996
NEGRAM PCO Manufacturing PPA0465/003/001 Tablets - NALIDIXIC ACID 29/11/1996
NICABATE PATCH Marion Merrell Limited PA0041/048/001 - NICOTINE 29/11/1996
NICABATE PATCH Marion Merrell Limited PA0041/048/002 - NICOTINE 29/11/1996
NICABATE PATCH Marion Merrell Limited PA0041/048/003 - NICOTINE 29/11/1996
OSCAL Marion Merrell Limited PA0041/049/001 Tablets - CALCIUM 29/11/1996
PERFAN ENOXIMONE Marion Merrell Limited PA0041/040/001 Withdrawn Form 29/11/1996
PERFAN ENOXIMONE Marion Merrell Limited PA0041/040/003 Withdrawn Form 29/11/1996
PHYLLODROPS ORAL Napp Laboratories Limited PA0114/056/001 - AMINOPHYLLINE 29/11/1996
LIQUID
REVERIN I.V. Hoechst Ireland Limited PA0023/012/004 Withdrawn Form - ROLITETRACYCLINE 29/11/1996
RIFADIN Marion Merrell Limited PA0041/029/001 Solution for Infusion - RIFAMPICIN 29/11/1996
RIFAPRIM Marion Merrell Limited PA0041/032/001 Tablets - RIFAMPICIN 29/11/1996
- TRIMETHOPRIM
SOFRAMYCIN Roussel Laboratories Limited PA0006/011/003 Cream - FRAMYCETIN SULFATE 29/11/1996
- GRAMICIDIN
SOFRAMYCIN Roussel Laboratories Limited PA0006/011/007 - FRAMYCETIN SULFATE 29/11/1996

SOFRAMYCIN SKIN Roussel Laboratories Limited PA0006/011/004 Ointment - FRAMYCETIN SULFATE 29/11/1996
- GRAMICIDIN
SURGAM DISPERSIBLE Roussel Laboratories Limited PA0006/023/007 Tablets - TIAPROFENIC ACID 29/11/1996

TARGOCID Marion Merrell Limited PA0041/041/001 Withdrawn Form - TEICOPLANIN 29/11/1996


TARIVID Hoechst Irl Ltd. PA0023/053/001 Tablets 29/11/1996
TENUATE Marion Merrell Limited PA0041/027/002 Tablets - AMFEPRAMONE 29/11/1996
HYDROCHLORIDE
UNIDOX Yamanouchi Pharma Ltd PA0062/025/005 Capsule 29/11/1996
UNIDOX SOLUTAB Yamanouchi Pharma Ltd PA0062/025/004 Tablets 29/11/1996
VIBRAMYCIN PCO Manufacturing PPA0465/015/001 Capsule - DOXYCYCLINE 29/11/1996
HYDROCHLORIDE
VICKS Marion Merrell Limited PA0041/007/001 Syrup 29/11/1996
VICKS MEDINITE Marion Merrell Limited PA0041/001/001 29/11/1996
KLARON Rorer Pharmaceuticals PA0468/027/001 - SULFUR 05/11/1996
Limited - SALICYLIC ACID
REZAMID Rorer Pharmaceuticals PA0468/031/001 - RESORCINOL 05/11/1996
Limited - SULFUR
- CHLOROXYLENOL
APS PROPRANOLOL Teva UK Limited PA0237/020/001 Tablets 31/10/1996
APS PROPRANOLOL Teva UK Limited PA0237/020/002 Tablets 31/10/1996
APS PROPRANOLOL Teva UK Limited PA0237/020/003 Tablets 31/10/1996
APS PROPRANOLOL Teva UK Limited PA0237/020/004 Tablets 31/10/1996
BENOXID Roche Products Limited PA0050/084/001 Gel - BENZOYL PEROXIDE 31/10/1996
BENOXID Roche Products Limited PA0050/084/003 Gel - BENZOYL PEROXIDE 31/10/1996
CENTOXIN Janssen Biologics B.V. PA0502/002/001 31/10/1996
EFEMOLINE EYE Dispersa (UK) Ltd PA0582/002/001 - FLUOROMETHOLONE 31/10/1996
- TETRYZOLINE
- BENZALKONIUM
CHLORIDE
FLEXCARE Alcon Laboratories (UK) Ltd PA0290/018/001 - CHLORHEXIDINE 31/10/1996
GLUCONATE
- THIOMERSAL
HEPARIN SODIUM 1000 Leo Laboratories Limited PA0046/036/004 Withdrawn Form 31/10/1996

Human Medicines Withdrawn Products Page 399 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFLUVAC SUB-UNIT Abbott Healthcare Products PA0108/017/003 Withdrawn Form 31/10/1996
Ltd
INFLUVAC SUB-UNIT Abbott Healthcare Products PA0108/017/001 Withdrawn Form 31/10/1996
Ltd
INTERCEPT Cilag Limited PA0059/019/001 Pessary - NONOXINOL 31/10/1996
IRUXOL Knoll A.G. (Clissmann) PA0058/001/001 Ointment - COLLAGENASE 31/10/1996
- CHLORAMPHENICOL
ISMELIN EYE Novartis Consumer Health PA0030/005/001 - GUANETHIDINE 31/10/1996
UK Limited MONOSULFATE
LAEVULOSE Baxter Healthcare Limited PA0167/036/005 Withdrawn Form - FRUCTOSE 31/10/1996
LAEVULOSE Baxter Healthcare Limited PA0167/036/006 Withdrawn Form - FRUCTOSE 31/10/1996
LAEVULOSE Baxter Healthcare Limited PA0167/036/009 Withdrawn Form - FRUCTOSE 31/10/1996
LAEVULOSE Baxter Healthcare Limited PA0167/036/010 Withdrawn Form - FRUCTOSE 31/10/1996
LAMPRENE Ciba Geigy Plc PA0011/011/001 Capsule - CLOFAZIMINE 31/10/1996
MULTIFUNGIN Knoll A.G. (Clissmann) PA0058/005/001 Ointment 31/10/1996
NICOTINELL TTS Ciba Geigy Plc PA0011/040/001 - NICOTINE 31/10/1996
NICOTINELL TTS Ciba Geigy Plc PA0011/040/002 - NICOTINE 31/10/1996
NICOTINELL TTS Ciba Geigy Plc PA0011/040/003 - NICOTINE 31/10/1996
NORMOL Alcon Laboratories (UK) Ltd PA0290/015/001 - CHLORHEXIDINE 31/10/1996
GLUCONATE
PLASMALYTE Baxter Healthcare Limited PA0167/040/001 - ELECTROLYTES NOS 31/10/1996
148/DEXTROSE - GLUCOSE
PLASMALYTE Baxter Healthcare Limited PA0167/040/002 - ELECTROLYTES NOS 31/10/1996
148/DEXTROSE - GLUCOSE
PLASMALYTE Baxter Healthcare Limited PA0167/040/003 - ELECTROLYTES NOS 31/10/1996
148/DEXTROSE - GLUCOSE
PLASMALYTE Baxter Healthcare Limited PA0167/040/004 - ELECTROLYTES NOS 31/10/1996
148/DEXTROSE - GLUCOSE
PROGRAM-20 Cilag Limited PA0059/007/001 Tablets - MESTRANOL 31/10/1996
PROGRAM-40 Cilag Limited PA0059/007/002 Tablets - MESTRANOL 31/10/1996
PROPRANOLOL Accord-UK Ltd PA0176/009/002 Tablets 31/10/1996
PROPRANOLOL Accord-UK Ltd PA0176/009/003 Tablets 31/10/1996
RONICOL TIMESPAN Tillomed Laboratories Limite PA0644/002/002 Tablets - NICOTINYL TARTRATE 31/10/1996

SODIUM LACTATE Baxter Healthcare Limited PA0167/056/001 Withdrawn Form - SODIUM LACTATE 31/10/1996
SODIUM LACTATE Baxter Healthcare Limited PA0167/056/002 Withdrawn Form - SODIUM LACTATE 31/10/1996
SODIUM LACTATE Baxter Healthcare Limited PA0167/056/003 Withdrawn Form - SODIUM LACTATE 31/10/1996
SODIUM LACTATE Baxter Healthcare Limited PA0167/056/004 Withdrawn Form - SODIUM LACTATE 31/10/1996
TALUSIN Knoll A.G. (Clissmann) PA0058/014/001 Tablets - PROSCILLARIDIN 31/10/1996
TRAVERT Baxter Healthcare Limited PA0167/038/001 - INVERT SUGAR 31/10/1996
TRAVERT Baxter Healthcare Limited PA0167/038/002 - INVERT SUGAR 31/10/1996
TRAVERT Baxter Healthcare Limited PA0167/038/003 - INVERT SUGAR 31/10/1996
TRAVERT Baxter Healthcare Limited PA0167/038/004 - INVERT SUGAR 31/10/1996
URISPAS Syntex Pharmaceuticals PA0033/008/001 Tablets - FLAVOXATE 31/10/1996
Limited
VALDERMA Roche Products Limited PA0050/088/001 Gel - BENZOYL PEROXIDE 31/10/1996
CLONURETIC Clonmel Healthcare Ltd PA0126/061/001 Tablets 13/10/1996
ANTEPAR Wellcome (Ireland) Limited PA0017/082/001 Unknown 30/09/1996
BACTERIOSTATIC Hospira UK Limited PA0437/015/002 - BENZYL ALCOHOL 30/09/1996
DILUENT - SODIUM CHLORIDE
- WATER FOR INJECTIONS

BISODOL EXTRA Pfizer Consumer Healthcare PA0172/022/001 Tablets - CALCIUM CARBONATE 30/09/1996
Ltd - MAGNESIUM
CARBONATE
- DIMETICONE, ACTIVATED
- SODIUM BICARBONATE

CASCARA Mercury Pharmaceuticals PA0073/125/001 Tablets 30/09/1996


(Ireland) Ltd
CASMIN CP Pharmaceuticals Ltd PA0409/013/001 Tablets 30/09/1996
trading as Wockhardt UK
CASMIN CP Pharmaceuticals Ltd PA0409/013/002 Tablets 30/09/1996
trading as Wockhardt UK
CASMIN CP Pharmaceuticals Ltd PA0409/013/003 Tablets 30/09/1996
trading as Wockhardt UK
CHOLERA VACCINE B.P. UCB Pharma Limited PA0365/062/001 - CHOLERA VACCINE 30/09/1996
CLOPIXOL INJECTION Lundbeck Limited PA0115/005/005 - CLOPENTHIXOL 30/09/1996
CO-FRAM Abbott Laboratories Ireland PA0038/025/001 Tablets 30/09/1996
Ltd
CREANOL Helsinn Birex PA0294/008/001 Capsule - PROPRANOLOL 30/09/1996
Pharmaceuticals Limited
CREANOL Helsinn Birex PA0294/008/002 Capsule - PROPRANOLOL 30/09/1996
Pharmaceuticals Limited
DEPIXOL Lundbeck Limited PA0115/001/005 30/09/1996

Human Medicines Withdrawn Products Page 400 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DEPIXOL Lundbeck Limited PA0115/001/006 30/09/1996
DEPIXOL Lundbeck Limited PA0115/001/008 Withdrawn Form - FLUPENTIXOL 30/09/1996
DIANEAL Baxter Healthcare Limited PA0167/064/001 30/09/1996
DIANEAL Baxter Healthcare Limited PA0167/064/002 30/09/1996
DIANEAL Baxter Healthcare Limited PA0167/064/003 30/09/1996
EPODYL Zeneca Limited PA0051/023/001 - ETOGLUCID 30/09/1996
FERROMYN Wellcome (Ireland) Limited PA0017/071/001 Syrup - FERROUS SUCCINATE 30/09/1996
GENTAMICIN Abbott Laboratories Ireland PA0038/042/001 Solution for Infusion 30/09/1996
Ltd
GENTAMICIN Abbott Laboratories Ireland PA0038/042/002 Solution for Infusion 30/09/1996
Ltd
GENTAMICIN Hospira UK Limited PA0437/016/006 Withdrawn Form - GENTAMICIN 30/09/1996
HYDROMET Merck Sharp and Dohme PA0035/025/001 Tablets - METHYLDOPA 30/09/1996
Limited - HYDROCHLOROTHIAZIDE

LOGIPARIN Novo Nordisk A/S PA0218/032/006 30/09/1996


MANERIX Roche Products Limited PA0050/081/001 Tablets - MOCLOBEMIDE 30/09/1996
MENTADENT S Elida Faberge Ireland PA0581/002/001 30/09/1996
TOOTHPASTE
METRONIDAZOLE Abbott Laboratories Ireland PA0038/041/001 Withdrawn Form 30/09/1996
Ltd
MONASPOR Ciba Geigy Plc PA0028/039/001 - CEFSULODIN SODIUM 30/09/1996
MONASPOR Ciba Geigy Plc PA0028/039/002 - CEFSULODIN SODIUM 30/09/1996
MONASPOR Ciba Geigy Plc PA0028/039/003 - CEFSULODIN SODIUM 30/09/1996
MONASPOR Ciba Geigy Plc PA0028/039/004 - CEFSULODIN SODIUM 30/09/1996
RAZOXIN Zeneca Limited PA0051/005/001 Tablets - RAZOXANE 30/09/1996
SALURIC Merck Sharp and Dohme PA0035/030/001 Tablets - CHLOROTHIAZIDE 30/09/1996
Limited
SPIRONOLACTONE Abbott Laboratories Ireland PA0038/027/001 Tablets 30/09/1996
Ltd
TOPILAR Syntex Pharmaceuticals PA0033/007/002 Cream - FLUCLOROLONE 30/09/1996
Limited ACETONIDE
TOPILAR Syntex Pharmaceuticals PA0033/007/003 Ointment - FLUCLOROLONE 30/09/1996
Limited ACETONIDE
TRAVOGEN HE Clissmann PA0012/046/001 Cream - ISOCONAZOLE NITRATE 30/09/1996
TYLENOL Johnson & Johnson (Ireland) PA0330/002/001 Tablets - PARACETAMOL 30/09/1996
Limited
TYLENOL Johnson & Johnson (Ireland) PA0330/002/002 Capsule - PARACETAMOL 30/09/1996
Limited
ZOVIRAX Wellcome (Ireland) Limited PA0017/078/003 Tablets - ACICLOVIR 30/09/1996
ZOVIRAX Wellcome (Ireland) Limited PA0017/078/006 Tablets - ACICLOVIR 30/09/1996
ZOVIRAX Wellcome (Ireland) Limited PA0017/078/007 Tablets - ACICLOVIR 30/09/1996
ACTIDIL Wellcome (Ireland) Limited PA0017/014/001 Tablets - TRIPROLIDINE 31/08/1996
HYDROCHLORIDE
ACTIDIL ELIXIR Wellcome (Ireland) Limited PA0017/014/002 Syrup - TRIPROLIDINE 31/08/1996
HYDROCHLORIDE
AEROSPORIN Wellcome (Ireland) Limited PA0017/003/001 Withdrawn Form - POLYMYXIN B SULFATE 31/08/1996
ALCOPAR Wellcome (Ireland) Limited PA0017/081/001 Granules Effervescent - BEPHENIUM 31/08/1996
HYDROXYNAPHTHOATE
ALKASID Leo Laboratories Limited PA0046/012/002 Tablets - MAGNESIUM ALUMINUM 31/08/1996
SILICATE
- DIMETICONE, ACTIVATED

ALKASID (SUSPENSION) Leo Laboratories Limited PA0046/012/001 - MAGNESIUM ALUMINUM 31/08/1996


SILICATE
- DIMETICONE, ACTIVATED

AMINOPLEX 24 Geistlich Sons Limited PA0143/012/002 - AMINO ACIDS 31/08/1996


BECONASE NASAL Allen and Hanburys Limited PA0024/012/001 - BECLOMETASONE 31/08/1996
(SPRAY) DIPROPIONATE
BENORAL Sanofi-Synthelabo Ireland PA0077/008/003 - BENORILATE 31/08/1996
Ltd
BETNOVATE C Glaxo Laboratories Limited PA0044/022/002 Ointment - BETAMETHASONE 31/08/1996
VALERATE
- CLIOQUINOL
BURAM FORTE Leo Laboratories Limited PA0046/059/003 Tablets - BUMETANIDE 31/08/1996
- AMILORIDE
HYDROCHLORIDE
CALAMINE Foran Healthcare Limited PA0484/016/001 - CALAMINE 31/08/1996
- ZINC OXIDE
- PHENOL
CEPOREX Glaxo Laboratories Limited PA0044/009/008 Tablets - CEFALEXIN 31/08/1996
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/004 - CHLORHEXIDINE 31/08/1996
ANTISEPTIC DIACETATE

Human Medicines Withdrawn Products Page 401 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/005 - CHLORHEXIDINE 31/08/1996
ANTISEPTIC DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/006 - CHLORHEXIDINE 31/08/1996
ANTISEPTIC DIACETATE
CHYMOCYCLAR Aventis Behring Limited PA0010/007/001 Capsule - TETRACYCLINE 31/08/1996
HYDROCHLORIDE
COMPOUND Baxter Healthcare Limited PA0167/063/001 Solution for Infusion - SODIUM LACTATE 31/08/1996
SODIUM/LACTATE COMPOUND INJECTION
COMPOUND Baxter Healthcare Limited PA0167/063/002 - SODIUM LACTATE 31/08/1996
SODIUM/LACTATE/DEXTR COMPOUND INJECTION
OSE
DIONOSIL OILY - Glaxo Laboratories Limited PA0044/073/001 - PROPYLIODONE 31/08/1996
(SUSPENSION)
DORALESE TILTAB SmithKline and French PA0060/052/001 Tablets 31/08/1996
Laboratories Ltd
DRIED FACTOR VIII Aventis Behring Limited PA0010/030/001 - FACTOR VIII 31/08/1996
FRACTION B.P. HEAT (ANTIHAEMOPHILIC
TREATED FACTOR)
ELOTRANS Rowa Pharmaceuticals PA0074/012/001 - GLUCOSE ANHYDROUS 31/08/1996
Limited - SODIUM CHLORIDE
- SODIUM CITRATE
- POTASSIUM CHLORIDE
ERYMAX Parke Davis & Company PA0056/040/002 Capsule - ERYTHROMYCIN 31/08/1996
ESBATAL Wellcome (Ireland) Limited PA0017/057/001 Tablets - BETANIDINE SULFATE 31/08/1996
FUCIDIN FOR Leo Laboratories Limited PA0046/004/007 - FUSIDATE SODIUM 31/08/1996
INTRAVENOUS INFUSION
GLUCAGON Eli Lilly and Company Limite PA0047/045/001 Withdrawn Form 31/08/1996

HEP RINSE Leo Laboratories Limited PA0046/028/002 - HEPARIN SODIUM 31/08/1996


HUMULIN I Eli Lilly and Company Limite PA0047/059/005 Withdrawn Form - HUMAN INSULIN 31/08/1996
RECOMBINANT
HUMULIN M1 Eli Lilly and Company Limite PA0047/065/003 Withdrawn Form 31/08/1996

HUMULIN M2 Eli Lilly and Company Limite PA0047/066/003 Withdrawn Form - HUMAN INSULIN 31/08/1996
RECOMBINANT
HUMULIN M3 Eli Lilly and Company Limite PA0047/069/003 Withdrawn Form - HUMAN INSULIN 31/08/1996
RECOMBINANT
HUMULIN M4 Eli Lilly and Company Limite PA0047/070/003 Withdrawn Form - HUMAN INSULIN 31/08/1996
RECOMBINANT
HYPON Wellcome (Ireland) Limited PA0017/001/001 - ACETYLSALICYLIC ACID 31/08/1996
- CAFFEINE
- CODEINE PHOSPHATE
- PHENOLPHTHALEIN
ICY HOT CREAM G.D. Searle & Company PA0001/024/002 Cream - METHYL SALICYLATE 31/08/1996
Limited - MENTHOL
MADECASSOL Syntex Pharmaceuticals PA0033/024/001 Ointment 31/08/1996
Limited
MADECASSOL Syntex Pharmaceuticals PA0033/024/002 31/08/1996
Limited
MALINAL A.H. Robins Company PA0086/022/002 Tablets - ALMASILATE 31/08/1996
Limited - DIMETICONE, ACTIVATED

MALINAL (SUSPENSION) A.H. Robins Company PA0086/022/001 - ALMASILATE 31/08/1996


Limited - DIMETICONE, ACTIVATED

MAXZIDE Cyanamid of Great Britain PA0037/058/001 Tablets - AMILORIDE 31/08/1996


HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

MOBIFLEX Roche Products Limited PA0050/067/004 Tablets Effervescent - TENOXICAM 31/08/1996


MONISTAT Cilag Limited PA0059/002/002 Cream - MICONAZOLE NITRATE 31/08/1996
ORALCER Vitabiotics Limited PA0256/001/001 31/08/1996
OXYTETRACYCLINE Accord-UK Ltd PA0176/003/001 Tablets 31/08/1996
PANALEVE ELIXIR Leo Laboratories Limited PA0046/047/001 Syrup - PARACETAMOL 31/08/1996
PARACETAMOL Accord-UK Ltd PA0176/011/001 Tablets - PARACETAMOL 31/08/1996
PARAHYPON Wellcome (Ireland) Limited PA0017/012/001 Tablets - PARACETAMOL 31/08/1996
- CODEINE PHOSPHATE
- CAFFEINE
PINDAC Leo Laboratories Limited PA0046/054/003 Capsule - PINACIDIL 31/08/1996
PIRITON Allen and Hanburys Limited PA0024/010/002 Tablets - CHLORPHENAMINE 31/08/1996
PRO-VENT Wellcome (Ireland) Limited PA0017/086/001 Capsule - THEOPHYLLINE 31/08/1996
PUMP-HEP Leo Laboratories Limited PA0046/044/002 Solution for Injection - HEPARIN SODIUM 31/08/1996
QUININE SULPHATE Accord-UK Ltd PA0176/027/001 Tablets 31/08/1996
RAMODAR John Wyeth & Brother PA0022/052/003 Tablets - ETODOLAC 31/08/1996
Limited

Human Medicines Withdrawn Products Page 402 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RAMODAR John Wyeth & Brother PA0022/052/004 Tablets - ETODOLAC 31/08/1996
Limited
SELEXID Leo Laboratories Limited PA0046/014/001 Tablets - PIVMECILLINAM 31/08/1996
SODIUM BICARBONATE Baxter Healthcare Limited PA0167/058/001 Withdrawn Form - SODIUM BICARBONATE 31/08/1996
SODIUM BICARBONATE Baxter Healthcare Limited PA0167/058/002 Withdrawn Form - SODIUM BICARBONATE 31/08/1996
TINEFAX Wellcome (Ireland) Limited PA0017/008/001 - ZINC UNDECYLENATE 31/08/1996
TUBARINE Wellcome (Ireland) Limited PA0017/053/001 Withdrawn Form - TUBOCURARINE 31/08/1996
CHLORIDE
VENTIDE INHALER Allen and Hanburys Limited PA0024/018/001 - SALBUTAMOL 31/08/1996
- BECLOMETASONE
DIPROPIONATE
VIRA-A (SUSPENSION) Parke Davis & Company PA0056/018/002 - VIDARABINE 31/08/1996
MONOHYDRATE
ZANTAC DISPERSIBLE Glaxo Laboratories Limited PA0044/076/005 Tablets - RANITIDINE 31/08/1996
ZIN-MET 1500 Glaxo Laboratories Limited PA0044/091/002 Powder for Oral Solution - CEFUROXIME 31/08/1996
- METRONIDAZOLE
ZIN-MET 750 Glaxo Laboratories Limited PA0044/091/001 Powder for Oral Solution - CEFUROXIME 31/08/1996
- METRONIDAZOLE
DURACARE STORING & Allergan Pharmaceuticals PA0148/053/001 - POLYVINYL ALCOHOL 26/08/1996
WETTING Ireland
EPIFRIN 0.5% STERILE Allergan Pharmaceuticals PA0148/008/001 - EPINEPHRINE 26/08/1996
OPTHALMIC Ireland
LOGYNON ED HE Clissmann PA0012/050/001 Tablets - LEVONORGESTREL 26/08/1996
- ETHINYLESTRADIOL
- LEVONORGESTREL
- ETHINYLESTRADIOL
- LEVONORGESTREL
- ETHINYLESTRADIOL
- LACTOSE ANHYDROUS
METHYLDOPA Pinewood Laboratories Ltd, PA0281/017/001 Coated Tablets - METHYLDOPA 25/08/1996
ADDAMEL Pharmacia Laboratories PA0187/002/001 - ELECTROLYTES NOS 31/07/1996
Limited
AMIKIN VIALS Bristol-Myers Squibb PA0048/004/005 Withdrawn Form - AMIKACIN 31/07/1996
(Holdings) Limited
AMINOFUSIN L600 E. Merck Ltd PA0054/036/001 - AMINO ACIDS 31/07/1996
- CARBOHYDRATES NOS
- VITAMINS NOS
- ELECTROLYTES NOS
AMINOGLUTETHIMI DE Farmitalia Carlo Erba Ltd PA0236/018/001 Tablets 31/07/1996
AMINOPLEX 24 Geistlich Sons Limited PA0143/012/001 - AMINO ACIDS 31/07/1996
BENORAL Sanofi-Synthelabo Ireland PA0077/008/001 Tablets - BENORILATE 31/07/1996
Ltd
BUPIVACAINE Hospira UK Limited PA0437/019/001 Withdrawn Form - BUPIVACAINE 31/07/1996
HYDROCHLORIDE HYDROCHLORIDE
CALLUSOLVE Dermal Laboratories Ltd PA0278/012/001 - BENZALKONIUM 31/07/1996
CHLORIDE
- BROMINE
CEDOCARD 20 J B Tillotts Limited PA0360/021/005 Tablets - ISOSORBIDE DINITRATE 31/07/1996
CEDOCARD 40 J B Tillotts Limited PA0360/021/006 Tablets - ISOSORBIDE DINITRATE 31/07/1996
CEDOCARD 5 J B Tillotts Limited PA0360/021/004 Tablets - ISOSORBIDE DINITRATE 31/07/1996
CISPLATIN Farmitalia Carlo Erba Ltd PA0236/013/005 Solution for Injection 31/07/1996
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/004 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/015 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/016 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/017 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/019 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/020 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/021 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/022 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD 2 Baxter Healthcare Limited PA0167/064/024 31/07/1996
PERITONEAL DIALYSIS
DIANEAL PD PERITONEAL Baxter Healthcare Limited PA0167/064/005 31/07/1996
DIALYSIS
DIANEAL PD2 Baxter Healthcare Limited PA0167/064/008 31/07/1996
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/009 31/07/1996
DIALYSIS

Human Medicines Withdrawn Products Page 403 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/010 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/011 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/012 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/013 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/014 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/018 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/006 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/007 31/07/1996
DIALYSIS
DIANEAL PD2 PERITONEAL Baxter Healthcare Limited PA0167/064/023 31/07/1996
DIALYSIS
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/001 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/002 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/003 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/004 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/005 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/006 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE

Human Medicines Withdrawn Products Page 404 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/008 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/009 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/010 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/011 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/012 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/013 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/014 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/015 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE

Human Medicines Withdrawn Products Page 405 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/016 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/017 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/019 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/020 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/021 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/022 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/023 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/DEXTROSE Baxter Healthcare Limited PA0167/049/024 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE

Human Medicines Withdrawn Products Page 406 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIANEAL PD3/GLUCOSE Baxter Healthcare Limited PA0167/049/018 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DIANEAL PD3/GLUCOSE Baxter Healthcare Limited PA0167/049/007 - GLUCOSE 31/07/1996
MONOHYDRATE
- SODIUM CHLORIDE
- SODIUM LACTATE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- GLUCOSE
DOXORUBICIN RAPID Farmitalia Carlo Erba Ltd PA0236/023/005 31/07/1996
DISSOLUTION
DUROMINE 3M Health Care Limited PA0057/063/001 Capsule - PHENTERMINE 31/07/1996
DUROMINE 3M Health Care Limited PA0057/063/002 Capsule - PHENTERMINE 31/07/1996
EUHYPNOS GELTHIX 15 Farmitalia Carlo Erba Ltd PA0236/009/004 31/07/1996
EUHYPNOS GELTHIX 30 Farmitalia Carlo Erba Ltd PA0236/009/005 31/07/1996
FARLUTAL Farmitalia Carlo Erba Ltd PA0236/011/001 Withdrawn Form 31/07/1996
FARLUTAL Farmitalia Carlo Erba Ltd PA0236/011/002 Withdrawn Form 31/07/1996
FARLUTAL 200 Farmitalia Carlo Erba Ltd PA0236/011/004 Tablets 31/07/1996
FERROCONTIN Napp Laboratories Limited PA0114/011/001 Tablets - FERROUS GLYCINE 31/07/1996
SULFATE
- FOLIC ACID
FERROCONTIN CONTINUS Napp Laboratories Limited PA0114/010/001 Tablets - FERROUS GLYCINE 31/07/1996
SULFATE
FERROUS GLUCONATE Mercury Pharmaceuticals PA0073/058/001 Tablets 31/07/1996
(Ireland) Ltd
GENOTROPIN Pharmacia Laboratories PA0187/032/002 - SOMATROPIN 31/07/1996
Limited
ICY HOT BALM G.D. Searle & Company PA0001/024/001 - METHYL SALICYLATE 31/07/1996
Limited - MENTHOL
LINCOCIN Pharmacia Limited PA0016/009/002 Syrup - LINCOMYCIN 31/07/1996
HYDROCHLORIDE
LINCOCIN Pharmacia Limited PA0016/009/003 Capsule - LINCOMYCIN 31/07/1996
HYDROCHLORIDE
LINCOCIN STERILE Pharmacia Limited PA0016/009/004 - LINCOMYCIN 31/07/1996
HYDROCHLORIDE
LINCOCIN STERILE Pharmacia Limited PA0016/009/001 - LINCOMYCIN 31/07/1996
HYDROCHLORIDE
LOCOBASE Yamanouchi Pharma Ltd PA0062/016/001 Ointment 31/07/1996
LOCOBASE Yamanouchi Pharma Ltd PA0062/016/002 Cream 31/07/1996
LOMOTIL G.D. Searle & Company PA0001/005/005 - DIPHENOXYLATE 31/07/1996
Limited HYDROCHLORIDE
- ATROPINE SULFATE
LONITEN Pharmacia Limited PA0016/032/004 Tablets - MINOXIDIL 31/07/1996
LONITEN Pharmacia Limited PA0016/032/005 Tablets - MINOXIDIL 31/07/1996
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/001 Pdr for Soln for Injection 31/07/1996
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/002 Pdr for Soln for Injection 31/07/1996
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/003 Pdr for Soln for Injection 31/07/1996
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/004 Pdr for Soln for Injection 31/07/1996
MAXTREX Farmitalia Carlo Erba Ltd PA0236/014/005 Pdr for Soln for Injection 31/07/1996
MAXTREX 5 Farmitalia Carlo Erba Ltd PA0236/014/009 Solution for Injection 31/07/1996
MAXTREX INTRATHECAL Farmitalia Carlo Erba Ltd PA0236/014/006 31/07/1996
MEDRONE ACNE Pharmacia Limited PA0016/019/001 - METHYLPREDNISOLONE 31/07/1996
ACETATE

METHOTREXAATE 1000 Farmitalia Carlo Erba Ltd PA0236/014/014 Solution for Injection 31/07/1996
METHOTREXATE 20 Farmitalia Carlo Erba Ltd PA0236/014/010 Solution for Injection 31/07/1996
METHOTREXATE 200 Farmitalia Carlo Erba Ltd PA0236/014/012 Solution for Injection 31/07/1996
METHOTREXATE 2000 Farmitalia Carlo Erba Ltd PA0236/014/015 Solution for Injection 31/07/1996
METHOTREXATE 50 Farmitalia Carlo Erba Ltd PA0236/014/011 Solution for Injection 31/07/1996
METHOTREXATE 500 Farmitalia Carlo Erba Ltd PA0236/014/013 Solution for Injection 31/07/1996
METHOTREXATE 5000 Farmitalia Carlo Erba Ltd PA0236/014/016 Solution for Injection 31/07/1996
MINTEC SmithKline and French PA0060/045/001 Capsule 31/07/1996
Laboratories Ltd
MYCIGUENT Pharmacia Limited PA0016/011/003 Ointment - NEOMYCIN SULFATE 31/07/1996
MYCIGUENT OPHTHALMIC Pharmacia Limited PA0016/011/002 Ointment - NEOMYCIN SULFATE 31/07/1996

Human Medicines Withdrawn Products Page 407 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NEO-MEDRONE Pharmacia Limited PA0016/013/002 Cream - NEOMYCIN SULFATE 31/07/1996
- METHYLPREDNISOLONE
ACETATE

NITROCONTIN CONTINUS Napp Laboratories Limited PA0114/029/001 Tablets - GLYCERYL TRINITRATE 31/07/1996
NITROCONTIN CONTINUS Napp Laboratories Limited PA0114/029/002 Tablets - GLYCERYL TRINITRATE 31/07/1996
PHARMORUBICIN Farmitalia Carlo Erba Ltd PA0236/016/003 31/07/1996
PRANOXEN CONTINUS Napp Laboratories Limited PA0114/061/001 Tablets - NAPROXEN 31/07/1996
PRANOXEN CONTINUS Napp Laboratories Limited PA0114/061/002 Tablets - NAPROXEN 31/07/1996
REFOLINON Farmitalia Carlo Erba Ltd PA0236/015/001 Withdrawn Form 31/07/1996
REFOLINON Farmitalia Carlo Erba Ltd PA0236/015/002 Withdrawn Form 31/07/1996
REFOLINON Farmitalia Carlo Erba Ltd PA0236/015/003 Tablets 31/07/1996
RONICOL TABLETS 25MG Roche Products Limited PA0050/048/001 Tablets - NICOTINYL ALCOHOL 31/07/1996
RONICOL TIMESPAN Roche Products Limited PA0050/048/002 Tablets - NICOTINYL ALCOHOL 31/07/1996
TABLETS 150MG
STAFOXIL Yamanouchi Pharma Ltd PA0062/024/005 Withdrawn Form 31/07/1996
SYNACTHEN DEPOT Ciba Geigy Plc PA0028/016/001 - TETRACOSACTIDE 31/07/1996
AMPOULES
TAMOXIFEN Farmitalia Carlo Erba Ltd PA0236/017/001 Tablets 31/07/1996
TAMOXIFEN 20 Farmitalia Carlo Erba Ltd PA0236/017/002 - TAMOXIFEN CITRATE 31/07/1996
TAMOXIFEN 40 Farmitalia Carlo Erba Ltd PA0236/017/003 Tablets 31/07/1996
TEMAZEPAM ELIXIR Farmitalia Carlo Erba Ltd PA0236/019/002 31/07/1996
TRIBIOTIC SPRAY 3M Health Care Limited PA0057/010/001 - NEOMYCIN SULFATE 31/07/1996
- BACITRACIN
- POLYMYXIN B SULFATE
TROBICIN Pharmacia Limited PA0016/015/001 - SPECTINOMYCIN 31/07/1996
DIHYDROCHLORIDE
PENTAHYDRATE
VIBROX Napp Laboratories Limited PA0114/045/003 Tablets - DOXYCYCLINE 31/07/1996
VOLTAROL Geigy Pharmaceuticals PA0011/027/014 Suppositories - DICLOFENAC SODIUM 31/07/1996
VOLTAROL Geigy Pharmaceuticals PA0011/027/015 Suppositories - DICLOFENAC SODIUM 31/07/1996
CROOKES HALIBUT LIVER Crookes Healthcare Ltd PA0043/001/001 Capsule 21/07/1996
OIL
ESSAVEN Hadensa (Ireland) Limited PA0145/007/001 Gel - ESCIN 04/07/1996
- HEPARIN SODIUM
- PHOSPHOLIPIDS
ALCOBON Roche Products Limited PA0050/006/002 Tablets - FLUCYTOSINE 30/06/1996
ASMAVEN INHALER Teva UK Limited PA0237/023/001 30/06/1996
ASPRO EXTRA STRENGH Nicholas Laboratories PA0032/007/002 Tablets - ACETYLSALICYLIC ACID 30/06/1996
CICATRIN Wellcome (Ireland) Limited PA0017/009/001 - NEOMYCIN SULFATE 30/06/1996
- BACITRACIN ZINC
- CYSTEINE
- AMINOACETIC ACID
FUCIDIN CAVIJECT Leo Laboratories Limited PA0046/004/002 Gel - FUSIDIC ACID 30/06/1996
HYDRAMIL Helsinn Birex PA0294/015/001 Tablets - AMILORIDE 30/06/1996
Pharmaceuticals Limited HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

HYDRAMIL Helsinn Birex PA0294/015/002 Tablets 30/06/1996


Pharmaceuticals Limited
METHRAZONE Boehringer Ingelheim Limited PA0007/029/001 Capsule - FEPRAZONE 30/06/1996

ORNIDYL Marion Merrell Limited PA0041/045/001 Withdrawn Form - EFLORNITHINE 30/06/1996


HYDROCHLORIDE
ORNIDYL Marion Merrell Limited PA0041/045/002 Withdrawn Form - EFLORNITHINE 30/06/1996
HYDROCHLORIDE
PERCUTOL Pliva Pharma Limited PA0585/001/001 Ointment - GLYCERYL TRINITRATE 30/06/1996
POLYBACTRIN Wellcome (Ireland) Limited PA0017/010/002 - POLYMYXIN B SULFATE 30/06/1996
- NEOMYCIN SULFATE
- BACITRACIN ZINC
PROSEPTIC Napp Laboratories Limited PA0114/047/001 - PROPANOL 30/06/1996
- ISOPROPANOL
SOTACOR Bristol-Myers Squibb PA0048/001/007 Tablets - SOTALOL 30/06/1996
(Holdings) Limited HYDROCHLORIDE
ASPERCREME Thompson Medical Co. Ltd PA0291/001/001 Cutaneous Solution - SALICYLIC ACID 23/06/1996
- TROLAMINE
BUPIVACINE Hospira UK Limited PA0437/019/002 Withdrawn Form - GENTAMICIN 31/05/1996
HYDROCHLORIDE - BUPIVACAINE
INJECTION HYDROCHLORIDE
CAPOZIDE Bristol-Myers Squibb PA0002/053/001 Tablets - CAPTOPRIL 31/05/1996
Pharmaceuticals uc - HYDROCHLOROTHIAZIDE

FLUPHENAZINE Hospira UK Limited PA0437/022/003 Withdrawn Form - FLUPHENAZINE 31/05/1996


DECANOATE DECANOATE

Human Medicines Withdrawn Products Page 408 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FLUPHENAZINE Hospira UK Limited PA0437/022/005 Withdrawn Form - FLUPHENAZINE 31/05/1996
DECANOATE DECANOATE
FLUPHENAZINE Hospira UK Limited PA0437/022/001 - FLUPHENAZINE 31/05/1996
DECANOTATE DECANOATE
FRUSEMIDE Pinewood Laboratories Ltd, PA0281/006/001 Tablets - FUROSEMIDE 31/05/1996
LENDORMIN Boehringer Ingelheim Limited PA0007/028/001 Tablets - BROTIZOLAM 31/05/1996

LENDORMIN Boehringer Ingelheim Limited PA0007/028/002 Tablets - BROTIZOLAM 31/05/1996

MOBIFLEX MILK Roche Products Limited PA0050/067/003 Granules - TENOXICAM 31/05/1996


GRANULES
MONOTRIM A/S GEA Farmaceutisk PA0310/001/004 Withdrawn Form - TRIMETHOPRIM 31/05/1996
Fabrik
NAPROSYN Syntex Pharmaceuticals PA0033/005/015 Tablets - NAPROXEN 31/05/1996
Limited
NIPRIDE Roche Products Limited PA0050/005/001 - NITROPRUSSIDE SODIUM 31/05/1996

PEKOLIN Mercury Pharmaceuticals PA0073/002/001 - KAOLIN 31/05/1996


(Ireland) Ltd - PECTIN
PONDERAX Les Laboratoires Servier PA0068/006/003 Tablets - FENFLURAMINE 31/05/1996
HYDROCHLORIDE
SYNFLEX FORTE Syntex Pharmaceuticals PA0033/016/003 - NAPROXEN SODIUM 31/05/1996
Limited
VELOSEF INJECTION Bristol-Myers Squibb PA0002/014/008 - ARGININE 31/05/1996
Pharmaceuticals uc - CEFRADINE
VIRAZOLE ICN Pharmaceuticals Holland PA0513/001/001 Capsule 31/05/1996
BV
FLUTACAN 250MG Bayer Schering Pharma Oy PA0771/001/001 Tablets - FLUTAMIDE 24/05/1996
HEXABRIX 200 May & Baker Limited PA0040/064/004 Solution for Injection - IOXAGLATE MEGLUMINE 19/05/1996
- IOXAGLATE SODIUM

MONISTAT Cilag Limited PA0059/002/003 Pessary - MICONAZOLE NITRATE 30/04/1996


URINOX Orion Pharma A/s PA0303/022/001 - EMEPRONIUM BROMIDE 30/04/1996
URINOX Orion Pharma A/s PA0303/022/002 Tablets - EMEPRONIUM BROMIDE 30/04/1996
URINOX Orion Pharma A/s PA0303/022/003 Tablets - EMEPRONIUM BROMIDE 30/04/1996
AMBAXIN Pharmacia Limited PA0016/033/003 Tablets 31/03/1996
AOSEPT Ciba Vision (UK) Ltd PA0628/001/001 - HYDROGEN PEROXIDE 31/03/1996
- SODIUM CHLORIDE
AQUEOUS Foran Healthcare Limited PA0484/018/001 Cream - EMULSIFYING WAX 31/03/1996
ARTHRIN Napp Laboratories Limited PA0114/058/001 Tablets - NAPROXEN 31/03/1996
ARTHRIN Napp Laboratories Limited PA0114/058/002 Tablets - NAPROXEN 31/03/1996
BINOVUM Cilag Limited PA0059/016/001 Tablets 31/03/1996
CLOXACILLIN Generics (UK) Limited PA0405/009/001 Capsule - CLOXACILLIN 31/03/1996
CLOXACILLIN Generics (UK) Limited PA0405/009/002 Capsule - CLOXACILLIN 31/03/1996
CO-TRIMOXAZOLE 800/160 Generics (UK) Limited PA0405/021/001 Tablets - SULFAMETHIZOLE 31/03/1996
- TRIMETHOPRIM
DANTRIUM (SUSPENSION) Procter & Gamble PA0170/002/003 - DANTROLENE SODIUM 31/03/1996
Pharmaceuticals UK Limited
DIPYRIDAMOLE Generics (UK) Limited PA0405/006/001 Tablets - DIPYRIDAMOLE 31/03/1996
DIPYRIDAMOLE Generics (UK) Limited PA0405/006/002 Tablets - DIPYRIDAMOLE 31/03/1996
GONOCIN Cyanamid of Great Britain PA0037/005/001 Capsule - MINOCYCLINE 31/03/1996
HYDROCHLORIDE
ISOLAN Elan Pharma Ltd PA0516/013/001 Capsule 31/03/1996
ISOLAN Elan Pharma Ltd PA0516/013/002 Capsule 31/03/1996
ISOLAN Elan Pharma Ltd PA0516/013/003 Capsule 31/03/1996
LABETALOL Generics (UK) Limited PA0405/013/001 Tablets - LABETALOL 31/03/1996
LABETALOL Generics (UK) Limited PA0405/013/002 Tablets - LABETALOL 31/03/1996
LABETALOL Generics (UK) Limited PA0405/013/003 Tablets - LABETALOL 31/03/1996
LOPRESORETIC Ciba Geigy Plc PA0011/029/001 Tablets - METOPROLOL TARTRATE 31/03/1996
- CHLORTALIDONE

METHYLDOPA Generics (UK) Limited PA0405/028/001 Tablets - METHYLDOPA 31/03/1996


METHYLDOPA Generics (UK) Limited PA0405/028/002 Tablets - METHYLDOPA 31/03/1996
METHYLDOPA Generics (UK) Limited PA0405/028/003 Tablets - METHYLDOPA 31/03/1996
MIRAXID FORTE Leo Laboratories Limited PA0046/031/001 Tablets - PIVAMPICILLIN 31/03/1996
- PIVMECILLINAM
HYDROCHLORIDE
NIFEDIPINE Generics (UK) Limited PA0405/002/001 Capsule - NIFEDIPINE 31/03/1996
NIFEDIPINE Generics (UK) Limited PA0405/002/002 Capsule - NIFEDIPINE 31/03/1996
PED EL Pharmacia Laboratories PA0187/003/001 - ELECTROLYTES NOS 31/03/1996
Limited

Human Medicines Withdrawn Products Page 409 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PEGALAX Nicholas Laboratories PA0032/037/001 - SODIUM CHLORIDE 31/03/1996
- SODIUM SULFATE
ANHYDROUS
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
- MACROGOL
PENBRITIN PCO Manufacturing PPA0465/022/001 - AMPICILLIN 31/03/1996
PHASAL Sandoz Ltd PA0372/002/001 Tablets - LITHIUM CARBONATE 31/03/1996
PROPRANOLOL Generics (UK) Limited PA0405/012/002 Tablets - PROPRANOLOL 31/03/1996
PROPRANOLOL Generics (UK) Limited PA0405/012/003 Tablets - PROPRANOLOL 31/03/1996
PROPRANOLOL Generics (UK) Limited PA0405/012/004 Tablets - PROPRANOLOL 31/03/1996
PROPRANOLOL Generics (UK) Limited PA0405/012/005 Tablets - PROPRANOLOL 31/03/1996
REDOXON Roche Products Limited PA0050/007/005 Tablets - ASCORBIC ACID 31/03/1996
EFFERVESCENT
SABIDAL Novartis Consumer Health PA0030/012/001 Tablets - CHOLINE 31/03/1996
UK Limited THEOPHYLLINATE
SABIDAL SR Novartis Consumer Health PA0030/012/002 Tablets - CHOLINE 31/03/1996
UK Limited THEOPHYLLINATE
SULPHACETAMIDE EYE Daniels Pharmaceutical Ltd PA0396/005/002 Ointment 31/03/1996
SULPHASALAZINE Generics (UK) Limited PA0405/015/001 Tablets - SULFASALAZINE 31/03/1996
SYNTOCINON (SPRAY) Novartis Pharmaceuticals UK PA0013/018/005 - OXYTOCIN 31/03/1996
Ltd
TIMPRON EC Teva UK Limited PA0237/055/003 Tablets 31/03/1996
TIMPRON EC Teva UK Limited PA0237/055/004 Tablets 31/03/1996
TRIAZOLAM Generics (UK) Limited PA0405/023/001 Tablets - TRIAZOLAM 31/03/1996
VENTOLIN SPANDETS Glaxo Laboratories Limited PA0044/003/007 Tablets - SALBUTAMOL SULFATE 31/03/1996
NICONIL Parke Davis & Company PA0056/064/002 - NICOTINE 18/03/1996
NICONIL 30 Parke Davis & Company PA0056/064/001 - NICOTINE 18/03/1996
KALTOSTAT CAVITY CV Laboratories Limited PA0500/001/002 08/03/1996
DRESSING
KALTOSTAT WOUND CV Laboratories Limited PA0500/001/001 08/03/1996
DRESSING
BACTRIM Roche Products Limited PA0050/003/007 Tablets - TRIMETHOPRIM 29/02/1996
- SULFAMETHOXAZOLE
CLOMIPHENE CITRATE Hogens Limited PA0515/002/001 Tablets 29/02/1996
CRUEX MEDICATED Fisons Pharmaceuticals PA0072/011/001 - CALCIUM UNDECYLEN 29/02/1996
(Ireland)
DDD MEDICATED LOTION D.D.D. Limited PA0302/007/001 - METHYL SALICYLATE 29/02/1996
- THYMOL
DUVADILAN Abbott Healthcare Products PA0108/001/002 Withdrawn Form - ISOXSUPRINE 29/02/1996
Ltd HYDROCHLORIDE
FENOPRON Dista Products Limited PA0447/002/002 Tablets - FENOPROFEN 29/02/1996
MICRO K E. Merck Ltd PA0054/060/001 Tablets - POTASSIUM CHLORIDE 29/02/1996
PROGESIC Eli Lilly and Company Limite PA0047/050/001 Tablets - FENOPROFEN 29/02/1996

RETROVIR Wellcome (Ireland) Limited PA0017/092/003 Withdrawn Form - ZIDOVUDINE 29/02/1996


SOMATONORM Pharmacia Laboratories PA0187/028/001 Solution for Injection - METHIONYL HUMAN 29/02/1996
Limited SOMATOTROPIN
TACHYROL Abbott Healthcare Products PA0108/002/001 Tablets - DIHYDROTACHYSTEROL 29/02/1996
Ltd
TIMOPTOL Merck Sharp and Dohme PA0035/053/004 - TIMOLOL MALEATE 29/02/1996
Limited
TRIDIL Du Pont De Nemours PA0200/007/003 Withdrawn Form - GLYCERYL TRINITRATE 29/02/1996
Intern.S.A.
VANCOSTAT Cyanamid of Great Britain PA0037/064/001 Withdrawn Form 29/02/1996
VIDEX Bristol-Myers Squibb PA0002/057/010 Tablets - DIDANOSINE 29/02/1996
Pharmaceuticals uc
AEROLIN INHALER 3M Health Care Limited PA0057/054/005 - SALBUTAMOL 31/01/1996
ALLEREZE ELIXIR Intercare Products Ltd PA0398/001/002 31/01/1996
AMPICILLIN Norton Healthcare Limited PA0282/004/005 - AMPICILLIN TRIHYDRATE 31/01/1996
T/A IVAX Pharmaceuticals
UK
AMPICILLIN SYRUP B P Norton Healthcare Limited PA0282/004/006 31/01/1996
T/A IVAX Pharmaceuticals
UK
BACTRIM Roche Products Limited PA0050/003/006 Tablets 31/01/1996
BACTRIM Roche Products Limited PA0050/003/002 Solution for Infusion 31/01/1996
BACTRIM ADULT Roche Products Limited PA0050/003/003 31/01/1996
(SUSPENSION)
BACTRIM PAEDIATRIC Roche Products Limited PA0050/003/005 Tablets 31/01/1996
CAPOTEN Parallel Lines Ltd PPA0384/010/002 Tablets 31/01/1996

Human Medicines Withdrawn Products Page 410 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CAVED-S J B Tillotts Limited PA0360/023/001 Tablets - DEGLYCYRRHIZINIZED 31/01/1996
EXTRACT OF LIQUORICE
- ALUMINIUM HYDROXIDE
GEL
- MAGNESIUM
CARBONATE
- SODIUM BICARBONATE
COAL TAR OINTMENT Foran Healthcare Limited PA0484/019/001 Ointment - COAL TAR SOLUTION 31/01/1996
DICAPEN Leo Laboratories Limited PA0046/057/002 Withdrawn Form - SULBACTAM 31/01/1996
- AMPICILLIN
DICAPEN Leo Laboratories Limited PA0046/057/003 Withdrawn Form - SULBACTAM 31/01/1996
- AMPICILLIN
EUSOL Foran Healthcare Limited PA0484/010/001 - CHLORINATED LIME AND 31/01/1996
BORIC ACID SOLUTION

GASTRITEX LIQUID Reckitt's (Ireland) Limited PA0027/041/001 - CARBOMER 31/01/1996


- CARBENOXOLONE
SODIUM
GYNATREN Solco Basle A.G. PA0186/001/001 - LACTOBACILLUS 31/01/1996
ACIDOPHILUS
HALIBUT LIVER OIL Clonmel Healthcare Ltd PA0126/083/001 Capsule 31/01/1996
HYSKON Pharmacia Biosystems PA0107/001/001 - DEXTRAN 31/01/1996
Limited
JUNIFEN (SUSPENSION) The Boots Company Plc PA0004/049/001 - IBUPROFEN 31/01/1996
KABIKINASE Pharmacia Laboratories PA0187/013/001 - STREPTOKINASE 31/01/1996
Limited
KABIKINASE Pharmacia Laboratories PA0187/013/003 - STREPTOKINASE 31/01/1996
Limited
KOATE-H.T. Bayer Diagnostics PA0079/015/004 - FACTOR VIII 31/01/1996
Manufacturing (ANTIHAEMOPHILIC
FACTOR)
KOATE-H.T. Bayer Diagnostics PA0079/015/005 - FACTOR VIII 31/01/1996
Manufacturing (ANTIHAEMOPHILIC
FACTOR)
KOATE-H.T. Bayer Diagnostics PA0079/015/006 - FACTOR VIII 31/01/1996
Manufacturing (ANTIHAEMOPHILIC
FACTOR)
LOBAK Sanofi-Synthelabo Ireland PA0077/025/001 - CHLORMEZANONE 31/01/1996
Ltd - PARACETAMOL
MONISTAT Cilag Limited PA0059/002/001 Pessary - MICONAZOLE NITRATE 31/01/1996
PEVARYL Cilag Limited PA0059/009/005 - ECONAZOLE NITRATE 31/01/1996
PLEGISOL Abbott Laboratories Ireland PA0038/037/001 31/01/1996
Ltd
SABIDAL RECTIOL Novartis Consumer Health PA0030/012/003 - CHOLINE 31/01/1996
UK Limited THEOPHYLLINATE
SABIDAL RECTIOL Novartis Consumer Health PA0030/012/004 - CHOLINE 31/01/1996
UK Limited THEOPHYLLINATE
SIMPLENE Chauvin Pharmaceuticals PA0118/001/001 - EPINEPHRINE 31/01/1996
Limited
SOTAZIDE Bristol-Myers Squibb PA0048/018/001 Tablets - SOTALOL 31/01/1996
(Holdings) Limited - HYDROCHLOROTHIAZIDE

TEGRETOL CHEWTABS Ciba Geigy Plc PA0011/001/007 Tablets - CARBAMAZEPINE 31/01/1996


TEGRETOL CHEWTABS Ciba Geigy Plc PA0011/001/008 Tablets - CARBAMAZEPINE 31/01/1996
TRANCOPAL Sanofi-Synthelabo Ireland PA0077/041/001 Tablets - CHLORMEZANONE 31/01/1996
Ltd
ACTHAR Rorer Pharmaceuticals PA0468/021/004 Gel - CORTICOTROPHIN 30/01/1996
Limited
HYDROCARE Allergan Pharmaceuticals PA0148/011/001 29/01/1996
Ireland
OSMOFUNDIN 20% B. Braun Medical Limited PA0179/008/002 29/01/1996
INADINE DRESSING Johnson & Johnson (Ireland) PA0330/004/001 Impregnated Dressing - POVIDONE-IODINE 09/01/1996
Limited
10-BENZAGEL May & Baker Limited PA0040/089/002 Gel 31/12/1995
5-BENZAGEL May & Baker Limited PA0040/089/001 Gel 31/12/1995
CEFATREXYL Bristol-Myers Squibb PA0048/002/002 Withdrawn Form - CEFAPIRIN SODIUM 31/12/1995
(Holdings) Limited
DITHROLAN Dermal Laboratories Ltd PA0278/002/001 - DITHRANOL 31/12/1995
- SALICYLIC ACID
FAVERIN Abbott Healthcare Products PA0108/016/002 Tablets - FLUVOXAMINE MALEATE 31/12/1995
Ltd
GENTICIN Nicholas Laboratories PA0032/004/006 Cream - GENTAMICIN 31/12/1995
GENTICIN EYE Nicholas Laboratories PA0032/004/009 Ointment - GENTAMICIN SULFATE 31/12/1995
GENTISONE HC Nicholas Laboratories PA0032/006/002 Cream - GENTAMICIN 31/12/1995
- HYDROCORTISONE
ACETATE

Human Medicines Withdrawn Products Page 411 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GENTISONE HC Nicholas Laboratories PA0032/006/003 Ointment - GENTAMICIN 31/12/1995
- HYDROCORTISONE
ACETATE
NICHOLAS CO2 GRANULE Nicholas Laboratories PA0032/018/001 Gel - DIMETHICONE 350 31/12/1995
- BETAINE
HYDROCHLORIDE
- SODIUM BICARBONATE
PHENERGAN May & Baker Limited PA0040/042/005 Solution for Injection - PROMETHAZINE 31/12/1995
HYDROCHLORIDE
PONDOCILLIN Leo Laboratories Limited PA0046/009/001 Tablets - PIVAMPICILLIN 31/12/1995
SANOID Ovelle Limited PA0206/013/001 - HEXACHLOROPHENE 31/12/1995
CEFATREXYL Bristol-Myers Squibb PA0048/002/001 Withdrawn Form - CEFAPIRIN SODIUM 30/12/1995
(Holdings) Limited
PLATET CLEARTAB Nicholas Laboratories PA0032/035/002 - ACETYLSALICYLIC ACID 29/12/1995
STARIL Bristol-Myers Squibb PA0002/056/001 Tablets - FOSINOPRIL SODIUM 29/12/1995
Pharmaceuticals uc
DOPAMINE Abbott Laboratories Ireland PA0038/038/001 Withdrawn Form 18/12/1995
HYDROCHLORIDE IN 5% Ltd
DEXTROSE
DOPAMINE Abbott Laboratories Ireland PA0038/038/002 Withdrawn Form 18/12/1995
HYDROCHLORIDE IN 5% Ltd
DEXTROSE
DOPAMINE Abbott Laboratories Ireland PA0038/038/003 Withdrawn Form 18/12/1995
HYDROCHLORIDE IN 5% Ltd
DEXTROSE
REGULAN Procter & Gamble (Health & PA0441/035/001 - ISPAGHULA HUSKS 15/11/1995
Beauty Care) Limited
CEREBRAL 280 MG Nycomed (UK) Limited PA0235/008/006 31/10/1995
CEREBRAL 280 MG Nycomed (UK) Limited PA0235/008/007 31/10/1995
CORONAR 370 MG Nycomed (UK) Limited PA0235/008/008 31/10/1995
DEPIXOL Lundbeck Limited PA0115/001/007 Withdrawn Form - FLUPENTIXOL 31/10/1995
DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/001 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/002 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/003 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/004 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/006 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/007 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/008 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/009 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/010 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/011 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/012 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/013 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/014 31/10/1995

DIANEAL K139/DEXTROSE Baxter Healthcare Limited PA0167/019/015 31/10/1995

DIANEAL K139/GLUCOSE Baxter Healthcare Limited PA0167/019/005 31/10/1995


ISOPAQUE 350 MG Nycomed (UK) Limited PA0235/008/001 31/10/1995
ISOPAQUE 350 MG Nycomed (UK) Limited PA0235/008/002 31/10/1995
ISOPAQUE AMIN 200 MG Nycomed (UK) Limited PA0235/008/004 31/10/1995
ISOPAQUE AMIN 200 MG Nycomed (UK) Limited PA0235/008/005 31/10/1995
PENIDURAL John Wyeth & Brother PA0022/009/002 - BENZATHINE 31/10/1995
(SUSPENSION) Limited BENZYLPENICILLIN
- PROCAINE PENICILLIN G
- BENZYLPENICILLIN

TOLECTIN Cilag Limited PA0059/003/003 Suppositories - TOLMETIN 31/10/1995


WHITE PETROLEUM JELLY Rusco Pharmaceuticals PA0392/009/001 - WHITE SOFT PARAFFIN 31/10/1995

ANTHRANOL 3.0 Stiefel Laboratories (U.K.) PA0144/017/003 Ointment - DITHRANOL 15/10/1995


Ltd.
VINBLASTINE SULPHATE Hospira UK Limited PA0437/009/002 Withdrawn Form - VINBLASTINE 15/10/1995

Human Medicines Withdrawn Products Page 412 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DDD MEDICATED CREAM D.D.D. Limited PA0302/005/001 Cream - METHYL SALICYLATE 10/10/1995
- THYMOL
STERILE WATER B. Braun Medical Limited PA0179/036/001 04/10/1995
STERILE WATER B. Braun Medical Limited PA0179/036/002 04/10/1995
APISATE John Wyeth & Brother PA0022/033/001 Tablets - AMFEPRAMONE 30/09/1995
Limited - THIAMINE
HYDROCHLORIDE
AREDIA Ciba Geigy Plc PA0028/060/001 - PAMIDRONATE 30/09/1995
BUTACOTE Ciba Geigy Plc PA0011/021/001 Tablets - PHENYLBUTAZONE 30/09/1995
DIPHTHERIA & TETANUS Wellcome (Ireland) Limited PA0017/028/002 Withdrawn Form - DIPHTHERIA AND 30/09/1995
TETANUS TOXOIDS
EMTEXATE Ferring Pharmaceuticals PA0224/007/004 Withdrawn Form 30/09/1995
METHOTREXATE Limited
EMTEXATE Ferring Pharmaceuticals PA0224/007/005 Withdrawn Form 30/09/1995
METHOTREXATE Limited
EMTEXATE Ferring Pharmaceuticals PA0224/007/006 Withdrawn Form 30/09/1995
METHOTREXATE Limited
INSUMAN BASAL HOE 36H Hoechst Ireland Limited PA0023/060/001 - HUMAN INSULIN 30/09/1995
RECOMBINANT
INSUMAN COMB 15/85 32H Hoechst Ireland Limited PA0023/061/001 - HUMAN INSULIN 30/09/1995
RECOMBINANT
INSUMAN COMB 25/75 33H Hoechst Ireland Limited PA0023/061/002 - HUMAN INSULIN 30/09/1995
RECOMBINANT
INSUMAN COMB 50/50 34H Hoechst Ireland Limited PA0023/061/003 - HUMAN INSULIN 30/09/1995
RECOMBINANT
INSUMAN RAPID HOE 31H Hoechst Ireland Limited PA0023/057/001 Withdrawn Form 30/09/1995
REDEPTIN SmithKline and French PA0060/002/003 30/09/1995
Laboratories Ltd
SEPTRIN I.M. Wellcome (Ireland) Limited PA0017/002/008 Withdrawn Form - SULFAMETHOXAZOLE 30/09/1995
- TRIMETHOPRIM
SEPTRIN PAEDIATRIC Wellcome (Ireland) Limited PA0017/002/009 Tablets - TRIMETHOPRIM 30/09/1995
DISPERSIBLE - SULFAMETHOXAZOLE
SINTHROME Ciba Geigy Plc PA0011/030/001 Tablets - ACENOCOUMAROL 30/09/1995
TOMAXEN Orion Pharma A/s PA0303/021/001 Tablets - TAMOXIFEN 30/09/1995
TOMAXEN Orion Pharma A/s PA0303/021/002 Tablets - TAMOXIFEN 30/09/1995
TRIMOXOL Yamanouchi Pharma Ltd PA0062/015/002 Tablets 30/09/1995
TRIMOXOL Yamanouchi Pharma Ltd PA0062/015/003 Tablets 30/09/1995
TRIMOXOL SYRUP Yamanouchi Pharma Ltd PA0062/015/001 30/09/1995
VAREMOID Novartis Consumer Health PA0030/011/001 Tablets 30/09/1995
UK Limited
KRYOBULIN Immuno Limited PA0212/001/001 27/09/1995
KRYOBULIN Immuno Limited PA0212/001/002 27/09/1995
KRYOBULIN Immuno Limited PA0212/001/003 27/09/1995
CYSTOPURIN Fisons Limited PA0018/043/001 - POTASSIUM CITRATE 19/09/1995
TOPICYCLINE Procter & Gamble PA0170/013/001 - TETRACYCLINE 13/09/1995
Pharmaceuticals UK Limited HYDROCHLORIDE
METRONIDAZOLE B. Braun Medical Limited PA0179/032/001 Solution for Infusion - METRONIDAZOLE 17/08/1995
ENDOXANA Asta Medica AG PA0088/003/001 Tablets - CYCLOPHOSPHAMIDE 10/08/1995
RHINOCORT Astra Pharmaceuticals Ltd PA0009/034/001 Nasal Spray Suspension - BUDESONIDE 10/08/1995
PEPCID (SUSPENSION) Merck Sharp and Dohme PA0035/069/003 - FAMOTIDINE 02/08/1995
Limited
DIANEAL 137/GLUCOSE Pharmacia Biosystems PA0107/017/020 01/08/1995
Limited
SYNETEX MENOPHASE Syntex Pharmaceuticals PA0033/001/002 Tablets 01/08/1995
Limited
BENYLIN DECONGESTANT Parke Davis & Company PA0056/012/001 - DIPHENHYDRAMINE 31/07/1995
- PSEUDOEPHEDRINE
HYDROCHLORIDE
BUTAZOLIDIN Ciba Geigy Plc PA0011/013/002 Tablets - PHENYLBUTAZONE 31/07/1995
BUTAZOLIDIN Ciba Geigy Plc PA0011/013/003 Tablets - PHENYLBUTAZONE 31/07/1995
CHLOROMYCETIN Parke Davis & Company PA0056/015/001 Capsule - CHLORAMPHENICOL 31/07/1995
CHLOROMYCETIN Parke Davis & Company PA0056/015/006 - CHLORAMPHENICOL 31/07/1995
OPHTHALMIC
(SUSPENSION)
DIACARDYNE Ethypharm PA0549/001/006 Capsule - DILTIAZEM 31/07/1995
HYDROCHLORIDE
DIACARDYNE Ethypharm PA0549/001/007 Capsule - DILTIAZEM 31/07/1995
HYDROCHLORIDE
DIACARDYNE LA Ethypharm PA0549/001/008 Capsule - DILTIAZEM 31/07/1995
HYDROCHLORIDE
DIACARDYNE LA Ethypharm PA0549/001/009 Capsule - DILTIAZEM 31/07/1995
HYDROCHLORIDE
DISIPAL Yamanouchi Pharma Ltd PA0062/010/002 Withdrawn Form 31/07/1995
ESKORNADE SPANSULE SmithKline and French PA0060/025/001 31/07/1995
CAPSULES (BOTTLES) Laboratories Ltd

Human Medicines Withdrawn Products Page 413 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ESKORNADE SYRUP Smith & Nephew PA0060/025/003 Syrup 31/07/1995
Pharmaceuticals
EXIREL 3M Health Care Limited PA0057/060/001 Capsule - PIRBUTEROL 31/07/1995
HYDROCHLORIDE
EXIREL 3M Health Care Limited PA0057/060/002 Capsule - PIRBUTEROL 31/07/1995
HYDROCHLORIDE
EXIREL 3M Health Care Limited PA0057/060/003 Tablets - PIRBUTEROL 31/07/1995
HYDROCHLORIDE
EXIREL 3M Health Care Limited PA0057/060/004 Tablets - PIRBUTEROL 31/07/1995
HYDROCHLORIDE
EXIREL 3M Health Care Limited PA0057/060/005 - PIRBUTEROL 31/07/1995
FLOXAPEN SYRUP SmithKline Beecham Pharm PA0049/018/013 - FLUCLOXACILLIN 31/07/1995
Ltd MAGNESIUM
FLOXAPEN SYRUP SmithKline Beecham Pharm PA0049/018/014 31/07/1995
Ltd
GENTIAN Nicholas Laboratories PA0032/004/004 Ointment - GENTAMICIN 31/07/1995
GENTIC PURE Nicholas Laboratories PA0032/004/008 - GENTAMICIN 31/07/1995
GENTICIN Nicholas Laboratories PA0032/004/007 Withdrawn Form - GENTAMICIN 31/07/1995
GENTICIN Nicholas Laboratories PA0032/004/002 Withdrawn Form - GENTAMICIN 31/07/1995
HIBITANE Zeneca Limited PA0051/046/001 Cream - CHLORHEXIDINE 31/07/1995
GLUCONATE
- BENZOCAINE
HYGROTON Ciba Geigy Plc PA0011/004/003 Tablets - CHLORTALIDONE 31/07/1995
LASORIDE Hoechst Ireland Limited PA0023/050/002 Tablets - FUROSEMIDE 31/07/1995
- AMILORIDE
HYDROCHLORIDE
LIGNOCAINE International Medication PA0255/018/003 Gel 31/07/1995
Systems (UK) Ltd
LORAZEPAM John Wyeth & Brother PA0022/044/003 Tablets - LORAZEPAM 31/07/1995
Limited
LORAZEPAM John Wyeth & Brother PA0022/044/004 Tablets - LORAZEPAM 31/07/1995
Limited
MESASAL SmithKline and French PA0060/047/002 Tablets 31/07/1995
Laboratories Ltd
METHYLPREDNISOLONE International Medication PA0255/035/001 31/07/1995
SODIUM Systems (UK) Ltd
METHYLPREDNISOLONE International Medication PA0255/035/002 31/07/1995
SODIUM SUCCINATE Systems (UK) Ltd
NAVIDREX - K Ciba Geigy Plc PA0028/022/001 Tablets - CYCLOPENTHIAZIDE 31/07/1995
- POTASSIUM CHLORIDE
PANADOL Sanofi-Synthelabo Ireland PA0077/023/003 - PARACETAMOL 31/07/1995
Ltd
PARENTROVITE SmithKline Beecham Pharm PA0049/042/003 - THIAMINE 31/07/1995
Ltd HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDARONE
- ASCORBIC ACID
- NICOTINAMIDE
PARENTROVITE IM/HP SmithKline Beecham Pharm PA0049/042/002 - THIAMINE 31/07/1995
Ltd HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDARONE
- ASCORBIC ACID
- NICOTINAMIDE
PARENTROVITE IV/HP SmithKline Beecham Pharm PA0049/042/001 - THIAMINE 31/07/1995
Ltd HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDARONE
- ASCORBIC ACID
- NICOTINAMIDE
PLATEMED Numed Research & PA0526/001/001 31/07/1995
Development Ltd
RIMACTANE Ciba Geigy Plc PA0028/002/001 Tablets - RIFAMPICIN 31/07/1995
RIMACTANE Ciba Geigy Plc PA0028/002/002 Tablets - RIFAMPICIN 31/07/1995
SYNFLEX Syntex Pharmaceuticals PA0033/016/001 Capsule - NAPROXEN SODIUM 31/07/1995
Limited
EREVAX SmithKline and French PA0060/042/002 Withdrawn Form 24/07/1995
Laboratories Ltd
EREVAX SmithKline and French PA0060/042/003 Withdrawn Form 24/07/1995
Laboratories Ltd
ISOVIST HE Clissmann PA0012/068/001 Withdrawn Form - IOTROLAN 24/07/1995
ISOVIST HE Clissmann PA0012/068/002 Withdrawn Form - IOTROLAN 24/07/1995
ISOVIST HE Clissmann PA0012/068/004 Withdrawn Form - IOTROLAN 24/07/1995
KERECID OPHTHALMIC Allergan Pharmaceuticals PA0148/041/001 - IDOXURIDINE 16/07/1995
Ireland
ABSTEM Cyanamid of Great Britain PA0037/041/001 Tablets - CALCIUM CARBIMIDE 08/07/1995

Human Medicines Withdrawn Products Page 414 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
WELLDORM Chauvin Pharmaceuticals PA0118/041/002 Tablets - CLORAL BETAINE 06/07/1995
Limited
WELLDORM ELIXIR Chauvin Pharmaceuticals PA0118/041/001 Oral Solution - CHLORAL HYDRATE 06/07/1995
Limited
ASERBINE SmithKline Beecham Pharm PA0049/038/001 Cream - BENZOIC ACID 31/05/1995
Ltd - SALICYLIC ACID
BIACTOL Procter & Gamble (Health & PA0441/022/001 31/05/1995
Beauty Care) Limited
CEDILANID Novartis Pharmaceuticals UK PA0013/027/001 Tablets - LANATOSIDE C 31/05/1995
Ltd
CLOXCIL 250 Clonmel Healthcare Ltd PA0126/064/001 Capsule 31/05/1995
CLOXCIL 500 Clonmel Healthcare Ltd PA0126/064/002 Capsule 31/05/1995
CYCLOPROPANE BOC Gases Ireland Ltd PA0208/010/001 31/05/1995
DIBENYLINE SmithKline and French PA0060/030/002 Capsule 31/05/1995
Laboratories Ltd
ECOSTATIN SPRAY Bristol-Myers Squibb PA0002/024/004 - ECONAZOLE NITRATE 31/05/1995
POWDER Pharmaceuticals uc
ECOSTATIN SPRAY Bristol-Myers Squibb PA0002/024/005 - ECONAZOLE NITRATE 31/05/1995
SOLUTION Pharmaceuticals uc
FRISIUM Hoechst Ireland Limited PA0023/018/004 Tablets - CLOBAZAM 31/05/1995
FRISIUM Hoechst Ireland Limited PA0023/018/006 Tablets - CLOBAZAM 31/05/1995
GERMOLOIDS SmithKlineBeecham PA0379/009/001 Suppositories - LIDOCAINE 31/05/1995
Consumer Brand HYDROCHLORIDE
- ZINC OXIDE
HALOTHANE Hoechst Ireland Limited PA0023/025/001 31/05/1995
HEADMASTER SHAMPOO Napp Laboratories Limited PA0114/046/001 - PHENOTHRIN 31/05/1995
HEMOCANE Intercare Products Ltd PA0398/003/002 Suppositories - LIDOCAINE 31/05/1995
HYDROCHLORIDE
- ZINC OXIDE
- BISMUTH OXIDE
- BENZOIC ACID
- CINNAMIC ACID
IFOMIDE Boehringer Ingelheim Limited PA0007/046/001 Solution for Injection - IFOSFAMIDE 31/05/1995

IFOMIDE Boehringer Ingelheim Limited PA0007/046/002 Solution for Injection - IFOSFAMIDE 31/05/1995

IFOMIDE Boehringer Ingelheim Limited PA0007/046/003 Solution for Injection - IFOSFAMIDE 31/05/1995

IFOMIDE Boehringer Ingelheim Limited PA0007/046/004 Solution for Injection - IFOSFAMIDE 31/05/1995

LISTERINE Parke Davis & Company PA0056/049/001 - ETHANOL 31/05/1995


- BENZOIC ACID
- CINEOLE
- MENTHOL
- METHYL SALICYLATE
- THYMOL
LUDIOMIL Ciba Geigy Plc PA0028/001/001 Tablets - MAPROTILINE 31/05/1995
HYDROCHLORIDE
LUDIOMIL Ciba Geigy Plc PA0028/001/002 Tablets - MAPROTILINE 31/05/1995
HYDROCHLORIDE
LUDIOMIL Ciba Geigy Plc PA0028/001/003 Tablets - MAPROTILINE 31/05/1995
HYDROCHLORIDE
LUDIOMIL Ciba Geigy Plc PA0028/001/004 Tablets - MAPROTILINE 31/05/1995
HYDROCHLORIDE
OPTIMAX E. Merck Ltd PA0054/009/003 - TRYPTOPHAN, L- 31/05/1995
- PYRIDOXINE
- ASCORBIC ACID
OPTIMAX E. Merck Ltd PA0054/009/004 - TRYPTOPHAN, L- 31/05/1995
- PYRIDOXINE
- ASCORBIC ACID
PAVACONTIN Napp Laboratories Limited PA0114/004/001 Tablets - PAPAVERINE 31/05/1995
HYDROCHLORIDE
PENIDURAL John Wyeth & Brother PA0022/009/001 - BENZATHINE 31/05/1995
Limited BENZYLPENICILLIN
- PROCAINE PENICILLIN G
- BENZYLPENICILLIN

PREGNAVITE FORTE SmithKline Beecham Pharm PA0049/027/001 - FERROUS SULFATE 31/05/1995


Ltd - FOLIC ACID
- MULTIVITAMINS
PROCAINAMIDE DURULES Astra Pharmaceuticals Ltd PA0009/001/001 - PROCAINAMIDE 31/05/1995
HYDROCHLORIDE
SELSUN Abbott Laboratories Ireland PA0038/026/001 31/05/1995
Ltd
SLOW-FE FOLIC Ciba Geigy Plc PA0028/032/001 Tablets - FERROUS SULFATE 31/05/1995
- FOLIC ACID

Human Medicines Withdrawn Products Page 415 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SODIUM CITRATE Baxter Healthcare Limited PA0167/020/001 - SODIUM CITRATE 31/05/1995
TRAIZOMEL 0.125 Clonmel Healthcare Ltd PA0126/078/001 31/05/1995
TRIAZOMEL 0.25 Clonmel Healthcare Ltd PA0126/078/002 Tablets 31/05/1995
TRILISATE Napp Laboratories Limited PA0114/023/001 Tablets - CHOLINE SALICYLATE 31/05/1995
- MAGNESIUM STEARATE
TRILISATE Napp Laboratories Limited PA0114/023/002 Tablets - CHOLINE SALICYLATE 31/05/1995
- MAGNESIUM SALICYLATE

VAMIN INFANT Pharmacia Laboratories PA0187/023/001 - AMINO ACIDS 31/05/1995


Limited
VAMIN INFANT Pharmacia Laboratories PA0187/023/002 - AMINO ACIDS 31/05/1995
Limited
VIBROCIL NASAL Ciba Geigy Plc PA0030/001/002 - DIMETINDENE MALEATE 31/05/1995
- PHENYLEPHRINE
- NEOMYCIN SULFATE
VIBROCIL NASAL Novartis Consumer Health PA0030/001/003 Gel - DIMETINDENE 31/05/1995
UK Limited - PHENYLEPHRINE
- NEOMYCIN SULFATE
VIBROX Napp Laboratories Limited PA0114/045/001 Capsule - DOXYCYCLINE 31/05/1995
VIBROX SACHETS Napp Laboratories Limited PA0114/045/002 - DOXYCYCLINE 31/05/1995
VILLESCON Boehringer Ingelheim Limited PA0007/019/001 Tablets - PROLINTANE 31/05/1995
- THIAMINE
HYDROCHLORIDE
- ASCORBIC ACID
X- PREP POWDER Napp Laboratories Limited PA0114/031/002 31/05/1995
XYLOCARD Astra Pharmaceuticals Ltd PA0009/018/002 Solution for Infusion - SODIUM CHLORIDE 31/05/1995
- LIDOCAINE
HYDROCHLORIDE
XYLOCARD Astra Pharmaceuticals Ltd PA0009/018/003 Solution for Infusion - LIDOCAINE 31/05/1995
HYDROCHLORIDE
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/015 Solution for Infusion - SODIUM CHLORIDE 22/05/1995
SODIUM CHLORIDE 0.9% B. Braun Medical Limited PA0179/002/016 Solution for Infusion - SODIUM CHLORIDE 22/05/1995
SOLU-MEDRONE Pharmacia Limited PA0016/022/006 - METHYLPREDNISOLONE 16/05/1995
SODIUM SUCCINATE

PHENERGAN May & Baker Limited PA0040/043/003 Cream - PROMETHAZINE 01/04/1995


PRAXILENE Helsinn Birex PA0294/002/003 - NAFTIDROFURYL 01/04/1995
Pharmaceuticals Limited OXALATE
XYLOCAINE EPIDURAL Astra Pharmaceuticals Ltd PA0009/016/015 Solution for Injection - LIDOCAINE 01/04/1995
HYDROCHLORIDE
ANTURAN Ciba Geigy Plc PA0011/012/001 Tablets - SULFINPYRAZONE 31/03/1995
ANTURAN Ciba Geigy Plc PA0011/012/002 Tablets - SULFINPYRAZONE 31/03/1995
DOPAMINE International Medication PA0255/011/006 31/03/1995
HYDROCHLORIDE Systems (UK) Ltd
DOPAMINE International Medication PA0255/011/004 31/03/1995
HYDROCHLORIDE Systems (UK) Ltd
DOPAMINE International Medication PA0255/011/005 31/03/1995
HYDROCHLORIDE Systems (UK) Ltd
STERILE POWDER
FERROMYN B Wellcome (Ireland) Limited PA0017/072/002 Tablets - FERROUS SUCCINATE 31/03/1995
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
FRUSEMIDE International Medication PA0255/010/001 Withdrawn Form 31/03/1995
Systems (UK) Ltd
FRUSEMIDE International Medication PA0255/010/002 Withdrawn Form 31/03/1995
Systems (UK) Ltd
HYGROTON Ciba Geigy Plc PA0011/004/001 Tablets - CHLORTALIDONE 31/03/1995
SYMMETREL Ciba Geigy Plc PA0011/002/001 Syrup - AMANTADINE 31/03/1995
HYDROCHLORIDE
TERONAC Novartis Pharmaceuticals UK PA0013/028/001 Tablets - MAZINDOL 31/03/1995
Ltd
TRASICOR Ciba Geigy Plc PA0028/003/004 Tablets - OXPRENOLOL 31/03/1995
HYDROCHLORIDE
VISKEN Novartis Pharmaceuticals UK PA0013/001/003 Withdrawn Form - PINDOLOL 31/03/1995
Ltd
ASERBINE SmithKline Beecham Pharm PA0049/038/002 - BENZOIC ACID 28/02/1995
Ltd - SALICYLIC ACID
BEECHAMS POWDERS SmithKlineBeecham PA0379/004/002 - ACETYLSALICYLIC ACID 28/02/1995
(REFORMULATION) Consumer Brand - CAFFEINE
BENEROC Roche Products Limited PA0050/030/001 - MULTIVITAMINS 28/02/1995
CHLORPROPAMIDE Norton Healthcare Limited PA0282/007/001 Tablets 28/02/1995
T/A IVAX Pharmaceuticals
UK

Human Medicines Withdrawn Products Page 416 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CHLORPROPAMIDE Norton Healthcare Limited PA0282/007/002 Tablets 28/02/1995
T/A IVAX Pharmaceuticals
UK
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/001/001 28/02/1995
(SUSPENSION)
CYSTOGARD Boehringer Ingelheim Limited PA0007/045/001 Solution for Injection - MESNA 28/02/1995

CYSTOGARD Boehringer Ingelheim Limited PA0007/045/002 Solution for Injection - MESNA 28/02/1995

CYSTOGARD Boehringer Ingelheim Limited PA0007/045/003 Solution for Injection - MESNA 28/02/1995

DAY NURSE COLD SmithKlineBeecham PA0379/018/002 - PARACETAMOL 28/02/1995


REMEDY Consumer Brand -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROCHLORIDE
DIAZEPAM RECTAL TUBES CP Pharmaceuticals Ltd PA0409/003/001 28/02/1995
trading as Wockhardt UK
DIAZEPAM RECTAL TUBES CP Pharmaceuticals Ltd PA0409/003/002 28/02/1995
trading as Wockhardt UK
DIBENYLINE SmithKline and French PA0060/030/001 Withdrawn Form 28/02/1995
Laboratories Ltd
DISADINE DP Zeneca Limited PA0051/045/001 - POVIDONE-IODINE 28/02/1995
FLEMOCIN Yamanouchi Pharma Ltd PA0062/026/008 Tablets Effervescent 28/02/1995
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/009 Tablets Effervescent 28/02/1995
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/010 Tablets Effervescent 28/02/1995
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/004 Capsule 28/02/1995
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/006 Capsule 28/02/1995
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/007 Tablets Effervescent 28/02/1995
FLEMOXIN FORTE Yamanouchi Pharma Ltd PA0062/026/002 28/02/1995
(SUSPENSION)
FLEMOXIN (SUSPENSION) Yamanouchi Pharma Ltd PA0062/026/001 28/02/1995

FLEMOXIN PAEDIATRIC Yamanouchi Pharma Ltd PA0062/026/003 28/02/1995


GENOTROPIN Pharmacia Laboratories PA0187/032/010 - SOMATROPIN 28/02/1995
Limited
GENOTROPIN Pharmacia Laboratories PA0187/032/012 - SOMATROPIN 28/02/1995
Limited
LIGNOCAINE International Medication PA0255/018/001 Gel 28/02/1995
Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/018/002 Gel 28/02/1995
Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/007 Withdrawn Form 28/02/1995
HYDROCHLORIDE Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/008 Withdrawn Form 28/02/1995
HYDROCHLORIDE Systems (UK) Ltd
LOREXANE Zeneca Limited PA0051/036/001 Cream - LINDANE 28/02/1995
LOREXANE Zeneca Limited PA0051/036/002 - LINDANE 28/02/1995
LOREXANE Zeneca Limited PA0051/036/003 - LINDANE 28/02/1995
NICO-2 Nicholas Laboratories PA0032/033/001 Granules Effervescent - SODIUM BICARBONATE 28/02/1995
NYSTATAIN DOME ORAL Bayer PLC PA0021/028/001 - NYSTATIN 28/02/1995
(SUSPENSION)
PEPTAVLON Zeneca Limited PA0051/035/001 Withdrawn Form - PENTAGASTRIN 28/02/1995
PRAMACE Astra Pharmaceuticals Ltd PA0009/045/001 Capsule - RAMIPRIL 28/02/1995
PRAMACE Astra Pharmaceuticals Ltd PA0009/045/002 Capsule - RAMIPRIL 28/02/1995
PRAMACE Astra Pharmaceuticals Ltd PA0009/045/003 Capsule - RAMIPRIL 28/02/1995
PRAMACE Astra Pharmaceuticals Ltd PA0009/045/004 Capsule - RAMIPRIL 28/02/1995
REMOXIPRIDE Astra Pharmaceuticals Ltd PA0009/046/001 Capsule - REMOXIPRIDE 28/02/1995
REMOXIPRIDE Astra Pharmaceuticals Ltd PA0009/046/002 Capsule - REMOXIPRIDE 28/02/1995
REMOXIPRIDE Astra Pharmaceuticals Ltd PA0009/046/003 Capsule - REMOXIPRIDE 28/02/1995
ROXIAM Astra Pharmaceuticals Ltd PA0009/047/001 Capsule - REMOXIPRIDE 28/02/1995
ROXIAM Astra Pharmaceuticals Ltd PA0009/047/002 Capsule - REMOXIPRIDE 28/02/1995
SINETENS Farmitalia Carlo Erba Ltd PA0236/001/001 Tablets 28/02/1995
SINETENS Farmitalia Carlo Erba Ltd PA0236/001/002 Tablets 28/02/1995
SINITOL Nicholas Laboratories PA0032/029/001 Capsule - PARACETAMOL 28/02/1995
- PSEUDOEPHEDRINE
HYDROCHLORIDE
STRONG STERILE UCB Pharma Limited PA0365/029/001 - DOPAMINE 28/02/1995
DOPAMINE HYDROCHLORIDE
HYDROCHLORIDE
STRONG STERILE UCB Pharma Limited PA0365/029/002 - DOPAMINE 28/02/1995
DOPAMINE HYDROCHLORIDE
HYDROCHLORIDE
TETMOSOL Zeneca Limited PA0051/038/002 - SULFIRAM 28/02/1995

Human Medicines Withdrawn Products Page 417 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
THIOPENTONE SODIUM International Medication PA0255/016/001 28/02/1995
WITH DILUENT Systems (UK) Ltd
THIOPENTONE SODIUM International Medication PA0255/016/002 28/02/1995
WITH DILUENT Systems (UK) Ltd
THIOPENTONE SODIUM International Medication PA0255/016/003 28/02/1995
WITH DILUENT Systems (UK) Ltd
THIOPENTONE SODIUM International Medication PA0255/016/004 28/02/1995
WITH DILUENT Systems (UK) Ltd
UNIDOX Yamanouchi Pharma Ltd PA0062/025/003 28/02/1995
UNIDOX (SUSPENSION) Yamanouchi Pharma Ltd PA0062/025/001 28/02/1995
UNIDOX (SUSPENSION) Yamanouchi Pharma Ltd PA0062/025/002 28/02/1995
VITAMIN C Clonmel Healthcare Ltd PA0126/047/001 Tablets 28/02/1995
VITAMIN C Clonmel Healthcare Ltd PA0126/047/002 Tablets 28/02/1995
VITAMIN C Clonmel Healthcare Ltd PA0126/047/003 Tablets 28/02/1995
ZARENT SYNCRONER Fisons Limited PA0018/052/001 - NEDOCROMIL SODIUM 28/02/1995
- SALBUTAMOL SULFATE
CAPOTEN Parallel Lines Ltd PPA0384/010/001 Tablets - CAPTOPRIL 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/001 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/002 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/003 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/004 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/007 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/008 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/011 Withdrawn Form - FRUCTOSE 31/01/1995
LAEVULOSE Baxter Healthcare Limited PA0167/036/012 Withdrawn Form - FRUCTOSE 31/01/1995
MEPTAZINOL John Wyeth & Brother PA0022/040/001 Tablets - MEPTAZINOL 31/01/1995
Limited
MEPTID John Wyeth & Brother PA0022/040/002 Tablets - MEPTAZINOL 31/01/1995
Limited
MEPTIDOL John Wyeth & Brother PA0022/040/003 Withdrawn Form - MEPTAZINOL 31/01/1995
Limited
AZALAN Elan Pharma Ltd PA0516/019/001 Capsule - MESALAZINE 16/01/1995
MOCARD SPANSULE SmithKline and French PA0060/051/001 Capsule 09/01/1995
Laboratories Ltd
FIBRONOCIS (HUMAN) Amersham Health Srl PA0401/001/001 22/12/1994
TRISONOVIN Menley & James PA0159/008/001 Cream - SULFUR 13/12/1994
Laboratories - RESORCINOL
CYTARABINE Hospira UK Limited PA0437/006/006 Solution for Injection - CYTARABINE 30/11/1994
CYTARABINE Hospira UK Limited PA0437/006/007 Solution for Injection - CYTARABINE 30/11/1994
CYTARABINE Hospira UK Limited PA0437/006/008 Solution for Injection - CYTARABINE 30/11/1994
DIHYDROCODEINE Accord-UK Ltd PA0176/051/001 Tablets - DIHYDROCODEINE 30/11/1994
DIORALYTE Rorer Pharmaceuticals PA0468/002/002 Tablets 30/11/1994
EFFERVESCENT Limited
DURABOLIN 50 MG/ML Organon Laboratories PA0261/013/003 - NANDROLONE 30/11/1994
SYRINGE Limited PHENPROPIONATE
DURABOLIN SYRINGE Organon Laboratories PA0261/013/002 - NANDROLONE 30/11/1994
Limited PHENPROPIONATE
FELDENE Parallel Lines Ltd PPA0384/012/001 Capsule 30/11/1994
HALICON Parallel Lines Ltd PPA0384/009/001 Tablets - TRIAZOLAM 30/11/1994
HYDROCORTISONE Organon Laboratories PA0261/005/001 - HYDROCORTISONE 30/11/1994
SODIUM Limited SODIUM SUCCINATE
HYDROCORTISONE Organon Laboratories PA0261/005/002 - HYDROCORTISONE 30/11/1994
SODIUM Limited SODIUM SUCCINATE
IMODIUM Parallel Lines Ltd PPA0384/013/001 Capsule - LOPERAMIDE 30/11/1994
HYDROCHLORIDE
KEMELEX Clonmel Healthcare Ltd PA0126/067/005 Tablets 30/11/1994
LOVAN Eli Lilly and Company Limite PA0047/071/001 Tablets - FLUOXETINE 30/11/1994
HYDROCHLORIDE
MELACTONE 50 Clonmel Healthcare Ltd PA0126/039/003 Tablets 30/11/1994
MOTILIUM Parallel Lines Ltd PPA0384/005/001 Tablets 30/11/1994
NAPROSYN Parallel Lines Ltd PPA0384/011/001 Tablets - NAPROXEN 30/11/1994
NAPROSYN Parallel Lines Ltd PPA0384/011/002 - NAPROXEN 30/11/1994
PRIMACOR Sanofi-Synthelabo Ireland PA0077/097/001 Withdrawn Form - MILRINONE 30/11/1994
Ltd
PRIMACOR Sanofi-Synthelabo Ireland PA0077/097/002 Withdrawn Form - MILRINONE 30/11/1994
Ltd
TAGAMET Parallel Lines Ltd PPA0384/003/001 Tablets - CIMETIDINE 30/11/1994
VENTIDE ROTACAPS Allen and Hanburys Limited PA0024/018/002 - SALBUTAMOL SULFATE 30/11/1994
- BECLOMETASONE
DIPROPIONATE
VENTIDE ROTACAPS Allen and Hanburys Limited PA0024/018/003 - SALBUTAMOL SULFATE 30/11/1994
- BECLOMETASONE
DIPROPIONATE
VERAPAMIL Accord-UK Ltd PA0176/068/001 Tablets 30/11/1994
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 418 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VERAPAMIL Accord-UK Ltd PA0176/068/002 Tablets 30/11/1994
HYDROCHLORIDE
VERAPAMIL Accord-UK Ltd PA0176/068/003 Tablets 30/11/1994
HYDROCHLORIDE
VERAPAMIL Accord-UK Ltd PA0176/068/004 Tablets 30/11/1994
HYDROCHLORIDE
ZYLORIC Parallel Lines Ltd PPA0384/014/001 - ALLOPURINOL 30/11/1994
ZYLORIC Parallel Lines Ltd PPA0384/014/002 - ALLOPURINOL 30/11/1994
DIANE HE Clissmann PA0012/045/001 Tablets - CYPROTERONE 24/11/1994
ACETATE
- ETHINYLESTRADIOL
DIPROCEL Schering-Plough Limited PA0277/038/002 Cream - BETAMETHASONE 20/11/1994
DIPROPIONATE
DURABOLIN 25MG/ML Organon Laboratories PA0261/013/001 - NANDROLONE 15/11/1994
Limited PHENPROPIONATE
PAEDIATRIC Sanofi-Synthelabo Ireland PA0077/098/001 Oral Suspension - PARACETAMOL 15/11/1994
PARACETAMOL Ltd
PROPRANOL Ranbaxy Ireland Limited PA0408/025/003 Tablets 10/11/1994
PROPRANOLOL Ranbaxy Ireland Limited PA0408/025/001 Tablets 10/11/1994
PROPRANOLOL Ranbaxy Ireland Limited PA0408/025/002 Tablets 10/11/1994
METHOTREXATE Hospira UK Limited PA0437/005/002 Withdrawn Form - METHOTREXATE 03/11/1994
METHOTREXATE Hospira UK Limited PA0437/005/004 Withdrawn Form - METHOTREXATE 03/11/1994
ASEP Galen Limited PA0185/009/001 - GLUTARAL 31/10/1994
ASEP Galen Limited PA0185/009/002 - GLUTARAL 31/10/1994
ASEP Galen Limited PA0185/009/003 31/10/1994
BECOTIDE FOR Allen and Hanburys Limited PA0024/005/008 - BECLOMETASONE 31/10/1994
NEBULISATION DIPROPIONATE
(SUSPENSION)
ECZEDERM Quinoderm Ltd PA0308/003/001 Cream - CALAMINE 31/10/1994
FABAHISTIN Bayer PLC PA0021/007/001 Tablets 31/10/1994
INDOCID Merck Sharp and Dohme PA0035/003/003 Suppositories - INDOMETACIN 31/10/1994
Limited
KLYX ENEMA Ferring Pharmaceuticals PA0224/004/002 31/10/1994
Limited
METRONIDAZOLE Roussel Laboratories Limited PA0006/035/003 Solution for Infusion - METRONIDAZOLE 31/10/1994

VELOSULIN Novo Nordisk A/S PA0218/037/002 31/10/1994


ALDOMET Parallel Lines Ltd PPA0384/004/001 Tablets - METHYLDOPA 30/10/1994
ADALAT Parallel Lines Ltd PPA0384/001/001 Capsule 27/10/1994
BRUFEN Parallel Lines Ltd PPA0384/006/001 Tablets - IBUPROFEN 27/10/1994
DUVADILAN RETARD Parallel Lines Ltd PPA0384/008/001 Capsule - ISOXSUPRINE 27/10/1994
HYDROCHLORIDE
VIBRAMYCIN Parallel Lines Ltd PPA0384/007/001 Capsule - DOXYCYCLINE 27/10/1994
HYDROCHLORIDE
NAUDICELLE Bio-Oil Research Limited PA0293/001/001 Capsule - LINOLEIC ACID 18/10/1994
TRIGLYCERIDES
- GAMOLENIC ACID
TRIGLYCERIDES
NAUDICELLE PLUS Bio-Oil Research Limited PA0293/001/002 Capsule - LINOLEIC ACID 18/10/1994
TRIGLYCERIDES
- GAMOLENIC ACID
TRIGLYCERIDES
- EICOSAPENTAENOIC
ACID TRIGLYCERIDE
ESTER
- DOCOSAHEXAENAIC
ACID TRIGLYCERIDE
ESTERS
- FATTY ACID
TRIGLYCERIDE ESTER
- D-ALPHA T0COPHERYL
ACETATE
BENOXYL 10 Stiefel Laboratories (U.K.) PA0144/024/002 Cream - BENZOYL PEROXIDE 01/10/1994
Ltd. - SULFUR
BENOXYL 5 Stiefel Laboratories (U.K.) PA0144/024/001 Cream - BENZOYL PEROXIDE 01/10/1994
Ltd. - SULFUR
BRASIVOL COARSE Stiefel Laboratories (U.K.) PA0144/025/003 - ALUMINIUM OXIDE 01/10/1994
Ltd.
OILATUM SOAP Stiefel Laboratories (U.K.) PA0144/023/001 - ARACHIS OIL 01/10/1994
Ltd.
EF CORTELAN Glaxo Laboratories Limited PA0044/041/001 Withdrawn Form - HYDROCORTISONE 30/09/1994
UROMITEXAN Asta Medica AG PA0088/002/001 29/09/1994
UROMITEXAN Asta Medica AG PA0088/002/002 29/09/1994
MEFENAMIC ACID Norton Waterford PA0436/015/001 Capsule - MEFENAMIC ACID 20/09/1994
CAMCOLIT Norgine Limited PA0102/003/003 Tablets - LITHIUM CARBONATE 01/09/1994

Human Medicines Withdrawn Products Page 419 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARBIDOPA Merck Sharp and Dohme PA0035/048/001 Tablets 01/09/1994
Limited
CARBIDOPA Merck Sharp and Dohme PA0035/048/003 Tablets 01/09/1994
Limited
COQ10 COENZYME Q10 Lifeplan Products Ltd PA0523/010/001 - CO ENZYM Q10 01/09/1994
HUMAN INSULATARD Novo Nordisk A/S PA0218/038/001 01/09/1994
HUMAN INSULATARD Novo Nordisk A/S PA0218/038/002 01/09/1994
HUMAN MIXTARD 15/85 Novo Nordisk A/S PA0218/042/001 01/09/1994
HUMAN MIXTARD 15/85 Novo Nordisk A/S PA0218/042/002 01/09/1994
HUMAN MIXTARD 30/70 Novo Nordisk A/S PA0218/039/001 01/09/1994
HUMAN MIXTARD 50/50 Novo Nordisk A/S PA0218/041/001 01/09/1994
HUMAN MIXTARD 50/50 Novo Nordisk A/S PA0218/041/002 01/09/1994
KLACID PAEDIATRIC Abbott Laboratories Ireland PA0038/051/005 - CLARITHROMYCIN 01/09/1994
(SUSPENSION) Ltd
LEUSTATIN Cilag Limited PA0059/044/001 - CLADRIBINE 01/09/1994
METRONIDAZOLE 5 G/1 CP Pharmaceuticals Ltd PA0409/002/002 Withdrawn Form 01/09/1994
trading as Wockhardt UK
METRONIDAZOLE 5G/1 CP Pharmaceuticals Ltd PA0409/002/001 Withdrawn Form 01/09/1994
trading as Wockhardt UK
NOVARUCA Bioglan Laboratories Ltd PA0469/006/001 Gel - GLUTARAL 01/09/1994
ORGANIC GERMANIUM Lifeplan Products Ltd PA0523/017/001 Capsule - PELARGONIUM 01/09/1994
ODORANTISSMUM
PUR-IN 15/85 CP Pharmaceuticals Ltd PA0409/011/003 01/09/1994
trading as Wockhardt UK
PUR-IN 25/75 CP Pharmaceuticals Ltd PA0409/011/002 01/09/1994
trading as Wockhardt UK
PUR-IN 50/50 CP Pharmaceuticals Ltd PA0409/011/001 01/09/1994
trading as Wockhardt UK
PUR-IN ISOPHANE CP Pharmaceuticals Ltd PA0409/010/001 01/09/1994
trading as Wockhardt UK
PUR-IN NEUTRAL CP Pharmaceuticals Ltd PA0409/009/001 01/09/1994
trading as Wockhardt UK
RHEUMATIC PAIN Ferrosan Healthcare Ltd PA0527/016/001 Tablets 01/09/1994
TEMAZEPAM DRP Farmitalia Carlo Erba Ltd PA0236/019/001 Capsule 01/09/1994
TIMOPTOL Merck Sharp and Dohme PA0035/053/001 - TIMOLOL MALEATE 01/09/1994
Limited
ULTRADIL HE Clissmann PA0012/030/002 Ointment - FLUOCORTOLONE 01/09/1994
CAPROATE
- FLUOCORTOLONE
PIVALATE
- CLEMIZOLE
ULTRADIL FATTY HE Clissmann PA0012/030/003 Ointment - FLUOCORTOLONE 01/09/1994
CAPROATE
- FLUOCORTOLONE
PIVALATE
UTINOR Merck Sharp and Dohme PA0035/065/002 Tablets - NORFLOXACIN 01/09/1994
Limited
V-CIL-K Eli Lilly and Company Limite PA0047/022/006 - 01/09/1994
PHENOXYMETHYLPENICI
LLIN
INTRAFUSIN E. Merck Ltd PA0054/067/001 - AMINO ACIDS 16/08/1994
INTRAFUSIN E. Merck Ltd PA0054/067/002 - AMINO ACIDS 16/08/1994
STAFOXIL Yamanouchi Pharma Ltd PA0062/024/003 Withdrawn Form 02/08/1994
STAFOXIL Yamanouchi Pharma Ltd PA0062/024/004 Withdrawn Form 02/08/1994
TERAZOL Cilag Limited PA0059/033/001 Pessary - TERCONAZOLE 01/08/1994
TERAZOL Cilag Limited PA0059/033/002 Cream - TERCONAZOLE 01/08/1994
TERAZOL Cilag Limited PA0059/033/003 Cream - TERCONAZOLE 01/08/1994
ANTRIL (ANAKINRA) 100 Synergen B.V. PA0699/001/001 20/07/1994
MG/ML
ANTRIL (ANAKINRA) 100 Synergen B.V. PA0699/001/002 20/07/1994
MG/ML
ANTRIL (ANAKINRA) 100 Synergen B.V. PA0699/001/003 20/07/1994
MG/ML
METERFOLIC Sinclair Pharmaceuticals PA0251/012/001 18/07/1994
Limited
SIMPLE LINCTUS Clonmel Healthcare Ltd PA0126/089/001 11/07/1994
DYSPAMET Bridge Pharmaceuticals (Ire) PA0560/001/003 Tablets Effervescent - CIMETIDINE 07/07/1994
Ltd
DYSPAMET Bridge Pharmaceuticals (Ire) PA0560/001/004 Tablets Effervescent - CIMETIDINE 07/07/1994
Ltd
TAGAMET SmithKline and French PA0060/006/009 07/07/1994
Laboratories Ltd
TAGAMET SmithKline and French PA0060/006/010 07/07/1994
Laboratories Ltd

Human Medicines Withdrawn Products Page 420 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TAGAMET SmithKline and French PA0060/006/011 07/07/1994
Laboratories Ltd
TAGAMET SmithKline and French PA0060/006/007 Tablets 07/07/1994
Laboratories Ltd
GENTACOLL IMPLANT Schering-Plough Limited PA0277/071/001 - GENTAMICIN 06/07/1994
GENTACOLL IMPLANT Schering-Plough Limited PA0277/071/002 - GENTAMICIN 06/07/1994
GESTANIN Organon Laboratories PA0261/011/001 - ALLYLESTRENOL 05/07/1994
Limited
SODIUM UROMIRO 300 E. Merck Ltd PA0054/045/001 - IODAMIDE 01/07/1994
SODIUM UROMIRO 300 E. Merck Ltd PA0054/045/002 - IODAMIDE 01/07/1994
OXYPERTINE Sterling Drug (Ireland) Ltd PA0077/009/002 Tablets - OXYPERTINE 27/06/1994
HYDROCHLORIDE
EVENING PRIMROSE OIL Beeline Healthcare PA0559/001/001 - OENOTHERA BIENNIS 22/06/1994
500
PRODOXOL Warner Lambert PA0039/001/001 20/06/1994
(SUSPENSION)
ANDURSIL Ciba Geigy Plc PA0028/051/002 Tablets - ALUMINIUM HYDROXIDE 15/06/1994
GEL
- MAGNESIUM HYDROXIDE
- ALUMINIUM HYDROXIDE
- ANTIFOAM M

FOAM ENEMA Reckitt's (Ireland) Limited PA0027/018/001 - DOCUSATE SODIUM 15/06/1994


VOLTAROL DISPERSIBLE Geigy Pharmaceuticals PA0011/027/008 Tablets - DICLOFENAC 15/06/1994
FACTORATE Aventis Behring Limited PA0010/006/006 - HUMAN 10/06/1994
PLASMAFRAKTION
(FACTOR VIII)
FACTORATE (DOUBLE- Aventis Behring Limited PA0010/006/005 - HUMAN 10/06/1994
FILL) PLASMAFRAKTION
(FACTOR VIII)
J. COLLIS BROWNES Napp Laboratories Limited PA0114/071/001 Tablets - KAOLIN, LIGHT 10/06/1994
- MORPHINE
HYDROCHLORIDE
- CALCIUM CARBONATE
DIMOTAPP P A.H. Robins Company PA0086/016/001 Tablets - BROMPHENIRAMINE 08/06/1994
Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
- PARACETAMOL

VIAFERON NASAL Schering-Plough Limited PA0277/051/001 - INTERFERON ALFA-2B 07/06/1994


ERYTHRELAN Elan Pharma Ltd PA0516/015/001 31/05/1994
(SUSPENSION)
ERYTHRELAN Elan Pharma Ltd PA0516/015/002 31/05/1994
(SUSPENSION)
TRINOVUM ED Cilag Limited PA0059/021/002 Tablets - NORETHISTERONE 25/05/1994
- ETHINYLESTRADIOL
CHEMOLASE Pharmotex Inc. PA0426/001/001 - CHYMOPAPAIN 19/05/1994
ANANASE Rorer Pharmaceuticals PA0468/012/001 Tablets - BROMELAINS 17/05/1994
Limited
ANTHICAL May & Baker Limited PA0040/038/001 Cream 17/05/1994
NATURAL FORM VITAMIN Lifeplan Products Ltd PA0354/005/004 - TOCOPHEROL 16/05/1994
E
V CIL K Eli Lilly and Company Limite PA0047/022/005 Syrup - 11/05/1994
PHENOXYMETHYLPENICI
LLIN
V CIL K Eli Lilly and Company Limite PA0047/022/002 Capsule - 11/05/1994
PHENOXYMETHYLPENICI
LLIN
V-CIL-K Eli Lilly and Company Limite PA0047/022/004 Tablets - 11/05/1994
PHENOXYMETHYLPENICI
LLIN
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/016 - GLUCOSE 07/05/1994
INFUSION
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/015 - GLUCOSE 05/05/1994
INFUSION
GLUCOSE INTRAVENOUS Baxter Healthcare Limited PA0167/009/017 - GLUCOSE 05/05/1994
INFUSION 50%
HALOPERIDOL Hospira UK Limited PA0437/031/001 Withdrawn Form - HALOPERIDOL 05/05/1994
DECANOATE DECANOATE
SYNTHAMIX 14/1200 Baxter Healthcare Limited PA0167/078/005 - AMINO ACIDS 05/05/1994
- ELECTROLYTES NOS
SYNTHAMIX 14/1800 Baxter Healthcare Limited PA0167/078/007 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS

Human Medicines Withdrawn Products Page 421 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SYNTHAMIX 14/1800 X Baxter Healthcare Limited PA0178/078/008 05/05/1994
PARENTERAL NUTRITION
SYNTHAMIX 14/1800X Baxter Healthcare Limited PA0167/078/008 05/05/1994
PARENTERAL
SYNTHAMIX 14/2200 Baxter Healthcare Limited PA0167/078/009 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 14/2800 Baxter Healthcare Limited PA0167/078/011 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 14/2800X Baxter Healthcare Limited PA0167/078/012 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 17/1800 Baxter Healthcare Limited PA0167/078/013 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 17/1800X Baxter Healthcare Limited PA0167/078/014 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 17/2800 Baxter Healthcare Limited PA0167/078/015 - ELECTROLYTES NOS 05/05/1994
- AMINO ACIDS
SYNTHAMIX 17/2800 X Baxter Healthcare Limited PA0167/078/016 - AMINO ACIDS 05/05/1994
- ELECTROLYTES NOS
SYNTHAMIX 9/1800 Baxter Healthcare Limited PA0167/078/001 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
SYNTHAMIX 9/1800 Baxter Healthcare Limited PA0167/078/003 - AMINO ACIDS 05/05/1994
PARENTERAL - ELECTROLYTES NOS
PERTOFRAN R Geigy Pharmaceuticals PA0011/026/001 Tablets - DESIPRAMINE 30/04/1994
PRIMENE 10% Clintec Nutrition Clinique PA0481/001/009 - AMINO ACIDS 29/04/1994
PRIMENE 10% Clintec Nutrition Clinique PA0481/001/010 - AMINO ACIDS 29/04/1994
PRIMENE 5% Clintec Nutrition Clinique PA0481/001/002 - AMINO ACIDS 29/04/1994
PRIMENE 5% Clintec Nutrition Clinique PA0481/001/003 - AMINO ACIDS 29/04/1994
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/051/003 Withdrawn Form - POTASSIUM CHLORIDE 27/04/1994
0.3% /DEXTROSE 5.0% - GLUCOSE
POTASSIUM CHLORIDE Baxter Healthcare Limited PA0167/051/004 Withdrawn Form - POTASSIUM CHLORIDE 27/04/1994
0.3%/DEXTROSE 5.0% - GLUCOSE
SUSCARD BUCCAL Forest Laboratories UK Ltd PA0100/033/002 Tablets 26/04/1994
DISPERSIBLE CO- Teva UK Limited PA0237/019/004 Tablets 22/04/1994
TRIMOXAZOLE
MANTADINE Bristol-Myers Squibb Pharma PA0700/010/001 Capsule - AMANTADINE 22/04/1994
HYDROCHLORIDE
QUINODERM CREAM Quinoderm Ltd PA0308/006/001 - BENZOYL PEROXIDE 21/04/1994
HYDROCORTISONE - POTASSIUM
HYDROXYQUINOLIN
SULFATE
- HYDROCORTISONE
DISOGRAM Prographarm Laboratories PA0472/002/003 Capsule - DISOPYRAMIDE 20/04/1994
- DISOPYRAMIDE
DISOGRAM CR CAPSULES Prographarm Laboratories PA0472/002/002 - DISOPYRAMIDE 20/04/1994

SUPERSUN EVENING GR Lane Health Products Lt PA0257/051/001 Capsule 20/04/1994


PRIMROSE OIL
NAVIDREX Ciba Geigy Plc PA0028/021/001 Tablets - CYCLOPENTHIAZIDE 19/04/1994
PRESCAL Ciba Geigy Plc PA0028/061/002 Tablets - ISRADIPINE 19/04/1994
PRESCAL 1.25 MT Ciba Geigy Plc PA0028/061/003 Tablets - ISRADIPINE 19/04/1994
NEOPLATIN Bristol-Myers Squibb PA0048/017/001 - CISPLATIN 07/04/1994
(Holdings) Limited
BRADILAN Napp Laboratories Limited PA0114/021/001 Tablets - NICOFURANOSE 01/04/1994
COLD RELIEF HOT LEMON SmithKlineBeecham PA0379/003/002 Powder for Oral Solution - ACETYLSALICYLIC ACID 01/04/1994
Consumer Brand - CAFFEINE
- ASCORBIC ACID
CONJUNCTIN LIQUIFILM Allergan Pharmaceuticals PA0148/019/001 - POLYMYXIN B SULFATE 01/04/1994
Ireland - NEOMYCIN SULFATE
HERPLEX-D Allergan Pharmaceuticals PA0148/018/001 - IDOXURIDINE 01/04/1994
Ireland
POLIOMYELITIS Wellcome (Ireland) Limited PA0017/043/001 Withdrawn Form 01/04/1994
PRIMOLUT DEPOT HE Clissmann PA0012/020/002 Solution for Injection - 01/04/1994
HYDROXYPROGESTERON
E CAPROATE
ISMELIN Ciba Geigy Plc PA0028/026/001 Tablets - GUANETHIDINE 30/03/1994
ISMELIN Ciba Geigy Plc PA0028/026/002 Tablets - GUANETHIDINE 30/03/1994
ISMELIN Ciba Geigy Plc PA0028/026/003 - GUANETHIDINE 30/03/1994
ROGITINE Ciba Geigy Plc PA0028/034/001 - PHENTOLAMINE 30/03/1994
MESILATE
CREFED Helsinn Birex PA0294/014/001 - NIFEDIPINE 29/03/1994
Pharmaceuticals Limited
CREFED Helsinn Birex PA0294/014/002 - NIFEDIPINE 29/03/1994
Pharmaceuticals Limited
ALLOFERIN AMPOULES Roche Products Limited PA0050/042/001 - ALCURONIUM CHLORIDE 22/03/1994

Human Medicines Withdrawn Products Page 422 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ARFONAD Roche Products Limited PA0050/046/001 - TRIMETAPHAN 22/03/1994
CAMSILATE
DECLINAX Roche Products Limited PA0050/033/002 Tablets - DEBRISOQUINE 22/03/1994
LARODOPA Roche Products Limited PA0050/036/001 Tablets - LEVODOPA 22/03/1994
NATULAN Roche Products Limited PA0050/034/001 Capsule - PROCARBAZINE 22/03/1994
HYDROCHLORIDE
PFT- PANCREATIC Roche Products Limited PA0050/063/001 - BENTIROMIDE 22/03/1994
FUNCTION TEST
PROSTIGMIN AMPOULES Roche Products Limited PA0050/041/002 - NEOSTIGMINE BROMIDE 22/03/1994
TENSILON Roche Products Limited PA0050/039/001 - EDROPHONIUM 22/03/1994
CHLORIDE
DIMOTAPP EXPECTORANT A.H. Robins Company PA0086/011/007 - GUAIFENESIN 21/03/1994
Limited - PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- BROMPHENIRAMINE
MALEATE
BISMAG ANTACID Pfizer Consumer Healthcare PA0172/016/001 - SODIUM BICARBONATE 18/03/1994
Ltd - MAGNESIUM
CARBONATE
BISMAG ANTACID Pfizer Consumer Healthcare PA0172/016/002 Tablets - SODIUM BICARBONATE 18/03/1994
Ltd - MAGNESIUM
CARBONATE
SECLODIN Pfizer Consumer Healthcare PA0172/019/001 Capsule - IBUPROFEN 18/03/1994
Ltd
ALUHYDE Sinclair Pharmaceuticals PA0251/006/001 Tablets 17/03/1994
Limited
BISMAG-LAC Professor Dr. Med. Much. PA0369/001/001 Tablets - MAGALDRATE 16/03/1994
A.G.
APS AMITRIPTYLINE Teva UK Limited PA0237/027/001 Tablets 15/03/1994
APS AMITRIPTYLINE Teva UK Limited PA0237/027/002 Tablets 15/03/1994
ERYTHROMYCIN Abbott Laboratories Ireland PA0038/056/001 10/03/1994
LACTOBIONATE Ltd
MEDIHALER ERGOTAMINE 3M Health Care Limited PA0057/037/001 - ERGOTAMINE TARTRATE 10/03/1994

MEDIHALER-ISO 3M Health Care Limited PA0057/028/001 - ISOPRENALINE 10/03/1994


SULPHATE
MEDIHALER-ISO FORTE 3M Health Care Limited PA0057/027/001 - ISOPRENALINE 10/03/1994
SULPHATE
PULMADIL INHALER 3M Health Care Limited PA0057/024/001 - RIMITEROL 10/03/1994
HYDROBROMIDE
CONOVA 30 G.D. Searle & Company PA0001/015/001 Tablets - ETHINYLESTRADIOL 09/03/1994
Limited - ETYNODIOL DIACETATE
ORTHOSORB Johnson & Johnson (Ireland) PA0330/007/001 09/03/1994
Limited
GARDRIN Syntex Pharmaceuticals PA0033/026/001 Capsule - ENPROSTIL 08/03/1994
Limited
NAPROSYN 375 Syntex Pharmaceuticals PA0033/005/005 - NAPROXEN 08/03/1994
Limited
HYGROTON K Geigy Pharmaceuticals PA0011/004/002 Tablets - CHLORTALIDONE 04/03/1994
- POTASSIUM CHLORIDE
SINTHROME Geigy Pharmaceuticals PA0011/030/002 Tablets - ACENOCOUMAROL 04/03/1994
FENOSTIL RETARD Novartis Consumer Health PA0030/002/001 Tablets - DIMETINDENE MALEATE 28/02/1994
UK Limited
FLEMOXIN Yamanouchi Pharma Ltd PA0062/026/005 Capsule 28/02/1994
LEOTONE Leo Laboratories Limited PA0046/041/001 - THIAMINE MONONITRATE 24/02/1994
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- DEXPANTHENOL
- CAFFEINE
- SODIUM
GLYCEROPHOSPHATE
- ETHANOL

PONSTAN Parke Davis & Company PA0056/001/004 Tablets - MEFENAMIC ACID 24/02/1994
METHOTREXATE Bristol-Myers Squibb PA0048/024/002 Withdrawn Form 22/02/1994
(Holdings) Limited
METHOTREXATE Bristol-Myers Squibb PA0048/024/003 Withdrawn Form 22/02/1994
(Holdings) Limited
METHOTREXATE Bristol-Myers Squibb PA0048/024/004 Withdrawn Form 22/02/1994
(Holdings) Limited

Human Medicines Withdrawn Products Page 423 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METHOTREXATE Bristol-Myers Squibb PA0048/024/005 Withdrawn Form 22/02/1994
(Holdings) Limited
LIPOFLAVONOID Lewis Laboratories Limited PA0222/002/001 Capsule 21/02/1994
VICKS CHLORASEPTIC Procter & Gamble (Health & PA0441/032/002 - PHENOL 21/02/1994
SORETHROAT LOZENGES Beauty Care) Limited

MODURET 25 Merck Sharp and Dohme PA0035/074/001 Tablets - HYDROCHLOROTHIAZIDE 20/02/1994


Limited - AMILORIDE
HYDROCHLORIDE

HUMAN Irish Blood Transfusion PA0225/001/001 - IMMUNOGLOBULIN 18/02/1994


IMMUNOGLOBULIN Service HUMAN NORMAL
DIPHTHERIA & TETANUS Abbott Healthcare Products PA0108/006/003 14/02/1994
TOXOIDS Ltd
HISMADRIN Janssen Pharmaceuticals Lt PA0545/027/001 Capsule 14/02/1994

INTERNATIONAL International Medication PA0255/017/002 11/02/1994


MEDICATION SYSTEMS Systems (UK) Ltd
LTD
MAGNESIUM SULPHATE International Medication PA0255/017/001 11/02/1994
2.5 G Systems (UK) Ltd
DIAZEPAM Bodkin E.J. & Company PA0292/001/001 Tablets - DIAZEPAM 09/02/1994
DIAZEPAM Bodkin E.J. & Company PA0292/001/002 Tablets - DIAZEPAM 09/02/1994
DIAZEPAM Bodkin E.J. & Company PA0292/001/003 Tablets - DIAZEPAM 09/02/1994
BACKACHE Seven Seas Health Care Ltd PA0416/013/001 Tablets 07/02/1994

CATARRH TABLETS Seven Seas Health Care Ltd PA0416/012/001 Tablets 07/02/1994

FERLIXIR A. Nattermann & CIE GmbH PA0326/002/001 - FERRIC CITRATE 07/02/1994


- COBALT GLUCONATE
- THIAMINE
- PYRIDOXINE
- FOLIC ACID
- CUPRIC GLYCINATE
FEVERFEW Seven Seas Health Care Ltd PA0416/015/001 Tablets - ASCORBIC ACID 07/02/1994

LAXATIVE Seven Seas Health Care Ltd PA0416/014/001 Tablets - PEPPERMINT OIL 07/02/1994

LIPOSTABIL A. Nattermann & CIE GmbH PA0326/001/001 Capsule - PHOSPHOLIPIDS 07/02/1994


- PYRIDOXINE
HYDROCHLORIDE
- TOCOPHEROL
- NICOTINIC ACID
LIPOSTABIL A. Nattermann & CIE GmbH PA0326/001/002 Withdrawn Form - PHOSPHOLIPIDS 07/02/1994
- PYRIDOXINE
HYDROCHLORIDE
- TOCOPHEROL
- NICOTINIC ACID
NERVE TABLETS Seven Seas Health Care Ltd PA0416/010/001 Tablets 07/02/1994

RESTFUL NIGHT Seven Seas Health Care Ltd PA0416/008/001 Tablets 07/02/1994

RHEUMATIC PAIN Seven Seas Health Care Ltd PA0416/011/001 Tablets 07/02/1994

STRESSTABS 600 T. P. Whelehan Son & Co. PA0137/003/001 - MULTIVITAMINS 07/02/1994


Limited
BURN RELIEF (SPRAY) Gannet Limited PA0280/002/001 04/02/1994
SPRAY ON BANDAGE Gannet Limited PA0280/003/001 - CETRIMONIUM BROMIDE 04/02/1994
- BENZOCAINE

WOUND CLEANSING Gannet Limited PA0280/001/001 - BENZALKONIUM 04/02/1994


CHLORIDE
- LIDOCAINE
HYDROCHLORIDE
SLOW-FE Ciba Geigy Plc PA0028/031/001 Tablets - FERROUS SULFATE 03/02/1994
SYNACTHEN DEPOT Ciba Geigy Plc PA0028/016/002 - TETRACOSACTIDE 03/02/1994
MULTIDOSE
BIOGLAN CO2 Bioglan Laboratories Ltd PA0469/014/001 Granules Effervescent - BETAINE 02/02/1994
HYDROCHLORIDE
- SODIUM BICARBONATE
- DIMETHICONE 350
MICROPAQUE Bioglan Laboratories Ltd PA0469/015/001 - BARIUM SULFATE 02/02/1994
(SUSPENSION)
CANTOPAL NATURTABS Larkhall Laboratories Plc PA0288/004/001 01/02/1994
CANTOPAL NATURTABS Larkhall Laboratories Plc PA0288/004/002 01/02/1994

Human Medicines Withdrawn Products Page 424 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MURINE Abbott Laboratories Ireland PA0038/053/001 Eye Drops Solution 01/02/1994
Ltd
NICOTINIC ACID Larkhall Laboratories Plc PA0288/018/001 Tablets 01/02/1994
NATURTABS
VITAMIN C NATURTABS Larkhall Laboratories Plc PA0288/005/001 01/02/1994
CALCIUM PANTOTHENATE GR Lane Health Products Lt PA0257/008/001 25/01/1994

BECALM Ferrosan Healthcare Ltd PA0527/010/001 Tablets 19/01/1994


EUGYNON 30 HE Clissmann PA0012/044/001 Tablets - ETHINYLESTRADIOL 18/01/1994
- NORGESTREL
MIRAFLOW Ciba Vision (UK) Ltd PA0628/008/001 - POLOXAMER 13/01/1994
- ISOPROPANOL
TERMONIL Novartis Pharmaceuticals UK PA0013/020/001 Tablets - METIXENE 13/01/1994
Ltd HYDROCHLORIDE
IRONPLAN Menley & James PA0159/007/001 Capsule - FERROUS SULFATE 10/01/1994
Laboratories - VITAMIN B NOS
SELEXID ORAL Leo Laboratories Limited PA0046/014/002 - PIVMECILLINAM 10/01/1994
(SUSPENSION)
STERILE WATER International Medication PA0255/015/001 Withdrawn Form 04/01/1994
Systems (UK) Ltd
STERILE WATER International Medication PA0255/015/002 Withdrawn Form 04/01/1994
Systems (UK) Ltd
STERILE WATER International Medication PA0255/015/003 Withdrawn Form 04/01/1994
Systems (UK) Ltd
STERILE WATER International Medication PA0255/015/004 Withdrawn Form 04/01/1994
Systems (UK) Ltd
STERILE WATER International Medication PA0255/015/005 Withdrawn Form 04/01/1994
Systems (UK) Ltd
STERILE WATER International Medication PA0255/015/006 Withdrawn Form 04/01/1994
Systems (UK) Ltd
TRIVAX D T P VACCINE Wellcome (Ireland) Limited PA0017/41/001 - DIPHTHERIA TOXOID 31/12/1993
- TETANUS TOXOID
- PERTUSSIS TOXOID
METHOCEL Dispersa (UK) Ltd PA0582/012/001 - 23/12/1993
METHYLHYDROXYPROPY
LCELLULOSE
NITRAZEPAM Norton Healthcare Limited PA0282/005/001 20/12/1993
T/A IVAX Pharmaceuticals
UK
LADIES ONLY Health & Diet Food Company PA0395/002/001 Capsule - PYRIDOXINE 15/12/1993
Ltd HYDROCHLORIDE
- LECITHIN
- TOCOPHEROL
- FERROUS SULFATE
- P-AMINOBENZOIC ACID
NICOTINAMIDE Larkhall Laboratories Plc PA0288/003/001 15/12/1993
NATURTABS
VITAMIN E Health & Diet Food Company PA0395/004/001 Capsule - TOCOPHEROL 15/12/1993
Ltd
FEMUREST Abbott Healthcare Products PA0108/019/001 Tablets - ESTRADIOL 09/12/1993
Ltd - DYDROGESTERONE
ADALAT LA Bayer PLC PA0021/003/009 Tablets - NIFEDIPINE 07/12/1993
BIO-STAR Medical & Pharmaceutical PA0309/002/001 Capsule 01/12/1993
Sales C
PHARMATOVIT United Pharmacists CoOp PA0337/007/001 Capsule - MULTIVITAMINS 30/11/1993
Ltd - FOLIC ACID
- IRON
PROVERA Pharmacia Limited PA0016/023/004 Tablets - 29/11/1993
MEDROXYPROGESTERO
NE ACETATE
CARDIAGUTT Karl Engelhard PA0425/003/001 Tablets - VERAPAMIL 26/11/1993
CARDIAGUTT Karl Engelhard PA0425/003/002 Tablets - VERAPAMIL 26/11/1993
HONVAN Asta Medica AG PA0088/004/001 26/11/1993
HONVAN Asta Medica AG PA0088/004/002 Tablets 26/11/1993
MITOXANA Asta Medica AG PA0088/005/001 - IFOSFAMIDE 26/11/1993
MITOXANA Asta Medica AG PA0088/005/002 - IFOSFAMIDE 26/11/1993
FLUVIRIN UCB Pharma Limited PA0365/024/003 18/11/1993
AMOXIL SmithKline Beecham Pharm PA0049/006/030 - AMOXICILLIN 17/11/1993
Ltd
GLUCAGON Eli Lilly and Company Limite PA0047/045/002 Withdrawn Form 16/11/1993

NOLTAM Cyanamid of Great Britain PA0037/055/001 Tablets 16/11/1993


NOLTAM Cyanamid of Great Britain PA0037/055/002 Tablets 16/11/1993

Human Medicines Withdrawn Products Page 425 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROFILATE HEAT- Grifols UK Limited PA0415/002/001 - FACTOR VIII 15/11/1993
TREATED (ANTIHAEMOPHILIC
FACTOR)
PROFILATE HEAT- Grifols UK Limited PA0415/002/002 - FACTOR VIII 15/11/1993
TREATED (ANTIHAEMOPHILIC
FACTOR)
DEPO-PROVERA 50 MG/ML Pharmacia Limited PA0016/024/003 - 12/11/1993
MEDROXYPROGESTERO
NE ACETATE
DEPO-PROVERA 50 MG/ML Pharmacia Limited PA0017/025/001 12/11/1993

DEPO-PROVERA 50 Pharmacia Limited PA0016/024/001 - 12/11/1993


MG/ML. 1 ML. MEDROXYPROGESTERO
NE ACETATE
IMMUNOVIR Leo Laboratories Limited PA0046/042/001 Syrup - INOSINE PRANOBEX 12/11/1993
APS ALLOPURINOL Teva UK Limited PA0237/024/001 Tablets 11/11/1993
APS ALLOPURINOL Teva UK Limited PA0237/024/002 Tablets 11/11/1993
ATENOLOL Teva UK Limited PA0237/028/001 Tablets 11/11/1993
ATENOLOL Teva UK Limited PA0237/028/002 Tablets 11/11/1993
PENDRAMINE Asta Medica AG PA0088/007/001 Tablets - PENICILLAMINE 11/11/1993
PENDRAMINE Asta Medica AG PA0088/007/002 Tablets - PENICILLAMINE 11/11/1993
VISCOTEARS LIQUID GEL Dispersa (UK) Ltd PA0582/013/001 Gel - CARBOMER 10/11/1993
- CETRIMONIUM BROMIDE
- SORBITOL
- EDETATE DISODIUM
- SODIUM HYDROXIDE

VICKS DOUBLE ACTION Procter & Gamble (Health & PA0441/011/001 Lozenges - CAMPHOR 07/11/1993
MEDICATED Beauty Care) Limited - MENTHOL
ESTER-C-250 Ferrosan Healthcare Ltd PA0527/036/002 04/11/1993
ESTER-C-60 Ferrosan Healthcare Ltd PA0527/036/001 04/11/1993
LADYCARE FOR WOMEN Ferrosan Healthcare Ltd PA0527/033/001 04/11/1993
AFTER THE MENOPAUSE
LADYCARE FOR WOMEN Ferrosan Healthcare Ltd PA0527/032/001 04/11/1993
GOING THROUGH THE
MENOPAUSE
LADYCARE FOR WOMEN Ferrosan Healthcare Ltd PA0527/031/001 04/11/1993
WITH MONTHLY PERIODS
SCHOOLDAYS Ferrosan Healthcare Ltd PA0527/029/001 04/11/1993
SUNSCENE Ferrosan Healthcare Ltd PA0527/037/001 Tablets 04/11/1993
SUPERTED VITAMIN C Ferrosan Healthcare Ltd PA0527/035/001 04/11/1993
TRAVELWELL Ferrosan Healthcare Ltd PA0527/034/001 Tablets 04/11/1993
AMITRIPTYLINE B P Norton Healthcare Limited PA0282/006/001 02/11/1993
T/A IVAX Pharmaceuticals
UK
AMITRIPTYLINE B P Norton Healthcare Limited PA0282/006/002 02/11/1993
T/A IVAX Pharmaceuticals
UK
BIOTIN NATURTABS Larkhall Laboratories Plc PA0288/006/001 02/11/1993
VITAMIN B NATURTABS Larkhall Laboratories Plc PA0288/007/001 02/11/1993
VICTORY V Mynish Ltd PA0546/002/001 28/10/1993
DILATRATE-SR Stafford Miller Limited PA0069/008/001 Capsule 26/10/1993
HIRUDOID Panpharma Ltd PA0532/001/001 Cream 26/10/1993
TUSS-IONEX Fisons Pharmaceuticals PA0072/001/001 - HYDROCODONE 26/10/1993
(SUSPENSION) (Ireland) - PHENYLTOLOXAMINE
NIPOLEPT 100 Fujisawa Deutschland GmbH PA0473/008/003 - ZOTEPINE 21/10/1993

NIPOLEPT 25 Fujisawa Deutschland GmbH PA0473/008/001 - ZOTEPINE 21/10/1993

NIPOLEPT 50 Fujisawa Deutschland GmbH PA0473/008/002 - ZOTEPINE 21/10/1993

CRYSTAPEN INJECTION Glaxo Laboratories Limited PA0044/017/001 Withdrawn Form - BENZYLPENICILLIN 20/10/1993
SODIUM
TYLENOL JUNIOR CAPLET Johnson & Johnson (Ireland) PA0330/002/006 - PARACETAMOL 15/10/1993
Limited
MFV VACCINE Sanofi Pasteur MSD Ltd PA0544/012/002 14/10/1993
INACTIVATED INFLUENZA
VACCINE
BUFEDON 800 J B Tillotts Limited PA0360/022/001 Tablets - IBUPROFEN 13/10/1993
SODIUM CROMOGLYCATE Norton Waterford PA0436/018/001 - CROMOGLICATE SODIUM 12/10/1993

SODIUM CROMOGLYCATE Norton Waterford PA0436/018/002 - CROMOGLICATE SODIUM 12/10/1993

SODIUM CROMOGLYCATE Norton Waterford PA0436/018/003 - CROMOGLICATE SODIUM 12/10/1993

Human Medicines Withdrawn Products Page 426 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METOCYL Rowa Pharmaceuticals PA0074/010/003 Capsule - METOCLOPRAMIDE 11/10/1993
Limited
PANOXYL Stiefel Laboratories (U.K.) PA0144/011/007 Unknown - BENZOYL PEROXIDE 11/10/1993
Ltd.
RAPENTON 250 Company Liquidated M123 PA0098/008/001 Capsule 11/10/1993
ULCIDIN Fujisawa Deutschland GmbH PA0473/007/001 Withdrawn Form - CIMETIDINE 11/10/1993

ULCIDIN Fujisawa Deutschland GmbH PA0473/007/002 Withdrawn Form - CIMETIDINE 11/10/1993

ULCIDIN Fujisawa Deutschland GmbH PA0473/007/004 Tablets - CIMETIDINE 11/10/1993

ULCIDIN Fujisawa Deutschland GmbH PA0473/007/005 Tablets - CIMETIDINE 11/10/1993

ULCIDIN Fujisawa Deutschland GmbH PA0473/007/006 Tablets - CIMETIDINE 11/10/1993

VICKS THROAT LOZENGES Procter & Gamble (Health & PA0441/030/001 - MENTHOL 11/10/1993
LEMON Beauty Care) Limited - CAMPHOR
LORAMET John Wyeth & Brother PA0022/037/003 Capsule - LORMETAZEPAM 10/10/1993
Limited
EMFLEX E. Merck Ltd PA0054/075/001 Capsule - ACEMETACIN 08/10/1993
NATRACALM Peter Black Healthcare Ltd PA0522/001/001 Tablets - PASSIFLORA INCARNATA 08/10/1993

NOCTZAM Berk Pharmaceuticals PA0082/064/001 Tablets - TRIAZOLAM 08/10/1993


Limited
NOCTZAM Berk Pharmaceuticals PA0082/064/002 Tablets - TRIAZOLAM 08/10/1993
Limited
PLUSERIX SmithKline and French PA0060/050/001 Withdrawn Form - MEASLES VIRUS - 03/10/1993
Laboratories Ltd SCHWARZ STRAIN LIVE
ATTENUATED
- MUMPS VIRUS (URABE
AM9 STRAIN)
- RUBELLA VIRUS (RA 27/3
STRAIN)
PLUSERIX SmithKline and French PA0060/050/002 Withdrawn Form - MEASLES VIRUS - 03/10/1993
Laboratories Ltd SCHWARZ STRAIN LIVE
ATTENUATED
- MUMPS VIRUS (URABE
AM9 STRAIN)
- RUBELLA VIRUS (RA 27/3
STRAIN)
FLURZEPAM Clonmel Healthcare Ltd PA0126/054/001 Capsule 28/09/1993
FLURZEPAM Clonmel Healthcare Ltd PA0126/054/002 Capsule 28/09/1993
PYRIDAMEL Clonmel Healthcare Ltd PA0126/075/001 Tablets 28/09/1993
PYRIDAMEL Clonmel Healthcare Ltd PA0126/075/002 Tablets 28/09/1993
FRAGMIN Pharmacia Laboratories PA0187/033/001 - HEPARIN-FRACTION 17/09/1993
Limited
FRAGMIN Pharmacia Laboratories PA0187/033/002 - HEPARIN-FRACTION 17/09/1993
Limited
FRAGMIN Pharmacia Laboratories PA0187/033/003 - HEPARIN-FRACTION 17/09/1993
Limited
FRAGMIN Pharmacia Laboratories PA0187/033/004 - HEPARIN-FRACTION 17/09/1993
Limited
APS FRUSEMIDE Teva UK Limited PA0237/018/001 Tablets 13/09/1993
MIANSERIN Generics (UK) Limited PA0405/022/002 Tablets - MIANSERIN 13/09/1993
CALAMINE Cupal Limited PA0258/037/001 10/09/1993
IBUPROFEN Regent Laboratories Limited PA0493/004/001 Tablets - IBUPROFEN 09/09/1993
IBUPROFEN Regent Laboratories Limited PA0493/004/002 Tablets - IBUPROFEN 09/09/1993
EVADYNE John Wyeth & Brother PA0022/060/001 Tablets - BUTRIPTYLINE 07/09/1993
Limited HYDROCHLORIDE
EVADYNE John Wyeth & Brother PA0022/060/002 Tablets - BUTRIPTYLINE 07/09/1993
Limited HYDROCHLORIDE
EVADYNE John Wyeth & Brother PA0022/060/003 Tablets - BUTRIPTYLINE 07/09/1993
Limited HYDROCHLORIDE
VENOS ANTITUSSIVE SmithKlineBeecham PA0379/016/001 - NOSCAPINE 06/09/1993
FORMULA Consumer Brand
IBUDROS Medical & Pharmaceutical PA0309/007/002 - IBUPROXAM 31/08/1993
Sales C
EMULSIFYING OINTMENT Foran Healthcare Limited PA0484/008/001 Ointment - EMULSIFYING WAX 27/08/1993
- PARAFFIN SOFT
- PARAFFIN, LIQUID
MERIEUX IMMRAVAX 10 Merieux UK Limited PA0504/009/002 25/08/1993
DOSE
TINADERM Schering-Plough Limited PA0277/002/001 - TOLNAFTATE 25/08/1993
MENZOL SCHWARZ PHARMA Limite PA0271/006/001 Tablets - NORETHISTERONE 19/08/1993

Human Medicines Withdrawn Products Page 427 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MERCK SKIN TESTING E. Merck Ltd PA0054/012/001 18/08/1993
SOLUTIONS
ZANTEC Blackrock Clinic Limited PA0661/001/001 Withdrawn Form - RANITIDINE 17/08/1993
FEMERON Janssen Pharmaceuticals Lt PA0545/032/001 Cream 13/08/1993

DYNABAC Eli Lilly and Company Limite PA0047/076/001 Tablets - DIRITHROMYCIN 11/08/1993

MESASAL SmithKline and French PA0060/047/001 Suppositories 10/08/1993


Laboratories Ltd
PRONDOL John Wyeth & Brother PA0022/012/001 Tablets - IPRINDOLE 06/08/1993
Limited
PRONDOL John Wyeth & Brother PA0022/012/002 Tablets - IPRINDOLE 06/08/1993
Limited
ULTRACACH ANALGESIC Wallace, Cameron & PA0402/001/001 Capsule - PARACETAMOL 06/08/1993
Company (Ire) - CAFFEINE
ULTRACEF (SUSPENSION) Bristol-Myers Squibb PA0048/014/005 - CEFADROXIL 19/07/1993
(Holdings) Limited
DICAPEN Leo Laboratories Limited PA0046/058/002 Tablets - SULTAMICILLIN 14/07/1993
DICAPEN (SUSPENSION) Leo Laboratories Limited PA0046/058/001 - SULTAMICILLIN 14/07/1993
METOCLOPRAMIDE Teva UK Limited PA0237/022/001 Tablets 14/07/1993
VIRA-A Parke Davis & Company PA0056/018/001 Ointment - VIDARABINE 07/07/1993
AMINOFUSIN L1000 E. Merck Ltd PA0054/036/002 - AMINO ACIDS 06/07/1993
- CARBOHYDRATES NOS
- VITAMINS NOS
- ELECTROLYTES NOS
ACNIDAZIL Janssen Pharmaceuticals Lt PA0545/029/001 05/07/1993

UNASYN Pfizer Limited PA0019/042/001 Powder for Oral Suspension - SULTAMICILLIN 02/07/1993
TOSILATE
UNASYN TOSYLATE Pfizer Limited PA0019/042/002 Tablets - SULTAMICILLIN 02/07/1993
TOSILATE
AMINOFUSIN L FORTE E. Merck Ltd PA0054/036/003 - AMINO ACIDS 01/07/1993
- CARBOHYDRATES NOS
- VITAMINS NOS
- ELECTROLYTES NOS
ROXANE Hoechst Ireland Limited PA0023/068/001 Tablets - ROXATIDINE ACETATE 01/07/1993
ROXANE Hoechst Ireland Limited PA0023/068/002 Tablets - ROXATIDINE ACETATE 01/07/1993
THEOPLUS Pierre Fabre Medicament PA0329/004/001 - THEOPHYLLINE 23/06/1993
THEOPLUS SUSTAINED Pierre Fabre Medicament PA0329/004/002 - THEOPHYLLINE 23/06/1993
FLUAX Merck Sharp and Dohme PA0035/035/001 - INFLUENZA VIRUS 21/06/1993
Limited VACCINE MONOVALENT
BAYOLIN Bayer PLC PA0021/017/001 Cream - HEPARINOID 17/06/1993
- ETHYLENE GLYCOL
MONOSTEARATE
- BENZYL NICOTINATE
CONGESTEZE Schering-Plough Limited PA0277/035/001 Syrup - AZATADINE MALEATE 16/06/1993
- PSEUDOEPHEDRINE
CONGESTEZE Schering-Plough Limited PA0277/035/002 Tablets - AZATADINE MALEATE 16/06/1993
- PSEUDOEPHEDRINE
SULFATE
DIPROCEL Schering-Plough Limited PA0277/038/001 Ointment - BETAMETHASONE 16/06/1993
DIPROPIONATE
ROSAMIN GR Lane Health Products Lt PA0257/011/001 Tablets 15/06/1993

AMOXIL SmithKline Beecham Pharm PA0049/006/024 Tablets Effervescent - AMOXICILLIN 08/06/1993


Ltd TRIHYDRATE
AMOXIL SmithKline Beecham Pharm PA0049/006/025 Tablets Effervescent - AMOXICILLIN 08/06/1993
Ltd TRIHYDRATE
AMOXIL SmithKline Beecham Pharm PA0049/006/026 Tablets Effervescent - AMOXICILLIN 08/06/1993
Ltd TRIHYDRATE
AMOXIL SmithKline Beecham Pharm PA0049/006/027 Tablets Effervescent - AMOXICILLIN 08/06/1993
Ltd TRIHYDRATE
SPIROCTAN 100 Boehringer Mannheim PA0130/016/003 Tablets 07/06/1993
SPIROCTAN 25 Boehringer Mannheim PA0130/016/001 Tablets 07/06/1993
SPIROCTAN 50 Boehringer Mannheim PA0130/016/002 Tablets 07/06/1993
INDOPON Mercury Pharmaceuticals PA0073/094/001 Capsule - INDOMETACIN 02/06/1993
(Ireland) Ltd
INDOPON Mercury Pharmaceuticals PA0073/094/002 Capsule - INDOMETACIN 02/06/1993
(Ireland) Ltd
AMPICILLIN B.P.C. Rosemont Pharmaceuticals PA0312/001/001 - AMPICILLIN 26/05/1993
Ltd
AMPICILLIN B.P.C. Rosemont Pharmaceuticals PA0312/001/003 - AMPICILLIN 26/05/1993
Ltd
DOUBLE CHECK Family Planning Sales Ltd PA0376/001/001 Pessary - NONOXINOL 25/05/1993
TWOS COMPANY Family Planning Sales Ltd PA0376/002/001 - NONOXINOL 25/05/1993

Human Medicines Withdrawn Products Page 428 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROTECTA FEMME Healthilife Limited PA0570/006/001 Capsule - OENOTHERA BIENNIS 24/05/1993
- SOYA OIL
- LECITHINUM SOYA
- FAT EMULSIONS
- TOCOPHEROL
- IRON
- PYRIDOXINE
HYDROCHLORIDE
- ASCORBIC ACID
- ZINC
- HEAVY MAGNESIUM
OXIDE
- CHROMIUM
MALINAL A.H. Robins Company PA0086/020/002 Tablets - ALMASILATE 19/05/1993
Limited
SALBUL Rowa Pharmaceuticals PA0074/022/003 - SALBUTAMOL 19/05/1993
Limited
DIMOTAPP BABY DROPS A.H. Robins Company PA0086/011/004 - BROMPHENIRAMINE 17/05/1993
Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
NOCTAMID HE Clissmann PA0012/051/003 - LORMETAZEPAM 17/05/1993
TANNACOMP Knoll A.G. (Clissmann) PA0058/011/001 Tablets - TANNIC ACID 17/05/1993
- ETHACRIDINE LACTATE
ACETYLCYSTEINE Bristol-Myers Squibb PA0048/043/001 13/05/1993
(Holdings) Limited
DURALIN Bristol-Myers Squibb PA0048/038/001 Capsule - ACETYLSALICYLIC ACID 13/05/1993
(Holdings) Limited - ALUMINIUM GLYCINATE
- MAGNESIUM
CARBONATE
- MAGNESIUM OXIDE
- CALCIUM CARBONATE
DURALIN Bristol-Myers Squibb PA0048/038/002 Tablets - ACETYLSALICYLIC ACID 13/05/1993
(Holdings) Limited - ALUMINIUM GLYCINATE
- MAGNESIUM
CARBONATE
- MAGNESIUM OXIDE
- CALCIUM CARBONATE
KERI CREAM Bristol-Myers Squibb PA0048/036/001 Cream - PARAFFIN, LIQUID 13/05/1993
(Holdings) Limited
KERI LOTION Bristol-Myers Squibb PA0048/036/002 - PARAFFIN, LIQUID 13/05/1993
(Holdings) Limited
NIGHT NURSE COLD SmithKlineBeecham PA0379/001/002 - PROMETHAZINE 12/05/1993
REMEDY Consumer Brand HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- PARACETAMOL
- ETHANOL
DEPO-MEDRONE Pharmacia Limited PA0016/018/003 - METHYLPREDNISOLONE 10/05/1993
ACETATE

DEPO-MEDRONE Pharmacia Limited PA0016/018/004 Withdrawn Form - METHYLPREDNISOLONE 10/05/1993


ACETATE

INTROPIN Du Pont De Nemours PA0200/006/002 - DOPAMINE 07/05/1993


Intern.S.A. HYDROCHLORIDE
INTROPIN SYRINGE Du Pont De Nemours PA0200/006/003 - DOPAMINE 07/05/1993
Intern.S.A. HYDROCHLORIDE
INTROPIN SYRINGE Du Pont De Nemours PA0200/006/004 - DOPAMINE 07/05/1993
Intern.S.A. HYDROCHLORIDE
INTROPIN SYRINGE Du Pont De Nemours PA0200/006/005 - DOPAMINE 07/05/1993
Intern.S.A. HYDROCHLORIDE
OXAZEPAM John Wyeth & Brother PA0022/043/001 Capsule - OXAZEPAM 07/05/1993
Limited
OXAZEPAM John Wyeth & Brother PA0022/043/004 Tablets - OXAZEPAM 07/05/1993
Limited
OXAZEPAM John Wyeth & Brother PA0022/043/005 Tablets - OXAZEPAM 07/05/1993
Limited
ASPIRIN & CODEINE Cupal Limited PA0258/006/001 Tablets 06/05/1993
BETADINE L M W Napp Laboratories Limited PA0114/002/010 - POVIDONE-IODINE 06/05/1993
IRRIGATING
EMOFORM Leo Laboratories Limited PA0046/049/002 06/05/1993

Human Medicines Withdrawn Products Page 429 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FLUPHENAZINE UCB Pharma Limited PA0365/031/004 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/005 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/006 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/007 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/001 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/002 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE 25 MG/ML DECANOATE
FLUPHENAZINE UCB Pharma Limited PA0365/031/003 Withdrawn Form - FLUPHENAZINE 06/05/1993
DECANOATE 25 MG/ML DECANOATE
OPAS Leo Laboratories Limited PA0046/051/002 Tablets - CALCIUM CARBONATE 06/05/1993
- HEAVY MAGNESIUM
CARBONATE
- SODIUM BICARBONATE
PEPTICHEMIO Napp Laboratories Limited PA0114/024/002 06/05/1993
SEROTULLE Leo Laboratories Limited PA0046/046/001 - CHLORHEXIDINE 06/05/1993
DIACETATE
TOOTHACHE TINCTURE Cupal Limited PA0258/010/001 06/05/1993
VITATHONE CHILBLAIN Cupal Limited PA0258/030/001 Tablets 06/05/1993
ALPARE D Bayer PLC PA0021/034/001 05/05/1993
PTERONYSSINUS
ALPARE D Bayer PLC PA0021/034/002 05/05/1993
PTERONYSSINUS
ALPARE D Bayer PLC PA0021/034/003 05/05/1993
PTERONYSSINUS
ALPARE TWO GRASS Bayer PLC PA0021/035/001 05/05/1993
ALPARE TWO GRASS Bayer PLC PA0021/035/003 05/05/1993
BEROFOR Boehringer Ingelheim Limited PA0007/050/001 - INTERFERON ALFA-2C 05/05/1993

BEROFOR Boehringer Ingelheim Limited PA0007/050/002 - INTERFERON ALFA-2C 05/05/1993

BEROFOR Boehringer Ingelheim Limited PA0007/050/003 - INTERFERON ALFA-2C 05/05/1993

LORAZEPAM Clonmel Healthcare Ltd PA0126/036/001 Tablets 05/05/1993


LORAZEPAM Clonmel Healthcare Ltd PA0126/036/002 Tablets 05/05/1993
SOLU-BILOPTIN HE Clissmann PA0012/036/001 - IOPODATE CALCIUM 05/05/1993
ULTRALAN HE Clissmann PA0012/031/001 Ointment - FLUOCORTOLONE 05/05/1993
ULTRALAN HE Clissmann PA0012/031/002 Cream - FLUOCORTOLONE 05/05/1993
ULTRALAN FATTY HE Clissmann PA0012/031/003 Ointment - FLUOCORTOLONE 05/05/1993
UROGRAFIN HE Clissmann PA0012/039/001 - MEGLUMINE 05/05/1993
AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

UROGRAFIN 76% HE Clissmann PA0012/039/004 - MEGLUMINE 05/05/1993


AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

UROGRAFIN 60% HE Clissmann PA0012/039/003 - MEGLUMINE 05/05/1993


AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

UROGRAFIN 76% HE Clissmann PA0012/039/005 - MEGLUMINE 05/05/1993


AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

UROVISON 58% HE Clissmann PA0012/040/001 - SODIUM AMIDOTRIZOATE 05/05/1993


- MEGLUMINE
AMIDOTRIZOATE

AMINOPLEX 5 NEW Geistlich Sons Limited PA0143/006/001 04/05/1993


FUROMEX Orion Pharma A/s PA0303/011/001 Tablets - FUROSEMIDE 04/05/1993
FUROMEX Orion Pharma A/s PA0303/011/002 Withdrawn Form - FUROSEMIDE 04/05/1993
ORIBUTOL Orion Pharma A/s PA0303/012/001 Tablets - ETHAMBUTOL 04/05/1993
DIHYDROCHLORIDE
ORIBUTOL Orion Pharma A/s PA0303/012/002 Tablets - ETHAMBUTOL 04/05/1993
DIHYDROCHLORIDE
AMILORIDE Rowa Pharmaceuticals PA0074/035/001 Tablets - HYDROCHLOROTHIAZIDE 03/05/1993
HYDROCHLORIDE Limited
EBRANTIL Sanofi-Synthelabo Ireland PA0077/062/001 Capsule 03/05/1993
Ltd

Human Medicines Withdrawn Products Page 430 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EBRANTIL Sanofi-Synthelabo Ireland PA0077/062/002 Withdrawn Form 03/05/1993
Ltd
FAMEL ORIGINAL Optrex Limited PA0275/008/001 - CODEINE 03/05/1993
- CREOSOTE
CARDIPRIN Reckitt's (Ireland) Limited PA0027/039/001 - ACETYLSALICYLIC ACID 29/04/1993
DECAL Ricesteele Manufacturing Ltd PA0095/011/001 Tablets 29/04/1993

RIAZINE WORM Ricesteele Manufacturing Ltd PA0095/010/001 Syrup 29/04/1993

TRIAZIDE Hoechst Ireland Limited PA0023/067/002 - RAMIPRIL 29/04/1993


- HYDROCHLOROTHIAZIDE

FERTIRAL Hoechst Ireland Limited PA0023/054/001 - GONADORELIN 26/04/1993


LASIX + K Hoechst Ireland Limited PA0023/006/001 - POTASSIUM CHLORIDE 26/04/1993
- FUROSEMIDE
DAY NURSE SmithKlineBeecham PA0379/018/001 - PARACETAMOL 18/04/1993
Consumer Brand -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- ETHANOL
PROZAC Dista Products Limited PA0447/005/002 - FLUOXETINE 16/04/1993
HYDROCHLORIDE
PROZAC Dista Products Limited PA0447/005/003 - FLUOXETINE 16/04/1993
HYDROCHLORIDE
VIBROCIL (SPRAY) Novartis Consumer Health PA0030/001/001 - DIMETINDENE MALEATE 14/04/1993
UK Limited - PHENYLEPHRINE
- NEOMYCIN SULFATE
VIBROCIL MICRODOSER Novartis Consumer Health PA0030/001/004 - DIMETINDENE MALEATE 14/04/1993
UK Limited - PHENYLEPHRINE
- NEOMYCIN SULFATE
EXIREL Pfizer Limited PA0019/031/004 Syrup - PIRBUTEROL 13/04/1993
HYDROCHLORIDE
VENTAMOL Pinewood Laboratories Ltd, PA0281/030/001 Tablets - SALBUTAMOL 13/04/1993
VENTAMOL Pinewood Laboratories Ltd, PA0281/030/002 Tablets - SALBUTAMOL 13/04/1993
NEZERIL ADULT Astra Pharmaceuticals Ltd PA0009/037/001 - OXYMETAZOLINE 11/04/1993
HYDROCHLORIDE
NEZERIL INFANT Astra Pharmaceuticals Ltd PA0009/037/002 - OXYMETAZOLINE 11/04/1993
HYDROCHLORIDE
NEZERIL JUNIOR Astra Pharmaceuticals Ltd PA0009/037/003 - OXYMETAZOLINE 11/04/1993
HYDROCHLORIDE
ENDOBIL E. Merck Ltd PA0054/043/003 - IODOXAMIC ACID 08/04/1993
UROMIRO 380 E. Merck Ltd PA0054/017/001 - IODAMIDE 08/04/1993
UROMIRO 380 E. Merck Ltd PA0054/017/002 - IODAMIDE 08/04/1993
UROMIRO 420 E. Merck Ltd PA0054/018/001 - IODAMIDE 08/04/1993
UROMIRO 420 E. Merck Ltd PA0054/018/002 - IODAMIDE 08/04/1993
LOFEXIDINE Marion Merrell Limited PA0041/037/001 Tablets 07/04/1993
HYDROCHLORIDE
LOFEXIDINE Marion Merrell Limited PA0041/037/002 Tablets 07/04/1993
HYDROCHLORIDE
LOFEXIDINE Marion Merrell Limited PA0041/037/003 Tablets 07/04/1993
HYDROCHLORIDE
RIFATER 75 Marion Merrell Limited PA0041/036/002 Tablets - ISONIAZID 07/04/1993
- PYRAZINAMIDE
- RIFAMPICIN
ACETYCYSTEINE Rowa Pharmaceuticals PA0074/040/004 06/04/1993
Limited
COMPOUND SODIUM Accord-UK Ltd PA0176/050/001 Powder for Oral Solution 06/04/1993
CHLORIDE AND GLUCOSE

COX PAIN RELIEF Accord-UK Ltd PA0176/020/001 Tablets - PARACETAMOL 06/04/1993


- CAFFEINE CITRATE
- CODEINE PHOSPHATE
- NICOTINAMIDE
COX TOOTHACHE Accord-UK Ltd PA0176/010/001 - PHENOL 06/04/1993
TINCTURE - MENTHOL
- CAMPHOR
- COMMIPHORA MOLMOL
- CLOVE OIL
PHENOBARBITONE & Accord-UK Ltd PA0176/007/001 Tablets - PHENOBARBITAL 06/04/1993
THEOBROMINE B.P.C. - THEOBROMINE
PROGRANE LA Prographarm Laboratories PA0472/001/001 - PROPRANOLOL 06/04/1993
BECLOMETHASONE Rowa Pharmaceuticals PA0074/038/001 Suppositories 05/04/1993
Limited

Human Medicines Withdrawn Products Page 431 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
0.9% SODIUM B. Braun Medical Limited PA0179/003/003 Withdrawn Form 01/04/1993
CHLORIDE/GLUCOSE
0.9% SODIUM B. Braun Medical Limited PA0179/003/004 Withdrawn Form 01/04/1993
CHLORIDE/GLUCOSE
0.9% SODIUM B. Braun Medical Limited PA0179/003/005 Withdrawn Form 01/04/1993
CHLORIDE/GLUCOSE
ACTH/CMC/PL Ferring Pharmaceuticals PA0224/003/001 01/04/1993
Limited
BAMBINO Ovelle Limited PA0206/012/001 Cream - CASTOR OIL 01/04/1993
- ZINC OXIDE
COMPOUND SODIUM B. Braun Medical Limited PA0179/004/005 Withdrawn Form 01/04/1993
LACTATE
CRESOPHENE Septodont PA0196/008/001 - DEXAMETHASONE 01/04/1993
- THYMOL
- PARACHLOROPHENOL,
CAMPHORATED
DARROWS B. Braun Medical Limited PA0179/007/001 - POTASSIUM CHLORIDE 01/04/1993
- SODIUM LACTATE
DARROWS B. Braun Medical Limited PA0179/007/002 - POTASSIUM CHLORIDE 01/04/1993
- SODIUM LACTATE
ENDOMETHASONE Septodont PA0196/010/001 - DEXAMETHASONE 01/04/1993
- HYDROCORTISONE
ACETATE
- THYMOL IODIDE
EPIPHYTAL Hadensa (Ireland) Limited PA0145/005/001 - PREDNISOLONE 01/04/1993
- SALICYLIC ACID
- CLIOQUINOL
GEVRAL Cyanamid of Great Britain PA0037/022/001 Capsule - RETINOL ACETATE 01/04/1993
- VITAMIN D SYNTHETIC
CALCIFEROL
- THIAMINE MONONITRATE
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- TOCOPHEROL
- NICOTINAMIDE
- CALCIUM
PANTOTHENATE
- CALCIUM PHOSPHATE
- PHOSPHORUS
- FERROUS FUMARATE
- MAGNESIUM OXIDE
- POTASSIUM SULFATE
- POTASSIUM IODIDE
- COPPER
- MANGANESE DIOXIDE
- ZINC OXIDE
- INOSITOL
- LYSINE
- CHOLINE BITARTRATE

GLUCOSE 10% B. Braun Medical Limited PA0179/001/005 Withdrawn Form 01/04/1993


GLUCOSE 10% B. Braun Medical Limited PA0179/001/006 Withdrawn Form 01/04/1993
GLUCOSE 20% B. Braun Medical Limited PA0179/001/007 Withdrawn Form 01/04/1993
GLUCOSE 25% B. Braun Medical Limited PA0179/001/010 Withdrawn Form 01/04/1993
GLUCOSE 40% B. Braun Medical Limited PA0179/001/011 Withdrawn Form 01/04/1993
GLUCOSE 50% B. Braun Medical Limited PA0179/001/013 Withdrawn Form 01/04/1993
GLUCOSE 50% B. Braun Medical Limited PA0179/001/014 Withdrawn Form 01/04/1993
HADENSA Hadensa (Ireland) Limited PA0145/004/001 Suppositories - ICHTHAMMOL 01/04/1993
- PREDNISOLONE
HADENSA Hadensa (Ireland) Limited PA0145/006/001 Ointment - ICHTHAMMOL 01/04/1993
- MENTHOL
- CHLORCARVACROL
HADENSA FORTE Hadensa (Ireland) Limited PA0145/003/001 Ointment - ICHTHAMMOL 01/04/1993
- PREDNISOLONE
HAELAN C Dista Products Limited PA0447/006/001 Cream - FLUDROXYCORTIDE 01/04/1993
- CLIOQUINOL
HAELAN C Dista Products Limited PA0447/006/002 Ointment - FLUDROXYCORTIDE 01/04/1993
- CLIOQUINOL
INTAL COMPOUND Fisons Limited PA0018/032/001 - CROMOGLICATE SODIUM 01/04/1993
SPINCAPS - ISOPRENALINE
SULPHATE

MYOCRISIN May & Baker Limited PA0040/068/001 Withdrawn Form 01/04/1993


MYOCRISIN May & Baker Limited PA0040/068/002 Withdrawn Form 01/04/1993

Human Medicines Withdrawn Products Page 432 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OVELLE CREAM OF Ovelle Limited PA0206/016/001 - CALAMINE 01/04/1993
CALAMINE - ZINC OXIDE
PLASMA PROTEIN Baxter Healthcare Limited PA0167/059/001 - PLASMA PROTEIN 01/04/1993
FRACTION FRACTION (HUMAN)
PLASMA PROTEIN Baxter Healthcare Limited PA0167/059/002 - PLASMA PROTEIN 01/04/1993
FRACTION FRACTION (HUMAN)
PLASMA PROTEIN Baxter Healthcare Limited PA0167/059/003 - PLASMA PROTEIN 01/04/1993
FRACTION FRACTION (HUMAN)
PLASMA PROTEIN Baxter Healthcare Limited PA0167/059/004 - PLASMA PROTEIN 01/04/1993
FRACTION FRACTION (HUMAN)
SODIUM CHLORIDE 3% B. Braun Medical Limited PA0179/002/012 Withdrawn Form 01/04/1993
YEAST VITE SmithKlineBeecham PA0379/008/001 Tablets - CAFFEINE 01/04/1993
Consumer Brand - NICOTINAMIDE
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
NORISEN EXTRACTS E. Merck Ltd PA0054/013/001 31/03/1993
NORISEN GRASS E. Merck Ltd PA0054/013/002 31/03/1993
EXTRACTS
NORISEN MITE M E. Merck Ltd PA0054/013/003 31/03/1993
ANTICOAGULANT 4% Baxter Healthcare Limited PA0167/024/001 - SODIUM CITRATE 30/03/1993
SODIUM CITRATE
SOLUTION
AVENTYL Eli Lilly and Company Limite PA0047/025/003 - NORTRIPTYLINE 30/03/1993
HYDROCHLORIDE
NU-SEALS ASPIRIN Eli Lilly and Company Limite PA0047/036/002 - ACETYLSALICYLIC ACID 30/03/1993

DOPMIN Orion Pharma A/s PA0303/013/001 - DOPAMINE 29/03/1993


EMPERAL Orion Pharma A/s PA0303/010/001 - METOCLOPRAMIDE 29/03/1993
GENISOL Fisons Limited PA0018/037/001 - SUCCINATE SODIUM 29/03/1993
- UNDECYLENIC
MONOETHANOLAMIDE
NAFTIDROFURYL Napp Laboratories Limited PA0114/050/001 Tablets 29/03/1993
OXALATE CONTINUS
OXIPOR VHC LOTION FOR Pfizer Consumer Healthcare PA0172/003/001 - COAL TAR SOLUTION 29/03/1993
PSORIASIS Ltd - SALICYLIC ACID
- BENZOCAINE
PHOLTEX 3M Health Care Limited PA0057/013/001 - PHOLCODINE 29/03/1993
- PHENYLTOLOXAMINE
RIMIFON Roche Products Limited PA0050/031/001 - ISONIAZID 29/03/1993
SERENID - D John Wyeth & Brother PA0022/035/001 Tablets - OXAZEPAM 29/03/1993
Limited
SERENID - D John Wyeth & Brother PA0022/035/002 Tablets - OXAZEPAM 29/03/1993
Limited
SERENID FORTE John Wyeth & Brother PA0022/035/003 Capsule - OXAZEPAM 29/03/1993
Limited
TYLENOL Johnson & Johnson (Ireland) PA0330/002/004 - PARACETAMOL 29/03/1993
Limited
TYLENOL Johnson & Johnson (Ireland) PA0330/002/005 - PARACETAMOL 29/03/1993
Limited
MANOPLAX The Boots Company Plc PA0004/050/001 Tablets - FLOSEQUINAN 26/03/1993
FEMODENE ED HE Clissmann PA0012/064/001 Tablets - GESTODENE 24/03/1993
- ETHINYLESTRADIOL
LIBRAXIN Roche Products Limited PA0050/016/001 Tablets - CHLORDIAZEPOXIDE 24/03/1993
- CLIDINIUM BROMIDE
POLYBACTRIN SOLUBLE G Wellcome (Ireland) Limited PA0017/010/001 - POLYMYXIN B SULFATE 24/03/1993
U - NEOMYCIN SULFATE
- BACITRACIN ZINC
BUCCALINE BERNA Capital Pharmaceuticals Ltd PA0249/008/001 - HAEMOPHILUS 22/03/1993
INFLUENZAE
COLCAPS Capital Pharmaceuticals Ltd PA0249/007/001 Capsule - 22/03/1993
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- CHLORPHENAMINE
MALEATE
TUSCALMAN BERNA Capital Pharmaceuticals Ltd PA0249/002/003 Suppositories - NOSCAPINE 22/03/1993
TUSCALMAN BERNA Capital Pharmaceuticals Ltd PA0249/002/004 Suppositories - NOSCAPINE 22/03/1993
TUSCALMAN BERNA Capital Pharmaceuticals Ltd PA0249/002/002 - NOSCAPINE 22/03/1993
SYRUP
BRONCHINOR E. Merck Ltd PA0054/025/001 Tablets - REPROTEROL 21/03/1993
HYDROCHLORIDE
PAEDMIN E. Merck Ltd PA0054/048/001 - AMINO ACIDS 18/03/1993
- ELECTROLYTES NOS
DOXORUBICIN Chiron B.V. PA0499/002/001 - DOXORUBICIN 17/03/1993
HYDROCHLORIDE HYDROCHLORIDE

Human Medicines Withdrawn Products Page 433 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOXORUBICIN Chiron B.V. PA0499/002/003 - DOXORUBICIN 17/03/1993
HYDROCHLORIDE HYDROCHLORIDE
MYLANTA Parke Davis & Company PA0056/032/001 - MAGNESIUM HYDROXIDE 17/03/1993
- ALUMINIUM HYDROXIDE
- DIMETICONE

MYLANTA Parke Davis & Company PA0056/032/002 Tablets - ALUMINIUM HYDROXIDE 17/03/1993
GEL
- MAGNESIUM HYDROXIDE

OXYCEL Parke Davis & Company PA0056/029/001 17/03/1993


CALRIN Mercury Pharmaceuticals PA0073/076/001 - CALAMINE 11/03/1993
(Ireland) Ltd
PROMETHAZINE Mercury Pharmaceuticals PA0073/053/003 11/03/1993
(Ireland) Ltd
PROCTOFIBE Roussel Laboratories Limited PA0006/020/001 - GRAIN FIBRE 10/03/1993
- CITRUS FIBRE
TRILUDAN PLUS Marion Merrell Limited PA0041/026/004 Tablets - TERFENADINE 09/03/1993
- PSEUDOEPHEDRINE
HYDROCHLORIDE
ZINCFRIN STERILE Alcon Laboratories (UK) Ltd PA0290/057/001 - ZINC SULFATE 09/03/1993
OPTHALMIC - PHENYLEPHRINE
HYDROCHLORIDE
ZINCFRIN STERILE Alcon Laboratories (UK) Ltd PA0290/057/002 09/03/1993
OPTHALMIC
MODALIM CAPS Sanofi-Synthelabo Ireland PA0077/100/001 - CIPROFIBRATE 08/03/1993
Ltd
TEMGESIC Schering AG PA0027/003/002 Withdrawn Form - BUPRENORPHINE 07/03/1993
HYDROCHLORIDE
CAMOMILE AND HONEY Foran Healthcare Limited PA0484/023/001 Syrup 05/03/1993
ALUMINIUM ACETATE Penn Pharmaceuticals Ltd PA0650/006/001 - ALUMINIUM SULFATE 04/03/1993
- ACETIC ACID
- L-TARTARIC ACID
- CALCIUM CARBONATE
- PURIFIED WATER
SPERSACARPINE EYE Dispersa (UK) Ltd PA0582/003/005 Ointment - PILOCARPINE 04/03/1993
OINTMENT HYDROCHLORIDE
SPERSACARPINE EYE Dispersa (UK) Ltd PA0582/003/006 Ointment - PILOCARPINE 04/03/1993
OINTMENT HYDROCHLORIDE
SPERSACARPINE EYE Dispersa (UK) Ltd PA0582/003/007 Ointment - PILOCARPINE 04/03/1993
OINTMENT HYDROCHLORIDE
VICKS COUGH CALMERS Procter & Gamble (Health & PA0441/010/001 Lozenges - DEXTROMETHORPHAN 04/03/1993
Beauty Care) Limited - BENZOCAINE
VICKS FORMULA 44 Procter & Gamble (Health & PA0441/008/001 - DOXYLAMINE 04/03/1993
Beauty Care) Limited SUCCINATE
- DEXTROMETHORPHAN
HYDROBROMIDE
VICKS SINEX Procter & Gamble (Health & PA0441/024/002 - OXYMETAZOLINE 04/03/1993
Beauty Care) Limited HYDROCHLORIDE
- MENTHOL
- CAMPHOR
- CINEOLE
VICKS VAPO-LEM Procter & Gamble (Health & PA0441/009/001 - PARACETAMOL 04/03/1993
Beauty Care) Limited - GUAIFENESIN
- PHENYLEPHRINE
HYDROCHLORIDE
- ASCORBIC ACID
TRIREXAN E. Merck Ltd PA0054/049/001 Tablets - XIPAMIDE 03/03/1993
- TRIAMTERENE
AKNE-MYCIN E. Merck Ltd PA0054/074/001 - ERYTHROMYCIN 01/03/1993
BRONCHINOR E. Merck Ltd PA0054/025/002 - REPROTEROL 01/03/1993
HYDROCHLORIDE
GAMANIL E. Merck Ltd PA0054/023/001 Tablets - LOFEPRAMINE 01/03/1993
HYDROCHLORIDE
KAODENE LIQUID The Boots Company Plc PA0004/046/001 - CODEINE 01/03/1993
- KAOLIN, LIGHT
BUTACOTE Ciba Geigy Plc PA0011/021/002 Tablets - PHENYLBUTAZONE 28/02/1993
COW & GATE INSTANT Cow & Gate Limited PA0445/001/001 26/02/1993
CAROBEL
COW & GATE LOCASOL Cow & Gate Limited PA0445/002/001 26/02/1993
NEW FORMULA
FORTICAL APPLE Cow & Gate Limited PA0445/003/001 26/02/1993
FORTICAL APRICOT Cow & Gate Limited PA0445/003/002 26/02/1993
FORTICAL Cow & Gate Limited PA0445/003/003 26/02/1993
BLACKCURRANT
FORTICAL LEMON Cow & Gate Limited PA0445/003/004 26/02/1993

Human Medicines Withdrawn Products Page 434 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FORTICAL NEUTRAL Cow & Gate Limited PA0445/003/005 26/02/1993
FORTICAL ORANGE Cow & Gate Limited PA0445/003/006 26/02/1993
FORTIMEL CHOCLATE Cow & Gate Limited PA0445/004/001 26/02/1993
FORTIMEL COFFEE Cow & Gate Limited PA0445/004/002 26/02/1993
FORTIMEL STRAWBERRY Cow & Gate Limited PA0445/004/003 26/02/1993
FORTIMEL VANILLA Cow & Gate Limited PA0445/004/004 26/02/1993
FORTISIP BANANA Cow & Gate Limited PA0445/005/001 26/02/1993
FORTISIP ENERGY PLUS Cow & Gate Limited PA0445/005/002 26/02/1993
NEUTRAL
FORTISIP ORANGE Cow & Gate Limited PA0445/005/003 26/02/1993
FORTISIP STANDARD Cow & Gate Limited PA0445/005/004 26/02/1993
FORTISIP VANILLA Cow & Gate Limited PA0445/005/005 26/02/1993
FORTISON ENERGY PLUS Cow & Gate Limited PA0445/006/001 26/02/1993
FORTISON LOW SODIUM Cow & Gate Limited PA0445/006/002 26/02/1993
FORTISON SOYA Cow & Gate Limited PA0445/006/004 26/02/1993
FORTISON STANDARD Cow & Gate Limited PA0445/006/005 26/02/1993
PRE-FORTISON Cow & Gate Limited PA0445/006/003 26/02/1993
AZACTAM Bristol-Myers Squibb PA0002/052/011 Withdrawn Form - AZTREONAM 25/02/1993
Pharmaceuticals uc - ARGININE
FERFOLIC S.V. Sinclair Pharmaceuticals PA0251/004/001 Tablets 25/02/1993
Limited
TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/001 - CHLORHEXIDINE 25/02/1993
DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/002 - CHLORHEXIDINE 25/02/1993


DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/003 - CHLORHEXIDINE 25/02/1993


DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 15 TOPICAL Baxter Healthcare Limited PA0167/032/007 - CHLORHEXIDINE 25/02/1993


IRRIGATING DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 15 TOPICAL Baxter Healthcare Limited PA0167/032/009 25/02/1993


IRRIGATING
TRAVASEPT 15 TOPICAL Baxter Healthcare Limited PA0167/032/008 25/02/1993
IRRIGATING SOLUTION
TRAVASEPT 30 Baxter Healthcare Limited PA0167/032/004 - CHLORHEXIDINE 25/02/1993
DIACETATE
- CETRIMONIUM BROMIDE

TRAVASEPT 30 TOPICAL Baxter Healthcare Limited PA0167/032/006 25/02/1993


IRRIGATING CETRIMIDE
0.5%
TRAVASEPT 30 TOPICAL Baxter Healthcare Limited PA0167/032/005 25/02/1993
IRRIGATION/CETRIMIDE
0.5%
ALU-TAB 3M Health Care Limited PA0057/032/001 - ALUMINIUM HYDROXIDE 23/02/1993
GEL, DRIED
BUF ACNE 3M Health Care Limited PA0057/040/001 - BENZOYL PEROXIDE 23/02/1993
NUELIN SA 3M Health Care Limited PA0057/005/006 Tablets - THEOPHYLLINE 23/02/1993
AMILORIDE AND UCB Pharma Limited PA0365/038/001 Tablets - AMILORIDE 19/02/1993
HYDROCHLOROTHIAZIDE HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

AMILORIDE AND UCB Pharma Limited PA0365/038/002 Tablets - AMILORIDE 19/02/1993


HYDROCHLOROTHIAZIDE HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

AMOXYCILLIN UCB Pharma Limited PA0365/025/001 Capsule - AMOXICILLIN 19/02/1993


AMOXYCILLIN UCB Pharma Limited PA0365/025/002 Capsule - AMOXICILLIN 19/02/1993
AMOXYCILLIN UCB Pharma Limited PA0365/025/003 - AMOXICILLIN 19/02/1993
AMOXYCILLIN UCB Pharma Limited PA0365/025/004 - AMOXICILLIN 19/02/1993
AMPICILLIN UCB Pharma Limited PA0365/006/001 Capsule - AMPICILLIN 19/02/1993
AMPICILLIN UCB Pharma Limited PA0365/006/002 Capsule - AMPICILLIN 19/02/1993
AMPICILLIN MIXTURE UCB Pharma Limited PA0365/006/003 - AMPICILLIN 19/02/1993
AMPICILLIN MIXTURE UCB Pharma Limited PA0365/006/004 - AMPICILLIN 19/02/1993
STRONG
ATENOLOL UCB Pharma Limited PA0365/022/001 Tablets - ATENOLOL 19/02/1993
ATENOLOL UCB Pharma Limited PA0365/022/002 Tablets - ATENOLOL 19/02/1993
CIMETIDINE UCB Pharma Limited PA0365/030/001 Tablets - CIMETIDINE 19/02/1993

Human Medicines Withdrawn Products Page 435 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CIMETIDINE UCB Pharma Limited PA0365/030/002 Tablets - CIMETIDINE 19/02/1993
DANAZOL UCB Pharma Limited PA0365/040/001 Capsule - DANAZOL 19/02/1993
DANAZOL UCB Pharma Limited PA0365/040/002 Capsule - DANAZOL 19/02/1993
DIAZEPAM UCB Pharma Limited PA0365/008/001 Tablets - DIAZEPAM 19/02/1993
DIAZEPAM UCB Pharma Limited PA0365/008/002 Tablets - DIAZEPAM 19/02/1993
DIAZEPAM UCB Pharma Limited PA0365/008/003 Tablets - DIAZEPAM 19/02/1993
DICLOFENAC SODIUM UCB Pharma Limited PA0365/043/001 Tablets - DICLOFENAC SODIUM 19/02/1993
DICLOFENAC SODIUM UCB Pharma Limited PA0365/043/002 Tablets - DICLOFENAC SODIUM 19/02/1993
FLAXEDIL GALLAMINE May & Baker Limited PA0040/047/002 Withdrawn Form 19/02/1993
FRUSEMIDE UCB Pharma Limited PA0365/015/001 Tablets - FUROSEMIDE 19/02/1993
GLIBENCLAMIDE UCB Pharma Limited PA0365/028/001 Tablets - GLIBENCLAMIDE 19/02/1993
GLIBENCLAMIDE UCB Pharma Limited PA0365/028/002 Tablets - GLIBENCLAMIDE 19/02/1993
INDOMETHACIN UCB Pharma Limited PA0365/007/001 Capsule - INDOMETACIN 19/02/1993
INDOMETHACIN UCB Pharma Limited PA0365/007/002 Capsule - INDOMETACIN 19/02/1993
ISOSORBIDE DINITRATE UCB Pharma Limited PA0365/027/001 Tablets - ISOSORBIDE DINITRATE 19/02/1993
ISOSORBIDE DINITRATE UCB Pharma Limited PA0365/027/002 Tablets - ISOSORBIDE DINITRATE 19/02/1993
ISOSORBIDE DINITRATE UCB Pharma Limited PA0365/027/003 Tablets - ISOSORBIDE DINITRATE 19/02/1993
METOPROLOL TARTRATE UCB Pharma Limited PA0365/034/001 Tablets - METOPROLOL TARTRATE 19/02/1993

METOPROLOL TARTRATE UCB Pharma Limited PA0365/034/002 Tablets - METOPROLOL TARTRATE 19/02/1993

NIFEDIPINE SOFT GELATI UCB Pharma Limited PA0365/026/001 Capsule - NIFEDIPINE 19/02/1993

NIFEDIPINE SOFT GELATI UCB Pharma Limited PA0365/026/002 Capsule - NIFEDIPINE 19/02/1993

NITRAZEPAM UCB Pharma Limited PA0365/014/001 Tablets - NITRAZEPAM 19/02/1993


PROPRANOLOL UCB Pharma Limited PA0365/005/001 Tablets - PROPRANOLOL 19/02/1993
PROPRANOLOL UCB Pharma Limited PA0365/005/002 Tablets - PROPRANOLOL 19/02/1993
PROPRANOLOL UCB Pharma Limited PA0365/005/003 Tablets - PROPRANOLOL 19/02/1993
PROPRANOLOL UCB Pharma Limited PA0365/005/004 Tablets - PROPRANOLOL 19/02/1993
SPIRONOLACTONE UCB Pharma Limited PA0365/011/001 Tablets - SPIRONOLACTONE 19/02/1993
SPIRONOLACTONE UCB Pharma Limited PA0365/011/002 Tablets - SPIRONOLACTONE 19/02/1993
TAMOXIFEN CITRATE UCB Pharma Limited PA0365/012/001 Tablets - TAMOXIFEN CITRATE 19/02/1993
TAMOXIFEN CITRATE UCB Pharma Limited PA0365/012/002 Tablets - TAMOXIFEN CITRATE 19/02/1993
TEMAZEPAM UCB Pharma Limited PA0365/032/001 Capsule - TEMAZEPAM 19/02/1993
TEMAZEPAM UCB Pharma Limited PA0365/032/002 Capsule - TEMAZEPAM 19/02/1993
TETRACYCLINE UCB Pharma Limited PA0365/023/001 Tablets - TETRACYCLINE 19/02/1993
TRIAZOLAM UCB Pharma Limited PA0365/037/001 Tablets - TRIAZOLAM 19/02/1993
TRIAZOLAM UCB Pharma Limited PA0365/037/002 Tablets - TRIAZOLAM 19/02/1993
VERAPAMIL UCB Pharma Limited PA0365/033/001 Tablets - VERAPAMIL 19/02/1993
HYDROCHLORIDE HYDROCHLORIDE
VERAPAMIL UCB Pharma Limited PA0365/033/002 Tablets - VERAPAMIL 19/02/1993
HYDROCHLORIDE HYDROCHLORIDE
VERAPAMIL UCB Pharma Limited PA0365/033/003 Tablets - VERAPAMIL 19/02/1993
HYDROCHLORIDE HYDROCHLORIDE
LEO K TABLET Leo Laboratories Limited PA0046/034/001 - POTASSIUM CHLORIDE 18/02/1993
LEONISONE Leo Laboratories Limited PA0046/023/001 Tablets - PHENYLBUTAZONE 18/02/1993
- PREDNISONE
- ALUMINIUM GLYCINATE
UROKINASE Leo Laboratories Limited PA0046/032/001 18/02/1993
UROKINASE Leo Laboratories Limited PA0046/032/002 18/02/1993
UROKINASE Leo Laboratories Limited PA0046/032/003 18/02/1993
BUMINATE 5.0% Baxter Healthcare Limited PA0167/001/004 15/02/1993
BUMINATE 5.0% Baxter Healthcare Limited PA0167/001/005 15/02/1993
BUNINATE 5/0% Baxter Healthcare Limited PA0167/001/003 - HUMAN ALBUMIN 15/02/1993
DIAZEPAM Norton Waterford PA0436/002/003 Tablets - DIAZEPAM 12/02/1993
NUTRIZYM E. Merck Ltd PA0054/059/001 Tablets - PANCREATIN 12/02/1993
- OX BILE EXTRACT
- BROMELAINS
PANETS BABY Optrex Limited PA0275/001/002 Syrup - PARACETAMOL 12/02/1993
DICYNENE Delandale Laboratories PA0080/001/002 Tablets - ETAMSILATE 11/02/1993
Limited
COTAZYM Organon Laboratories PA0261/022/001 Capsule - LIPASE 05/02/1993
Limited - AMYLASE
METOCLOPRAMIDE Accord-UK Ltd PA0176/057/001 Tablets 05/02/1993
NITROGLYCERIN U. S. P. International Medication PA0255/037/002 Withdrawn Form 05/02/1993
5MG/ML Systems (UK) Ltd
NITROGLYCERIN U.S. P. 5 International Medication PA0255/037/001 Withdrawn Form 05/02/1993
MG/ML Systems (UK) Ltd
BRONCONOVAG Medical & Pharmaceutical PA0309/003/001 Capsule - AMOXICILLIN 04/02/1993
Sales C TRIHYDRATE
- BROMHEXINE
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 436 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BRONCONOVAG Medical & Pharmaceutical PA0309/003/002 - AMOXICILLIN 04/02/1993
EXTEMPORANEOUS Sales C TRIHYDRATE
(SUSPENSION) - BROMHEXINE
HYDROCHLORIDE
VICKS LOZENGES Procter & Gamble (Health & PA0441/025/003 Lozenges - MENTHOL 04/02/1993
CHERRY Beauty Care) Limited - CAMPHOR
ANCOLOXIN Duncan, Flockhard & Co. PA0065/014/001 Tablets 03/02/1993
Limited
ERYTHROMYCIN ETHYL Eli Lilly and Company Limite PA0047/055/001 03/02/1993
SUCCINATE
(SUSPENSION)
ERYTHROMYCIN ETHYL Eli Lilly and Company Limite PA0047/055/002 03/02/1993
SUCCINATE
(SUSPENSION)
ERYTHROMYCIN ETHYL Eli Lilly and Company Limite PA0047/055/003 03/02/1993
SUCCINATE
(SUSPENSION)
IBUPROFEN Accord-UK Ltd PA0176/059/001 Tablets 03/02/1993
IBUPROFEN Accord-UK Ltd PA0176/059/002 Tablets 03/02/1993
IBUPROFEN Accord-UK Ltd PA0176/059/003 Tablets 03/02/1993
METFORMIN Accord-UK Ltd PA0176/040/001 Tablets - METFORMIN 03/02/1993
METFORMIN Accord-UK Ltd PA0176/040/002 Tablets 03/02/1993
METHYLDOPA Accord-UK Ltd PA0176/022/002 Tablets 03/02/1993
METHYLDOPA Accord-UK Ltd PA0176/022/003 Tablets 03/02/1993
METRONIDAZOLE Accord-UK Ltd PA0176/058/001 Tablets 03/02/1993
METRONIDAZOLE Accord-UK Ltd PA0176/058/002 Tablets 03/02/1993
OXPRENOLOL Accord-UK Ltd PA0176/008/001 Tablets 03/02/1993
OXPRENOLOL Accord-UK Ltd PA0176/008/002 Tablets 03/02/1993
OXPRENOLOL Accord-UK Ltd PA0176/008/003 Tablets 03/02/1993
OXPRENOLOL Accord-UK Ltd PA0176/008/004 Tablets 03/02/1993
PECTAMOL Duncan, Flockhard & Co. PA0065/004/001 Syrup 03/02/1993
Limited
PECTAMOL Duncan, Flockhard & Co. PA0065/044/001 Syrup 03/02/1993
Limited
PROPRANOLOL Accord-UK Ltd PA0176/009/001 Tablets 03/02/1993
PROPRANOLOL Accord-UK Ltd PA0176/009/004 Tablets 03/02/1993
PROSPAROL Duncan, Flockhard & Co. PA0065/016/001 03/02/1993
Limited
CISTOBIL E. Merck Ltd PA0054/042/001 02/02/1993
DECAZATE (PRE-FILLED Berk Pharmaceuticals PA0082/063/002 Withdrawn Form - FLUPHENAZINE 01/02/1993
SYRINGE) 25 MG/ML Limited DECANOATE
DECAZATE 100 MG/ML Berk Pharmaceuticals PA0082/063/004 Withdrawn Form - FLUPHENAZINE 01/02/1993
Limited DECANOATE
DECAZATE 100 MG/ML Berk Pharmaceuticals PA0082/063/005 Withdrawn Form - FLUPHENAZINE 01/02/1993
Limited DECANOATE
DECAZATE 25 MG/ML Berk Pharmaceuticals PA0082/063/003 Withdrawn Form - FLUPHENAZINE 01/02/1993
Limited DECANOATE
DECAZATE 25 MG/ML Berk Pharmaceuticals PA0082/063/001 Withdrawn Form - FLUPHENAZINE 01/02/1993
Limited DECANOATE
MICROPAQUE Nicholas Laboratories PA0032/016/001 - BARIUM SULFATE 01/02/1993
MICROPAQUE HD Nicholas Laboratories PA0469/015/002 - BARIUM SULFATE 01/02/1993
MICROPAQUE STANDARD Nicholas Laboratories PA0032/016/002 - BARIUM SULFATE 01/02/1993

MICROTRAST Nicholas Laboratories PA0032/017/001 - BARIUM SULFATE 01/02/1993


POLYCROL Nicholas Laboratories PA0032/023/001 Tablets - DIMETICONE 01/02/1993
- ALUMINIUM HYDROXIDE-
MAGNESIUM CARBONATE
GEL
- MAGNESIUM HYDROXIDE

POLYCROL Nicholas Laboratories PA0032/023/002 Gel - DIMETICONE 01/02/1993


- ALUMINIUM HYDROXIDE
- MAGNESIUM HYDROXIDE

POLYCROL FORTE Nicholas Laboratories PA0032/024/001 Tablets - ALUMINIUM HYDROXIDE 01/02/1993


GEL
- DIMETICONE
- ALUMINIUM HYDROXIDE-
MAGNESIUM CARBONATE
GEL
- MAGNESIUM HYDROXIDE

Human Medicines Withdrawn Products Page 437 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
POLYCROL FORTE Nicholas Laboratories PA0032/024/002 Gel - DIMETICONE 01/02/1993
- ALUMINIUM HYDROXIDE
GEL
- MAGNESIUM HYDROXIDE

RO-A-VIT Roche Products Limited PA0050/058/001 Tablets - RETINOL ACETATE 01/02/1993


SYNKAVIT Roche Products Limited PA0050/050/003 01/02/1993
ALPARE TWO GRASS Bayer PLC PA0021/035/002 31/01/1993
HEMOFIL-T Baxter Healthcare Limited PA0167/007/010 - ANTIHEMOPHILIC HUMAN 31/01/1993
ANTIHAEMOPHILIC PLASMA
DYTIDE SmithKline and French PA0060/020/001 Capsule 29/01/1993
Laboratories Ltd
ESKAMEL SmithKline and French PA0060/037/001 Cream 29/01/1993
Laboratories Ltd
CARBELLON Medo Pharmaceuticals PA0109/007/001 Tablets - ATROPA BELLADONNA 28/01/1993
Limited - MAGNESIUM HYDROXIDE
- CHARCOAL, ACTIVATED

DIOCTYL MEDO Medo Pharmaceuticals PA0109/010/001 Syrup - DOCUSATE SODIUM 28/01/1993


Limited
DIOCTYL MEDO Medo Pharmaceuticals PA0109/010/002 - DOCUSATE SODIUM 28/01/1993
CONENTRATE Limited
DOANS BACKACHE PILLS Fulford Williams PA0263/001/001 28/01/1993
(International)
ALORBAT E. Merck Ltd PA0054/026/010 26/01/1993
ALORBAT E. Merck Ltd PA0054/026/008 26/01/1993
ALORBAT - SYRINGE E. Merck Ltd PA0054/026/009 26/01/1993
ALORBAT 81 E. Merck Ltd PA0054/026/002 - INFLUENZA VIRUS 26/01/1993
VACCINE MONOVALENT
ALORBAT 81 - E. Merck Ltd PA0054/026/001 - INFLUENZA VIRUS 26/01/1993
DISPOSABLE SYRINGE VACCINE MONOVALENT
ALORBAT 81 MULTIDOSE E. Merck Ltd PA0054/026/003 - INFLUENZA VIRUS 26/01/1993
VACCINE MONOVALENT
INDOPTOL OPHTHALMIC Merck Sharp and Dohme PA0035/066/001 - INDOMETACIN 26/01/1993
(SUSPENSION) Limited
GLUCAGON NOVO Novo Nordisk A/S PA0218/004/001 25/01/1993
GLUCAGON NOVO Novo Nordisk A/S PA0218/004/002 25/01/1993
GLUCAGON NOVO Novo Nordisk A/S PA0218/004/003 25/01/1993
PURE COD LIVER OIL Superpac Products Limited PA0552/013/001 25/01/1993
ALMASILATE A.H. Robins Company PA0086/020/001 - ALMASILATE 21/01/1993
(SUSPENSION) Limited
DISCASE Baxter Healthcare Limited PA0167/018/001 Withdrawn Form - CHYMOPAPAIN 21/01/1993
DISCASE (CHYMOPAPAIN) Baxter Healthcare Limited PA0167/018/002 Withdrawn Form - CHYMOPAPAIN 21/01/1993

DYTAC SmithKline and French PA0060/019/001 Capsule 21/01/1993


Laboratories Ltd
HEMOFIL -T Baxter Healthcare Limited PA0167/007/013 - ANTIHEMOPHILIC HUMAN 21/01/1993
ANTIHAEMOPHILIC PLASMA
HEMOFIL-HT (HUMAN) Baxter Healthcare Limited PA0167/076/001 - FACTOR VIII 21/01/1993
(ANTIHAEMOPHILIC
FACTOR)
HEMOFIL-HT (HUMAN) Baxter Healthcare Limited PA0167/076/002 - FACTOR IX 21/01/1993
HEMOFIL-T Baxter Healthcare Limited PA0167/007/009 - ANTIHEMOPHILIC HUMAN 21/01/1993
ANTIHAEMOPHILIC PLASMA
HEMOFIL-T Baxter Healthcare Limited PA0167/007/011 - ANTIHEMOPHILIC HUMAN 21/01/1993
ANTIHAEMOPHILIC PLASMA
HEMOFIL-T Baxter Healthcare Limited PA0167/007/012 - ANTIHEMOPHILIC HUMAN 21/01/1993
ANTIHAEMOPHILIC PLASMA
HEMOFIL-T Baxter Healthcare Limited PA0167/007/008 Capsule - FACTOR VIII 21/01/1993
ANTIHAEMOPHILIC (ANTIHAEMOPHILIC
FACTOR FACTOR)
IMFERON Fisons Limited PA0018/017/001 Withdrawn Form - DEXTRIFERRON 21/01/1993
IMFERON Fisons Limited PA0018/017/002 Withdrawn Form - DEXTRIFERRON 21/01/1993
IMFERON Fisons Limited PA0018/017/003 Withdrawn Form - DEXTRIFERRON 21/01/1993
MINIMS CASTOR OIL Chauvin Pharmaceuticals PA0118/030/001 21/01/1993
Limited
TAGAMET (SUSPENSION) SmithKline and French PA0060/006/008 21/01/1993
Laboratories Ltd
TARCORTIN Stafford Miller Limited PA0069/005/001 Cream 21/01/1993
AKROTHERM Napp Laboratories Limited PA0114/039/001 Cream - HISTAMINE 20/01/1993
- ACETYLCHOLINE
CHLORIDE
- CHOLESTEROL
BETADINE AEROSOL Napp Laboratories Limited PA0114/002/013 - POVIDONE-IODINE 20/01/1993
SPRAY

Human Medicines Withdrawn Products Page 438 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CORTENEMA Bengue & Company Limited PA0096/003/001 20/01/1993
CRADOCAP SHAMPOO Napp Laboratories Limited PA0114/035/001 - CETRIMONIUM BROMIDE 20/01/1993

FIBRAMED Napp Laboratories Limited PA0114/041/001 20/01/1993


K CONTIN CONTINUS Napp Laboratories Limited PA0114/032/001 Tablets 20/01/1993
PIMAFUCORT Yamanouchi Pharma Ltd PA0062/008/001 Ointment 20/01/1993
X PREP-LIQUID Napp Laboratories Limited PA0114/031/001 20/01/1993
DROMORAN Roche Products Limited PA0050/023/001 Tablets - LEVORPHANOL 19/01/1993
TARTRATE
DROMORAN Roche Products Limited PA0050/023/002 - LEVORPHANOL 19/01/1993
TARTRATE
ZESTRIL Zeneca Limited PA0051/059/004 - LISINOPRIL 19/01/1993
ZESTRIL Zeneca Limited PA0051/059/005 - LISINOPRIL 19/01/1993
ZYMAFLUOR Novartis Consumer Health PA0030/003/001 Tablets - SODIUM FLUORIDE 19/01/1993
UK Limited
ZYMAFLUOR Novartis Consumer Health PA0030/003/002 Tablets - SODIUM FLUORIDE 19/01/1993
UK Limited
ROACCUTANE Roche Products Limited PA0050/053/001 Capsule - ISOTRETINOIN 18/01/1993
FAMEL EXPECTORANT Optrex Limited PA0275/009/001 - GUAIFENESIN 15/01/1993
PARACETAMOL F.F.C. Ltd PA0647/001/001 Tablets 13/01/1993
PLATINEX Bristol-Myers Squibb PA0048/034/001 Solution for Injection - CISPLATIN 13/01/1993
(Holdings) Limited
PLATINEX Bristol-Myers Squibb PA0048/034/002 Solution for Injection - CISPLATIN 13/01/1993
(Holdings) Limited
PLATINEX Bristol-Myers Squibb PA0048/034/003 Solution for Injection - CISPLATIN 13/01/1993
(Holdings) Limited
THERADERM Bristol-Myers Squibb PA0048/028/001 Cream - BENZOYL PEROXIDE 13/01/1993
(Holdings) Limited
THERADERM Bristol-Myers Squibb PA0048/028/002 Cream - BENZOYL PEROXIDE 13/01/1993
(Holdings) Limited
TOLERZIDE Bristol-Myers Squibb PA0048/029/001 - SOTALOL 13/01/1993
(Holdings) Limited HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

VINCRISTINE Bristol-Myers Squibb PA0048/025/001 Withdrawn Form 13/01/1993


(Holdings) Limited
BRINALDIX K Novartis Pharmaceuticals UK PA0013/012/001 Tablets Effervescent - CLOPAMIDE 11/01/1993
Ltd - POTASSIUM CHLORIDE
- POTASSIUM
BICARBONATE
- DOCUSATE SODIUM
MARPLAN Roche Products Limited PA0050/022/001 Tablets - ISOCARBOXAZID 11/01/1993
PETHIDINE ROCHE Roche Products Limited PA0050/026/001 Tablets 11/01/1993
LAROXYL Roche Products Limited PA0050/021/001 Tablets - AMITRIPTYLINE 08/01/1993
HYDROCHLORIDE
AMINOPLEX 12 Geistlich Sons Limited PA0143/005/001 07/01/1993
AMINOPLEX 12 Geistlich Sons Limited PA0143/005/002 07/01/1993
ANAFLEX Geistlich Sons Limited PA0143/009/001 Cream - POLYNOXYLIN 07/01/1993
ANAFLEX Geistlich Sons Limited PA0143/009/002 - POLYNOXYLIN 07/01/1993
ANAFLEX Geistlich Sons Limited PA0143/009/003 - POLYNOXYLIN 07/01/1993
ANAFLEX Geistlich Sons Limited PA0143/009/004 - POLYNOXYLIN 07/01/1993
BURNEZE Charwell Pharmaceuticals PA0158/012/001 - MEPYRAMINE MALEATE 07/01/1993
Limited - BENZOCAINE
CELEVAC Boehringer Ingelheim Limited PA0007/036/001 Granules Effervescent - METHYLCELLULOSE 07/01/1993

GLUCOPLEX 1000 Geistlich Sons Limited PA0143/002/001 - GLUCOSE 07/01/1993


- ELECTROLYTES NOS
GLUCOPLEX 1000 Geistlich Sons Limited PA0143/002/002 - GLUCOSE 07/01/1993
- ELECTROLYTES NOS
GLUCOPLEX 1600 Geistlich Sons Limited PA0143/003/001 - GLUCOSE 07/01/1993
- ELECTROLYTES NOS
GLUCOPLEX 1600 Geistlich Sons Limited PA0143/003/002 07/01/1993
TRAMIL Pfizer Consumer Healthcare PA0172/009/002 Tablets - PARACETAMOL 07/01/1993
Ltd - CAFFEINE
FRUSEMIDE Hospira UK Limited PA0437/013/001 Withdrawn Form - FUROSEMIDE 04/01/1993
FRUSEMIDE Hospira UK Limited PA0437/013/002 Withdrawn Form - FUROSEMIDE 04/01/1993
METROVEX Hospira UK Limited PA0437/007/001 Solution for Infusion - METRONIDAZOLE 04/01/1993
ALDOMET Company Liquidated M123 PA0183/004/001 - METHYLDOPA 01/01/1993
AUGMENTIN SmithKline Beecham Pharm PA0049/035/012 01/01/1993
Ltd
AUGMENTIN SmithKline Beecham Pharm PA0049/035/013 - AMOXICILLIN 01/01/1993
Ltd TRIHYDRATE
AZACTAM Bristol-Myers Squibb PA0002/052/007 Withdrawn Form - AZTREONAM 01/01/1993
Pharmaceuticals uc - ARGININE

Human Medicines Withdrawn Products Page 439 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AZACTAM Bristol-Myers Squibb PA0002/052/008 Withdrawn Form - AZTREONAM 01/01/1993
Pharmaceuticals uc - ARGININE
AZACTAM Bristol-Myers Squibb PA0002/052/009 Withdrawn Form - AZTREONAM 01/01/1993
Pharmaceuticals uc - ARGININE
AZACTAM Bristol-Myers Squibb PA0002/052/010 Withdrawn Form - AZTREONAM 01/01/1993
Pharmaceuticals uc - ARGININE
AZACTAM Bristol-Myers Squibb PA0002/052/012 Withdrawn Form - AZTREONAM 01/01/1993
Pharmaceuticals uc - ARGININE
CERTAL LOZENGES Company Liquidated M123 PA0183/005/001 - BENZOCAINE 01/01/1993
- CETYLPYRIDINIUM
CHLORIDE
- ASCORBIC ACID
CERTAL PLUS Company Liquidated M123 PA0183/009/001 - GUAIFENESIN 01/01/1993
- PHENYLEPHRINE
HYDROCHLORIDE
- PARACETAMOL
DIOCALM SmithKlineBeecham PA0379/006/001 Tablets - MORPHINE 01/01/1993
Consumer Brand HYDROCHLORIDE
- ATTAPULGITE
HEDCOF Company Liquidated M123 PA0183/008/001 Tablets 01/01/1993
INDOMETHACIN Company Liquidated M123 PA0183/007/001 Capsule - INDOMETACIN 01/01/1993
INDOMETHACIN Company Liquidated M123 PA0183/007/002 Capsule - INDOMETACIN 01/01/1993
INFLEXAL BERNA Capital Pharmaceuticals Ltd PA0249/004/001 01/01/1993
NAPROSYN Syntex Pharmaceuticals PA0033/005/007 Tablets - NAPROXEN 01/01/1993
Limited
NAPROSYN Syntex Pharmaceuticals PA0033/005/008 Tablets - NAPROXEN 01/01/1993
Limited
NAPROSYN 500 Syntex Pharmaceuticals PA0033/005/009 Tablets - NAPROXEN 01/01/1993
Limited
TAY-KA-VITE Company Liquidated M123 PA0183/006/001 Tablets 01/01/1993
TOSUMAN BERNA Capital Pharmaceuticals Ltd PA0249/006/001 01/01/1993
GAMMAGARD Baxter Healthcare Limited PA0167/079/002 - GAMMA GLOBULIN 30/12/1992
- WATER FOR INJECTIONS

VENOS ORIGINAL WITH SmithKlineBeecham PA0379/014/001 - GUAIFENESIN 23/12/1992


EXPECTORANT Consumer Brand
ENDOXANA Boehringer Ingelheim Limited PA0007/011/001 22/12/1992

HONVAN Boehringer Ingelheim Limited PA0007/012/001 22/12/1992

PERSANTIN PL Boehringer Ingelheim Limited PA0007/008/004 - DIPYRIDAMOLE 22/12/1992


PERLONGETS
PERSANTIN PL Boehringer Ingelheim Limited PA0007/008/005 - DIPYRIDAMOLE 22/12/1992
PERLONGETS
RYBARVIN Rybar Laboratories Ltd PA0003/001/001 Inhalation solution - ATROPINE 22/12/1992
METHONITRATE
- PAPAVERINE
HYDROCHLORIDE
- EPINEPHRINE
- BENZOCAINE
TRINORDIOL 28 John Wyeth & Brother PA0022/038/001 Tablets - LEVONORGESTREL 22/12/1992
Limited - ETHINYLESTRADIOL
MOXALACTAM DISODIUM Eli Lilly and Company Limite PA0047/054/001 Withdrawn Form - LATAMOXEF SODIUM 18/12/1992

MOXALACTAM DISODIUM Eli Lilly and Company Limite PA0047/054/002 Withdrawn Form - LATAMOXEF SODIUM 18/12/1992

MOXALACTAM DISODIUM Eli Lilly and Company Limite PA0047/054/003 Withdrawn Form - LATAMOXEF SODIUM 18/12/1992

MOXALACTAM DISODIUM Eli Lilly and Company Limite PA0047/054/004 Withdrawn Form - LATAMOXEF SODIUM 18/12/1992

POLIOVIRUS VACCINE Abbott Healthcare Products PA0108/004/001 - POLIOVIRUS VACCINE 18/12/1992


Ltd LIVE ORAL
- POLYMYXIN B
- NEOMYCIN
SOTACOR Bristol-Myers Squibb PA0048/001/004 Withdrawn Form - SOTALOL 18/12/1992
(Holdings) Limited
TAMARINE (LAXATIVE) Regina Plc PA0443/001/001 18/12/1992
XYLOTOX 2% Astra Pharmaceuticals Ltd PA0009/038/001 - LIDOCAINE 18/12/1992
HYDROCHLORIDE
- EPINEPHRINE
XYLOTOX 2% E80 Astra Pharmaceuticals Ltd PA0009/038/002 - LIDOCAINE 18/12/1992
HYDROCHLORIDE
- EPINEPHRINE
PULMADIL AUTO 3M Health Care Limited PA0057/033/001 - RIMITEROL 11/12/1992
HYDROBROMIDE

Human Medicines Withdrawn Products Page 440 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BECOSYM SYRUP Roche Products Limited PA0050/054/002 - THIAMINE 10/12/1992
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
- PYRIDOXINE
HYDROCHLORIDE
BENERVA COMPOUND Roche Products Limited PA0050/059/001 Tablets - THIAMINE 09/12/1992
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
CETAVLON Zeneca Limited PA0051/051/001 - CETRIMONIUM BROMIDE 08/12/1992

MERCUROCHROME Superpac Products Limited PA0552/012/001 04/12/1992


SODIUM IODIDE 1-131 Amersham Health Srl PA0401/002/001 Capsule - SODIUM IODIDE 03/12/1992
AMIZIDE Pinewood Laboratories Ltd, PA0281/037/001 Tablets - AMILORIDE 02/12/1992
HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

ATROPINE EYE OINTMENT Schering-Plough Limited PA0277/010/002 Ointment - ATROPINE SULFATE 02/12/1992

CHLORAMPHENICOL EYE Schering-Plough Limited PA0277/011/002 Ointment 02/12/1992


OINTMENT
HYDRALAZINE Pinewood Laboratories Ltd, PA0281/039/001 Tablets - HYDRALAZINE 02/12/1992
HYDROCHLORIDE HYDROCHLORIDE
HYDRALAZINE Pinewood Laboratories Ltd, PA0281/039/002 Tablets - HYDRALAZINE 02/12/1992
HYDROCHLORIDE HYDROCHLORIDE
OPRAM Pinewood Laboratories Ltd, PA0281/040/001 Tablets - METOCLOPRAMIDE 02/12/1992
SULFAZINE Pinewood Laboratories Ltd, PA0281/034/001 Tablets - SULFASALAZINE 02/12/1992
SULPHACETAMIDE EYE Schering-Plough Limited PA0277/019/004 Ointment 02/12/1992
OINTMENT
CONGESTEZE Schering-Plough Limited PA0277/035/003 Syrup - AZATADINE MALEATE 01/12/1992
PAEDIATRIC - PSEUDOEPHEDRINE
SULFATE
EXOLAN Dermal Laboratories Ltd PA0278/013/001 Cream 01/12/1992
GAMMAGARD Baxter Healthcare Limited PA0167/079/001 - WATER FOR INJECTIONS 01/12/1992
- GAMMA GLOBULIN

ADRENALINE ACID Galway Laboratories PA0367/010/001 - EPINEPHRINE 27/11/1992


TARTRATE BITARTRATE
ASPIRIN Rusco Pharmaceuticals PA0392/002/001 Tablets - ACETYLSALICYLIC ACID 27/11/1992
CEENU Bristol-Myers Squibb PA0048/012/003 Capsule - LOMUSTINE 27/11/1992
(Holdings) Limited
DIALITE 134 Galway Laboratories PA0367/013/001 - CHLORIDE 27/11/1992
- SODIUM
- CALCIUM
- MAGNESIUM
- POTASSIUM
DIALITE 134 WITHOUT Galway Laboratories PA0367/013/003 - SODIUM CHLORIDE 27/11/1992
DEXTROSE - CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
ANHYDROUS
- POTASSIUM CHLORIDE
- SODIUM HYDROXIDE
- ACETIC ACID
DIALITE 136 Galway Laboratories PA0367/013/002 - SODIUM 27/11/1992
- CALCIUM
- MAGNESIUM
- POTASSIUM
- CHLORIDE
GLYCERIN LEMON & Galway Laboratories PA0367/001/001 - GLYCEROL 27/11/1992
HONEY - HONEY
- LEMON FLAVOUR
HUMAN ALBUMIN 3M Health Care Limited PA0057/047/001 27/11/1992
MICROSPHERES
KAOLIN & MORPHINE Galway Laboratories PA0367/008/001 - KAOLIN 27/11/1992
MIXTURE - MORPHINE
MORPHINE SULPHATE Galway Laboratories PA0367/015/001 Withdrawn Form - MORPHINE SULFATE 27/11/1992
MORPHINE SULPHATE Galway Laboratories PA0367/015/002 Withdrawn Form - MORPHINE SULFATE 27/11/1992
PAEDIATRIC Galway Laboratories PA0367/006/001 - PARACETAMOL 27/11/1992
PARACETAMOL
PARALDEHYDE Galway Laboratories PA0367/021/001 Withdrawn Form - PARALDEHYDE 27/11/1992
PETHIDINE Galway Laboratories PA0367/014/001 Withdrawn Form - PETHIDINE 27/11/1992
PETHIDINE Galway Laboratories PA0367/014/002 Withdrawn Form - PETHIDINE 27/11/1992
SODIUM CHLORIDE 0.9% Galway Laboratories PA0367/016/001 Withdrawn Form - SODIUM CHLORIDE 27/11/1992
SODIUM CHLORIDE 0.9% Galway Laboratories PA0367/016/002 Withdrawn Form - SODIUM CHLORIDE 27/11/1992

Human Medicines Withdrawn Products Page 441 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SOLUBLE ASPIRIN Rusco Pharmaceuticals PA0392/002/002 Tablets Effervescent - ACETYLSALICYLIC ACID 27/11/1992
SURGICAL SPIRITS Galway Laboratories PA0367/007/001 - METHYL SALICYLATE 27/11/1992
DOXY 100 Karl Engelhard PA0425/001/001 Capsule - DOXYCYCLINE 26/11/1992
DOXY KOMB Karl Engelhard PA0425/002/002 Capsule - DOXYCYCLINE 26/11/1992
HYDROCHLORIDE
NOVOFLUEN Karl Engelhard PA0425/004/001 - DIHYDROERGOCRISTINE 26/11/1992

NERISONE HE Clissmann PA0012/002/003 Cream - DIFLUCORTOLONE 25/11/1992


VALERATE
NERISONE HE Clissmann PA0012/002/001 Ointment - DIFLUCORTOLONE 25/11/1992
VALERATE
NERISONE FATTY HE Clissmann PA0012/002/002 Ointment - DIFLUCORTOLONE 25/11/1992
VALERATE
CHLORHEXAMED Mercury Pharmaceuticals PA0073/061/001 - CHLORHEXIDINE 24/11/1992
(Ireland) Ltd GLUCONATE
CHLORHEXAMED Mercury Pharmaceuticals PA0073/061/002 - CHLORHEXIDINE 24/11/1992
CONCENTRATE (Ireland) Ltd GLUCONATE
RIKOSPRAY BALSAM 3M Health Care Limited PA0057/049/001 - BENZOIN 24/11/1992
EFAMAST Scotia Pharmaceuticals PA0457/003/001 Capsule - OENOTHERA BIENNIS 23/11/1992
Limited
ECZEDERM CREAM WITH Quinoderm Ltd PA0308/004/001 Cream - CALAMINE 19/11/1992
HYDROCORTISONE
CLAIRVAN Sinclair Pharmaceuticals PA0251/002/002 Withdrawn Form 16/11/1992
Limited
CLAIRVAN ORAL Sinclair Pharmaceuticals PA0251/002/001 16/11/1992
Limited
MEDIDERM Sanofi-Synthelabo Ireland PA0077/056/001 Cream - SULFUR 16/11/1992
Ltd - RESORCINOL
TERAZOL Cilag Limited PA0059/033/004 Pessary - TERCONAZOLE 16/11/1992
SYNERGISTIC 1 LECITHIN GR Lane Health Products Lt PA0257/005/001 Tablets 13/11/1992
VITAMIN E & SELENIUM
SYNERGISTIC 4. VITAMIN GR Lane Health Products Lt PA0257/004/001 Tablets 13/11/1992
B6 HERB
CIBACALCIN Ciba Geigy Plc PA0028/005/001 - CALCITONIN 12/11/1992
MORPHINE SULPHATE Roche Products Limited PA0050/070/001 11/11/1992
AMPOULES
MORPHINE SULPHATE Roche Products Limited PA0050/070/002 11/11/1992
AMPOULES
PARAPLATIN Bristol-Myers Squibb PA0048/044/001 - CARBOPLATIN 11/11/1992
(Holdings) Limited
PARAPLATIN Bristol-Myers Squibb PA0048/044/002 - CARBOPLATIN 11/11/1992
(Holdings) Limited
PARAPLATIN Bristol-Myers Squibb PA0048/044/003 - CARBOPLATIN 11/11/1992
(Holdings) Limited
TEMETEX Roche Products Limited PA0050/004/001 Cream - DIFLUCORTOLONE 11/11/1992
TEMETEX Roche Products Limited PA0050/004/002 Ointment - DIFLUCORTOLONE 11/11/1992
TEMETEX (FATTY) Roche Products Limited PA0050/004/003 Ointment - DIFLUCORTOLONE 11/11/1992
DARROWS The Boots Company Plc PA0004/036/001 10/11/1992
DARROWS The Boots Company Plc PA0004/036/002 10/11/1992
FACTOR VIII NORDISK Nordisk Gentofte A/S PA0217/007/001 10/11/1992
FACTOR VIII NORDISK Nordisk Gentofte A/S PA0217/007/002 10/11/1992
FACTOR VIII NORDISK Nordisk Gentofte A/S PA0217/007/004 10/11/1992
RAYVIST 180 HE Clissmann PA0012/055/001 Solution for Infusion - MEGLUMINE 10/11/1992
- IOGLICIC ACID
RAYVIST 300 HE Clissmann PA0012/056/001 Solution for Infusion - IOGLICIC ACID 10/11/1992
- MEGLUMINE
RAYVIST 300 HE Clissmann PA0012/056/002 Solution for Infusion - IOGLICIC ACID 10/11/1992
- MEGLUMINE
RAYVIST 300 HE Clissmann PA0012/056/003 Solution for Infusion - IOGLICIC ACID 10/11/1992
- MEGLUMINE
RAYVIST 350 HE Clissmann PA0012/057/001 - IOGLICIC ACID 10/11/1992
- MEGLUMINE
- SODIUM HYDROXIDE
RAYVIST 350 HE Clissmann PA0012/057/002 - IOGLICIC ACID 10/11/1992
- MEGLUMINE
- SODIUM HYDROXIDE
RAYVIST 350 HE Clissmann PA0012/057/010 Solution for Infusion 10/11/1992
RAYVIST 370 HE Clissmann PA0012/058/001 Solution for Infusion - IOGLICIC ACID 05/11/1992
- MEGLUMINE
- SODIUM HYDROXIDE
HAEMORRHOIDAL SPRAY Pfizer Consumer Healthcare PA0172/001/001 - CHLORHEXIDINE 04/11/1992
Ltd
KOATE Bayer Diagnostics PA0079/015/001 - FACTOR VIII 04/11/1992
Manufacturing (ANTIHAEMOPHILIC
FACTOR)

Human Medicines Withdrawn Products Page 442 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KOATE Bayer Diagnostics PA0079/015/002 - FACTOR VIII 04/11/1992
Manufacturing (ANTIHAEMOPHILIC
FACTOR)
KOATE Bayer Diagnostics PA0079/015/003 - FACTOR VIII 04/11/1992
Manufacturing (ANTIHAEMOPHILIC
FACTOR)
QUINELAN Elan Pharma Ltd PA0516/004/001 Capsule 04/11/1992
QUINELAN Elan Pharma Ltd PA0516/004/002 Capsule 04/11/1992
QUINELAN Elan Pharma Ltd PA0516/004/003 Capsule 04/11/1992
VANCOCIN Eli Lilly and Company Limite PA0047/004/001 Oral Solution - VANCOMYCIN 04/11/1992
HYDROCHLORIDE
ANGIERS JUNIOR Bristol-Myers Squibb PA0048/039/003 Tablets - PARACETAMOL 03/11/1992
PARACETAMOL (Holdings) Limited
ANGIERS PARACETAMOL Bristol-Myers Squibb PA0048/039/001 03/11/1992
DROPS FOR CHILDREN (Holdings) Limited
GENTIGAN 1 ML E. Merck Ltd PA0054/054/004 - GENTAMICIN 03/11/1992
GENTIGAN 2 ML E. Merck Ltd PA0054/054/002 - GENTAMICIN 03/11/1992
GENTIGAN 2 ML E. Merck Ltd PA0054/054/003 03/11/1992
GENTIGAN-L 2 ML E. Merck Ltd PA0054/055/001 - GENTAMICIN 03/11/1992
GENTIGAN-L 2 ML E. Merck Ltd PA0054/055/002 - GENTAMICIN 03/11/1992
MIRAXID Leo Laboratories Limited PA0046/031/002 Tablets - PIVAMPICILLIN 03/11/1992
- PIVMECILLINAM
HYDROCHLORIDE
MIRAXID PAEDIATRIC Leo Laboratories Limited PA0046/031/003 Tablets - PIVAMPICILLIN 03/11/1992
- PIVMECILLINAM
HYDROCHLORIDE
AMILORIDE/HYDROCHLO Stephin B.V. PA0765/001/001 Tablets - AMILORIDE 30/10/1992
ORTHIAZIDE - HYDROCHLOROTHIAZIDE

ORGALUTREL Organon Laboratories PA0261/031/001 - GONADORELIN 30/10/1992


Limited
SYRAPRIM Wellcome (Ireland) Limited PA0017/077/001 Tablets - TRIMETHOPRIM 30/10/1992
SYRAPRIM Wellcome (Ireland) Limited PA0017/077/002 Tablets - TRIMETHOPRIM 30/10/1992
ULCIDIN Fujisawa Deutschland GmbH PA0473/007/003 Withdrawn Form - CIMETIDINE 29/10/1992

MULTITEST CMI Sanofi Pasteur MSD Ltd PA0544/006/001 28/10/1992


TICLID Sanofi-Synthelabo Ireland PA0077/120/001 - TICLOPIDINE 28/10/1992
Ltd HYDROCHLORIDE
ALCUSAL Alcusal Ireland Limited PA0631/001/001 Gel - COPPER 27/10/1992
- SALICYLATES
BENDROFLUAZIDE Teva UK Limited PA0237/017/001 Tablets 27/10/1992
MILORANT Mercury Pharmaceuticals PA0073/095/001 Tablets - AMILORIDE 24/10/1992
(Ireland) Ltd HYDROCHLORIDE
- HYDROCHLOROTHIAZIDE

ECZENSA Hadensa (Ireland) Limited PA0145/001/002 Ointment - DEXAMETHASONE 20/10/1992


- FRAMYCETIN
- RETINOL ACETATE
- COLECALCIFEROL
- TOCOPHERYL ACETATE
- CLIOQUINOL
ECZENSA - S Hadensa (Ireland) Limited PA0145/002/001 Ointment - DIPHENYLPYRALINE 20/10/1992
HYDROCHLORIDE
- CLIOQUINOL
HADENSA Hadensa (Ireland) Limited PA0145/006/002 Suppositories - MENTHOL 20/10/1992
- ICHTHAMMOL
- CHLORCARVACROL
ROVAKTIVIT Rowa Pharmaceuticals PA0074/023/001 - MELISSA EXTRACT 19/10/1992
Limited - EUGENOL
- LECITHINUM SOYA
SYSTRAL E. Merck Ltd PA0054/030/001 Cream - CHLORPHENOXAMINE 19/10/1992
HYDROCHLORIDE
DEXATOPIC Organon Laboratories PA0261/034/001 Cream - DEXAMETHASONE 16/10/1992
Limited - NANDROLONE
DECANOATE
- CHLORHEXIDINE
HYDROCHLORIDE
CREMALGIN BALM Berk Pharmaceuticals PA0082/045/001 - CAPSAICIN 15/10/1992
Limited - METHYL NICOTINATE
NEURALGON Pinewood Laboratories Ltd, PA0281/033/001 Tablets - CARBAMAZEPINE 15/10/1992
NEURALGON Pinewood Laboratories Ltd, PA0281/033/002 Tablets - CARBAMAZEPINE 15/10/1992
LEJ-FIBRE Britannia Pharmaceuticals PA0356/004/001 - BRAN 14/10/1992
Ltd
LOXENE HEAD GUARD Reckitt's (Ireland) Limited PA0027/030/001 - MALATHION 14/10/1992
PENNCODIN Fisons Pharmaceuticals PA0072/009/001 - CHLORPHENAMINE 08/10/1992
(SUSPENSION) (Ireland) - CODEINE

Human Medicines Withdrawn Products Page 443 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SUPER WATE-ON D.D.D. Limited PA0302/010/001 - CORN OIL 08/10/1992
EMULSION - VITAMIN B NOS
WATE-ON EMULSION D.D.D. Limited PA0302/009/001 - CORN OIL 08/10/1992
- VITAMIN B NOS
CALDESENE Fisons Pharmaceuticals PA0072/002/002 - CALCIUM UNDECYLEN 06/10/1992
(Ireland)
CORTI FLEXIOLE Pharma-Global Limited PA0141/005/001 - HYDROCORTISONE 06/10/1992
- CHLORAMPHENICOL
- RETINOL
DOXORUBICIN Farmitalia Carlo Erba Ltd PA0236/023/001 06/10/1992
HYDROCHLORIDE
DOXORUBICIN Farmitalia Carlo Erba Ltd PA0236/023/002 06/10/1992
HYDROCHLORIDE
DOXORUBICIN Farmitalia Carlo Erba Ltd PA0236/023/003 06/10/1992
HYDROCHLORIDE
HALYCITROL Laboratories for Applied PA0300/001/001 - RETINOL 06/10/1992
Biology - VITAMIN D SYNTHETIC
CALCIFEROL
OTO FLEXIOLE Pharma-Global Limited PA0141/014/001 - PHENAZONE 06/10/1992
RECTOSELLAN Pharma-Global Limited PA0141/022/001 Ointment 06/10/1992
(HEMORRHOIDAL
OINTMENT)
AMPICILLIN Company Liquidated M123 PA0432/003/003 Capsule - AMPICILLIN 01/10/1992
CHLOROQUINE Company Liquidated M123 PA0432/002/001 Syrup - CHLOROQUINE 01/10/1992
PHOSPHATE
PARACETAMOL ELIXIR Company Liquidated M123 PA0432/001/001 - PARACETAMOL 01/10/1992
PAEDIATRIC
TETRACYCLINE Company Liquidated M123 PA0432/004/001 Capsule - TETRACYCLINE 01/10/1992
ALEUDRIN Lewis Laboratories Limited PA0222/004/001 Tablets 30/09/1992
ALEUDRIN Lewis Laboratories Limited PA0222/004/002 Inhalation solution 30/09/1992
LIPOTRIAD Lewis Laboratories Limited PA0222/001/002 30/09/1992
SYMPATOL Lewis Laboratories Limited PA0222/003/001 30/09/1992
TEMPAIN United Pharmacists CoOp PA0337/016/001 Tablets - PARACETAMOL 30/09/1992
Ltd
TEMPAIN PAEDIATRIC United Pharmacists CoOp PA0337/016/002 - PARACETAMOL 30/09/1992
Ltd
U.P.C. EXPECTORANT United Pharmacists CoOp PA0337/002/001 Syrup - AMMONIUM CHLORIDE 30/09/1992
Ltd - DIPHENHYDRAMINE
HYDROCHLORIDE
VISTA METHASONE N Daniels Pharmaceutical Ltd PA0396/001/001 - BETAMETHASONE 30/09/1992
SODIUM PHOSPHATE
- NEOMYCIN SULFATE
ASMAVEN Teva UK Limited PA0237/023/002 Tablets 29/09/1992
ASMAVEN Teva UK Limited PA0237/023/003 Tablets 29/09/1992
AURALTONE EAR Wade Pharmaceuticals PA0005/001/001 - PHENAZONE 29/09/1992
Limited - BENZOCAINE
BRONCHOTONE MIXTURE Wade Pharmaceuticals PA0005/006/001 - SODIUM SALICYLATE 29/09/1992
Limited - CAFFEINE
- SODIUM IODIDE
- EPHEDRINE
HYDROCHLORIDE
- ATROPA BELLADONNA
COPHOLCO COUGH Wade Pharmaceuticals PA0005/003/001 Syrup - PHOLCODINE 29/09/1992
SYRUP Limited - TERPIN HYDRATE
- MENTHOL
- CINEOLE
COPHOLCOIDS Wade Pharmaceuticals PA0005/007/001 - PHOLCODINE 29/09/1992
Limited - TERPIN HYDRATE
- MENTHOL
- CINEOLE
HYDROCORTISONE Schering-Plough Limited PA0277/030/002 Ointment 29/09/1992
HYDROCORTISONE EYE Schering-Plough Limited PA0277/030/004 29/09/1992
DROPS
HYDROCORTISONE SCALP Schering-Plough Limited PA0277/030/003 29/09/1992
APPLICATION
NEURODYNE Wade Pharmaceuticals PA0005/002/001 Capsule - PARACETAMOL 29/09/1992
Limited - CODEINE PHOSPHATE
PHYTOCIL Wade Pharmaceuticals PA0005/004/001 Cream - FENOXYPROPAZINE 29/09/1992
Limited - SALICYLIC ACID
PHYTOCIL Wade Pharmaceuticals PA0005/004/002 29/09/1992
Limited
IMOTEST - TUBERCULIN Merieux UK Limited PA0504/002/001 28/09/1992
MERIEUX ORAL Merieux UK Limited PA0504/003/001 28/09/1992
POLIOMYELITIS
MERIEUX ORAL Merieux UK Limited PA0504/003/002 28/09/1992
POLIOMYELITIS

Human Medicines Withdrawn Products Page 444 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SOMATONORM Pharmacia Laboratories PA0187/028/002 - METHIONYL HUMAN 25/09/1992
Limited SOMATOTROPIN
CHLOROPHENIRAMINE Mercury Pharmaceuticals PA0073/048/001 Tablets 24/09/1992
(Ireland) Ltd
CHLORPHENIRAMINE Mercury Pharmaceuticals PA0073/048/002 24/09/1992
(Ireland) Ltd
NEOCONES Septodont PA0196/001/001 Tablets - POLYMYXIN B SULFATE 23/09/1992
- TYROTHRICIN
- NEOMYCIN
- TETRACAINE
HYDROCHLORIDE
PERIDONTONE Immunetech PA0196/003/001 Ointment - NEOMYCIN SULFATE 23/09/1992
Pharmaceuticals Inc. - PAPAIN
- SODIUM BENZOATE
PULPOMIXINE Septodont PA0196/009/001 - DEXAMETHASONE 23/09/1992
ACETATE
- FRAMYCETIN SULFATE
- POLYMYXIN B SULFATE
SCANDONEST SPECIAL Septodont PA0196/011/001 - MEPIVACAINE 23/09/1992
HYDROCHLORIDE
- EPINEPHRINE
SCANDONEST WITHOUT Septodont PA0196/012/001 - MEPIVACAINE 23/09/1992
VASO-CONSTRICTOR HYDROCHLORIDE
SEPTOMIXINE FORTE Septodont PA0196/002/001 - NEOMYCIN 23/09/1992
- DEXAMETHASONE
- POLYMYXIN B SULFATE
- TYROTHRICIN
- HALETAZOLE
TERPOIN Hough, Hoseason & Co. Ltd PA0242/001/001 - CODEINE PHOSPHATE 23/09/1992
- GUAIFENESIN
AMPICILLIN Parle & Hickey Ltd PA0399/002/001 Capsule - AMPICILLIN 22/09/1992
AMPICILLIN Parle & Hickey Ltd PA0399/002/003 Syrup - AMPICILLIN 22/09/1992
AMPICILLIN Parle & Hickey Ltd PA0399/002/004 Syrup - AMPICILLIN 22/09/1992
AMPICILLIN TRIHYDRATE Parle & Hickey Ltd PA0399/002/002 Capsule - AMPICILLIN 22/09/1992
BUPROFAN Fannin & Company Ltd PA0399/003/002 Tablets 22/09/1992
COTRIFAN Fannin & Company Ltd PA0399/004/001 Tablets - COTRIMOXAZOLE 22/09/1992
IBUPROFEN Parle & Hickey Ltd PA0399/003/001 Tablets 22/09/1992
METHYLDOPA Parle & Hickey Ltd PA0399/001/001 Tablets - METHYLDOPA 22/09/1992
METHYLDOPA Parle & Hickey Ltd PA0399/001/002 Tablets - METHYLDOPA 22/09/1992
METHYLDOPA Parle & Hickey Ltd PA0399/001/003 Tablets - METHYLDOPA 22/09/1992
PERFAN Marion Merrell Limited PA0041/040/004 Capsule - ENOXIMONE 22/09/1992
PERFAN Marion Merrell Limited PA0041/040/005 Capsule - ENOXIMONE 22/09/1992
PERFAN Marion Merrell Limited PA0041/040/006 Capsule - ENOXIMONE 22/09/1992
PERFAN Marion Merrell Limited PA0041/040/007 Capsule - ENOXIMONE 22/09/1992
NIFEREX Mayne Pharma (Ireland) PA0422/003/003 Tablets - POLYSACCHARIDE-K 21/09/1992
Limited
NIFEREX Mayne Pharma (Ireland) PA0422/003/001 Capsule - POLYSACCHARIDE-K 21/09/1992
Limited
NIFEREX ELIXIR Mayne Pharma (Ireland) PA0422/003/002 - POLYSACCHARIDE-K 21/09/1992
Limited
AFRAZINE NOSE Schering-Plough Limited PA0277/006/002 - OXYMETAZOLINE 16/09/1992
HYDROCHLORIDE
AFRAZINE NOSE SPRAY Schering-Plough Limited PA0277/006/003 - OXYMETAZOLINE 16/09/1992
HYDROCHLORIDE
DIPROSONE 5 MG/ML Schering-Plough Limited PA0277/034/004 Withdrawn Form - BETAMETHASONE 16/09/1992
DIPROPIONATE
DIPROSONE 5 MG/ML Schering-Plough Limited PA0277/034/005 Withdrawn Form - BETAMETHASONE 16/09/1992
DIPROPIONATE
GARASONE EYE Schering-Plough Limited PA0277/041/001 Ointment - GENTAMICIN 16/09/1992
OINTMENT - BETAMETHASONE
GARASONE EYE/EAR Schering-Plough Limited PA0277/041/002 - GENTAMICIN 16/09/1992
DROPS - BETAMETHASONE
GEOMYCIN Schering-Plough Limited PA0277/004/001 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN (PAEDIATRIC) Schering-Plough Limited PA0277/004/008 Withdrawn Form - GENTAMICIN 16/09/1992
20MG
GEOMYCIN 60 MG/1.5 ML Schering-Plough Limited PA0277/004/002 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN 60 MG/1.5 ML Schering-Plough Limited PA0277/004/005 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN 80 MG/2 ML Schering-Plough Limited PA0277/004/006 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN 80 MG/2 ML Schering-Plough Limited PA0277/004/003 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN 80 MG/2 ML Schering-Plough Limited PA0277/004/004 Withdrawn Form - GENTAMICIN 16/09/1992
VIAL
GEOMYCIN 80 MG/ML Schering-Plough Limited PA0277/004/009 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN 80 MG/ML Schering-Plough Limited PA0277/004/010 Withdrawn Form - GENTAMICIN 16/09/1992
GEOMYCIN CHAINS Schering-Plough Limited PA0277/004/011 - GENTAMICIN 16/09/1992
HYDROCORTISONE Schering-Plough Limited PA0277/030/005 Cream 16/09/1992

Human Medicines Withdrawn Products Page 445 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HYDROCORTISONE Schering-Plough Limited PA0277/030/006 Ointment 16/09/1992
HYDROCORTISONE Schering-Plough Limited PA0277/030/007 16/09/1992
KADERM Schering-Plough Limited PA0277/028/002 Gel - BENZOYL PEROXIDE 16/09/1992
KADERM-10 Schering-Plough Limited PA0277/028/003 Gel - BENZOYL PEROXIDE 16/09/1992
KADERM-3 Schering-Plough Limited PA0277/028/001 Gel - BENZOYL PEROXIDE 16/09/1992
ZINC SULPHATE WITH Schering-Plough Limited PA0277/021/001 16/09/1992
ADRENALINE EYE DROPS
ZYDERM 65 Schering-Plough Limited PA0277/033/003 - LIDOCAINE 16/09/1992
- SODIUM CHLORIDE
- SODIUM PHOSPHATE
ZYDERM COLLAGEN Schering-Plough Limited PA0277/033/002 - LIDOCAINE 16/09/1992
IMPLANT
PLATOSIN Ferring Pharmaceuticals PA0224/010/004 Solution for Injection 14/09/1992
Limited
PLATOSIN Ferrer Internacional PA0224/010/005 Solution for Injection 14/09/1992
PLATOSIN Ferring Pharmaceuticals PA0224/010/006 Solution for Injection 14/09/1992
Limited
RESCUFOLIN Ferring Pharmaceuticals PA0224/009/001 Withdrawn Form 14/09/1992
Limited
RESCUFOLIN Ferring Pharmaceuticals PA0224/009/002 Withdrawn Form 14/09/1992
Limited
RESCUFOLIN Ferring Pharmaceuticals PA0224/009/003 Tablets 14/09/1992
Limited
BLOCADREN Merck Sharp and Dohme PA0035/044/004 Tablets - TIMOLOL MALEATE 11/09/1992
Limited
BLOCADREN Merck Sharp and Dohme PA0035/044/006 Tablets - TIMOLOL MALEATE 11/09/1992
Limited
BLOCADREN Merck Sharp and Dohme PA0035/044/007 Tablets - TIMOLOL 11/09/1992
Limited
BRICANYL COMPOUND Astra Pharmaceuticals Ltd PA0009/006/001 Tablets - TERBUTALINE SULFATE 11/09/1992
- GUAIFENESIN
COMPRECIN Parke Davis & Company PA0056/042/001 - ENOXACIN 10/09/1992
COMPRECIN Parke Davis & Company PA0056/042/002 - ENOXACIN 10/09/1992
PARKOL Parke Davis & Company PA0056/037/001 - PARACETAMOL 10/09/1992
VI-SIBLIN Parke Davis & Company PA0056/007/001 - ISPAGHULA HUSKS 10/09/1992
ALANA BABY CREAM Ricesteele Manufacturing Ltd PA0095/001/001 Cream 07/09/1992

AZEPAM Pinewood Laboratories Ltd, PA0281/023/001 Tablets - LORAZEPAM 07/09/1992


AZEPAM Pinewood Laboratories Ltd, PA0281/023/002 - LORAZEPAM 07/09/1992
PERATIL Pinewood Laboratories Ltd, PA0281/032/001 Tablets - PROCHLORPERAZINE 07/09/1992
PERCLODIN Pinewood Laboratories Ltd, PA0281/029/001 Tablets - DIPYRIDAMOLE 07/09/1992
PERCLODIN DIPRIDAMOLE Pinewood Laboratories Ltd, PA0281/029/002 Tablets - DIPYRIDAMOLE 07/09/1992

PRAXOL Pinewood Laboratories Ltd, PA0281/020/001 Tablets - OXPRENOLOL 07/09/1992


PRAXOL Pinewood Laboratories Ltd, PA0281/020/002 Tablets - OXPRENOLOL 07/09/1992
PRAXOL Pinewood Laboratories Ltd, PA0281/020/003 Tablets - OXPRENOLOL 07/09/1992
PROPRANOLOL LA Pinewood Laboratories Ltd, PA0281/016/005 Tablets - PROPRANOLOL 07/09/1992
RHEUMACID Pinewood Laboratories Ltd, PA0281/018/003 Capsule - INDOMETACIN 07/09/1992
PAMERGAN AP 100/25 Martindale Pharmaceuticals PA0361/001/001 Withdrawn Form 04/09/1992
Ltd
PAMERGAN P100 Martindale Pharmaceuticals PA0361/002/001 Withdrawn Form 04/09/1992
Ltd
SALBUTAMOL 200 Norton Waterford PA0436/008/009 - SALBUTAMOL 28/08/1992
SALOMOL 200 Norton Waterford PA0436/007/007 Inhalation solution - SALBUTAMOL 28/08/1992
ACRIFLAVINE Foran Healthcare Limited PA0484/003/001 - ACRIFLAVINIUM 27/08/1992
CHLORIDE
ANTIPHLOGISTINE RUB Foran Healthcare Limited PA0484/020/001 Cream - SALICYLIC ACID 27/08/1992
A:535 - MENTHOL
- CAMPHOR
- METHYL SALICYLATE
BETNOVATE RECTAL Glaxo Laboratories Limited PA0044/025/001 Ointment - BETAMETHASONE 27/08/1992
CENDEVAX RUBELLA SmithKline and French PA0060/018/001 27/08/1992
VACCINE Laboratories Ltd
CENDEVAX RUBELLA SmithKline and French PA0060/018/002 27/08/1992
VACCINE Laboratories Ltd
CEPORIN (S-FORM) Glaxo Laboratories Limited PA0044/008/004 - CEFALORIDINE 27/08/1992
ETHNINE Glaxo Laboratories Limited PA0044/051/001 Syrup - PHOLCODINE 27/08/1992
GOLDEN HONEY LEMSIP Reckitt's (Ireland) Limited PA0027/009/001 - PARACETAMOL 27/08/1992
PIRIEX Allen and Hanburys Limited PA0024/008/001 Syrup - CHLORPHENAMINE 27/08/1992
MALEATE
SKEFRON SmithKline and French PA0060/029/001 27/08/1992
Laboratories Ltd
STERISPON NO 4 Allen and Hanburys Limited PA0024/009/002 - GELATIN 27/08/1992
MULTIFUNGIN Knoll A.G. (Clissmann) PA0058/005/002 25/08/1992
MULTIFUNGIN Knoll A.G. (Clissmann) PA0058/005/003 25/08/1992

Human Medicines Withdrawn Products Page 446 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MULTIFUNGIN H Knoll A.G. (Clissmann) PA0058/006/001 Cream - HYDROCORTISONE 25/08/1992
ACETATE
TALUSIN Knoll A.G. (Clissmann) PA0058/014/002 Tablets - PROSCILLARIDIN 25/08/1992
STERISPON NO 1 Allen and Hanburys Limited PA0024/009/001 - GELATIN 24/08/1992
ASPIRIN AND CODEINE Irish Pharmaceuticals Limite PA0227/002/001 19/08/1992

PARACETAMOL TABLETS Irish Pharmaceuticals Limite PA0227/004/001 Tablets 19/08/1992

GENTIGAN 2 ML E. Merck Ltd PA0054/054/001 - GENTAMICIN 18/08/1992


LIGNOCAINE & International Medication PA0255/033/001 10/08/1992
ADRENALINE INJECTION Systems (UK) Ltd
10 MG/ML
CORINDOLAN HE Clissmann PA0012/059/001 Tablets 30/07/1992
CORINDOLAN HE Clissmann PA0012/059/002 Tablets 30/07/1992
PARACETAMOL Rusco Pharmaceuticals PA0392/003/001 Tablets - PARACETAMOL 30/07/1992
FLUOCALCIC Yamanouchi Pharma Ltd PA0062/033/001 Tablets 27/07/1992
MINADEX UCB Pharma Limited PA0365/016/001 Syrup - RETINOL 27/07/1992
- VITAMIN D SYNTHETIC
CALCIFEROL
- IRON
NOVOTRIMOX D.S. McFadden Pharmaceuticals PA0333/001/002 Tablets - TRIMETHOPRIM 25/07/1992
Ltd - SULFAMETHOXAZOLE
KEFEXIN FX Orion Pharma A/s PA0303/017/003 Granules Effervescent - CEFALEXIN 24/07/1992
PRATSIOL Orion Pharma A/s PA0303/008/001 Tablets - PRAZOSIN 19/07/1992
HYDROCHLORIDE
PRATSIOL Orion Pharma A/s PA0303/008/002 Tablets - PRAZOSIN 19/07/1992
HYDROCHLORIDE
PRATSIOL Orion Pharma A/s PA0303/008/003 Tablets - PRAZOSIN 19/07/1992
HYDROCHLORIDE
NARCAN Du Pont De Nemours PA0200/001/003 - NALOXONE 17/07/1992
Intern.S.A.
YOTOPAR Abbott Healthcare Products PA0108/013/002 Withdrawn Form - RITODRINE 17/07/1992
Ltd HYDROCHLORIDE
PHOLCOMED DIABETIC Medo Pharmaceuticals PA0109/004/004 - PHOLCODINE 16/07/1992
LINCTUS Limited - PAPAVERINE
PHOLCOMED FORTE Medo Pharmaceuticals PA0109/004/005 - PHOLCODINE 16/07/1992
DIABETIC LINCTUS Limited - PAPAVERINE
PHOLCOMED FORTE Medo Pharmaceuticals PA0109/004/003 - PHOLCODINE 16/07/1992
LINCTUS Limited - PAPAVERINE
PHOLCOMED LINCTUS Medo Pharmaceuticals PA0109/004/001 16/07/1992
Limited
PHOLCOMED LINCTUS Medo Pharmaceuticals PA0109/004/002 - PHOLCODINE 16/07/1992
Limited - PAPAVERINE
TONIRON Medo Pharmaceuticals PA0109/011/001 Capsule - FERROUS GLYCINE 16/07/1992
Limited SULFATE
IBEROL Abbott Laboratories Ireland PA0038/023/001 Tablets 15/07/1992
Ltd
IROFOL C Abbott Laboratories Ireland PA0038/024/001 Tablets 15/07/1992
Ltd
LIQUIFER-CR Abbott Laboratories Ireland PA0038/004/001 15/07/1992
Ltd
NOVAMOXIN McFadden Pharmaceuticals PA0333/006/001 Capsule - AMOXICILLIN 15/07/1992
Ltd
NOVAMOXIN McFadden Pharmaceuticals PA0333/006/002 Capsule - AMOXICILLIN 15/07/1992
Ltd
NOVAMOXIN McFadden Pharmaceuticals PA0333/006/003 Granules for Oral - AMOXICILLIN 15/07/1992
Ltd Suspension
NOVAMOXIN McFadden Pharmaceuticals PA0333/006/004 Granules for Oral - AMOXICILLIN 15/07/1992
Ltd Suspension
NOVOAMPICILLIN McFadden Pharmaceuticals PA0333/005/001 Capsule - AMPICILLIN TRIHYDRATE 15/07/1992
Ltd
NOVOAMPICILLIN McFadden Pharmaceuticals PA0333/005/002 Capsule - AMPICILLIN TRIHYDRATE 15/07/1992
Ltd
NOVOAMPICILLIN McFadden Pharmaceuticals PA0333/005/003 - AMPICILLIN TRIHYDRATE 15/07/1992
(SUSPENSION) Ltd
NOVOAMPICILLIN McFadden Pharmaceuticals PA0333/005/004 - AMPICILLIN TRIHYDRATE 15/07/1992
(SUSPENSION) Ltd
NOVOMETHACIN McFadden Pharmaceuticals PA0333/002/001 Capsule - INDOMETACIN 15/07/1992
Ltd
NOVOMETHACIN McFadden Pharmaceuticals PA0333/002/002 Capsule - INDOMETACIN 15/07/1992
Ltd
NOVORIDAZINE McFadden Pharmaceuticals PA0333/004/001 Tablets - THIORIDAZINE 15/07/1992
Ltd HYDROCHLORIDE
NOVORIDAZINE McFadden Pharmaceuticals PA0333/004/002 Tablets - THIORIDAZINE 15/07/1992
Ltd HYDROCHLORIDE

Human Medicines Withdrawn Products Page 447 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NOVORIDAZINE McFadden Pharmaceuticals PA0333/004/003 Tablets - THIORIDAZINE 15/07/1992
Ltd HYDROCHLORIDE
NOVOTRIMOX McFadden Pharmaceuticals PA0333/001/001 Tablets - TRIMETHOPRIM 15/07/1992
Ltd - SULFAMETHOXAZOLE
NOVOTRIMOX McFadden Pharmaceuticals PA033/001/001 Tablets 15/07/1992
Ltd
NOVOTRIPTYN McFadden Pharmaceuticals PA0333/003/001 Tablets - AMITRIPTYLINE 15/07/1992
Ltd
NOVOTRIPTYN McFadden Pharmaceuticals PA0333/003/002 Tablets - AMITRIPTYLINE 15/07/1992
Ltd
NOVOTRIPTYN McFadden Pharmaceuticals PA0333/003/003 Tablets - AMITRIPTYLINE 15/07/1992
Ltd
THEOGRAD Abbott Laboratories Ireland PA0038/015/001 Tablets 15/07/1992
Ltd
TRIDIONE Abbott Laboratories Ireland PA0038/014/002 Capsule 15/07/1992
Ltd
GENTAMICIN Hospira UK Limited PA0437/016/002 Withdrawn Form - GENTAMICIN 14/07/1992
GENTAMICIN Hospira UK Limited PA0437/016/005 Withdrawn Form - GENTAMICIN 14/07/1992
RENEDIL EXTENDED Hoechst Ireland Limited PA0023/062/001 Tablets - FELODIPINE 14/07/1992
RELEASE
RENEDIL EXTENDED Hoechst Ireland Limited PA0023/062/002 Tablets - FELODIPINE 14/07/1992
RELEASE
RINSTEAD ORALIEF Schering-Plough Limited PA0277/058/001 Gel - BENZOCAINE 14/07/1992
- CETYLPYRIDINIUM
CHLORIDE
SODIUM CHLORIDE B. Braun Medical Limited PA0179/003/009 14/07/1992
0.45/GLUCOSE 2.5
SODIUM CHLORIDE B. Braun Medical Limited PA0179/003/010 14/07/1992
0.45/GLUCOSE 2.5
SODIUM CHLORIDE B. Braun Medical Limited PA0179/003/011 14/07/1992
0.9%/GLUCOSE 5%
SODIUM CHLORIDE B. Braun Medical Limited PA0179/003/012 14/07/1992
0.9%/GLUCOSE 5%
ARTHITREX Cyanamid of Great Britain PA0037/066/001 Tablets 09/07/1992
BENOXYL 20 Stiefel Laboratories (U.K.) PA0144/002/001 - BENZOYL PEROXIDE 09/07/1992
Ltd.
SASTID Stiefel Laboratories (U.K.) PA0144/005/001 09/07/1992
Ltd.
AEROLIN 3M Health Care Limited PA0057/054/001 Tablets - SALBUTAMOL 08/07/1992
AEROLIN 3M Health Care Limited PA0057/054/002 Tablets - SALBUTAMOL 08/07/1992
AEROLIN 3M Health Care Limited PA0057/054/003 Syrup - SALBUTAMOL 08/07/1992
AEROLIN INHALER 3M Health Care Limited PA0057/054/004 - SALBUTAMOL 08/07/1992
PULMADIL RESPIRATOR 3M Health Care Limited PA0057/024/002 Capsule - RIMITEROL 08/07/1992
HYDROBROMIDE
RAUWILOID 3M Health Care Limited PA0057/020/001 Tablets - RAUWOLFIA 08/07/1992
SERPENTINA
- ALSEROXYLON
ALLBEE WITH C A.H. Robins Company PA0086/001/001 - THIAMINE MONONITRATE 07/07/1992
Limited - RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- NICOTINAMIDE
- ASCORBIC ACID

FEAC A.H. Robins Company PA0086/005/001 Tablets 07/07/1992


Limited
0.9% S/V SODIUM Baxter Healthcare Limited PA0167/012/001 - SODIUM CHLORIDE 06/07/1992
CHLORIDE FOR
IRRIGATION
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/002 - CHLORHEXIDINE 06/07/1992
B P C 0.02%
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/003 - CHLORHEXIDINE 06/07/1992
B P C 0.05% DIACETATE
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/004 - CHLORHEXIDINE 06/07/1992
B P C 0.05% DIACETATE
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/001 - CHLORHEXIDINE 06/07/1992
B. P. C. 0.02% DIACETATE
DARROWS INJECTION Baxter Healthcare Limited PA0167/053/003 Withdrawn Form 06/07/1992
(LACTATED POTASSIC
SALINE INJ)
DARROWS INJECTION Baxter Healthcare Limited PA0167/053/004 Withdrawn Form 06/07/1992
(LACTATED POTASSIC
SALINE INJ)
HUMAN MONOTARD HM Novo Nordisk A/S PA0218/015/003 06/07/1992
PLASMA-LYTE Baxter Healthcare Limited PA0167/041/003 Withdrawn Form - ELECTROLYTES NOS 06/07/1992
PLASMA-LYTE Baxter Healthcare Limited PA0167/041/004 Withdrawn Form - ELECTROLYTES NOS 06/07/1992

Human Medicines Withdrawn Products Page 448 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/012/002 - SODIUM CHLORIDE 06/07/1992
STERILE WATER FOR Baxter Healthcare Limited PA0167/011/001 - WATER 06/07/1992
IRRIGATION
STERILE WATER FOR Baxter Healthcare Limited PA0167/011/002 - WATER FOR IRRIGATION 06/07/1992
IRRIGATION
ANGICREM Napp Laboratories Limited PA0114/027/001 Cream - GLYCERYL TRINITRATE 03/07/1992
BROVON INHALANT Napp Laboratories Limited PA0114/019/001 - EPINEPHRINE 03/07/1992
- ATROPINE
METHONITRATE
- PAPAVERINE
HYDROCHLORIDE
CHOLEBRIN Napp Laboratories Limited PA0114/030/001 Tablets - IOCETAMIC ACID 03/07/1992
DICYNENE Delandale Laboratories PA0080/001/001 - ETAMSILATE 03/07/1992
Limited
GASTROBID Napp Laboratories Limited PA0114/044/001 Capsule - METOCLOPRAMIDE 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/004 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/005 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/006 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/007 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/008 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/009 Withdrawn Form 03/07/1992
HEPARIN PABYRN - 5ML Paines and Byrne Limited PA0090/006/001 Withdrawn Form 03/07/1992
HEPARIN PABYRN - 5ML Paines and Byrne Limited PA0090/006/002 Withdrawn Form 03/07/1992
HEPARIN PABYRN - 5ML Paines and Byrne Limited PA0090/006/003 Withdrawn Form 03/07/1992
HEPARIN PABYRN Paines and Byrne Limited PA0090/006/010 Withdrawn Form 03/07/1992
(PREFILLED SYRINGES)
SEDONAN EAR Napp Laboratories Limited PA0114/034/001 - PHENAZONE 03/07/1992
- CHLOROBUTANOL
XERUMENEX EAR Napp Laboratories Limited PA0114/040/001 - TROLAMINE 03/07/1992
ANTRADERM Yamanouchi Pharma Ltd PA0062/020/002 02/07/1992
ANTRADERM FORTE Yamanouchi Pharma Ltd PA0062/020/003 02/07/1992
ANTRADERM MILD Yamanouchi Pharma Ltd PA0062/020/001 02/07/1992
ELAMOL Yamanouchi Pharma Ltd PA0062/005/001 Capsule 02/07/1992
EXTRA STRENGTH Cheseborough Pond;s (Ire) PA0403/001/001 02/07/1992
VASELINE INTENSIVE Ltd
CARE
MEDITAR Yamanouchi Pharma Ltd PA0062/019/001 Unknown 02/07/1992
MEDITAR Yamanouchi Pharma Ltd PA0062/019/002 Cream 02/07/1992
MEDITAR Yamanouchi Pharma Ltd PA0062/019/003 02/07/1992
NEOTULLE Fisons Limited PA0018/008/001 - NEOMYCIN 02/07/1992
- BACITRACIN
- POLYMYXIN B
PROPRANOLOL Norgine Limited PA0102/021/001 - PROPRANOLOL 02/07/1992
HYDROCHLORIDE
PROPRANOLOL Norgine Limited PA0102/021/002 - PROPRANOLOL 02/07/1992
HYDROCHLORIDE
PROPRANOLOL Norgine Limited PA0102/021/003 - PROPRANOLOL 02/07/1992
HYDROCHLORIDE
PROPRANOLOL Norgine Limited PA0102/021/004 - PROPRANOLOL 02/07/1992
HYDROCHLORIDE
SOMNITE Norgine Limited PA0102/004/001 Tablets - NITRAZEPAM 02/07/1992
TAMPOVAGAN Norgine Limited PA0102/007/001 - DIETHYLSTILBESTROL 02/07/1992
STILBOESTROL & LACTIC - LACTIC ACID
ACID PESSARIES
COLDREX Sanofi-Synthelabo Ireland PA0077/027/001 Tablets - PARACETAMOL 01/07/1992
Ltd - NOSCAPINE
- PHENYLEPHRINE
GERIFIT Galen Limited PA0185/008/001 Capsule - FERROUS FUMARATE 01/07/1992
- VITAMIN B NOS
NARCAN SYRINGE Du Pont De Nemours PA0200/001/007 - NALOXONE 01/07/1992
Intern.S.A. HYDROCHLORIDE
NARCAN SYRINGE Du Pont De Nemours PA0200/001/008 - NALOXONE 01/07/1992
Intern.S.A. HYDROCHLORIDE
ONCOVIN Eli Lilly and Company Limite PA0047/046/007 Solution for Injection - VINCRISTINE 01/07/1992

POLYALK Galen Limited PA0185/006/003 Gel - ALUMINIUM HYDROXIDE 01/07/1992


GEL, DRIED
- MAGNESIUM OXIDUM
LEVE
- MAGNESIUM TRISILICATE

Human Medicines Withdrawn Products Page 449 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
POLYALK (SUSPENSION) Galen Limited PA0185/006/004 - ALUMINIUM HYDROXIDE 01/07/1992
GEL
- MAGNESIUM TRISILICATE
- DIMETHICONE 350

THROMBOLASE Sanofi-Synthelabo Ireland PA0077/054/001 - UROKINASE 01/07/1992


Ltd
TRANCOPRIN Sanofi-Synthelabo Ireland PA0077/057/001 Tablets - ACETYLSALICYLIC ACID 01/07/1992
Ltd - CHLORMEZANONE
LEDERCORT PARENTERAL Cyanamid of Great Britain PA0037/030/003 29/06/1992
(SUSPENSION)

XYLOCAINE VISCOUS Astra Pharmaceuticals Ltd PA0009/016/004 - LIDOCAINE 29/06/1992


DIOVOL Forest Laboratories UK Ltd PA0100/036/002 Tablets - ALUMINIUM HYDROXIDE- 24/06/1992
MAGNESIUM CARBONATE
GEL
- MAGNESIUM HYDROXIDE
- DIMETICONE, ACTIVATED

GAMIMUNE - N Bayer Diagnostics PA0079/018/001 Solution for Injection - HUMAN NORMAL 23/06/1992
Manufacturing IMMUNOGLOBULIN FOR IV
ADMINISTRATION
GAMIMUNE - N Bayer Diagnostics PA0079/018/002 Solution for Injection - HUMAN NORMAL 23/06/1992
Manufacturing IMMUNOGLOBULIN FOR IV
ADMINISTRATION
GAMIMUNE - N Bayer Diagnostics PA0079/018/003 Solution for Infusion - HUMAN NORMAL 23/06/1992
Manufacturing IMMUNOGLOBULIN FOR IV
ADMINISTRATION
GAMIMUNE - N Bayer Diagnostics PA0079/018/004 Solution for Injection - HUMAN NORMAL 23/06/1992
Manufacturing IMMUNOGLOBULIN FOR IV
ADMINISTRATION
LIDAPRIM E. Merck Ltd PA0054/057/003 Tablets - SULFAMETHIZOLE 19/06/1992
- TRIMETHOPRIM
LIDAPRIM E. Merck Ltd PA0054/057/004 Tablets - SULFAMETHIZOLE 19/06/1992
- TRIMETHOPRIM
LIDAPRIM FORTE E. Merck Ltd PA0054/057/001 Tablets - SULFAMETHIZOLE 19/06/1992
- TRIMETHOPRIM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/006 - AMOXICILLIN 19/06/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
TEMAFLOXACIN Abbott Laboratories Ireland PA0038/054/001 Tablets 19/06/1992
Ltd
TEMAFLOXACIN Abbott Laboratories Ireland PA0038/054/002 Tablets 19/06/1992
Ltd
TEMAFLOXACIN Abbott Laboratories Ireland PA0038/054/003 Tablets 19/06/1992
Ltd
TEMAFLOXACIN Abbott Laboratories Ireland PA0038/054/004 Tablets 19/06/1992
Ltd
SACCHAROMYCES Alax Healthcare Ltd PA0624/001/001 - SACCHAROMYCES 16/06/1992
BOULARDII BOULARDII
VIDEX Bristol-Myers Squibb PA0002/057/007 Powder for Oral Solution - DIDANOSINE 15/06/1992
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/008 Powder for Oral Solution - DIDANOSINE 15/06/1992
Pharmaceuticals uc
VIDEX Bristol-Myers Squibb PA0002/057/009 Powder for Oral Solution - DIDANOSINE 15/06/1992
Pharmaceuticals uc
ZARENE Fisons Pharmaceuticals PA0072/005/001 Tablets - METOLAZONE 15/06/1992
(Ireland) - GLYCERYL TRINITRATE
IOCON Alcon Laboratories (UK) Ltd PA0290/059/001 Gel - COAL TAR SOLUTION 08/06/1992
MYDFRIN STERILE Alcon Laboratories (UK) Ltd PA0290/038/001 - PHENYLEPHRINE 08/06/1992
OPTHALMIC HYDROCHLORIDE
NUTRAPLUS Alcon Laboratories (UK) Ltd PA0290/035/002 - UREA 08/06/1992
OPULETS - HOMATROPINE Alcon Laboratories (UK) Ltd PA0290/045/002 08/06/1992
EYE
OPULETS - HOMATROPINE Alcon Laboratories (UK) Ltd PA0290/045/001 - HOMATROPINE 08/06/1992
EYE DROPS

GYNO-TRAVOGEN Schering AG PA0012/046/003 - ISOCONAZOLE NITRATE 05/06/1992


ZYDOL G.D. Searle & Company PA0001/030/005 Suppositories - TRAMADOL 04/06/1992
Limited HYDROCHLORIDE
ZYDOL G.D. Searle & Company PA0001/030/006 Tablets - TRAMADOL 04/06/1992
Limited HYDROCHLORIDE
AMIKIN Bristol-Myers Squibb PA0048/004/001 - AMIKACIN 27/05/1992
(Holdings) Limited

Human Medicines Withdrawn Products Page 450 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMIKIN Bristol-Myers Squibb PA0048/004/002 - AMIKACIN 27/05/1992
(Holdings) Limited
AMIKIN Bristol-Myers Squibb PA0048/004/003 - AMIKACIN 27/05/1992
(Holdings) Limited
CEFACIDAL Bristol-Myers Squibb PA0048/019/001 Withdrawn Form - CEFAZOLIN SODIUM 27/05/1992
(Holdings) Limited
CEFACIDAL Bristol-Myers Squibb PA0048/019/002 Withdrawn Form - CEFAZOLIN SODIUM 27/05/1992
(Holdings) Limited
CEFACIDAL Bristol-Myers Squibb PA0048/019/003 Withdrawn Form - CEFAZOLIN SODIUM 27/05/1992
(Holdings) Limited
CORGARETIC Bristol-Myers Squibb PA0002/047/003 - NADOLOL 27/05/1992
Pharmaceuticals uc - BENDROFLUMETHIAZIDE

DEXACILLIN Bristol-Myers Squibb PA0002/032/001 Capsule - EPICILLIN 27/05/1992


Pharmaceuticals uc
ENGRAN Bristol-Myers Squibb PA0002/050/001 Tablets - MULTIVITAMINS 27/05/1992
Pharmaceuticals uc
ENKAID Bristol-Myers Squibb PA0048/045/001 Capsule - ENCAINIDE 27/05/1992
(Holdings) Limited HYDROCHLORIDE
ENKAID Bristol-Myers Squibb PA0048/045/002 Capsule - ENCAINIDE 27/05/1992
(Holdings) Limited HYDROCHLORIDE
IPRAL PAEDIATRIC Bristol-Myers Squibb PA0002/036/002 - TRIMETHOPRIM 27/05/1992
(SUSPENSION) Pharmaceuticals uc
NEOPLATIN Bristol-Myers Squibb PA0048/017/002 Withdrawn Form - CISPLATIN 27/05/1992
(Holdings) Limited
PHOSPHOTEC Bristol-Myers Squibb PA0002/001/001 - SODIUM 27/05/1992
Pharmaceuticals uc PYROPHOSPHATE
- STANNOUS FLUORIDE
- SODIUM FLUORIDE
PRE-MED CREAM Bristol-Myers Squibb PA0048/030/001 Cream - SULFUR 27/05/1992
(Holdings) Limited - SALICYLIC ACID
- POLYETHYLENE
STADOL Bristol-Myers Squibb PA0048/010/005 Tablets - BUTORPHANOL 27/05/1992
(Holdings) Limited TARTRATE
STADOL Bristol-Myers Squibb PA0048/010/006 Tablets - BUTORPHANOL 27/05/1992
(Holdings) Limited TARTRATE
VERDIVITON ELIXIR Bristol-Myers Squibb PA0002/049/001 Oral Solution - MULTIVITAMINS 27/05/1992
Pharmaceuticals uc
ATROVENT NEBULISER Boehringer Ingelheim Limited PA0007/002/002 - IPRATROPIUM BROMIDE 26/05/1992

BISOLVOMYCIN Boehringer Ingelheim Limited PA0007/005/001 - BROMHEXINE 26/05/1992


HYDROCHLORIDE
- OXYTETRACYCLINE
HYDROCHLORIDE
SPIROPENT Company Liquidated M123 PA0098/010/001 Tablets 26/05/1992
GLUCOSE 5% B. Braun Medical Limited PA0179/001/024 Solution for Infusion 22/05/1992
CEENU Bristol-Myers Squibb PA0048/012/001 Capsule - LOMUSTINE 15/05/1992
(Holdings) Limited
CEENU Bristol-Myers Squibb PA0048/012/002 Capsule - LOMUSTINE 15/05/1992
(Holdings) Limited
HICONCIL Bristol-Myers Squibb PA0048/005/001 Capsule - AMOXICILLIN 15/05/1992
(Holdings) Limited TRIHYDRATE
HICONCIL Bristol-Myers Squibb PA0048/005/003 Capsule - AMOXICILLIN 15/05/1992
(Holdings) Limited TRIHYDRATE
HICONCIL Bristol-Myers Squibb PA0048/005/005 - AMOXICILLIN 15/05/1992
(Holdings) Limited
HICONCIL Bristol-Myers Squibb PA0048/005/006 - AMOXICILLIN 15/05/1992
(Holdings) Limited
HICONCIL (SUSPENSION) Bristol-Myers Squibb PA0048/005/004 15/05/1992
(Holdings) Limited
KERALYT Bristol-Myers Squibb PA0048/026/001 - SALICYLIC ACID 15/05/1992
(Holdings) Limited
ZIPIX Bristol-Myers Squibb PA0048/011/001 Tablets - XIPAMIDE 15/05/1992
(Holdings) Limited
ZIPIX Bristol-Myers Squibb PA0048/011/002 Tablets - XIPAMIDE 15/05/1992
(Holdings) Limited
ELLIMANS UNIVERSAL Beecham Group Plc PA0449/002/001 - TURPENTINE OIL 14/05/1992
EMBROCATION - ACETIC ACID
DIOVOL Forest Laboratories UK Ltd PA0100/036/001 Tablets - ALUMINIUM HYDROXIDE- 12/05/1992
MAGNESIUM CARBONATE
GEL
- MAGNESIUM HYDROXIDE
- DIMETICONE, ACTIVATED

Human Medicines Withdrawn Products Page 451 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
COD LIVER OIL Health & Diet Food Company PA0395/013/001 Capsule - COD LIVER OIL 04/05/1992
Ltd - RETINOL
- VITAMIN D SYNTHETIC
CALCIFEROL
REV UP CAPSULES GR Lane Health Products Lt PA0252/032/001 04/05/1992

SLIPPERY ELM FOOD GR Lane Health Products Lt PA0257/037/001 04/05/1992

SUPERSUN CHILDRENS Supersun Nutrition Ltd PA0498/002/001 Tablets - RETINOL 04/05/1992


VITAMIN TABLETS - VITAMIN D SYNTHETIC
CALCIFEROL
- ASCORBIC ACID
SUPERSUN VITAMIN B6 Supersun Nutrition Ltd PA0498/007/001 Tablets - PYRIDOXINE 04/05/1992
HYDROCHLORIDE
SUPERSUN VITAMIN E Supersun Nutrition Ltd PA0498/004/001 Capsule - TOCOPHEROL 04/05/1992
ILOMEDIN IV HE Clissmann PA0012/069/001 - ILOPROST 01/05/1992
COPPER OINTMENT Weleda (UK) Limited PA0407/008/001 Ointment - COPPER 29/04/1992
MINIMS HYOSCINE Chauvin Pharmaceuticals PA0118/015/001 24/04/1992
HYDROBROMIDE Limited
NACTON SmithKline Beecham Pharm PA0049/039/001 Tablets - POLDINE METILSULFATE 23/04/1992
Ltd
NACTON FORTE SmithKline Beecham Pharm PA0049/039/002 Tablets - POLDINE METILSULFATE 23/04/1992
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/005 - AMOXICILLIN 21/04/1992
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/009 - AMOXICILLIN 21/04/1992
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/010 - AMOXICILLIN 21/04/1992
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/011 - AMOXICILLIN 21/04/1992
Ltd
AMOXIL VIAL SmithKline Beecham Pharm PA0049/006/012 - AMOXICILLIN 21/04/1992
Ltd
AUGMENTIN JUNIOR SmithKline Beecham Pharm PA0049/035/003 Tablets - CLAVULANATE 21/04/1992
Ltd POTASSIUM
- AMOXICILLIN
AUGMENTIN JUNIOR SmithKline Beecham Pharm PA0049/035/004 Tablets Effervescent - CLAVULANATE 21/04/1992
Ltd POTASSIUM
- AMOXICILLIN
AUGMENTIN PAEDIATRIC SmithKline Beecham Pharm PA0049/035/008 - CLAVULANIC ACID 21/04/1992
Ltd - AMOXICILLIN
FLOXAPEN 125 MG/5 ML SmithKline Beecham Pharm PA0049/018/009 Syrup - FLUCLOXACILLIN 21/04/1992
Ltd MAGNESIUM
FLOXAPEN 250 MG/5 ML SmithKline Beecham Pharm PA0049/018/011 Syrup - FLUCLOXACILLIN 21/04/1992
Ltd MAGNESIUM
MAXOLON SmithKline Beecham Pharm PA0049/024/005 Withdrawn Form 21/04/1992
Ltd
MENTHODEX Bell, Sons & Co. PA0607/001/001 21/04/1992
(Druggists)Ltd
PYOPEN SmithKline Beecham Pharm PA0049/011/003 - CARBENICILLIN 21/04/1992
Ltd DISODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/001 Capsule - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/002 Tablets - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/003 Syrup - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/004 - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/005 - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM
SUPRAPEN SmithKline Beecham Pharm PA0049/031/007 - AMOXICILLIN 21/04/1992
Ltd TRIHYDRATE
- FLUCLOXACILLIN
SODIUM

Human Medicines Withdrawn Products Page 452 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TICAR SmithKline Beecham Pharm PA0049/029/004 Withdrawn Form 21/04/1992
Ltd
TICAR SmithKline Beecham Pharm PA0049/029/005 21/04/1992
Ltd
TICAR SmithKline Beecham Pharm PA0049/029/007 Withdrawn Form 21/04/1992
Ltd
PONDOCILLIN Leo Laboratories Limited PA0046/009/004 Tablets - PIVAMPICILLIN 17/04/1992
SUDAFED S A CAPSULES Wellcome (Ireland) Limited PA0017/054/004 Capsule - PSEUDOEPHEDRINE 16/04/1992
HYDROCHLORIDE
SYRAPRIM Wellcome (Ireland) Limited PA0017/077/003 Withdrawn Form - TRIMETHOPRIM 16/04/1992
SYRAPRIM PAEDIATRIC Wellcome (Ireland) Limited PA0017/077/004 - TRIMETHOPRIM 16/04/1992
SUSPENSION
ANDOZAC Bristol-Myers Squibb Pharma PA0700/003/001 Tablets - FINASTERIDE 14/04/1992

EMTEXATE/METHOTREXA Ferring Pharmaceuticals PA0224/007/002 14/04/1992


TE FREEZE Limited
EMTEXATE/METHOTREXA Ferring Pharmaceuticals PA0224/007/003 14/04/1992
TE FREEZE Limited
EMTHEXATE/METHOTREX Ferring Pharmaceuticals PA0224/007/001 14/04/1992
ATE FREEZE Limited
AMYTAL Eli Lilly and Company Limite PA0047/009/006 Withdrawn Form - AMOBARBITAL 10/04/1992

CALMIGEN Mercury Pharmaceuticals PA0073/041/001 - DIAZEPAM 10/04/1992


(Ireland) Ltd
CALMIGEN Mercury Pharmaceuticals PA0073/041/002 - DIAZEPAM 10/04/1992
(Ireland) Ltd
CALMIGEN Mercury Pharmaceuticals PA0073/041/003 - DIAZEPAM 10/04/1992
(Ireland) Ltd
DORMIGEN Mercury Pharmaceuticals PA0073/052/001 Tablets - NITRAZEPAM 10/04/1992
(Ireland) Ltd
FRUSEIDE Mercury Pharmaceuticals PA0073/059/001 Tablets 10/04/1992
(Ireland) Ltd
FRUSEMIDE Mercury Pharmaceuticals PA0073/059/002 Tablets 10/04/1992
(Ireland) Ltd
LIDAPRIM E. Merck Ltd PA0054/057/002 - SULFAMETHIZOLE 10/04/1992
- TRIMETHOPRIM
NIFURAN Mercury Pharmaceuticals PA0073/011/001 Tablets - NITROFURANTOIN 10/04/1992
(Ireland) Ltd
NIFURAN Mercury Pharmaceuticals PA0073/011/002 Tablets - NITROFURANTOIN 10/04/1992
(Ireland) Ltd
PAEDAFER Mercury Pharmaceuticals PA0073/013/001 - FERROUS SULFATE 10/04/1992
(Ireland) Ltd
CHLOROMYCETIN Parke Davis & Company PA0056/015/003 - CHLORAMPHENICOL 09/04/1992
CHLOROMYCETIN Parke Davis & Company PA0056/015/004 - CHLORAMPHENICOL 09/04/1992
OPHTHALMIC
ISOKET SCHWARZ PHARMA Limite PA0271/002/001 Cream - ISOSORBIDE 09/04/1992
MONONITRATE
PROPRANOLOL Roussel Laboratories Limited PA0006/036/004 Tablets - PROPRANOLOL 08/04/1992

ANECTINE INJECTION Wellcome (Ireland) Limited PA0017/044/002 07/04/1992


BANOCIDE Wellcome (Ireland) Limited PA0017/079/001 Tablets - DIETHYLCARBAMAZINE 07/04/1992
CITRATE
ISOPHANE INSULIN B. P. Wellcome (Ireland) Limited PA0017/065/001 07/04/1992
LOASID Wellcome (Ireland) Limited PA0017/088/001 Tablets - MAGNESIUM HYDROXIDE 07/04/1992
- DIMETICONE, ACTIVATED

NITRO DU 10CM The Boots Company Plc PA0004/047/001 Withdrawn Form - GLYCERYL TRINITRATE 07/04/1992
PROTAMINE ZINC INSULIN Wellcome (Ireland) Limited PA0017/064/001 07/04/1992
B.P.
PROVENT Wellcome (Ireland) Limited PA0017/086/002 - THEOPHYLLINE 07/04/1992
SEPTRIN PAEDIATRIC Wellcome (Ireland) Limited PA0017/002/004 Tablets - SULFAMETHOXAZOLE 07/04/1992
- TRIMETHOPRIM
TETANUS ANTITOXIN B P Wellcome (Ireland) Limited PA0017/039/006 07/04/1992
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/062/002 07/04/1992
INSULIN B P
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/065/002 07/04/1992
ISOPHANE
BRIETAL SODIUM Eli Lilly and Company Limite PA0047/062/003 - METHOHEXITAL SODIUM 06/04/1992

DIMELOR Eli Lilly and Company Limite PA0047/044/001 Tablets 06/04/1992

EMLAB BREWERS-YEAST 3M Health Care Limited PA0057/045/001 Tablets - YEAST DRIED 06/04/1992
EMLAB IRON & BREWERS- 3M Health Care Limited PA0057/046/001 Tablets - YEAST DRIED 06/04/1992
YEAST

Human Medicines Withdrawn Products Page 453 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ONCOVIN Eli Lilly and Company Limite PA0047/046/006 Solution for Injection - VINCRISTINE 06/04/1992

PENTRAL 80 Aventis Behring Limited PA0010/017/001 - PENTAERITHRITYL 06/04/1992


TETRANITRATE
ROVAMYCIN May & Baker Limited PA0040/007/001 Tablets 06/04/1992
VELBE Eli Lilly and Company Limite PA0047/048/001 Withdrawn Form - VINBLASTINE SULFATE 06/04/1992

RORCAL-D Rorer Pharmaceuticals PA0468/029/001 Tablets - CALCIUM CARBONATE 02/04/1992


Limited - COLECALCIFEROL
TICAR SmithKline Beecham Pharm PA0049/029/002 Withdrawn Form 02/04/1992
Ltd
AMYTAL SODIUM Eli Lilly and Company Limite PA0047/009/007 Capsule - AMOBARBITAL 01/04/1992

AMYTAL SODIUM Eli Lilly and Company Limite PA0047/009/008 Capsule - AMOBARBITAL 01/04/1992

FLUCLOXACILLIN Athlone Laboratories Ltd PA0298/009/001 Capsule - FLUCLOXACILLIN 01/04/1992


FLUCLOXACILLIN Athlone Laboratories Ltd PA0298/009/002 Capsule - FLUCLOXACILLIN 01/04/1992
INDOMETHACIN Athlone Laboratories Ltd PA0298/003/002 Capsule - INDOMETACIN 01/04/1992
INDOMETHACIN/INDOLON Athlone Laboratories Ltd PA0298/003/001 Capsule - INDOMETACIN 01/04/1992
E
PARACETAMOL ELIXIR Athlone Laboratories Ltd PA0298/006/001 - PARACETAMOL 01/04/1992
REVERIN I.M. Hoechst Ireland Limited PA0023/012/001 - LIDOCAINE 01/04/1992
HYDROCHLORIDE
- ROLITETRACYCLINE
SECONAL SODIUM Eli Lilly and Company Limite PA0047/011/001 Capsule - SECOBARBITAL SODIUM 01/04/1992

SECONAL SODIUM Eli Lilly and Company Limite PA0047/011/002 Capsule - SECOBARBITAL SODIUM 01/04/1992

SOLIVITO Pharmacia Laboratories PA0187/005/001 - VITAMINS NOS 01/04/1992


Limited
TUINAL Eli Lilly and Company Limite PA0047/012/001 Capsule - AMOBARBITAL 01/04/1992
- SECOBARBITAL SODIUM
VITLIPID ADULT Pharmacia Laboratories PA0187/004/001 - SOYBEAN OIL 01/04/1992
Limited
VITLIPID INFANT Pharmacia Laboratories PA0187/004/002 - SOYBEAN OIL 01/04/1992
Limited
DIPARIM 25 B.V. Pharbita PA0508/006/001 31/03/1992
DIPARIM 75 B.V. Pharbita PA0508/006/002 31/03/1992
ASACOL J B Tillotts Limited PA0360/007/001 Tablets - MESALAZINE 30/03/1992
DYCALIN Berk Pharmaceuticals PA0082/065/001 Tablets - CARBAMAZEPINE 30/03/1992
Limited
DYCALIN Berk Pharmaceuticals PA0082/065/002 Tablets - CARBAMAZEPINE 30/03/1992
Limited
DYCALIN Berk Pharmaceuticals PA0082/065/003 Tablets - CARBAMAZEPINE 30/03/1992
Limited
CALVEPEN 333 Leo Laboratories Limited PA0046/007/004 - PENICILLIN CALCIUM 27/03/1992
(SUSPENSION)
CALVEPEN PAEDIATRIC Leo Laboratories Limited PA0046/007/001 - 27/03/1992
(SUSPENSION) PHENOXYMETHYLPENICI
LLIN CALCIUM
FUCIDIN ENTERIC Leo Laboratories Limited PA0046/004/011 - FUSIDATE SODIUM 27/03/1992
COATED
KEFLIN Eli Lilly and Company Limite PA0047/015/001 - CEFALOTIN 27/03/1992

MERALEN Marion Merrell Limited PA0041/023/001 Capsule - FLUFENAMIC ACID 27/03/1992


MINIHEP DARTS Leo Laboratories Limited PA0046/037/001 27/03/1992
MINIHEP DARTS Leo Laboratories Limited PA0046/037/002 27/03/1992
NETHAPRIN DOSPAN Marion Merrell Limited PA0041/018/002 Tablets - ETAFEDRINE 27/03/1992
HYDROCHLORIDE
- BUFYLLINE
- DOXYLAMINE
SUCCINATE
- PHENYLEPHRINE
HYDROCHLORIDE
PONDOCILLIN Leo Laboratories Limited PA0046/009/002 Tablets - PIVAMPICILLIN 27/03/1992
PONDOCILLIN Leo Laboratories Limited PA0046/009/003 Tablets - PIVAMPICILLIN 27/03/1992
PRESTIM Leo Laboratories Limited PA0046/006/002 Tablets - TIMOLOL MALEATE 27/03/1992
- BENDROFLUMETHIAZIDE

SYNDETTE Marion Merrell Limited PA0041/019/001 Syrup - PARACETAMOL 27/03/1992


- DOXYLAMINE
SUCCINATE
TENAVOID Leo Laboratories Limited PA0046/015/001 Tablets - BENDROFLUMETHIAZIDE 27/03/1992
- MEPROBAMATE

Human Medicines Withdrawn Products Page 454 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TENSANYL Leo Laboratories Limited PA0046/026/001 Tablets - RESERPINE 27/03/1992
- BENDROFLUMETHIAZIDE
- POTASSIUM CHLORIDE

NIZORAL OVULES Janssen Pharmaceutica PA0045/022/004 - KETOCONAZOLE 26/03/1992


SUFENTA FORTE Janssen Pharmaceutica PA0045/029/003 - SUFENTANIL 26/03/1992
MINIHEP Leo Laboratories Limited PA0046/045/001 Capsule - HEPARIN CALCIUM 25/03/1992
HERLEX Allergan Pharmaceuticals PA0148/033/001 - IDOXURIDINE 23/03/1992
Ireland
VELOSEF INJECTION Bristol-Myers Squibb PA0002/014/006 - CEFRADINE 23/03/1992
Pharmaceuticals uc
VELOSEF INJECTION Bristol-Myers Squibb PA0002/014/007 - CEFRADINE 23/03/1992
Pharmaceuticals uc
VELOSEF INJECTION Bristol-Myers Squibb PA0002/014/005 - CEFRADINE 23/03/1992
(Holdings) Limited
DIPRIVAN Zeneca Limited PA0051/056/001 Withdrawn Form - PROPOFOL 20/03/1992
FLUOTHANE Zeneca Limited PA0051/032/002 20/03/1992
TRILENE Zeneca Limited PA0051/033/001 - TRICHLOROETHYLENE 20/03/1992
LOMODEX 40 IN Fisons Limited PA0018/022/002 - DEXTRAN 19/03/1992
DEXTROSE
LOMODEX 40 IN SALINE Fisons Limited PA0018/022/001 - DEXTRAN 19/03/1992
LOMODEX 70 IN Fisons Limited PA0018/023/002 - DEXTRAN 19/03/1992
DEXTROSE
LOMODEX 70 IN SALINE Fisons Limited PA0018/023/001 - DEXTRAN 19/03/1992
CIDOMYCIN Roussel Laboratories Limited PA0006/003/002 Cream - MICRONOMICIN 17/03/1992

GENTICIN PAEDIATRIC Nicholas Laboratories PA0032/004/001 Withdrawn Form - GENTAMICIN 17/03/1992


SELDANE Marion Merrell Limited PA0041/046/001 Tablets - TERFENADINE 16/03/1992
D.D.D. D.D.D. Limited PA0302/008/001 - METHYL SALICYLATE 13/03/1992
- THYMOL
PENELAN Elan Pharma Ltd PA0516/001/001 Capsule 13/03/1992
BAMBEC Astra Pharmaceuticals Ltd PA0009/048/001 Capsule - BAMBUTEROL 12/03/1992
HYDROCHLORIDE
BAMBEC Astra Pharmaceuticals Ltd PA0009/048/002 Tablets - BAMBUTEROL 12/03/1992
HYDROCHLORIDE
SOTACOR Bristol-Myers Squibb PA0048/001/011 Withdrawn Form - SOTALOL 11/03/1992
(Holdings) Limited
ALBUMINAR 20 Aventis Behring Limited PA0010/022/004 - HUMAN ALBUMIN 10/03/1992
ALBUMINAR 25 Aventis Behring Limited PA0010/022/007 - HUMAN ALBUMIN 10/03/1992
PRO-PLUS Nicholas Laboratories PA0032/040/001 Tablets - CAFFEINE 10/03/1992
GRANEODIN Bristol-Myers Squibb PA0002/008/001 Ointment - NEOMYCIN SULFATE 09/03/1992
Pharmaceuticals uc - GRAMICIDIN
KANFOTREX Bristol-Myers Squibb PA0048/006/001 Ointment - KANAMYCIN 09/03/1992
(Holdings) Limited - AMFOMYCIN
- HYDROCORTISONE
KENACORT A WITH Bristol-Myers Squibb PA0002/010/002 Ointment - TRIAMCINOLONE 09/03/1992
GRANEODIN Pharmaceuticals uc - NEOMYCIN
- GRAMICIDIN
METHOTREXATE Bristol-Myers Squibb PA0048/024/001 09/03/1992
(Holdings) Limited
MYCOSTATIN Bristol-Myers Squibb PA0002/007/008 - NYSTATIN 09/03/1992
(SUSPENSION) Pharmaceuticals uc
MYCOSTATIN DUSTING Bristol-Myers Squibb PA0002/007/006 - NYSTATIN 09/03/1992
POWDER Pharmaceuticals uc
MYCOSTATIN E.V.T. Bristol-Myers Squibb PA0002/007/005 - NYSTATIN 09/03/1992
Pharmaceuticals uc
PALITREX Bristol-Myers Squibb PA0048/008/001 Capsule - CEFALEXIN 09/03/1992
(Holdings) Limited MONOHYDRATE
PALITREX Bristol-Myers Squibb PA0048/008/002 Capsule - CEFALEXIN 09/03/1992
(Holdings) Limited MONOHYDRATE
PALITREX (SUSPENSION) Bristol-Myers Squibb PA0048/008/003 - CEFALEXIN 09/03/1992
(Holdings) Limited MONOHYDRATE
PALITREX (SUSPENSION) Bristol-Myers Squibb PA0048/008/004 - CEFALEXIN 09/03/1992
(Holdings) Limited MONOHYDRATE
PALITREX (SUSPENSION) Bristol-Myers Squibb PA0048/008/005 - CEFALEXIN 09/03/1992
(Holdings) Limited MONOHYDRATE
PALITREX PAEDIATRIC Bristol-Myers Squibb PA0048/008/006 - CEFALEXIN 09/03/1992
DROPS (Holdings) Limited MONOHYDRATE
PENTREXYL Bristol-Myers Squibb PA0048/009/001 Capsule - AMPICILLIN TRIHYDRATE 09/03/1992
(Holdings) Limited
PENTREXYL Bristol-Myers Squibb PA0048/009/002 Capsule - AMPICILLIN TRIHYDRATE 09/03/1992
(Holdings) Limited
PENTREXYL Bristol-Myers Squibb PA0048/009/003 Withdrawn Form - AMPICILLIN SODIUM 09/03/1992
(Holdings) Limited

Human Medicines Withdrawn Products Page 455 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PENTREXYL Bristol-Myers Squibb PA0048/009/004 Withdrawn Form - AMPICILLIN SODIUM 09/03/1992
(Holdings) Limited
PENTREXYL Bristol-Myers Squibb PA0048/009/005 Withdrawn Form - AMPICILLIN SODIUM 09/03/1992
(Holdings) Limited
PENTREXYL Bristol-Myers Squibb PA0048/009/006 - AMPICILLIN TRIHYDRATE 09/03/1992
(SUSPENSION) (Holdings) Limited
PENTREXYL PAEDIATRIC Bristol-Myers Squibb PA0048/009/007 - AMPICILLIN TRIHYDRATE 09/03/1992
DROPS (Holdings) Limited
SECRON E.C. De Witt & Company PA0299/007/001 Syrup 09/03/1992
Limited
FINALGON Windsor Healthcare Ltd PA0429/005/001 Cream - NONIVAMIDE 06/03/1992
- BUTOXYETHYL
NICOTINATE
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/009 - CHLORHEXIDINE 05/03/1992
DIACETATE
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/010 - CHLORHEXIDINE 05/03/1992
DIACETATE
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/011 - CHLORHEXIDINE 05/03/1992
DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/001 - CHLORHEXIDINE 05/03/1992
DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/002 - CHLORHEXIDINE 05/03/1992
DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/003 - CHLORHEXIDINE 05/03/1992
DIACETATE
FRUSEMIDE Ranbaxy Ireland Limited PA0408/007/002 Tablets - FUROSEMIDE 05/03/1992
FRUSEMIDE Ranbaxy Ireland Limited PA0408/007/003 Tablets - FUROSEMIDE 05/03/1992
HALOPERIDOL Ranbaxy Ireland Limited PA0408/044/001 Tablets - HALOPERIDOL 05/03/1992
HALOPERIDOL Ranbaxy Ireland Limited PA0408/044/002 Tablets 05/03/1992
HALOPERIDOL Ranbaxy Ireland Limited PA0408/044/003 Tablets 05/03/1992
HALOPERIDOL Ranbaxy Ireland Limited PA0408/044/004 Tablets - HALOPERIDOL 05/03/1992
HALOPERIDOL Ranbaxy Ireland Limited PA0408/044/005 Tablets 05/03/1992
AMITRIPTYLINE Ranbaxy Ireland Limited PA0408/048/001 Tablets - AMITRIPTYLINE 03/03/1992
AMITRIPTYLINE Ranbaxy Ireland Limited PA0408/048/002 Tablets - AMITRIPTYLINE 03/03/1992
FIBROSINE ANALGESIC Pfizer Consumer Healthcare PA0172/015/001 - METHYL NICOTINATE 03/03/1992
BALM Ltd - GLYCOL SALICYLATE
- HISTAMINE
HYDROCHLORIDE
- CAPSAICIN
LORAZEPAM Ranbaxy Ireland Limited PA0408/046/001 Tablets - LORAZEPAM 03/03/1992
LORAZEPAM Ranbaxy Ireland Limited PA0408/046/002 Tablets 03/03/1992
OXAZEPAM Ranbaxy Ireland Limited PA0408/045/001 Tablets 03/03/1992
OXAZEPAM Ranbaxy Ireland Limited PA0408/045/002 Tablets 03/03/1992
OXAZEPAM Ranbaxy Ireland Limited PA0408/045/003 Tablets 03/03/1992
REDOXON Roche Products Limited PA0050/065/002 03/03/1992
SPIRONOLACTONE Ranbaxy Ireland Limited PA0408/043/001 Tablets 03/03/1992
SPIRONOLACTONE Ranbaxy Ireland Limited PA0408/043/002 Tablets - SPIRONOLACTONE 03/03/1992
SPIRONOLACTONE Ranbaxy Ireland Limited PA0408/043/003 Tablets 03/03/1992
SOFRAMYCIN Roussel Laboratories Limited PA0006/011/005 Tablets - FRAMYCETIN SULFATE 02/03/1992

MYCIFRADIN SULPHATE Pharmacia Limited PA0016/010/001 - NEOMYCIN SULFATE 27/02/1992


AMITRIPTYLINE Accord-UK Ltd PA0176/032/001 Tablets - AMITRIPTYLINE 26/02/1992
AMITRIPTYLINE Accord-UK Ltd PA0176/032/002 Tablets - AMITRIPTYLINE 26/02/1992
AMITRIPTYLINE Accord-UK Ltd PA0176/032/003 Tablets - AMITRIPTYLINE 26/02/1992
ATEBOLOL Accord-UK Ltd PA0176/064/002 Tablets 26/02/1992
ATENOLOL Accord-UK Ltd PA0176/064/001 Tablets 26/02/1992
CO-CODAMOL Accord-UK Ltd PA0176/054/001 Tablets - PARACETAMOL 26/02/1992
- CODEINE PHOSPHATE
METOPROLOL Accord-UK Ltd PA0176/069/001 Tablets - METOPROLOL 26/02/1992
METOPROLOL Accord-UK Ltd PA0176/069/002 Tablets - METOPROLOL 26/02/1992
OXAZEPAM Accord-UK Ltd PA0176/062/001 Tablets 26/02/1992
OXAZEPAM Accord-UK Ltd PA0176/062/002 Tablets 26/02/1992
TETRACYCLINE Accord-UK Ltd PA0176/004/001 Tablets 26/02/1992
DUOBACT Orion Pharma A/s PA0303/015/001 - SULFAMETHOXAZOLE 25/02/1992
- TRIMETHOPRIM
HYPERPAX-L Orion Pharma A/s PA0303/007/001 Tablets - METHYLDOPA 25/02/1992
HYPERPAX-L Orion Pharma A/s PA0303/007/002 Tablets - METHYLDOPA 25/02/1992
ORIBACT Orion Pharma A/s PA0303/015/002 Tablets - SULFAMETHOXAZOLE 25/02/1992
- TRIMETHOPRIM
DOUBLE-STRENGTH Superpac Products Limited PA0552/007/001 21/02/1992
SEIDLITZ
OCUSOL The Boots Company Plc PA0004/007/001 - SULFACETAMIDE 20/02/1992
AMYTAL Eli Lilly and Company Limite PA0047/009/010 Tablets - AMOBARBITAL 19/02/1992

Human Medicines Withdrawn Products Page 456 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BRETYLOL Du Pont De Nemours PA0200/005/001 - BRETYLIUM TOSILATE 19/02/1992
Intern.S.A.
ILOSONE Dista Products Limited PA0447/004/004 Tablets - ERYTHROMYCIN 19/02/1992
ESTOLATE
KEFZOL Eli Lilly and Company Limite PA0047/021/001 - CEFAZOLIN SODIUM 19/02/1992

KEFZOL Eli Lilly and Company Limite PA0047/021/002 - CEFAZOLIN SODIUM 19/02/1992

VERICAPS Cuxson Gerrard & Company PA0229/001/001 19/02/1992


Ltd
BENAFED Parke Davis & Company PA0056/017/001 - DIPHENHYDRAMINE 18/02/1992
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
CO TRIMOXAZOLE Roussel Laboratories Limited PA0006/029/002 Tablets - SULFAMETHOXAZOLE 18/02/1992
- TRIMETHOPRIM
CO-TRIMOXAZOLE Roussel Laboratories Limited PA0006/029/003 Tablets - SULFAMETHOXAZOLE 18/02/1992
- TRIMETHOPRIM LACTATE

CO-TRIMOXAZOLE Roussel Laboratories Limited PA0006/029/004 Tablets - SULFAMETHOXAZOLE 18/02/1992


- TRIMETHOPRIM
CO-TRIMOXAZOLE Roussel Laboratories Limited PA0006/029/001 - SULFAMETHOXAZOLE 18/02/1992
DISPERSIBLE TABLETS - TRIMETHOPRIM
B.P.
IMUNOX Cilag Limited PA0059/037/001 Withdrawn Form - THYMOPENTIN 18/02/1992
IMUNOX Cilag Limited PA0059/037/002 Withdrawn Form - THYMOPENTIN 18/02/1992
ELANOL Elan Corporation Plc PA0116/002/003 17/02/1992
VENTOLIN METERED Parallel Lines Ltd PPA0384/002/001 17/02/1992
DOSE
ZEPHOLIN GRANULATE Fujisawa Deutschland GmbH PA0473/003/005 - THEOPHYLLINE 17/02/1992
100
ZEPHOLIN GRANULATE Fujisawa Deutschland GmbH PA0473/003/006 - THEOPHYLLINE 17/02/1992
200
ZEPHOLIN GRANULATE Fujisawa Deutschland GmbH PA0473/003/007 - THEOPHYLLINE 17/02/1992
350
ZEPHOLIN GRANULATE Fujisawa Deutschland GmbH PA0473/003/008 - THEOPHYLLINE 17/02/1992
500
GERI-OPTIOLE Pharma-Global Limited PA0141/021/001 - DIGITALIN 14/02/1992
TFT OPHTIOLE EYE Pharma-Global Limited PA0141/008/001 - POLYMYXIN 14/02/1992
DROPS
BIAVAX II VACCINE Merck Sharp and Dohme PA0035/034/002 - RUBELLAVIRUS 07/02/1992
Limited - MUMPS VACCINE (LIVE
ATTENUATED)
CLINORIL Merck Sharp and Dohme PA0035/004/004 Tablets - SULINDAC 07/02/1992
Limited
CLINORIL Merck Sharp and Dohme PA0035/004/005 Tablets - SULINDAC 07/02/1992
Limited
CODELSOL Merck Sharp and Dohme PA0035/015/001 Withdrawn Form - PREDNISOLONE SODIUM 07/02/1992
Limited PHOSPHATE
H-B-VAX HEPATITIS B Merck Sharp and Dohme PA0035/058/004 - HEPATITIS B VACCINE 07/02/1992
VACCINE Limited
INDOCID INTRA- Merck Sharp and Dohme PA0035/003/008 Withdrawn Form - INDOMETACIN 07/02/1992
MUSCULAR Limited
INDOCID INTRA- Merck Sharp and Dohme PA0035/003/009 Withdrawn Form - INDOMETACIN 07/02/1992
MUSCULAR Limited
INDOCID-R Merck Sharp and Dohme PA0035/003/007 Capsule - INDOMETACIN 07/02/1992
Limited
MANOPLAX The Boots Company Plc PA0004/050/002 - FLOSEQUINAN 07/02/1992
M-M-VAX (SINGLE DOSE) Merck Sharp and Dohme PA0035/038/001 - MEASLES VIRUS 07/02/1992
Limited VACCINE LIVE
ATTENUATED
- MUMPS VACCINE (LIVE
ATTENUATED)
M-R-VAX II VACCINE Merck Sharp and Dohme PA0035/036/002 07/02/1992
Limited
PROPRANOLOL Pinewood Laboratories Ltd, PA0281/016/004 Tablets 07/02/1992
DECADRON EAR/EYE Merck Sharp and Dohme PA0035/016/005 - DEXAMETHASONE 05/02/1992
Limited SODIUM PHOSPHATE
DECADRON EYE/EAR Merck Sharp and Dohme PA0035/016/006 - DEXAMETHASONE 05/02/1992
Limited SODIUM PHOSPHATE
HYDROCORTONE Merck Sharp and Dohme PA0035/021/004 Cream - HYDROCORTISONE 05/02/1992
Limited
CRYPTOCUR Hoechst Ireland Limited PA0023/051/001 - GONADORELIN 03/02/1992
BABY MELTUS LINCTUS Cupal Limited PA0258/028/001 02/02/1992

Human Medicines Withdrawn Products Page 457 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KAO-C Cupal Limited PA0258/017/003 Tablets 02/02/1992
Q-PANOL PARACETAMOL Cupal Limited PA0258/015/002 Tablets 02/02/1992
WAX AID EAR Cupal Limited PA0258/016/001 02/02/1992
CHYMACORT Aventis Behring Limited PA0010/008/003 Ointment - CHYMOTRYPSIN 31/01/1992
- HYDROCORTISONE
ACETATE
CHYMACORT Aventis Behring Limited PA0010/008/004 Ointment - CHYMOTRYPSIN 31/01/1992
- HYDROCORTISONE
ACETATE
DEXTROSE 5% B. Braun Medical Limited PA0179/001/021 Withdrawn Form 30/01/1992
DEXTROSE 5% B. Braun Medical Limited PA0179/001/022 Withdrawn Form 30/01/1992
DEXTROSE 5% B. Braun Medical Limited PA0179/001/023 Withdrawn Form 30/01/1992
SPARINE John Wyeth & Brother PA0022/010/003 Tablets - PROMAZINE 30/01/1992
Limited - PROMAZINE EMBONATE
- PROMAZINE
HYDROCHLORIDE
SPARINE John Wyeth & Brother PA0022/010/004 Tablets - PROMAZINE 30/01/1992
Limited - PROMAZINE EMBONATE
- PROMAZINE
HYDROCHLORIDE
SPARINE John Wyeth & Brother PA0022/010/005 Tablets - PROMAZINE 30/01/1992
Limited - PROMAZINE EMBONATE
- PROMAZINE
HYDROCHLORIDE
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/002/002 28/01/1992
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/002/005 28/01/1992
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/002/008 28/01/1992
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/002/009 28/01/1992
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/002/006 28/01/1992
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/002/003 28/01/1992
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/002/004 - AMINO ACIDS 28/01/1992
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/002/007 28/01/1992
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/002/001 - AMINO ACIDS NOS 28/01/1992
KONYNE H.T. Bayer Diagnostics PA0079/017/001 25/01/1992
Manufacturing
KONYNE H.T. Bayer Diagnostics PA0079/017/002 25/01/1992
Manufacturing
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/006 Cream - MICONAZOLE NITRATE 24/01/1992
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/007 Cream - MICONAZOLE NITRATE 24/01/1992
DISPOSABLE
HALDOL Janssen Pharmaceutica PA0045/005/008 Tablets - HALOPERIDOL 24/01/1992
HYPNOMIDATE Janssen Pharmaceutica PA0045/024/001 Withdrawn Form - ETOMIDATE 24/01/1992
HYPNOMIDATE PRO- Janssen Pharmaceutica PA0045/024/002 - ETOMIDATE 24/01/1992
INFUSION
MEVILIN - L 10 SINGLE UCB Pharma Limited PA0365/009/002 - MEASLES VIRUS 24/01/1992
DOSE VACCINE LIVE
ATTENUATED
MEVILIN - L 50 DOSE UCB Pharma Limited PA0365/009/003 - MEASLES VIRUS 24/01/1992
VACCINE LIVE
ATTENUATED
MEVILIN - L SINGLE DOSE UCB Pharma Limited PA0365/009/001 - MEASLES VIRUS 24/01/1992
VACCINE LIVE
ATTENUATED
PENICILLIN G HOECHST Hoechst Ireland Limited PA0023/033/001 - BENZYL-PENICILLINATE- 21/01/1992
OXYTITANIQUE
- NA-SALT AV 4,4-DIOXI-3,3
DIAMINO-
ARSENOBENSOLDIMETHY
LENDISUF.
STREPTASE Hoechst Ireland Limited PA0023/029/001 - STREPTOKINASE 21/01/1992
MEGACLOR Forest Laboratories UK Ltd PA0100/002/001 Capsule - CLOMOCYCLINE 17/01/1992
SOFRAMYCIN NEBULISER Roussel Laboratories Limited PA0006/011/006 - FRAMYCETIN SULFATE 17/01/1992
- GRAMICIDIN
- PHENYLEPHRINE
HYDROCHLORIDE
SULPHADIMIDINE Mercury Pharmaceuticals PA0073/085/001 Tablets 15/01/1992
(Ireland) Ltd
CARDIOVAR Pfizer Limited PA0019/035/001 Tablets - TRIMAZOSIN 14/01/1992
CARDIOVAR Pfizer Limited PA0019/035/002 Tablets - TRIMAZOSIN 14/01/1992
CARDIOVAR Pfizer Limited PA0019/035/003 Tablets - TRIMAZOSIN 14/01/1992
CETRAM Mercury Pharmaceuticals PA0073/087/001 Tablets - IBUPROFEN 13/01/1992
(Ireland) Ltd
HOSTACYCLINE Hoechst Ireland Limited PA0023/013/002 Capsule - TETRACYCLINE 13/01/1992
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 458 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PEVIDINE ANTISEPTIC Berk Pharmaceuticals PA0082/047/001 - POVIDONE-IODINE 13/01/1992
Limited
PEVIDINE SURGICAL Berk Pharmaceuticals PA0082/047/002 - POVIDONE-IODINE 13/01/1992
SCRUB Limited
TRICANIX Electramed Ireland Limited PA0303/014/003 - TINIDAZOLE 08/01/1992
AC-FEN-GS 200 ac-Pharma AG PA0548/001/002 Tablets 07/01/1992
AC-FEN-GS 400 ac-Pharma AG PA0548/001/003 Tablets 07/01/1992
AC-FEN-GS 600 ac-Pharma AG PA0548/001/004 Tablets 07/01/1992
CISPLATINUM H.N. Norton & Company Ltd PA0382/003/001 - CISPLATIN 02/01/1992
LYOPHILISED
CISPLATINUM H.N. Norton & Company Ltd PA0382/003/002 - CISPLATIN 02/01/1992
LYOPHILISED
EMCORETIC E. Merck Ltd PA0054/077/001 Tablets - BISOPROLOL FUMARATE 02/01/1992
- HYDROCHLOROTHIAZIDE

SALBUTAMOL H.N. Norton & Company Ltd PA0382/002/001 - SALBUTAMOL 02/01/1992


GAMMAGARD S/D Baxter Healthcare Limited PA0167/079/004 - GAMMA GLOBULIN 01/01/1992
- ELECTROLYTES NOS
CYSTRIN J B Tillotts Limited PA0360/005/001 Tablets - OXYBUTYNIN 31/12/1991
HYDROCHLORIDE
STELAZINE SmithKline and French PA0060/016/012 Tablets 30/12/1991
Laboratories Ltd
GENTAMICIN SULFATE International Medication PA0255/034/001 Withdrawn Form 20/12/1991
Systems (UK) Ltd
SILBE Berk Pharmaceuticals PA0082/026/001 - EPINEPHRINE 20/12/1991
Limited BITARTRATE
- PAPAVERINE
HYDROCHLORIDE
- ATROPINE
METHONITRATE
LIOTON 1000 A. Menarini Industrie PA0512/002/001 Gel 18/12/1991
Farmaceutische Riunite S.r.l.

MINIMS SULPHACETAMIDE Chauvin Pharmaceuticals PA0118/021/001 18/12/1991


SODIUM Limited

PARDALE Cahill-May Roberts Limited PA0129/003/001 Tablets 18/12/1991


VALIUM Roche Products Limited PA0050/017/004 Capsule - DIAZEPAM 18/12/1991
VALIUM Roche Products Limited PA0050/017/005 Capsule - DIAZEPAM 18/12/1991
VALIUM Roche Products Limited PA0050/017/008 - DIAZEPAM 18/12/1991
WELLDORM Chauvin Pharmaceuticals PA0118/007/001 Tablets - DICHLORALPHENAZONE 18/12/1991
Limited
WELLDORM ELIXIR Chauvin Pharmaceuticals PA0118/007/002 - DICHLORALPHENAZONE 18/12/1991
Limited
BETAMETHASONE Norton Healthcare Limited PA0282/044/002 Ointment 16/12/1991
VALERATE T/A IVAX Pharmaceuticals
UK
BETAMETHASONE Norton Healthcare Limited PA0282/044/001 Cream 16/12/1991
VALERATE B P T/A IVAX Pharmaceuticals
UK
SALBUTAMOL B P Norton Healthcare Limited PA0282/031/003 Tablets 16/12/1991
T/A IVAX Pharmaceuticals
UK
SALBUTAMOL B P Norton Healthcare Limited PA0282/031/004 Tablets 16/12/1991
T/A IVAX Pharmaceuticals
UK
TANDERIL- Dispersa (UK) Ltd PA0582/009/001 Ointment - OXYPHENBUTAZONE 13/12/1991
CHLORAMPHENICOL - CHLORAMPHENICOL
- ETHANOL
ROTAHALER - BECOTIDE Glaxo Laboratories Limited PA0044/065/002 12/12/1991
ROTAHALER & Glaxo Laboratories Limited PA0044/065/001 12/12/1991
ROTAHALER BOX
VENTOLIN
BUDALE Dales Pharmaceuticals PA0129/002/001 Tablets 11/12/1991
Limited
FENNINGS GRIPE Fenning Pharmaceuticals PA0279/002/001 11/12/1991
MIXTURE
INOLAXINE Dales Pharmaceuticals PA0129/001/001 11/12/1991
Limited
NIGHT NURSE SmithKlineBeecham PA0379/001/003 Capsule - PARACETAMOL 11/12/1991
Consumer Brand - PROMETHAZINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE

Human Medicines Withdrawn Products Page 459 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/001/004 Tablets 10/12/1991
DISPERSIBLE
PIMAFUCIN Yamanouchi Pharma Ltd PA0062/007/006 Tablets 10/12/1991
PIMAFUCIN Yamanouchi Pharma Ltd PA0062/007/001 Cream 10/12/1991
PIMAFUCIN (SUSPENSION) Yamanouchi Pharma Ltd PA0062/007/003 10/12/1991

PIMAFUCIN (SUSPENSION) Yamanouchi Pharma Ltd PA0062/007/004 10/12/1991

PIMAFUCIN EYE Yamanouchi Pharma Ltd PA0062/007/005 Ointment 10/12/1991


PIMAFUCIN VAGINAL Yamanouchi Pharma Ltd PA0062/007/002 Tablets 10/12/1991
PIMAFUCIN VAGINAL Yamanouchi Pharma Ltd PA0062/0007/00 Tablets 10/12/1991
VENDARCIN Yamanouchi Pharma Ltd PA0062/006/002 Withdrawn Form 10/12/1991
VENDARCIN Yamanouchi Pharma Ltd PA0062/006/003 Withdrawn Form 10/12/1991
VENDARCIN Yamanouchi Pharma Ltd PA0062/006/004 10/12/1991
VENDARCIN Yamanouchi Pharma Ltd PA0062/006/005 Capsule 10/12/1991
AQUAFRESH MILD & SmithKlineBeecham PA0379/027/002 Toothpaste - CALCIUM 09/12/1991
MINTY Consumer Brand GLYCEROPHOSPHATE
- SODIUM FLUORIDE
AQUAFRESH ORIGINAL SmithKlineBeecham PA0379/027/001 Toothpaste - CALCIUM 09/12/1991
Consumer Brand GLYCEROPHOSPHATE
- SODIUM FLUORIDE
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/007 - CHLORHEXIDINE 09/12/1991
BPC DIACETATE
CHLORHEXIDINE ACETATE Baxter Healthcare Limited PA0167/010/006 - CHLORHEXIDINE 09/12/1991
B P C 0.02% FOR DIACETATE
IRRIGATION
MACLEANS ACTIVE SmithKlineBeecham PA0379/028/001 Unknown - SODIUM FLUORIDE 09/12/1991
MOUTHGUARD Consumer Brand - CETYLPYRIDINIUM
CHLORIDE
MACLEANS FRESHMINT SmithKlineBeecham PA0379/029/002 Toothpaste - CALCIUM 09/12/1991
Consumer Brand GLYCEROPHOSPHATE
- TRICLOSAN
MACLEANS MILDMINT SmithKlineBeecham PA0379/029/001 Toothpaste - CALCIUM 09/12/1991
Consumer Brand GLYCEROPHOSPHATE
- TRICLOSAN
MEGACILLIN T. P. Whelehan Son & Co. PA0137/015/001 - CLEMIZOLE PENICILLIN 09/12/1991
Limited
MEGACILLIN T. P. Whelehan Son & Co. PA0137/015/002 - CLEMIZOLE PENICILLIN 09/12/1991
(SUSPENSION) Limited
NEURO-GRUNOVIT T. P. Whelehan Son & Co. PA0137/050/001 - THIAMINE 09/12/1991
DRAGEES Limited - NICOTINAMIDE
- CYANOCOBALAMIN
SODIUM CHLORIDE 0.9% Baxter Healthcare Limited PA0167/012/003 - SODIUM CHLORIDE 09/12/1991
W/V FOR IRRIGATION
ULTRA-GRUNOVIT T. P. Whelehan Son & Co. PA0137/052/001 Capsule - RETINOL ACETATE 09/12/1991
Limited - THIAMINE MONONITRATE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- FOLIC ACID
- NICOTINAMIDE

CANDEPTIN Forest Laboratories UK Ltd PA0100/008/001 Tablets - CANDICIDIN 05/12/1991


CANDEPTIN Forest Laboratories UK Ltd PA0100/008/002 Ointment - CANDICIDIN 05/12/1991
COLOMYCIN Forest Laboratories UK Ltd PA0100/001/006 05/12/1991
HAYMINE Forest Laboratories UK Ltd PA0100/024/001 Tablets - CHLORPHENAMINE 05/12/1991
MALEATE
- EPHEDRINE
HYDROCHLORIDE
MEDI-SACHE Forest Laboratories UK Ltd PA0100/014/001 - CETRIMONIUM BROMIDE 05/12/1991
- CHLORHEXIDINE
DIACETATE

MORFLIN Forest Laboratories UK Ltd PA0100/038/002 Syrup - MORPHINE SULFATE 05/12/1991


RUBELIX Forest Laboratories UK Ltd PA0100/009/001 - PHOLCODINE 05/12/1991
- EPHEDRINE
HYDROCHLORIDE
SUSTAC LA Forest Laboratories UK Ltd PA0100/032/001 Tablets - GLYCERYL TRINITRATE 05/12/1991
SUSTAC LA Forest Laboratories UK Ltd PA0100/032/002 Tablets - GLYCERYL TRINITRATE 05/12/1991
SUSTAC LA Forest Laboratories UK Ltd PA0100/032/003 Tablets - GLYCERYL TRINITRATE 05/12/1991
VALIUM Roche Products Limited PA0050/017/009 Suppositories - DIAZEPAM 04/12/1991
VALIUM Roche Products Limited PA0050/017/010 Suppositories - DIAZEPAM 04/12/1991
EUDENINE Allen and Hanburys Limited PA0024/013/001 Tablets - DIAZOXIDE 03/12/1991
MAWS BABY CREAM Ashe Laboratories Limited PA0254/001/001 03/12/1991

Human Medicines Withdrawn Products Page 460 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MERVAN Ovelle Limited PA0206/007/002 Tablets - ALCLOFENAC 02/12/1991
BRONCHIPAX Ashe Laboratories Limited PA0254/008/001 Tablets 27/11/1991
KRUSCHEN SALTS Ashe Laboratories Limited PA0254/005/001 27/11/1991
LANTIGEN B LIQUID Ashe Laboratories Limited PA0254/009/001 27/11/1991
MAWS COLD SORE Ashe Laboratories Limited PA0254/001/002 Ointment 27/11/1991
MAWS GOLDEN EYE Ashe Laboratories Limited PA0254/001/003 Ointment 27/11/1991
PERSOMNIA Ashe Laboratories Limited PA0254/003/001 Tablets 27/11/1991
TEST-SIXTY LOZENGES Ashe Laboratories Limited PA0254/007/002 - SULFURIC ACID 27/11/1991
- SULFURIC ACID
ETOPHYLATE CHILDREN Delandale Laboratories PA0080/005/006 Syrup - ACEFYLLINE 25/11/1991
Limited
ETOPHYLATE FORTE Delandale Laboratories PA0080/005/007 Syrup - ACEFYLLINE 25/11/1991
Limited
ETOPHYLATE FORTE Delandale Laboratories PA0080/005/003 Tablets - ACEFYLLINE 25/11/1991
Limited
KIDITARD Delandale Laboratories PA0080/003/001 - QUINIDINE BISULFATE 25/11/1991
Limited
BERKMYCEN Berk Pharmaceuticals PA0082/007/003 Capsule - OXYTETRACYCLINE 22/11/1991
Limited
CEPTON CLENSING MILK Zeneca Limited PA0051/014/003 - CHLORHEXIDINE 22/11/1991
GLUCONATE
GASTRESE A.H. Robins Company PA0086/026/001 - METOCLOPRAMIDE 22/11/1991
Limited
K-SALT Berk Pharmaceuticals PA0082/048/001 Granules Effervescent 22/11/1991
Limited
ORAP Janssen Pharmaceutica PA0045/009/002 Tablets - PIMOZIDE 22/11/1991
OXY WASH Berk Pharmaceuticals PA0082/037/003 Unknown - BENZOYL PEROXIDE 22/11/1991
Limited
OXY-10 Berk Pharmaceuticals PA0082/037/002 - BENZOYL PEROXIDE 22/11/1991
Limited
OXY-5 Berk Pharmaceuticals PA0082/037/001 - BENZOYL PEROXIDE 22/11/1991
Limited
SYNALAR N Zeneca Limited PA0051/017/003 - FLUOCINOLONE 22/11/1991
ACETONIDE
- NEOMYCIN
RIMACTANE Ciba Geigy Plc PA0028/002/007 - RIFAMPICIN SODIUM 21/11/1991
BURINEX Leo Laboratories Limited PA0046/016/001 Withdrawn Form 20/11/1991
BURINEX Leo Laboratories Limited PA0046/016/004 Withdrawn Form - BUMETANIDE 20/11/1991
BURINEX Leo Laboratories Limited PA0046/016/005 Withdrawn Form - BUMETANIDE 20/11/1991
ELYZOL CP Pharmaceuticals Ltd PA0409/002/003 Suppositories 20/11/1991
trading as Wockhardt UK
ELYZOL CP Pharmaceuticals Ltd PA0409/002/004 Suppositories 20/11/1991
trading as Wockhardt UK
FLOWERS OF SULPHUR Rusco Pharmaceuticals PA0392/023/001 - SULFUR 20/11/1991
KERECID OPHTHALMIC Allergan Pharmaceuticals PA0148/041/002 Ointment - IDOXURIDINE 20/11/1991
Ireland
MENTHACOL Sanofi-Synthelabo Ireland PA0077/032/001 - PARACETAMOL 19/11/1991
Ltd - MENTHOL
MODRENAL Sanofi-Synthelabo Ireland PA0077/053/001 Capsule - TRILOSTANE 19/11/1991
Ltd
SILBE ATOMISER Berk Pharmaceuticals PA0082/026/002 19/11/1991
Limited
ALCABUTAZONE LEO Leo Laboratories Limited PA0046/020/001 - PHENYLBUTAZONE 18/11/1991
BURINEX Leo Laboratories Limited PA0046/016/006 Withdrawn Form - BUMETANIDE 18/11/1991
DIPHEBUZOL Leo Laboratories Limited PA0046/021/001 Tablets - PHENYLBUTAZONE 18/11/1991
DIPHEBUZOL Leo Laboratories Limited PA0046/021/002 Withdrawn Form - PHENYLBUTAZONE 18/11/1991
SELEXIDIN Leo Laboratories Limited PA0046/029/002 Withdrawn Form - MECILLINAM 18/11/1991
SELEXIDIN Leo Laboratories Limited PA0046/029/003 Withdrawn Form - MECILLINAM 18/11/1991
TYPHOID PARATYPHOID A Wellcome (Ireland) Limited PA0017/036/001 18/11/1991
B&C
DURANOL Elan Pharma Ltd PA0516/002/001 Capsule 15/11/1991
DURANOL Elan Pharma Ltd PA0516/002/002 Capsule 15/11/1991
DURANOL Elan Pharma Ltd PA0516/002/003 Capsule 15/11/1991
DURANOL Elan Pharma Ltd PA0516/002/004 Capsule 15/11/1991
ELANPRES Elan Pharma Ltd PA0516/005/001 Capsule 15/11/1991
ELANPRES Elan Pharma Ltd PA0516/005/002 Capsule 15/11/1991
ELANPRES Elan Pharma Ltd PA0516/005/003 Capsule 15/11/1991
KANACILLIN Ovelle Limited PA0206/001/001 - PROCAINE 15/11/1991
BENZYLPENICILLIN
- KANAMYCIN
MUCOGEL (SUSPENSION) Forest Laboratories UK Ltd PA0100/039/001 - ALUMINIUM HYDROXIDE 15/11/1991
GEL, DRIED
- MAGNESIUM HYDROXIDE

VIONEURIN FORTE Ovelle Limited PA0206/009/001 15/11/1991

Human Medicines Withdrawn Products Page 461 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CORTRIL Pfizer Limited PA0019/018/003 Ointment - HYDROCORTISONE 14/11/1991
CORTRIL Pfizer Limited PA0019/018/004 Ointment - HYDROCORTISONE 14/11/1991
CORTRIL (SPRAY) Pfizer Limited PA0019/018/001 - HYDROCORTISONE 14/11/1991
DOXOFYLLINE Monmouth Pharmaceuticals PA0488/003/001 Withdrawn Form - DOXOFYLLINE 14/11/1991
Ltd
ADRENALINE Galway Laboratories PA0367/020/001 Withdrawn Form - EPINEPHRINE 13/11/1991
BITARTRATE
ATROPINE SULPHATE Galway Laboratories PA0367/005/001 Withdrawn Form - ATROPINE SULFATE 13/11/1991
CAMBISON EAR Hoechst Ireland Limited PA0023/011/003 - PREDNAZOLINE 13/11/1991
- NEOMYCIN
- PREDNISOLONE
CAMBISON SPRAY Hoechst Ireland Limited PA0023/011/004 - PREDNISOLONE 13/11/1991
- NEOMYCIN
PENBRITIN KS SmithKline Beecham Pharm PA0049/013/001 - AMPICILLIN 13/11/1991
Ltd - SULFADIMIDINE
WATER FOR INJECTION Galway Laboratories PA0367/003/003 - WATER FOR INJECTIONS 13/11/1991
10ML
WATER FOR INJECTION Galway Laboratories PA0367/003/001 - WATER FOR INJECTIONS 13/11/1991
2ML
WATER FOR INJECTION Galway Laboratories PA0367/003/002 - WATER FOR INJECTIONS 13/11/1991
5ML
ALORBAT Mercury Pharmaceuticals PA0073/003/011 11/11/1991
(Ireland) Ltd
ALORBAT (DISPOSABLE Mercury Pharmaceuticals PA0073/003/015 11/11/1991
SYRINGE) (Ireland) Ltd
ALORBAT MULTIDOSE Mercury Pharmaceuticals PA0073/003/016 11/11/1991
(Ireland) Ltd
CHAPSTICK - REGULAR A.H. Robins Company PA0086/021/001 - CAMPHOR 11/11/1991
Limited - LANOLIN
GAMIMUNE Bayer Diagnostics PA0079/016/001 - IMMUNGLOBULIN 08/11/1991
Manufacturing
GAMIMUNE Bayer Diagnostics PA0079/016/002 - IMMUNGLOBULIN 08/11/1991
Manufacturing
DEXTRAN 40 BRAUN IN B. Braun Medical Limited PA0179/013/001 07/11/1991
DEXTROSE 5%
DEXTRAN 70 BRAUN IN B. Braun Medical Limited PA0179/014/001 07/11/1991
DEXTROSE 5%
DEXTRAN 70 BRAUN IN B. Braun Medical Limited PA0179/012/001 07/11/1991
SODIUM CHLORIDE 0.9%
IMUNOVIR Leo Laboratories Limited PA0046/042/003 Tablets - INOSINE PRANOBEX 04/11/1991
CUNIL SURECAPS Helsinn Birex PA0294/005/001 - IBUPROFEN 01/11/1991
Pharmaceuticals Limited
MICRO K E. Merck Ltd PA0054/060/002 Capsule - POTASSIUM CHLORIDE 31/10/1991
HUMAN ACTRAPHANE Novo Nordisk A/S PA0218/020/001 30/10/1991
HUMAN ACTRAPHANE Novo Nordisk A/S PA0218/020/002 30/10/1991
PENFILL
HUMAN ACTRAPID HI Novo Nordisk A/S PA0218/016/001 30/10/1991
HUMAN ACTRAPID HM Novo Nordisk A/S PA0218/016/002 30/10/1991
HUMAN ACTRAPID HM Novo Nordisk A/S PA0218/016/003 30/10/1991
HUMAN MONOTARD HI Novo Nordisk A/S PA0218/015/001 30/10/1991
HUMAN MONOTARD HM Novo Nordisk A/S PA0218/015/002 30/10/1991
HUMAN PROTAPHANE Novo Nordisk A/S PA0218/017/001 30/10/1991
HUMAN PROTAPHANE Novo Nordisk A/S PA0218/017/002 30/10/1991
PENFILL
HUMAN ULTRATARD Novo Nordisk A/S PA0218/018/001 30/10/1991
INFLUVAC Abbott Healthcare Products PA0108/003/012 30/10/1991
Ltd
NANORMON Nordisk Gentofte A/S PA0217/006/002 30/10/1991
TIZIPRAMINE Ticen Limited PA0117/008/001 Tablets - IMIPRAMINE 30/10/1991
VELOSULIN 100 IU/ML Nordisk Gentofte A/S PA0217/002/004 30/10/1991
VELOSULIN CARTRIDGE Nordisk Gentofte A/S PA0217/002/006 30/10/1991
VIVONEX Procter & Gamble PA0170/004/001 - AMINO ACIDS 29/10/1991
Pharmaceuticals UK Limited
VIVONEX HN Procter & Gamble PA0170/003/001 - AMINO ACIDS 29/10/1991
Pharmaceuticals UK Limited
VITAMIN B6 NATURTABS Larkhall Laboratories Plc PA0288/017/001 Tablets 21/10/1991
DAY NURSE SmithKlineBeecham PA0379/017/001 Capsule - PARACETAMOL 18/10/1991
Consumer Brand -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DEXTROMETHORPHAN
HYDROBROMIDE
FROBEN The Boots Company Plc PA0004/004/004 Capsule - FLURBIPROFEN 18/10/1991
FROBEN The Boots Company Plc PA0004/004/005 Capsule - FLURBIPROFEN 18/10/1991
FROBEN The Boots Company Plc PA0004/004/006 Capsule - FLURBIPROFEN 18/10/1991

Human Medicines Withdrawn Products Page 462 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALCIA Peter Black Healthcare Ltd PA0522/003/001 Tablets 15/10/1991
VESAGEX Leo Laboratories Limited PA0046/053/001 Cream - CETRIMONIUM BROMIDE 15/10/1991

CHLORDIAZEPOXIDE Ticen Limited PA0117/014/001 10/10/1991


CILPEN Ticen Limited PA0117/012/003 Capsule - AMPICILLIN TRIHYDRATE 10/10/1991

CILPEN SYRUP FORTE Ticen Limited PA0117/012/004 - AMPICILLIN TRIHYDRATE 10/10/1991

CILPEN SYRUP FORTE Ticen Limited PA0117/012/005 - AMPICILLIN TRIHYDRATE 10/10/1991

DIACEN Ticen Limited PA0117/013/001 Tablets - DIAZEPAM 10/10/1991


DIACEN Ticen Limited PA0117/013/002 Tablets - DIAZEPAM 10/10/1991
DIACEN Ticen Limited PA0117/013/003 Tablets - DIAZEPAM 10/10/1991
DOPACEN Ticen Limited PA0117/016/001 Tablets - METHYLDOPA 10/10/1991
DOPACEN Ticen Limited PA0117/016/002 Tablets - METHYLDOPA 10/10/1991
DOPACEN Ticen Limited PA0117/016/003 Tablets - METHYLDOPA 10/10/1991
HISTEND Ticen Limited PA0117/017/001 Tablets - CHLORPHENAMINE 10/10/1991
INFLUVAC Abbott Healthcare Products PA0108/003/004 Withdrawn Form 10/10/1991
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/005 Withdrawn Form 10/10/1991
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/013 10/10/1991
Ltd
INFLUVAC MULTIDOSE Abbott Healthcare Products PA0108/003/014 10/10/1991
Ltd
LACEN Ticen Limited PA0117/015/001 Tablets - FUROSEMIDE 10/10/1991
ROCEPHIN VIALS Roche Products Limited PA0050/062/004 Withdrawn Form - CEFTRIAXONE 10/10/1991
ROCEPHIN VIALS Roche Products Limited PA0050/062/006 - CEFTRIAXONE 10/10/1991
- LIDOCAINE
SOLIUM Ticen Limited PA0117/018/001 Tablets - NITRAZEPAM 10/10/1991
TASPRIN SOL Ticen Limited PA0117/009/001 Tablets - ACETYLSALICYLIC ACID 10/10/1991
TIBUTAZONE Ticen Limited PA0117/010/001 Tablets - PHENYLBUTAZONE 10/10/1991
TICELGESIC Ticen Limited PA0117/003/001 Tablets - PARACETAMOL 10/10/1991
TICILLIN VK Ticen Limited PA0117/005/001 - 10/10/1991
PHENOXYMETHYLPENICI
LLIN
TICIPECT COUGH Ticen Limited PA0117/019/001 - DIPHENHYDRAMINE 10/10/1991
EXPECTORANT HYDROCHLORIDE
- AMMONIUM CHLORIDE
- SODIUM CITRATE
TICYCLINE Ticen Limited PA0117/004/001 Tablets - OXYTETRACYCLINE 10/10/1991
TISOM Ticen Limited PA0117/020/001 - PARACETAMOL 10/10/1991
- DIPHENHYDRAMINE
HYDROCHLORIDE
BURAM Leo Laboratories Limited PA0046/059/004 - BUMETANIDE 09/10/1991
- AMILORIDE
HYDROCHLORIDE
LABITON KOLA TONIC Laboratories for Applied PA0300/003/001 - VITAMIN B NOS 06/10/1991
Biology - ETHANOL
- CAFFEINE
- COLA ACUMINATA
TABANO Laboratories for Applied PA0300/002/001 - LIDOCAINE 06/10/1991
Biology HYDROCHLORIDE
INSULIN INITARD 50/50 Nordisk Gentofte A/S PA0217/004/001 01/10/1991
NORDISK
INSULIN INITARD 50/50 Nordisk Gentofte A/S PA0217/004/002 01/10/1991
NORDISK
IRUXOL Knoll A.G. (Clissmann) PA0058/001/002 - COLLAGENASE 01/10/1991
- CHLORAMPHENICOL
TOTAMOL CP Pharmaceuticals Ltd PA0409/016/001 Tablets 01/10/1991
trading as Wockhardt UK
TOTAMOL CP Pharmaceuticals Ltd PA0409/016/002 Tablets 01/10/1991
trading as Wockhardt UK
MYCIL UCB Pharma Limited PA0365/020/001 Ointment - CHLORPHENESIN 23/09/1991
MYCIL UCB Pharma Limited PA0365/020/002 - CHLORPHENESIN 23/09/1991
CIMETIDINE Accord-UK Ltd PA0176/067/001 Tablets 19/09/1991
CIMETIDINE Accord-UK Ltd PA0176/067/002 Tablets - CIMETIDINE 19/09/1991
CIMETIDINE Accord-UK Ltd PA0176/067/003 Tablets 19/09/1991
BALMOSA Forest Laboratories UK Ltd PA0100/015/002 Cream 17/09/1991
TEROLIN Pharmacia Laboratories PA0187/027/001 Tablets - TERODILINE 16/09/1991
Limited
TEROLINE Pharmacia Laboratories PA0187/027/002 Tablets - TERODILINE 16/09/1991
Limited HYDROCHLORIDE
HALDOL AMPOULE Janssen Pharmaceutica PA0045/005/005 - HALOPERIDOL 12/09/1991
CORWIN Zeneca Limited PA0051/060/001 Tablets - XAMOTEROL 09/09/1991

Human Medicines Withdrawn Products Page 463 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ERASIS Orion Pharma A/s PA0303/023/001 Tablets - ERYTHROMYCIN 09/09/1991
ACISTRATE
ERASIS Orion Pharma A/s PA0303/023/002 Tablets - ERYTHROMYCIN 09/09/1991
ACISTRATE
OPAZIMES Rybar Laboratories Ltd PA0003/008/001 Tablets - ALUMINIUM HYDROXIDE 30/08/1991
GEL, DRIED
- KAOLIN, LIGHT
- ATROPA BELLADONNA
- MORPHINE
HYDROCHLORIDE
BEXALIN EXPECTORANT Pinewood Laboratories Ltd, PA0281/003/001 Oral Solution - DIPHENHYDRAMINE 25/08/1991
HYDROCHLORIDE
- AMMONIUM CHLORIDE
- SODIUM CITRATE
- CHLOROFORM
- MENTHOL
SNO PHENICOL MULTI- Chauvin Pharmaceuticals PA0118/022/001 - CHLORAMPHENICOL 12/08/1991
DOSE EYE Limited
AMILORIDE Accord-UK Ltd PA0176/045/001 Tablets - AMILORIDE 07/08/1991
HYDROCHLORIDE HYDROCHLORIDE
BENDROFLUAZIDE Accord-UK Ltd PA0176/023/001 Tablets - BENDROFLUMETHIAZIDE 07/08/1991

BENDROFLUAZIDE Accord-UK Ltd PA0176/023/002 Tablets - BENDROFLUMETHIAZIDE 07/08/1991

COSOVAL Accord-UK Ltd PA0176/042/001 Tablets 07/08/1991


COX CETRIMIDE Accord-UK Ltd PA0176/012/001 Cream - CETRIMONIUM BROMIDE 07/08/1991
ANTISEPTIC
ERYTHROMYCIN ETHYL Accord-UK Ltd PA0176/049/002 Granules for Oral 07/08/1991
SUCCINATE Suspension
ERYTHROMYCIN ETHYL Accord-UK Ltd PA0176/049/003 Granules for Oral 07/08/1991
SUCCINATE Suspension
GLIBENCLAMIDE Accord-UK Ltd PA0176/056/001 Tablets 07/08/1991
GLIBENCLAMIDE Accord-UK Ltd PA0176/056/002 Tablets 07/08/1991
HYDRALAZINE Accord-UK Ltd PA0176/037/002 - HYDRALAZINE 07/08/1991
HYDROCHLORIDE
MIRAXID (SUSPENSION) Leo Laboratories Limited PA0046/031/004 - PIVAMPICILLIN 07/08/1991
- PIVMECILLINAM
HYDROCHLORIDE
MIRAXID PAEDIATRIC Leo Laboratories Limited PA0046/031/005 - PIVAMPICILLIN 07/08/1991
(SUSPENSION) - PIVMECILLINAM
HYDROCHLORIDE
PHENYTOIN Accord-UK Ltd PA0176/063/001 Capsule - PHENYTOIN 07/08/1991
PHENYTOIN Accord-UK Ltd PA0176/063/002 Capsule 07/08/1991
RELCOFEN Accord-UK Ltd PA0176/060/001 Tablets - IBUPROFEN 07/08/1991
SCHOLL ONIXOL Scholl Consumer Products PA0455/004/001 - UREA 29/07/1991
INGROWN TOENAIL Limited - EXSICCATED SODIUM
TREATMENT SULPHITE
DISTAMINE Dista Products Limited PA0447/001/003 Tablets - PENICILLAMINE 26/07/1991
PROVERA GRANULES Pharmacia Limited PA0016/023/009 - 24/07/1991
MEDROXYPROGESTERO
NE ACETATE
PROVERA GRANULES Pharmacia Limited PA0016/023/010 - 24/07/1991
MEDROXYPROGESTERO
NE ACETATE
HERPIDU C United Drug Distributors PA0182/008/001 Ointment - IDOXURIDINE 16/07/1991
- CHLORAMPHENICOL
SPERSALLERG United Drug Distributors PA0182/012/001 - ANTAZOLINE 16/07/1991
HYDROCHLORIDE
- TETRYZOLINE
HYDROCHLORIDE
- HYPROMELLOSE
TRIHERPINE United Drug Distributors PA0182/011/001 16/07/1991
TRIHERPINE United Drug Distributors PA0182/011/002 Ointment 16/07/1991
MORFLIN BUCCAL Astra Zeneca PA0459/001/001 Tablets - MORPHINE SULFATE 15/07/1991
Pharmaceuticals (Ire) Ltd
APS DIAZEPAM Teva UK Limited PA0237/015/001 05/07/1991
APS DIAZEPAM Teva UK Limited PA0237/015/002 Tablets 05/07/1991
APS DIAZEPAM Teva UK Limited PA0237/015/003 Tablets 05/07/1991
APS NITRAZEPAM Teva UK Limited PA0237/014/001 Tablets 05/07/1991
ABSORBINE ARTHRITIC Clonmel Healthcare Ltd PA0126/010/001 28/06/1991
PAIN
FUCIDIN Leo Laboratories Limited PA0046/004/001 Capsule - FUSIDATE SODIUM 26/06/1991
H.P. VITAMIN E Ferrosan Healthcare Ltd PA0527/027/002 Capsule 25/06/1991
SULFAMYLON Sanofi-Synthelabo Ireland PA0077/020/001 Cream - MAFENIDE 17/06/1991
Ltd

Human Medicines Withdrawn Products Page 464 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ANTACIN John Wyeth & Brother PA0022/064/001 Tablets - OXAPROZIN 12/06/1991
Limited
AXID (100 MG NIZATIDINE) Eli Lilly and Company Limite PA0047/067/003 Withdrawn Form - NIZATIDINE 07/06/1991

AXID (150 MG NIZATIDINE) Eli Lilly and Company Limite PA0047/067/004 Withdrawn Form - NIZATIDINE 07/06/1991

AXID (300 MG NIZATIDINE) Eli Lilly and Company Limite PA0047/067/005 Withdrawn Form - NIZATIDINE 07/06/1991

ANTEPAR Wellcome (Ireland) Limited PA0017/082/002 Tablets 06/06/1991


BURONIL Knoll A.G. (Clissmann) PA0058/016/001 Solution for Injection - MELPERONE 06/06/1991
HYDROCHLORIDE
REMEGEL Hall Brothers PA0539/001/001 Tablets 04/06/1991
MAXICAM Parke Davis & Company PA0056/036/001 Capsule - ISOXICAM 31/05/1991
MAXICAM Parke Davis & Company PA0056/036/002 Capsule - ISOXICAM 31/05/1991
MAXICAM Parke Davis & Company PA0056/036/003 Capsule - ISOXICAM 31/05/1991
ACCUPRO Parke Davis & Company PA0056/045/004 Tablets - QUINAPRIL 30/05/1991
HYDROCHLORIDE
ALLOPURINOL John Wyeth & Brother PA0022/045/001 Tablets - ALLOPURINOL 30/05/1991
Limited
ALLOPURINOL John Wyeth & Brother PA0022/045/002 Tablets - ALLOPURINOL 30/05/1991
Limited
DULCOLAX RECTAL Windsor Healthcare Ltd PA0429/002/001 - BISACODYL 30/05/1991
FLUCLOXACILLIN John Wyeth & Brother PA0022/046/001 Capsule 30/05/1991
Limited
FLUCLOXACILLIN John Wyeth & Brother PA0022/046/002 Capsule 30/05/1991
Limited
GLIBENCLAMIDE John Wyeth & Brother PA0022/047/001 Capsule 30/05/1991
Limited
VASCULIT Boehringer Ingelheim Limited PA0007/018/001 Tablets - BAMETHAN SULFATE 29/05/1991

LEOTUSS Leo Laboratories Limited PA0046/027/001 - DIPHENHYDRAMINE 24/05/1991


HYDROCHLORIDE
SANATOGEN ROYAL Fisons Pharmaceuticals PA0072/024/001 Capsule 23/05/1991
JELLY (Ireland)
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/013 Withdrawn Form - SODIUM CHLORIDE 21/05/1991
SODIUM CHLORIDE Baxter Healthcare Limited PA0167/008/014 Withdrawn Form - SODIUM CHLORIDE 21/05/1991
KIDDIPRIN Ricesteele Manufacturing Ltd PA0095/005/001 Tablets 06/05/1991

AMBAXIN Pharmacia Limited PA0016/033/002 Tablets 30/04/1991


TOLECTIN Cilag Limited PA0059/003/001 Tablets - TOLMETIN 30/04/1991
BONFIELDS IPECAC & Foran Healthcare Limited PA0484/027/001 - DRIMIA MARITIMA 22/04/1991
SQUILL - IPECACUANHA FLUID
EXTRACT
- GLYCEROL
- HONEY
GENTIAN VIOLET Foran Healthcare Limited PA0484/017/001 - METHYLROSANILINIUM 22/04/1991
CHLORIDE
ALBUMIN NORDISK Nordisk Gentofte A/S PA0217/005/001 Solution for Infusion - HUMAN ALBUMIN 15/04/1991
FLUZONE Wellcome (Ireland) Limited PA0017/095/001 12/04/1991
DILTIAZEM Lorex Synthelabo Limited PA0362/006/002 - DILTIAZEM 11/04/1991
HYDROCHLORIDE
REHIDRAT G.D. Searle & Company PA0001/022/003 - SODIUM CHLORIDE 09/04/1991
BLACKCURRANT Limited - POTASSIUM CHLORIDE
- SODIUM BICARBONATE
COBADEX Accord-UK Ltd PA0176/030/001 Cream - HYDROCORTISONE 08/04/1991
- DIMETICONE
COBADEX Accord-UK Ltd PA0176/030/002 Cream - HYDROCORTISONE 08/04/1991
- DIMETICONE
POTASSIUM Accord-UK Ltd PA0176/044/001 Tablets - POTASSIUM 05/04/1991
EFFERVESCENT BPC BICARBONATE
MODUCREN 20 Merck Sharp and Dohme PA0035/055/002 - TIMOLOL MALEATE 03/04/1991
Limited - HYDROCHLOROTHIAZIDE
- AMILORIDE
HYDROCHLORIDE

SULPHACETAMIDE EYE Schering-Plough Limited PA0277/019/002 25/03/1991


DROPS
SULPHACETAMIDE EYE Schering-Plough Limited PA0277/019/003 25/03/1991
DROPS
ANEMET 1 MG/ML Marion Merrell Limited PA0041/044/001 Withdrawn Form - TROPISETRON 22/03/1991
ANEMET 1 MG/ML Marion Merrell Limited PA0041/044/002 Withdrawn Form - TROPISETRON 22/03/1991
REDOXON Roche Products Limited PA0050/065/001 Tablets 22/03/1991
FLUOSOL Grifols UK Limited PA0415/004/001 - PERFLUNAFENE 19/03/1991
ROBAXIN 750 A.H. Robins Company PA0086/010/001 Tablets - METHOCARBAMOL 19/03/1991
Limited

Human Medicines Withdrawn Products Page 465 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROBAXIN 750 A.H. Robins Company PA0086/010/002 Withdrawn Form - METHOCARBAMOL 19/03/1991
Limited
DIMOTAPP CO A.H. Robins Company PA0086/011/005 Syrup - GUAIFENESIN 15/03/1991
Limited - CODEINE PHOSPHATE
- BROMPHENIRAMINE
MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PHENYLEPHRINE
HYDROCHLORIDE
VARICLENE Dermal Laboratories Ltd PA0278/010/001 Gel - BRILLIANT GREEN CI 12/03/1991
42040
- LACTIC ACID
CODURAL (BLISTER PACK) 3M Health Care Limited PA0057/014/002 Tablets - PARACETAMOL 04/03/1991
- CAFFEINE
CODURAL (PLASTIC 3M Health Care Limited PA0057/014/001 Tablets - PARACETAMOL 04/03/1991
TUBES) - CAFFEINE
REDOXON Roche Products Limited PA0050/066/001 Tablets 03/03/1991
CHLORPHENIRAMINE Accord-UK Ltd PA0176/043/001 Tablets - CHLORPHENAMINE 28/02/1991
DAYOVITE Accord-UK Ltd PA0176/035/001 Granules for Oral - VITAMIN B NOS 28/02/1991
Suspension - ASCORBIC ACID
SPIRONOLACTONE Accord-UK Ltd PA0176/041/001 Tablets 28/02/1991
SPIRONOLACTONE Accord-UK Ltd PA0176/041/002 Tablets 28/02/1991
SPIRONOLACTONE Accord-UK Ltd PA0176/041/003 Tablets 28/02/1991
ESBATAL Wellcome (Ireland) Limited PA0017/057/002 Tablets - BETANIDINE SULFATE 22/02/1991
ORTHO-NOVIN Cilag Limited PA0059/012/003 Tablets - NORETHISTERONE 20/02/1991
- MESTRANOL
FLORONE Pharmacia Limited PA0016/034/001 Cream 19/02/1991
FLORONE Pharmacia Limited PA0016/034/002 Ointment - ALPRAZOLAM 19/02/1991
PHAZET SKIN PRICK TEST Pharmacia Biosystems PA0107/016/001 19/02/1991
Limited
DIOCARE PRD 463 SmithKlineBeecham PA0379/024/001 - MORPHINE 18/02/1991
Consumer Brand HYDROCHLORIDE
- GLUCOSE
- SODIUM CITRATE
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
TRASICOR Ciba Geigy Plc PA0028/003/005 - OXPRENOLOL 06/02/1991
CISPLATIN Hospira UK Limited PA0437/004/002 Withdrawn Form - WATER FOR INJECTIONS 01/02/1991

CISPLATIN Hospira UK Limited PA0437/004/004 Withdrawn Form - WATER FOR INJECTIONS 01/02/1991

CISPLATIN Hospira UK Limited PA0437/004/005 Withdrawn Form - WATER FOR INJECTIONS 01/02/1991

CISPLATIN Hospira UK Limited PA0437/004/006 Withdrawn Form - WATER FOR INJECTIONS 01/02/1991

CISPLATIN Hospira UK Limited PA0437/004/008 Withdrawn Form - WATER FOR INJECTIONS 01/02/1991

STRONG STERILE Hospira UK Limited PA0437/003/002 - DOPAMINE 01/02/1991


DOPAMINE HYDROCHLORIDE
HYDROCHLORIDE
VIBRAMYCIN Pfizer Limited PA0019/013/002 Syrup - DOXYCYCLINE 01/02/1991
CORVATON Hoechst Ireland Limited PA0023/042/001 Tablets - MOLSIDOMINE 30/01/1991
SANATOGEN VITAMIN E Fisons Pharmaceuticals PA0072/021/001 - TOCOPHEROL 30/01/1991
(Ireland)
TRENTAL Hoechst Ireland Limited PA0023/005/001 Tablets - PENTOXIFYLLINE 30/01/1991
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/061/001 30/01/1991
INSULIN ZINC
ACTRAPID MC PENFILL Novo Nordisk A/S PA0218/021/001 25/01/1991
HUMAN ACTRAPID Novo Nordisk A/S PA0218/019/001 25/01/1991
PENFILL
B-PLUS Natures Way (Dublin) Ltd PA0563/009/001 Tablets - THIAMINE 18/01/1991
- RIBOFLAVIN
- PYRIDOXINE
- CYANOCOBALAMIN
- BIOTIN
- FOLIC ACID
- PANTOTHENIC ACID
- NICOTINIC ACID
- ASCORBIC ACID

Human Medicines Withdrawn Products Page 466 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CHILDRENS ONE-A-DAY Natures Way (Dublin) Ltd PA0563/012/001 Tablets - RETINOL 18/01/1991
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- BIOTIN
- FOLIC ACID
- NICOTINIC ACID
- ASCORBIC ACID
- COLECALCIFEROL
- TOCOPHEROL
- CALCIUM
- IODINE
- IRON
- MAGNESIUM
- ZINC
COD LIVER OIL Natures Way (Dublin) Ltd PA0563/007/001 Capsule - COD LIVER OIL 18/01/1991
GAMBROSOL 10 X 1.5% Gambro UK Limited PA0479/001/010 - GLUCOSE 18/01/1991
DEXTROSE
GAMBROSOL 10 X 2.5% Gambro UK Limited PA0479/001/015 - GLUCOSE 18/01/1991
DEXTROSE
GAMBROSOL 10 X 4.0% Gambro UK Limited PA0479/001/020 - GLUCOSE 18/01/1991
DEXTROSE
SUPER SEA KELP Natures Way (Dublin) Ltd PA0563/013/001 Tablets - IODINE 18/01/1991
- CALCIUM
DISPRIN CV A/S Alfred Benzon PA0317/008/001 - ACETYLSALICYLIC ACID 16/01/1991
DOLOMITE Natures Way (Dublin) Ltd PA0563/002/001 Tablets - CALCIUM 15/01/1991
- MAGNESIUM
H-B-VAX HEPATITIS B Merck Sharp and Dohme PA0035/058/001 - HEPATITIS B VACCINE 15/01/1991
VACCINE Limited
H-B-VAX HEPATITIS B Merck Sharp and Dohme PA0035/058/002 - HEPATITIS B VACCINE 15/01/1991
VACCINE Limited
H-B-VAX HEPATITIS B Merck Sharp and Dohme PA0035/058/003 - HEPATITIS B VACCINE 15/01/1991
VACCINE Limited
AUDICORT Cyanamid of Great Britain PA0037/027/001 14/01/1991
BRICANYL Astra Pharmaceuticals Ltd PA0009/004/002 Tablets - TERBUTALINE SULFATE 12/01/1991
DIAZEPAM ELIXIR Accord-UK Ltd PA0176/001/004 10/01/1991
IBERET 500 Abbott Laboratories Ireland PA0038/019/001 Tablets 13/12/1990
Ltd
BCG VACCINE UCB Pharma Limited PA0365/001/002 - BCG VACCINE 12/12/1990
PANOXYL Stiefel Laboratories (U.K.) PA0144/019/001 Unknown 10/12/1990
Ltd.
DOXORUBICIN Hospira UK Limited PA0437/026/003 Withdrawn Form - DOXORUBICIN 07/12/1990
HYDROCHLORIDE HYDROCHLORIDE
NEW METATONE TONIC Parke Davis & Company PA0056/065/001 - NICOTINAMIDE 07/12/1990
- RIBOFLAVIN SODIUM
PHOSPHATE
- THIAMINE
HYDROCHLORIDE
- PYRIDOXINE
HYDROCHLORIDE
- CALCIUM
GLYCEROPHOSPHATE
- MANGANESE
GLYCEROPHOSPHATE
MULCETS 3M Health Care Limited PA0057/048/001 Tablets - ASCORBIC ACID 05/12/1990
- CETYLPYRIDINIUM
CADRILAN Ciba Geigy Plc PA0028/062/001 Tablets - CADRALAZINE 30/11/1990
CADRILAN Ciba Geigy Plc PA0028/062/002 Tablets - CADRALAZINE 30/11/1990
CADRILAN Ciba Geigy Plc PA0028/062/003 Tablets - CADRALAZINE 30/11/1990
PARACETAMOL Norton Waterford PA0436/004/002 Tablets - PARACETAMOL 29/11/1990
PARACETAMOL ELIXIR Norton Waterford PA0436/004/001 - PARACETAMOL 29/11/1990
PAEDIATRIC BPC
PHENOBARBITONE Norton Waterford PA0436/005/001 Tablets - PHENOBARBITAL 29/11/1990
PHENOBARBITONE Norton Waterford PA0436/005/002 Tablets - PHENOBARBITAL 29/11/1990
PHENOBARBITONE Norton Waterford PA0436/005/003 Tablets - PHENOBARBITAL 29/11/1990
PREDNISOLONE Norton Waterford PA0436/006/001 - PREDNISOLONE 29/11/1990
MACKENZIE SMELLING Dr. Mackenzies Laboratories PA0411/001/001 20/11/1990
SALTS Ltd
SALBUTAMOL Accord-UK Ltd PA0176/065/001 Tablets 20/11/1990
SALBUTAMOL Accord-UK Ltd PA0176/065/002 Tablets 20/11/1990
SUN N SEA COD LIVER OIL Cupal Limited PA0258/025/001 Ointment 20/11/1990

Human Medicines Withdrawn Products Page 467 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SUN N SEA COD LIVER OIL Cupal Limited PA0258/025/002 Capsule 20/11/1990

NATURAL VITAMIN E Larkhall Laboratories Plc PA0288/023/001 Capsule 19/11/1990


PLATET CLEARTAB Nicholas Laboratories PA0032/035/001 - ACETYLSALICYLIC ACID 19/11/1990
FORADIL Ciba Geigy Plc PA0028/066/002 Tablets - FORMOTEROL 07/11/1990
FUMARATE
FORADIL Ciba Geigy Plc PA0028/066/003 Tablets - FORMOTEROL 07/11/1990
FUMARATE
FORADIL Ciba Geigy Plc PA0028/066/004 Tablets - FORMOTEROL 07/11/1990
FUMARATE
FORADIL PUFF Ciba Geigy Plc PA0028/066/001 Inhalation solution - FORMOTEROL 07/11/1990
FUMARATE
ONCOTICE Organon Teknika Ltd PA0374/002/001 - BCG VACCINE 07/11/1990
SUFREXAL Janssen Pharmaceuticals Lt PA0545/022/001 Withdrawn Form 07/11/1990

SUFREXAL Janssen Pharmaceuticals Lt PA0545/022/002 07/11/1990

SUFREXAL (KETANSERIN) Janssen Pharmaceuticals Lt PA0545/022/003 Tablets 07/11/1990

SUFREXAL (KETANSERIN) Janssen Pharmaceuticals Lt PA0545/022/004 Tablets 07/11/1990

FENOX Crookes Healthcare Ltd PA0043/010/001 - PHENYLEPHRINE 05/11/1990


FENOX (SPRAY) Crookes Healthcare Ltd PA0043/010/002 - PHENYLEPHRINE 05/11/1990
HIGH IRON YEAST Wassen International Ltd PA0538/004/001 24/10/1990
VISACOR Zeneca Limited PA0051/061/001 Tablets - EPANOLOL 19/10/1990
CYCLOGEST L.D. Collins & Co. Ltd PA0462/001/001 Suppositories - TRYPSIN 17/10/1990
CYCLOGEST L.D. Collins & Co. Ltd PA0462/001/002 Suppositories 17/10/1990
NYBADEX Accord-UK Ltd PA0176/029/001 Ointment - HYDROCORTISONE 16/10/1990
- BENZALKONIUM
CHLORIDE
- DIMETICONE
- NYSTATIN
VASOTROPE Sanofi-Synthelabo Ireland PA0077/097/003 Tablets - MILRINONE 09/10/1990
Ltd
VASOTROPE Sanofi-Synthelabo Ireland PA0077/097/004 - MILRINONE 09/10/1990
Ltd
VASOTROPE Sanofi-Synthelabo Ireland PA0077/097/005 Tablets - MILRINONE 09/10/1990
Ltd
JUNIOR DISPRIN Reckitt's (Ireland) Limited PA0027/011/002 - ACETYLSALICYLIC ACID 25/09/1990
DIMOTAPP CO A.H. Robins Company PA0086/011/006 Syrup - GUAIFENESIN 15/09/1990
PAEDIATRIC Limited - CODEINE PHOSPHATE
- BROMPHENIRAMINE
MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PHENYLEPHRINE
HYDROCHLORIDE
DISOPYRAMIDE Norton Healthcare Limited PA0282/045/001 Capsule 01/09/1990
T/A IVAX Pharmaceuticals
UK
DISOPYRAMIDE Norton Healthcare Limited PA0282/045/002 Capsule 01/09/1990
T/A IVAX Pharmaceuticals
UK
NORPACE G.D. Searle & Company PA0001/003/001 Capsule - DISOPYRAMIDE 29/08/1990
Limited
NORPACE G.D. Searle & Company PA0001/003/002 Capsule - DISOPYRAMIDE 29/08/1990
Limited
EMOFORM Leo Laboratories Limited PA0046/049/001 - CALCIUM CARBONATE 20/08/1990
- MAGNESIUM OXIDUM
LEVE
ASPIRIN Accord-UK Ltd PA0176/015/002 Tablets - ACETYLSALICYLIC ACID 17/08/1990
TOPISOLONE N Hoechst Ireland Limited PA0023/010/002 - DESOXIMETASONE 17/08/1990
- NEOMYCIN
TOFRANIL R Geigy Pharmaceuticals PA0011/024/004 Withdrawn Form - IMIPRAMINE 16/08/1990
HYDROCHLORIDE
AEROBEC INHALER 3M Health Care Limited PA0057/056/002 - BECLOMETASONE 13/08/1990
ADULT COUGH BALSAM Cupal Limited PA0258/041/001 06/08/1990
TERODILINE H.C.I. McDermott Laboratories Ltd PA0577/001/001 Tablets - TERODILINE 02/08/1990
t/a Gerard Laboratories
CORANGIN Ciba Geigy Plc PA0028/059/001 Tablets - ISOSORBIDE 24/07/1990
MONONITRATE
RESOLVE SmithKlineBeecham PA0379/021/001 - PARACETAMOL 17/07/1990
Consumer Brand - CITRIC ACID

Human Medicines Withdrawn Products Page 468 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VICKS MEDINITE Procter & Gamble (Health & PA0441/001/001 - PARACETAMOL 11/07/1990
Beauty Care) Limited - DEXTROMETHORPHAN
- DOXYLAMINE
SUCCINATE
- EPHEDRINE SULFATE
NEURET SmithKline and French PA0060/055/001 Syrup 10/07/1990
Laboratories Ltd
NEURET SmithKline and French PA0060/055/002 10/07/1990
Laboratories Ltd
OVRAN 20 John Wyeth & Brother PA0022/030/001 Tablets - ETHINYLESTRADIOL 10/07/1990
Limited - LEVONORGESTREL
NOXYFLEX Geistlich Sons Limited PA0143/010/001 - TETRACAINE 25/06/1990
HYDROCHLORIDE
- NOXYTIOLIN
- TETRACAINE
HYDROCHLORIDE
CORTISONE ACETATE Merck Sharp and Dohme PA0035/072/001 Tablets 14/06/1990
Limited
CORTISONE ACETATE Merck Sharp and Dohme PA0035/072/002 Tablets 14/06/1990
Limited
BENZYL BENZOAT William Ransom & Son Plc PA0506/001/001 05/06/1990
APPLICATION
CODEINE LINCTUS William Ransom & Son Plc PA0506/002/001 05/06/1990
COMPOUND THYMOL William Ransom & Son Plc PA0506/011/001 05/06/1990
GLYCERIN
FLEXIBLE COLLODION William Ransom & Son Plc PA0506/003/001 05/06/1990
HAMAMELIS WATER William Ransom & Son Plc PA0506/004/001 05/06/1990
METHYL SALICYLATE William Ransom & Son Plc PA0506/006/001 05/06/1990
PAEDIATRIC William Ransom & Son Plc PA0506/007/001 05/06/1990
PARACETAMOL ELIXIR
PHOLCODINE William Ransom & Son Plc PA0506/008/001 05/06/1990
RANSOMS GLYCERIN, William Ransom & Son Plc PA0506/012/001 05/06/1990
LEMON & HONEY
RANSOMS PAEDIATRIC William Ransom & Son Plc PA0506/010/001 05/06/1990
DIPHENHYDRAMINE
WEAK IODINE William Ransom & Son Plc PA0506/005/001 05/06/1990
CIMENIL Foxken Co. Limited PA0660/001/001 Tablets - CIMETIDINE 31/05/1990
CIMENIL Foxken Co. Limited PA0660/001/002 Tablets - CIMETIDINE 31/05/1990
CIMENIL Foxken Co. Limited PA0660/001/003 Tablets - CIMETIDINE 31/05/1990
AGRIPPAL AMPOULE Ashford Pharmaceuticals PA0301/046/001 30/05/1990
Limited
DIAZEPAM Ashford Pharmaceuticals PA0301/028/001 Withdrawn Form - DIAZEPAM 30/05/1990
Limited
FRUSEMIDE Ashford Pharmaceuticals PA0301/030/003 Withdrawn Form - FUROSEMIDE 30/05/1990
Limited
FELODIPINE Hoechst Ireland Limited PA0023/056/001 Tablets - FELODIPINE 25/05/1990
FELODIPINE Hoechst Ireland Limited PA0023/056/002 Tablets - FELODIPINE 25/05/1990
FENTAZIN Allen and Hanburys Limited PA0024/002/001 Withdrawn Form - PERPHENAZINE 24/05/1990
HYDRODERM Merck Sharp and Dohme PA0035/022/001 Ointment 23/05/1990
Limited
ILOTYCIN Eli Lilly and Company Limite PA0047/020/001 - ERYTHROMYCIN 15/05/1990

PROVENTEX Wellcome (Ireland) Limited PA0017/090/002 Capsule - THEOPHYLLINE 10/05/1990


PROVENTEX Wellcome (Ireland) Limited PA0017/090/003 Capsule - THEOPHYLLINE 10/05/1990
STERILE WATER FOR Baxter Healthcare Limited PA0167/011/003 - WATER FOR IRRIGATION 10/05/1990
IRRIGATION
LANITOP Roussel - Uclaf PA0006/001/001 09/05/1990
WOMANKIND VITAMIN B6 Windsor Healthcare Ltd PA0429/006/001 Tablets - PYRIDOXINE 09/05/1990
HYDROCHLORIDE
PREGFOL John Wyeth & Brother PA0022/032/001 Capsule - FERROUS SULFATE 08/05/1990
Limited EXSICCATED
- FOLIC ACID
AGRIPPAL VIAL Ashford Pharmaceuticals PA0301/046/002 05/05/1990
Limited
DIAZEPAM Ashford Pharmaceuticals PA0301/028/003 Tablets - DIAZEPAM 05/05/1990
Limited
DIAZEPAM Ashford Pharmaceuticals PA0301/028/005 Tablets - DIAZEPAM 05/05/1990
Limited
FURETIC Ashford Pharmaceuticals PA0301/030/002 Tablets 05/05/1990
Limited
OPTOMYCIN Ashford Pharmaceuticals PA0301/034/001 - CHLORAMPHENICOL 05/05/1990
CHLORAMPHENICOL EYE Limited
ATROFORD Company Liquidated M123 PA0301/011/001 - ATROPINE SULFATE 01/05/1990
BETOPIC CREAM Company Liquidated M123 PA0301/005/001 Cream - BETAMETHASONE 01/05/1990
VALERATE

Human Medicines Withdrawn Products Page 469 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLIOTOPIC H CREAM Company Liquidated M123 PA0301/006/001 Cream - CLIOQUINOL 01/05/1990
- HYDROCORTISONE
DIAZEPAM Ashford Pharmaceuticals PA0301/028/002 Withdrawn Form - DIAZEPAM 01/05/1990
Limited
DIAZEPAM Ashford Pharmaceuticals PA0301/028/004 Tablets - DIAZEPAM 01/05/1990
Limited
FLUOSYN Company Liquidated M123 PA0301/014/001 Cream - FLUOCINOLONE 01/05/1990
ACETONIDE
GUNEVAX RUBELLA VIRU Ashford Pharmaceuticals PA0301/041/001 - RUBELLA VIRUS 01/05/1990
Limited VACCINE LIVE
ATTENUATED
HYDROTOPIC Company Liquidated M123 PA0301/016/001 Cream - HYDROCORTISONE 01/05/1990
HYDROTOPIC Company Liquidated M123 PA0301/016/002 Ointment - HYDROCORTISONE 01/05/1990
PILOPTIC OPTH. Company Liquidated M123 PA0301/004/002 - PILOCARPINE 01/05/1990
SOLUTION HYDROCHLORIDE
PILOPTIC OPTH. Company Liquidated M123 PA0301/004/003 - PILOCARPINE 01/05/1990
SOLUTION HYDROCHLORIDE
PILOPTIC OPTH. Company Liquidated M123 PA0301/004/004 - PILOCARPINE 01/05/1990
SOLUTION HYDROCHLORIDE
TRISYN Company Liquidated M123 PA0301/015/002 Cream - TRIAMCINOLONE 01/05/1990
ACETONIDE
FELODIPINE Astra Pharmaceuticals Ltd PA0009/042/001 Tablets - FELODIPINE 30/04/1990
FELODIPINE Astra Pharmaceuticals Ltd PA0009/042/002 Tablets - FELODIPINE 30/04/1990
MICROPAQUE D.C. Nicholas Laboratories PA0032/013/001 - BARIUM SULFATE 19/04/1990
VASCARDIN Nicholas Laboratories PA0032/015/002 - ISOSORBIDE DINITRATE 19/04/1990
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/004 - PILOCARPINE 18/04/1990
Ireland
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/005 - PILOCARPINE 18/04/1990
Ireland
P.V. CARPINE Allergan Pharmaceuticals PA0148/032/006 - PILOCARPINE 18/04/1990
Ireland
ISORDIL TITRADOSE Ayerst Laboratories Limited PA0149/007/005 Tablets 17/04/1990
ISORDIL TITRADOSE Ayerst Laboratories Limited PA0149/007/006 Tablets 17/04/1990
ISORDIL TITRADOSE Ayerst Laboratories Limited PA0149/007/007 Tablets 17/04/1990
VANCOCIN Eli Lilly and Company Limite PA0047/052/001 17/04/1990

SUCCINYL-ASTA Mercury Pharmaceuticals PA0073/040/001 Solution for Injection - SUXAMETHONIUM 12/04/1990


(Ireland) Ltd CHLORIDE
SUCCINYL-ASTA Mercury Pharmaceuticals PA0073/040/002 Solution for Injection 12/04/1990
(Ireland) Ltd
SUCCINYL-ASTA E. Merck Ltd PA0054/029/003 - SUXAMETHONIUM 12/04/1990
CHLORIDE
SUCCINYL-ASTA 2% E. Merck Ltd PA0054/029/001 Solution for Injection - SUXAMETHONIUM 12/04/1990
CHLORIDE
SUCCINYL-ASTA 5% E. Merck Ltd PA0054/029/002 Solution for Injection - SUXAMETHONIUM 12/04/1990
CHLORIDE
BENYLIN EXPECTORANT Parke Davis & Company PA0056/048/001 - DIPHENHYDRAMINE 11/04/1990
HYDROCHLORIDE
- GUAIFENESIN
- MENTHOL
PROVENTEX Wellcome (Ireland) Limited PA0017/090/001 Capsule - THEOPHYLLINE 10/04/1990
RENGASIL Ciba Geigy Plc PA0028/038/001 Capsule - PIRPROFEN 10/04/1990
RENGASIL Ciba Geigy Plc PA0028/038/002 Capsule - PIRPROFEN 10/04/1990
PROTEIN Healthilife Limited PA0570/013/001 - CALCIUM CASEINATE 09/04/1990
- SOYA PROTEIN
- FRUCTOSE
- FLAVOUR
- PROTEIN HYDROLYSATE
- LECITHINUM SOYA

CYCLOBRAL Norgine Limited PA0102/005/001 Capsule - CYCLANDELATE 06/04/1990


JUNIOR MU-CRON Ciba Geigy Plc PA0028/063/001 Syrup - 05/04/1990
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- IPECACUANHA
ASPIRIN Cupal Limited PA0258/023/001 Tablets 04/04/1990
CUTINEA FOOT & BODY Cupal Limited PA0258/027/001 04/04/1990
ZINC & CASTOR OIL Cupal Limited PA0258/024/001 Cream 04/04/1990
ASPIRIN Wigglesworth (1982) Limited PA0063/005/001 Tablets 01/04/1990

ASPIRIN & CODEINE Wigglesworth (1982) Limited PA0063/008/001 Tablets 01/04/1990

ASPRIN JUNIOR Wigglesworth (1982) Limited PA0063/007/001 Tablets 01/04/1990

Human Medicines Withdrawn Products Page 470 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALMO RHEUMATIC Wigglesworth (1982) Limited PA0063/006/001 Tablets 01/04/1990

KAOLIN & MORPHINE Wigglesworth (1982) Limited PA0063/002/001 01/04/1990


MIXTURE
PARACETAMOL Wigglesworth (1982) Limited PA0063/004/001 Tablets 01/04/1990

PILOPTIC OPTH. Company Liquidated M123 PA0301/004/001 - PILOCARPINE 01/04/1990


SOLUTION HYDROCHLORIDE
RESTWELL Wigglesworth (1982) Limited PA0063/009/001 Tablets 01/04/1990

ULTRALAN ORAL HE Clissmann PA0012/031/005 Tablets - FLUOCORTOLONE 01/04/1990


PEFLACIN May & Baker Limited PA0040/083/001 Withdrawn Form 29/03/1990
PEFLACIN May & Baker Limited PA0040/083/002 Tablets 29/03/1990
CITANEST 0.5% Astra Pharmaceuticals Ltd PA0009/021/001 - PRILOCAINE 28/03/1990
CITANEST 0.5% Astra Pharmaceuticals Ltd PA0009/021/002 - PRILOCAINE 28/03/1990
CITANEST PLAIN Astra Pharmaceuticals Ltd PA0009/021/003 - PRILOCAINE 28/03/1990
SOLUTION 1.0% - 20 ML.
VIALS
CITANEST PLAIN Astra Pharmaceuticals Ltd PA0009/021/004 - PRILOCAINE 28/03/1990
SOLUTION 1.0% - 50 ML.
VIALS
MYODIL Glaxo Laboratories Limited PA0044/072/001 - IOFENDYLATE 28/03/1990
XYLOCAINE 0.5% Astra Pharmaceuticals Ltd PA0009/016/008 - LIDOCAINE 28/03/1990
XYLOCAINE 1.0% Astra Pharmaceuticals Ltd PA0009/016/011 - LIDOCAINE 28/03/1990
HYDROCHLORIDE
XYLOCAINE 1.0% Astra Pharmaceuticals Ltd PA0009/016/012 - LIDOCAINE 28/03/1990
XYLOCAINE 2.0% Astra Pharmaceuticals Ltd PA0009/016/016 - LIDOCAINE 28/03/1990
XYLOCAINE WITH Astra Pharmaceuticals Ltd PA0009/019/004 - LIDOCAINE 28/03/1990
ADRENALINE 1% - EPINEPHRINE
LIGNOSTAB The Boots Company Plc PA0004/012/001 - LIDOCAINE 27/03/1990
HYDROCHLORIDE
LIGNOSTAB A The Boots Company Plc PA0004/013/001 - LIDOCAINE 27/03/1990
HYDROCHLORIDE
- EPINEPHRINE
LIGNOSTAB A 100 The Boots Company Plc PA0004/014/001 - LIDOCAINE 27/03/1990
HYDROCHLORIDE
- EPINEPHRINE
LIGNOSTAB N The Boots Company Plc PA0004/015/001 - LIDOCAINE 27/03/1990
HYDROCHLORIDE
- NOREPINEPHRINE
CHLORPROMAZINE Galway Laboratories PA0367/009/002 Withdrawn Form - CHLORPROMAZINE 26/03/1990
CHLORPROMAZINE ELIXIR Galway Laboratories PA0367/009/001 - CHLORPROMAZINE 26/03/1990

CYSTOPURIN Fisons Limited PA0018/027/001 Tablets - METHENAMINE 23/03/1990


HIPPURATE
- SODIUM ACETATE
MESASAL RETENTION SmithKline and French PA0060/047/003 20/03/1990
ENEMA Laboratories Ltd
DOXATET Accord-UK Ltd PA0176/021/001 Tablets - DOXYCYCLINE 16/03/1990
HYDROCHLORIDE
INDORAMIN SmithKline and French PA0060/052/003 Tablets 14/03/1990
Laboratories Ltd
INDORAMIN SmithKline and French PA0060/052/004 Tablets 14/03/1990
Laboratories Ltd
LOPRESOR Geigy Pharmaceuticals PA0011/003/003 Withdrawn Form - METOPROLOL TARTRATE 05/03/1990

DICYNENE 1000 Delandale Laboratories PA0080/001/005 Withdrawn Form - ETAMSILATE 28/02/1990


Limited
HAYMINE Forest Laboratories UK Ltd PA0100/024/002 Syrup 27/02/1990
LISERDOL Farmitalia Carlo Erba Ltd PA0236/021/001 Tablets 27/02/1990
KENOGAM May & Baker Limited PA0040/085/001 Tablets 21/02/1990
KENOGAM May & Baker Limited PA0040/085/002 Tablets 21/02/1990
METOPROLOL OROS Geigy Pharmaceuticals PA0011/037/001 - METOPROLOL 20/02/1990
FUMARATE
METOPROLOL OROS Geigy Pharmaceuticals PA0011/037/002 - METOPROLOL 20/02/1990
FUMARATE
JIFFY TOOTHACHE Stafford Miller Limited PA0069/007/002 15/02/1990
LOFTYL Abbott Laboratories Ireland PA0038/052/001 14/02/1990
Ltd
LOFTYL Abbott Laboratories Ireland PA0038/052/002 Tablets 14/02/1990
Ltd
FISHERMANS FRIEND Lofthouse of Fleetwood Ltd PA0542/001/001 Syrup 13/02/1990
HONEY
HALDOL DECANOATE Janssen Pharmaceutica PA0045/025/002 - HALOPERIDOL 02/02/1990
DECANOATE

Human Medicines Withdrawn Products Page 471 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROWAFENAC Rowa Pharmaceuticals PA0074/013/001 Capsule - DICLOFENAC 02/02/1990
Limited
ROWAFENAC Rowa Pharmaceuticals PA0074/013/002 Capsule - DICLOFENAC 02/02/1990
Limited
ROWAFENAC Rowa Pharmaceuticals PA0074/013/003 - DICLOFENAC 02/02/1990
Limited
ROWAFENAC Rowa Pharmaceuticals PA0074/013/004 Suppositories - DICLOFENAC 02/02/1990
Limited
ROWAFENAC Rowa Pharmaceuticals PA0074/013/006 - DICLOFENAC 02/02/1990
Limited
ROWAFENAC Rowa Pharmaceuticals PA0074/013/007 - DICLOFENAC 02/02/1990
Limited
ROWAFENAC AMPOULES Rowa Pharmaceuticals PA0074/013/005 - DICLOFENAC 02/02/1990
Limited
FRUSEMIDE Accord-UK Ltd PA0176/013/001 Tablets 29/01/1990
FRUSEMIDE Accord-UK Ltd PA0176/013/002 Tablets - FUROSEMIDE 29/01/1990
FRUSEMIDE Accord-UK Ltd PA0176/013/003 Tablets - FUROSEMIDE 29/01/1990
HEXABRIX 320 May & Baker Limited PA0040/064/003 Solution for Injection - IOXAGLATE SODIUM 25/01/1990
- IOXAGLATE MEGLUMINE

IONAX SCRUB Alcon Laboratories (UK) Ltd PA0290/041/001 - BENZALKONIUM 25/01/1990


CHLORIDE
- ETHANOL
- POLYETHYLENE
IONIL T SHAMPOO Alcon Laboratories (UK) Ltd PA0290/040/001 - SALICYLIC ACID 25/01/1990
- BENZALKONIUM
CHLORIDE
- COAL TAR
NUTRAPLUS Alcon Laboratories (UK) Ltd PA0290/035/001 Cream - UREA 25/01/1990
PSORIGEL Alcon Laboratories (UK) Ltd PA0290/036/001 Gel - COAL TAR SOLUTION 25/01/1990
L-BUNOLOL PARKE-DAVIS Parke Davis & Company PA0056/038/001 - LEVOBUNOLOL 23/01/1990

L-BUNOLOL PARKE-DAVIS Parke Davis & Company PA0056/038/002 - LEVOBUNOLOL 23/01/1990

THEO 24 G.D. Searle & Company PA0001/028/001 - THEOPHYLLINE 23/01/1990


Limited
THEO 24 G.D. Searle & Company PA0001/028/002 - THEOPHYLLINE 23/01/1990
Limited
THEO 24 G.D. Searle & Company PA0001/028/003 - THEOPHYLLINE 23/01/1990
Limited
MINILYN Organon Laboratories PA0261/014/001 - LYNESTRENOL 17/01/1990
Limited - ETHINYLESTRADIOL
AVLOSULFON Zeneca Limited PA0051/008/001 Tablets - DAPSONE 11/01/1990
MEDOCODENE Wilcox Jozeau (Ireland) PA0120/005/001 Tablets 30/12/1989
Limited
PENERIN Mayne Pharma (Ireland) PA0078/013/004 Syrup - AMPICILLIN TRIHYDRATE 19/12/1989
Limited
ABSTEM T. P. Whelehan Son & Co. PA0137/041/001 Tablets 15/12/1989
Limited
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/001 Capsule - TETRACYCLINE 15/12/1989
Limited HYDROCHLORIDE
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/003 Withdrawn Form - TETRACYCLINE 15/12/1989
Limited HYDROCHLORIDE
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/006 Ointment - TETRACYCLINE 15/12/1989
Limited HYDROCHLORIDE
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/007 Withdrawn Form 15/12/1989
Limited
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/008 Withdrawn Form 15/12/1989
Limited
ACHROMYCIN T. P. Whelehan Son & Co. PA0137/010/009 Capsule 15/12/1989
Limited
ACHROMYCIN EYE/EAR T. P. Whelehan Son & Co. PA0137/010/004 Ointment - TETRACYCLINE 15/12/1989
OINTMENT Limited HYDROCHLORIDE
ACHROMYCIN OPHTH. T. P. Whelehan Son & Co. PA0137/010/005 - TETRACYCLINE 15/12/1989
(SUSPENSION) Limited HYDROCHLORIDE
ACHROMYCIN V T. P. Whelehan Son & Co. PA0137/025/001 Capsule 15/12/1989
Limited
ACHROMYCIN V T. P. Whelehan Son & Co. PA0137/025/002 Syrup 15/12/1989
Limited
ANADIN ANALGESIC Pfizer Consumer Healthcare PA0172/004/002 Tablets - ACETYLSALICYLIC ACID 15/12/1989
Ltd
ANADIN ANALGESIC Pfizer Consumer Healthcare PA0172/004/003 Tablets - ACETYLSALICYLIC ACID 15/12/1989
Ltd
ARISTOCORT A T. P. Whelehan Son & Co. PA0137/002/001 Cream - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE

Human Medicines Withdrawn Products Page 472 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ARISTOCORT A T. P. Whelehan Son & Co. PA0137/002/002 Cream - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
ATROPINE SULFATE BP Chauvin Pharmaceuticals PA0118/011/002 15/12/1989
Limited
AUDICORT EAR SOLUTION T. P. Whelehan Son & Co. PA0137/027/001 - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
- NEOMYCIN
AURECORT OINTMENT T. P. Whelehan Son & Co. PA0137/028/001 Ointment - CHLORTETRACYCLINE 15/12/1989
Limited - TRIAMCINOLONE
ACETONIDE
AUREOMYCIN T. P. Whelehan Son & Co. PA0137/012/001 Ointment 15/12/1989
Limited
AUREOMYCIN T. P. Whelehan Son & Co. PA0137/012/002 Ointment 15/12/1989
OPHTHALMIC Limited
CALCIUM LEUCOVORIN T. P. Whelehan Son & Co. PA0137/045/001 Tablets 15/12/1989
Limited
CINOPAL T. P. Whelehan Son & Co. PA0137/026/001 Capsule - FENBUFEN 15/12/1989
Limited
CINOPAL T. P. Whelehan Son & Co. PA0137/026/002 Capsule - FENBUFEN 15/12/1989
Limited
CLOPIXOL ACUPHASE Lundbeck Limited PA0115/012/001 Withdrawn Form 15/12/1989
CLOPIXOL ACUPHASE Lundbeck Limited PA0115/012/002 Withdrawn Form 15/12/1989
COPHOLCO COUGH T. P. Whelehan Son & Co. PA0137/044/001 Syrup - PHOLCODINE 15/12/1989
SYRUP Limited - TERPIN HYDRATE
- MENTHOL
CYCLOPENTOLATE Chauvin Pharmaceuticals PA0118/012/001 15/12/1989
HYDROCHLORIDE Limited
DEMOLOX T. P. Whelehan Son & Co. PA0137/039/001 Tablets - AMOXAPINE 15/12/1989
Limited
DEMOLOX T. P. Whelehan Son & Co. PA0137/039/002 Tablets - AMOXAPINE 15/12/1989
Limited
DEMOLOX T. P. Whelehan Son & Co. PA0137/039/003 Tablets - AMOXAPINE 15/12/1989
Limited
DETECLO T. P. Whelehan Son & Co. PA0137/006/001 15/12/1989
Limited
DIAMOX T. P. Whelehan Son & Co. PA0137/029/003 Tablets - ACETAZOLAMIDE 15/12/1989
Limited - PARENTEROL
HYDROCHLORIDE
DIAMOX PARENTERAL T. P. Whelehan Son & Co. PA0137/029/001 - ACETAZOLAMIDE 15/12/1989
Limited - PARENTEROL
HYDROCHLORIDE
DIAMOX SUSTETS T. P. Whelehan Son & Co. PA0137/029/002 - ACETAZOLAMIDE 15/12/1989
Limited - PARENTEROL
HYDROCHLORIDE
DISPHEX SPRAY T. P. Whelehan Son & Co. PA0137/033/001 15/12/1989
Limited
DOXY Mayne Pharma (Ireland) PA0078/047/002 Capsule - DOXYCYCLINE 15/12/1989
Limited
FENOBELLADINE Medo Pharmaceuticals PA0109/001/001 Tablets - PHENOBARBITAL 15/12/1989
Limited
FLAMAZINE Chauvin Pharmaceuticals PA0118/006/002 - SULFADIAZINE SILVER 15/12/1989
Limited
GLYCINE 1.5% B. Braun Medical Limited PA0179/035/001 - AMINOACETIC ACID 15/12/1989
(IRRIGATION)
GONADOTRAPHON L.H. Paines and Byrne Limited PA0090/007/001 15/12/1989
GONOCIN 030 T. P. Whelehan Son & Co. PA0137/005/001 Capsule - MINOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
HEMOFIL Baxter Healthcare Limited PA0167/029/001 15/12/1989
ANTIHAEMOPHILIC
FACTOR
HOMATROPINE Chauvin Pharmaceuticals PA0118/014/001 15/12/1989
HYDROBROMIDE Limited
INDOMETHACIN Clonmel Healthcare Ltd PA0126/014/001 Capsule 15/12/1989
ISOPAQUE CYSTO 100 Electramed Ireland Limited PA0161/013/004 15/12/1989
LEDERCORT T. P. Whelehan Son & Co. PA0137/030/004 Tablets - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
LEDERCORT T. P. Whelehan Son & Co. PA0137/030/005 Tablets - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
LEDERCORT ACETONIDE T. P. Whelehan Son & Co. PA0137/030/001 Cream - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
LEDERCORT ACETONIDE T. P. Whelehan Son & Co. PA0137/030/002 Ointment - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
LEDERCORT DIACETATE T. P. Whelehan Son & Co. PA0137/030/003 - TRIAMCINOLONE 15/12/1989
PARENTERAL Limited ACETONIDE
- PARENTEROL
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 473 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LEDERKYN T. P. Whelehan Son & Co. PA0137/011/001 Tablets 15/12/1989
Limited
LEDERMYCIN T. P. Whelehan Son & Co. PA0137/013/004 Syrup - DEMECLOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
LEDERMYCIN T. P. Whelehan Son & Co. PA0137/013/005 Syrup - DEMECLOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
LEDERMYCIN T. P. Whelehan Son & Co. PA0137/013/006 Capsule 15/12/1989
Limited
LEDERMYCIN T. P. Whelehan Son & Co. PA0137/013/001 Capsule - DEMECLOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
LEDERMYCIN T. P. Whelehan Son & Co. PA0137/013/002 Tablets - DEMECLOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
LEDERMYCIN PAEDIATRIC T. P. Whelehan Son & Co. PA0137/013/003 - DEMECLOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
LEDERSPAN PARENTERAL T. P. Whelehan Son & Co. PA0137/031/001 - TRIAMCINOLONE 15/12/1989
Limited ACETONIDE
LEDERSPAN PARENTERAL T. P. Whelehan Son & Co. PA0137/031/002 - TRIAMCINOLONE 15/12/1989
Limited HEXACETONIDE
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/006 Capsule 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/007 Capsule - LOXAPINE SUCCINATE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/008 Capsule - LOXAPINE SUCCINATE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/010 - LOXAPINE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/011 - LOXAPINE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/001 Tablets - LOXAPINE SUCCINATE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/002 Tablets - LOXAPINE SUCCINATE 15/12/1989
Limited
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/003 Tablets - LOXAPINE SUCCINATE 15/12/1989
Limited
LOXAPAC (ORAL T. P. Whelehan Son & Co. PA0137/004/004 - LOXAPINE 15/12/1989
CONCENTRATE) Limited
LOXAPAC (ORAL T. P. Whelehan Son & Co. PA0137/004/005 - LOXAPINE 15/12/1989
SUSPENSION) Limited
MAGALDRATE PLUS Ayerst Laboratories Limited PA0149/016/001 Tablets 15/12/1989
SIMETHICONE
MEDOCODENE Medo Pharmaceuticals PA0109/002/001 Tablets - PARACETAMOL 15/12/1989
Limited - CODEINE PHOSPHATE
- PHENOLPHTHALEIN
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/001 15/12/1989
Limited
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/002 15/12/1989
Limited
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/003 Tablets 15/12/1989
Limited
METHOTREXATE IT T. P. Whelehan Son & Co. PA0137/036/001 15/12/1989
Limited
METHOTREXATE IT T. P. Whelehan Son & Co. PA0137/036/002 15/12/1989
Limited
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/004 15/12/1989
PARENTERAL Limited
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/005 15/12/1989
PARENTERAL Limited
MINOCIN T. P. Whelehan Son & Co. PA0137/007/002 Tablets - MINOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
MINOCIN T. P. Whelehan Son & Co. PA0137/007/003 Withdrawn Form - MINOCYCLINE 15/12/1989
Limited HYDROCHLORIDE
MINOCIN (60 CC) T. P. Whelehan Son & Co. PA0137/007/001 Syrup - MINOCYCLINE 15/12/1989
Limited
MRS CULLENS SLEEP Cullen and Davison Limited PA0184/005/001 Syrup - PARACETAMOL 15/12/1989
EZEE - PROMETHAZINE
HYDROCHLORIDE
MYAMBOTOL T. P. Whelehan Son & Co. PA0137/008/001 Tablets 15/12/1989
Limited
MYAMBOTOL T. P. Whelehan Son & Co. PA0137/008/002 Tablets 15/12/1989
Limited
MYNAH T. P. Whelehan Son & Co. PA0137/009/001 Tablets 15/12/1989
Limited
MYNAH T. P. Whelehan Son & Co. PA0137/009/002 Tablets 15/12/1989
Limited
MYNAH T. P. Whelehan Son & Co. PA0137/009/003 Tablets 15/12/1989
Limited

Human Medicines Withdrawn Products Page 474 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MYNAH T. P. Whelehan Son & Co. PA0137/009/004 Tablets 15/12/1989
Limited
NEURODYNE T. P. Whelehan Son & Co. PA0137/037/001 Capsule - PARACETAMOL 15/12/1989
Limited - CODEINE PHOSPHATE
NEURODYNE (CELLULOSE T. P. Whelehan Son & Co. PA0137/037/002 Capsule 15/12/1989
ACETATE STRIPS) Limited

PARFENAC T. P. Whelehan Son & Co. PA0137/032/001 Cream - BUFEXAMAC 15/12/1989


Limited
PHOLCOMED DIABETIC Medo Pharmaceuticals PA0109/005/002 15/12/1989
FORTE Limited
PHOLCOMED DIABETIC Medo Pharmaceuticals PA0109/006/001 15/12/1989
LINCTUS Limited
PHOLCOMED FORTE Medo Pharmaceuticals PA0109/005/001 15/12/1989
LINCTUS Limited
PILOCARPINE NITRATE BP Chauvin Pharmaceuticals PA0118/017/003 15/12/1989
Limited
SALIGEL Stiefel Laboratories (U.K.) PA0144/009/001 15/12/1989
Ltd.
SALIMED Medo Pharmaceuticals PA0109/003/001 Tablets 15/12/1989
Limited
SOOTHING Accord-UK Ltd PA0176/046/001 Cream - ANTAZOLINE 15/12/1989
HYDROCHLORIDE
- CALAMINE
- CAMPHOR
- CETRIMONIUM BROMIDE

STAINS SULFACETAMIDE Chauvin Pharmaceuticals PA0118/021/002 15/12/1989


SODIUM B P Limited
VISDERM H (AMCINONIDE) T. P. Whelehan Son & Co. PA0137/038/002 Cream - AMCINONIDE 15/12/1989
Limited
VISDERM H AMCINONIDE T. P. Whelehan Son & Co. PA0137/038/001 Cream - AMCINONIDE 15/12/1989
Limited
TIXYLIX LINCTUS May & Baker Limited PA0040/050/001 12/12/1989
PEPTARD 3M Health Care Limited PA0057/002/001 - HYOSCYAMINE SULFATE 07/12/1989

SULPHACETAMIDE EYE Daniels Pharmaceutical Ltd PA0396/005/001 06/12/1989


DROPS
BEGRIVAC - S MULTIDOSE Hoechst Ireland Limited PA0023/043/002 05/12/1989

LYPSYL COLD SORE Ciba Geigy Plc PA0028/047/001 Unknown - HEPARIN SODIUM 27/11/1989
TREATMENT - ZINC SULFATE
COBUTOLIN Accord-UK Ltd PA0176/016/003 Syrup - SALBUTAMOL 23/11/1989
MUCOLEX Warner Lambert PA0039/034/002 Tablets 17/11/1989
HISMANAL (SUSPENSION) Janssen Pharmaceutica PA0045/028/002 - ASTEMIZOLE 14/11/1989

COBUTOLIN Accord-UK Ltd PA0176/016/001 Tablets - SALBUTAMOL 10/11/1989


COBUTOLIN Accord-UK Ltd PA0176/016/002 Tablets - SALBUTAMOL 10/11/1989
COBUTOLIN INHALER Accord-UK Ltd PA0176/016/004 Inhalation solution - SALBUTAMOL 10/11/1989
MONOTARD M.C. INSULIN Novo Nordisk A/S PA0218/001/001 10/11/1989
ZINC (SUSPENSION)
TRICANIX Orion Pharma A/s PA0303/014/001 Tablets - TINIDAZOLE 09/11/1989
TRICANIX Orion Pharma A/s PA0303/014/002 Tablets - TINIDAZOLE 09/11/1989
AMINOFUSIN E. Merck Ltd PA0054/008/002 28/10/1989
AMINOFUSIN FORTE E. Merck Ltd PA0054/008/003 28/10/1989
AMINOFUSIN L600 E. Merck Ltd PA0054/008/001 28/10/1989
BROCADOPA Yamanouchi Pharma Ltd PA0062/011/006 Tablets 28/10/1989
COSOME E. Merck Ltd PA0054/019/001 Syrup - EPHEDRINE 28/10/1989
HYDROCHLORIDE
- ETHYLMORPHINE
HYDROCHLORIDE
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/014/001 Tablets 28/10/1989
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/014/002 Capsule 28/10/1989
CYCLOSPASMOL Yamanouchi Pharma Ltd PA0062/014/003 28/10/1989
(SUSPENSION)
DECODERM E. Merck Ltd PA0054/010/001 Cream - FLUPREDNIDENE 28/10/1989
ACETATE
ENCEPHABOL FORTE E. Merck Ltd PA0054/004/002 Tablets - PYRITINOL 28/10/1989
ERALDIN Zeneca Limited PA0051/041/001 Withdrawn Form - PRACTOLOL 28/10/1989
HIBISCRUB Zeneca Limited PA0051/031/002 - CHLORHEXIDINE 28/10/1989
GLUCONATE
HIBISCRUB Zeneca Limited PA0051/031/003 - CHLORHEXIDINE 28/10/1989
GLUCONATE
MERIEUX ORAL Servier Laboratories (Ireland) PA0068/008/001 28/10/1989
POLIOMYELITIS Ltd

Human Medicines Withdrawn Products Page 475 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MERIEUX ORAL Servier Laboratories (Ireland) PA0068/008/002 28/10/1989
POLIOMYELITIS VACCINE Ltd
NIKEVIT Rowa Pharmaceuticals PA0074/001/001 - MULTIVITAMINS 28/10/1989
Limited
PANADOL Sanofi-Synthelabo Ireland PA0077/023/002 Tablets 28/10/1989
Ltd
SEPTOPAL BEADS/CHAINS E. Merck Ltd PA0054/014/002 28/10/1989
30
SYNALAR C Zeneca Limited PA0051/018/003 Cream 28/10/1989
SYNALAR C Zeneca Limited PA0051/018/004 Ointment 28/10/1989
SYNALAR N Zeneca Limited PA0051/017/004 Cream - FLUOCINOLONE 28/10/1989
ACETONIDE
- NEOMYCIN
SYNANDONE Zeneca Limited PA0051/019/003 Cream 28/10/1989
TOLVON Organon (Ireland) Limited PA0061/001/001 28/10/1989
TRIVASTAL 50 RETARD Servier Laboratories (Ireland) PA0068/012/001 28/10/1989
Ltd
UROMIRO 300 E. Merck Ltd PA0054/015/001 28/10/1989
UROMIRO 300 E. Merck Ltd PA0054/015/002 28/10/1989
VENDARCIN Yamanouchi Pharma Ltd PA0062/006/001 Capsule 28/10/1989
DEFENCIN CP Bristol-Myers Squibb PA0048/015/001 Capsule - ISOXSUPRINE 13/10/1989
(Holdings) Limited
ELECTROLYTE 20.0% Baxter Healthcare Limited PA0167/015/001 - MAGNESIUM CHLORIDE 13/10/1989
DEXTROSE ANHYDROUS
- CALCIUM CHLORIDE
DIHYDRATE
- ZINC ACETATE
- MANGANESE CHLORIDE
ELECTROLYTE SOLUTION Baxter Healthcare Limited PA0167/016/001 - POTASSIUM PHOSPHATE 13/10/1989
B MONOBASIC
BCG INTRADERMAL 0.8 TO Glaxo Laboratories Limited PA0044/045/003 06/10/1989
2.6
FUCIDIN DISCS Leo Laboratories Limited PA0046/004/003 06/10/1989
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/005 Cream - MICONAZOLE NITRATE 06/10/1989
IMPERACIN Zeneca Limited PA0051/011/001 Capsule - OXYTETRACYCLINE 06/10/1989
DIHYDRATE
KEFADOL Eli Lilly and Company Limite PA0047/038/002 - CEFAMANDOLE NAFATE 06/10/1989

KEFADOL Eli Lilly and Company Limite PA0047/038/005 06/10/1989

MOTILIUM Janssen Pharmaceutica PA0045/016/007 Withdrawn Form - DOMPERIDONE 06/10/1989


MOTILIUM ORAL Janssen Pharmaceutica PA0045/016/004 - DOMPERIDONE 06/10/1989
NEPENTHE INJECTION Glaxo Laboratories Limited PA0044/038/001 - PAPAVERETUM 06/10/1989
- MORPHINE
HYDROCHLORIDE
OCERAL ROCHE Roche Products Limited PA0050/069/001 Cream - OXICONAZOLE NITRATE 06/10/1989
OCERAL ROCHE Roche Products Limited PA0050/069/002 - OXICONAZOLE NITRATE 06/10/1989
OCERAL ROCHE Roche Products Limited PA0050/069/003 Tablets - OXICONAZOLE NITRATE 06/10/1989
ZINACEF (CEFUROXINE) Glaxo Laboratories Limited PA0044/037/004 06/10/1989
VIALS
CALCISORB 3M Health Care Limited PA0057/043/001 - SODIUM CELLULOSE 02/10/1989
PHOSPHATE
DISALCID 3M Health Care Limited PA0057/007/002 Capsule - SALSALATE 02/10/1989
MEDIHALER-DUO 3M Health Care Limited PA0057/026/001 - PHENYLEPHRINE 02/10/1989
BITARTRATE
- ISOPRENALINE
HYDROCHLORIDE
MEDIHALER-EPI 3M Health Care Limited PA0057/025/001 - EPINEPHRINE 02/10/1989
BITARTRATE
NORFLEX 3M Health Care Limited PA0057/023/002 Withdrawn Form - ORPHENADRINE 02/10/1989
CITRATE
NUMOTAC 3M Health Care Limited PA0057/015/001 Tablets - ISOETARINE 02/10/1989
HYDROCHLORIDE
RIKOSPRAY SILICONE 3M Health Care Limited PA0057/050/001 - CETYLPYRIDINIUM 02/10/1989
CHLORIDE
- SILICONE FLUID SFD 119

NORPACE G.D. Searle & Company PA0001/003/003 - DISOPYRAMIDE 27/09/1989


Limited PHOSPHATE
INTRAVAL May & Baker Limited PA0040/017/002 Suppositories 25/09/1989
TIXYLIX May & Baker Limited PA0040/035/001 25/09/1989
ALUDROX John Wyeth & Brother PA0022/015/001 Gel - ALUMINIUM HYDROXIDE 15/09/1989
Limited
ALUDROX John Wyeth & Brother PA0022/015/003 Gel 15/09/1989
Limited

Human Medicines Withdrawn Products Page 476 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALUDROX John Wyeth & Brother PA0022/015/004 Gel 15/09/1989
Limited
ALUDROX John Wyeth & Brother PA0022/015/005 Tablets - ALUMINIUM HYDROXIDE 15/09/1989
Limited
ALUDROX John Wyeth & Brother PA0022/016/001 Tablets 15/09/1989
Limited
ATARAX Pfizer Limited PA0019/003/003 Tablets - HYDROXYZINE 15/09/1989
HYDROCHLORIDE
CORTRIL 1.0% Pfizer Limited PA0019/018/005 Ointment - HYDROCORTISONE 15/09/1989
DAONIL Hoechst Ireland Limited PA0023/019/003 Tablets 15/09/1989
HOSTACYCLINE P Hoechst Ireland Limited PA0023/014/001 Capsule - TETRACYCLINE 15/09/1989
HYDROCHLORIDE
ISMELIN - NAVIDREX K Ciba Geigy Plc PA0028/029/001 - GUANETHIDINE SULFATE 15/09/1989
- CYCLOPENTHIAZIDE

LEMSIP Reckitt's (Ireland) Limited PA0027/006/001 - PARACETAMOL 15/09/1989


- PHENYLEPHRINE
- SODIUM CITRATE
- ASCORBIC ACID
POTABA Glenwood Laboratories PA0031/001/003 Capsule - POTASSIUM 15/09/1989
Limited AMINOBENZOATE
TERRAMYCIN Pfizer Limited PA0019/009/008 Withdrawn Form 15/09/1989
INTRAVENOUS
INFLUVAC Abbott Healthcare Products PA0108/003/015 Withdrawn Form 07/09/1989
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/016 Withdrawn Form 07/09/1989
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/017 Withdrawn Form 07/09/1989
Ltd
ALPHACILLIN Merck Sharp and Dohme PA0035/001/005 Capsule - PIVAMPICILLIN 03/09/1989
Limited HYDROCHLORIDE
PENERIN Mayne Pharma (Ireland) PA0078/013/002 Syrup - AMPICILLIN TRIHYDRATE 28/08/1989
Limited
CALSALETTES Torbet Laboratories Limited PA0456/001/002 - ALOIN 22/08/1989
(UNCOATED)
GLURENORM Sanofi-Synthelabo Ireland PA0077/058/001 Tablets - GLIQUIDONE 14/08/1989
Ltd
BISOLVON AMPOULES Boehringer Ingelheim Limited PA0007/025/003 - BROMHEXINE 10/08/1989
HYDROCHLORIDE
OPILON Warner Lambert PA0039/016/001 Withdrawn Form 10/08/1989
OPILON FORTE Warner Lambert PA0039/016/002 Withdrawn Form 10/08/1989
PERITRATE S.A. Warner Lambert PA0039/019/002 Tablets 10/08/1989
PHOLCOLIC Warner Lambert PA0039/030/001 10/08/1989
SINUTAB Warner Lambert PA0039/022/001 10/08/1989
SINUTAB Warner Lambert PA0039/022/003 Tablets 10/08/1989
SLOANS LINIMENT Lambert Chemicals Co. Ltd PA0377/002/001 - TURPENTINE OIL 10/08/1989
- PINE OIL
- METHYL SALICYLATE
- CAMPHOR
PANADEINE FORTE Sanofi-Synthelabo Ireland PA0077/036/003 - PARACETAMOL 06/08/1989
Ltd - CODEINE PHOSPHATE
HEMIHYDRATE
SOLPADEINE FORTE Sanofi-Synthelabo Ireland PA0077/033/002 - PARACETAMOL 06/08/1989
Ltd - CODEINE PHOSPHATE
- CAFFEINE
RINSTEAD PHEROL Schering-Plough Limited PA0277/057/001 - BENZOCAINE 04/08/1989
THROAT (SPRAY) - CETYLPYRIDINIUM
CHLORIDE
DILOPECT Duncan, Flockhard & Co. PA0065/006/001 Syrup 02/08/1989
Limited
BURINEX A Leo Laboratories Limited PA0046/059/002 Tablets - BUMETANIDE 01/08/1989
- AMILORIDE
NIROLEX The Boots Company Plc PA0004/029/001 Syrup - EPHEDRINE 01/08/1989
HYDROCHLORIDE
- GUAIFENESIN
- MENTHOL
- GLYCEROL
CETAVLON Zeneca Limited PA0051/044/001 - CETRIMONIUM BROMIDE 31/07/1989

ALMEVAX RUBELLA Wellcome (Ireland) Limited PA0017/022/003 - RUBELLA VIRUS 28/07/1989


VACCINE VACCINE LIVE
ATTENUATED
CYTOSAR Pharmacia Limited PA0016/025/002 28/07/1989
DIPHTHERIA ANTITOXIN Wellcome (Ireland) Limited PA0017/025/002 - DIPHTHERIA ANTITOXIN 28/07/1989
DIPHTHERIA ANTITOXIN Wellcome (Ireland) Limited PA0017/025/004 - DIPHTHERIA ANTITOXIN 28/07/1989

Human Medicines Withdrawn Products Page 477 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIPHTHERIA VACCINE P T Wellcome (Ireland) Limited PA0017/026/002 - DIPHTHERIA TOXOID 28/07/1989
AP
DIPHTHERIAL ANTITOXIN Wellcome (Ireland) Limited PA0017/025/003 - DIPHTHERIA ANTITOXIN 28/07/1989
BP
GAZ GANGRENE Wellcome (Ireland) Limited PA0017/030/001 28/07/1989
ANTITOXIN B P
PAMINAL ELIXIR Pharmacia Limited PA0016/014/001 28/07/1989
TETANUS ANTITOXIN Wellcome (Ireland) Limited PA0017/039/001 28/07/1989
TETANUS ANTITOXIN B P Wellcome (Ireland) Limited PA0017/039/002 28/07/1989
TETANUS ANTITOXIN B P Wellcome (Ireland) Limited PA0017/039/003 28/07/1989
10000
TETANUS ANTITOXIN B P Wellcome (Ireland) Limited PA0017/039/004 28/07/1989
50,000
TRIOGESIC Novartis Pharmaceuticals UK PA0013/009/001 Tablets - 28/07/1989
Ltd PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PARACETAMOL
TRIOGESIC ELIXIR Novartis Pharmaceuticals UK PA0013/009/002 Oral Solution - 28/07/1989
Ltd PHENYLPROPANOLAMINE
HYDROCHLORIDE
- PARACETAMOL
TRIOMINIC Novartis Pharmaceuticals UK PA0013/023/001 Tablets - MEPYRAMINE MALEATE 28/07/1989
Ltd - PHENIRAMINE MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
TRIOMINIC Novartis Pharmaceuticals UK PA0013/023/002 Syrup - MEPYRAMINE MALEATE 28/07/1989
Ltd - PHENIRAMINE MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/037/001 28/07/1989
& B AND
CHOLERAVACCINE
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/037/002 28/07/1989
& B/CHOLERA VACCINE
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/038/001 28/07/1989
B & TETANUS VACCINE
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/038/002 28/07/1989
B AND TETANUS VACCINE

TYPHOLD-PARATYPHOID Wellcome (Ireland) Limited PA0017/034/001 28/07/1989


A & B VACCINE
TYPHOLD-PARATYPHOID Wellcome (Ireland) Limited PA0017/034/002 28/07/1989
A & B VACCINE B P
ALUPENT Boehringer Ingelheim Limited PA0007/015/006 - ORCIPRENALINE 25/07/1989
SULFATE
BUDESONIDE AEROSOL Astra Pharmaceuticals Ltd PA0009/013/003 - BUDESONIDE 25/07/1989
BUDESONIDE AEROSOL Astra Pharmaceuticals Ltd PA0009/013/004 - BUDESONIDE 25/07/1989
MODITEN ENANTHATE Bristol-Myers Squibb PA0002/016/002 25/07/1989
Pharmaceuticals uc
NOROXIN Merck Sharp and Dohme PA0035/065/001 Tablets - NORFLOXACIN 25/07/1989
Limited
PROCTOSEDYL Roussel Laboratories Limited PA0006/018/003 Ointment 25/07/1989

TESULOID Bristol-Myers Squibb PA0002/043/001 - SULFUR 25/07/1989


Pharmaceuticals uc
TONOCARD Astra Pharmaceuticals Ltd PA0009/027/005 Solution for Infusion - TOCAINIDE 25/07/1989
HYDROCHLORIDE
SANATOGEN JUNIOR Fisons Limited PA0018/030/001 19/07/1989
VITAMINS
SANATOGEN Fisons Limited PA0018/031/001 Tablets 19/07/1989
MULTIVITAMINS
SANATOGEN Fisons Limited PA0018/026/001 - FERROUS FUMARATE 19/07/1989
MULTIVITIMINS PLUS IRON

ANTYLIN Mercury Pharmaceuticals PA0073/119/001 - DIPHENHYDRAMINE 18/07/1989


(Ireland) Ltd HYDROCHLORIDE
HALDOL Janssen Pharmaceutica PA0045/005/006 - HALOPERIDOL 14/07/1989
SOLVEZINK Astra Pharmaceuticals Ltd PA0009/032/001 Tablets - ZINC SULFATE 12/07/1989
THEAN Astra Pharmaceuticals Ltd PA0009/011/002 Tablets - PROXYPHYLLINE 12/07/1989
THEAN Astra Pharmaceuticals Ltd PA0009/011/003 Suppositories - PROXYPHYLLINE 12/07/1989
THEAN AMPOULES Astra Pharmaceuticals Ltd PA0009/011/001 - PROXYPHYLLINE 12/07/1989
LASILACTONE Hoechst Ireland Limited PA0023/049/001 Tablets - SPIRONOLACTONE 11/07/1989
- FUROSEMIDE

Human Medicines Withdrawn Products Page 478 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ROBITUSSIN AC A.H. Robins Company PA0086/009/001 Syrup - GUAIFENESIN 11/07/1989
Limited - PHENIRAMINE MALEATE
- CODEINE PHOSPHATE
HYPOTEARS CV Limited PA0383/002/001 - MACROGOL 05/07/1989
- POLYVINYL ALCOHOL
- BENZALKONIUM
CHLORIDE
PHENSEDYL May & Baker Limited PA0040/034/001 29/06/1989
ANXON SmithKline Beecham Pharm PA0049/030/001 Capsule - KETAZOLAM 27/06/1989
Ltd
FLOXAPEN 125 MG/5 ML SmithKline Beecham Pharm PA0049/018/006 Syrup - FLUCLOXACILLIN 27/06/1989
Ltd SODIUM
FLOXAPEN 125 MG/5 ML SmithKline Beecham Pharm PA0049/018/007 Syrup - FLUCLOXACILLIN 27/06/1989
Ltd SODIUM
MIRETILAN Novartis Pharmaceuticals UK PA0013/034/001 Capsule - ENDRALAZINE 23/06/1989
Ltd
MIRETILAN Novartis Pharmaceuticals UK PA0013/034/002 Capsule - ENDRALAZINE 23/06/1989
Ltd
MEASAVAX 50 DOSE Sanofi Pasteur MSD Ltd PA0544/003/003 22/06/1989
RUBAVAX 50 DOSE Sanofi Pasteur MSD Ltd PA0544/002/003 Withdrawn Form - RUBELLA VIRUS 22/06/1989
VACCINE LIVE
ATTENUATED
ALUPENT AMPOULES Boehringer Ingelheim Limited PA0007/015/008 Withdrawn Form - ORCIPRENALINE 13/06/1989
SULFATE
VASOPROST SCHWARZ PHARMA Limite PA0271/005/001 - ALPROSTADIL 12/06/1989

GONDAFON HE Clissmann PA0012/009/001 Tablets - GLYMIDINE SODIUM 02/06/1989


PRIMOBOLAN DEPOT HE Clissmann PA0012/017/002 Withdrawn Form 02/06/1989
PRIMOBOLAN DEPOT HE Clissmann PA0012/017/001 - METENOLONE 02/06/1989
AMPS ENANTATE
PRIMOLUT DEPOT HE Clissmann PA0012/020/003 - 02/06/1989
HYDROXYPROGESTERON
E CAPROATE
PRIMOLUT DEPOT HE Clissmann PA0012/020/004 - 02/06/1989
HYDROXYPROGESTERON
E CAPROATE
PRIMOLUT DEPOT AMPS HE Clissmann PA0012/020/001 - 02/06/1989
HYDROXYPROGESTERON
E CAPROATE
PROVIRONUM HE Clissmann PA0012/025/001 Tablets - MESTEROLONE 02/06/1989
HALIN Nicholas Laboratories PA0032/027/001 Tablets - DEXBROMPHENIRAMINE 25/05/1989
MALEATE
- PSEUDOEPHEDRINE
SULFATE

RENNIE PLUS Nicholas Laboratories PA0032/032/001 Gel - ALUMINIUM HYDROXIDE 18/05/1989


- MAGNESIUM HYDROXIDE

DIHYDERGOT Novartis Pharmaceuticals UK PA0013/015/001 Tablets - DIHYDROERGOTAMINE 17/05/1989


Ltd MESILATE
CHYMAR-F Aventis Behring Limited PA0010/005/001 Ointment - FENTICLOR 16/05/1989
CHYMAR-F Aventis Behring Limited PA0010/005/002 Ointment - FENTICLOR 16/05/1989
DIALUME Aventis Behring Limited PA0010/023/001 Capsule - ALUMINIUM HYDROXIDE 16/05/1989
PNEUMOVAX VACCINE Merck Sharp and Dohme PA0035/054/001 - PNEUMOCOCCAL 16/05/1989
Limited VACCINE
- POLYVALENT E.
COLIVACCIN
PNEUMOVAX VACCINE Merck Sharp and Dohme PA0035/054/002 - PNEUMOCOCCAL 16/05/1989
Limited VACCINE
- POLYVALENT E.
COLIVACCIN
PNEUMOVAX VACCINE Merck Sharp and Dohme PA0035/054/003 - PNEUMOCOCCAL 16/05/1989
Limited VACCINE
- POLYVALENT E.
COLIVACCIN
PNEUMOVAX VACCINE Merck Sharp and Dohme PA0035/054/004 - PNEUMOCOCCAL 16/05/1989
Limited VACCINE
- POLYVALENT E.
COLIVACCIN
RENNIE PLUS Nicholas Laboratories PA0032/032/002 Tablets - ALUMINIUM HYDROXIDE 08/05/1989
- MAGNESIUM HYDROXIDE

XYLOCAINE 0.5% Astra Pharmaceuticals Ltd PA0009/016/010 - LIDOCAINE 02/05/1989


XYLOCAINE 1.0% Astra Pharmaceuticals Ltd PA0009/016/014 Withdrawn Form - LIDOCAINE 02/05/1989
XYLOCAINE 2.0% Astra Pharmaceuticals Ltd PA0009/016/018 - LIDOCAINE 02/05/1989

Human Medicines Withdrawn Products Page 479 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
XYLOCAINE WITH Astra Pharmaceuticals Ltd PA0009/019/001 - LIDOCAINE 02/05/1989
ADRENALINE - EPINEPHRINE
XYLOCAINE WITH Astra Pharmaceuticals Ltd PA0009/019/003 - LIDOCAINE 02/05/1989
ADRENALINE 1% - EPINEPHRINE
XYLOCAINE WITH Astra Pharmaceuticals Ltd PA0009/019/006 - LIDOCAINE 02/05/1989
ADRENALINE 2.0% - EPINEPHRINE
CANTIL Boehringer Mannheim PA0130/002/001 Tablets 21/04/1989
CANTIL ELIXIR Boehringer Mannheim PA0130/002/002 21/04/1989
DACTIL Boehringer Mannheim PA0130/004/001 Tablets 21/04/1989
PIPTAL Boehringer Mannheim PA0130/005/001 Tablets 21/04/1989
PIPTALIN ELIXIR Boehringer Mannheim PA0130/014/001 21/04/1989
POSALFILIN Norgine Limited PA0102/017/002 - PODOPHYLLUM RESIN 17/04/1989
- SALICYLIC ACID
EYEZONE EYE LOTION Chauvin Pharmaceuticals PA0118/031/001 14/04/1989
Limited
DUVADILAN Abbott Healthcare Products PA0108/001/003 Tablets - ISOXSUPRINE 11/04/1989
Ltd HYDROCHLORIDE
ALEVAIRE Sanofi-Synthelabo Ireland PA0077/074/001 - TYLOXAPOL 06/04/1989
Ltd
BILOPAQUE Sanofi-Synthelabo Ireland PA0077/005/001 - SODIUM TYROPANOATE 06/04/1989
Ltd
CALCICARD 3M Health Care Limited PA0057/057/001 Tablets - DILTIAZEM 06/04/1989
FORTRAL Sanofi-Synthelabo Ireland PA0077/035/006 Suppositories - PENTAZOCINE 06/04/1989
Ltd
HYPAQUE 65% Sanofi-Synthelabo Ireland PA0077/070/001 - MEGLUMINE 06/04/1989
Ltd AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

HYPAQUE 85% Sanofi-Synthelabo Ireland PA0077/071/001 - MEGLUMINE 06/04/1989


Ltd AMIDOTRIZOATE
- SODIUM AMIDOTRIZOATE

LEVOPHED Sanofi-Synthelabo Ireland PA0077/044/001 - NOREPINEPHRINE 06/04/1989


Ltd
LUMINAL Sanofi-Synthelabo Ireland PA0077/013/001 Tablets - PHENOBARBITAL 06/04/1989
Ltd
LUMINAL Sanofi-Synthelabo Ireland PA0077/013/002 Tablets - PHENOBARBITAL 06/04/1989
Ltd
LUMINAL Sanofi-Synthelabo Ireland PA0077/013/003 Tablets - PHENOBARBITAL 06/04/1989
Ltd
NEOPHRYN NASAL SPRAY Sanofi-Synthelabo Ireland PA0077/084/002 - PHENYLEPHRINE 06/04/1989
Ltd HYDROCHLORIDE
PHANODORM Sanofi-Synthelabo Ireland PA0077/018/001 Tablets - CYCLOBARBITAL 06/04/1989
Ltd
PHISOHEX Sanofi-Synthelabo Ireland PA0077/063/001 - HEXACHLOROPHENE 06/04/1989
Ltd
PROMINAL Sanofi-Synthelabo Ireland PA0077/019/001 Tablets 06/04/1989
Ltd
PROMINAL Sanofi-Synthelabo Ireland PA0077/019/002 Tablets 06/04/1989
Ltd
PROMINAL Sanofi-Synthelabo Ireland PA0077/019/003 Tablets 06/04/1989
Ltd
KOLANTYL NV Marion Merrell Limited PA0041/015/001 Tablets 01/04/1989
STROMBA Sanofi-Synthelabo Ireland PA0077/045/002 Solution for Injection - STANOZOLOL 01/04/1989
Ltd
EPHEDRINE Mercury Pharmaceuticals PA0073/038/001 21/03/1989
HYDROCHLORIDE (Ireland) Ltd
ONCOVIN Eli Lilly and Company Limite PA0047/046/001 Withdrawn Form - VINCRISTINE SULFATE 16/03/1989

ONCOVIN Eli Lilly and Company Limite PA0047/046/002 Withdrawn Form - VINCRISTINE SULFATE 16/03/1989

ONCOVIN Eli Lilly and Company Limite PA0047/046/003 Withdrawn Form - VINCRISTINE SULFATE 16/03/1989

FRUMIL LS Berk Pharmaceuticals PA0082/049/002 Tablets - FUROSEMIDE 14/03/1989


Limited - AMILORIDE
ALUPENT EXPECTORANT Boehringer Ingelheim Limited PA0007/015/001 Tablets - ORCIPRENALINE 13/03/1989
- BROMHEXINE
ALUPENT INHALANT Boehringer Ingelheim Limited PA0007/015/007 - ORCIPRENALINE 13/03/1989
SULFATE
ALUPENT OBSTETRIC Boehringer Ingelheim Limited PA0007/015/009 - ORCIPRENALINE 13/03/1989
AMPOULES SULFATE
VENOS NIGHT-TIME PRD SmithKlineBeecham PA0379/023/001 - CHLORPHENAMINE 10/03/1989
448 Consumer Brand - DEXTROMETHORPHAN
DROXARYL Ovelle Limited PA0206/006/002 Suppositories - BUFEXAMAC 07/03/1989
EUDEMINE Allen and Hanburys Limited PA0024/013/002 Withdrawn Form - DIAZOXIDE 03/03/1989

Human Medicines Withdrawn Products Page 480 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TOSMILEN EYE DROPS Sinclair Pharmaceuticals PA0251/013/001 01/03/1989
Limited
TOSMILEN EYE DROPS Sinclair Pharmaceuticals PA0251/013/002 01/03/1989
Limited
OVULEN 50 G.D. Searle & Company PA0001/013/001 Tablets - ETHINYLESTRADIOL 24/02/1989
Limited - ETYNODIOL DIACETATE
AFLOXAN Opfermann PA0485/001/001 Capsule 22/02/1989
MEDIQUELL Parke Davis & Company PA0056/044/001 Tablets - DEXTROMETHORPHAN 22/02/1989
HYDROBROMIDE
PRESSURISED BROVON Napp Laboratories Limited PA0114/018/001 - EPINEPHRINE 22/02/1989
- ATROPINE
METHONITRATE
PRESSURISED ISO- Napp Laboratories Limited PA0114/017/001 - ISOPRENALINE 22/02/1989
BROVON HYDROCHLORIDE
- ATROPINE
METHONITRATE
PRESSURISED ISO- Napp Laboratories Limited PA0114/017/002 - ISOPRENALINE 22/02/1989
BROVON PLUS HYDROCHLORIDE
- ATROPINE
METHONITRATE
ADALAT 1C Bayer PLC PA0021/003/004 - NIFEDIPINE 17/02/1989
TEMGESIC-NX Reckitt's (Ireland) Limited PA0027/040/001 Withdrawn Form - BUPRENORPHINE 15/02/1989
HYDROCHLORIDE
- NALOXONE
HYDROCHLORIDE
TEMGESIC-NX Reckitt's (Ireland) Limited PA0027/040/002 - BUPRENORPHINE 15/02/1989
HYDROCHLORIDE
- NALOXONE
HYDROCHLORIDE
OSPOLOT Bayer PLC PA0021/008/001 Tablets - SULTIAME 10/02/1989
OSPOLOT Bayer PLC PA0021/008/002 Tablets - SULTIAME 10/02/1989
OSPOLOT (SUSPENSION) Bayer PLC PA0021/008/003 - SULTIAME 10/02/1989

DROXARYL Ovelle Limited PA0206/006/001 Cream - BUFEXAMAC 07/02/1989


TEDRAL Warner Lambert PA0039/024/005 07/02/1989
TEDRAL Warner Lambert PA0039/024/008 Tablets 07/02/1989
TEDRAL SA Warner Lambert PA0039/024/006 Tablets 07/02/1989
INDULATERM Schering-Plough Limited PA0277/049/001 Syrup - AZATADINE MALEATE 06/02/1989
- PSEUDOEPHEDRINE
SULFATE
- PARACETAMOL
INDULAFRIN Schering-Plough Limited PA0277/048/001 Syrup - AZATADINE MALEATE 03/02/1989
- PSEUDOEPHEDRINE
SULFATE
- DEXTROMETHORPHAN
HYDROBROMIDE
MASTERIL Syntex Pharmaceuticals PA0033/015/001 03/02/1989
Limited
ROFERON - A Roche Products Limited PA0050/068/006 - INTERFERON ALFA-2A 02/02/1989
TELESRYINGE
ROFERON A Roche Products Limited PA0050/068/004 - INTERFERON ALFA-2A 02/02/1989
TELESYRINGE
ROFERON A Roche Products Limited PA0050/068/005 - INTERFERON ALFA-2A 02/02/1989
TELESYRINGE
ESTROVIS Warner Lambert PA0039/010/001 Tablets 01/02/1989
PENTOVIS Warner Lambert PA0039/018/001 Capsule 01/02/1989
TEDRAL ELIXIR Warner Lambert PA0039/024/009 01/02/1989
DISTACLOR Eli Lilly and Company Limite PA0047/039/007 Tablets Effervescent - CEFACLOR 30/01/1989

SYNADRIN Hoechst Ireland Limited PA0023/028/001 Tablets - PRENYLAMINE 30/01/1989


CORTUCID EYE Nicholas Laboratories PA0032/025/001 Cream - SULFACETAMIDE 26/01/1989
SODIUM
- HYDROCORTISONE
ACETATE
VIVALAN Zeneca Limited PA0051/001/001 - VILOXAZINE 25/01/1989
HYDROCHLORIDE
THEOCLEAR Mayne Pharma (Ireland) PA0078/041/001 Capsule - THEOPHYLLINE 24/01/1989
Limited
DISTACLOR Eli Lilly and Company Limite PA0047/039/005 - CEFACLOR 23/01/1989
(SUSPENSION)
DISTACLOR Eli Lilly and Company Limite PA0047/039/006 - CEFACLOR 23/01/1989
(SUSPENSION)
CINOBAC Eli Lilly and Company Limite PA0047/041/001 Capsule - CINOXACIN 18/01/1989

CINOBAC Eli Lilly and Company Limite PA0047/041/002 Capsule - CINOXACIN 18/01/1989

Human Medicines Withdrawn Products Page 481 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FLOXAPEN SmithKline Beecham Pharm PA0049/018/008 - FLUCLOXACILLIN 18/01/1989
Ltd SODIUM
FOLIC ACID Eli Lilly and Company Limite PA0047/063/001 Tablets 18/01/1989

KEFLEX (SUSPENSION) Eli Lilly and Company Limite PA0047/008/007 - CEFALEXIN 18/01/1989
MONOHYDRATE
KEFLEX REDI-MIX ORAL Eli Lilly and Company Limite PA0047/008/008 - CEFALEXIN 18/01/1989
(SUSPENSION) MONOHYDRATE
MERTHIOLATE TINCTURE Eli Lilly and Company Limite PA0047/042/001 - THIOMERSAL 18/01/1989

CROOKES ONE-A-DAY Crookes Healthcare Ltd PA0043/002/001 13/01/1989


WITH IRON
CROOKES ONE-A-DAY Crookes Healthcare Ltd PA0043/005/001 - RETINOL PALMITATE 13/01/1989
WITHOUT IRON - THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- PYRIDOXINE
HYDROCHLORIDE
- CYANOCOBALAMIN
- ASCORBIC ACID
- COLECALCIFEROL
SECRETIN The Boots Company Plc PA0004/020/001 - SECRETIN 13/01/1989
BLOCADREN 0.25MG/ML Merck Sharp and Dohme PA0035/044/008 Withdrawn Form - TIMOLOL MALEATE 09/01/1989
Limited
BLOCADREN 0.25MG/ML Merck Sharp and Dohme PA0035/044/009 Withdrawn Form - TIMOLOL MALEATE 09/01/1989
Limited
BLOCADREN 0.25MG/ML Merck Sharp and Dohme PA0035/044/010 Withdrawn Form 09/01/1989
Limited
BLOCADREN 0.25MG/ML Merck Sharp and Dohme PA0035/044/011 Withdrawn Form - TIMOLOL MALEATE 09/01/1989
Limited
CYTARABINE Hospira UK Limited PA0437/006/001 Solution for Injection - CYTARABINE 09/01/1989
CYTARABINE Hospira UK Limited PA0437/006/002 Solution for Injection - CYTARABINE 09/01/1989
CO-BETALOC SA Astra Pharmaceuticals Ltd PA0009/010/002 Tablets - METOPROLOL TARTRATE 06/01/1989
- HYDROCHLOROTHIAZIDE

MESTINON AMPOULES Roche Products Limited PA0050/040/002 - PYRIDOSTIGMINE 15/12/1988


BROMIDE
TRH ROCHE Roche Products Limited PA0050/044/001 Tablets - PROTIRELIN 15/12/1988
NERIBAS HE Clissmann PA0012/002/004 Cream 13/12/1988
NAPROSYN SLOW Syntex Pharmaceuticals PA0033/005/010 Tablets - NAPROXEN 08/12/1988
RELEASE Limited
NAPROSYN SLOW Syntex Pharmaceuticals PA0033/005/011 Tablets - NAPROXEN 08/12/1988
RELEASE Limited
ORTHOXICOL Pharmacia Limited PA0016/026/001 Syrup 06/12/1988
ORTHOXIN Pharmacia Limited PA0016/027/001 06/12/1988
HYDROCHLORIDE
TERRAMYCIN Pfizer Limited PA0019/022/001 Ointment - OXYTETRACYCLINE 06/12/1988
OPHTHALMIC - POLYMYXIN B SULFATE
VIBRAMYCIN Pfizer Limited PA0019/013/004 Tablets - DOXYCYCLINE 06/12/1988
HYDROCHLORIDE
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/006/008 - AMINO ACIDS 05/12/1988
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/006/002 - AMINO ACIDS 05/12/1988
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/006/005 - AMINO ACIDS 05/12/1988
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/006/006 - AMINO ACIDS 05/12/1988
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/006/003 - AMINO ACIDS 05/12/1988
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/006/009 - AMINO ACIDS 05/12/1988
SYNTHAMIN 7S 4.0% Baxter Healthcare Limited PA0167/003/001 Withdrawn Form - AMINO ACIDS 05/12/1988
SYNTHAMIN 7S Baxter Healthcare Limited PA0167/003/002 Withdrawn Form - AMINO ACIDS 05/12/1988
4.0%/AMINO ACID
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/006/001 - AMINO ACIDS 05/12/1988
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/006/004 - AMINO ACIDS 05/12/1988
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/006/007 - AMINO ACIDS 05/12/1988
ALLPYRAL ALLERGEN Bayer Diagnostics PA0079/010/001 - ALLERGENEXTRACT, 30/11/1988
Manufacturing GR\NALGER
CONJUVAC Bayer Diagnostics PA0079/013/001 Withdrawn Form 30/11/1988
Manufacturing
CONJUVAC Bayer Diagnostics PA0079/013/002 Withdrawn Form 30/11/1988
Manufacturing
CONJUVAC Bayer Diagnostics PA0079/013/003 Withdrawn Form 30/11/1988
Manufacturing
DIALYSED DIAGNOSTIC Bayer Diagnostics PA0079/014/001 30/11/1988
Manufacturing

Human Medicines Withdrawn Products Page 482 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOME GLYCERINATED Bayer Diagnostics PA0079/011/001 30/11/1988
SKIN TESTING SOLUTIONS Manufacturing

HYMENOPTERA VENOM - Bayer Diagnostics PA0079/012/001 Withdrawn Form 30/11/1988


HONEY BEE VENOM Manufacturing
HYMENOPTERA VENOM - Bayer Diagnostics PA0079/012/002 Withdrawn Form 30/11/1988
VESPID WASP Manufacturing
ANTACIN PLUS John Wyeth & Brother PA0022/064/002 25/11/1988
(SUSPENSION) Limited
SILBEPHYLLINE Berk Pharmaceuticals PA0082/024/001 Tablets - DIPROPHYLLINE 22/11/1988
Limited
SILBEPHYLLINE Berk Pharmaceuticals PA0082/024/002 Syrup - DIPROPHYLLINE 22/11/1988
Limited
SILBEPHYLLINE Berk Pharmaceuticals PA0082/024/003 Suppositories - DIPROPHYLLINE 22/11/1988
Limited
SILBEPHYLLINE Berk Pharmaceuticals PA0082/024/004 - DIPROPHYLLINE 22/11/1988
Limited
BANISTYL May & Baker Limited PA0040/041/001 Tablets 21/11/1988
PHENERGAN COMPOUND May & Baker Limited PA0040/043/001 21/11/1988
PHENERGAN COMPOUND May & Baker Limited PA0040/043/002 21/11/1988
MILLOPHYLINE Dales Pharmaceuticals PA0129/004/001 Withdrawn Form 10/11/1988
Limited
MILLOPHYLINE Dales Pharmaceuticals PA0129/004/002 Suppositories 10/11/1988
Limited
MILLOPHYLINE Dales Pharmaceuticals PA0129/004/003 Suppositories 10/11/1988
Limited
MILLOPHYLINE Dales Pharmaceuticals PA0129/004/004 Tablets 10/11/1988
Limited
BACTRIM ROCHE Roche Products Limited PA0050/003/008 Withdrawn Form - SULFAMETHOXAZOLE 02/11/1988
- TRIMETHOPRIM
SULPHACETAMIDE EYE Schering-Plough Limited PA0277/019/001 27/10/1988
DROPS
TUTOPLAST DURA E. Merck Ltd PA0054/051/001 - GENTAMICIN SULFATE 27/10/1988
ANTADINE Du Pont De Nemours PA0200/003/002 Syrup - AMANTADINE 26/10/1988
Intern.S.A. HYDROCHLORIDE
DIAZOXIDE J B Tillotts Limited PA0360/016/001 Withdrawn Form - DIAZOXIDE 19/10/1988
BUFEXINE Ovelle Limited PA0206/018/001 Withdrawn Form - BUFEXAMAC 14/10/1988
ALDOMET Merck Sharp and Dohme PA0035/051/004 Withdrawn Form - METHYLDOPA 11/10/1988
Limited
INDOCID Merck Sharp and Dohme PA0035/003/010 Gel - INDOMETACIN 11/10/1988
Limited
ASILONE FORTE Berk Pharmaceuticals PA0082/003/002 - DIMETICONE 10/10/1988
(SUSPENSION) Limited - ALUMINIUM HYDROXIDE
- MAGNESIUM HYDROXIDE

LYOPHILISED Aventis Behring Limited PA0010/028/001 - MULTIVITAMINS 07/10/1988


ELANGESIC Elan Pharma Ltd PA0516/006/001 Capsule 06/10/1988
NAPRELAN Elan Pharma Ltd PA0516/010/001 Capsule 06/10/1988
OS-CAL 500 Martindale Pharmaceuticals PA0361/003/001 - CALCIUM CARBONATE 30/09/1988
Ltd - OYSTER SHELL POWDER

SPIROPROP G.D. Searle & Company PA0001/021/001 Tablets - SPIRONOLACTONE 29/09/1988


Limited - PROPRANOLOL
NORMACOL Norgine Limited PA0102/012/002 - STERCULIA 23/09/1988
- FRANGULA
PERIFUSIN S E. Merck Ltd PA0054/046/001 - AMINO ACIDS 22/09/1988
- SORBITOL
PYRIFOAM SHAMPOO Schering-Plough Limited PA0277/040/001 - PYRETHRUM EXTRACT 22/09/1988
- PIPERONYL BUTOXIDE
BENYLIN MENTHOLATED Parke Davis & Company PA0056/034/001 - DIPHENHYDRAMINE 20/09/1988
LINCTUS - DEXTROMETHORPHAN
- PSEUDOEPHEDRINE
- MENTHOL
SUPROFEN Cilag Limited PA0059/020/001 Capsule 20/09/1988
SUPROFEN Cilag Limited PA0059/020/002 Capsule 20/09/1988
NODILON Berk Pharmaceuticals PA0082/035/001 Tablets - COTRIMOXAZOLE 16/09/1988
Limited - SULFAMETHIZOLE
- TRIMETHOPRIM
SERC SR Abbott Healthcare Products PA0108/011/002 Capsule - BETAHISTINE 14/09/1988
Ltd HYDROCHLORIDE
AMINOPHYLLINE Mercury Pharmaceuticals PA0073/099/002 02/09/1988
(Ireland) Ltd
NORMORYTMIN Knoll A.G. (Clissmann) PA0058/012/004 Tablets - PROPAFENONE 30/08/1988
(RYTMONORM)

Human Medicines Withdrawn Products Page 483 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TEMPOPHORE Septodont PA0196/005/001 - MENTHOL 24/08/1988
- THYMOL
- CREOSOTE
- IODOFORM
- CAMPHOR
ELASTOPLAST Smith & Nephew-Southalls PA0378/001/002 Cutaneous Solution - CETRIMONIUM BROMIDE 22/08/1988
ANTISEPTIC (Ire) L - CHLORHEXIDINE
GLUCONATE

ELASTOPLAST Smith & Nephew-Southalls PA0378/001/001 Cream - CHLOROXYLENOL 22/08/1988


ANTISPETIC (Ire) L - TRICLOSAN
- EDETIC ACID
MERUVAX II Merck Sharp and Dohme PA0035/037/004 Withdrawn Form - RUBELLA VIRUS 22/08/1988
Limited VACCINE LIVE
ATTENUATED
TAZ (TRIAMCINOLONE Ethical Pharmaceuticals UK PA0467/005/001 - TRIAMCINOLONE 10/08/1988
ACENTONIDE 0.05% IN Ltd. ACETONIDE
AZONE)
ASILONE ORANGE Berk Pharmaceuticals PA0082/030/001 Tablets - DIMETICONE 09/08/1988
Limited - ALUMINIUM HYDROXIDE
GEL, DRIED
CEPORIN Glaxo Laboratories Limited PA0044/008/002 - CEFALORIDINE 08/08/1988
FASIGYN INTRAVENOUS Pfizer Limited PA0019/037/002 - TINIDAZOLE 27/07/1988
FASIGYN INTRAVENOUS Pfizer Limited PA0019/037/003 Solution for Infusion 27/07/1988
COGARD Bristol-Myers Squibb PA0002/025/003 Tablets - NADOLOL 20/07/1988
Pharmaceuticals uc
FLORINEF Bristol-Myers Squibb PA0002/019/002 Tablets - FLUDROCORTISONE 20/07/1988
Pharmaceuticals uc ACETATE
HALCIDERM Bristol-Myers Squibb PA0002/020/004 - HALCINONIDE 20/07/1988
Pharmaceuticals uc
HALCIDERM 0.1% Bristol-Myers Squibb PA0002/020/002 Ointment - HALCINONIDE 20/07/1988
Pharmaceuticals uc
HALCIDERM 0.025% Bristol-Myers Squibb PA0002/020/003 Ointment 20/07/1988
Pharmaceuticals uc
HALICOMB Bristol-Myers Squibb PA0002/002/001 Cream - HALCINONIDE 20/07/1988
Pharmaceuticals uc - NEOMYCIN
- NYSTATIN
HALICOMB Bristol-Myers Squibb PA0002/002/002 Ointment - HALCINONIDE 20/07/1988
Pharmaceuticals uc - NEOMYCIN
- NYSTATIN
IPRAL Bristol-Myers Squibb PA0002/036/004 Withdrawn Form - TRIMETHOPRIM 20/07/1988
Pharmaceuticals uc
IZAL ANTISEPTEC Sanofi-Synthelabo Ireland PA0077/090/001 - CHLORAMINE 20/07/1988
Ltd - DICHLOROXYLENOL
KENACORT Bristol-Myers Squibb PA0002/022/001 Tablets - TRIAMCINOLONE 20/07/1988
Pharmaceuticals uc
KENACORT A Bristol-Myers Squibb PA0002/021/005 Ointment - TRIAMCINOLONE 20/07/1988
Pharmaceuticals uc ACETONIDE
KINEVAC Bristol-Myers Squibb PA0002/026/001 Withdrawn Form - SINCALIDE 20/07/1988
Pharmaceuticals uc
RAUDIXIN Bristol-Myers Squibb PA0002/028/001 Tablets - RAUWOLFIA 20/07/1988
Pharmaceuticals uc SERPENTINA
RAUTRAX SINE K Bristol-Myers Squibb PA0002/030/001 Tablets - RAUWOLFIA 20/07/1988
Pharmaceuticals uc - HYDROFLUMETHIAZIDE
GRISOVIN Glaxo Laboratories Limited PA0044/018/001 Tablets - GRISEOFULVIN 15/07/1988
GRISOVIN Glaxo Laboratories Limited PA0044/018/002 Tablets - GRISEOFULVIN 15/07/1988
LOCAN Duncan, Flockhard & Co. PA0065/003/001 Cream 15/07/1988
Limited
NEOPLASMAGEL B. Braun Medical Limited PA0179/015/001 - GELATIN 14/07/1988
- SODIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
ENDOBIL E. Merck Ltd PA0054/043/001 - IODOXAMIC ACID 07/07/1988
ENDOBIL E. Merck Ltd PA0054/043/002 - IODOXAMIC ACID 07/07/1988
NORMOFUNDIN MD Mercury Pharmaceuticals PA0073/043/001 - AMINO ACIDS 06/07/1988
(Ireland) Ltd - SORBITOL
NORMOFUNDIN MD Mercury Pharmaceuticals PA0073/043/002 - AMINO ACIDS 06/07/1988
(Ireland) Ltd - SORBITOL
DIURESAL Sandoz Ltd PA0372/005/001 Withdrawn Form - FUROSEMIDE 01/07/1988
DIURESAL Sandoz Ltd PA0372/005/002 Withdrawn Form - FUROSEMIDE 01/07/1988
CISPLATIN Eli Lilly and Company Limite PA0047/057/001 Withdrawn Form - CISPLATIN 17/06/1988

CISPLATIN Eli Lilly and Company Limite PA0047/057/002 Withdrawn Form - CISPLATIN 17/06/1988

HUMULIN I (ISOPHANE Eli Lilly and Company Limite PA0047/059/001 Withdrawn Form 17/06/1988
INJECTION)

Human Medicines Withdrawn Products Page 484 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
HUMULIN I (ISOPHANE Eli Lilly and Company Limite PA0047/059/002 Withdrawn Form 17/06/1988
INJECTION)
HUMULIN S (REGULAR Eli Lilly and Company Limite PA0047/058/001 Withdrawn Form 17/06/1988
INJECTION)
HUMULIN S (REGULAR Eli Lilly and Company Limite PA0047/058/002 Withdrawn Form 17/06/1988
INJECTION)
NABILONE Eli Lilly and Company Limite PA0047/056/002 Capsule - NABILONE 17/06/1988

NEUTRADONNA Nicholas Laboratories PA0032/022/001 - ALUMINIUM SODIUM 13/06/1988


SILICATE
- BELLADONNA
ALKALOIDS
NEUTRADONNA Nicholas Laboratories PA0032/022/002 Tablets - ALUMINIUM SODIUM 13/06/1988
SILICATE
- BELLADONNA
ALKALOIDS
OPTIMAX E. Merck Ltd PA0054/009/001 Tablets - TRYPTOPHAN, L- 07/06/1988
- ASCORBIC ACID
- PYRIDOXINE
HYDROCHLORIDE
PARALIEF Clonmel Healthcare Ltd PA0126/020/002 Unknown 31/05/1988
CHAPSTICK - CHERRY A.H. Robins Company PA0086/021/003 27/05/1988
Limited
CHAPSTICK - GRAPE A.H. Robins Company PA0086/021/004 27/05/1988
Limited
CHAPSTICK - LEMON-LIME A.H. Robins Company PA0086/021/006 27/05/1988
Limited
CHAPSTICK - MINT A.H. Robins Company PA0086/021/002 27/05/1988
Limited
CHAPSTICK - ORANGE A.H. Robins Company PA0086/021/005 27/05/1988
Limited
ORBENIN SmithKline Beecham Pharm PA0049/009/009 - CLOXACILLIN 26/05/1988
Ltd
ORBENIN SYRUP SmithKline Beecham Pharm PA0049/009/005 - CLOXACILLIN 26/05/1988
Ltd
EMETROL Rorer Pharmaceuticals PA0119/014/001 - FRUCTOSE 23/05/1988
Limited - GLUCOSE
- PHOSPHORIC ACID
SCHERISOLON HE Clissmann PA0012/027/001 - PREDNISOLONE 19/05/1988
CRYSTALLINE ACETATE
(SUSPENSION)
ZAROXOLYN 10 Fisons Pharmaceuticals PA0072/003/003 - METOLAZONE 19/05/1988
(Ireland)
ADRIAMYCIN Farmitalia Carlo Erba Ltd PA0236/008/001 17/05/1988
ADRIAMYCIN Farmitalia Carlo Erba Ltd PA0236/008/002 17/05/1988
ADRENALINE 1 IN 1000 Schering-Plough Limited PA0277/009/001 - EPINEPHRINE 12/05/1988
EYE
AFRAZINE PAEDIATRIC Schering-Plough Limited PA0277/006/001 - OXYMETAZOLINE 12/05/1988
NOSE
ALGISPRAY (SPRAY) Schering-Plough Limited PA0277/027/001 - METHYL STEARATE 12/05/1988
- DIETHYLAMINE
SALICYLATE
CONOTRANE Company Liquidated M123 PA0098/018/001 Cream 12/05/1988
CO-TRIMOXAZOLE United Pharmacists CoOp PA0337/011/001 Tablets - SULFAMETHOXAZOLE 12/05/1988
Ltd - TRIMETHOPRIM
GEOMYCIN EYE Schering-Plough Limited PA0277/004/013 Ointment - GENTAMICIN 12/05/1988
GEOMYCIN EYE/EAR Schering-Plough Limited PA0277/004/012 - GENTAMICIN 12/05/1988
GOLDEN EYE Schering-Plough Limited PA0277/023/001 Ointment - MERCURIC OXIDE, 12/05/1988
YELLOW
HYOSCINE EYE Schering-Plough Limited PA0277/013/001 - HYOSCINE 12/05/1988
IBUPROFEN United Pharmacists CoOp PA0337/012/001 Tablets - IBUPROFEN 12/05/1988
Ltd
IBUPROFEN United Pharmacists CoOp PA0337/012/002 Tablets - IBUPROFEN 12/05/1988
Ltd
INDOMETHACIN Teva Pharma B.V. PA0337/013/001 Capsule - INDOMETACIN 12/05/1988
INDOMETHACIN United Pharmacists CoOp PA0337/013/002 Capsule - INDOMETACIN 12/05/1988
Ltd
LACHESINE EYE Schering-Plough Limited PA0277/015/001 12/05/1988
NITRAZEPAM United Pharmacists CoOp PA0337/014/001 Tablets - NITRAZEPAM 12/05/1988
Ltd
OXYMTAZOLINE Schering-Plough Limited PA0277/026/001 12/05/1988
HYDROCHLORIDE NASAL
PAEDIATRIC CO- United Pharmacists CoOp PA0337/011/002 - TRIMETHOPRIM 12/05/1988
TRIMOXAZOLE Ltd - SULFAMETHOXAZOLE
PHENYLEPHRINE EYE Schering-Plough Limited PA0277/016/001 12/05/1988
DROPS

Human Medicines Withdrawn Products Page 485 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHYSOSTIGMINE EYE Schering-Plough Limited PA0277/017/001 12/05/1988
DROPS
PHYSOSTIGMINE EYE Schering-Plough Limited PA0277/017/002 12/05/1988
DROPS
UVISTAT Company Liquidated M123 PA0098/016/001 Cream 12/05/1988
UVISTAT L Company Liquidated M123 PA0098/016/002 12/05/1988
ZINC SULPHATE EYE Schering-Plough Limited PA0277/020/001 12/05/1988
DROPS
ANGIOGRAFIN HE Clissmann PA0012/033/002 - MEGLUMINE 10/05/1988
AMIDOTRIZOATE
ANGIOGRAFIN 65% HE Clissmann PA0012/033/001 - MEGLUMINE 10/05/1988
AMIDOTRIZOATE
DIAZEPAM United Pharmacists CoOp PA0337/008/001 Tablets - DIAZEPAM 09/05/1988
Ltd
DIAZEPAM United Pharmacists CoOp PA0337/008/002 Tablets - DIAZEPAM 09/05/1988
Ltd
DIAZEPAM United Pharmacists CoOp PA0337/008/003 Tablets - DIAZEPAM 09/05/1988
Ltd
FRUSEMIDE United Pharmacists CoOp PA0337/009/001 Tablets - FUROSEMIDE 09/05/1988
Ltd
FRUSEMIDE United Pharmacists CoOp PA0337/009/002 Tablets - FUROSEMIDE 09/05/1988
Ltd
METHYLDOPA United Pharmacists CoOp PA0337/017/001 Tablets - METHYLDOPA 09/05/1988
Ltd
PREDNISOLONE United Pharmacists CoOp PA0337/010/001 Tablets - PREDNISOLONE 09/05/1988
Ltd
PROPRANOLOL United Pharmacists CoOp PA0337/015/001 Tablets - PROPRANOLOL 09/05/1988
Ltd
PROPRANOLOL United Pharmacists CoOp PA0337/015/002 Tablets - PROPRANOLOL 09/05/1988
Ltd
PROPRANOLOL United Pharmacists CoOp PA0337/015/003 Tablets - PROPRANOLOL 09/05/1988
Ltd
PROPRANOLOL United Pharmacists CoOp PA0337/015/004 Tablets - PROPRANOLOL 09/05/1988
Ltd
EMPERAL SOLUTION Orion Pharma A/s PA0303/010/002 Withdrawn Form - METOCLOPRAMIDE 03/05/1988
ALUMINIUM HYDROXIDE Accord-UK Ltd PA0176/048/001 Tablets 28/04/1988
NEUROTOL Clonmel Healthcare Ltd PA0126/066/002 Tablets 19/04/1988
NEUROTOL SYRUP Clonmel Healthcare Ltd PA0126/066/001 19/04/1988
SAVLON Care Laboratories Limited PA0351/001/002 Cream - CETRIMONIUM BROMIDE 19/04/1988

SULPHADIMIDINE Clonmel Healthcare Ltd PA0126/017/001 Tablets 19/04/1988


THEOLAN Helsinn Birex PA0294/007/003 - THEOPHYLLINE 15/04/1988
Pharmaceuticals Limited
ALLEGRON Eli Lilly and Company Limite PA0047/024/001 Tablets - NORTRIPTYLINE 11/04/1988
HYDROCHLORIDE
ALLEGRON Eli Lilly and Company Limite PA0047/024/002 Tablets - NORTRIPTYLINE 11/04/1988
HYDROCHLORIDE
DISTALGESIC Eli Lilly and Company Limite PA0047/027/001 Tablets Effervescent - 11/04/1988
DEXTROPROPOXYPHENE
NAPSILATE
- PARACETAMOL
FOPANE Eli Lilly and Company Limite PA0047/040/001 Tablets - FENOPROFEN 11/04/1988
- PARACETAMOL
HAELAN TAPE Eli Lilly and Company Limite PA0047/032/001 - FLUDROXYCORTIDE 11/04/1988

HAELAN X Eli Lilly and Company Limite PA0047/037/001 Cream - FLUDROXYCORTIDE 11/04/1988

HAELAN X Eli Lilly and Company Limite PA0047/037/002 Ointment - FLUDROXYCORTIDE 11/04/1988

NAPSALGESIC Eli Lilly and Company Limite PA0047/035/001 Tablets - 11/04/1988


DEXTROPROPOXYPHENE
NAPSILATE
- ACETYLSALICYLIC ACID
SANATOGEN TONIC Fisons Limited PA0018/028/001 - VITAMIN-B-KOMPLEX 07/04/1988
STANDARD
- CAFFEINE
- FERROUS GLUCONATE
FURACIN Procter & Gamble PA0170/007/002 - NITROFURAL 05/04/1988
Pharmaceuticals UK Limited
FURACIN SOLUBLE Procter & Gamble PA0170/007/001 Ointment - NITROFURAL 05/04/1988
Pharmaceuticals UK Limited
0.45% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/010 Withdrawn Form 01/04/1988
0.45% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/011 Withdrawn Form 01/04/1988
GLUCOSE 20% B. Braun Medical Limited PA0179/001/008 Withdrawn Form 01/04/1988
GLUCOSE 25% B. Braun Medical Limited PA0179/001/009 Withdrawn Form 01/04/1988

Human Medicines Withdrawn Products Page 486 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
GLUCOSE 40% B. Braun Medical Limited PA0179/001/012 Withdrawn Form 01/04/1988
SCHERIPROCT HE Clissmann PA0012/026/003 Ointment - PREDNISOLONE 01/04/1988
CAPROATE
- HEXACHLOROPHENE
- CINCHOCAINE
- CLEMIZOLE
VENOS COUGH MIXTURE SmithKlineBeecham PA0379/005/001 01/04/1988
ORIGINAL FORMULA Consumer Brand
WATER B. Braun Medical Limited PA0179/009/001 Withdrawn Form 01/04/1988
WATER B. Braun Medical Limited PA0179/009/002 Withdrawn Form 01/04/1988
DELTASTAB The Boots Company Plc PA0004/008/001 Withdrawn Form - PREDNISOLONE 29/03/1988
ACETATE
DIALAFLEX NO 61 The Boots Company Plc PA0004/041/001 - GLUCOSE 29/03/1988
INTRAPERITONEAL 1.36 - SODIUM LACTATE
- SODIUM CHLORIDE
DIALAFLEX NO 61 The Boots Company Plc PA0004/041/002 - GLUCOSE 29/03/1988
INTRAPERITONEAL 1.36% - SODIUM LACTATE
- SODIUM CHLORIDE
DIALAFLEX NO 62 The Boots Company Plc PA0004/042/001 - GLUCOSE 29/03/1988
INTRAPERITONEAL - SODIUM LACTATE
DIALAFLEX NO 62 The Boots Company Plc PA0004/042/002 - GLUCOSE 29/03/1988
INTRAPERITONEAL 6.36% - SODIUM LACTATE
- SODIUM CHLORIDE
DIALAFLEX NO 63 The Boots Company Plc PA0004/043/001 - GLUCOSE 29/03/1988
INTRAPERITONEAL - SODIUM LACTATE
- SODIUM CHLORIDE
DIALAFLEX NO 63 The Boots Company Plc PA0004/043/002 - GLUCOSE 29/03/1988
INTRAPERITONEAL - SODIUM LACTATE
- SODIUM CHLORIDE
FAMEL PASTILLES Optrex Limited PA0275/010/001 Lozenges - CREOSOTE 29/03/1988
- MENTHOL
HARTMANNS The Boots Company Plc PA0004/037/001 Solution for Injection 29/03/1988
HARTMANNS The Boots Company Plc PA0004/037/002 Solution for Injection 29/03/1988
PANASORB Sanofi-Synthelabo Ireland PA0077/024/001 Tablets - PARACETAMOL 29/03/1988
Ltd
PANASORB Sanofi-Synthelabo Ireland PA0077/024/002 Tablets - PARACETAMOL 29/03/1988
Ltd
PANETS Optrex Limited PA0275/001/001 Tablets - PARACETAMOL 29/03/1988
PROTUSSA The Boots Company Plc PA0004/019/001 Syrup - EPHEDRINE 29/03/1988
HYDROCHLORIDE
- ATROPA BELLADONNA
- IPECACUANHA FLUID
EXTRACT
- TOLU SYRUP
RINGERS The Boots Company Plc PA0004/035/001 Solution for Injection - SODIUM CHLORIDE 29/03/1988
COMPOUND INJECTION
RINGERS The Boots Company Plc PA0004/035/002 Solution for Injection - SODIUM CHLORIDE 29/03/1988
COMPOUND INJECTION
STERIFLEX NO 20 The Boots Company Plc PA0004/038/002 Withdrawn Form - FRUCTOSE 29/03/1988
LAEVULOSE
STERIFLEX NO 21 The Boots Company Plc PA0004/039/002 - FRUCTOSE 29/03/1988
LAEVULOSE 20%
STERIFLEX NO 21 The Boots Company Plc PA0004/039/001 Withdrawn Form - FRUCTOSE 29/03/1988
LAEVULOSE 20%
STERIFLEX NO 22 The Boots Company Plc PA0004/040/001 Withdrawn Form - FRUCTOSE 29/03/1988
LAEVULOSE 40%
STERIFLEX NO 22 The Boots Company Plc PA0004/040/002 - FRUCTOSE 29/03/1988
LAEVULOSE 40%
STERIFLEX NO. 1 The Boots Company Plc PA0004/032/001 Withdrawn Form - SODIUM CHLORIDE 29/03/1988
STERIFLEX NO. 1 The Boots Company Plc PA0004/032/002 Withdrawn Form - SODIUM CHLORIDE 29/03/1988
STERIFLEX NO. 18 The Boots Company Plc PA0004/034/001 Withdrawn Form - SODIUM CHLORIDE 29/03/1988
- GLUCOSE
STERIFLEX NO. 18 Bodkin E.J. & Company PA0004/034/002 Withdrawn Form - GLUCOSE 29/03/1988
- SODIUM CHLORIDE
STERIFLEX NO. 20 The Boots Company Plc PA0004/038/001 Withdrawn Form - FRUCTOSE 29/03/1988
STERIFLEX NO. 3 The Boots Company Plc PA0004/033/001 Withdrawn Form - SODIUM CHLORIDE 29/03/1988
- GLUCOSE
STERIFLEX NO. 3 The Boots Company Plc PA0004/033/002 Withdrawn Form - SODIUM CHLORIDE 29/03/1988
- GLUCOSE
STERIFLEX NO. 6 The Boots Company Plc PA0004/030/001 Withdrawn Form - GLUCOSE 29/03/1988
STERIFLEX NO. 6 The Boots Company Plc PA0004/030/002 Withdrawn Form - GLUCOSE 29/03/1988
STERIFLEX NO. 7 The Boots Company Plc PA0004/031/001 Withdrawn Form - GLUCOSE 29/03/1988
STERIFLEX NO. 7 The Boots Company Plc PA0004/031/002 Withdrawn Form - GLUCOSE 29/03/1988
PAREPECTOLIN Rhone-Poulenc Rorer PA0119/012/001 - PECTIN 28/03/1988
(SUSPENSION) Pharms. - KAOLIN

Human Medicines Withdrawn Products Page 487 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BRAN PRODUCT Bristol-Myers Squibb PA0048/042/001 - BRAN 24/03/1988
(Holdings) Limited - SUCROSE
BROLINCTUS Sanofi-Synthelabo Ireland PA0077/026/001 - AMMONIUM CHLORIDE 23/03/1988
Ltd - DEXTROMETHORPHAN
- IPECACUANHA FLUID
EXTRACT
- PHENYLEPHRINE
HYDROCHLORIDE
RUSCO BLACKCURRANT Rusco Pharmaceuticals PA0392/001/001 - IPECACUANHA 18/03/1988
COUGH SYRUP TINCTURE
- TOLU SYRUP
- SQUILL EXTRACT
CALTHOR Ayerst Laboratories Limited PA0149/009/001 Tablets 17/03/1988
CALTHOR Ayerst Laboratories Limited PA0149/009/002 Tablets 17/03/1988
CALTHOR (SUSPENSION) Ayerst Laboratories Limited PA0149/009/003 17/03/1988
CALTHOR (SUSPENSION) Ayerst Laboratories Limited PA0149/009/004 17/03/1988
PREMPAK 0.625 Ayerst Laboratories Limited PA0149/005/001 - ESTROGENS 17/03/1988
CONJUGATED
PREMPAK 1.25 Ayerst Laboratories Limited PA0149/005/002 17/03/1988
CILPEN POWDER Ticen Limited PA0117/012/002 - AMPICILLIN TRIHYDRATE 16/03/1988

DEXTRO-BRONCHINE Magnamed International Ltd PA0340/001/001 - DEXTROMETHORPHAN 16/03/1988


HYDROBROMIDE
- MEPYRAMINE
- GUAIFENESIN
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/008 Capsule - MICONAZOLE NITRATE 16/03/1988
NEOTOPIC H CREAM Company Liquidated M123 PA0301/008/001 Cream - HYDROCORTISONE 16/03/1988
- NEOMYCIN SULFATE
OCULSUF Company Liquidated M123 PA0301/013/001 - SULFACETAMIDE 16/03/1988
SULFACETAMIDE SODIUM SODIUM
OPTH.
OCUSULF Company Liquidated M123 PA0301/013/002 - SULFACETAMIDE 16/03/1988
SULFACETAMIDE SODIUM SODIUM
OPTH.
OCUSULF Company Liquidated M123 PA0301/013/003 - SULFACETAMIDE 16/03/1988
SULFACETAMIDE SODIUM SODIUM
OPTH.
OCUSULF Company Liquidated M123 PA0301/013/004 - SULFACETAMIDE 16/03/1988
SULFACETAMIDE SODIUM SODIUM
OPTH.
URINFEX Ticen Limited PA0117/012/001 Capsule - NITROFURANTOIN 16/03/1988
XYLOTOX Wigglesworth (1982) Limited PA0063/011/001 16/03/1988

XYLOTOX Wigglesworth (1982) Limited PA0063/011/002 16/03/1988

CHLORPROPAMIDE Clonmel Healthcare Ltd PA0126/035/001 Film-coated tablet 15/03/1988


CHLORPROPAMIDE Clonmel Healthcare Ltd PA0126/035/011 Tablets 15/03/1988
CODEINE LINCTUS Mercury Pharmaceuticals PA0073/027/001 14/03/1988
(Ireland) Ltd
CODEINE PHOSPHATE Mercury Pharmaceuticals PA0073/028/001 Syrup 14/03/1988
(Ireland) Ltd
PETHILAN Mercury Pharmaceuticals PA0073/015/001 Tablets - PETHIDINE 14/03/1988
(Ireland) Ltd
PETHILAN Mercury Pharmaceuticals PA0073/015/002 Tablets - PETHIDINE 14/03/1988
(Ireland) Ltd
PHANTUSS Mercury Pharmaceuticals PA0073/017/001 Syrup - PHOLCODINE 14/03/1988
(Ireland) Ltd - DIPHENHYDRAMINE
PREDNISONE Mercury Pharmaceuticals PA0073/032/001 Tablets 14/03/1988
(Ireland) Ltd
SCORBAN Mercury Pharmaceuticals PA0073/077/002 Tablets - ASCORBIC ACID 14/03/1988
(Ireland) Ltd
SCORBAN Mercury Pharmaceuticals PA0073/077/003 Tablets 14/03/1988
(Ireland) Ltd
SOLUBLE ASPIRIN Mercury Pharmaceuticals PA0073/026/001 Tablets Effervescent - ACETYLSALICYLIC ACID 14/03/1988
(Ireland) Ltd
VITAMINORUM Mercury Pharmaceuticals PA0073/078/001 Capsule - MULTIVITAMINS 14/03/1988
(Ireland) Ltd
FLUOR-I-STRIP Ayerst Laboratories Limited PA0149/013/001 08/03/1988
FLUOR-I-STRIP AT Ayerst Laboratories Limited PA0149/013/002 08/03/1988
MURIPSIN - FILM-COATED Norgine Limited PA0102/016/001 Tablets - PEPSIN 07/03/1988
- STERCULIA
- GLUTAMIC ACID
FLUCON Alcon Laboratories (UK) Ltd PA0290/044/001 - FLUOROMETHOLONE 04/03/1988
ISOPTO CARPINE Alcon Laboratories (UK) Ltd PA0290/058/006 - PILOCARPINE 04/03/1988

Human Medicines Withdrawn Products Page 488 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NAPHCON-A STERILE Alcon Laboratories (UK) Ltd PA0290/039/001 - NAPHAZOLINE 04/03/1988
OPTHALMIC HYDROCHLORIDE
- PHENIRAMINE MALEATE
NAPHCON-A STERILE Alcon Laboratories (UK) Ltd PA0290/039/002 - NAPHAZOLINE 04/03/1988
OPTHALMIC HYDROCHLORIDE
- PHENIRAMINE MALEATE
KOLANTICON Marion Merrell Limited PA0041/016/002 Tablets - MAGNESIUM OXIDUM 02/03/1988
LEVE
- ALUMINIUM HYDROXIDE
GEL, DRIED
- DIMETICONE, ACTIVATED
- DICYCLOVERINE
HYDROCHLORIDE

KOLANTYL Marion Merrell Limited PA0041/014/002 Tablets - DICYCLOVERINE 02/03/1988


HYDROCHLORIDE
- MAGNESIUM TRISILICATE
- ALUMINIUM HYDROXIDE
GEL, DRIED
- MAGNESIUM HYDROXIDE

DYSPAMET SmithKline and French PA0060/044/001 Tablets 01/03/1988


Laboratories Ltd
SAFAPRYN Pfizer Limited PA0019/019/001 Tablets - ASPIRIN ALUMINIUM 01/03/1988
- PARACETAMOL
SAFAPRYN CO Pfizer Limited PA0019/020/001 Tablets - PARACETAMOL 01/03/1988
- ACETYLSALICYLIC ACID
- CODEINE PHOSPHATE
SCOTTS EMULSION Scott & Bowne Limited PA0450/001/001 - COD LIVER OIL 01/03/1988
ALAVAC-P SmithKline Beecham Pharm PA0049/016/001 29/02/1988
Ltd
ALAVAC-S SmithKline Beecham Pharm PA0049/021/001 29/02/1988
Ltd
ALLERGEN DIAGNOSTICS SmithKline Beecham Pharm PA0049/023/001 29/02/1988
(INTRADERMAL TEST Ltd
SOLUTIONS)
ALLERGEN DIAGNOSTICS SmithKline Beecham Pharm PA0049/022/001 29/02/1988
(PRICK TEST SOLUTIONS) Ltd

BREMAX Abbott Laboratories Ireland PA0038/035/002 Tablets 29/02/1988


Ltd
MIGEN SmithKline Beecham Pharm PA0049/015/001 - DERMATOPHAGOIDES 29/02/1988
Ltd PTER.
- TYROSINE
POLLINEX SmithKline Beecham Pharm PA0049/014/001 - TYROSINE 29/02/1988
Ltd
SPECIFIC DESENSITISING SmithKline Beecham Pharm PA0049/017/001 29/02/1988
VACCINE Ltd
BILISCOPIN HE Clissmann PA0012/048/003 Solution for Infusion - IOTROXATE MEGLUMINE 26/02/1988

DEXACORTISYL Roussel Laboratories Limited PA0006/015/001 Tablets - DEXAMETHASONE 24/02/1988

DELTA-CORTEF Pharmacia Limited PA0016/017/001 Tablets - PREDNISOLONE 23/02/1988


MEDRONE Pharmacia Limited PA0016/020/001 Cream - METHYLPREDNISOLONE 23/02/1988

TANDALGESIC Geigy Pharmaceuticals PA0011/016/001 Tablets - OXYPHENBUTAZONE 23/02/1988


- PARACETAMOL
EVADYNE Ayerst Laboratories Limited PA0149/003/004 Tablets - BUTRIPTYLINE 22/02/1988
HYDROCHLORIDE
PARAGESIC Novartis Pharmaceuticals UK PA0013/010/001 Tablets Effervescent - PARACETAMOL 22/02/1988
Ltd - PSEUDOEPHEDRINE
- CAFFEINE
PREMARIN (PARENTERAL) Ayerst Laboratories Limited PA0149/002/005 - ESTROGENS 22/02/1988
CONJUGATED
ALBUCID HE Clissmann PA0012/041/001 - SULFACETAMIDE 19/02/1988
SODIUM
EUMYDRIN Sanofi-Synthelabo Ireland PA0077/040/001 - ATROPINE 19/02/1988
Ltd METHONITRATE
GYNOVLAR HE Clissmann PA0012/010/001 Tablets - ETHINYLESTRADIOL 18/02/1988
- NORETHISTERONE
ACETATE
MINOVLAR HE Clissmann PA0012/013/001 Tablets - ETHINYLESTRADIOL 18/02/1988
- NORETHISTERONE
NEOGYNON HE Clissmann PA0012/015/001 Tablets - ETHINYLESTRADIOL 18/02/1988

Human Medicines Withdrawn Products Page 489 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SEDOLAR Mayne Pharma (Ireland) PA0078/015/001 Tablets - NITRAZEPAM 18/02/1988
Limited
AMPLICOX SmithKline Beecham Pharm PA0049/007/007 17/02/1988
Ltd
AMPICILLIN United Pharmacists CoOp PA0337/001/001 Capsule - AMPICILLIN 16/02/1988
Ltd
AMPICILLIN United Pharmacists CoOp PA0337/001/002 Capsule - AMPICILLIN 16/02/1988
Ltd
AMPICILLIN 125 MG/5 ML United Pharmacists CoOp PA0337/001/003 Syrup - AMPICILLIN 16/02/1988
Ltd
AMPICILLIN 125 MG/5 ML United Pharmacists CoOp PA0337/001/004 Syrup - AMPICILLIN 16/02/1988
Ltd
AMPICILLIN 250 MG/5 ML United Pharmacists CoOp PA0337/001/005 Syrup - AMPICILLIN 16/02/1988
FORTE Ltd
AMPICILLIN 250 MG/5 ML United Pharmacists CoOp PA0337/001/006 Syrup - AMPICILLIN 16/02/1988
FORTE Ltd
GALENDIAZEPAM 10 Galen Limited PA0185/011/003 Capsule - DIAZEPAM 16/02/1988
OPAQUE VIOLET/PINK
GALENDIAZEPAM 2 Galen Limited PA0185/011/001 Capsule - DIAZEPAM 16/02/1988
OPAQUE
VIOLET/TURQUOISE
GALENDIAZEPAM 5 Galen Limited PA0185/011/002 Capsule - DIAZEPAM 16/02/1988
OPAQUE VIOLET/MAUVE
PROTHYL Septodont PA0196/007/001 - BENZOCAINE 16/02/1988
- RETINOL
- HYDROXYQUINOLINE
GELUSIL Warner Lambert PA0039/011/001 Tablets 12/02/1988
GELUSIL (SUSPENSION) Warner Lambert PA0039/011/002 12/02/1988
RELEFACT Hoechst Ireland Limited PA0023/016/001 12/02/1988
SAROTEN Warner Lambert PA0039/021/001 12/02/1988
SAROTEN Warner Lambert PA0039/021/002 12/02/1988
SINUTAB Warner Lambert PA0039/022/002 Tablets 12/02/1988
RETRO CONRAY May & Baker Limited PA0040/055/001 11/02/1988
AURALGAN EAR Ayerst Laboratories Limited PA0149/018/001 10/02/1988
AMITRIPTYLINE Norgine Limited PA0102/010/001 Tablets - AMITRIPTYLINE 09/02/1988
HYDROCHLORIDE
AMITRIPTYLINE Norgine Limited PA0102/010/002 Tablets - AMITRIPTYLINE 09/02/1988
HYDROCHLORIDE
AMITRIPTYLINE Norgine Limited PA0102/010/003 Tablets - AMITRIPTYLINE 09/02/1988
HYDROCHLORIDE
PYRIDIUM Warner Lambert PA0039/020/001 04/02/1988
ISTIN Pfizer Limited PA0019/038/001 - CISPLATIN 02/02/1988
ISTIN Pfizer Limited PA0019/038/002 - CISPLATIN 02/02/1988
ISOPRENALINE International Medication PA0255/003/001 Withdrawn Form 28/01/1988
HYDROCHLORIDE Systems (UK) Ltd
ISOPRENALINE International Medication PA0255/003/002 Withdrawn Form 28/01/1988
HYDROCHLORIDE 0.02% Systems (UK) Ltd
HIBITANE LOZENGES Zeneca Limited PA0051/046/002 - CHLORHEXIDINE 27/01/1988
GLUCONATE
- BENZOCAINE
INITARD 50/50 Nordisk Gentofte A/S PA0217/004/003 20/01/1988
INSULTARD 100 IU/ML Nordisk Gentofte A/S PA0217/001/003 20/01/1988
MIXTARD 30/70 Nordisk Gentofte A/S PA0217/003/003 20/01/1988
OPULETS Alcon Laboratories (UK) Ltd PA0290/053/001 - SULFACETAMIDE 20/01/1988
SULPHACETAMIDE EYE
VELOSULIN 100 IU/ML Nordisk Gentofte A/S PA0217/002/003 20/01/1988
BENODERM Leo Laboratories Limited PA0046/055/001 Cream - FUSIDIC ACID 15/01/1988
- HYDROCORTISONE
ACETATE
- TIOCONAZOLE
HEMOFIL Baxter Healthcare Limited PA0167/007/002 - HUMAN ALBUMIN 15/01/1988
ANTIHAEMOPHILIC - STANNOUS CHLORIDE
- SODIUM CHLORIDE
HEMOFIL Baxter Healthcare Limited PA0167/007/003 - ANTIHEMOPHILIC HUMAN 15/01/1988
ANTIHAEMOPHILIC PLASMA
HEMOFIL Baxter Healthcare Limited PA0167/007/004 - ANTIHEMOPHILIC HUMAN 15/01/1988
ANTIHAEMOPHILIC PLASMA
HEMOFIL Baxter Healthcare Limited PA0167/007/005 - ANTIHEMOPHILIC HUMAN 15/01/1988
ANTIHAEMOPHILIC PLASMA
HEMOFIL Baxter Healthcare Limited PA0167/007/006 - ANTIHEMOPHILIC HUMAN 15/01/1988
ANTIHAEMOPHILIC PLASMA
HEMOFIL Baxter Healthcare Limited PA0167/007/001 - ANTIHEMOPHILIC HUMAN 15/01/1988
ANTIHAEMOPHILIC PLASMA
FACTOR

Human Medicines Withdrawn Products Page 490 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MODITEN ELIXIR Bristol-Myers Squibb PA0002/041/004 Oral Solution - FLUPHENAZINE 15/01/1988
Pharmaceuticals uc
MALIASIN Knoll A.G. (Clissmann) PA0058/002/001 14/01/1988
MALIASIN Knoll A.G. (Clissmann) PA0058/002/002 14/01/1988
EPHYNAL Roche Products Limited PA0050/057/001 Tablets - TOCOPHERYL ACETATE 13/01/1988
OMNOPON Roche Products Limited PA0050/024/001 Tablets - PAPAVERINE 13/01/1988
SYNKAVIT Roche Products Limited PA0050/050/001 Tablets 13/01/1988
SYNKAVIT Roche Products Limited PA0050/050/002 13/01/1988
OTRIVINE HAY FEVER Ciba Geigy Plc PA0028/048/001 12/01/1988
FORMULA
OTRIVINE HAY FEVER Ciba Geigy Plc PA0028/048/002 12/01/1988
FORMULA (SPRAY)
INSULIN ACTRAPID MC Novo Nordisk A/S PA0218/003/003 07/01/1988
INSULIN LENTARD MC Novo Nordisk A/S PA0218/014/003 07/01/1988
INSULIN MONOTARD Novo Nordisk A/S PA0218/001/003 07/01/1988
INSULIN RAPITARD MC Novo Nordisk A/S PA0218/013/003 07/01/1988
INSULIN SEMITARD Novo Nordisk A/S PA0218/002/003 07/01/1988
BENERVA Roche Products Limited PA0050/056/001 Tablets - THIAMINE 23/12/1987
HYDROCHLORIDE
BENERVA Roche Products Limited PA0050/056/002 Tablets - THIAMINE 23/12/1987
HYDROCHLORIDE
BENERVA Roche Products Limited PA0050/056/007 - THIAMINE 23/12/1987
HYDROCHLORIDE
- NICOTINAMIDE
- RIBOFLAVIN
BENERVA AMPOULES Roche Products Limited PA0050/056/008 - THIAMINE 23/12/1987
HYDROCHLORIDE
- NICOTINAMIDE
- RIBOFLAVIN
OTRIVINE - ANTISTIN Ciba Geigy Plc PA0028/030/002 - ANTAZOLINE SULFATE 22/12/1987
- XYLOMETAZOLINE
HYDROCHLORIDE
OTRIVINE - ANTISTIN Ciba Geigy Plc PA0028/030/003 - ANTAZOLINE SULFATE 22/12/1987
(SPRAY) - XYLOMETAZOLINE
HYDROCHLORIDE
NEULENTE INSULIN ZINC Wellcome (Ireland) Limited PA0017/074/003 21/12/1987
(SUSPENSION)
SYSTRAL-C E. Merck Ltd PA0054/031/001 Tablets - CHLORPHENOXAMINE 21/12/1987
HYDROCHLORIDE
- CAFFEINE
NEUPHANE ISOPHANE Wellcome (Ireland) Limited PA0017/075/003 Withdrawn Form - ISOPHANE INSULIN 18/12/1987
INSULIN
POLIOVIRUS VACCINE Abbott Healthcare Products PA0108/004/002 - POLIOVIRUS VACCINE 18/12/1987
Ltd LIVE ORAL
- STREPTOMYCIN
- POLYMYXIN B
- NEOMYCIN
HALCION Pharmacia Limited PA0016/016/002 Tablets - TRIAZOLAM 15/12/1987
NEO-CORTEF Pharmacia Limited PA0016/012/003 - NEOMYCIN SULFATE 15/12/1987
- HYDROCORTISONE
ACETATE
NEO-CORTEF Pharmacia Limited PA0016/012/004 - NEOMYCIN SULFATE 15/12/1987
- HYDROCORTISONE
ACETATE
NEO-CORTEF Pharmacia Limited PA0016/012/005 Ointment - NEOMYCIN 15/12/1987
- HYDROCORTISONE
NEO-CORTEF Pharmacia Limited PA0016/012/006 Ointment - NEOMYCIN 15/12/1987
- HYDROCORTISONE
BILIMIRO E. Merck Ltd PA0054/047/001 Tablets - IOPANOIC ACID 14/12/1987
FRAMYSPRAY Fisons Limited PA0018/011/001 - NEOMYCIN 11/12/1987
- POLYMYXIN B
- BACITRACIN ZINC
SYSTRAL E. Merck Ltd PA0054/030/002 Cream - CHLORPHENOXAMINE 07/12/1987
SYSTRAL E. Merck Ltd PA0054/030/003 Syrup - CHLORPHENOXAMINE 07/12/1987
HYDROCHLORIDE
ILOTYCIN Abbott GmbH & Co KG PA0047/053/001 Capsule - ERYTHROMYCIN 27/11/1987
SCORBAN Mercury Pharmaceuticals PA0073/077/001 Tablets - ASCORBIC ACID 27/11/1987
(Ireland) Ltd
GENETICIN INTRATHECAL Nicholas Laboratories PA0032/001/001 - GENTAMICIN SULFATE 25/11/1987

INTRAMIN FORTE Pharmacia Laboratories PA0187/009/001 - INTRAMIN NOVUM 24/11/1987


Limited
INTRAMIN FORTE Pharmacia Laboratories PA0187/009/002 - INTRAMIN NOVUM 24/11/1987
Limited

Human Medicines Withdrawn Products Page 491 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NICHOLAS CO2 Nicholas Laboratories PA0032/018/002 Tablets - SODIUM BICARBONATE 24/11/1987
- SUCCINIC ACID
TUTOLIPID E. Merck Ltd PA0054/061/001 - FAT EMULSIONS 24/11/1987
TUTOLIPID E. Merck Ltd PA0054/061/002 - FAT EMULSIONS 24/11/1987
TUTOLIPID E. Merck Ltd PA0054/061/003 24/11/1987
TUTOLIPID E. Merck Ltd PA0054/061/004 24/11/1987
TUTOLIPID E. Merck Ltd PA0054/061/005 24/11/1987
TUTOLIPID E. Merck Ltd PA0054/061/006 24/11/1987
PHENOBARBITONE Mercury Pharmaceuticals PA0073/082/001 Tablets - PHENOBARBITAL 23/11/1987
(Ireland) Ltd
PHENOBARBITONE Mercury Pharmaceuticals PA0073/082/002 Tablets 23/11/1987
(Ireland) Ltd
PHENOBARBITONE Mercury Pharmaceuticals PA0073/082/003 23/11/1987
(Ireland) Ltd
LINCTIFED EXPECTORANT Wellcome (Ireland) Limited PA0017/019/001 - TRIPROLIDINE 20/11/1987
HYDROCHLORIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- CODEINE PHOSPHATE
- GUAIFENESIN
DIGAMEL Clonmel Healthcare Ltd PA0126/021/001 Tablets 19/11/1987
ALPHAMIN Ayerst Laboratories Limited PA0149/014/001 Tablets 17/11/1987
ALPHAMIN Ayerst Laboratories Limited PA0149/014/002 Tablets 17/11/1987
EPANUTIN/PHENOBARBIT Parke Davis & Company PA0056/024/001 Capsule - PHENOBARBITAL 17/11/1987
PERITRATE Warner Lambert PA0039/019/001 Tablets 17/11/1987
CARDIO CONRAY May & Baker Limited PA0040/056/001 11/11/1987
CARDIO CONRAY May & Baker Limited PA0040/056/002 11/11/1987
CONRAY 480 May & Baker Limited PA0040/052/001 11/11/1987
DIAGINOL-VISCOUS May & Baker Limited PA0040/058/001 11/11/1987
M & B ANTISEPTIC CREAM May & Baker Limited PA0040/067/001 Cream 11/11/1987

NEFROLAN May & Baker Limited PA0040/036/001 Tablets 11/11/1987


NEFROLAN May & Baker Limited PA0040/036/002 Tablets 11/11/1987
PATENT BLUE V May & Baker Limited PA0040/060/001 11/11/1987
PHYTODERMINE May & Baker Limited PA0040/061/001 11/11/1987
VALLEX May & Baker Limited PA0040/072/001 11/11/1987
ENZYPAN FORTE Norgine Limited PA0102/008/001 - PANCREATIN 10/11/1987
FERROMYN Wellcome (Ireland) Limited PA0017/071/002 Tablets - FERROUS SUCCINATE 09/11/1987
FERROMYN B ELIXIR Wellcome (Ireland) Limited PA0017/072/001 - FERROUS SUCCINATE 09/11/1987
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
FERROMYN S Wellcome (Ireland) Limited PA0017/073/001 Tablets - FERROUS SUCCINATE 09/11/1987
- SUCCINIC ACID
MIXOGEN Organon Laboratories PA0261/007/001 Tablets - METHYLTESTOSTERONE 09/11/1987
Limited - ETHINYLESTRADIOL

TESTORAL Organon Laboratories PA0261/010/001 - TESTOSTERONE 09/11/1987


Limited
ONE-ALPHA Leo Laboratories Limited PA0046/024/003 - ALFACALCIDOL 06/11/1987
IROLENTIN Leo Laboratories Limited PA0046/013/001 Tablets - FERROUS SULFATE 05/11/1987
SYNALAR Zeneca Limited PA0051/015/004 - FLUOCINOLONE 05/11/1987
ACETONIDE
ACNIL Fisons Limited PA0018/035/001 Cream - RESORCINOL 27/10/1987
- SULPHUR
- CETRIMONIUM BROMIDE

ANTHISAN May & Baker Limited PA0040/039/001 Tablets 27/10/1987


ANTHISAN May & Baker Limited PA0040/039/002 Tablets 27/10/1987
ANTHISAN May & Baker Limited PA0040/039/003 27/10/1987
ANTHISAN May & Baker Limited PA0040/039/005 Solution for Injection 27/10/1987
ISO-BRONCHISAN Berk Pharmaceuticals PA0082/025/001 Tablets - ISOPRENALINE 27/10/1987
Limited SULPHATE
- EPHEDRINE
HYDROCHLORIDE
- THEOPHYLLINE
RODAVAN Mercury Pharmaceuticals PA0073/021/001 Tablets - CHLORPHENOXAMINE 27/10/1987
(Ireland) Ltd HYDROCHLORIDE
- CHLOROTHEOPHYLLINE
- CAFFEINE
SYSTRAL Mercury Pharmaceuticals PA0073/022/001 Tablets - CHLORPHENOXAMINE 27/10/1987
(Ireland) Ltd
SYSTRAL Mercury Pharmaceuticals PA0073/022/002 Cream - CHLORPHENOXAMINE 27/10/1987
(Ireland) Ltd

Human Medicines Withdrawn Products Page 492 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SYSTRAL Mercury Pharmaceuticals PA0073/022/003 Syrup - CHLORPHENOXAMINE 27/10/1987
(Ireland) Ltd
SYSTRAL-C Mercury Pharmaceuticals PA0073/023/001 Tablets - CHLORPHENOXAMINE 27/10/1987
(Ireland) Ltd
CETIPRIN Pharmacia Laboratories PA0187/007/001 Tablets - EMEPRONIUM BROMIDE 23/10/1987
Limited
CETIPRIN NOVUM Pharmacia Laboratories PA0187/014/001 Tablets - EMEPRONIUM BROMIDE 23/10/1987
Limited
FACTOR VIII NORDISK Nordisk Gentofte A/S PA0217/007/003 21/10/1987
ONE-ALPHA Leo Laboratories Limited PA0046/024/004 - ALFACALCIDOL 21/10/1987
DICAPEN Leo Laboratories Limited PA0046/057/001 Withdrawn Form - SULBACTAM 20/10/1987
- AMPICILLIN
DICAPEN Leo Laboratories Limited PA0046/057/004 Withdrawn Form - SULBACTAM 20/10/1987
- AMPICILLIN
PHYSEPTONE Wellcome (Ireland) Limited PA0017/020/002 Tablets - METHADONE 20/10/1987
HYDROCHLORIDE
ALCOMICIN STERILE Alcon Laboratories (UK) Ltd PA0290/043/001 - GENTAMICIN 16/10/1987
OPTHALMIC
ZANTAC Glaxo Laboratories Limited PA0044/076/002 Withdrawn Form - RANITIDINE 15/10/1987
VERAMIL Orion Pharma A/s PA0303/001/005 Tablets - VERAPAMIL 08/10/1987
UNIVER Berk Pharmaceuticals PA0082/054/002 Capsule - VERAPAMIL 01/10/1987
Limited
LYODURA B. Braun Medical Limited PA0179/023/001 29/09/1987
NOVASIL ANTACID Cupal Limited PA0258/019/002 Tablets 29/09/1987
NOVASIL ANTACID Cupal Limited PA0258/019/001 29/09/1987
(SUSPENSION)
PALACOS E WITH Schering-Plough Limited PA0277/005/005 - GENTAMICIN 24/09/1987
GENTAMICIN
DO-DO Cilag Limited PA0028/055/001 Tablets - CAFFEINE 22/09/1987
- EPHEDRINE
HYDROCHLORIDE
- THEOPHYLLINE
REFOSPOREN 1 G I.V. E. Merck Ltd PA0054/020/005 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987
REFOSPOREN 2 G I.V. E. Merck Ltd PA0054/020/006 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987
REFOSPOREN 2 G I.V. E. Merck Ltd PA0054/020/007 - CEFAZEDONE SODIUM 22/09/1987
REFOSPOREN 250 MG I.M. E. Merck Ltd PA0054/020/002 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987

REFOSPOREN 250 MG I.V. E. Merck Ltd PA0054/020/001 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987

REFOSPOREN 500 MG I.M. E. Merck Ltd PA0054/020/004 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987

REFOSPOREN 500 MG I.V. E. Merck Ltd PA0054/020/003 Withdrawn Form - CEFAZEDONE SODIUM 22/09/1987

CATHEJELL TUBES Mayne Pharma (Ireland) PA0078/009/001 - DIPHENHYDRAMINE 21/09/1987


Limited HYDROCHLORIDE
CDCA-CEDONA Mayne Pharma (Ireland) PA0078/043/001 - CHENODEOXYCHOLIC 21/09/1987
Limited ACID
CEDURAN Mayne Pharma (Ireland) PA0078/007/001 Tablets - NITROFURANTOIN 21/09/1987
Limited - DEGLYCYRRHIZINIZED
EXTRACT OF LIQUORICE
DOXY Mayne Pharma (Ireland) PA0078/048/001 - OXYBUTYNIN 21/09/1987
Limited HYDROCHLORIDE
DOXY Mayne Pharma (Ireland) PA0078/048/002 - DOXYCYCLINE 21/09/1987
Limited HYDROCHLORIDE
DOXYSCHEL Mayne Pharma (Ireland) PA0078/004/001 Capsule - DOXYCYCLINE 21/09/1987
Limited
EFFERALGAN Mayne Pharma (Ireland) PA0078/006/001 - PARACETAMOL 21/09/1987
Limited - ASCORBIC ACID
FLUOROURACIL Mayne Pharma (Ireland) PA0078/054/003 Withdrawn Form 21/09/1987
Limited
FRUSEMIDE Mayne Pharma (Ireland) PA0078/019/002 Tablets - FUROSEMIDE 21/09/1987
Limited
INDOMETHACIN Mayne Pharma (Ireland) PA0078/021/002 Capsule - INDOMETACIN 21/09/1987
Limited
INDOMETHACIN Mayne Pharma (Ireland) PA0078/021/003 Suppositories - INDOMETACIN 21/09/1987
Limited
IRIMONT Mayne Pharma (Ireland) PA0078/036/001 21/09/1987
Limited
LARBROFEN Mayne Pharma (Ireland) PA0078/042/001 Tablets - IBUPROFEN 21/09/1987
Limited
LARBROFEN Mayne Pharma (Ireland) PA0078/042/002 Tablets - IBUPROFEN LYSINATE 21/09/1987
Limited
LAROLOL Mayne Pharma (Ireland) PA0078/040/001 Tablets - PROPRANOLOL 21/09/1987
Limited HYDROCHLORIDE

Human Medicines Withdrawn Products Page 493 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LAROLOL Mayne Pharma (Ireland) PA0078/040/002 Tablets - PROPRANOLOL 21/09/1987
Limited HYDROCHLORIDE
LAROLOL Mayne Pharma (Ireland) PA0078/040/003 Tablets - PROPRANOLOL 21/09/1987
Limited HYDROCHLORIDE
LAROLOL Mayne Pharma (Ireland) PA0078/040/004 Tablets - PROPRANOLOL 21/09/1987
Limited HYDROCHLORIDE
LOWTEN Central Pharmaceuticals PA0078/017/001 Tablets - CHLORDIAZEPOXIDE 21/09/1987
Limited HYDROCHLORIDE
- CHLORDIAZEPOXIDE
LOWTEN Central Pharmaceuticals PA0078/017/002 Tablets - CHLORDIAZEPOXIDE 21/09/1987
Limited HYDROCHLORIDE
- CHLORDIAZEPOXIDE
METHYLDOPA Mayne Pharma (Ireland) PA0078/032/001 Tablets 21/09/1987
Limited
METHYLDOPA Mayne Pharma (Ireland) PA0078/032/002 Tablets 21/09/1987
Limited
METHYLDOPA Mayne Pharma (Ireland) PA0078/032/003 Tablets 21/09/1987
Limited
NIFEREX F A Mayne Pharma (Ireland) PA0078/035/001 Tablets - POLYSACCHARIDE-K 21/09/1987
Limited - FOLIC ACID
- ASCORBIC ACID
- CYANOCOBALAMIN
NIFLURIL Mayne Pharma (Ireland) PA0078/039/002 Cream - NIFLUMIC ACID 21/09/1987
Limited
NIRYLIN EXPECTORANT Mayne Pharma (Ireland) PA0078/027/001 - DIPHENHYDRAMINE 21/09/1987
Limited HYDROCHLORIDE
PENERIN Mayne Pharma (Ireland) PA0078/013/001 Capsule - AMPICILLIN TRIHYDRATE 21/09/1987
Limited
PHENYKBUTAZONE Mayne Pharma (Ireland) PA0078/029/001 Tablets 21/09/1987
Limited
TENCALM Mayne Pharma (Ireland) PA0078/016/001 Tablets - DIAZEPAM 21/09/1987
Limited
TENCALM Mayne Pharma (Ireland) PA0078/016/002 Tablets - DIAZEPAM 21/09/1987
Limited
TETRACHEL Mayne Pharma (Ireland) PA0078/003/003 Tablets - TETRACYCLINE 21/09/1987
Limited HYDROCHLORIDE
TETRACHEL Mayne Pharma (Ireland) PA0078/003/001 Capsule - TETRACYCLINE 21/09/1987
Limited HYDROCHLORIDE
THEOCLEAR Mayne Pharma (Ireland) PA0078/041/002 Capsule - THEOPHYLLINE 21/09/1987
Limited
URIFLOW Mayne Pharma (Ireland) PA0078/019/001 Tablets - FUROSEMIDE 21/09/1987
Limited
AMPICILLIN MIXTURE Norton Healthcare Limited PA0282/004/003 18/09/1987
B.P.C. T/A IVAX Pharmaceuticals
UK
AMPICILLIN MIXTURE Norton Healthcare Limited PA0282/004/004 18/09/1987
B.P.C. T/A IVAX Pharmaceuticals
UK
DEXTROSE INJECTION International Medication PA0255/008/002 17/09/1987
50% Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/003 Withdrawn Form 16/09/1987
HYDROCHLORIDE 1% Systems (UK) Ltd
RACESTYPTINE Septodont PA0196/004/002 - LIDOCAINE 10/09/1987
- HYDROXYQUINOLINE
SULFATE
- ALUMINIUM CHLORIDE
HEXAHYDRATE
RACESTYPTINE CORD Septodont PA0196/004/001 - LIDOCAINE 10/09/1987
- HYDROXYQUINOLINE
SULFATE
- ALUMINIUM CHLORIDE
HEXAHYDRATE
PROCYCLIDINE Norgine Limited PA0102/011/001 Tablets - PROCYCLIDINE 09/09/1987
HYDROCHLORIDE
FERFOLIC Sinclair Pharmaceuticals PA0251/003/001 Tablets 08/09/1987
Limited
NETILLIN Schering-Plough Limited PA0277/007/005 Withdrawn Form - NETILMICIN SULFATE 01/09/1987
NETILLIN Schering-Plough Limited PA0277/007/007 Withdrawn Form - NETILMICIN SULFATE 01/09/1987
TYLENOL Johnson & Johnson (Ireland) PA0330/002/003 Tablets - PARACETAMOL 31/08/1987
Limited
DULCODOS Boehringer Ingelheim Limited PA0007/022/001 - BISACODYL 28/08/1987
- DOCUSATE SODIUM
DISULPHINE BLUE Zeneca Limited PA0051/034/001 Withdrawn Form - SULPHAN BLUE 14/08/1987
INTRAVENOUS
TRUXAL Lundbeck Limited PA0115/009/004 Tablets - CHLORPROTHIXENE 11/08/1987
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 494 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TRUXAL Lundbeck Limited PA0115/009/005 Tablets - CHLORPROTHIXENE 11/08/1987
HYDROCHLORIDE
ULTRALAN ORAL HE Clissmann PA0012/031/004 Tablets - FLUOCORTOLONE 11/08/1987
HAVAPEN John Wyeth & Brother PA0022/006/001 Tablets - PENAMECILLIN 07/08/1987
Limited
PENIDURAL L A John Wyeth & Brother PA0022/008/001 Withdrawn Form - BENZATHINE 07/08/1987
Limited BENZYLPENICILLIN
- PROCAINE PENICILLIN G
- BENZYLPENICILLIN

ANTOXOL Mercury Pharmaceuticals PA0073/074/001 Tablets - OXPRENOLOL 05/08/1987


(Ireland) Ltd
ANTOXOL Mercury Pharmaceuticals PA0073/074/002 Tablets - OXPRENOLOL 05/08/1987
(Ireland) Ltd
ANTOXOL Mercury Pharmaceuticals PA0073/074/003 Tablets - OXPRENOLOL 05/08/1987
(Ireland) Ltd
ANTOXOL Mercury Pharmaceuticals PA0073/074/004 Tablets - OXPRENOLOL 05/08/1987
(Ireland) Ltd
CEFOBID Pfizer Limited PA0019/032/001 - CEFOPERAZONE 05/08/1987
SODIUM
CEFOBID Pfizer Limited PA0019/032/002 - CEFOPERAZONE 05/08/1987
SODIUM
CEFOBID Pfizer Limited PA0019/032/003 - CEFOPERAZONE 05/08/1987
SODIUM
VIBRAMYCIN Pfizer Limited PA0019/013/003 - DOXYCYCLINE 05/08/1987
INTRAVENOUS HYDROCHLORIDE
UROMIDE Consolidated Chemicals PA0132/001/001 Tablets - SULFACARBAMIDE 04/08/1987
Limited - PHENAZOPYRIDINE
HYDROCHLORIDE
NETILLIN Schering-Plough Limited PA0277/007/002 Withdrawn Form - NETILMICIN SULFATE 01/08/1987
TRUXAL Lundbeck Limited PA0115/009/001 Tablets - CHLORPROTHIXENE 29/07/1987
HYDROCHLORIDE
TRUXAL Lundbeck Limited PA0115/009/002 Tablets - CHLORPROTHIXENE 29/07/1987
HYDROCHLORIDE
TRUXAL Lundbeck Limited PA0115/009/003 Tablets - CHLORPROTHIXENE 29/07/1987
HYDROCHLORIDE
PRED-MILD OPHTHALMIC T. P. Whelehan Son & Co. PA0137/021/002 27/07/1987
(SUSPENSION) Limited
DIGANOX BP Wilcox Laboratories Limited PA0233/001/001 Tablets - DIGOXIN 15/07/1987
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/015 - CHLORHEXIDINE 14/07/1987
DIACETATE
CHLORASEPT 2000 Baxter Healthcare Limited PA0167/069/016 - CHLORHEXIDINE 14/07/1987
DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/007 - CHLORHEXIDINE 14/07/1987
DIACETATE
CHLORASEPT 5000 Baxter Healthcare Limited PA0167/069/008 - CHLORHEXIDINE 14/07/1987
DIACETATE
OPTREX EYE Optrex Limited PA0275/007/001 Ointment - ALLANTOIN 14/07/1987
- CHLOROBUTANOL
SODIUM CHLORIDE 0.9% Baxter Healthcare Limited PA0167/012/010 Solution for Bladder & - SODIUM CHLORIDE 14/07/1987
W/V FOR IRRIGATION Topical Irrigation
SODIUM CHLORIDE 0.9% Baxter Healthcare Limited PA0167/012/009 Solution for Bladder & - SODIUM CHLORIDE 14/07/1987
W/VFOR IRRIGATION Topical Irrigation
STERILE WATER FOR Baxter Healthcare Limited PA0167/011/009 - WATER FOR IRRIGATION 14/07/1987
IRRIGATION
STERILE WATER FOR Baxter Healthcare Limited PA0167/011/010 - WATER FOR IRRIGATION 14/07/1987
IRRIGATION
TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/015 14/07/1987
ANTISEPTIC SODIUM
TRAVASEPT 100 Baxter Healthcare Limited PA0167/032/014 14/07/1987
ANTISEPTIC SOL
TRAVASEPT 30 Baxter Healthcare Limited PA0167/032/012 14/07/1987
ANTISEPTIC SOLUTION
TRAVESEPT 15 Baxter Healthcare Limited PA0167/032/010 14/07/1987
ANTISEPTIC
TRAVESEPT 15 Baxter Healthcare Limited PA0167/032/011 14/07/1987
ANTISEPTIC SOLUTION
TRAVESEPT 30 Baxter Healthcare Limited PA0167/032/013 14/07/1987
ANTISEPTIC SOLUTION
ADSORBED DIPHTHERIA & Glaxo Laboratories Limited PA0044/049/001 - DIPHTHERIA AND 09/07/1987
TETANUS VACCINE TETANUS TOXOIDS
ADSORBED DIPHTHERIA & Glaxo Laboratories Limited PA0044/049/002 - DIPHTHERIA AND 09/07/1987
TETANUS VACCINE TETANUS TOXOIDS
BETA-CARDONE Glaxo Laboratories Limited PA0044/002/001 - SOTALOL 09/07/1987
(SOTALOL)

Human Medicines Withdrawn Products Page 495 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BETA-CORLAN Glaxo Laboratories Limited PA0044/050/001 - BETAMETHASONE 09/07/1987
SODIUM PHOSPHATE
INSULIN ZINC Glaxo Laboratories Limited PA0044/054/001 09/07/1987
SUSPENSION BP LENTE
AB BRAND
INSULIN ZINC Glaxo Laboratories Limited PA0044/054/002 09/07/1987
SUSPENSION BP LENTE
AB BRAND
ISOPHANE INSULIN Glaxo Laboratories Limited PA0044/057/001 09/07/1987
ISOPHANE INSULIN Glaxo Laboratories Limited PA0044/057/002 09/07/1987
PREDNELAN Glaxo Laboratories Limited PA0044/053/001 Tablets - PREDNISOLONE 09/07/1987
SOLUBLE INSULIN B P Glaxo Laboratories Limited PA0044/056/001 09/07/1987
SOLUBLE INSULIN B P Glaxo Laboratories Limited PA0044/056/002 09/07/1987
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/004 09/07/1987
PROTEIN DERIVATIVE B P
HALCION Pharmacia Limited PA0016/016/003 Tablets - TRIAZOLAM 06/07/1987
ADSORBED DIPHTHERIA Glaxo Laboratories Limited PA0044/036/001 - DIPHTHERIA AND 02/07/1987
TETANUS & PERTUSSIS TETANUS TOXOIDS AND
PERTUSSIS
ADSORBED TETANUS Glaxo Laboratories Limited PA0044/035/001 02/07/1987
VACCINE BP
ADSORBED TETANUS Glaxo Laboratories Limited PA0044/035/002 - TETANUS VACCINE 02/07/1987
VACCINE BP ADSORBED
BETNESOL Glaxo Laboratories Limited PA0044/042/004 Withdrawn Form 02/07/1987
BETNESOL Glaxo Laboratories Limited PA0044/042/005 Withdrawn Form - BETAMETHASONE 02/07/1987
SODIUM PHOSPHATE
DINDEVAN Glaxo Laboratories Limited PA0044/085/003 - PHENINDAMINE 02/07/1987
DIPHTHERIA TETANUS Glaxo Laboratories Limited PA0044/036/002 02/07/1987
FLUVIRIN Glaxo Laboratories Limited PA0044/046/001 02/07/1987
FLUVIRIN Glaxo Laboratories Limited PA0044/046/002 02/07/1987
PREDSOL Glaxo Laboratories Limited PA0044/044/001 Suppositories - PREDNISOLONE SODIUM 02/07/1987
PHOSPHATE
PROTAMINE SULPHATE Glaxo Laboratories Limited PA0044/074/001 Withdrawn Form - PROTAMINE SULFATE 02/07/1987
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/003 02/07/1987
PROTEIN DERIVATIVE B P

TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/005 02/07/1987


PROTEIN DERIVATIVE B P
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/008 02/07/1987
PROTEIN DERIVATIVE B P
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/009 02/07/1987
PROTEIN DERIVATIVE B P
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/010 02/07/1987
PROTEIN DERIVATIVE B P
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/002 02/07/1987
PROTEIN DERIVATIVE B P
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/001 02/07/1987
PROTEIN DERIVATIVE BP
ADMUNE MULTIDOSE Glaxo Laboratories Limited PA0044/007/002 01/07/1987
ADMUNE SINGLE DOSE Glaxo Laboratories Limited PA0044/007/001 01/07/1987
CEPOREX Glaxo Laboratories Limited PA0044/009/001 Tablets 01/07/1987
FAZADON Glaxo Laboratories Limited PA0044/020/001 - FAZADINIUM BROMIDE 01/07/1987
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/003 Cream - MICONAZOLE NITRATE 01/07/1987
PROPADERM Glaxo Laboratories Limited PA0044/028/001 Cream - BECLOMETASONE 01/07/1987
DIPROPIONATE
PROPADERM Glaxo Laboratories Limited PA0044/028/002 Ointment - BECLOMETASONE 01/07/1987
DIPROPIONATE
PROPADERM Glaxo Laboratories Limited PA0044/028/003 - BECLOMETASONE 01/07/1987
DIPROPIONATE
PROPADERM A Glaxo Laboratories Limited PA0044/031/001 Ointment - BECLOMETASONE 01/07/1987
DIPROPIONATE
- CHLORTETRACYCLINE
HYDROCHLORIDE
PROPADERM C Glaxo Laboratories Limited PA0044/029/002 Ointment - BECLOMETASONE 01/07/1987
DIPROPIONATE
- CLIOQUINOL
PROPADERN N Glaxo Laboratories Limited PA0044/030/001 Cream - BECLOMETASONE 01/07/1987
DIPROPIONATE
- NEOMYCIN SULFATE
TRIPTAFEN FORTE Glaxo Laboratories Limited PA0044/015/003 Tablets - AMITRIPTYLINE 01/07/1987
HYDROCHLORIDE
- PERPHENAZINE
ADMUNE (FLUVAC) Glaxo Laboratories Limited PA0044/007/009 Withdrawn Form 30/06/1987
ADMUNE (FLUVAC) Glaxo Laboratories Limited PA0044/007/010 Withdrawn Form 30/06/1987
ADMUNE MULTIDOSE Glaxo Laboratories Limited PA0044/007/003 Withdrawn Form 30/06/1987

Human Medicines Withdrawn Products Page 496 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ADMUNE MULTIDOSE Glaxo Laboratories Limited PA0044/007/005 Withdrawn Form 30/06/1987
ADMUNE SINGLE DOSE Glaxo Laboratories Limited PA0044/007/004 Withdrawn Form 30/06/1987
CEPOREX (SUSPENSION) Glaxo Laboratories Limited PA0044/009/006 - CEFALEXIN 30/06/1987

PROPADERM C Glaxo Laboratories Limited PA0044/029/001 Cream - BECLOMETASONE 30/06/1987


DIPROPIONATE
- CLIOQUINOL
CAPD 2 FLUID WITH Allpharm (UK) Ltd PA0297/007/004 29/06/1987
DEXTROSE
CAPD 3 FLUID WITH 4.25% Allpharm (UK) Ltd PA0297/009/004 29/06/1987
DEXTROSE
CAPD 3K WITH 4.25% Allpharm (UK) Ltd PA0297/008/003 29/06/1987
DEXTROSE AND
POTASSIUM
CAPD 3K WITH 4.25% Allpharm (UK) Ltd PA0297/008/004 29/06/1987
DEXTROSE AND
POTASSIUM
CEPOREX (SUSPENSION) Glaxo Laboratories Limited PA0044/009/007 - CEFALEXIN 29/06/1987

FLUVIRIN Glaxo Laboratories Limited PA0044/046/003 29/06/1987


FLUVIRIN Glaxo Laboratories Limited PA0044/046/004 29/06/1987
KANFOTREX Bristol-Myers Squibb PA0048/006/002 Ointment 29/06/1987
(Holdings) Limited
MEVILIN L Glaxo Laboratories Limited PA0044/032/002 29/06/1987
NASOFLU (RIT 4040 SmithKline and French PA0060/003/005 29/06/1987
STRAIN) MONODOSE 10 Laboratories Ltd
NASOFLU (RIT 4050 SmithKline and French PA0060/003/004 29/06/1987
STRAIN) MONODOSE Laboratories Ltd
VIALS
NASOFLU (RIT 4050 SmithKline and French PA0060/003/006 29/06/1987
STRAIN) MULTIDOSE 10 Laboratories Ltd
NEUPHANE Wellcome (Ireland) Limited PA0017/075/002 Withdrawn Form - ISOPHANE INSULIN 29/06/1987
NEUPHANE ISOPHANE Wellcome (Ireland) Limited PA0017/075/001 - ISOPHANE INSULIN 29/06/1987
INSULIN INJECTION
40U/ML
PERITOFLEX Allpharm (UK) Ltd PA0297/008/002 29/06/1987
PERITOFLEX Allpharm (UK) Ltd PA0297/006/004 29/06/1987
PERITOFLEX Allpharm (UK) Ltd PA0297/007/001 29/06/1987
PERITOFLEX Allpharm (UK) Ltd PA0297/007/002 29/06/1987
PERITOFLEX Allpharm (UK) Ltd PA0297/007/003 29/06/1987
PERITOFLEX (DEXTROSE Allpharm (UK) Ltd PA0297/008/001 29/06/1987
& POTASSIUM)
PERITOFLEX CAPD 1 Allpharm (UK) Ltd PA0297/010/001 29/06/1987
PERITOFLEX CAPD 1 Allpharm (UK) Ltd PA0297/010/002 29/06/1987
PERITOFLEX CAPD 1 Allpharm (UK) Ltd PA0297/010/003 29/06/1987
PERITOFLEX CAPD 1 Allpharm (UK) Ltd PA0297/010/004 29/06/1987
PERITOFLEX CAPD 4 Allpharm (UK) Ltd PA0297/011/001 29/06/1987
PERITOFLEX CAPD 4 Allpharm (UK) Ltd PA0297/011/002 29/06/1987
PERITOFLEX CAPD 4 Allpharm (UK) Ltd PA0297/011/003 29/06/1987
PERITOFLEX CAPD 4 Allpharm (UK) Ltd PA0297/011/004 29/06/1987
PERITOFLEX CAPD 4K Allpharm (UK) Ltd PA0297/012/001 29/06/1987
PERITOFLEX CAPD 4K Allpharm (UK) Ltd PA0297/012/002 29/06/1987
PERITOFLEX CAPD 4K Allpharm (UK) Ltd PA0297/012/003 29/06/1987
PERITOFLEX CAPD 4K Allpharm (UK) Ltd PA0297/012/004 29/06/1987
ALBAMYCIN T Pharmacia Limited PA0016/007/001 Capsule - NOVOBIOCIN 26/06/1987
ALBAMYCIN T PAEDIATRIC Pharmacia Limited PA0016/007/002 - NOVOBIOCIN 26/06/1987

ALORBAT Mercury Pharmaceuticals PA0073/003/008 26/06/1987


(Ireland) Ltd
ALORBAT Mercury Pharmaceuticals PA0073/003/009 26/06/1987
(Ireland) Ltd
ALORBAT Mercury Pharmaceuticals PA0073/003/021 26/06/1987
(Ireland) Ltd
ALORBAT (DISPOSABLE Mercury Pharmaceuticals PA0073/003/020 26/06/1987
SYRINGE) (Ireland) Ltd
ALORBAT MULTIDOSE Mercury Pharmaceuticals PA0073/003/022 26/06/1987
(Ireland) Ltd
ANAPOLON Syntex Pharmaceuticals PA0033/019/001 Tablets - OXYMETHOLONE 26/06/1987
Limited
BETADINE SKIN Napp Laboratories Limited PA0114/002/002 - POVIDONE-IODINE 26/06/1987
CLEANSER
BROCADOPA Yamanouchi Pharma Ltd PA0062/011/004 Tablets 26/06/1987
BRONTINA Yamanouchi Pharma Ltd PA0062/012/001 Tablets 26/06/1987
BRONTISOL Yamanouchi Pharma Ltd PA0062/013/001 26/06/1987

Human Medicines Withdrawn Products Page 497 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CANESTEN VAGINAL Bayer PLC PA0021/004/007 Cream - CLOTRIMAZOLE 26/06/1987
CREAM
COMPOUND SODIUM Allpharm (UK) Ltd PA0297/003/001 Withdrawn Form - SODIUM LACTATE 26/06/1987
LACTATE COMPOUND INJECTION
COMPOUND SODIUM Allpharm (UK) Ltd PA0297/003/002 Withdrawn Form - SODIUM LACTATE 26/06/1987
LACTATE COMPOUND INJECTION
DEXTROSE Allpharm (UK) Ltd PA0297/002/001 Withdrawn Form - GLUCOSE 26/06/1987
DEXTROSE Allpharm (UK) Ltd PA0297/002/002 Withdrawn Form - GLUCOSE 26/06/1987
DURABOLIN Organon Laboratories PA0261/013/004 - NANDROLONE 26/06/1987
Limited PHENPROPIONATE
DUVADILAN OBSTETRIC Abbott Healthcare Products PA0108/001/001 Withdrawn Form - ISOXSUPRINE 26/06/1987
Ltd HYDROCHLORIDE
ELTOFAN Warner Lambert PA0039/032/001 26/06/1987
EVIDORM Sanofi-Synthelabo Ireland PA0077/011/001 Tablets - HEXOBARBITONE 26/06/1987
Ltd - CYCLOBARBITAL
GERISOM Sanofi-Synthelabo Ireland PA0077/012/001 Tablets - AMOBARBITAL 26/06/1987
Ltd - PARACETAMOL
- CHLORMEZANONE
HEMINEVRIN Astra Pharmaceuticals Ltd PA0009/005/002 Tablets - CLOMETHIAZOLE 26/06/1987
EDISILATE
HYDROCORTISONE Organon Laboratories PA0261/005/003 - HYDROCORTISONE 26/06/1987
SODIUM SUCCINATE Limited SODIUM SUCCINATE
IMPERACIN Zeneca Limited PA0051/011/002 Syrup - OXYTETRACYCLINE 26/06/1987
INFLUVAC Abbott Healthcare Products PA0108/003/010 26/06/1987
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/011 26/06/1987
Ltd
INFLUVAC 0.5 ML Abbott Healthcare Products PA0108/003/009 26/06/1987
Ltd
MOTILIUM Janssen Pharmaceutica PA0045/016/008 Withdrawn Form - DOMPERIDONE 26/06/1987
MRS CULLENS CUTS & Cullen and Davison Limited PA0184/004/001 Cream - CHLORHEXIDINE 26/06/1987
GRAZES GLUCONATE
NEULENTE INSULIN ZINC Wellcome (Ireland) Limited PA0017/074/002 - INSULIN ZINC 26/06/1987
SUSP 80 U SUSPENSION
ORHEPTAL E. Merck Ltd PA0054/024/001 - LIVER EXTRACT 26/06/1987
- CAFFEINE
POLYALK Galen Limited PA0185/006/002 Tablets - ALUMINIUM HYDROXIDE 26/06/1987
GEL, DRIED
- SORBITOL
RELCOFEN Accord-UK Ltd PA0176/060/002 Tablets - IBUPROFEN 26/06/1987
RESTANDOL Organon Laboratories PA0261/015/001 Capsule 26/06/1987
Limited
RIFADIN Company Liquidated M123 PA0070/001/001 Tablets 26/06/1987
SINAXAR Aventis Behring Limited PA0010/012/001 Tablets - STYRAMATE 26/06/1987
SODIUM CHLORIDE Allpharm (UK) Ltd PA0297/005/001 Withdrawn Form - SODIUM CHLORIDE 26/06/1987
COMPOUND INJECTION
SODIUM CHLORIDE Allpharm (UK) Ltd PA0297/005/002 Withdrawn Form - SODIUM CHLORIDE 26/06/1987
COMPOUND INJECTION
SODIUM CHLORIDE & Allpharm (UK) Ltd PA0297/001/002 Withdrawn Form - SODIUM CHLORIDE 26/06/1987
DEXTROSE - GLUCOSE
SODIUM CHLORIDE WITH Allpharm (UK) Ltd PA0297/001/001 Withdrawn Form - SODIUM CHLORIDE 26/06/1987
DEXTROSE - GLUCOSE
SUSTANON 100 SYRINGE Organon Laboratories PA0261/009/002 - TESTOSTERONE 26/06/1987
Limited
SUSTANON 250 SYRINGE Organon Laboratories PA0261/009/004 - TESTOSTERONE 26/06/1987
Limited
TACE Marion Merrell Limited PA0041/013/001 Tablets - CHLOROTRIANISENE 26/06/1987
TOTOLIN PAEDIATRIC Galen Limited PA0185/005/001 Syrup - 26/06/1987
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- GUAIFENESIN
XYLOCAINE 2.0% Astra Pharmaceuticals Ltd PA0009/016/019 Withdrawn Form - LIDOCAINE 26/06/1987
XYLOCAINE ANTISEPTIC Astra Pharmaceuticals Ltd PA0009/016/001 Gel - LIDOCAINE 26/06/1987
HYDROCHLORIDE
- CHLORHEXIDINE
GLUCONATE
XYLODASE Ashford Pharmaceuticals PA0009/017/001 Cream - LIDOCAINE 26/06/1987
Limited - HYALURONIDASE
KANAMYCIN CP Ovelle Limited PA0206/003/001 24/06/1987
BREOPRIN Sanofi-Synthelabo Ireland PA0077/030/001 Tablets - ACETYLSALICYLIC ACID 23/06/1987
Ltd
DIBOTIN SR Sanofi-Synthelabo Ireland PA0077/007/001 - PHENFORMIN 12/06/1987
Ltd
DIBOTIN SR Sanofi-Synthelabo Ireland PA0077/007/002 - PHENFORMIN 12/06/1987
Ltd

Human Medicines Withdrawn Products Page 498 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROSTAP SINGLE DOSE Cyanamid of Great Britain PA0037/059/001 Withdrawn Form 12/06/1987
AMYTAL Eli Lilly and Company Limite PA0047/009/001 Tablets - AMOBARBITAL 10/06/1987

AMYTAL Eli Lilly and Company Limite PA0047/009/002 Tablets - AMOBARBITAL 10/06/1987

AMYTAL Eli Lilly and Company Limite PA0047/009/003 Tablets - AMOBARBITAL 10/06/1987

AMYTAL Eli Lilly and Company Limite PA0047/009/004 Tablets - AMOBARBITAL 10/06/1987

AMYTAL Eli Lilly and Company Limite PA0047/009/005 Tablets - AMOBARBITAL 10/06/1987

AMYTAL SODIUM Eli Lilly and Company Limite PA0047/009/009 Tablets - AMOBARBITAL 10/06/1987

CAPASTAT Eli Lilly and Company Limite PA0047/017/001 Withdrawn Form - CAPREOMYCIN SULFATE 10/06/1987

PENICILLIN V POTASSIUM Eli Lilly and Company Limite PA0047/023/001 - 10/06/1987


PHENOXYMETHYLPENICI
LLIN
TUINAL Eli Lilly and Company Limite PA0047/012/002 Capsule - AMOBARBITAL 10/06/1987
- SECOBARBITAL SODIUM
V CIL K Eli Lilly and Company Limite PA0047/022/003 Tablets - 10/06/1987
PHENOXYMETHYLPENICI
LLIN
V CIL K PEDIPACS Eli Lilly and Company Limite PA0047/022/007 - 10/06/1987
PHENOXYMETHYLPENICI
LLIN
BRIETAL SODIUM Eli Lilly and Company Limite PA0047/062/004 - METHOHEXITAL SODIUM 09/06/1987

BRIETAL SODIUM Eli Lilly and Company Limite PA0047/062/005 - METHOHEXITAL SODIUM 09/06/1987

ERYTHROMYCIN Roussel Laboratories Limited PA0006/030/001 Tablets - ERYTHROMYCIN 08/06/1987

METRONIDAZOLE Roussel Laboratories Limited PA0006/035/001 Tablets - METRONIDAZOLE 08/06/1987

METRONIDAZOLE Roussel Laboratories Limited PA0006/035/002 Tablets - METRONIDAZOLE 08/06/1987

MULTONE Cupal Limited PA0258/002/001 Tablets 07/06/1987


ILOSONE Eli Lilly and Company Limite PA0047/006/005 Tablets - ERYTHROMYCIN 04/06/1987
ESTOLATE
ILOSONE Eli Lilly and Company Limite PA0047/006/006 Tablets - ERYTHROMYCIN 04/06/1987
ESTOLATE
TRAVENOL I.V. Baxter Healthcare Limited PA0167/075/001 Solution for Infusion - MULTIVITAMINS 03/06/1987
MULTIVITAMIN
DIXARIT LA Company Liquidated M123 PA0098/007/002 02/06/1987
FML GENTOPIC TOPICAL Allergan Pharmaceuticals PA0148/036/002 Suspension for Infusion 26/05/1987
OPHTHALMIC 15 ML Ireland
FML GENTOPIC TOPICAL Allergan Pharmaceuticals PA0148/036/001 - FLUOROMETHOLONE 26/05/1987
OPTHALMIC 15 ML Ireland - GENTAMICIN
(SUSPENSION)
LANCE B + C Schering-Plough Limited PA0277/025/001 Tablets 26/05/1987
RONA-PHYLLIN Rona Laboratories Limited PA0087/002/002 Tablets - THEOPHYLLINE 19/05/1987
RONA-PHYLLIN Rona Laboratories Limited PA0087/002/003 Tablets - THEOPHYLLINE 19/05/1987
RONA-PHYLLIN GG Rona Laboratories Limited PA0087/003/001 Syrup - THEOPHYLLINE 19/05/1987
- GUAIFENESIN
RONA-PHYLLIN-80 Rona Laboratories Limited PA0087/002/001 Syrup - THEOPHYLLINE 19/05/1987
DIBAN A.H. Robins Company PA0086/018/001 Tablets - POLYCARBOPHIL 18/05/1987
Limited CALCIUM
INSULIN INSULATARD Nordisk Gentofte A/S PA0217/001/002 13/05/1987
NORDISK
INSULIN MIXTARD 30/70 Nordisk Gentofte A/S PA0217/003/001 13/05/1987
NORDISK
INSULIN MIXTARD 30/70 Nordisk Gentofte A/S PA0217/003/002 13/05/1987
NORDISK
INSULIN VELOSULIN Nordisk Gentofte A/S PA0217/002/002 13/05/1987
NORDISK
PAEDO-SED Forest Laboratories UK Ltd PA0100/005/001 - DICHLORALPHENAZONE 08/05/1987
- PARACETAMOL
DECODERM COMPOUND E. Merck Ltd PA0054/005/001 Cream - GENTAMICIN 30/04/1987
- FLUPREDNIDENE
CITOCILLIN T. P. Whelehan Son & Co. PA0137/034/001 Tablets - CICLACILLIN 28/04/1987
Limited
CITOCILLIN T. P. Whelehan Son & Co. PA0137/034/002 Tablets - CICLACILLIN 28/04/1987
Limited
CITOCILLIN (SUSPENSION) T. P. Whelehan Son & Co. PA0137/034/004 - CICLACILLIN 28/04/1987
Limited

Human Medicines Withdrawn Products Page 499 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RHINAMID Bengue & Company Limited PA0096/002/001 27/04/1987
OPAS Leo Laboratories Limited PA0046/051/001 - CALCIUM CARBONATE 23/04/1987
- HEAVY MAGNESIUM
CARBONATE
- SODIUM BICARBONATE
GLINTEEL Leo Laboratories Limited PA0046/050/001 - MYROXYLON PEREIRAE 10/04/1987
- TANNIC ACID
ULCANON Leo Laboratories Limited PA0046/052/001 - TANNIC ACID 10/04/1987
- ETHYL PHTHALATE
KELFIZINE W Farmitalia Carlo Erba Ltd PA0236/005/002 07/04/1987
(SUSPENSION)
KELFIZINE W PAEDIATRIC Farmitalia Carlo Erba Ltd PA0236/005/003 07/04/1987
(SUSPENSION)
RONDOMYCIN Pfizer Limited PA0019/005/001 Capsule - METACYCLINE 01/04/1987
TERACYN Pfizer Limited PA0019/011/001 Capsule - TETRACYCLINE 01/04/1987
TERRA-BRON Pfizer Limited PA0019/006/001 - OXYTETRACYCLINE 01/04/1987
- EPHEDRINE
- IPECAC
TERRAMYCIN Pfizer Limited PA0019/009/005 Syrup - OXYTETRACYCLINE 01/04/1987
TERRAMYCIN Pfizer Limited PA0019/009/006 Tablets - OXYTETRACYCLINE 01/04/1987
TERRAMYCIN Pfizer Limited PA0019/009/002 Withdrawn Form - OXYTETRACYCLINE 01/04/1987
INTRAMUSCULAR
TERRAMYCIN SF Pfizer Limited PA0019/010/001 Capsule - OXYTETRACYCLINE 01/04/1987
- VITAMINS NOS
TETEACYN Pfizer Limited PA0019/011/004 Tablets - TETRACYCLINE 01/04/1987
TETRACYN Pfizer Limited PA0019/011/002 Withdrawn Form - TETRACYCLINE 01/04/1987
INTRAMUSCULAR
TETRACYN SF Pfizer Limited PA0019/012/001 Capsule - TETRACYCLINE 01/04/1987
- VITAMINS NOS
UROLUCOSIL Warner Lambert PA0039/026/002 Tablets 01/04/1987
LIGNOCAINE International Medication PA0255/004/011 Withdrawn Form 31/03/1987
HYDROCHLORIDE 4% Systems (UK) Ltd
DISIPIDIN Paines and Byrne Limited PA0090/008/001 Capsule 30/03/1987
STELABID FORTE SmithKline and French PA0060/015/001 27/03/1987
Laboratories Ltd
SULFOMYL Sanofi-Synthelabo Ireland PA0077/016/001 27/03/1987
Ltd
ERYTHOCIN Abbott Laboratories Ireland PA0038/002/005 24/03/1987
(SUSPENSION) Ltd
ERYTHROCIN I.V. Abbott Laboratories Ireland PA0038/002/002 24/03/1987
Ltd
NEUSULIN NEUTRAL Wellcome (Ireland) Limited PA0017/076/003 Withdrawn Form - ISOPHANE INSULIN 18/03/1987
INSULIN
OTOSEPTIL EAR DROPS Napp Laboratories Limited PA0114/005/001 - TYROTHRICIN 17/03/1987
- NEOMYCIN
- HYDROCORTISONE
GANTRISIN Roche Products Limited PA0050/009/001 Tablets - SULFAFURAZOLE 10/03/1987
GANTRISIN Roche Products Limited PA0050/009/002 Syrup - SULFAFURAZOLE 10/03/1987
EQUIVERT Pfizer Limited PA0019/026/001 Tablets - BUCLIZINE 09/03/1987
HYDROCHLORIDE
- NICOTINE
HYPNOVEL Roche Products Limited PA0050/061/003 Tablets - MIDAZOLAM 04/03/1987
PRISCOL Cilag Limited PA0028/041/001 Tablets - TOLAZOLINE 03/03/1987
TRIMETHOPRIM Accord-UK Ltd PA0176/061/001 Tablets - TRIMETHOPRIM 27/02/1987
TRIMETHOPRIM Accord-UK Ltd PA0176/061/002 Tablets - TRIMETHOPRIM 27/02/1987
TRIMETHOPRIM Accord-UK Ltd PA0176/061/003 Tablets 27/02/1987
ROHYPNOL Roche Products Limited PA0050/008/002 Tablets 26/02/1987
REVERIN IM Hoechst Ireland Limited PA0023/012/002 - ROLITETRACYCLINE 23/02/1987
ACHROMYCIN V Cyanamid of Great Britain PA0037/025/002 Syrup 20/02/1987
LEDERKYN Cyanamid of Great Britain PA0037/011/001 Tablets 20/02/1987
LEDERMYCIN Cyanamid of Great Britain PA0037/013/003 20/02/1987
LEDERMYCIN Cyanamid of Great Britain PA0037/013/004 Syrup 20/02/1987
PHENYLBUTAZONE Norton Healthcare Limited PA0282/012/001 Tablets 17/02/1987
T/A IVAX Pharmaceuticals
UK
PHENYLBUTAZONE Norton Healthcare Limited PA0282/012/002 Tablets 17/02/1987
T/A IVAX Pharmaceuticals
UK
SUREM Galen Limited PA0185/012/001 Capsule - NITRAZEPAM 17/02/1987
SUREM Galen Limited PA0185/012/002 Capsule - NITRAZEPAM 17/02/1987
NEMBUTAL Abbott Laboratories Ireland PA0038/005/002 Capsule 16/02/1987
Ltd
ARISTOCORT A Cyanamid of Great Britain PA0037/002/001 Cream - TRIAMCINOLONE 11/02/1987
ACETONIDE

Human Medicines Withdrawn Products Page 500 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ARISTOCORT A Cyanamid of Great Britain PA0037/002/002 Cream - TRIAMCINOLONE 11/02/1987
ACETONIDE
LEDERCORT Cyanamid of Great Britain PA0037/030/001 Cream 11/02/1987
GARDENAL May & Baker Limited PA0040/073/001 Tablets 06/02/1987
GARDENAL May & Baker Limited PA0040/073/002 Tablets 06/02/1987
LARGACTIL 1% May & Baker Limited PA0040/018/001 Withdrawn Form 06/02/1987
MAJEPTIL May & Baker Limited PA0040/019/001 Tablets 06/02/1987
MAJEPTIL May & Baker Limited PA0040/019/002 Tablets 06/02/1987
NEULACTIL May & Baker Limited PA0040/021/001 Withdrawn Form 06/02/1987
NEULACTIL May & Baker Limited PA0040/021/002 Syrup 06/02/1987
NEULACTIL FORTE May & Baker Limited PA0040/020/001 Syrup 06/02/1987
SULPHATRIAD May & Baker Limited PA0040/010/001 06/02/1987
(SUSPENSION)
THALAZOLE May & Baker Limited PA0040/011/001 Tablets 06/02/1987
THIAZAMIDE May & Baker Limited PA0040/012/001 Tablets 06/02/1987
TRESCATYL May & Baker Limited PA0040/013/001 Tablets 06/02/1987
VERACTIL May & Baker Limited PA0040/030/003 Tablets 06/02/1987
HEALONID Pharmacia Biosystems PA0107/013/001 - HYALURONATE SODIUM 04/02/1987
Limited
STRONG POTASSIUM International Medication PA0255/005/003 Withdrawn Form 03/02/1987
CHLORIDE 15% Systems (UK) Ltd
STRONG POTASSIUM International Medication PA0255/005/004 Withdrawn Form 03/02/1987
CHLORIDE 15% Systems (UK) Ltd
STRONG POTASSIUM International Medication PA0255/005/005 Withdrawn Form 03/02/1987
CHLORIDE 15% Systems (UK) Ltd
KELFEX Eli Lilly and Company Limite PA0047/008/002 Capsule - CEFALEXIN 02/02/1987
MONOHYDRATE
STEROXIN Geigy Pharmaceuticals PA0011/008/001 Ointment - CHLORQUINALDOL 30/01/1987
TREVINTIX May & Baker Limited PA0040/014/001 Tablets 29/01/1987
FRUSEMIDE International Medication PA0255/010/003 Withdrawn Form 28/01/1987
Systems (UK) Ltd
FRUSEMIDE International Medication PA0255/010/005 Withdrawn Form 28/01/1987
Systems (UK) Ltd
FRUSEMIDE International Medication PA0255/010/006 Withdrawn Form 28/01/1987
Systems (UK) Ltd
FRUSEMIDE International Medication PA0255/010/007 Withdrawn Form 28/01/1987
Systems (UK) Ltd
ERYTHROMYCIN Accord-UK Ltd PA0176/049/001 Tablets 27/01/1987
FLUCLOXACILLIN Accord-UK Ltd PA0176/047/001 Capsule 27/01/1987
FLUCLOXACILLIN Accord-UK Ltd PA0176/047/002 Capsule - FLUCLOXACILLIN 27/01/1987
ALBUCID HE Clissmann PA0012/041/002 - SULFACETAMIDE 26/01/1987
SODIUM
ALBUCID HE Clissmann PA0012/041/003 - SULFACETAMIDE 26/01/1987
SODIUM
KENACORT A.Q. (SPRAY) Bristol-Myers Squibb PA0002/010/001 - TRIAMCINOLONE 22/01/1987
Pharmaceuticals uc ACETONIDE
- HALQUINOL
MYSTECLIN F Bristol-Myers Squibb PA0002/012/002 Syrup - TETRACYCLINE 22/01/1987
Pharmaceuticals uc - AMPHOTERICIN B
REMIDERM Bristol-Myers Squibb PA0002/011/001 Ointment - TRIAMCINOLONE 22/01/1987
Pharmaceuticals uc ACETONIDE
- HALQUINOL
REMIDERM Bristol-Myers Squibb PA0002/011/002 Cream - HALQUINOL 22/01/1987
Pharmaceuticals uc
SUMYCIN Bristol-Myers Squibb PA0002/013/001 Capsule 22/01/1987
Pharmaceuticals uc
VELOSEF (SUSPENSION) Bristol-Myers Squibb PA0002/014/003 - CEFRADINE 22/01/1987
Pharmaceuticals uc
DORBANEX 3M Health Care Limited PA0057/039/001 Capsule - DANTRON 16/01/1987
- POLOXALCOL
DORBANEX 3M Health Care Limited PA0057/039/002 - DANTRON 16/01/1987
- POLOXAMER
DORBANEX FORTE 3M Health Care Limited PA0057/038/002 16/01/1987
DORBANEX FORTE 3M Health Care Limited PA0057/039/003 - DANTRON 16/01/1987
(SUSPENSION) - POLOXAMER
VIOFORM - Ciba Geigy Plc PA0028/015/001 Cream - CLIOQUINOL 13/01/1987
HYDROCORTISONE - HYDROCORTISONE
BILISCOPIN HE Clissmann PA0012/048/001 - IOTROXATE MEGLUMINE 12/01/1987

BILISCOPIN HE Clissmann PA0012/048/002 - IOTROXATE MEGLUMINE 12/01/1987

BILISCOPIN HE Clissmann PA0012/048/004 Solution for Infusion - IOTROXATE MEGLUMINE 12/01/1987

DARTALAN G.D. Searle & Company PA0001/006/001 Tablets - THIOPROPAZATE 07/01/1987


Limited HYDROCHLORIDE

Human Medicines Withdrawn Products Page 501 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DARTALAN G.D. Searle & Company PA0001/006/002 Tablets - THIOPROPAZATE 07/01/1987
Limited HYDROCHLORIDE
DIGOXIN Accord-UK Ltd PA0176/052/001 Tablets - DIGOXIN 07/01/1987
DIGOXIN Accord-UK Ltd PA0176/052/002 Tablets - DIGOXIN 07/01/1987
DIGOXIN Accord-UK Ltd PA0176/052/003 Tablets - DIGOXIN 07/01/1987
FLORAQUIN G.D. Searle & Company PA0001/007/001 Tablets - 07/01/1987
Limited DIIODOHYDROXYQUINOLI
NE
PRO-BANTHINE WITH G.D. Searle & Company PA0001/008/001 Tablets - PROPANTHELINE 07/01/1987
DARTALAN Limited BROMIDE
- THIOPROPAZATE
EPSIKAPRON Pharmacia Laboratories PA0187/012/002 Syrup - AMINOCAPROIC ACID 24/12/1986
Limited
EPSIKAPRON 50% Pharmacia Laboratories PA0187/012/001 - AMINOCAPROIC ACID 24/12/1986
Limited
MANDELAMINE Warner Lambert PA0039/014/002 Tablets 19/12/1986
HALFGRAM
CUPRIMINE Merck Sharp and Dohme PA0035/011/001 Capsule - PENICILLAMINE 17/12/1986
(PENICILLLAMINE) Limited
OXYMATHAZOLE Schering-Plough Limited PA0277/024/001 17/12/1986
HYDROCHLORIDE
TONOCARD Astra Pharmaceuticals Ltd PA0009/027/001 Tablets - TOCAINIDE 15/12/1986
TONOCARD Astra Pharmaceuticals Ltd PA0009/027/002 Tablets - TOCAINIDE 15/12/1986
TONOCARD Astra Pharmaceuticals Ltd PA0009/027/003 Withdrawn Form - TOCAINIDE 15/12/1986
BIOMYDRIN Warner Lambert PA0039/007/001 13/12/1986
ARVIN Berk Pharmaceuticals PA0082/001/001 12/12/1986
Limited
BERKFURIN Berk Pharmaceuticals PA0082/008/001 Tablets - NITROFURANTOIN 12/12/1986
Limited
BERKFURIN Berk Pharmaceuticals PA0082/008/002 Tablets - NITROFURANTOIN 12/12/1986
Limited
MANDELAMINE Warner Lambert PA0039/014/001 Tablets 12/12/1986
SPIREX Warner Lambert PA0039/035/001 Tablets 12/12/1986
SPIREX Warner Lambert PA0039/035/002 12/12/1986
SYTUSSAR Aventis Behring Limited PA0010/011/001 - DEXTROMETHORPHAN 12/12/1986
HYDROBROMIDE
- PHENIRAMINE MALEATE
TYROSOLVEN Warner Lambert PA0039/025/001 12/12/1986
ARDINEX 430 The Boots Company Plc PA0004/048/002 Tablets - IBUPROFEN 11/12/1986
- CODEINE
TONOCARD Astra Pharmaceuticals Ltd PA0009/027/004 Withdrawn Form - TOCAINIDE 05/12/1986
TROSYL 2% Pfizer Limited PA0019/030/002 Cream - TIOCONAZOLE 03/12/1986
THYTROPAR Aventis Behring Limited PA0010/019/001 - THYROTROPHIN 01/12/1986
ENLON Anaquest Limited PA0531/002/001 Withdrawn Form 28/11/1986
NEULENTE INSULIN ZINE Wellcome (Ireland) Limited PA0017/074/001 - INSULIN ZINC 27/11/1986
SUSPENSION B P 40 UNIT SUSPENSION

JIFFY Stafford Miller Limited PA0069/007/001 24/11/1986


K LONGULES BIOVAIL Boehringer Ingelheim Limited PA0007/009/001 Capsule - POTASSIUM CHLORIDE 20/11/1986
POTASSIUM CHLORIDE
UNIFLAM Elan Corporation Plc PA0116/005/001 Capsule - INDOMETACIN 20/11/1986
IMURAN Wellcome (Ireland) Limited PA0017/056/004 Tablets - AZATHIOPRINE 17/11/1986
NERVO FOOT EASE Wilcox Jozeau (Ireland) PA0120/002/001 Ointment - SALICYLIC ACID 14/11/1986
ANTISEPTIC Limited
KEST Berk Pharmaceuticals PA0082/046/001 Tablets - MAGNESIUM SULFATE 13/11/1986
Limited - PHENOLPHTHALEIN
GANDA 3.05 Chauvin Pharmaceuticals PA0118/010/001 - GUANETHIDINE 12/11/1986
Limited - EPINEPHRINE
GANDA 5.05 EYE Chauvin Pharmaceuticals PA0118/010/002 - GUANETHIDINE 12/11/1986
Limited - EPINEPHRINE
PARACETAMOL & Mercury Pharmaceuticals PA0073/054/001 Tablets - PARACETAMOL 06/11/1986
CODEINE (Ireland) Ltd - CODEINE PHOSPHATE
ELDESINE Eli Lilly and Company Limite PA0047/049/004 - VINDESINE SULPHATE 29/10/1986

LUDIOMIL Ciba Geigy Plc PA0028/001/005 Tablets - MAPROTILINE 28/10/1986


ANAFRANIL Geigy Pharmaceuticals PA0011/005/002 - CLOMIPRAMINE 21/10/1986
HYDROCHLORIDE
PHOLCOMED Medo Pharmaceuticals PA0109/004/006 - GUAIFENESIN 20/10/1986
EXPECTORANT Limited - METHYLEPHEDRINE
HYDROCHLORIDE-DL
BETADINE ANTISEPTIC Napp Laboratories Limited PA0114/002/009 Gel - POVIDONE-IODINE 17/10/1986
LUBRICATING
BEECHAMS SmithKlineBeecham PA0379/013/001 - ALOIN 09/10/1986
Consumer Brand

Human Medicines Withdrawn Products Page 502 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FYNNON CALCIUM SmithKline Beecham Pharm PA0049/001/001 - ACETYLSALICYLIC ACID 09/10/1986
ASPIRIN Ltd - CALCIUM CARBONATE
IRON JELLOIDS SmithKline Beecham Pharm PA0049/036/001 Tablets - FERROUS SULFATE 09/10/1986
Ltd - VITAMIN B NOS
- ASCORBIC ACID
FACTORATE Aventis Behring Limited PA0010/006/001 - FACTOR VIII 08/10/1986
(ANTIHAEMOPHILIC
FACTOR)
FACTORATE Aventis Behring Limited PA0010/006/003 - FACTOR VIII 08/10/1986
(ANTIHAEMOPHILIC
FACTOR)
FACTORATE (DOUBLE- Aventis Behring Limited PA0010/006/002 - FACTOR VIII 08/10/1986
FILL) (ANTIHAEMOPHILIC
FACTOR)
HIGH POTENCY Aventis Behring Limited PA0010/025/003 - FACTOR VIII 08/10/1986
FACTORATE (ANTIHAEMOPHILIC
FACTOR)
HIGH POTENCY Aventis Behring Limited PA0010/025/001 - FACTOR VIII 08/10/1986
FACTORATE (ANTIHAEMOPHILIC
FACTOR)
HITH POTENCY Aventis Behring Limited PA0010/025/002 - FACTOR VIII 08/10/1986
FACTORATE (ANTIHAEMOPHILIC
FACTOR)
VANQUIN (SUSPENSION) Parke Davis & Company PA0056/030/001 - PYRVINIUM EMBONATE 06/10/1986
GELUSIL PLUS Warner Lambert PA0039/036/001 02/10/1986
(SUSPENSION)
HEPARIN UCB Pharma Limited PA0365/010/001 Withdrawn Form - HEPARIN SODIUM 02/10/1986
HEPARIN UCB Pharma Limited PA0365/010/002 Withdrawn Form - HEPARIN SODIUM 02/10/1986
HEPARIN UCB Pharma Limited PA0365/010/004 Withdrawn Form - HEPARIN SODIUM 02/10/1986
HEPARIN PRESERVED UCB Pharma Limited PA0365/010/005 Withdrawn Form - HEPARIN SODIUM 02/10/1986
HEPARIN PRESERVED UCB Pharma Limited PA0365/010/006 Withdrawn Form - HEPARIN SODIUM 02/10/1986
HEPARIN PRESERVED UCB Pharma Limited PA0365/010/003 Withdrawn Form - HEPARIN SODIUM 02/10/1986
NYDRANE Lipha Pharmaceuticals PA0289/004/001 Tablets 22/09/1986
Limited
HYPERNAN Astra Pharmaceuticals Ltd PA0009/029/001 Withdrawn Form - PRENALTEROL 15/09/1986
HYDROCHLORIDE
UROMON Napp Laboratories Limited PA0114/022/001 Capsule - SULFADIAZINE 05/09/1986
PHANSPECT Mercury Pharmaceuticals PA0073/009/001 - GUAIFENESIN 03/09/1986
(Ireland) Ltd - AMMONIUM CHLORIDE
- SODIUM CITRATE
NETHAPRIN Marion Merrell Limited PA0041/018/001 Syrup - ETAFEDRINE 02/09/1986
- BUFYLLINE
- DOXYLAMINE
THEO-DUR Fisons Limited PA0018/025/001 Tablets - THEOPHYLLINE 01/09/1986
THEO-DUR Fisons Limited PA0018/025/002 Tablets - THEOPHYLLINE 01/09/1986
GAVISCON Reckitt's (Ireland) Limited PA0027/022/002 Granules Effervescent - SODIUM BICARBONATE 28/08/1986
- ALGINIC ACID
- SODIUM ALGINATE
- MAGNESIUM TRISILICATE
- ALUMINIUM HYDROXIDE

LYOSTYPT HAEMOSTATIC B. Braun Medical Limited PA0179/010/001 - COLLAGEN 21/08/1986


FELT
RYNACROM NASAL SPRA Fisons Limited PA0018/003/002 - CROMOGLICATE SODIUM 19/08/1986

NANORMON Nordisk Gentofte A/S PA0217/006/001 18/08/1986


KLOREF-S Accord-UK Ltd PA0176/028/002 - BETAINE 31/07/1986
HYDROCHLORIDE
- POTASSIUM
BICARBONATE
- POTASSIUM CHLORIDE
ALDAFRUSE G.D. Searle & Company PA0001/025/001 Capsule - SPIRONOLACTONE 30/07/1986
Limited - FUROSEMIDE
CEMAC B 12 TABLETS Larkhall Laboratories Plc PA0288/002/001 30/07/1986
PLATOSIN Ferring Pharmaceuticals PA0224/010/001 Withdrawn Form 30/07/1986
Limited
PLATOSIN Ferring Pharmaceuticals PA0224/010/002 Withdrawn Form 30/07/1986
Limited
PLATOSIN Ferring Pharmaceuticals PA0224/010/003 Withdrawn Form 30/07/1986
Limited
FELICUR HE Clissmann PA0012/008/001 Capsule 23/07/1986
PENICILLIN Sanofi-Synthelabo Ireland PA0077/006/001 Tablets 22/07/1986
Ltd
PENICILLIN ELIXIR Sanofi-Synthelabo Ireland PA0077/006/002 22/07/1986
Ltd

Human Medicines Withdrawn Products Page 503 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TRIOCOS Novartis Pharmaceuticals UK PA0013/003/001 - PHOLCODINE 22/07/1986
Ltd - PSEUDOEPHEDRINE
HYDROCHLORIDE
- CHLORPHENAMINE
MALEATE
GAMMONATIV Pharmacia Laboratories PA0187/025/001 - IMMUNOGLOBULIN 21/07/1986
Limited HUMAN NORMAL
- WATER FOR INJECTIONS

GAMMONATIV Pharmacia Laboratories PA0187/025/002 - IMMUNOGLOBULIN 21/07/1986


Limited HUMAN NORMAL
- WATER FOR INJECTIONS

ERYFER F Hoechst Ireland Limited PA0023/004/001 Capsule - FERROUS SULFATE 09/07/1986


- FOLIC ACID
PARAZOLIDIN Geigy Pharmaceuticals PA0011/014/001 Tablets - PHENYLBUTAZONE 02/07/1986
- PARACETAMOL
TANDACOTE R Geigy Pharmaceuticals PA0011/017/001 Tablets - OXYPHENBUTAZONE 02/07/1986
TANDERIL Geigy Pharmaceuticals PA0011/006/003 Tablets - OXYPHENBUTAZONE 02/07/1986
DEPOCILLIN Company Liquidated M123 PA0055/001/001 Withdrawn Form 30/06/1986
DEPOCILLIN Company Liquidated M123 PA0055/001/002 Withdrawn Form 30/06/1986
ARMODIAR Aventis Behring Limited PA0010/003/001 - ALUMINIUM HYDROXIDE 18/06/1986
GEL
- SORBITOL
COPARVAX-VIAL Wellcome (Ireland) Limited PA0017/083/001 - CORYNEBACTERIUM 16/06/1986
PARVUM
LOMOTIL JUNIOR G.D. Searle & Company PA0001/005/001 - DIPHENOXYLATE 16/06/1986
Limited HYDROCHLORIDE
ERYFER Hoechst Ireland Limited PA0023/009/001 Capsule - FERROUS SULFATE 11/06/1986
- ASCORBIC ACID
TALPEN SmithKline Beecham Pharm PA0049/003/001 Tablets - TALAMPICILLIN 10/06/1986
Ltd
TALPEN SmithKline Beecham Pharm PA0049/003/002 Syrup - TALAMPICILLIN 10/06/1986
Ltd
TALPEN SmithKline Beecham Pharm PA0049/003/003 - TALAMPICILLIN 10/06/1986
Ltd
TALPEN 125 MG/5 ML SmithKline Beecham Pharm PA0049/003/004 Syrup - TALAMPICILLIN 10/06/1986
Ltd
TALPEN 125 MG/5 ML SmithKline Beecham Pharm PA0049/003/005 Syrup - TALAMPICILLIN 10/06/1986
Ltd
ANGIDISC 5 G.D. Searle & Company PA0001/023/001 - GLYCERYL TRINITRATE 05/06/1986
Limited
ALBAY BEE VENOM Bayer Diagnostics PA0079/012/003 03/06/1986
Manufacturing
ALBAY WASP VENOM Bayer Diagnostics PA0079/012/004 03/06/1986
Manufacturing
ESTRIFAM Novo Nordisk A/S PA0218/010/001 03/06/1986
ESTRIFAM Novo Nordisk A/S PA0218/011/001 03/06/1986
UNIFEN 300 Elan Corporation Plc PA0116/008/002 - IBUPROFEN 03/06/1986
GLIBENESE Pfizer Limited PA0019/002/001 - GLIPIZIDE 30/05/1986
TREOSUFLAN Leo Laboratories Limited PA0046/002/002 Withdrawn Form 26/05/1986
SYNERGEL Servier Laboratories (Ireland) PA0068/003/001 12/05/1986
Ltd
ANGIDISC 10 G.D. Searle & Company PA0001/023/002 - GLYCERYL TRINITRATE 07/05/1986
Limited
NEUSULIN NEUTRAL Wellcome (Ireland) Limited PA0017/076/001 - INSULIN 02/05/1986
NEUSULIN NEUTRAL Wellcome (Ireland) Limited PA0017/076/002 Withdrawn Form - INSULIN 02/05/1986
INSULIN
CO-DYDRAMOL Accord-UK Ltd PA0176/053/001 Tablets - DIHYDROCODEINE 01/05/1986
BITARTRATE
- PARACETAMOL
RABRO Sinclair Pharmaceuticals PA0251/008/001 Tablets 30/04/1986
Limited
DISTACLOR Dista Products Limited PA0447/003/001 Tablets - CEFACLOR 07/04/1986
DISTACLOR Dista Products Limited PA0447/003/002 Tablets - CEFACLOR 07/04/1986
UNIPHYLLIN UNICONTIN Napp Laboratories Limited PA0114/042/003 Tablets - THEOPHYLLINE 19/03/1986
TEMAZEPAM Generics (UK) Limited PA0405/004/001 Capsule - TEMAZEPAM 13/03/1986
TEMAZEPAM Generics (UK) Limited PA0405/004/002 Capsule - TEMAZEPAM 13/03/1986
DISPRAY 1. QUICK PREP Stuart Pharmaceuticals PA0451/001/001 - CHLORHEXIDINE 11/03/1986
Limited GLUCONATE
TRISEP Zeneca Limited PA0051/050/001 - NEOMYCIN SULFATE 11/03/1986
- POLYMYXIN B SULFATE
- BACITRACIN ZINC
GENTAMICIN (WITH Hospira UK Limited PA0437/016/007 Withdrawn Form - GENTAMICIN 10/03/1986
PRESERVATIVE)

Human Medicines Withdrawn Products Page 504 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TEDRAL (SUSPENSION) Warner Lambert PA0039/024/007 10/03/1986
XYLOTOX Wigglesworth (1982) Limited PA0063/011/003 Withdrawn Form 10/03/1986

XYLOTOX Wigglesworth (1982) Limited PA0063/011/004 Withdrawn Form 10/03/1986

XYLOTOX NORMAL PASTE Wigglesworth (1982) Limited PA0063/011/006 10/03/1986

XYLOTOX SPRAY Wigglesworth (1982) Limited PA0063/011/005 10/03/1986

STEROGYL 15 Roussel Laboratories Limited PA0006/028/001 - ERGOCALCIFEROL 27/02/1986

NORPACE G.D. Searle & Company PA0001/003/005 Tablets 25/02/1986


Limited
NORQUEST Syntex Pharmaceuticals PA0033/006/001 - NORETHISTERONE 22/02/1986
Limited - ETHINYLESTRADIOL
MERITAL Hoechst Ireland Limited PA0023/003/002 Capsule - NOMIFENSINE 19/02/1986
MERITAL 25 Hoechst Ireland Limited PA0023/003/001 Capsule - NOMIFENSINE 19/02/1986
AEROPAX Orion Pharma A/s PA0303/002/002 Tablets - DIMETICONE, ACTIVATED 14/02/1986

AEROPAX EMULSION Orion Pharma A/s PA0303/002/001 - DIMETICONE, ACTIVATED 14/02/1986

KEFLEX Eli Lilly and Company Limite PA0047/008/009 Tablets - CEFALEXIN 14/02/1986
MONOHYDRATE
KEFLEX Eli Lilly and Company Limite PA0047/008/010 Tablets - CEFALEXIN 14/02/1986
MONOHYDRATE
DOME ACNE CREAM Bayer PLC PA0021/019/001 Cream - RESORCINOL 12/02/1986
MONOACETATE
DOME ACNE LOTION Bayer PLC PA0021/019/002 12/02/1986
DOME ACNE MEDICATED Bayer PLC PA0021/020/001 - SALICYLIC ACID 12/02/1986
CLEANSER
KALSPARE Aventis Behring Limited PA0010/024/001 Tablets - CHLORTALIDONE 12/02/1986
- TRIAMTERENE
LOTUSSIN EXPECTORANT G.D. Searle & Company PA0001/027/001 - EPHEDRINE 12/02/1986
Limited HYDROCHLORIDE
- GUAIFENESIN
YOTOPAR Abbott Healthcare Products PA0108/013/001 Tablets - RITODRINE 12/02/1986
Ltd HYDROCHLORIDE
YUTOPAR S.R. Abbott Healthcare Products PA0108/013/004 - RITODRINE 12/02/1986
Ltd HYDROCHLORIDE
ARDINEX 215 The Boots Company Plc PA0004/048/001 Tablets - IBUPROFEN 11/02/1986
- CODEINE
DAKTARIN Janssen Pharmaceutica PA0045/013/007 10/02/1986
HAYPHRYN NASAL SPRAY Sanofi-Synthelabo Ireland PA0077/075/001 - PHENYLEPHRINE 10/02/1986
Ltd - THENYLDIAMINE
CALCIUM LEUCOVORIN Hospira UK Limited PA0437/010/004 Withdrawn Form - CALCIUM FOLINATE 06/02/1986
NEOPHRYN NASAL Sanofi-Synthelabo Ireland PA0077/084/001 - PHENYLEPHRINE 06/02/1986
Ltd HYDROCHLORIDE
RASTINON HOECHST Hoechst Ireland Limited PA0023/021/002 - TOLBUTAMIDE 06/02/1986
AMPOULES
TOPISOLONE N Hoechst Ireland Limited PA0023/010/003 Cream - DESOXIMETASONE 06/02/1986
- NEOMYCIN SULFATE
BSS BALANCED SALT Alcon Laboratories (UK) Ltd PA0290/005/002 - SODIUM CHLORIDE 04/02/1986
SOLUTION - POTASSIUM CHLORIDE
- CALCIUM CHLORIDE
DIHYDRATE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- SODIUM ACETATE
- SODIUM CITRATE
DENDRID OPTHALMIC Alcon Laboratories (UK) Ltd PA0290/006/001 - IDOXURIDINE 04/02/1986
DILORAN Rona Laboratories Limited PA0087/001/002 Tablets - MAGNESIUM OXIDE 03/02/1986
DILORAN (SUSPENSION) Rona Laboratories Limited PA0087/001/001 - MAGNESIUM OXIDE 03/02/1986
UROLUCOSIL Warner Lambert PA0039/026/001 03/02/1986
(SUSPENSION)
FRUSEMIDE Thomas Kerfoot & Co. Ltd PA0315/003/001 Tablets - FUROSEMIDE 30/01/1986
DRY CLEAR ACNE LOTION Pfizer Consumer Healthcare PA0172/008/001 - BENZOYL PEROXIDE 29/01/1986
Ltd
KALTEN Zeneca Limited PA0051/054/002 Capsule - ATENOLOL 29/01/1986
- HYDROCHLOROTHIAZIDE
- AMILORIDE
HYDROCHLORIDE

TCP FIRST AID GEL Unicliffe Limited PA0231/001/001 23/01/1986


MERITAL AM Schering AG PA0023/003/003 Tablets - NOMIFENSINE MALEATE 22/01/1986
MYCIGUENT Pharmacia Limited PA0016/011/001 - NEOMYCIN SULFATE 17/01/1986

Human Medicines Withdrawn Products Page 505 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DEMI-TRASMOTIC Ciba Geigy Plc PA0028/046/001 - OXPRENOLOL 14/01/1986
DEMI-TRASMOTIC Ciba Geigy Plc PA0028/046/002 - OXPRENOLOL 14/01/1986
XYLOCARD Astra Pharmaceuticals Ltd PA0009/003/001 - LIDOCAINE 14/01/1986
CLINGRIL Merck Sharp and Dohme PA0035/004/003 Suppositories - SULINDAC 19/12/1985
Limited
EXPULIN PAEDIATRIC Gaelta Research & PA0418/003/001 - EPHEDRINE 19/12/1985
(SUGAR FREE) Development Lt HYDROCHLORIDE
- CHLORPHENAMINE
FRUSEMIDE Mercury Pharmaceuticals PA0073/059/003 Tablets 19/12/1985
(Ireland) Ltd
LISKONUM CARBONATE SmithKline and French PA0060/028/001 16/12/1985
Laboratories Ltd
OROBRONZE United Drug Distributors PA0182/010/001 Capsule - CANTHAXANTHIN 13/12/1985
SALONPAS MEDICATED Salonpas (1983) Ltd PA0307/001/001 - METHYL SALICYLATE 10/12/1985
PLASTER - MENTHOL
- GLYCOL SALICYLATE
OPTREX EYE DEW BLUE Optrex Limited PA0275/012/001 - NAPHAZOLINE 04/12/1985
HYDROCHLORIDE
OPTREX EYE DEW CLEAR Optrex Limited PA0275/012/002 - NAPHAZOLINE 04/12/1985
HYDROCHLORIDE
INSULIN ULTRATARD MC Novo Nordisk A/S PA0218/012/003 03/12/1985
HYPON Wellcome (Ireland) Limited PA0017/001/002 - ACETYLSALICYLIC ACID 02/12/1985
- CODEINE PHOSPHATE
- CAFFEINE
BIOFERRIN COMPLEX Hoechst Ireland Limited PA0023/027/001 - HAEMOGLOBINUM SICC. 29/11/1985
- LIVER EXTRACT
- IRON
- COBALT
- MANGANESE
CO-FEROL Accord-UK Ltd PA0176/038//00 Tablets 28/11/1985
TRAVOGEN HE Clissmann PA0012/046/002 - ISOCONAZOLE NITRATE 26/11/1985
LOXAZOL Wellcome (Ireland) Limited PA0017/089/001 - PERMETHRIN 25/11/1985
ERGAMISOL Janssen Pharmaceutica PA0045/018/002 Tablets - LEVAMISOLE 22/11/1985
HYDROCHLORIDE
DIORALYTE Aventis Behring Limited PA0010/027/001 - GLUCOSE 20/11/1985
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CITRIC ACID
MONOHYDRATE
- SODIUM CITRATE
DIORALYTE CHERRY Aventis Behring Limited PA0010/027/002 - GLUCOSE 20/11/1985
- SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CITRIC ACID
MONOHYDRATE
- SODIUM CITRATE
DIORALYTE Aventis Behring Limited PA0010/027/003 - GLUCOSE 20/11/1985
PINEAPPLE/GRAPEFRUIT - SODIUM CHLORIDE
- POTASSIUM CHLORIDE
- CITRIC ACID
MONOHYDRATE
- SODIUM CITRATE
GYNO-DAKTARIN COMBI Janssen Pharmaceutica PA0045/002/004 18/11/1985
PACK
PETHILORFAN Roche Products Limited PA0050/027/001 - PETHIDINE 18/11/1985
HYDROCHLORIDE
- LEVALLORPHAN
TARTRATE
PETHILORFAN Roche Products Limited PA0050/027/002 - PETHIDINE 18/11/1985
HYDROCHLORIDE
- LEVALLORPHAN
TARTRATE
FORTRAL N Sanofi-Synthelabo Ireland PA0077/035/007 Capsule - PENTAZOCINE 14/11/1985
Ltd - NALOXONE
FORTRAL N Sanofi-Synthelabo Ireland PA0077/035/008 Tablets 14/11/1985
Ltd
COLLYRE BLUE LAITER Laboratoires Laiter PA0359/001/001 - NAPHAZOLINE NITRATE 13/11/1985
- BENZALKONIUM
CHLORIDE
- SODIUM CHLORIDE
DORBAFIBE 3M Health Care Limited PA0057/055/001 Granules Effervescent 12/11/1985
LYSOFIBRIN MULTIDOSE Novo Nordisk A/S PA0218/023/001 29/10/1985
KIT
STEROXIN- Geigy Pharmaceuticals PA0011/009/001 Cream - CHLORQUINALDOL 29/10/1985
HYDROCORTISONE

Human Medicines Withdrawn Products Page 506 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VICKS THROAT LOZENGES Procter & Gamble (Health & PA0441/031/001 Lozenges - MENTHOL 25/10/1985
LIQUORICE Beauty Care) Limited - CAMPHOR
PANALEVE Leo Laboratories Limited PA0046/047/002 Tablets - PARACETAMOL 10/10/1985
TICAR SmithKline Beecham Pharm PA0049/029/001 Withdrawn Form - TICARCILLIN DISODIUM 10/10/1985
Ltd
TICAR SmithKline Beecham Pharm PA0049/029/003 Withdrawn Form 10/10/1985
Ltd
TICAR SmithKline Beecham Pharm PA0049/029/006 10/10/1985
Ltd
ERYTHROPED FORTE Abbott Laboratories Ireland PA0038/009/004 09/10/1985
SINGLE DOSE Ltd
FERRAVITE Ticen Limited PA0117/002/001 - FERROUS FUMARATE 07/10/1985
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN
- NICOTINAMIDE
VITELIX Ticen Limited PA0117/001/001 - MULTIVITAMINS 07/10/1985
SEDERGINE Mayne Pharma (Ireland) PA0078/012/001 Tablets - ACETYLSALICYLIC ACID 06/10/1985
Limited - ASCORBIC ACID
KLOREF Accord-UK Ltd PA0176/028/001 - BETAINE 02/10/1985
HYDROCHLORIDE
- POTASSIUM
BICARBONATE
- POTASSIUM CHLORIDE
CHROMIUM TRACE Baxter Healthcare Limited PA0167/074/001 - CHROMIC CHLORIDE 01/10/1985
ELEMENT
CHROMIUM TRACE Baxter Healthcare Limited PA0167/074/002 - CHROMIC CHLORIDE 01/10/1985
ELEMENT
M.T.E. 4 MIXTURE Baxter Healthcare Limited PA0167/061/004 - ZINC SULFATE 01/10/1985
ELEMENT - COPPER SULFATE
PENTAHYDRATE
- MANGANESE SULFATE
- CHROMIC CHLORIDE
M.T.E. 4 MIXTURE TRACE Baxter Healthcare Limited PA0167/061/005 - ZINC SULFATE 01/10/1985
ELEMENT ADDITIVES - COPPER SULFATE
PENTAHYDRATE
- MANGANESE SULFATE
- CHROMIC CHLORIDE
MTE-4 Baxter Healthcare Limited PA0167/061/001 Solution for Injection - ZINC 01/10/1985
- MANGANESE
- CHROMIUM
- COPPER
MTE-4 Baxter Healthcare Limited PA0167/061/002 Solution for Injection - ZINC 01/10/1985
- COPPER
- CHROMIUM
- MANGANESE
MTE-4 Baxter Healthcare Limited PA0167/061/003 Solution for Injection 01/10/1985
ZINC TRACE ELEMENT Baxter Healthcare Limited PA0167/070/001 - ZINC SULFATE 01/10/1985
ZINC TRACE ELEMENT Baxter Healthcare Limited PA0167/070/002 - ZINC SULFATE 01/10/1985
COPPER TRACE ELEMENT Baxter Healthcare Limited PA0167/072/001 - COPPER SULFATE 30/09/1985
PENTAHYDRATE
COPPER TRACE ELEMENT Baxter Healthcare Limited PA0167/072/002 - COPPER SULFATE 30/09/1985
PENTAHYDRATE
MANGANESE TRACE Baxter Healthcare Limited PA0167/073/001 - MANGANESE SULFATE 30/09/1985
ELEMENT
MANGANESE TRACE Baxter Healthcare Limited PA0167/073/002 - MANGANESE SULFATE 30/09/1985
ELEMENT
INSULIN INSULATARD Nordisk Gentofte A/S PA0217/001/001 24/09/1985
NORDISK
INSULIN VELOSULIN Nordisk Gentofte A/S PA0217/002/001 24/09/1985
NORDISK
AMITRIPTYLINE Mayne Pharma (Ireland) PA0078/033/001 Tablets 23/09/1985
Limited
AMITRIPTYLINE Mayne Pharma (Ireland) PA0078/033/002 Tablets 23/09/1985
Limited
AMITRIPTYLINE Mayne Pharma (Ireland) PA0078/033/003 Tablets 23/09/1985
Limited
AMPICILLIN Mayne Pharma (Ireland) PA0078/031/001 Capsule 23/09/1985
Limited
AMPICILLIN Mayne Pharma (Ireland) PA0078/031/002 Syrup 23/09/1985
Limited
AMPICILLIN Mayne Pharma (Ireland) PA0078/031/003 Syrup 23/09/1985
Limited
AMPICILLIN TRIHYDRATE Mayne Pharma (Ireland) PA0078/031/004 Capsule 23/09/1985
Limited

Human Medicines Withdrawn Products Page 507 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIAZEPAM Mayne Pharma (Ireland) PA0078/022/001 Tablets 23/09/1985
Limited
DIAZEPAM Mayne Pharma (Ireland) PA0078/022/002 Tablets 23/09/1985
Limited
DIAZEPAM Mayne Pharma (Ireland) PA0078/022/003 Tablets 23/09/1985
Limited
DOXCYCLINE Mayne Pharma (Ireland) PA0078/025/001 23/09/1985
Limited
E MYCIN Mayne Pharma (Ireland) PA0078/002/001 Tablets - ERYTHROMYCIN 23/09/1985
Limited STEARATE
ERYTHROMYCIN Mayne Pharma (Ireland) PA0078/026/001 Tablets 23/09/1985
STEARATE Limited
FRUSEMIDE Mayne Pharma (Ireland) PA0078/024/001 Tablets 23/09/1985
Limited
FRUSEMIDE Mayne Pharma (Ireland) PA0078/024/002 Tablets 23/09/1985
Limited
INDOMETHACIN Mayne Pharma (Ireland) PA0078/037/001 Capsule 23/09/1985
Limited
LEVITONE Mayne Pharma (Ireland) PA0078/018/001 Tablets - AMITRIPTYLINE 23/09/1985
Limited HYDROCHLORIDE
LEVITONE Mayne Pharma (Ireland) PA0078/018/002 Tablets - AMITRIPTYLINE 23/09/1985
Limited HYDROCHLORIDE
LEVITONE Mayne Pharma (Ireland) PA0078/018/003 Tablets - AMITRIPTYLINE 23/09/1985
Limited HYDROCHLORIDE
MEDOPAL Mayne Pharma (Ireland) PA0078/014/001 Tablets - METHYLDOPA 23/09/1985
Limited
MEDOPAL Mayne Pharma (Ireland) PA0078/014/002 Tablets - METHYLDOPA 23/09/1985
Limited
MEDOPAL Mayne Pharma (Ireland) PA0078/014/003 Tablets - METHYLDOPA 23/09/1985
Limited
NIFEREX 150 FORTE Mayne Pharma (Ireland) PA0078/045/001 Capsule - POLYSACCHARIDE-K 23/09/1985
Limited - FOLIC ACID
NITRAZEPAM Mayne Pharma (Ireland) PA0078/030/001 Tablets 23/09/1985
Limited
TETRACYCLINE Mayne Pharma (Ireland) PA0078/023/001 Capsule - TETRACYCLINE 23/09/1985
HYDROCHLORIDE Limited HYDROCHLORIDE
TETRACYCLINE Mayne Pharma (Ireland) PA0078/023/002 Tablets - TETRACYCLINE 23/09/1985
HYDROCHLORIDE Limited HYDROCHLORIDE
TETRACYCLINE Mayne Pharma (Ireland) PA0078/023/003 Syrup - TETRACYCLINE 23/09/1985
HYDROCHLORIDE Limited HYDROCHLORIDE
CHARABS GR Lane Health Products Lt PA0257/023/001 19/09/1985

LANES P.P. Boots the Chemists PA0257/019/001 Tablets 19/09/1985


INOCOR INJECTION Sanofi-Synthelabo Ireland PA0077/061/002 - AMRINONE 18/09/1985
Ltd
LUSTYS CHARCOAL GR Lane Health Products Lt PA0257/030/001 Tablets 17/09/1985

BARITOP G. POWDER Clonmel Healthcare Ltd PA0126/009/001 12/09/1985


ANGIPLEX Roussel Laboratories Limited PA0006/022/001 Ointment - GLYCERYL TRINITRATE 23/08/1985

LANITOP Roussel Laboratories Limited PA0006/001/002 23/08/1985

MONOCID SmithKline and French PA0060/043/001 Withdrawn Form 09/08/1985


Laboratories Ltd
MONOCID SmithKline and French PA0060/043/002 Withdrawn Form 09/08/1985
Laboratories Ltd
FLOSINT Farmitalia Carlo Erba Ltd PA0236/012/001 Tablets 30/07/1985
FLOSINT FOR INJECTION Farmitalia Carlo Erba Ltd PA0236/012/002 30/07/1985
FLOSINT FOR INJECTION Farmitalia Carlo Erba Ltd PA0236/012/003 30/07/1985
ANGIAM Roche Products Limited PA0050/002/001 Capsule - BUFURALOL 29/07/1985
ANGIAM Roche Products Limited PA0050/002/002 Capsule - BUFURALOL 29/07/1985
ANGIAM Roche Products Limited PA0050/002/003 Capsule - BUFURALOL 29/07/1985
ANGIAM Roche Products Limited PA0050/002/004 Capsule - BUFURALOL 29/07/1985
FENOPRON DISPERSIBLE Eli Lilly and Company Limite PA0047/002/004 Tablets - FENOPROFEN 26/07/1985

SIRDALUD Novartis Pharmaceuticals UK PA0013/035/003 Tablets - TIZANIDINE 25/07/1985


Ltd
PEXID Marion Merrell Limited PA0041/003/001 - PERHEXILINE MALEATE 24/07/1985
CHILDRENS MULTIVITAMI Galway Laboratories PA0367/004/001 Syrup - MULTIVITAMINS 19/07/1985

CYANOCOBALAMIN Galway Laboratories PA0367/011/001 Withdrawn Form - CYANOCOBALAMIN 19/07/1985


SOOTHOL GRIPE MIXTUR Galway Laboratories PA0367/002/001 - SODIUM BICARBONATE 19/07/1985

SIRDALUD Novartis Pharmaceuticals UK PA0013/035/001 Tablets - TIZANIDINE 18/07/1985


Ltd

Human Medicines Withdrawn Products Page 508 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SIRDALUD Novartis Pharmaceuticals UK PA0013/035/002 Tablets - TIZANIDINE 18/07/1985
Ltd
CORNERGEN IN DER Pharma-Global Limited PA0141/018/001 15/07/1985
OPHTHIOLE
DEXABIOTAN OPTHIOLE Pharma-Global Limited PA0141/019/001 15/07/1985
GENTAMYTREX OPHTIOLE Pharma-Global Limited PA0141/016/001 - GENTAMICIN 15/07/1985

VIDISEPT OPHTHIOLE Pharma-Global Limited PA0141/017/001 15/07/1985


ILVICO E. Merck Ltd PA0054/011/003 - SALICYLAMIDE 03/07/1985
- BROMPHENIRAMINE
MALEATE
- ASCORBIC ACID
- QUININE
HYDROCHLORIDE
- CAFFEINE
MONOHYDRATE
- PARACETAMOL
TRIPLE ACTION COLD Accord-UK Ltd PA0176/039/001 Tablets - PARACETAMOL 03/07/1985
RELIEF - PHENYLEPHRINE
- NOSCAPINE
- ASCORBIC ACID
CHOLERA VACCINE Wellcome (Ireland) Limited PA0017/024/002 - CHOLERA VACCINE 28/06/1985
CHOLERA VACCINE Wellcome (Ireland) Limited PA0017/024/003 - CHOLERA VACCINE 28/06/1985
DIPHTHERIA VACCINE T A Wellcome (Ireland) Limited PA0017/027/001 - DIPHTHERIA TOXOID 28/06/1985
B
TETANUS VACCINE Wellcome (Ireland) Limited PA0017/032/004 - TETANUS VACCINE 28/06/1985
TETANUS VACCINE Wellcome (Ireland) Limited PA0017/033/001 - TETANUS VACCINE 28/06/1985
ADSORBED ADSORBED
TETANUS VACCINE B P Wellcome (Ireland) Limited PA0017/032/002 - TETANUS VACCINE 28/06/1985
LIFETIME Menley & James PA0159/001/001 - FERROUS SULFATE 21/06/1985
Laboratories EXSICCATED
- VITAMIN B NOS
- ASCORBIC ACID
BON VOYAGE Cupal Limited PA0258/012/001 Tablets 14/06/1985
LAXOBERAL Company Liquidated M123 PA0098/001/001 14/06/1985
SOLARCAINE Plough (UK) Limited PA0397/001/001 Cream 10/06/1985
SOLARCAINE Plough (UK) Limited PA0397/001/002 10/06/1985
SOLARCAINE (SPRAY) Plough (UK) Limited PA0397/001/003 - BENZOCAINE 10/06/1985
- TRICLOSAN
INFLUVAC Abbott Healthcare Products PA0108/003/006 Withdrawn Form 07/06/1985
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/007 Withdrawn Form 07/06/1985
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/008 Withdrawn Form 07/06/1985
Ltd
DIGESTIVE MINTS Accord-UK Ltd PA0176/036/001 Granules for Oral - DIHYDROXYALUMINUM 05/06/1985
Suspension SODIUM CARBONATE
ENDURONYL Abbott Laboratories Ireland PA0038/012/001 Tablets 05/06/1985
Ltd
MADRIBON Roche Products Limited PA0050/011/001 Tablets - SULFADIMETHOXINE 04/06/1985
HALOTHANE Anaquest Limited PA0331/002/001 - HALOTHANE 28/05/1985
MIXOGEN Organon Laboratories PA0261/007/002 Withdrawn Form - ESTRADIOL BENZOATE 22/05/1985
Limited - TESTOSTERONE
PROPIONATE
PHENOBARBITONE Accord-UK Ltd PA0176/005/001 Tablets 17/05/1985
PHENOBARBITONE Accord-UK Ltd PA0176/005/002 Tablets 17/05/1985
PHENOBARBITONE Accord-UK Ltd PA0176/005/003 Tablets 17/05/1985
PHENOBARBITONE Accord-UK Ltd PA0176/005/004 Tablets - PHENOBARBITAL 17/05/1985
NOXACORN Accord-UK Ltd PA0176/014/001 - BENZOCAINE 15/05/1985
- CAMPHOR
- SALICYLIC ACID
- IODINE
- CASTOR OIL
- PHENOL
LIPANTIL Nicholas Laboratories PA0032/019/001 Capsule - FENOFIBRATE 10/05/1985
ALLCOCKS POROUS Richards & Appleby Ltd PA0306/001/001 08/05/1985
PLASTER
PENOTRANE PESSARIES Company Liquidated M123 PA0098/019/002 08/05/1985
WATER FOR INJECTION Allpharm (UK) Ltd PA0297/004/001 - WATER FOR INJECTIONS 01/05/1985

WATER FOR INJECTION Allpharm (UK) Ltd PA0297/004/002 - WATER FOR INJECTIONS 01/05/1985

CRESCORMON Pharmacia Laboratories PA0187/006/001 - GROWTH HORMONE 25/04/1985


Limited

Human Medicines Withdrawn Products Page 509 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DORMIGEN Mercury Pharmaceuticals PA0073/052/002 Tablets - NITRAZEPAM 19/04/1985
(Ireland) Ltd
GLUTRIL Roche Products Limited PA0050/001/001 15/04/1985
COTAZYM B Organon Laboratories PA0261/023/001 Tablets - LIPASE 04/04/1985
Limited - AMYLASE
KALTEN Zeneca Limited PA0051/054/001 Capsule - ATENOLOL 03/04/1985
- HYDROCHLOROTHIAZIDE
- AMILORIDE
HYDROCHLORIDE

LOMUSOL Fisons Limited PA0018/001/001 27/03/1985


GAVISCOLONE Reckitt's (Ireland) Limited PA0027/033/001 - CARBENOXOLONE 22/03/1985
- SODIUM ALGINATE
- SODIUM BICARBONATE
AMIPAQUE Nycomed (UK) Limited PA0235/001/004 Withdrawn Form - METRIZAMIDE 19/03/1985
- SODIUM CALCIUM
EDETATE
H-2090 A.H. Robins Company PA0086/025/001 18/03/1985
Limited
RITALIN Ciba Geigy Plc PA0028/033/002 - METHYLPHENIDATE 14/03/1985
HYDROCHLORIDE
STERILE WATER FOR Galen Research Laboratories PA0295/004/004 - WATER FOR IRRIGATION 12/03/1985
IRRAGATION Ltd
STERILE WATER FOR Galen Research Laboratories PA0295/004/003 - WATER FOR IRRIGATION 12/03/1985
IRRIGATION Ltd
AMODEX Pharmacia Biosystems PA0107/003/001 - AMINO ACIDS 07/03/1985
Limited
HALAZEPAM Schering-Plough Limited PA0277/031/001 Tablets 04/03/1985
HALAZEPAM Schering-Plough Limited PA0277/031/002 Tablets 04/03/1985
HALAZEPAM Schering-Plough Limited PA0277/031/003 Tablets 04/03/1985
ALRHEUMAT Bayer PLC PA0021/002/002 Suppositories - KETOPROFEN 27/02/1985
EPONTOL Bayer PLC PA0021/010/001 27/02/1985
ACTRAPID MC NEUTRAL Novo Nordisk A/S PA0218/003/002 Withdrawn Form 22/02/1985
INSULIN
MONOTARD MC INSULIN Novo Nordisk A/S PA0218/001/002 22/02/1985
SEMITARD MC INSULIN Novo Nordisk A/S PA0218/002/001 22/02/1985
ZINC
CLOPIXOL AQUEOUS Lundbeck Limited PA0115/005/008 Withdrawn Form - FLUPENTIXOL 21/02/1985
LUCIDRIL Reckitt's (Ireland) Limited PA0027/017/001 Tablets - MECLOFENOXATE 20/02/1985
LUCIDRIL PAEDIATRIC Reckitt's (Ireland) Limited PA0027/017/002 Tablets - MECLOFENOXATE 20/02/1985
MACKENZIE Accord-UK Ltd PA0176/033/001 Tablets - CHLORPHENAMINE 20/02/1985
DECONGESTANT - METHYLEPHEDRINE
- MENTHOL
- PARACETAMOL
STERILE WATER FOR Galen Research Laboratories PA0295/004/002 - WATER FOR IRRIGATION 20/02/1985
IRRIGATION Ltd
GYNO-DAKTARIN Janssen Pharmaceutica PA0045/002/009 - MICONAZOLE NITRATE 19/02/1985
TAMPONS
MOTILIUM ORAL Janssen Pharmaceutica PA0045/016/009 - DOMPERIDONE 19/02/1985
COSYLAN Parke Davis & Company PA0056/009/001 - DEXTROMETHORPHAN 14/02/1985
HYDROBROMIDE
PARAMANTIN Orion Pharma A/s PA0303/018/001 - AMANTADINE 14/02/1985
HYDROCHLORIDE
BRONDECON Parke Davis & Company PA0056/039/001 Syrup - CHOLINE 11/02/1985
THEOPHYLLINATE
- GUAIFENESIN
CITOCILLIN T. P. Whelehan Son & Co. PA0137/034/003 Tablets - CICLACILLIN 11/02/1985
Limited
FENNINGS SOLUBLE Fenning Pharmaceuticals PA0279/001/001 Tablets - PARACETAMOL 11/02/1985
CHILDRENS COOLING - SODIUM BICARBONATE
- CITRIC ACID
- MAGNESIUM
CARBONATE
EXTRA ENERGY Schering-Plough Limited PA0277/008/001 Tablets - VITAMIN B NOS 08/02/1985
- ASCORBIC ACID
- CAFFEINE
OTO-FLEXIOLE WITH Pharma-Global Limited PA0141/007/001 - NEOMYCIN 07/02/1985
NEOMYCIN EAR DROPS - CHLORAMPHENICOL
- PHENAZONE
FE-CAP Boehringer Mannheim PA0130/006/001 Capsule 06/02/1985
FE-CAP C Boehringer Mannheim PA0130/007/002 Capsule 06/02/1985
FE-CAP FOLIC Boehringer Mannheim PA0130/008/001 Capsule 06/02/1985
GASTROVITE Boehringer Mannheim PA0130/009/001 Tablets 06/02/1985
HISTICAPS Geistlich Sons Limited PA0143/001/001 - HISTIDINE 06/02/1985
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 510 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KELFERON Boehringer Mannheim PA0130/010/001 Tablets 06/02/1985
KELFOLATE Boehringer Mannheim PA0130/011/001 Tablets 06/02/1985
LEPONEX Novartis Pharmaceuticals UK PA0013/037/001 - CLOZAPINE 04/02/1985
Ltd
LEPONEX Novartis Pharmaceuticals UK PA0013/037/002 - CLOZAPINE 04/02/1985
Ltd
FERRAPLEX B SmithKline Beecham Pharm PA0049/028/001 - FERROUS SULFATE 31/01/1985
Ltd - VITAMIN B NOS
PREGNAVITE FORTE SmithKline Beecham Pharm PA0049/026/001 - FERROUS SULFATE 31/01/1985
Ltd - VITAMIN B NOS
- ASCORBIC ACID
UTICILLIN (BRL 3475) SmithKline Beecham Pharm PA0049/002/001 - CARFECILLIN 31/01/1985
Ltd
XYLOCAINE EYE Astra Pharmaceuticals Ltd PA0009/016/007 - LIDOCAINE 29/01/1985
ELDESINE Eli Lilly and Company Limite PA0047/049/001 - VINDESINE SULPHATE 28/01/1985

ELDESINE Eli Lilly and Company Limite PA0047/049/002 Withdrawn Form - VINDESINE SULPHATE 28/01/1985

METRULEN G.D. Searle & Company PA0001/012/001 Tablets - MESTRANOL 24/01/1985


Limited - ETYNODIOL DIACETATE
DAKTARIN TINCTURE Janssen Pharmaceutica PA0045/013/006 - MICONAZOLE NITRATE 20/01/1985
HALDOL Janssen Pharmaceutica PA0045/005/009 - HALOPERIDOL 20/01/1985
MELLERIL RETARD Novartis Pharmaceuticals UK PA0013/004/008 Tablets - THIORIDAZINE 17/01/1985
Ltd
PANCREOZYMIN The Boots Company Plc PA0004/021/001 - PANCREOZYMIN 13/01/1985
VITAMIN C The Boots Company Plc PA0004/023/001 Tablets - ASCORBIC ACID 13/01/1985
VITAMIN C The Boots Company Plc PA0004/023/002 Tablets - ASCORBIC ACID 13/01/1985
DINNEFORDS GRIPE SmithKlineBeecham PA0379/011/001 - HEAVY MAGNESIUM 10/01/1985
MIXTURE Consumer Brand CARBONATE
- SODIUM BICARBONATE
- CITRIC ACID
MONOHYDRATE
BREVIDIL M May & Baker Limited PA0040/049/001 09/01/1985
PROFILATE Grifols UK Limited PA0415/001/001 - HUMAN 09/01/1985
PLASMAFRAKTION
(FACTOR VIII)
MEDOMIN Geigy Pharmaceuticals PA0011/007/001 Tablets - HEPTABARB 02/01/1985
BILE BEANS Fisons Limited PA0018/039/001 - GENTIAN 21/12/1984
RAPITARD MC BIPHASIC Novo Nordisk A/S PA0218/013/001 Withdrawn Form 16/12/1984
INSULIN
PINDOLOL Novartis Pharmaceuticals UK PA0013/001/001 Tablets - CARBAMAZEPINE 14/12/1984
Ltd
TROSYL DERMAL Pfizer Limited PA0019/030/007 Cream 03/12/1984
MADECASSOL Rona Laboratories Limited PA0087/012/001 - ASIATIC ACID 29/11/1984
- MADECASSIC ACID
- ASIATICOSIDE
MADECASSOL Rona Laboratories Limited PA0087/012/002 Ointment - ASIATIC ACID 29/11/1984
- MADECASSIC ACID
- ASIATICOSIDE
IMAP INJECTABLE Janssen Pharmaceutica PA0045/007/001 - FLUSPIRILENE 27/11/1984
(SUSPENSION)
THALAMONAL Janssen Pharmaceutica PA0045/006/001 Withdrawn Form - DROPERIDOL 27/11/1984
- FENTANYL
LARBUTAZONE Mayne Pharma (Ireland) PA0078/011/001 Tablets - PHENYLBUTAZONE 26/11/1984
Limited
ETOPHYLATE ADULT Delandale Laboratories PA0080/005/005 Suppositories - ACEFYLLINE 13/11/1984
Limited
ETOPHYLATE PAEDIATRIC Delandale Laboratories PA0080/005/004 Suppositories - ACEFYLLINE 13/11/1984
Limited
JAAPS HEALTH SALT Nicholas Laboratories PA0032/026/001 - POTASSIUM SODIUM 12/11/1984
TARTRATE
- TARTARIC ACID
- SODIUM BICARBONATE
PENTACIL Athlone Laboratories Ltd PA0298/001/005 Syrup - AMPICILLIN 08/11/1984
PENTACIL Athlone Laboratories Ltd PA0298/001/006 Syrup - AMPICILLIN 08/11/1984
PENTACIL Athlone Laboratories Ltd PA0298/001/007 Syrup - AMPICILLIN 08/11/1984
QUININE BISULPHATE Accord-UK Ltd PA0176/026/001 Tablets - QUININE BISULFATE 30/10/1984
SETHOTOPE Bristol-Myers Squibb PA0002/017/001 25/10/1984
Pharmaceuticals uc
FEMIPAUSIN Hoechst Ireland Limited PA0023/030/001 Tablets - METHYLTESTOSTERONE 12/10/1984

NITRISKEN Novartis Pharmaceuticals UK PA0013/038/001 - PINDOLOL 11/10/1984


Ltd - ISOSORBIDE DINITRATE
BIO-STAR VIALS Medical & Pharmaceutical PA0309/002/002 05/10/1984
Sales C

Human Medicines Withdrawn Products Page 511 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
UNIFEN 200 Elan Corporation Plc PA0116/008/001 - IBUPROFEN 05/10/1984
AMINOPHYLLINE Accord-UK Ltd PA0176/018/001 Suppositories - AMINOPHYLLINE 03/10/1984
INDOMETHACIN Accord-UK Ltd PA0176/017/003 Suppositories - INDOMETACIN 03/10/1984
LORAZEPAM Accord-UK Ltd PA0176/024/001 Tablets - LORAZEPAM 03/10/1984
LORAZEPAM Accord-UK Ltd PA0176/024/002 Tablets - LORAZEPAM 03/10/1984
TOLBUTAMIDE Accord-UK Ltd PA0176/025/001 Tablets - TOLBUTAMIDE 03/10/1984
FLOXAPEN SmithKline Beecham Pharm PA0049/018/005 Syrup - FLUCLOXACILLIN 01/10/1984
Ltd SODIUM
HOSTACYCLINE P Hoechst Ireland Limited PA0023/014/002 Syrup - TETRACYCLINE 26/09/1984
HYDROCHLORIDE
AVACAN E. Merck Ltd PA0054/027/001 - CAMYLOFIN 13/09/1984
AVACAN E. Merck Ltd PA0054/027/002 Tablets - CAMYLOFIN 13/09/1984
LUSTYS JUNABEAN GR Lane Health Products Lt PA0257/025/001 Tablets 13/09/1984

AMOXIL SmithKline Beecham Pharm PA0049/006/017 Syrup - AMOXICILLIN 07/09/1984


Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/018 Syrup - AMOXICILLIN 07/09/1984
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/019 - AMOXICILLIN 07/09/1984
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/020 Syrup - AMOXICILLIN 07/09/1984
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/021 Syrup - AMOXICILLIN 07/09/1984
Ltd
AMOXIL SmithKline Beecham Pharm PA0049/006/022 - AMOXICILLIN 07/09/1984
Ltd
PENBRITIN SmithKline Beecham Pharm PA0049/010/025 - AMPICILLIN TRIHYDRATE 07/09/1984
Ltd
PENBRITIN SmithKline Beecham Pharm PA0049/010/028 - AMPICILLIN TRIHYDRATE 07/09/1984
Ltd
PENBRITIN (REDUCED SmithKline Beecham Pharm PA0049/010/023 - AMPICILLIN TRIHYDRATE 07/09/1984
SUGAR) 125 MG Ltd
PENBRITIN (REDUCED SmithKline Beecham Pharm PA0049/010/024 - AMPICILLIN TRIHYDRATE 07/09/1984
SUGAR) 125 MG Ltd
PENBRITIN (REDUCED SmithKline Beecham Pharm PA0049/010/026 - AMPICILLIN TRIHYDRATE 07/09/1984
SUGAR) 250 MG Ltd
PENBRITIN (REDUCED SmithKline Beecham Pharm PA0049/010/027 - AMPICILLIN TRIHYDRATE 07/09/1984
SUGAR) 250 MG Ltd
DEXACILLIN Bristol-Myers Squibb PA0002/032/007 - EPICILLIN 05/09/1984
(SUSPENSION) Pharmaceuticals uc
TETRACHEL Berk Pharmaceuticals PA0082/015/002 Capsule - TETRACYCLINE 05/09/1984
Limited
TETRACHEL Berk Pharmaceuticals PA0082/015/003 Syrup 05/09/1984
Limited
DEXACILLIN Bridge Pharmaceuticals (Ire) PA0002/032/002 Capsule - EPICILLIN 29/08/1984
Ltd
DEXACILLIN Bristol-Myers Squibb PA0002/032/003 Withdrawn Form - EPICILLIN 29/08/1984
Pharmaceuticals uc
DEXACILLIN Bristol-Myers Squibb PA0002/032/004 Withdrawn Form - EPICILLIN 29/08/1984
Pharmaceuticals uc
DEXACILLIN Bristol-Myers Squibb PA0002/032/005 Withdrawn Form - EPICILLIN 29/08/1984
Pharmaceuticals uc
DEXACILLIN Bristol-Myers Squibb PA0002/032/006 - EPICILLIN 29/08/1984
(SUSPENSION) Pharmaceuticals uc
HALCIDERM TOPICAL Bristol-Myers Squibb PA0002/020/005 Cream - HALCINONIDE 29/08/1984
0.025% Pharmaceuticals uc
VARBIAN AMPOULES Ciba Geigy Plc PA0028/037/001 - PRENALTEROL 20/08/1984
HYDROCHLORIDE
ALBUMIN HUMAN Pharmacia Laboratories PA0187/015/001 - HUMAN ALBUMIN 09/08/1984
Limited
VASIGIL Combe International Limited PA0238/002/001 Cream 08/08/1984
MAGSORBENT D.D.D. Limited PA0302/006/001 - MAGNESIUM TRISILICATE 06/08/1984

CARBO CORT 0.25% Bayer PLC PA0021/029/001 Cream 31/07/1984


COR-TAR-QUIN Bayer PLC PA0021/031/001 Cream 31/07/1984
DOME CORT Bayer PLC PA0021/030/001 Cream 31/07/1984
PROBRONTYL Reckitt's (Ireland) Limited PA0027/031/001 Tablets - PROCATEROL 31/07/1984
GLUCOPHAGE-DR Rona Laboratories Limited PA0087/005/003 Tablets - METFORMIN 26/07/1984
HYDROCHLORIDE
DINDEVAN Duncan, Flockhard & Co. PA0065/012/002 Tablets 23/07/1984
Limited
BLEOMYCIN LUNDBECK Lundbeck Limited PA0115/004/001 Withdrawn Form 20/07/1984
DE WITTS KIDNEY & E.C. De Witt & Company PA0299/002/001 - POTASSIUM NITRATE 20/07/1984
BLADDER Limited
TOPICYCLINE Yamanouchi Pharma Ltd PA0062/028/001 20/07/1984

Human Medicines Withdrawn Products Page 512 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DORIDEN Ciba Geigy Plc PA0028/011/001 Tablets - GLUTETHIMIDE 11/07/1984
MYSOLINE PHENYTOIN Zeneca Limited PA0051/026/001 Tablets - PRIMIDONE 11/07/1984
- PHENYTOIN SODIUM
BISMA-REX 3M Health Care Limited PA0057/041/001 - SODIUM BICARBONATE 10/07/1984
- MAGNESIUM
CARBONATE
- BISMUTH
CAMPHOCARBONATE
- MAGNESIUM TRISILICATE

BISMA-REX 3M Health Care Limited PA0057/041/002 Tablets - SODIUM BICARBONATE 10/07/1984


- MAGNESIUM
CARBONATE
- BISMUTH
CAMPHOCARBONATE
- MAGNESIUM TRISILICATE

BN LINIMENT 3M Health Care Limited PA0057/042/001 - TURPENTINE OIL 10/07/1984


- STRONG AMMONIA
SOLUTION
TITRALAC 3M Health Care Limited PA0057/052/001 - CALCIUM CARBONATE 10/07/1984
- AMINOACETIC ACID
BUTAZOLIDIN Geigy Pharmaceuticals PA0011/013/001 Suppositories - PHENYLBUTAZONE 05/07/1984
FLENAC Reckitt's (Ireland) Limited PA0027/013/001 Tablets - FENCLOFENAC 05/07/1984
ADULT TRAVEL Rumon (Ireland) Limited PA0156/004/001 Tablets - CHLOROBUTANOL 04/07/1984
CHILD TRAVEL Rumon (Ireland) Limited PA0156/003/001 Tablets 04/07/1984
MENTHOL & EUCALYPTOL Rumon (Ireland) Limited PA0156/005/001 - MENTHOL 04/07/1984
PASTILLES - CINEOLE
SURE SHIELD MOUTH Rumon (Ireland) Limited PA0156/001/001 Tablets - BENZOCAINE 04/07/1984
ULCER - TYROTHRICIN
- ASCORBIC ACID
- CETYLPYRIDINIUM
CHLORIDE
VOCALZONES PASTILLE Rumon (Ireland) Limited PA0156/006/001 - MENTHOL 04/07/1984
- PEPPERMINT OIL
INABRIN Pharmacia Limited PA0016/040/001 Tablets 28/06/1984
TYPHUS VACCINE B P Wellcome (Ireland) Limited PA0017/042/001 27/06/1984
OVOL Forest Laboratories UK Ltd PA0100/035/001 - DICYCLOVERINE 26/06/1984
BUTAZOLIDIN ALKA Geigy Pharmaceuticals PA0011/018/001 Tablets - PHENYLBUTAZONE 25/06/1984
BUTAZOLIDIN R WITH Geigy Pharmaceuticals PA0011/020/001 - PHENYLBUTAZONE 25/06/1984
XYLOCAINE R - LIDOCAINE
TANDERIL Geigy Pharmaceuticals PA0011/006/002 Suppositories - OXYPHENBUTAZONE 25/06/1984
ALLEGRON Eli Lilly and Company Limite PA0047/024/003 - NORTRIPTYLINE 21/06/1984
HYDROCHLORIDE
HISTADYL EC Eli Lilly and Company Limite PA0047/034/001 Syrup - METHAPYRILENE 21/06/1984
HYDROCHLORIDE
- EPHEDRINE
HYDROCHLORIDE
- CODEINE PHOSPHATE
- AMMONIUM CHLORIDE
PARAPAV Accord-UK Ltd PA0176/019/001 Tablets - PARACETAMOL 19/06/1984
- PAPAVERINE
TRILOBAL Beaufour Schwabe PA0353/002/001 - GINKGO BILOBA 19/06/1984
TRILOBAL Beaufour Schwabe PA0353/002/002 Tablets - GINKGO BILOBA 19/06/1984
AMESEC Eli Lilly and Company Limite PA0047/010/002 Capsule - AMOBARBITAL 13/06/1984
- EPHEDRINE
HYDROCHLORIDE
- AMINOPHYLLINE
CORGARD Bristol-Myers Squibb PA0002/025/004 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/005 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/006 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/007 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/008 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
CORGARD Bristol-Myers Squibb PA0002/025/009 Tablets - NADOLOL 12/06/1984
Pharmaceuticals uc
NUBAIN Endo Laboratories PA0194/002/001 Withdrawn Form - NALBUPHINE 01/06/1984
Incorporated HYDROCHLORIDE
NUBAIN Endo Laboratories PA0194/002/002 Withdrawn Form - NALBUPHINE 01/06/1984
Incorporated HYDROCHLORIDE
NUBAIN Endo Laboratories PA0194/002/003 Withdrawn Form - NALBUPHINE 01/06/1984
Incorporated HYDROCHLORIDE

Human Medicines Withdrawn Products Page 513 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CEDILANID AMPOULES Novartis Pharmaceuticals UK PA0013/027/002 - DESLANOSIDE 25/05/1984
Ltd
NORPACE G.D. Searle & Company PA0001/003/004 - DISOPYRAMIDE 24/05/1984
Limited PHOSPHATE
BREVIDIL E May & Baker Limited PA0040/048/001 23/05/1984
BETAPRESSIN Roussel Laboratories Limited PA0006/025/001 Capsule - PENBUTOLOL 03/05/1984

BETAPRESSIN Roussel Laboratories Limited PA0006/025/002 Capsule - PENBUTOLOL 03/05/1984

BETAPRESSIN Roussel Laboratories Limited PA0006/025/003 Tablets - PENBUTOLOL 03/05/1984

NASOFLU (RIT 4199 SmithKline and French PA0060/003/009 30/04/1984


STRAIN) FIFTY DOSE Laboratories Ltd
NASOFLU (RIT 4199 SmithKline and French PA0060/003/007 30/04/1984
STRAIN) MONODOSE Laboratories Ltd
NASOFLU (RIT 4199 SmithKline and French PA0060/003/008 30/04/1984
STRAIN) TEN DOSE Laboratories Ltd
CALCIUM LEUCOVORIN Mayne Pharma (Ireland) PA0078/053/003 Withdrawn Form 24/04/1984
Limited
FEMIPAUSIN MANOJECT Hoechst Ireland Limited PA0023/031/001 - ESTRADIOL 24/04/1984
- TESTOSTERONE
PROPIONATE
CENADEX Mayne Pharma (Ireland) PA0078/046/001 Capsule 17/04/1984
Limited
DUO-AUTOHALER 3M Health Care Limited PA0057/030/001 - ISOPRENALINE 17/04/1984
- PHENYLEPHRINE
BITARTRATE
ISO-AUTOHALER 3M Health Care Limited PA0057/029/001 - ISOPRENALINE 17/04/1984
SULPHATE
RAUWILOID + VERILOID 3M Health Care Limited PA0057/019/001 Tablets - VERATRUM VIRIDE 17/04/1984
- RAUWOLFIA
SERPENTINA
THIAVER 3M Health Care Limited PA0057/018/001 Tablets - VERATRUM VIRIDE 17/04/1984
- EPITIZIDE
VERILOID 3M Health Care Limited PA0057/016/001 Tablets - VERATRUM VIRIDE 17/04/1984
IDOSORB TIL (Medical) Limited PA0350/001/001 - CADEXOMER IODINE 16/04/1984
ALKA MINTS Bayer PLC PA0021/023/001 - ALUMINIUM HYDROXIDE 02/04/1984
- CALCIUM CARBONATE
FRANOL PLUS Sanofi-Synthelabo Ireland PA0077/017/003 Tablets - THEOPHYLLINE 30/03/1984
Ltd - THENYLDIAMINE
HYDROCHLORIDE
- EPHEDRINE SULFATE
PRO-BANTHINE G.D. Searle & Company PA0001/002/003 - PROPANTHELINE 28/03/1984
Limited BROMIDE
INDERAL Zeneca Limited PA0051/006/004 Tablets - PROPRANOLOL 27/03/1984
INTRAVAL SODIUM May & Baker Limited PA0040/017/006 24/03/1984
OPULETS BENOXINATE Forest Laboratories UK Ltd PA0100/018/001 - OXYBUPROCAINE 21/03/1984
HYDROCHLORIDE
PAMINE Pharmacia Limited PA0016/030/001 Tablets 21/03/1984
SENSORCAINE 0.75% Astra Pharmaceuticals Ltd PA0009/031/006 Solution for Injection - BUPIVACAINE 20/03/1984
HYDROCHLORIDE
SENSORCAINE 0.75% Astra Pharmaceuticals Ltd PA0009/031/007 - BUPIVACAINE 20/03/1984
HYDROCHLORIDE
PSOROX Fisons Limited PA0018/034/001 Ointment - SALICYLIC ACID 19/03/1984
ZADITEN Novartis Pharmaceuticals UK PA0013/013/002 Syrup - KETOTIFEN FUMARATE 13/03/1984
Ltd
HALDOL Janssen Pharmaceutica PA0045/005/002 Tablets - HALOPERIDOL 12/03/1984
ALTHESIN Duncan, Flockhard & Co. PA0065/015/001 Solution for Injection 09/03/1984
Limited
ESTULIC Novartis Pharmaceuticals UK PA0013/025/001 Tablets - GUANFACINE 09/03/1984
Ltd HYDROCHLORIDE
ESTULIC Novartis Pharmaceuticals UK PA0013/025/002 Tablets - GUANFACINE 09/03/1984
Ltd HYDROCHLORIDE
ESTULIC Novartis Pharmaceuticals UK PA0013/025/003 Tablets - GUANFACINE 09/03/1984
Ltd HYDROCHLORIDE
PARATHORMONE Eli Lilly and Company Limite PA0047/047/001 Withdrawn Form 07/03/1984

TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/034/003 07/03/1984


&B
ETOPHYLATE Delandale Laboratories PA0080/005/001 Withdrawn Form - ACEFYLLINE 06/03/1984
Limited
ETOPHYLATE Delandale Laboratories PA0080/005/002 Tablets - ACEFYLLINE 06/03/1984
Limited

Human Medicines Withdrawn Products Page 514 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIMOTANE EXPECTORANT A.H. Robins Company PA0086/014/001 - GUAIFENESIN 05/03/1984
DC Limited - PHENYLEPHRINE
HYDROCHLORIDE
- BROMPHENIRAMINE
MALEATE
DIMOTANE EXPECTORANT A.H. Robins Company PA0086/013/004 - BROMPHENIRAMINE 05/03/1984
PAEDIATRIC Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- GUAIFENESIN
PITOCIN BUCCAL Parke Davis & Company PA0056/020/001 Tablets 01/03/1984
ACTRON Bayer PLC PA0021/022/001 - ACETYLSALICYLIC ACID 29/02/1984
- PARACETAMOL
- CAFFEINE
- SODIUM BICARBONATE
- CITRIC ACID
CARBO-DOME Bayer PLC PA0021/021/001 Cream - COAL TAR SOLUTION 29/02/1984
CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/012 Withdrawn Form - GENTAMICIN 24/02/1984

CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/013 Withdrawn Form - GENTAMICIN 24/02/1984

HEDEX SOLUBLE Sanofi-Synthelabo Ireland PA0077/073/001 20/02/1984


Ltd
LENTARD MC INSULIN Novo Nordisk A/S PA0218/014/001 16/02/1984
ZINC SUSPENSION
LENTARD MC INSULIN Novo Nordisk A/S PA0218/014/002 16/02/1984
ZINC SUSPENSION
MYCANDEN HE Clissmann PA0012/043/002 - HALOPROGIN 16/02/1984
PRIMODIAN DEPOT AMPS HE Clissmann PA0012/018/001 - TESTOSTERONE 16/02/1984
ENANTATE
- ESTRADIOL VALERATE
PRIMOSTAT AMPS HE Clissmann PA0012/022/001 - GESTONORONE 16/02/1984
CAPROATE
TESTOVIRON HE Clissmann PA0012/028/001 Tablets - METHYLTESTOSTERONE 16/02/1984

ULRATARD MC INSULIN Novo Nordisk A/S PA0218/012/001 16/02/1984


ZINC SUSPENSION
ULTRATARD MC INSULIN Novo Nordisk A/S PA0218/012/002 16/02/1984
DILAUDID Knoll A.G. (Clissmann) PA0058/003/001 Tablets - HYDROMORPHONE 10/02/1984
FERMERGIN Novartis Pharmaceuticals UK PA0013/016/002 - ERGOTAMINE TARTRATE 10/02/1984
Ltd
ANTIMET Mercury Pharmaceuticals PA0073/060/003 Withdrawn Form - METOCLOPRAMIDE 02/02/1984
(Ireland) Ltd
TERRACORTRIL (SPRAY) Pfizer Limited PA0019/007/003 - OXYTETRACYCLINE 02/02/1984
- HYDROCORTISONE
LIMBRON Berk Pharmaceuticals PA0082/011/001 Tablets - BENZYDAMINE 27/01/1984
Limited
FENTAZIN Allen and Hanburys Limited PA0024/002/005 Tablets - PERPHENAZINE 25/01/1984
INOCOR Sanofi-Synthelabo Ireland PA0077/061/001 Capsule - AMRINONE 25/01/1984
Ltd
FLURAZEPAM Clonmel Healthcare Ltd PA0126/043/001 Capsule 24/01/1984
FLURAZEPAM Clonmel Healthcare Ltd PA0126/043/002 Capsule 24/01/1984
OPULETS AMETHOCAINE Alcon Laboratories (UK) Ltd PA0290/054/001 - TETRACAINE 19/01/1984
EYE
OPULETS Alcon Laboratories (UK) Ltd PA0290/055/001 - PHYSOSTIGMINE 19/01/1984
PHYSOSTIGMINE EYE
PNU-IMUNE MULTIPLE Cyanamid of Great Britain PA0037/019/003 17/01/1984
PNU-IMUNE SINGLE DOSE Cyanamid of Great Britain PA0037/019/002 17/01/1984

PNU-IMUNE SINGLE DOSE Cyanamid of Great Britain PA0037/019/001 17/01/1984


SYRINGES
OSMOSIN Merck Sharp and Dohme PA0035/059/001 - INDOMETACIN 16/01/1984
Limited
ANXON SmithKline Beecham Pharm PA0049/030/002 Capsule - KETAZOLAM 13/01/1984
Ltd
ANXON SmithKline Beecham Pharm PA0049/030/003 Capsule - KETAZOLAM 13/01/1984
Ltd
ERYCEN Berk Pharmaceuticals PA0082/044/001 Tablets - ERYTHROMYCIN 09/01/1984
Limited
TAMPOVAGAN N Norgine Limited PA0102/002/001 - NEOMYCIN SULFATE 01/01/1984
TETMOSOL Zeneca Limited PA0051/038/001 Soap - SULFIRAM 21/12/1983

Human Medicines Withdrawn Products Page 515 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
POLYALK (SUSPENSION) Galen Limited PA0185/006/001 - ALUMINIUM HYDROXIDE 17/12/1983
GEL
- MAGNESIUM TRISILICATE
- DIMETHICONE 350

PERDIASTAN E. Merck Ltd PA0054/028/001 Ointment - CHLORPHENOXAMINE 15/12/1983


HYDROCHLORIDE
- BENZYL NICOTINATE
- BORNYL SALICYLATE
PERDIASTAN E. Merck Ltd PA0054/028/002 - CHLORPHENOXAMINE 15/12/1983
- BENZYL NICOTINATE
- BORNYL SALICYLATE
COLOGEL Eli Lilly and Company Limite PA0047/060/001 - METHYLCELLULOSE 13/12/1983

PHARMACIN Optrex Limited PA0275/004/001 Capsule - ACETYLSALICYLIC ACID 08/12/1983


SINE-OFF Menley & James PA0159/004/001 Solution for Infusion - ACETYLSALICYLIC ACID 02/12/1983
Laboratories -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- CHLORPHENAMINE
MALEATE
ALKA-SELTZER Bayer Diagnostics PA0079/008/001 - ACETYLSALICYLIC ACID 22/11/1983
Manufacturing
CITOCILLIN T. P. Whelehan Son & Co. PA0137/034/005 - CICLACILLIN 22/11/1983
Limited
NYSTAFORM Bayer Diagnostics PA0079/003/001 22/11/1983
Manufacturing
NYSTAFORM Bayer Diagnostics PA0079/003/002 Ointment - NYSTATIN 22/11/1983
Manufacturing
NYSTAFORM-HC Bayer Diagnostics PA0079/004/001 Cream - NYSTATIN 22/11/1983
Manufacturing - CLIOQUINOL
- HYDROCORTISONE
NYSTATIN-DOME Bayer Diagnostics PA0079/002/002 Cream - NYSTATIN 22/11/1983
Manufacturing
OPOBYL Bengue & Company Limited PA0096/010/001 22/11/1983
AMIPAQUE VIALS Nycomed (UK) Limited PA0235/001/001 - METRIZAMIDE 09/11/1983
- SODIUM CALCIUM
EDETATE
AMIPAQUE VIALS Nycomed (UK) Limited PA0235/001/002 - SODIUM BICARBONATE 09/11/1983
SOLVENT
ROCEPHINE VIALS Roche Products Limited PA0050/062/002 Withdrawn Form - CEFTRIAXONE 02/11/1983
- LIDOCAINE
TOPICAL SOLUTION Bristol-Myers Squibb PA0048/031/001 - ERYTHROMYCIN 24/10/1983
CONTAINING 1.5% (Holdings) Limited
ERYTHROMYCIN
VERACOLATE Warner Lambert PA0039/028/001 Tablets 20/10/1983
ILVICO E. Merck Ltd PA0054/011/004 Tablets - BROMPHENIRAMINE 10/10/1983
- CALCIUM ASCORBATE
- CAFFEINE
MONOHYDRATE
- PARACETAMOL
NETHAPRIN DOSPAN Marion Merrell Limited PA0041/033/001 07/10/1983
THERAGRAN Bristol-Myers Squibb PA0002/048/001 Tablets - MULTIVITAMINS 07/10/1983
Pharmaceuticals uc
DIPHTHERIA TOXOID & Abbott Healthcare Products PA0108/006/001 - DIPHTHERIA TOXOID 04/10/1983
TETANUS Ltd - TETANUS TOXOID
DIPHTHERIA TOXOID & Abbott Healthcare Products PA0108/006/002 - DIPHTHERIA TOXOID 04/10/1983
TETANUS TOXOID Ltd - TETANUS TOXOID
- ALUMINIUM PHOSPHATE

HEPACORT PLUS Rona Laboratories Limited PA0087/004/001 Cream - HEPARIN 30/09/1983


- HYDROCORTISONE
ACETATE
- METHYLPARABEN E218
HEPACORT PLUS Rona Laboratories Limited PA0087/004/002 Suppositories - HEPARIN SODIUM 30/09/1983
- HYDROCORTISONE
ACETATE
RYTHMODAN Roussel Laboratories Limited PA0006/005/004 Withdrawn Form - DISOPYRAMIDE 29/09/1983

ZELMID Astra Pharmaceuticals Ltd PA0009/026/003 Tablets - ZIMELDINE 28/09/1983


HYDROCHLORIDE
ZELMID 100 MG Astra Pharmaceuticals Ltd PA0009/026/002 Tablets - ZIMELDINE 28/09/1983
HYDROCHLORIDE
ZELMID 50 MG Astra Pharmaceuticals Ltd PA0009/026/001 Tablets - ZIMELDINE 28/09/1983
HYDROCHLORIDE
AMINOPLEX 14 Geistlich Sons Limited PA0143/008/001 - AMINO ACIDS 26/09/1983

Human Medicines Withdrawn Products Page 516 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/011/001 15/09/1983
NR. 2 Limited
BETNOVATE A Glaxo Laboratories Limited PA0044/024/001 Ointment - BETAMETHASONE 08/09/1983
VALERATE
- CHLORTETRACYCLINE
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/007 08/09/1983
PROTEIN DERIVATIVE B P
GUANIMYCIN FORTE Allen and Hanburys Limited PA0024/011/001 - 07/09/1983
(SUSPENSION) DIHYDROSTREPTOMYCIN
- SULFAGUANIDINE
- KAOLIN, LIGHT
NYSTAFORM-HC Bayer Diagnostics PA0079/004/002 - NYSTATIN 07/09/1983
Manufacturing - CLIOQUINOL
- HYDROCORTISONE
NYSTAFORM-HC Bayer Diagnostics PA0079/004/003 Ointment - NYSTATIN 07/09/1983
Manufacturing - CLIOQUINOL
- HYDROCORTISONE
SODIUM PHOSPHATE
AMPICILLIN Ross Pharmaceuticals Ltd PA0339/001/001 Capsule - AMPICILLIN 06/09/1983
AMPICILLIN Ross Pharmaceuticals Ltd PA0339/001/002 Capsule - AMPICILLIN 06/09/1983
AMPICILLIN 125 MG/5 ML Ross Pharmaceuticals Ltd PA0339/001/003 Syrup - AMPICILLIN 06/09/1983
AMPICILLIN 250 MG/5 ML Ross Pharmaceuticals Ltd PA0339/001/005 Syrup - AMPICILLIN 06/09/1983
AMPICILLIN 50 MG/5 ML Ross Pharmaceuticals Ltd PA0339/001/006 Syrup - AMPICILLIN 06/09/1983
AMPICILLIN TRIHYDRATE Parle & Hickey Ltd PA0399/001/004 Capsule - AMPICILLIN TRIHYDRATE 06/09/1983

LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/010/001 05/09/1983


NR. 1 Limited
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/016/001 05/09/1983
NR. 16 Limited
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/012/001 05/09/1983
NR. 5 Limited
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/013/001 05/09/1983
NR. 6 Limited
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/015/001 05/09/1983
NR. 8 Limited
LAPIDAR HERBTABLETS Wilcox Jozeau (Ireland) PA0120/014/001 05/09/1983
NR.7 Limited
CODANIN Pfizer Consumer Healthcare PA0172/002/001 - CODEINE PHOSPHATE 31/08/1983
Ltd - PARACETAMOL
GLIPTIDE Nicholas Laboratories PA0032/021/001 Tablets - SULGLICOTIDE 26/08/1983
DRIXORAL SUSTAINED Schering-Plough Limited PA0277/043/001 Tablets - DEXBROMPHENIRAMINE 19/08/1983
ACTION MALEATE
- PSEUDOEPHEDRINE

LENDORMIN Boehringer Ingelheim Limited PA0007/017/001 Tablets - BROTIZOLAM 19/08/1983

LENDORMIN Boehringer Ingelheim Limited PA0007/017/002 Tablets - BROTIZOLAM 19/08/1983

AMOXICILLIN Ashford Pharmaceuticals PA0301/054/004 - AMOXICILLIN 18/08/1983


(SUSPENSION) Limited
KANACILLIN FORTE Ovelle Limited PA0206/002/001 - PROCAINE PENICILLIN G 05/08/1983
- KANAMYCIN

HALOSPOR Ciba Geigy Plc PA0028/043/001 - CEFOTIAM 02/08/1983


HYDROCHLORIDE
HALOSPOR Ciba Geigy Plc PA0028/043/002 - CEFOTIAM 02/08/1983
HYDROCHLORIDE
HALOSPOR Ciba Geigy Plc PA0028/043/003 - CEFOTIAM 02/08/1983
HYDROCHLORIDE
HALOSPOR Ciba Geigy Plc PA0028/043/004 - CEFOTIAM 02/08/1983
HYDROCHLORIDE
HALOSPOR Ciba Geigy Plc PA0028/043/005 Withdrawn Form - CEFOTIAM 02/08/1983
HYDROCHLORIDE
KANAMYCIN CP Ovelle Limited PA0206/003/002 02/08/1983
LLOYDS Reckitt's (Ireland) Limited PA0027/016/001 Cream - DIETHYLAMINE 29/07/1983
SALICYLATE
OWBRIDGES COLD Chefaro Proprietaries Limited PA0091/001/001 29/07/1983
CONTROL
CALCIUM HEPARIN UCB Pharma Limited PA0365/003/001 Withdrawn Form - HEPARIN CALCIUM 27/07/1983
SODIUM HEPARIN UCB Pharma Limited PA0365/004/001 Withdrawn Form - HEPARIN SODIUM 27/07/1983
SODIUM HEPARIN UCB Pharma Limited PA0365/004/002 Withdrawn Form - HEPARIN SODIUM 27/07/1983
CLONMEL B-ALERT Hausmann Laboratories Inc. PA0241/001/001 20/07/1983
ENTERO-SEDIV T. P. Whelehan Son & Co. PA0137/014/001 Tablets 20/07/1983
Limited

Human Medicines Withdrawn Products Page 517 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KAOMYCIN Pharmacia Limited PA0016/008/001 - KAOLIN 20/07/1983
- NEOMYCIN
ADMUNE Glaxo Laboratories Limited PA0044/007/006 14/07/1983
ADMUNE Glaxo Laboratories Limited PA0044/007/007 14/07/1983
ADMUNE Glaxo Laboratories Limited PA0044/007/008 14/07/1983
INFACOL Marion Merrell Limited PA0041/025/001 Syrup - DICYCLOVERINE 14/07/1983
HYDROCHLORIDE
ROTERSEPT Crookes Healthcare B.V. PA0342/001/002 Lozenges 07/07/1983
INTRALGIN 3M Health Care Limited PA0057/036/001 Gel - SALICYLAMIDE 06/07/1983
- BENZOCAINE
ZOMAC SODIUM Cilag Limited PA0059/014/001 Tablets - ZOMEPIRAC SODIUM 04/07/1983
ZOMAC SODIUM Cilag Limited PA0059/014/002 Tablets - ZOMEPIRAC SODIUM 04/07/1983
CELBENIN SmithKline Beecham Pharm PA0049/008/001 Withdrawn Form - METICILLIN 01/07/1983
Ltd
FRAMYGEN STERILE Fisons Limited PA0018/010/004 - FRAMYCETIN 01/07/1983
PAMINAL Pharmacia Limited PA0016/014/002 Tablets 01/07/1983
INDERECTIC Zeneca Limited PA0051/029/002 Capsule 28/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/006 Syrup - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/007 Tablets - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/008 Tablets - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/047 Tablets 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/002 Withdrawn Form - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/003 Withdrawn Form - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT Napp Laboratories Limited PA0114/043/004 - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT AEROSOL Napp Laboratories Limited PA0114/043/001 - SALBUTAMOL SULFATE 24/06/1983
SALBUVENT RESPIRATOR Napp Laboratories Limited PA0114/043/005 - SALBUTAMOL SULFATE 24/06/1983

MYOTONINE Glenwood Laboratories PA0031/003/002 Tablets - BETHANECHOL 14/06/1983


Limited CHLORIDE
MYOTONINE Glenwood Laboratories PA0031/003/003 Tablets - BETHANECHOL 14/06/1983
Limited CHLORIDE
NITRO DUR 20 CM The Boots Company Plc PA0004/047/002 - GLYCERYL TRINITRATE 14/06/1983
POTABA Glenwood Laboratories PA0031/001/002 Tablets - POTASSIUM 14/06/1983
Limited AMINOBENZOATE
- PYRIDOXINE
POTABA ENVULES Glenwood Laboratories PA0031/001/001 - POTASSIUM 14/06/1983
Limited AMINOBENZOATE
ADJU-FLUAX VACCINE Merck Sharp and Dohme PA0035/032/001 - INFLUENSA VIRUS 13/06/1983
Limited VACCIN BIVALENT TYP A
OCH B
DEBENDOX Marion Merrell Limited PA0041/017/001 Tablets - DICYCLOVERINE 09/06/1983
HYDROCHLORIDE
- DOXYLAMINE
SUCCINATE
- PYRIDOXINE
HYDROCHLORIDE
METHOTREXATE Cyanamid of Great Britain PA0037/036/001 Withdrawn Form 03/06/1983
MODURET Merck Sharp and Dohme PA0035/063/001 Tablets 03/06/1983
Limited
BLOCADREN 0.25MG/ML Merck Sharp and Dohme PA0035/044/012 Withdrawn Form - TIMOLOL MALEATE 01/06/1983
Limited
IMPROMIDINE SmithKline and French PA0060/035/001 31/05/1983
Laboratories Ltd
MRS CULLENS Cullen and Davison Limited PA0184/006/001 - ACETYLSALICYLIC ACID 31/05/1983
LEMSOOTHE - CAFFEINE
- ASCORBIC ACID
CODEINE COMPOUND Mercury Pharmaceuticals PA0073/030/001 Tablets - PHENACETIN 27/05/1983
(Ireland) Ltd - ACETYLSALICYLIC ACID
- CODEINE PHOSPHATE
SPECTRALGEN POLLEN Pharmacia Biosystems PA0107/010/001 16/05/1983
ALLERGEN EXTRACT Limited
ADRENALINE 1 IN 1000 Company Liquidated M123 PA0301/017/001 Withdrawn Form - EPINEPHRINE 13/05/1983
AMINOPHYLLINE Ashford Pharmaceuticals PA0301/037/001 Withdrawn Form - AMINOPHYLLINE 13/05/1983
Limited
AMINOPHYLLINE Ashford Pharmaceuticals PA0301/037/002 Withdrawn Form - AMINOPHYLLINE 13/05/1983
Limited
AMINOPHYLLINE Ashford Pharmaceuticals PA0301/037/003 Withdrawn Form - AMINOPHYLLINE 13/05/1983
Limited
AMINOPHYLLINE Ashford Pharmaceuticals PA0301/037/004 Withdrawn Form - AMINOPHYLLINE 13/05/1983
Limited
ANATETALL Ashford Pharmaceuticals PA0301/049/001 Withdrawn Form - TETANUS TOXOID 13/05/1983
Limited
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/002 - ATROPINE SULFATE 13/05/1983
EUR. P.

Human Medicines Withdrawn Products Page 518 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/003 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/004 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/005 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/006 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/007 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/008 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/009 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
ATROPINE SULPHATE Company Liquidated M123 PA0301/011/010 Withdrawn Form - ATROPINE SULFATE 13/05/1983
EUR. P.
CALCIUM LEUCOVORIN Cyanamid of Great Britain PA0037/045/002 Withdrawn Form 13/05/1983
CHLORPROMAZINE Ashford Pharmaceuticals PA0301/033/001 Tablets - CHLORPROMAZINE 13/05/1983
Limited
CHLORPROMAZINE Ashford Pharmaceuticals PA0301/033/002 Tablets - CHLORPROMAZINE 13/05/1983
Limited
CHLORPROMAZINE Ashford Pharmaceuticals PA0301/033/003 Withdrawn Form - CHLORPROMAZINE 13/05/1983
Limited
CHLORPROMAZINE Ashford Pharmaceuticals PA0301/033/004 Withdrawn Form - CHLORPROMAZINE 13/05/1983
Limited
DEXSONE Ashford Pharmaceuticals PA0301/040/001 Withdrawn Form - DEXAMETHASONE 13/05/1983
Limited SODIUM PHOSPHATE
DIF-PER-TET-ALL Ashford Pharmaceuticals PA0301/052/001 Withdrawn Form - DIPHTHERIA AND 13/05/1983
Limited TETANUS TOXOIDS AND
PERTUSSIS
DIF-TET-ALL Ashford Pharmaceuticals PA0301/051/001 Withdrawn Form - DIPHTHERIA AND 13/05/1983
Limited TETANUS TOXOIDS
DIGOXIN Ashford Pharmaceuticals PA0301/039/001 Withdrawn Form - DIGOXIN 13/05/1983
Limited
DOLAFEN Company Liquidated M123 PA0301/010/001 Tablets - IBUPROFEN 13/05/1983
GASTRO CONRAY May & Baker Limited PA0040/057/001 13/05/1983
HOMATROPINE Company Liquidated M123 PA0301/012/001 - HOMATROPINE 13/05/1983
HYDROBROMIDE
HYPADOPA Ashford Pharmaceuticals PA0301/031/002 Tablets - METHYLDOPA 13/05/1983
Limited
HYPADOPA/METHYLDOPA Ashford Pharmaceuticals PA0301/031/003 Tablets - METHYLDOPA 13/05/1983
Limited
HYPADOPA/METHYLDOPA Ashford Pharmaceuticals PA0301/031/001 Tablets - METHYLDOPA 13/05/1983
Limited
INDOGESIC Company Liquidated M123 PA0301/009/001 Capsule - INDOMETACIN 13/05/1983
ISOPRENALINE Company Liquidated M123 PA0301/018/001 Withdrawn Form - ISOPRENALINE 13/05/1983
HYDROCHLORIDE HYDROCHLORIDE
ISOPRENALINE Company Liquidated M123 PA0301/018/002 Withdrawn Form - ISOPRENALINE 13/05/1983
HYDROCHLORIDE HYDROCHLORIDE
JECTRAN/IRON DEXTRAN Ashford Pharmaceuticals PA0301/038/006 Withdrawn Form 13/05/1983
Limited
JECTRAN-50 Ashford Pharmaceuticals PA0301/038/002 Withdrawn Form 13/05/1983
Limited
JECTRAN-50 Ashford Pharmaceuticals PA0301/038/004 Withdrawn Form 13/05/1983
Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/005 Withdrawn Form 13/05/1983
DEXTRAN Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/003 Withdrawn Form 13/05/1983
DEXTRAN Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/007 Withdrawn Form 13/05/1983
DEXTRAN Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/008 Withdrawn Form 13/05/1983
DEXTRAN Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/009 Withdrawn Form 13/05/1983
DEXTRAN Limited
JECTRAN-50/IRON Ashford Pharmaceuticals PA0301/038/001 Withdrawn Form 13/05/1983
DEXTRAN Limited
JINTAMYCIN/GENTAMICIN Ashford Pharmaceuticals PA0301/035/001 Withdrawn Form - GENTAMICIN SULFATE 13/05/1983
Limited
LINCOMYCETIN Ashford Pharmaceuticals PA0301/029/001 Withdrawn Form - LINCOMYCIN 13/05/1983
Limited
MORBILVAX MEASLES Ashford Pharmaceuticals PA0301/048/001 - IMMUNOGLOBULIN 13/05/1983
VIRUS Limited MEASLES
MORPHINE SULPHATE Company Liquidated M123 PA0301/019/001 Withdrawn Form - MORPHINE SULFATE 13/05/1983
MORPHINE SULPHATE Company Liquidated M123 PA0301/019/002 Withdrawn Form - MORPHINE SULFATE 13/05/1983

Human Medicines Withdrawn Products Page 519 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MORPHINE SULPHATE Company Liquidated M123 PA0301/019/003 Withdrawn Form - MORPHINE SULFATE 13/05/1983
MORPHINE SULPHATE Company Liquidated M123 PA0301/019/004 Withdrawn Form - MORPHINE SULFATE 13/05/1983
NALORPHINE 0.2 MG/ML Company Liquidated M123 PA0301/020/001 Withdrawn Form - NALORPHINE 13/05/1983
NALORPHINE 0.2 MG/ML Company Liquidated M123 PA0301/020/002 Withdrawn Form - NALORPHINE 13/05/1983
NALORPHINE 0.2 MG/ML Company Liquidated M123 PA0301/020/003 Withdrawn Form - NALORPHINE 13/05/1983
NALORPHINE 5 MG/ML Company Liquidated M123 PA0301/020/004 Withdrawn Form - NALORPHINE 13/05/1983
NALORPHINE 5 MG/ML Company Liquidated M123 PA0301/020/005 Withdrawn Form - NALORPHINE 13/05/1983
NALORPHINE 5 MG/ML Company Liquidated M123 PA0301/020/006 Withdrawn Form - NALORPHINE 13/05/1983
NEOCILLIN/AMPICILLIN Ashford Pharmaceuticals PA0301/036/001 Withdrawn Form - AMPICILLIN SODIUM 13/05/1983
Limited
NEOCILLIN/AMPICILLIN Ashford Pharmaceuticals PA0301/036/002 Withdrawn Form - AMPICILLIN SODIUM 13/05/1983
Limited
NEOCILLIN/AMPICILLIN Ashford Pharmaceuticals PA0301/036/003 Withdrawn Form - AMPICILLIN SODIUM 13/05/1983
Limited
NEOCILLIN/AMPICILLIN Ashford Pharmaceuticals PA0301/036/004 Withdrawn Form - AMPICILLIN SODIUM 13/05/1983
Limited
NEOCILLIN/AMPICILLIN Ashford Pharmaceuticals PA0301/036/005 Withdrawn Form - AMPICILLIN SODIUM 13/05/1983
Limited
NIKETHAMIDE Ashford Pharmaceuticals PA0301/021/001 Withdrawn Form - NIKETHAMIDE 13/05/1983
Limited
NIKETHAMIDE Ashford Pharmaceuticals PA0301/021/002 Withdrawn Form - NIKETHAMIDE 13/05/1983
Limited
NIKETHAMIDE Ashford Pharmaceuticals PA0301/021/003 Withdrawn Form - NIKETHAMIDE 13/05/1983
Limited
NIKETHAMIDE Ashford Pharmaceuticals PA0438/021/001 Withdrawn Form 13/05/1983
Limited
NITRAZEPAM Ashford Pharmaceuticals PA0301/032/001 Tablets - NITRAZEPAM 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/001 Withdrawn Form - PETHIDINE 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/002 Withdrawn Form - PETHIDINE 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/003 Withdrawn Form - PETHIDINE 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/004 Withdrawn Form - PETHIDINE 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/005 Withdrawn Form - PETHIDINE 13/05/1983
Limited
PETHIDINE Ashford Pharmaceuticals PA0301/023/006 Withdrawn Form - PETHIDINE 13/05/1983
Limited
POLIORAL POLIOMYELITIS Ashford Pharmaceuticals PA0301/043/001 - POLIOMYELITIS VACCINE 13/05/1983
Limited
PROPRANOLOL Ashford Pharmaceuticals PA0301/024/001 Withdrawn Form - PROPRANOLOL 13/05/1983
Limited
PTZ Ashford Pharmaceuticals PA0301/025/001 Withdrawn Form - PENTAZOCINE LACTATE 13/05/1983
Limited
PTZ Ashford Pharmaceuticals PA0301/025/002 Withdrawn Form - PENTAZOCINE LACTATE 13/05/1983
Limited
SCALAVOTEST PPD Ashford Pharmaceuticals PA0301/044/001 13/05/1983
Limited
STRONG STERILE Ashford Pharmaceuticals PA0301/022/001 - NOREPINEPHRINE 13/05/1983
NORADRENALINE Limited
TETANUS ANTITOXIN Ashford Pharmaceuticals PA0301/050/001 Withdrawn Form - TETANUS ANTITOXIN 13/05/1983
Limited
TRANQUIN Ashford Pharmaceuticals PA0301/042/001 Withdrawn Form 13/05/1983
Limited
TRIMEX Ashford Pharmaceuticals PA0301/047/002 Tablets 13/05/1983
Limited
TRIMEX FOR INFUSION Ashford Pharmaceuticals PA0301/047/001 Withdrawn Form 13/05/1983
Limited
DIMENHYDRINATE 50 International Medication PA0255/030/001 Withdrawn Form 12/05/1983
MG/ML Systems (UK) Ltd
NUTRIPHOS K Pharmacia Laboratories PA0187/017/001 - POTASSIUM ACETATE 12/05/1983
Limited - POTASSIUM PHOSPHATE
DIBASIC
- SORBITOL
PHYTOMENADOINE 1 International Medication PA0255/029/001 Withdrawn Form 12/05/1983
MG/0.5 ML Systems (UK) Ltd
SEOMINAL Sanofi-Synthelabo Ireland PA0077/014/001 Tablets - PHENOBARBITAL 11/05/1983
Ltd - THEOBROMINE
- RESERPINE
THEOMINAL Sanofi-Synthelabo Ireland PA0077/022/001 Tablets - PHENOBARBITAL 11/05/1983
Ltd - THEOBROMINE
MINIZIDE Pfizer Limited PA0019/027/002 Tablets - PRAZOSIN 10/05/1983
- POLYTHIAZIDE

Human Medicines Withdrawn Products Page 520 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
METHARAMINOL International Medication PA0255/012/001 06/05/1983
INJECTION 1% Systems (UK) Ltd
AMPICILLIN Sanofi-Synthelabo Ireland PA0077/037/002 Capsule 05/05/1983
Ltd
AMPICILLIN MIXTURE Sanofi-Synthelabo Ireland PA0077/037/001 05/05/1983
Ltd
ASPIRIN PHENACETIN AND Company Liquidated M123 PA0211/013/001 Tablets 05/05/1983
CODEINE
FRUSEMIDE Sanofi-Synthelabo Ireland PA0077/038/001 Tablets 05/05/1983
Ltd
IMIPRAMINE Company Liquidated M123 PA0211/007/002 Tablets 05/05/1983
IMIPRAMINE Company Liquidated M123 PA0211/007/001 Tablets 05/05/1983
HYDROCHLORIDE
MICRO-K Rona Laboratories Limited PA0087/009/001 Capsule - POTASSIUM CHLORIDE 05/05/1983
PHENOBARBITONE Company Liquidated M123 PA0211/012/004 Tablets - PHENOBARBITAL 05/05/1983
SULPHAMETHIZOLE Company Liquidated M123 PA0211/003/001 Tablets 05/05/1983
DERMACAINE Medo Pharmaceuticals PA0109/009/001 Cream - CINCHOCAINE 04/05/1983
Limited
KETHAMED Medo Pharmaceuticals PA0109/008/001 Tablets - PEMOLINE 04/05/1983
Limited
SOPALAMIN-3B Pharma-Global Limited PA0141/011/002 Withdrawn Form 04/05/1983
SOPALAMIN-3B DRAGEES Pharma-Global Limited PA0141/011/001 - CYANOCOBALAMIN 04/05/1983
- THIAMINE
HYDROCHLORIDE
TAUROFLEX Geistlich Sons Limited PA0143/007/001 - TAUROLIDINE 04/05/1983
FRANOLYN Sanofi-Synthelabo Ireland PA0077/060/001 - THEOPHYLLINE 03/05/1983
EXPECTORANT Ltd - EPHEDRINE
- GUAIFENESIN
ALDORETIC Merck Sharp and Dohme PA0035/064/001 Tablets - AMILORIDE 02/05/1983
Limited - HYDROCHLOROTHIAZIDE

ALDORETIC FORTE Merck Sharp and Dohme PA0035/064/002 Tablets - METHYLDOPA 02/05/1983
Limited - AMILORIDE
- HYDROCHLOROTHIAZIDE

MIXTURE KAOLIN Company Liquidated M123 PA0183/003/001 02/05/1983


MORPHINE B.P.C. Company Liquidated M123 PA0183/002/001 02/05/1983
ANDURSIL Ciba Geigy Plc PA0028/051/001 - ALUMINIUM HYDROXIDE 30/04/1983
GEL
- MAGNESIUM HYDROXIDE
- ALUMINIUM HYDROXIDE
- ANTIFOAM M

NEVIN T. P. Whelehan Son & Co. PA0137/048/002 Tablets - SULFAMOXOLE 29/04/1983


Limited - TRIMETHOPRIM
PRAXILENE AMPOULES Helsinn Birex PA0294/002/002 - NAFTIDROFURYL 29/04/1983
Pharmaceuticals Limited OXALATE
DOLOBID Merck Sharp and Dohme PA0035/014/001 Tablets - DIFLUNISAL 28/04/1983
Limited
DOLOBID Merck Sharp and Dohme PA0035/014/003 Tablets - DIFLUNISAL 28/04/1983
Limited
SALIMED Wilcox Jozeau (Ireland) PA0120/006/001 Tablets - SALICYLAMIDE 28/04/1983
Limited
OXYTETRACYCLINE Sanofi-Synthelabo Ireland PA0077/047/001 Tablets 25/04/1983
Ltd
EP Gillespie & Company Ltd PA0266/003/001 Tablets 22/04/1983
ENDOGRAFIN AMPS HE Clissmann PA0012/037/001 21/04/1983
PROPAX S.R. Controlled Medications PA0157/015/001 Capsule - 21/04/1983
Limited DEXTROPROPOXYPHENE
HYDROCHLORIDE
EUPNINE VERNADE Wilcox Laboratories Limited PA0233/007/001 - CAFFEINE 20/04/1983
MYCOLACTINE Wilcox Laboratories Limited PA0233/009/001 Tablets - ATROPA BELLADONNA 20/04/1983
NATIROSE DRAGEES Wilcox Laboratories Limited PA0233/003/001 - GLYCERYL TRINITRATE 20/04/1983
- ETHYLMORPHINE
OUABAINE ARNAUD Wilcox Laboratories Limited PA0233/002/002 Tablets 20/04/1983
OUABAINE ARNAUD Wilcox Laboratories Limited PA0233/002/001 20/04/1983
AMPOULES
QUINICARDINE Wilcox Laboratories Limited PA0233/005/001 Tablets - QUINIDINE SULFATE 20/04/1983
TETRACHEL SYRUP Mayne Pharma (Ireland) PA0078/003/002 - TETRACYCLINE 18/04/1983
Limited HYDROCHLORIDE
LIBROFEM Ciba Geigy Plc PA0028/052/001 Tablets - IBUPROFEN 14/04/1983
ZYDERM COLLAGEN Schering-Plough Limited PA0277/033/001 - LIDOCAINE 13/04/1983
IMPLANT
METRONIDAZOLE Berk Pharmaceuticals PA0082/040/001 Withdrawn Form 11/04/1983
Limited

Human Medicines Withdrawn Products Page 521 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BLEOMYCIN Lundbeck Limited PA0115/004/003 - BLEOMYCIN SULFATE 07/04/1983
CREMOSTREP Merck Sharp and Dohme PA0035/005/001 - 05/04/1983
(SUSPENSION) Limited SUCCINYLSULFATHIAZOL
E
- STREPTOMYCIN
SULFATE
0.18% SODIUM CHLORIDE B. Braun Medical Limited PA0179/002/009 Withdrawn Form 01/04/1983
ACTIFED COMPOUND Wellcome (Ireland) Limited PA0017/013/003 Syrup - TRIPROLIDINE 01/04/1983
LINCTUS HYDROCHLORIDE
- PSEUDOEPHEDRINE
HYDROCHLORIDE
- CODEINE PHOSPHATE
KINEBIL Ovelle Limited PA0206/010/001 Granules Effervescent - PROCAINE 01/04/1983
HYDROCHLORIDE
- SORBITOL
CEPTIPRIN Pharmacia Laboratories PA0187/007/002 Tablets 31/03/1983
Limited
DINDEVAN Duncan, Flockhard & Co. PA0065/012/001 Tablets 24/03/1983
Limited
DINDEVAN Duncan, Flockhard & Co. PA0065/012/003 Tablets 24/03/1983
Limited
MEVILIN-L Duncan, Flockhard & Co. PA0065/009/001 24/03/1983
Limited
SULPHAMAGNA John Wyeth & Brother PA0022/011/001 - STREPTOMYCIN 21/03/1983
(SUSPENSION) Limited - SULFADIAZINE
-
PHTHALYLSULFATHIAZOL
E
ARGOTONE NASAL DROP Rona Laboratories Limited PA0087/011/001 - EPHEDRINE 18/03/1983
- MILD SILVER PROTEIN
- SODIUM CHLORIDE
ARGOTONE SPRAY Rona Laboratories Limited PA0087/011/002 - EPHEDRINE 18/03/1983
- MILD SILVER PROTEIN
- SODIUM CHLORIDE
B-G-PHOS ELIXIR Merck Sharp and Dohme PA0035/061/001 - GLYCEROPHOSPHATE 17/03/1983
Limited SODIUM
CUPRIMINE Merck Sharp and Dohme PA0035/011/002 Capsule - PENICILLAMINE 17/03/1983
Limited
INVERSINE Merck Sharp and Dohme PA0035/052/001 Tablets 17/03/1983
Limited
INVERSINE Merck Sharp and Dohme PA0035/052/002 Tablets 17/03/1983
Limited
PROCAINE PENICILLIN Hoechst Ireland Limited PA0023/032/002 16/03/1983
(SUSPENSION)
PROCAINE PENICILLIN - 3 Hoechst Irl Ltd. PA0023/032/001 16/03/1983
MEGA SUSP.
BELLERGAL Novartis Pharmaceuticals UK PA0013/007/001 Tablets - BELLADONNA 15/03/1983
Ltd ALKALOIDS
- ERGOTAMINE TARTRATE
- PHENOBARBITAL

DEPRONAL S.A. Warner Lambert PA0039/009/001 15/03/1983


MESONTOIN Novartis Pharmaceuticals UK PA0013/022/001 Tablets - MEPHENYTOIN 15/03/1983
Ltd
CLARADIN Nicholas Laboratories PA0032/009/001 - ACETYLSALICYLIC ACID 11/03/1983
BRUFEN (SUSPENSION) The Boots Company Plc PA0004/003/002 - IBUPROFEN 09/03/1983
SYNALAR FORTE Zeneca Limited PA0051/016/001 Cream - FLUOCINOLONE 08/03/1983
ACETONIDE
SYNALAR N Zeneca Limited PA0051/017/005 Ointment - FLUOCINOLONE 08/03/1983
ACETONIDE
- NEOMYCIN
SYNANDON Zeneca Limited PA0051/019/001 Cream - FLUOCINOLONE 08/03/1983
ACETONIDE
SYNANDONE Zeneca Limited PA0051/019/002 Ointment - FLUOCINOLONE 08/03/1983
ACETONIDE
ACTHAR Aventis Behring Limited PA0010/009/001 - CORTICOTROPHIN 01/03/1983
ACTHAR Aventis Behring Limited PA0010/009/002 - CORTICOTROPHIN 01/03/1983
BRINALDIX Novartis Pharmaceuticals UK PA0013/011/001 Tablets - CLOPAMIDE 01/03/1983
Ltd
FAMEL LINCTUS Optrex Limited PA0275/003/001 - PHOLCODINE 22/02/1983
- PAPAVERINE
HYDROCHLORIDE
CODELCORTONE Merck Sharp and Dohme PA0035/018/001 - PREDNISOLONE 15/02/1983
Limited
DECADRON Merck Sharp and Dohme PA0035/016/002 Tablets - DEXAMETHASONE 15/02/1983
Limited

Human Medicines Withdrawn Products Page 522 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DELTACORTONE Merck Sharp and Dohme PA0035/020/001 Tablets - PREDNISONE 15/02/1983
Limited
MERUVAX (MULTIDOSE) Merck Sharp and Dohme PA0035/037/002 - RUBELLA VIRUS 15/02/1983
Limited VACCINE LIVE
ATTENUATED
MERUVAX (SINGLE DOSE) Merck Sharp and Dohme PA0035/037/001 - RUBELLA VIRUS 15/02/1983
Limited VACCINE LIVE
ATTENUATED
NERFACTOR Beaufour Schwabe PA0353/001/001 Capsule - ISAXONINE 15/02/1983
THEO-DUR Astra Pharmaceuticals Ltd PA0009/023/001 - THEOPHYLLINE 14/02/1983
THEO-DUR Astra Pharmaceuticals Ltd PA0009/023/002 - THEOPHYLLINE 14/02/1983
DECODERM E. Merck Ltd PA0054/010/004 Cream - FLUPREDNIDENE 11/02/1983
ACETATE
DECODERM E. Merck Ltd PA0054/010/005 Ointment - FLUPREDNIDENE 08/02/1983
ACETATE
DECODERM E. Merck Ltd PA0054/010/002 Ointment - FLUPREDNIDENE 08/02/1983
ACETATE
DECODERM LOTION E. Merck Ltd PA0054/010/003 - FLUPREDNIDENE 08/02/1983
ACETATE
DEXA-SCHEROSON AMPS HE Clissmann PA0012/006/001 - DEXAMETHASONE 08/02/1983

MINOVLAR ED HE Clissmann PA0012/014/001 Tablets 08/02/1983


NEOGYNON ED HE Clissmann PA0012/016/001 Tablets - ETHINYLESTRADIOL 08/02/1983
ANADIN ANALGESIC Pfizer Consumer Healthcare PA0172/004/001 Tablets - ACETYLSALICYLIC ACID 07/02/1983
Ltd
DRISTAN DECONGESTANT Pfizer Consumer Healthcare PA0172/005/001 Tablets - CAFFEINE 07/02/1983
Ltd - ACETYLSALICYLIC ACID
- PHENYLEPHRINE
- PHENINDAMINE
POWERIN ANALGESIC Pfizer Consumer Healthcare PA0172/006/001 Tablets - ACETYLSALICYLIC ACID 07/02/1983
Ltd - PARACETAMOL
- SALICYLAMIDE
- CAFFEINE
DAPTA Wyeth (Ireland) Ltd PA0332/001/001 04/02/1983
DAPTA 12 ORAL Wyeth (Ireland) Ltd PA0322/001/001 - MULTIVITAMINS 04/02/1983
MEADOW CROFT Kelkin Naturproducts Ltd PA0305/005/001 Tablets 03/02/1983
EXECUTIVE B COMPLEX
PLUS VITAMIN C
MEADOW CROFT Kelkin Naturproducts Ltd PA0305/006/001 Tablets 03/02/1983
EXECUTIVE B COMPLEX
PLUS VITAMIN E
MEADOW CROFT Kelkin Naturproducts Ltd PA0305/007/001 Tablets 03/02/1983
EXECUTIVE B PLUS
GINSENG
DIARITE Berk Pharmaceuticals PA0082/038/001 - SODIUM CHLORIDE 01/02/1983
Limited - GLUCOSE
MONOHYDRATE
- POTASSIUM CHLORIDE
- SODIUM BICARBONATE
MERASYN Marion Merrell Limited PA0041/004/002 Tablets - ALUMINIUM HYDROXIDE 18/01/1983
GEL, DRIED
- MAGNESIUM HYDROXIDE

ACNAID Cupal Limited PA0258/018/001 13/01/1983


ACNAID Cupal Limited PA0258/018/002 Cream 13/01/1983
AGIOLAX May & Baker Limited PA0040/045/001 13/01/1983
ABBOKINASE Abbott Laboratories Ireland PA0038/017/001 Withdrawn Form 12/01/1983
Ltd
HEPATIC PHARMATON United Pharmacists CoOp PA0337/003/001 Capsule - VITAMINS NOS 10/01/1983
Ltd
DEXTRAVEN 110 IN Fisons Limited PA0018/020/002 - DEXTRAN 07/01/1983
DEXTROSE
DEXTRAVEN 110 IN Fisons Limited PA0018/020/001 - DEXTRAN 07/01/1983
SALINE
DEXTRAVEN 150 IN Fisons Limited PA0018/021/002 - DEXTRAN 07/01/1983
DEXTROSE
DEXTRAVEN 150 IN Fisons Limited PA0018/021/001 - DEXTRAN 07/01/1983
SALINE
GRIPPON Pinewood Laboratories Ltd, PA0281/014/001 Capsule - PARACETAMOL 07/01/1983
- CHLORPHENAMINE
MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
- ASCORBIC ACID
- CAFFEINE
PEPTICHEMIO Napp Laboratories Limited PA0114/024/001 07/01/1983

Human Medicines Withdrawn Products Page 523 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SASTID BAR Stiefel Laboratories (U.K.) PA0144/006/001 - SALICYLIC ACID 07/01/1983
Ltd. - SULFUR
TRIMOPAN Berk Pharmaceuticals PA0082/034/001 Tablets - TRIMETHOPRIM 07/01/1983
Limited
HEPARIN INJECTION International Medication PA0255/020/002 06/01/1983
Systems (UK) Ltd
HEPARIN INJECTION International Medication PA0255/020/003 06/01/1983
Systems (UK) Ltd
HEPARIN INJECTION 10 IU International Medication PA0255/020/001 06/01/1983
Systems (UK) Ltd
HEPARIN INJECTION 500 International Medication PA0255/020/004 06/01/1983
IU/ML Systems (UK) Ltd
KENACORT A.I.V. Bristol-Myers Squibb PA0002/021/007 - TRIAMCINOLONE 06/01/1983
Pharmaceuticals uc ACETONIDE DIPOTASSIUM
PHOSPHATE

LYCAMED UCB S.A. PA0230/001/001 21/12/1982


LYCAMED Ferring A/S PA0230/001/002 21/12/1982
LYCAMED UCB S.A. PA0230/001/003 Granules Effervescent 21/12/1982
ATCIL Athlone Laboratories Ltd PA0298/001/003 Syrup - AMPICILLIN 20/12/1982
ATCIL Athlone Laboratories Ltd PA0298/001/004 Syrup 20/12/1982
CIPROL Sanofi-Synthelabo Ireland PA0077/059/001 Capsule - CIPROFIBRATE 20/12/1982
Ltd
CIPROL Sanofi-Synthelabo Ireland PA0077/059/002 Capsule - CIPROFIBRATE 20/12/1982
Ltd
GONNE PAIN RELIEVING Kelkin Naturproducts Ltd PA0305/001/001 Ointment - MENTHOL 20/12/1982
BALM - CAMPHOR
- MELALEUCA
LEUCADENDRON
- TURPENTINE OIL
- MUSTARD OIL
- METHYL SALICYLATE
LETHIDRONE (NEONATAL) Wellcome (Ireland) Limited PA0017/018/002 - NALORPHINE 20/12/1982
INJ
LETHIDRONE INJECTION Wellcome (Ireland) Limited PA0017/018/001 - NALORPHINE 20/12/1982
RENSAR Procter & Gamble PA0170/012/001 Withdrawn Form - SARALASIN 20/12/1982
Pharmaceuticals UK Limited
SURE SHIELD DYSPEPSIA Rumon (Ireland) Limited PA0156/002/001 Tablets - PEPSIN 20/12/1982
- HEAVY MAGNESIUM
CARBONATE
- SODIUM BICARBONATE
- CALCIUM CARBONATE
- PANCREATIN
- ETHER, SOLVENT
HYPNOMIDATE PRO- Janssen Pharmaceutica PA0045/024/003 10/12/1982
INFUSION
SPOROSTACIN Cilag Limited PA0059/013/001 Cream - CLODANTOIN 10/12/1982
- BENZALKONIUM
CHLORIDE
PRO-BANTHINE WITH G.D. Searle & Company PA0001/009/001 Tablets - PROPANTHELINE 09/12/1982
PHENOBARBITONE Limited BROMIDE
- PHENOBARBITAL
ALORBAT-S E. Merck Ltd PA0054/026/004 03/12/1982
ALORBAT-S E. Merck Ltd PA0054/026/006 03/12/1982
ALORBAT-S E. Merck Ltd PA0054/026/007 03/12/1982
ALORBAT-S - DISPOSABLE E. Merck Ltd PA0054/026/005 03/12/1982
SYRINGE
CEPORACIN Glaxo Laboratories Limited PA0044/004/001 - CEFALOTIN SODIUM 03/12/1982
EX LAW CHOCOLATE Ex-Lax Limited PA0103/002/001 - PHENOLPHTHALEIN 03/12/1982
LAXATIVE
EX LAX Ex-Lax Limited PA0103/001/001 - PHENOLPHTHALEIN 03/12/1982
EX-LAX JUNIOR LAXATIVE Ex-Lax Limited PA0103/003/001 - PHENOLPHTHALEIN 03/12/1982

MIPRALINE Warner Lambert PA0039/031/001 Capsule 03/12/1982


LUSTYS PASSIFLORA Kelkin Naturproducts Ltd PA0305/003/001 Tablets 02/12/1982
ENTERO-SEDIV T. P. Whelehan Son & Co. PA0137/014/002 24/11/1982
Limited
PREVECILLIN PLUS T. P. Whelehan Son & Co. PA0137/016/001 24/11/1982
Limited
PREVETHENAT INFANT T. P. Whelehan Son & Co. PA0137/017/001 24/11/1982
Limited
PREVETHENAT NORMAL T. P. Whelehan Son & Co. PA0137/017/002 24/11/1982
Limited
PREVETHENAT ULTRA T. P. Whelehan Son & Co. PA0137/017/003 24/11/1982
Limited
PIPTALIAN ELIXIR Boehringer Mannheim PA0130/005/002 12/11/1982

Human Medicines Withdrawn Products Page 524 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROTAMINE ZINC INSULIN Glaxo Laboratories Limited PA0044/055/001 11/11/1982
BP
AMINESS Pharmacia Laboratories PA0187/008/002 - AMINO ACIDS 10/11/1982
Limited
NITRADISC PADS G.D. Searle & Company PA0001/019/001 - GLYCERYL TRINITRATE 05/11/1982
Limited
NITRADISC PADS G.D. Searle & Company PA0001/019/002 - GLYCERYL TRINITRATE 05/11/1982
Limited
URACIL MUSTARD Pharmacia Limited PA0016/029/001 Capsule 28/10/1982
ULTANDREN Ciba Geigy Plc PA0028/036/001 Tablets - FLUOXYMESTERONE 15/10/1982
MYCETIN OPHTIOLE Pharma-Global Limited PA0141/003/001 - CHLORAMPHENICOL 08/10/1982
OPREN Eli Lilly and Company Limite PA0047/051/004 Suppositories - BENOXAPROFEN 08/10/1982

PREDNI OPHTIOLE Pharma-Global Limited PA0141/004/001 - PREDNISOLONE 08/10/1982


- CHLORAMPHENICOL
ENTERFRAM Fisons Limited PA0018/006/001 - FRAMYCETIN 30/09/1982
PREDNISONE Company Liquidated M123 PA0211/004/001 Tablets 30/09/1982
PREDNISONE Company Liquidated M123 PA0211/004/002 Tablets 30/09/1982
CLONT Bayer PLC PA0021/015/002 - METRONIDAZOLE 27/09/1982
CLONT INFUSION Bayer PLC PA0021/015/001 - METRONIDAZOLE 27/09/1982
ANTIPRESSAN Berk Pharmaceuticals PA0082/031/002 Tablets - METHYLDOPA 26/09/1982
Limited
WATER FOR INJECTION Bayer PLC PA0021/013/008 - WATER FOR INJECTIONS 23/09/1982

DESTOLIT Marion Merrell Limited PA0041/035/001 Tablets - URSODEOXYCHOLIC 20/09/1982


ACID
DESTOLIT Marion Merrell Limited PA0041/035/002 Tablets - URSODEOXYCHOLIC 20/09/1982
ACID
TENUATE Marion Merrell Limited PA0041/027/001 Tablets - AMFEPRAMONE 20/09/1982
HYDROCHLORIDE
MRS. CULLENS SLEEP- Cullen and Davison Limited PA0184/003/001 - PROMETHAZINE 19/09/1982
EZEE HYDROCHLORIDE
INSOMIN Orion Pharma A/s PA0303/003/001 Tablets - NITRAZEPAM 16/09/1982
BUFFERIN Bristol-Myers Squibb PA0048/021/001 08/09/1982
(Holdings) Limited
HIPREX Carnegie Medical (3M) PA0357/009/002 Tablets - METHENAMINE 08/09/1982
Incorp. HIPPURATE
ALUDROX S A John Wyeth & Brother PA0022/002/001 - SECBUTABARBITAL 03/09/1982
(SUSPENSION) Limited
BETNOVATE Glaxo Laboratories Limited PA0044/021/003 - BETAMETHASONE 02/09/1982
VALERATE
OPREN Eli Lilly and Company Limite PA0047/051/005 Suppositories - BENOXAPROFEN 25/08/1982

OPREN Eli Lilly and Company Limite PA0047/051/006 Tablets - BENOXAPROFEN 25/08/1982

TERRAMYCIN Pfizer Limited PA0019/009/004 Ointment - OXYTETRACYCLINE 23/08/1982


AMOXICILLIN Ashford Pharmaceuticals PA0301/054/001 Capsule - AMOXICILLIN 19/08/1982
Limited
AMOXICILLIN Ashford Pharmaceuticals PA0301/054/002 Capsule - AMOXICILLIN 19/08/1982
Limited
AMOXICILLIN Ashford Pharmaceuticals PA0301/054/003 - AMOXICILLIN 19/08/1982
(SUSPENSION) Limited
BENYLETS CHERRY Parke Davis & Company PA0056/019/002 Lozenges - DIPHENHYDRAMINE 19/08/1982
FLAVOURED
NO-NICOT P.D.S. (Nocofin) Ltd PA0260/001/001 19/08/1982
MINIZIDE Pfizer Limited PA0019/027/001 Tablets - PRAZOSIN 18/08/1982
- POLYTHIAZIDE
CARBRITAL Parke Davis & Company PA0056/013/001 Capsule - PENTOBARBITAL 13/08/1982
SODIUM
NEVIN SYRUP T. P. Whelehan Son & Co. PA0137/048/001 Syrup - SULFAMOXOLE 10/08/1982
Limited - TRIMETHOPRIM
SULBENIL Yamanouchi Pharma Ltd PA0062/017/001 04/08/1982
SULBENIL Yamanouchi Pharma Ltd PA0062/017/002 04/08/1982
SULBENIL Yamanouchi Pharma Ltd PA0062/017/003 04/08/1982
FLOGAR Aventis Behring Limited PA0010/021/001 Tablets - OXAMETACIN 03/08/1982
FLOGAR Aventis Behring Limited PA0010/021/002 Capsule - OXAMETACIN 03/08/1982
FUROXONE Procter & Gamble PA0170/008/002 Tablets - FURAZOLIDONE 28/07/1982
Pharmaceuticals UK Limited
FUROXONE Procter & Gamble PA0170/008/001 - FURAZOLIDONE 28/07/1982
(SUSPENSION) Pharmaceuticals UK Limited
ISONIAZID Accord-UK Ltd PA0176/006/001 Tablets - ISONIAZID 27/07/1982
STUGERON Janssen Pharmaceutica PA0045/020/002 - CINNARIZINE 26/07/1982
METOPROLOL TARTRATE Geigy Pharmaceuticals PA0011/033/001 Tablets - METOPROLOL TARTRATE 20/07/1982
+ CHLORTHALIDONE - CHLORTALIDONE

Human Medicines Withdrawn Products Page 525 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PHOLCOLIX Parke Davis & Company PA0056/033/001 Syrup 20/07/1982
BROCADOPA TEM Yamanouchi Pharma Ltd PA0062/011/005 Tablets 19/07/1982
KEFLIN Eli Lilly and Company Limite PA0047/015/002 - CEFALOTIN 19/07/1982

BELLERGAL RETARD Novartis Pharmaceuticals UK PA0013/008/001 Tablets - BELLADONNA 14/07/1982


Ltd ALKALOIDS
- ERGOTAMINE TARTRATE
- PHENOBARBITAL

LOMOTIL WITH NEOMYCIN G.D. Searle & Company PA0001/005/002 Tablets - DIPHENOXYLATE 06/07/1982
Limited - NEOMYCIN
- ATROPINE
LOMOTIL WITH NEOMYCIN G.D. Searle & Company PA0001/005/003 - DIPHENOXYLATE 06/07/1982
Limited HYDROCHLORIDE
- ATROPINE SULFATE
- NEOMYCIN SULFATE
CHLOROPTIC T. P. Whelehan Son & Co. PA0137/020/001 28/06/1982
OPHTHALMIC Limited
FENTAZIN Glaxo Laboratories Limited PA0044/012/002 Syrup - PERPHENAZINE 22/06/1982
KERFOOT NITRAZEPAM Thomas Kerfoot & Co. Ltd PA0315/004/001 Tablets - NITRAZEPAM 17/06/1982
CVK 250 Abbott Laboratories Ireland PA0038/001/001 Tablets 03/06/1982
Ltd
SUMYCIN Bristol-Myers Squibb PA0002/013/002 Syrup 26/05/1982
Pharmaceuticals uc
MYDFRIN STERILE Alcon Laboratories (UK) Ltd PA0290/038/002 23/05/1982
OPTHALMIC
AMITRIPTYLINE Thomas Kerfoot & Co. Ltd PA0315/001/001 Tablets - AMITRIPTYLINE 19/05/1982
DIAZEPAM Thomas Kerfoot & Co. Ltd PA0315/002/001 Tablets - DIAZEPAM 19/05/1982
DIAZEPAM Thomas Kerfoot & Co. Ltd PA0315/002/002 - DIAZEPAM 19/05/1982
DIAZEPAM Thomas Kerfoot & Co. Ltd PA0315/002/003 Tablets - DIAZEPAM 19/05/1982
KERFOOT AMITRIPTYLINE Thomas Kerfoot & Co. Ltd PA0315/001/002 Tablets 19/05/1982

KERFOOT AMITRIPTYLINE Thomas Kerfoot & Co. Ltd PA0315/001/003 Tablets 19/05/1982

KERFOOT AMPICILLIN Thomas Kerfoot & Co. Ltd PA0315/005/001 Capsule - AMPICILLIN 19/05/1982
KERFOOT AMPICILLIN Thomas Kerfoot & Co. Ltd PA0315/005/002 Capsule - AMPICILLIN 19/05/1982
KERFOOT AMPICILLIN Thomas Kerfoot & Co. Ltd PA0315/005/003 Syrup - AMPICILLIN 19/05/1982
KERFOOT AMPICILLIN Thomas Kerfoot & Co. Ltd PA0315/005/004 Syrup - AMPICILLIN 19/05/1982
ATROPINE SULPHATE International Medication PA0255/006/001 Withdrawn Form 18/05/1982
Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/009 Withdrawn Form 18/05/1982
HYDROCHLORIDE Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/004 18/05/1982
HYDROCHLORIDE 1% Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/006 Withdrawn Form 18/05/1982
HYDROCHLORIDE 2% Systems (UK) Ltd
LIGNOCAINE International Medication PA0255/004/010 Withdrawn Form 18/05/1982
HYDROCHLORIDE 4% Systems (UK) Ltd
SODIUM BICARBONATE International Medication PA0255/001/001 18/05/1982
INJ 4.2% Systems (UK) Ltd
SODIUM BICARBONATE International Medication PA0255/001/003 18/05/1982
INJ 7.5% Systems (UK) Ltd
STRONG POTASSIUM International Medication PA0255/005/001 Withdrawn Form 18/05/1982
CHLORIDE 15% Systems (UK) Ltd
STRONG POTASSIUM International Medication PA0255/005/002 Withdrawn Form 18/05/1982
CHLORIDE 15% Systems (UK) Ltd
BINOTAL Bayer PLC PA0021/012/001 - AMPICILLIN SODIUM 13/05/1982
BINOTAL Bayer PLC PA0021/012/002 - AMPICILLIN SODIUM 13/05/1982
PENIDURAL A P John Wyeth & Brother PA0022/007/001 Withdrawn Form - BENZATHINE 30/04/1982
Limited BENZYLPENICILLIN
- PROCAINE PENICILLIN G
- BENZYLPENICILLIN

SOTINE Fisons Limited PA0018/024/001 Tablets - TIARAMIDE 30/04/1982


SOTINE Fisons Limited PA0018/024/002 Tablets - TIARAMIDE 30/04/1982
MECLAN Cilag Limited PA0059/022/001 Cream - MECLOCYCLINE 28/04/1982
SULFOSALICYLATE
ERYTHROCIN I.M. Abbott Laboratories Ireland PA0038/002/001 21/04/1982
Ltd
MICRALAX MICRO ENEMA SmithKline and French PA0060/039/001 07/04/1982
Laboratories Ltd
NEURO PHOSPHATES SmithKline and French PA0060/040/001 07/04/1982
Laboratories Ltd
ENTERO-VIOFORM Ciba Geigy Plc PA0028/013/001 Tablets - CLIOQUINOL 01/04/1982

Human Medicines Withdrawn Products Page 526 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ICIPEN Zeneca Limited PA0051/010/001 Syrup - 01/04/1982
PHENOXYMETHYLPENICI
LLIN
ICIPEN Zeneca Limited PA0051/010/002 Tablets - 01/04/1982
PHENOXYMETHYLPENICI
LLIN
KIRON HE Clissmann PA0012/003/001 - SULFAMETOXYDIAZINE 01/04/1982
F S S (SUSPENSION) Leo Laboratories Limited PA0046/011/001 - FRAMYCETIN 31/03/1982
- STREPTOMYCIN
- SULFAGUANIDINE
LEOCYCLINE Leo Laboratories Limited PA0046/008/001 Capsule - OXYTETRACYCLINE 31/03/1982
LEOCYCLINE 333 Leo Laboratories Limited PA0046/008/002 Capsule - OXYTETRACYCLINE 31/03/1982
CEPORIN Glaxo Laboratories Limited PA0044/008/001 - CEFALORIDINE 30/03/1982
CEPORIN (A-FORM) Glaxo Laboratories Limited PA0044/008/003 - CEFALORIDINE 30/03/1982
CLINIMYCIN Glaxo Laboratories Limited PA0044/019/002 Tablets - OXYTETRACYCLINE 30/03/1982
CLINIMYCIN SYRUP Glaxo Laboratories Limited PA0044/019/003 - OXYTETRACYCLINE 30/03/1982
CRYSTAMYCIN Glaxo Laboratories Limited PA0044/016/001 Withdrawn Form - BENZYLPENICILLIN 30/03/1982
- STREPTOMYCIN
NAVANE Pfizer Limited PA0019/004/001 Tablets - THIOTHIXENE 30/03/1982
NEOMIN Glaxo Laboratories Limited PA0044/011/001 Tablets - NEOMYCIN 30/03/1982
RONDOMYCIN Pfizer Limited PA0019/005/002 Syrup - METACYCLINE 30/03/1982
TERRAMYCIN Pfizer Limited PA0019/009/003 Withdrawn Form - OXYTETRACYCLINE 30/03/1982
INTRAVENOUS
TRIPLOPEN Glaxo Laboratories Limited PA0044/013/001 - BENETHAMINE 30/03/1982
PENICILLIN
- PROCAINE
BERKMYCEN Berk Pharmaceuticals PA0082/007/001 Syrup - OXYTETRACYCLINE 29/03/1982
Limited
CHLORAMPHENICOL Forest Laboratories UK Ltd PA0100/003/001 Ointment - CHLORAMPHENICOL 29/03/1982
OPULETS
CHLORAMPHENICOL Forest Laboratories UK Ltd PA0100/003/002 - CHLORAMPHENICOL 29/03/1982
OPULETS
CITANEST 4% TOPICAL Astra Pharmaceuticals Ltd PA0009/021/006 - PRILOCAINE 29/03/1982
SOLUTION
SULPHACETAMIDE Forest Laboratories UK Ltd PA0100/004/002 - SULFACETAMIDE 29/03/1982
OPULETS SODIUM
AMESEC Eli Lilly and Company Limite PA0047/010/001 - AMOBARBITAL 26/03/1982
- EPHEDRINE
HYDROCHLORIDE
- AMINOPHYLLINE
ATASORB-N Eli Lilly and Company Limite PA0047/016/001 - CAPREOMYCIN 26/03/1982
(SUSPENSION)
CYCLOSERINE Eli Lilly and Company Limite PA0047/018/001 Capsule 26/03/1982

CYCLOSERINE Eli Lilly and Company Limite PA0047/018/002 Capsule 26/03/1982

MONOTHEAMIN & AMYTAL Eli Lilly and Company Limite PA0047/013/001 Capsule - AMOBARBITAL 26/03/1982

V CIL-K SULPHA Eli Lilly and Company Limite PA0047/019/001 Tablets - 26/03/1982
PHENOXYMETHYLPENICI
LLIN
- SULFADIMIDINE
V-CIL-K Eli Lilly and Company Limite PA0047/022/001 Capsule - 26/03/1982
PHENOXYMETHYLPENICI
LLIN
IVAX (SUSPENSION) The Boots Company Plc PA0004/006/001 - NEOMYCIN 24/03/1982
- KAOLIN
STELAZINE SmithKline and French PA0060/016/009 24/03/1982
Laboratories Ltd
STELAZINE SmithKline and French PA0060/016/010 24/03/1982
Laboratories Ltd
CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/008 Withdrawn Form - GENTAMICIN 19/03/1982

CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/009 Withdrawn Form - GENTAMICIN 19/03/1982

RYTHMODAN Roussel Laboratories Limited PA0006/005/002 Withdrawn Form - DISOPYRAMIDE 19/03/1982

SONERGAN May & Baker Limited PA0040/024/001 Tablets 18/03/1982


THEOGARDENAL May & Baker Limited PA0040/028/001 Tablets 18/03/1982
GENTICIN Nicholas Laboratories PA0032/004/005 - GENTAMICIN 16/03/1982
NOVODERM HE Clissmann PA0012/042/001 Ointment - FLUOCORTIN BUTYL 11/03/1982
NOVODERM FATTY HE Clissmann PA0012/042/002 Ointment - FLUOCORTIN BUTYL 11/03/1982
SEQUILAR HE Clissmann PA0012/001/002 11/03/1982
ACHROMYCIN Cyanamid of Great Britain PA0037/025/001 Capsule 10/03/1982
ACHROMYCIN Cyanamid of Great Britain PA0037/010/003 Withdrawn Form 10/03/1982

Human Medicines Withdrawn Products Page 527 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ACHROMYCIN Cyanamid of Great Britain PA0037/010/009 Capsule 10/03/1982
ALORBAT Mercury Pharmaceuticals PA0073/003/004 10/03/1982
(Ireland) Ltd
LEDERMYCIN Cyanamid of Great Britain PA0037/013/001 Capsule 10/03/1982
LOXAPAC Cyanamid of Great Britain PA0037/004/009 Capsule - LOXAPINE SUCCINATE 10/03/1982
TRANQUO-ADAMON E. Merck Ltd PA0054/032/001 Tablets - CICLONIUM BROMIDE 10/03/1982
- MEPROBAMATE
CHLOROMYCETIN Parke Davis & Company PA0056/015/002 Cream - CHLORAMPHENICOL 08/03/1982
CHLOROMYCETIN Parke Davis & Company PA0056/002/002 - CHLORAMPHENICOL 08/03/1982
CHYMACORT Aventis Behring Limited PA0010/008/001 Ointment - HYDROCORTISONE 04/03/1982
ACETATE
- NEOMYCIN PALMITATE
CHYMACORT Aventis Behring Limited PA0010/008/002 Ointment - NEOMYCIN 04/03/1982
- CHYMOTRYPSIN
AMYLOZINE SPANSULE SmithKline and French PA0060/010/001 Capsule 03/03/1982
Laboratories Ltd
DEVRYL SmithKline and French PA0060/005/001 03/03/1982
Laboratories Ltd
DEVRYL SmithKline and French PA0060/005/002 03/03/1982
Laboratories Ltd
DEVRYL SmithKline and French PA0060/005/003 03/03/1982
Laboratories Ltd
STELABID ELIXIR SmithKline and French PA0060/014/002 03/03/1982
Laboratories Ltd
SULFEX NASAL DROPS SmithKline and French PA0060/008/001 03/03/1982
Laboratories Ltd
PRODOXOL Warner Lambert PA0039/001/002 Tablets 01/03/1982
ERYTHROPED 200 MG/5 Abbott Laboratories Ireland PA0038/003/002 Granules Effervescent 25/02/1982
ML Ltd
NEMBU-DONNA Abbott Laboratories Ireland PA0038/006/001 25/02/1982
Ltd
NEMBUTAL Abbott Laboratories Ireland PA0038/005/001 Capsule 25/02/1982
Ltd
NEMBUTAL SODIUM Abbott Laboratories Ireland PA0038/011/001 25/02/1982
Ltd
PENTOTHAL Abbott Laboratories Ireland PA0038/007/001 25/02/1982
Ltd
PENTOTHAL Abbott Laboratories Ireland PA0038/007/002 25/02/1982
Ltd
PENTOTHAL Abbott Laboratories Ireland PA0038/007/003 25/02/1982
Ltd
PENTOTHAL Abbott Laboratories Ireland PA0038/007/004 25/02/1982
Ltd
DONNATAL A.H. Robins Company PA0086/006/001 Tablets - PHENOBARBITAL 24/02/1982
Limited - HYOSCYAMINE
- ATROPINE
- HYOSCINE
DONNATAL ELIXIR A.H. Robins Company PA0086/006/003 - PHENOBARBITAL 24/02/1982
Limited - HYOSCYAMINE
- ATROPINE
- HYOSCINE
HYDROBROMIDE
DONNATAL LA A.H. Robins Company PA0086/006/002 Tablets - PHENOBARBITAL 24/02/1982
Limited - HYOSCYAMINE
- ATROPINE
- HYOSCINE
HYDROBROMIDE
ERYTHROPED 200 MG/5 Abbott Laboratories Ireland PA0038/003/001 Granules Effervescent 24/02/1982
ML Ltd
TETRAZETS Merck Sharp and Dohme PA0035/010/001 Lozenges - BACITRACIN ZINC 23/02/1982
Limited - TYROTHRICIN
- NEOMYCIN
- BENZOCAINE
MINICORT Syntex Pharmaceuticals PA0033/003/001 - HYDROCORTISONE 22/02/1982
Limited
MINICORT-C Syntex Pharmaceuticals PA0033/004/001 - HYDROCORTISONE 22/02/1982
Limited - CLIOQUINOL
DIATENS G.D. Searle & Company PA0001/016/001 Tablets - SPIRONOLACTONE 19/02/1982
Limited
VICKS EXPECTORANT Procter & Gamble (Health & PA0441/007/001 Syrup - AMMONIUM CHLORIDE 04/02/1982
Beauty Care) Limited
GANTANOL Roche Products Limited PA0050/010/001 Tablets - SULFAMETHOXAZOLE 01/02/1982
GANTRISIN Roche Products Limited PA0050/009/003 - SULFAFURAZOLE 01/02/1982
PHENYLBUTAZONE Mercury Pharmaceuticals PA0073/050/001 Tablets 22/01/1982
(Ireland) Ltd

Human Medicines Withdrawn Products Page 528 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ANAPAX 3M Health Care Limited PA0057/003/002 Tablets - PARACETAMOL 19/01/1982
- CAFFEINE
- PHENYLEPHRINE
- ASCORBIC ACID
ANAPAX ADULTS COUGH 3M Health Care Limited PA0057/003/003 - EPHEDRINE 19/01/1982
HYDROCHLORIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE
HYDROCHLORIDE
- IPECACUANHA FLUID
EXTRACT
ANAPAX CHILDRENS 3M Health Care Limited PA0057/003/004 - DEXTROMETHORPHAN 19/01/1982
COUGH - EPHEDRINE
HYDROCHLORIDE
- PHENYLEPHRINE
HYDROCHLORIDE
- IPECACUANHA FLUID
EXTRACT
FERRUM HAUSMANN I.V. Hausmann Laboratories Inc. PA0241/002/005 13/01/1982
INAPASADE Chauvin Pharmaceuticals PA0118/004/001 12/01/1982
Limited
INAPASADE PAEDIATRIC Chauvin Pharmaceuticals PA0118/004/002 12/01/1982
Limited
INAPASADE SQ Chauvin Pharmaceuticals PA0118/005/001 12/01/1982
Limited
SECADREX 25 May & Baker Limited PA0040/069/002 Tablets 23/12/1981
WATER B.P. The Boots Company Plc PA0004/028/001 Withdrawn Form - WATER FOR INJECTIONS 16/12/1981

WATER B.P. The Boots Company Plc PA0004/028/002 Withdrawn Form - WATER FOR INJECTIONS 16/12/1981

INDOMETHACIN Clonmel Healthcare Ltd PA0126/014/002 Capsule 11/12/1981


CEFOBID Pfizer Limited PA0019/032/004 - CEFOPERAZONE 09/12/1981
SODIUM
TRUXAL Lundbeck Limited PA0115/009/006 Withdrawn Form - CHLORPROTHIXENE 02/12/1981
HYDROCHLORIDE
TRUXAL Lundbeck Limited PA0115/009/007 Withdrawn Form - CHLORPROTHIXENE 02/12/1981
HYDROCHLORIDE
ARMODIAR WITH Aventis Behring Limited PA0010/004/001 - ALUMINIUM HYDROXIDE 24/11/1981
NEOMYCIN - SORBITOL
- NEOMYCIN SULFATE
IONTOFERRON United Drug Distributors PA0182/002/001 - FERROUS SULFATE 16/11/1981
- SUCCINIC ACID
METILAR Syntex Pharmaceuticals PA0033/009/001 11/11/1981
Limited
ALORBAT Mercury Pharmaceuticals PA0073/003/010 03/11/1981
(Ireland) Ltd
UTICILLIN SmithKline Beecham Pharm PA0049/002/002 - CARFECILLIN 02/11/1981
Ltd
NEUROPLEX Company Liquidated M123 PA0211/017/001 Tablets 28/10/1981
BENZAC Wigglesworth (1982) Limited PA0063/003/001 Tablets 23/10/1981

ERGOTROPAL Rowa Pharmaceuticals PA0074/006/001 Tablets - ERGOTAMINE TARTRATE 23/10/1981


Limited - BELLADONNA
ALKALOIDS
- PHENOBARBITAL

BENYLETS LEMON Parke Davis & Company PA0056/019/001 Lozenges - DIPHENHYDRAMINE 20/10/1981
FLAVOURED
BENOCTEN Medinova GmbH PA0178/001/001 Tablets - DIPHENHYDRAMINE 12/10/1981
DEXALOCAL Medinova GmbH PA0178/002/001 Ointment - DEXAMETHASONE 12/10/1981
DEXALOCAL Medinova GmbH PA0178/002/002 Cream - DEXAMETHASONE 12/10/1981
DEXALOCAL - F Medinova GmbH PA0178/004/001 Ointment - DEXAMETHASONE 12/10/1981
- FRAMYCETIN
DEXALOCAL - F Medinova GmbH PA0178/004/002 Cream - DEXAMETHASONE 12/10/1981
- FRAMYCETIN
DEXALOCAL - J Medinova GmbH PA0178/003/001 Ointment - DEXAMETHASONE 12/10/1981
- CLIOQUINOL
DEXALOCAL - J Medinova GmbH PA0178/003/002 Cream 12/10/1981
DEXALOCAL (SCALP Medinova GmbH PA0178/002/003 - DEXAMETHASONE 12/10/1981
APPLICATION)
VAGOMYCIN Medinova GmbH PA0178/005/001 - 12/10/1981
PHTHALYLSULFAMETHIZ
OLE
- NEOMYCIN SULFATE
SURGAM Roussel Laboratories Limited PA0006/023/002 Suppositories - TIAPROFENIC ACID 07/10/1981

Human Medicines Withdrawn Products Page 529 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
KETRAX Zeneca Limited PA0051/037/002 Syrup - LEVAMISOLE 28/09/1981
COMPLAMEX Mayne Pharma (Ireland) PA0078/001/001 Tablets 12/09/1981
Limited
BAYPEN VIAL Bayer PLC PA0021/009/001 - MEZLOCILLIN 03/09/1981
BAYPEN VIAL Bayer PLC PA0021/009/002 - MEZLOCILLIN 03/09/1981
BAYPEN VIAL Bayer PLC PA0021/009/003 - MEZLOCILLIN 03/09/1981
BAYPEN VIAL Bayer PLC PA0021/009/004 - MEZLOCILLIN 03/09/1981
SONALGIN May & Baker Limited PA0040/002/001 24/08/1981
CULANT Mercury Pharmaceuticals PA0073/004/001 - DIPHENHYDRAMINE 22/08/1981
(Ireland) Ltd - CALAMINE
COMPLAMEX Mayne Pharma (Ireland) PA0078/001/002 Tablets 12/08/1981
Limited
COMPLAMEX Mayne Pharma (Ireland) PA0078/001/004 Withdrawn Form 12/08/1981
Limited
COMPLAMEX Mayne Pharma (Ireland) PA0078/001/005 Withdrawn Form 12/08/1981
Limited
COMPLAMEX RETARD Mayne Pharma (Ireland) PA0078/001/003 Tablets 12/08/1981
Limited
FENOPRON Eli Lilly and Company Limite PA0047/002/001 Capsule - FENOPROFEN CALCIUM 05/08/1981

MENTACOUGH Sanofi-Synthelabo Ireland PA0077/034/001 30/07/1981


DEMULCENT Ltd
NORINYL-2 Syntex Pharmaceuticals PA0033/012/001 - MESTRANOL 22/07/1981
Limited - NORETHISTERONE
UROVISON VIALS HE Clissmann PA0012/040/002 20/07/1981
CARDIACAP Consolidated Chemicals PA0132/002/001 Capsule - PENTAERITHRITYL 17/07/1981
Limited TETRANITRATE
CARDIACAP A Consolidated Chemicals PA0132/003/001 Capsule 17/07/1981
Limited
URINFEX Ticen Limited PA0117/011/001 Tablets 17/07/1981
X-EVESS HE Clissmann PA0012/054/002 - SODIUM BICARBONATE 09/07/1981
- CITRIC ACID
- POTASSIUM
BICARBONATE
X-EVESS GRANULES HE Clissmann PA0012/054/001 - SODIUM BICARBONATE 09/07/1981
- CITRIC ACID
- POTASSIUM
BICARBONATE
X-FOAM HE Clissmann PA0012/053/001 - DIMETICONE, ACTIVATED 09/07/1981

X-OPAQUE HE Clissmann PA0012/052/001 - BARIUM SULFATE 09/07/1981


X-OPAQUE HE Clissmann PA0012/052/002 - BARIUM SULFATE 09/07/1981
FERMERGIN Novartis Pharmaceuticals UK PA0013/016/001 Tablets - ERGOTAMINE TARTRATE 22/06/1981
Ltd
PHENYLBUTAZONE B P Norton Healthcare Limited PA0282/016/001 Tablets 29/05/1981
T/A IVAX Pharmaceuticals
UK
CLAFORAN Roussel Laboratories Limited PA0006/024/001 - CEFOTAXIME SODIUM 13/05/1981

CLONVITE Clonmel Healthcare Ltd PA0126/004/001 08/05/1981


EUVERNIL Pharma-Global Limited PA0141/001/001 Tablets - SULFACARBAMIDE 08/05/1981
SOLCOSERYL Capital Pharmaceuticals Ltd PA0249/001/002 08/05/1981
SOLCOSERYL Capital Pharmaceuticals Ltd PA0249/001/003 Ointment 08/05/1981
SOLCOSERYL Capital Pharmaceuticals Ltd PA0249/001/004 08/05/1981
SOLCOSERYL AMPOULES Capital Pharmaceuticals Ltd PA0249/001/001 08/05/1981

ROWAROLAN Rowa Pharmaceuticals PA0074/003/001 Cream - ZINC OXIDE 07/05/1981


Limited - HEXACHLOROPHENE
ROWATANAL Rowa Pharmaceuticals PA0074/004/001 Suppositories - BISMUTH SUBGALLATE 07/05/1981
Limited - RESORCINOL
- MENTHOL
BCG PERCUTANEOUS Glaxo Laboratories Limited PA0044/045/004 06/05/1981
FURETIC Ashford Pharmaceuticals PA0301/030/001 Tablets 27/04/1981
Limited
B VIT C Mercury Pharmaceuticals PA0073/006/001 Tablets - VITAMIN B NOS 13/04/1981
(Ireland) Ltd - ASCORBIC ACID
HIPPUTOPE Bristol-Myers Squibb PA0002/046/001 - IODOHIPPURATE 09/04/1981
Pharmaceuticals uc SODIUM
TRISYN Company Liquidated M123 PA0301/015/001 Cream - TRIAMCINOLONE 08/04/1981
ACETONIDE
POVISOL (DEXTROSE IN Clonmel Healthcare Ltd PA0126/001/002 31/03/1981
WATER 10%)
REVONAL E. Merck Ltd PA0054/007/001 Tablets - METHAQUALONE 26/03/1981

Human Medicines Withdrawn Products Page 530 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALIGESIC Merck Sharp and Dohme PA0035/056/001 Ointment - CALAMINE 24/03/1981
Limited - BENZOCAINE
- CRESOL-M HEXYLATED
RENOTEC Bristol-Myers Squibb PA0002/042/001 - PENTETIC ACID 24/03/1981
Pharmaceuticals uc
LENTARD INSULIN Novo Nordisk A/S PA0218/005/001 23/03/1981
LENTARD INSULIN Novo Nordisk A/S PA0218/005/002 23/03/1981
RAPITARD INSULIN Novo Nordisk A/S PA0218/006/001 23/03/1981
RAPITARD INSULIN Novo Nordisk A/S PA0218/006/002 23/03/1981
ULTRATARD INSULIN Novo Nordisk A/S PA0218/007/001 23/03/1981
ULTRATARD INSULIN Novo Nordisk A/S PA0218/007/002 23/03/1981
FABAHISTIN Bayer PLC PA0021/007/002 16/03/1981
(SUSPENSION)
POVISOL Clonmel Healthcare Ltd PA0126/001/004 13/03/1981
POVISOL Clonmel Healthcare Ltd PA0126/001/005 13/03/1981
POVISOL Clonmel Healthcare Ltd PA0126/001/006 13/03/1981
POVISOL (DESTROSE IN Clonmel Healthcare Ltd PA0126/001/003 13/03/1981
WATER 20%)
POVISOL (DEXTROSE 10% Clonmel Healthcare Ltd PA0126/001/007 13/03/1981
IN NORMAL SALIVE)
POVISOL (DEXTROSE 3.3% Clonmel Healthcare Ltd PA0126/001/010 13/03/1981
IN SODIUM CHLORIDE
0.3%)
POVISOL (DEXTROSE 4.3% Clonmel Healthcare Ltd PA0126/001/009 13/03/1981
IN SODIUM CHLORIDE
0.18%)
POVISOL (DEXTROSE 5% ) Clonmel Healthcare Ltd PA0126/001/008 13/03/1981

POVISOL (DEXTROSE IN Clonmel Healthcare Ltd PA0126/001/001 13/03/1981


WATER 5%)
MINITEC Bristol-Myers Squibb PA0002/045/001 - TECHNETIUM 12/03/1981
Pharmaceuticals uc
STRESSTABS 600 Cyanamid of Great Britain PA0037/017/001 27/02/1981
BETOPIC OINTMENT Company Liquidated M123 PA0301/005/002 Ointment - BETAMETHASONE 18/02/1981
VALERATE
CHLORPROPAMIDE Mercury Pharmaceuticals PA0073/042/001 Tablets 18/02/1981
(Ireland) Ltd
CHLORPROPAMIDE Mercury Pharmaceuticals PA0073/042/002 Tablets 18/02/1981
(Ireland) Ltd
CLIOTOPIC H OINTMENT Company Liquidated M123 PA0301/006/002 Ointment - CLIOQUINOL 18/02/1981
- HYDROCORTISONE
FLUOSYN Company Liquidated M123 PA0301/014/002 Cream - FLUOCINOLONE 18/02/1981
ACETONIDE
FLUOSYN Company Liquidated M123 PA0301/014/003 Cream - FLUOCINOLONE 18/02/1981
ACETONIDE
FLUOSYN Company Liquidated M123 PA0301/014/004 Ointment - FLUOCINOLONE 18/02/1981
ACETONIDE
FLUOSYN Company Liquidated M123 PA0301/014/005 Ointment - FLUOCINOLONE 18/02/1981
ACETONIDE
FLUOSYN Company Liquidated M123 PA0301/014/006 Ointment - FLUOCINOLONE 18/02/1981
ACETONIDE
TRISYN Company Liquidated M123 PA0301/015/003 Ointment - TRIAMCINOLONE 18/02/1981
ACETONIDE
TRISYN Company Liquidated M123 PA0301/015/004 Ointment - TRIAMCINOLONE 18/02/1981
ACETONIDE
OROVITE 7 SmithKline Beecham Pharm PA0049/005/001 - MULTIVITAMINS 12/02/1981
Ltd
H-115 ANTI FUNGUS T. P. Whelehan Son & Co. PA0137/051/002 - CHLORMIDAZOLE 11/02/1981
TINCTURE Limited HYDROCHLORIDE
H-115 ANTI-FUNGUS T. P. Whelehan Son & Co. PA0137/051/001 Cream - CHLORMIDAZOLE 11/02/1981
Limited HYDROCHLORIDE
ORTHO-NOVIN 1/80 Cilag Limited PA0059/012/002 Tablets - NORETHISTERONE 11/02/1981
- MESTRANOL
BETIM LEO Leo Laboratories Limited PA0046/001/001 - TIMOLOL 09/02/1981
BETIM LEO Leo Laboratories Limited PA0046/001/003 - TIMOLOL 06/02/1981
DECASPRAY TOPICAL Merck Sharp and Dohme PA0035/017/001 05/02/1981
Limited
DECASPRAY TOPICAL Merck Sharp and Dohme PA0035/017001 - DEXAMETHASONE 05/02/1981
Limited - NEOMYCIN SULFATE
ENCEPHABOL AMPOULES E. Merck Ltd PA0054/004/001 - PYRITINOL 29/01/1981
HYDROCHLORIDE
ILIACORTIN E. Merck Ltd PA0054/002/001 - OXYMETAZOLINE 29/01/1981
HYDROCHLORIDE
- DEXAMETHASONE
ISONICOTINATE

Human Medicines Withdrawn Products Page 531 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DISALCID 3M Health Care Limited PA0057/007/001 Tablets 27/01/1981
CITROSAN The Boots Company Plc PA0004/002/002 - PARACETAMOL 23/01/1981
PHENYLBUTAZONE Mercury Pharmaceuticals PA0073/050/002 Tablets 22/01/1981
(Ireland) Ltd
TOLBUTAMIDE Mercury Pharmaceuticals PA0073/055/001 Tablets 22/01/1981
(Ireland) Ltd
TOPILAR Syntex Pharmaceuticals PA0033/007/001 - FLUCLOROLONE 20/01/1981
Limited ACETONIDE
A.R.M. Menley & James PA0159/003/001 - CHLORPHENAMINE 19/01/1981
Laboratories MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
COLDPRIN Menley & James PA0159/002/001 - CHLORPHENAMINE 19/01/1981
Laboratories MALEATE
-
PHENYLPROPANOLAMINE
HYDROCHLORIDE
LYNORAL Organon Laboratories PA0261/008/004 Tablets - ETHINYLESTRADIOL 16/01/1981
Limited
LYNORAL 0.01 MG Organon Laboratories PA0261/008/001 Tablets - ETHINYLESTRADIOL 16/01/1981
Limited
LYNORAL 0.05 MG Organon Laboratories PA0261/008/002 Tablets - ETHINYLESTRADIOL 16/01/1981
Limited
LYNORAL 0.1 MG Organon Laboratories PA0261/008/003 Tablets - ETHINYLESTRADIOL 16/01/1981
Limited
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/063/001 16/01/1981
GLOBIN ZINC INSULIN B.P.
80 IU
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/062/001 16/01/1981
INSULIN B P
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/062/003 16/01/1981
INSULIN B P
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/061/002 16/01/1981
INSULIN ZINC
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/060/002 16/01/1981
INSULIN ZINC
(SUSPENSION)
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/059/002 16/01/1981
INSULIN ZINC
(SUSPENSION)
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/060/001 16/01/1981
INSULIN ZINC 40 UNITS
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/066/001 16/01/1981
NEUTRAL INSULIN
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/066/002 16/01/1981
NEUTRAL INSULIN NUSO
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/064/002 16/01/1981
PROTAMINE ZINC INSULIN
B. P. 80 IU
MEGIMIDE Nicholas Laboratories PA0032/014/001 Withdrawn Form - BEMEGRIDE 14/01/1981
NOVOBUTE 3M Health Care Limited PA0057/008/001 Tablets - PHENYLBUTAZONE 05/01/1981
NOVOBUTE 3M Health Care Limited PA0057/008/002 Tablets - PHENYLBUTAZONE 05/01/1981
NESTOSYL Bengue & Company Limited PA0096/005/001 Ointment 31/12/1980
CLIFT Knoll A.G. (Clissmann) PA0058/015/001 Solution for Injection - MEPROSCILLARIN 22/12/1980
CLIFT Knoll A.G. (Clissmann) PA0058/015/002 Tablets - MEPROSCILLARIN 22/12/1980
PEROIDIN Larkhall Laboratories Plc PA0288/001/002 Tablets 08/12/1980
ROBENGATOPE Bristol-Myers Squibb PA0002/003/001 - ROSE BENGAL 08/12/1980
Pharmaceuticals uc
ALDOCORTEN Ciba Geigy Plc PA0028/023/001 - ALDOSTERONE 04/12/1980
TACITIN Ciba Geigy Plc PA0028/008/001 - BENZOCTAMINE 04/12/1980
HYDROCHLORIDE
BEOGEX ADULT Forest Laboratories UK Ltd PA0100/026/001 Suppositories - SODIUM BICARBONATE 24/11/1980
- SODIUM ACID
PHOSPHATE
BEOGEX PAEDIATRIC Forest Laboratories UK Ltd PA0100/026/002 Suppositories - SODIUM BICARBONATE 24/11/1980
- SODIUM ACID
PHOSPHATE
LIPRINAL Bristol-Myers Squibb PA0048/003/001 - CLOFIBRATE 21/11/1980
(Holdings) Limited
LIPRINAL Bristol-Myers Squibb PA0048/003/002 - CLOFIBRATE 21/11/1980
(Holdings) Limited
STERILE MULTIPLE International Medication PA0255/032/001 14/11/1980
VITAMIN SOL Systems (UK) Ltd

Human Medicines Withdrawn Products Page 532 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CAMBISON OINTMENT Hoechst Ireland Limited PA0023/011/001 - PREDNAZOLINE 13/11/1980
- NEOMYCIN
- PREDNISOLONE
CAMBISON OINTMENT Hoechst Ireland Limited PA0023/011/002 - PREDNAZOLINE 13/11/1980
- NEOMYCIN
- PREDNISONE
REVERIN I. V. Hoechst Ireland Limited PA0023/012/003 - ROLITETRACYCLINE 13/11/1980
SOLASIL Cuticura Laboratories Limite PA0214/001/001 06/11/1980

JUNIOR DISPRIN Reckitt's (Ireland) Limited PA0027/011/001 - ACETYLSALICYLIC ACID 04/11/1980


FUCIDIN CREAM Leo Laboratories Limited PA0046/004/013 22/10/1980
MOLIPAXIN Roussel Laboratories Limited PA0006/012/001 Capsule - TRAZODONE 22/10/1980
HYDROCHLORIDE
SELACRYN SmithKline and French PA0060/027/001 Tablets 16/10/1980
Laboratories Ltd
DISPRIN FOILSTRIP Reckitt's (Ireland) Limited PA0027/005/002 Tablets 05/10/1980
PARADIONE Abbott Laboratories Ireland PA0038/013/001 Capsule 02/10/1980
Ltd
ACABEL DRAGEES T. P. Whelehan Son & Co. PA0137/049/001 - BEVONIUM 26/09/1980
Limited METILSULFATE
PHENYLBUTAZONE Company Liquidated M123 PA0211/011/001 Tablets 03/09/1980
ERGAMISOL SYRUP Janssen Pharmaceutica PA0045/018/001 - LEVAMISOLE 28/08/1980
HYDROCHLORIDE
MINIHEP CALCIUM Leo Laboratories Limited PA0046/025/002 Withdrawn Form - HEPARIN CALCIUM 27/08/1980
HEPARIN
MED-E-JET INJECTION Leo Laboratories Limited PA0046/030/001 07/08/1980
TACE Marion Merrell Limited PA0041/013/002 Capsule 07/08/1980
PSYCHO-SOMA COATED Medical & Pharmaceutical PA0309/004/001 Tablets - MAGNESIUM 30/07/1980
Sales C GLUTAMATE
HYDROBROMIDE
BILIGRAM AMPS HE Clissmann PA0012/034/001 - IOGLYCAMATE 28/07/1980
MEGLUMINE
- EDETATE DISODIUM
BILIGRAM VIALS HE Clissmann PA0012/034/002 28/07/1980
TRIDIONE Abbott Laboratories Ireland PA0038/014/001 26/07/1980
Ltd
COMPOUND SODIUM Company Liquidated M123 PA0301/002/001 Withdrawn Form - SODIUM LACTATE 07/07/1980
LACTATE COMPOUND INJECTION
COMPOUND SODIUM Company Liquidated M123 PA0301/002/002 Withdrawn Form - SODIUM LACTATE 07/07/1980
LACTATE COMPOUND INJECTION
DARROWS SOLUTION Company Liquidated M123 PA0301/007/001 - LACTIC ACID 07/07/1980
- SODIUM HYDROXIDE
- HYDROCHLORIC ACID
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
DARROWS SOLUTION Company Liquidated M123 PA0301/007/002 - LACTIC ACID 07/07/1980
- SODIUM HYDROXIDE
- HYDROCHLORIC ACID
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
DEXTROSE 5% Company Liquidated M123 PA0301/003/001 Withdrawn Form - GLUCOSE 07/07/1980
DEXTROSE 5% Company Liquidated M123 PA0301/003/002 Withdrawn Form - GLUCOSE 07/07/1980
RINGERS Ashford Pharmaceuticals PA0301/027/001 Withdrawn Form 07/07/1980
Limited
RINGERS Ashford Pharmaceuticals PA0301/027/002 Withdrawn Form 07/07/1980
Limited
SODIUM CHLORIDE & Ashford Pharmaceuticals PA0301/026/001 Withdrawn Form - SODIUM CHLORIDE 07/07/1980
DEXTROSE Limited - GLUCOSE
SODIUM CHLORIDE & Ashford Pharmaceuticals PA0301/026/002 Withdrawn Form - SODIUM CHLORIDE 07/07/1980
DEXTROSE Limited - GLUCOSE
SODIUM CHLORIDE 0.9% Company Liquidated M123 PA0301/001/001 Withdrawn Form - SODIUM CHLORIDE 07/07/1980
SODIUM CHLORIDE 0.9% Company Liquidated M123 PA0301/001/002 Withdrawn Form - SODIUM CHLORIDE 07/07/1980
PSYCHO-SOMA Medical & Pharmaceutical PA0309/004/002 Syrup - MAGNESIUM 01/07/1980
Sales C GLUTAMATE
HYDROBROMIDE
CORT-ACNE LOTION Rhone-Poulenc Rorer PA0119/001/001 - HYDROCORTISONE 26/06/1980
Pharms. - RESORCINOL
HISTRYL ELIXIR SmithKline and French PA0060/024/003 26/06/1980
Laboratories Ltd
AUTRIN Cyanamid of Great Britain PA0037/015/001 Capsule 06/06/1980
FOLVITE Cyanamid of Great Britain PA0037/014/001 Withdrawn Form 06/06/1980
KENACORT A Bristol-Myers Squibb PA0002/021/006 Cream - TRIAMCINOLONE 06/06/1980
Pharmaceuticals uc ACETONIDE
PRIMALAN Berk Pharmaceuticals PA0082/006/001 - MEQUITAZINE 15/05/1980
Limited

Human Medicines Withdrawn Products Page 533 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CELABS Kelkin Naturproducts Ltd PA0305/002/001 Tablets - SALICYLAMIDE 13/05/1980
BENYLIN DAY & NIGHT Parke Davis & Company PA0056/028/002 Tablets - PARACETAMOL 28/04/1980
COLD - BLUE -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DIPHENHYDRAMINE
BENYLIN DAY & NIGHT Parke Davis & Company PA0056/028/001 Tablets - PARACETAMOL 28/04/1980
COLD - YELLOW -
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- DIPHENHYDRAMINE
HYDROCHLORIDE
DIGITALINE NATIVELLE Wilcox Laboratories Limited PA0233/006/001 - DIGITOXIN 28/04/1980
DIGITALINE NATIVELLE Wilcox Laboratories Limited PA0233/006/002 Tablets - DIGITOXIN 28/04/1980
DIGITALINE NATIVELLE Wilcox Laboratories Limited PA0233/006/003 Tablets - DIGITOXIN 28/04/1980
DIGITALINE NATIVELLE Wilcox Laboratories Limited PA0233/006/004 - DIGITOXIN 28/04/1980
AMPOULES
CUNIL Helsinn Birex PA0294/004/001 Capsule - DIAZEPAM 21/04/1980
Pharmaceuticals Limited
CUNIL Helsinn Birex PA0294/004/002 Capsule - DIAZEPAM 21/04/1980
Pharmaceuticals Limited
COLBENEMID Merck Sharp and Dohme PA0035/013/001 Tablets - PROBENECID 11/04/1980
Limited - COLCHICINE
CREMOMYCIN Merck Sharp and Dohme PA0035/006/001 - NEOMYCIN 11/04/1980
(SUSPENSION) Limited -
SUCCINYLSULFATHIAZOL
E
CREMOSUXIDINE Merck Sharp and Dohme PA0035/007/001 - 11/04/1980
(SUSPENSION) Limited SUCCINYLSULFATHIAZOL
E
SILOXYL Clonmel Healthcare Ltd PA0126/013/001 Tablets 10/04/1980
SILOXYL Clonmel Healthcare Ltd PA0126/013/002 Tablets 10/04/1980
PERYLENE ULTRA Septodont PA0196/006/001 - TETRACAINE 01/04/1980
HYDROCHLORIDE
- BENZOCAINE
DI TER PER ANATOXAL Capital Pharmaceuticals Ltd PA0249/003/001 24/03/1980
BERNA
INFLEXAL BERNA Capital Pharmaceuticals Ltd PA0249/004/002 24/03/1980
INFLEXAL BERNA Capital Pharmaceuticals Ltd PA0249/004/004 24/03/1980
OPULETS ATROPINE Forest Laboratories UK Ltd PA0100/011/002 - ATROPINE SULFATE 24/03/1980
OPULETS Forest Laboratories UK Ltd PA0100/019/001 - CYCLOPENTOLATE 24/03/1980
CYCLOPENTOLATE HYDROCHLORIDE
OPULETS Forest Laboratories UK Ltd PA0100/019/002 - CYCLOPENTOLATE 24/03/1980
CYCLOPENTOLATE HYDROCHLORIDE
OPULETS FLUORESCEIN Forest Laboratories UK Ltd PA0100/010/001 - FLUORESCEIN SODIUM 24/03/1980
OPULETS HOMATROPINE Forest Laboratories UK Ltd PA0100/012/001 - HOMATROPINE 24/03/1980
HYDROBROMIDE
OPULETS HOMATROPINE Forest Laboratories UK Ltd PA0100/012/002 - HOMATROPINE 24/03/1980
HYDROBROMIDE
OPULETS PILOCARPINE Forest Laboratories UK Ltd PA0100/013/001 - PILOCARPINE 24/03/1980
HYDROCHLORIDE
OPULETS PILOCARPINE Forest Laboratories UK Ltd PA0100/013/002 - PILOCARPINE 24/03/1980
HYDROCHLORIDE
OPULETS PILOCARPINE Forest Laboratories UK Ltd PA0100/013/003 - PILOCARPINE 24/03/1980
HYDROCHLORIDE
OPULETS SALINE Forest Laboratories UK Ltd PA0100/020/001 - SODIUM CHLORIDE 24/03/1980
TE ANATOXAL BERNA Capital Pharmaceuticals Ltd PA0249/005/001 - TETANUS TOXOID 24/03/1980
TE ANATOXAL BERNA Capital Pharmaceuticals Ltd PA0249/005/002 - TETANUS TOXOID 24/03/1980
ARAMINE 10 MG/ML Merck Sharp and Dohme PA0035/049/002 Withdrawn Form - METARAMINOL 07/03/1980
Limited
DELTA-BUTAZOLIDIN Geigy Pharmaceuticals PA0011/019/001 Tablets - PHENYLBUTAZONE 05/03/1980
- PREDNISONE
PRO-BANTHINE G.D. Searle & Company PA0001/002/001 Tablets - PROPANTHELINE 05/03/1980
Limited BROMIDE
ILVICO E. Merck Ltd PA0054/011/002 Syrup - BROMPHENIRAMINE 01/03/1980
MALEATE
- METHYLEPHEDRINE
- SODIUM ASCORBATE
-
PHENYLDIMETHYLJODPY
RAZOLON
- SODIUM SALICYLATE
CALMODEN Berk Pharmaceuticals PA0082/018/001 Tablets - CHLORDIAZEPOXIDE 29/02/1980
Limited
CALMODEN Berk Pharmaceuticals PA0082/018/002 Tablets - CHLORDIAZEPOXIDE 29/02/1980
Limited

Human Medicines Withdrawn Products Page 534 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CALMODEN Berk Pharmaceuticals PA0082/018/003 Tablets - CHLORDIAZEPOXIDE 29/02/1980
Limited
CALMODEN Berk Pharmaceuticals PA0082/018/004 Capsule - CHLORDIAZEPOXIDE 29/02/1980
Limited
CALMODEN Berk Pharmaceuticals PA0082/018/005 Capsule - CHLORDIAZEPOXIDE 29/02/1980
Limited
FLEXAZONE Berk Pharmaceuticals PA0082/009/001 Tablets - PHENYLBUTAZONE 29/02/1980
Limited
FLEXAZONE Berk Pharmaceuticals PA0082/009/002 Tablets - PHENYLBUTAZONE 29/02/1980
Limited
CORTRIL Pfizer Limited PA0019/018/002 Ointment - HYDROCORTISONE 25/02/1980
LOWTEN Central Pharmaceuticals PA0078/017/003 Tablets - CHLORDIAZEPOXIDE 25/02/1980
Limited HYDROCHLORIDE
- CHLORDIAZEPOXIDE
LOWTEN Central Pharmaceuticals PA0078/017/005 Tablets - CHLORDIAZEPOXIDE 25/02/1980
Limited HYDROCHLORIDE
- CHLORDIAZEPOXIDE
VAGRAN 50 Mayne Pharma (Ireland) PA0078/008/001 - PROPIZEPINE 25/02/1980
Limited
CO-PYRONIL Eli Lilly and Company Limite PA0047/043/001 Capsule - PYRROBUTAMINE 18/02/1980
PHOSPHATE
- METHAPYRILENE
HYDROCHLORIDE
- CYCLOPENTAMINE
HYDROCHLORIDE
BEPLETE ELIXIR John Wyeth & Brother PA0022/018/001 31/01/1980
Limited
DIPHTHERIA & TETANUS Wellcome (Ireland) Limited PA0017/028/001 - DIPHTHERIA AND 30/01/1980
VACCINE TETANUS TOXOIDS
TOFRANIL R WITH Geigy Pharmaceuticals PA0011/025/001 - IMIPRAMINE 30/01/1980
PROMAZINE CAPS - PROMAZINE
TYPHOID VACCINE Wellcome (Ireland) Limited PA0017/035/002 30/01/1980
SEMAP Janssen Pharmaceutica PA0045/001/001 - PENFLURIDOL 29/01/1980
HEPABIONTA E. Merck Ltd PA0054/003/001 Withdrawn Form 24/01/1980
NEUROBION FORTE E. Merck Ltd PA0054/006/001 - THIAMINE DISULFIDE 24/01/1980
- CYANOCOBALAMIN
ALPHACILLIN Merck Sharp and Dohme PA0035/001/002 Powder for Oral Suspension - PIVAMPICILLIN 18/01/1980
Limited HYDROCHLORIDE
ALPHACILLIN 60 M Merck Sharp and Dohme PA0035/001/001 Powder for Oral Suspension - PIVAMPICILLIN 18/01/1980
Limited HYDROCHLORIDE
ALPHACILLIN PAEDIATRIC Merck Sharp and Dohme PA0035/001/003 - PIVAMPICILLIN 18/01/1980
Limited HYDROCHLORIDE
CITROSAN The Boots Company Plc PA0004/002/001 - PARACETAMOL 18/01/1980
- SODIUM CITRATE
- ASCORBIC ACID
VERILOID VP 3M Health Care Limited PA0057/017/001 Tablets - VERATRUM VIRIDE 04/01/1980
- PHENOBARBITAL
DIPAR Hoechst Ireland Limited PA0023/020/001 Tablets 31/12/1979
PERITRATE WITH Warner Lambert PA0039/033/001 Tablets 12/12/1979
PHENOBARBITONE
LOESTRIN 20 Parke Davis & Company PA0056/011/001 - ETHINYLESTRADIOL 04/12/1979
- NORETHISTERONE
ACETATE
STELAZINE MULTI-DOSE SmithKline and French PA0060/016/011 Withdrawn Form 28/11/1979
Laboratories Ltd
ANAPAX FAMILY COUGH 3M Health Care Limited PA0057/003/001 27/11/1979
FILAIR 3M Health Care Limited PA0057/004/001 Tablets - TERBUTALINE SULFATE 27/11/1979
FILAIR 3M Health Care Limited PA0057/004/002 - TERBUTALINE SULFATE 27/11/1979
FILAIR AUTO 3M Health Care Limited PA0057/004/005 - TERBUTALINE SULFATE 27/11/1979
FILAIR INHALER 3M Health Care Limited PA0057/004/004 - TERBUTALINE SULFATE 27/11/1979
NUELIN PAEDIATRIC 3M Health Care Limited PA0057/005/002 - AMINOPHYLLINE 27/11/1979
ALLBEE WITH C 550 A.H. Robins Company PA0086/001/002 Capsule - VITAMIN B NOS 21/11/1979
Limited - ASCORBIC ACID
SEQUILAR ED DRAGEES HE Clissmann PA0012/001/001 19/11/1979
LEMONEXA LEMON FLUE Cupal Limited PA0258/014/001 Syrup 06/11/1979
BETIM EYE Leo Laboratories Limited PA0046/001/006 - TIMOLOL 01/11/1979
BETIM EYE DROPS Leo Laboratories Limited PA0046/001/004 - TIMOLOL 01/11/1979
BETRIM EYE DROP Leo Laboratories Limited PA0046/001/005 - TIMOLOL 01/11/1979
CLORHEXITULLE Roussel Laboratories Limited PA0006/021/001 - CHLORHEXIDINE 16/10/1979
DIACETATE
MELADININE Yamanouchi Pharma Ltd PA0062/009/003 12/10/1979
NORLESTRIN Parke Davis & Company PA0056/003/001 - ETHINYLESTRADIOL 03/10/1979
- NORETHISTERONE
ACETATE

Human Medicines Withdrawn Products Page 535 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ANTIPRESSAN Berk Pharmaceuticals PA0082/031/001 Tablets - METHYLDOPA 26/09/1979
Limited
ANTIPRESSAN Berk Pharmaceuticals PA0082/031/003 Tablets - METHYLDOPA 26/09/1979
Limited
POTENSAN FORTE Medo Pharmaceuticals PA0120/003/001 - YOHIMBINE 26/09/1979
Limited HYDROCHLORIDE
- METHYLTESTOSTERONE
- STRYCHNINE
HYDROCHLORIDE
- PEMOLINE

PARITANE Berk Pharmaceuticals PA0082/023/001 Tablets - CHLORTALIDONE 13/09/1979


Limited
PARITANE Berk Pharmaceuticals PA0082/023/002 Tablets - CHLORTALIDONE 13/09/1979
Limited
ATROPINE SULPHATE International Medication PA0255/026/001 Withdrawn Form 05/09/1979
WITH NEOSTIGMINE Systems (UK) Ltd
MULTIPLE ELECTROLYTE International Medication PA0255/022/001 05/09/1979
ADDITIVE STERILE Systems (UK) Ltd
NORADRENALINE ACID International Medication PA0255/031/001 Withdrawn Form 05/09/1979
TARTRATE Systems (UK) Ltd
OXYTOCIN 10 I U/ML International Medication PA0255/027/001 Withdrawn Form 05/09/1979
Systems (UK) Ltd
OXYTOCIN 10 I U/ML International Medication PA0255/027/002 Withdrawn Form 05/09/1979
Systems (UK) Ltd
SODIUM CHLORIDE 0.1% International Medication PA0255/025/001 Withdrawn Form 05/09/1979
Systems (UK) Ltd
SODIUM CHLORIDE 0.1% International Medication PA0255/025/002 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/003 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/004 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/005 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/006 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/007 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
SODIUM CHLORIDE 0.9% International Medication PA0255/025/008 Withdrawn Form 05/09/1979
W/V Systems (UK) Ltd
STERILE International Medication PA0255/023/001 05/09/1979
SUXAMETHONIUM Systems (UK) Ltd
CHLORIDE
ESKORADE SPANSULE SmithKline and French PA0060/025/002 Capsule 21/08/1979
Laboratories Ltd
SYNALAR OINTMENT Zeneca Limited PA0051/015/005 03/08/1979
ORADEXON-ORGANON Organon Laboratories PA0261/006/003 Withdrawn Form - DEXAMETHASONE 30/07/1979
Limited SODIUM PHOSPHATE
DENTINOX D.D.D. Limited PA0302/002/001 Gel - LIDOCAINE 10/07/1979
HYDROCHLORIDE
- CETYLPYRIDINIUM
CHLORIDE
DENTINOX D.D.D. Limited PA0302/002/002 - LIDOCAINE 10/07/1979
HYDROCHLORIDE
- CETYLPYRIDINIUM
CHLORIDE
DIBOTIN Sanofi-Synthelabo Ireland PA0077/042/001 - PHENFORMIN 06/07/1979
Ltd
PRINALGIN Berk Pharmaceuticals PA0082/010/001 Capsule - ALCLOFENAC 04/07/1979
Limited
MEROCAINE Marion Merrell Limited PA0041/020/001 Lozenges - CINCHOCAINE 08/06/1979
- BENZOCAINE
- CETYLPYRIDINIUM
CHLORIDE
MEROCAINE Marion Merrell Limited PA0041/020/002 Unknown - CINCHOCAINE 08/06/1979
- BENZOCAINE
- CETYLPYRIDINIUM
CHLORIDE
OPULETS ATROPINE Forest Laboratories UK Ltd PA0100/011/001 Ointment - ATROPINE SULFATE 29/05/1979
SULPHACETAMIDE Forest Laboratories UK Ltd PA0100/004/001 Ointment - SULFACETAMIDE 29/05/1979
OPULETS SODIUM

Human Medicines Withdrawn Products Page 536 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TANDERIL ALKA Geigy Pharmaceuticals PA0011/015/001 - OXYPHENBUTAZONE 23/05/1979
- ALUMINIUM HYDROXIDE
GEL
- MAGNESIUM TRISILICATE

COLESTERINEX Mercury Pharmaceuticals PA0073/024/001 Tablets - PYRICARBATE 22/05/1979


(Ireland) Ltd
CHLORONASE Hoechst Ireland Limited PA0023/035/001 Tablets 21/05/1979
CHLORONASE Hoechst Ireland Limited PA0023/035/002 Tablets 21/05/1979
HOSTACYCLINE P DROPS Hoechst Ireland Limited PA0023/014/003 - TETRACYCLINE 21/05/1979
HYDROCHLORIDE
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/006 02/05/1979
PARENTERAL Limited
METHOTREXATE T. P. Whelehan Son & Co. PA0137/023/007 02/05/1979
PARENTERAL Limited
TRENTADIL Aventis Behring Limited PA0010/014/001 Tablets - BAMIFYLLINE 04/04/1979
HYDROCHLORIDE
ALLERCUR HE Clissmann PA0012/004/002 Ointment - CLEMIZOLE 22/03/1979
ALLERCUR HE Clissmann PA0012/004/003 Syrup - CLEMIZOLE 22/03/1979
- CLEMIZOLE
ALUMINIUM HYDROXIDE Teva UK Limited PA0237/002/001 Tablets 16/03/1979
ASCORBIC ACID Teva UK Limited PA0237/004/001 Tablets 16/03/1979
ASCORBIC ACID Teva UK Limited PA0237/004/002 Tablets 16/03/1979
ASCORBIC ACID Teva UK Limited PA0237/004/003 Tablets 16/03/1979
ASPIRIN Teva UK Limited PA0237/005/001 Tablets 16/03/1979
CASCARA Teva UK Limited PA0237/012/001 Tablets 16/03/1979
CASCARA Teva UK Limited PA0237/012/002 Tablets 16/03/1979
COMPOUND CODEINE Teva UK Limited PA0237/011/001 Tablets 16/03/1979
DIGOXIN Teva UK Limited PA0237/003/001 Tablets 16/03/1979
FERROUS GLUCONATE Teva UK Limited PA0237/010/001 Tablets 16/03/1979
IMIPRAMINE Teva UK Limited PA0237/009/001 Tablets 16/03/1979
IMIPRAMINE Teva UK Limited PA0237/009/002 Tablets 16/03/1979
PARACETAMOL Teva UK Limited PA0237/008/001 Tablets 16/03/1979
SOLUBLE ASPIRIN Teva UK Limited PA0237/007/001 Tablets 16/03/1979
STILBOESTROL Teva UK Limited PA0237/006/001 Tablets 16/03/1979
STILBOESTROL Teva UK Limited PA0237/006/002 Tablets 16/03/1979
STILBOESTROL Teva UK Limited PA0237/006/003 Tablets 16/03/1979
STRONG CALCIFEROL Teva UK Limited PA0237/013/001 Tablets 16/03/1979
PHYLLOCALM Napp Laboratories Limited PA0114/015/001 Tablets - AMINOPHYLLINE 07/03/1979
- HYDROXYZINE
SOVENTOL Knoll A.G. (Clissmann) PA0058/010/002 Tablets - BAMIPINE LACTATE 07/03/1979
- BAMIPINE
HYDROCHLORIDE
SOVENTOL JELLY Knoll A.G. (Clissmann) PA0058/010/001 - BAMIPINE LACTATE 07/03/1979
- BAMIPINE
HYDROCHLORIDE
BENURIDE Bengue & Company Limited PA0096/004/001 Tablets 27/02/1979
NORGESIC 3M Health Care Limited PA0057/012/002 Tablets 26/02/1979
RHINO-FLEXIOLE C Pharma-Global Limited PA0141/006/001 - EPHEDRINE 26/02/1979
NEOMYCIN NOSE DROPS - NEOMYCIN
- CHLORAMPHENICOL
SARIDONE (ALUMINIUM Roche Products Limited PA0050/028/002 Tablets 26/02/1979
SLIDE TINS)
ENTERO-SEDIV T. P. Whelehan Son & Co. PA0137/014/003 Granules Effervescent 06/02/1979
Limited
POLYCID T. P. Whelehan Son & Co. PA0137/024/001 Lozenges 06/02/1979
Limited
FLAVELIX Forest Laboratories UK Ltd PA0100/021/001 - EPHEDRINE 31/01/1979
HYDROCHLORIDE
- MEPYRAMINE MALEATE
PROGESTASERT (TRAY) May & Baker Limited PA0040/037/001 30/01/1979
PYLURA Forest Laboratories UK Ltd PA0100/023/001 Ointment - LIDOCAINE 30/01/1979
HYDROCHLORIDE
- EPINEPHRINE
BITARTRATE
- PHENOL
PYLURA Forest Laboratories UK Ltd PA0100/023/002 Suppositories - LIDOCAINE 30/01/1979
HYDROCHLORIDE
- EPINEPHRINE
BITARTRATE
- PHENOL
INSULIN-TORONTO Abbott Healthcare Products PA0108/007/001 24/01/1979
Ltd
INSULIN-TORONTO Abbott Healthcare Products PA0108/008/001 24/01/1979
Ltd

Human Medicines Withdrawn Products Page 537 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NPH INSULIN Abbott Healthcare Products PA0108/009/001 24/01/1979
Ltd
NPH INSULIN Abbott Healthcare Products PA0108/009/002 24/01/1979
Ltd
SALUPRES Merck Sharp and Dohme PA0035/031/001 Tablets - HYDROCHLOROTHIAZIDE 24/01/1979
Limited - POTASSIUM CHLORIDE
- RESERPINE

ALLERCUR HE Clissmann PA0012/004/001 Tablets 18/01/1979


SEDOLAR Mayne Pharma (Ireland) PA0078/015/002 Capsule - NITRAZEPAM 11/01/1979
Limited
BENZEDREX INHALER SmithKline and French PA0060/026/001 09/01/1979
Laboratories Ltd
AQUA-BAN Company Liquidated M123 PA0291/002/001 01/01/1979
PARITANE (BLISTER Berk Pharmaceuticals PA0082/023/003 Tablets - CHLORTALIDONE 18/12/1978
PACKS) Limited
PARITANE (BLISTER Berk Pharmaceuticals PA0082/023/004 Tablets - CHLORTALIDONE 18/12/1978
PACKS) Limited
ILVICO COATED E. Merck Ltd PA0054/011/001 Tablets - SALICYLAMIDE 15/12/1978
- BROMPHENIRAMINE
MALEATE
- ASCORBIC ACID
- QUININE
HYDROCHLORIDE
- CAFFEINE
BENZYDAMINE TOPICAL 3M Health Care Limited PA0057/034/001 14/12/1978
PREPARATION
ASMAPAX Nicholas Laboratories PA0032/010/001 Tablets 11/12/1978
CARTAGYL Pharma-Global Limited PA0141/009/001 Capsule - CLOFIBRATE 28/11/1978
ALORBAT Mercury Pharmaceuticals PA0073/003/014 23/11/1978
(Ireland) Ltd
GEOMYCIN (PAEDIATRIC) Schering-Plough Limited PA0277/004/007 Withdrawn Form - GENTAMICIN 14/11/1978
10MG
SULOCTIDIL Astra Pharmaceuticals Ltd PA0009/012/001 Capsule 09/11/1978
LERGOBAN 3M Health Care Limited PA0057/022/001 Tablets - DIPHENYLPYRALINE 19/10/1978
THEODROX 3M Health Care Limited PA0057/021/001 Tablets - AMINOPHYLLINE 19/10/1978
- ALUMINIUM HYDROXIDE
GEL, DRIED
MELADINE EMULSION Yamanouchi Pharma Ltd PA0062/009/002 12/10/1978
MELADININE Yamanouchi Pharma Ltd PA0062/009/001 Tablets 12/10/1978
INDOMETHACIN Mayne Pharma (Ireland) PA0078/021/001 Capsule - INDOMETACIN 21/09/1978
Limited
NZYM-3 Controlled Medications PA0157/009/001 Capsule - DEHYDROCHOLIC ACID 18/09/1978
Limited - HYOSCYAMINE SULFATE
- HYOSCINE
HYDROBROMIDE
- ATROPINE SULFATE
- ENZYMES NOS

ELIXIR GABAIL Wilcox Laboratories Limited PA0233/008/001 - STRONTIUM BROMIDE 17/09/1978


HICONCIL Bristol-Myers Squibb PA0048/005/002 Capsule - AMOXICILLIN 25/08/1978
(Holdings) Limited TRIHYDRATE
MAGNESIUM/POTASSIUM SmithKline and French PA0060/001/001 Capsule 10/08/1978
SPANSULE Laboratories Ltd
PAEDO-SED Forest Laboratories UK Ltd PA0100/005/003 08/08/1978
PABIREX DIARRHOEA 3M Health Care Limited PA0057/011/001 - CLIOQUINOL 02/08/1978
- KAOLIN, LIGHT
PERIDECA Merck Sharp and Dohme PA0035/023/001 Tablets - CYPROHEPTADINE 31/07/1978
Limited HYDROCHLORIDE
- DEXAMETHASONE
TISED Ticen Limited PA0117/006/001 Tablets 31/07/1978
SYNOGIST SHAMPOO Mercury Pharmaceuticals PA0073/001/001 27/07/1978
(Ireland) Ltd
BIOSCAL Ricesteele Manufacturing Ltd PA0095/002/001 26/07/1978

OCAL EYE DROPS Pharma-Global Limited PA0141/010/001 - MERCURIC OXYCYANIDE 25/07/1978

SOPACYCLINE Pharma-Global Limited PA0141/002/001 - TETRACYCLINE 25/07/1978


SOPACYCLINE Pharma-Global Limited PA0141/002/002 Capsule - TETRACYCLINE 25/07/1978
SOPARON Pharma-Global Limited PA0141/012/001 Capsule - FERROUS FUMARATE 25/07/1978
ULTRA-K Pharma-Global Limited PA0141/013/001 - POTASSIUM GLUCONATE 25/07/1978

ISOPTO CETAPRED Electramed Ireland Limited PA0161/003/001 - PREDNISOLONE 21/07/1978


ACETATE
- SULFACETAMIDE
SODIUM

Human Medicines Withdrawn Products Page 538 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MAXIDEX STERILE Electramed Ireland Limited PA0161/002/001 - DEXAMETHASONE 21/07/1978
OPHTHALMIC
MAXITROL (SUSPENSION) Electramed Ireland Limited PA0161/001/001 - DEXAMETHASONE 21/07/1978
- NEOMYCIN SULFATE
- POLYMYXIN B
MAXITROL OINTMENT Electramed Ireland Limited PA0161/001/002 21/07/1978
TRIPERIDOL Janssen Pharmaceutica PA0045/008/001 Tablets - TRIFLUPERIDOL 27/06/1978
INFLUVAC Abbott Healthcare Products PA0108/003/001 Withdrawn Form 12/06/1978
Ltd
INFLUVAC Abbott Healthcare Products PA0108/003/003 Withdrawn Form 12/06/1978
Ltd
INFLUVAC SPRAY Abbott Healthcare Products PA0108/003/002 12/06/1978
Ltd
CODELCORTONE TRA Merck Sharp and Dohme PA0035/019/001 Withdrawn Form - PREDNISOLONE 26/05/1978
Limited BUTYLACETATE
PECOMBIN Rhone-Poulenc Rorer PA0119/008/001 Capsule - AMPICILLIN TRIHYDRATE 23/05/1978
Pharms. - BROMELAINS

MILTOWN - 200 T. P. Whelehan Son & Co. PA0137/022/002 Tablets - MEPROBAMATE 22/05/1978
Limited
MILTOWN - 400 T. P. Whelehan Son & Co. PA0137/022/001 Tablets - MEPROBAMATE 22/05/1978
Limited
TUBERCULIN PURIFIED Glaxo Laboratories Limited PA0044/048/006 22/05/1978
PROTEIN DERIVATIVE B P
AMM-1 Napp Laboratories Limited PA0114/016/001 - AMPICILLIN TRIHYDRATE 16/05/1978
- MORPHINE

AMM-2 Napp Laboratories Limited PA0114/016/002 - AMPICILLIN TRIHYDRATE 16/05/1978


- MORPHINE

MEDRONE ACNE Pharmacia Limited PA0016/019/002 05/04/1978


DUOGYNON ORAL HE Clissmann PA0012/007/001 Tablets 03/04/1978
PRIMOGYN DEPOT AMPS HE Clissmann PA0012/019/001 03/04/1978
ENDOMETHASONE (PINK) Septodont PA0196/010/002 - DEXAMETHASONE 01/04/1978
- HYDROCORTISONE
ACETATE
- THYMOL IODIDE
ESKACEF SmithKline and French PA0060/009/002 Capsule 30/03/1978
Laboratories Ltd
ESKACEF SmithKline and French PA0060/009/005 Withdrawn Form 30/03/1978
Laboratories Ltd
ESKACEF SmithKline and French PA0060/009/006 Withdrawn Form 30/03/1978
Laboratories Ltd
ESKACEF SmithKline and French PA0060/009/007 Withdrawn Form 30/03/1978
Laboratories Ltd
ESKACEF DRY MIX SmithKline and French PA0060/009/003 30/03/1978
(SUSPENSION) Laboratories Ltd
BARQUINOL HC Fisons Limited PA0018/012/001 - CLIOQUINOL 17/03/1978
- HYDROCORTISONE
ACETATE
DROLEPTAN Janssen Pharmaceutica PA0045/012/001 Tablets - DROPERIDOL 01/03/1978
ESIDREX Ciba Geigy Plc PA0028/019/001 Tablets - HYDROCHLOROTHIAZIDE 01/03/1978

ESIDREX Ciba Geigy Plc PA0028/019/002 Tablets 01/03/1978


ESIDREX-K Ciba Geigy Plc PA0028/020/001 - HYDROCHLOROTHIAZIDE 01/03/1978
- POTASSIUM CHLORIDE

PERCORTEN M CRYSTULE Ciba Geigy Plc PA0028/024/001 - DESOXYCORTONE 01/03/1978

ULTRACORTENOL Ciba Geigy Plc PA0028/018/001 - PREDNISOLONE 01/03/1978


PIVALATE
DIMYRIL Fisons Limited PA0018/013/002 Capsule 28/02/1978
DIMYRIL LINCTUS Fisons Limited PA0018/013/001 Capsule 28/02/1978
VISKEN Novartis Pharmaceuticals UK PA0013/001/005 Tablets - PINDOLOL 28/02/1978
Ltd
LOWTEN Central Pharmaceuticals PA0078/017/004 Tablets - CHLORDIAZEPOXIDE 25/02/1978
Limited HYDROCHLORIDE
- CHLORDIAZEPOXIDE
FILAIR 3M Health Care Limited PA0057/004/003 Withdrawn Form 23/02/1978
BCG INTRADERMAL 0.4/1.3 Glaxo Laboratories Limited PA0044/045/002 21/02/1978

PANAX GINSENG MIT BIO- T. P. Whelehan Son & Co. PA0137/035/001 20/02/1978
EISEN Limited
GENASPRIN Fisons Limited PA0018/015/001 Tablets - ACETYLSALICYLIC ACID 14/02/1978

Human Medicines Withdrawn Products Page 539 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DOVENOL LINCTUS John Wyeth & Brother PA0022/019/001 - PHOLCODINE 07/02/1978
Limited - EPHEDRINE
- CARBINOXAMINE
MALEATE
ANALGESIC (SPRAY) Gannet Limited PA0280/004/001 - SALICYLATES 04/02/1978
- METHYL NICOTINATE
NIAMID Pfizer Limited PA0019/016/001 Tablets - NIALAMIDE 31/01/1978
TETANUS ANTITOXIN B P Wellcome (Ireland) Limited PA0017/039/005 01/01/1978
DIPIDOLOR Janssen Pharmaceutica PA0045/014/001 - PIRITRAMIDE 07/12/1977
HYBIN Leo Laboratories Limited PA0046/022/001 Tablets 02/12/1977
LOCORTEN VIOFORM EAR Ciba Geigy Plc PA0028/012/001 - FLUMETASONE 01/12/1977
DROPS PIVALATE
- CLIOQUINOL
ORISULF Ciba Geigy Plc PA0028/009/001 Tablets - SULFAPHENAZOLE 01/12/1977
ORISULF (SUSPENSION) Ciba Geigy Plc PA0028/009/002 - SULFAPHENAZOLE 01/12/1977
VIOFORM Ciba Geigy Plc PA0028/014/001 Cream - CLIOQUINOL 01/12/1977
VIOFORM Ciba Geigy Plc PA0028/014/002 Ointment - CLIOQUINOL 01/12/1977
SARIDONE (GLASS Roche Products Limited PA0050/028/001 Tablets 28/11/1977
BOTTLES)
HYDROSALURIC-K Merck Sharp and Dohme PA0035/027/001 Tablets - HYDROCHLOROTHIAZIDE 24/11/1977
Limited - POTASSIUM CHLORIDE

STIEVAA Stiefel Laboratories (U.K.) PA0144/008/001 - TRETINOIN 16/11/1977


Ltd.
KANTREXIL (SUSPENSION Bristol-Myers Squibb PA0048/007/001 - KANAMYCIN 15/11/1977
(Holdings) Limited - ATTAPULGITE
- PECTIN
- BISMUTH
CAMPHOCARBONATE
DIUROMIL Gillespie & Company Ltd PA0266/001/001 14/11/1977
ISOXYL Ovelle Limited PA0206/004/001 Tablets - TIOCARLIDE 02/11/1977
COPTIN Pfizer Limited PA0019/001/001 Tablets - TOLAMOLOL 10/10/1977
HYDROCHLORIDE
COPTIN Pfizer Limited PA0019/001/002 Tablets - TOLAMOLOL 10/10/1977
HYDROCHLORIDE
COPTIN Pfizer Limited PA0019/001/003 Tablets - TOLAMOLOL 10/10/1977
HYDROCHLORIDE
COPTIN INTRAVENOUS Pfizer Limited PA0019/001/004 - TOLAMOLOL 10/10/1977
HYDROCHLORIDE
NATISEDINE Wilcox Laboratories Limited PA0233/004/001 Tablets - PHENOBARBITAL 07/10/1977
ASMACORT Roussel Laboratories Limited PA0006/007/001 - EPHEDRINE 04/10/1977
HYDROCHLORIDE
- PREDNISONE
- PHENOBARBITAL
- THEOPHYLLINE
MIPRALINE Warner Lambert PA0039/031/002 Capsule 03/10/1977
ENDURON Abbott Laboratories Ireland PA0038/010/001 27/09/1977
Ltd
BEPLETE John Wyeth & Brother PA0022/003/001 Tablets 19/09/1977
Limited
ANTIDOTE TO ANCROD Lister Institute of PA0202/001/001 - SNAKE VENOM 22/08/1977
B.P.C. Preventative ANTISERUM
MYOTONINE Glenwood Laboratories PA0031/003/001 Tablets 13/07/1977
Limited
PENIDURAL John Wyeth & Brother PA0022/009/003 Tablets - BENZATHINE 13/07/1977
Limited BENZYLPENICILLIN
- PROCAINE PENICILLIN G
- BENZYLPENICILLIN

POTABA + 6 Glenwood Laboratories PA0031/002/001 - POTASSIUM 13/07/1977


Limited AMINOBENZOATE
- PYRIDOXINE
CENTROSED Mayne Pharma (Ireland) PA0078/005/001 Tablets - MEPROBAMATE 15/06/1977
Limited
RYNOTAB 3M Health Care Limited PA0057/006/001 - 19/05/1977
PHENYLPROPANOLAMINE
HYDROCHLORIDE
- BROMPHENIRAMINE
MALEATE
HALDRATE Eli Lilly and Company Limite PA0047/033/001 Tablets 09/05/1977

MADRIBON Roche Products Limited PA0050/011/002 Syrup - SULFADIMETHOXINE 26/04/1977


NEO-CANTIL ELIXIR Boehringer Mannheim PA0130/001/001 31/03/1977
KEMICETINE Farmitalia Carlo Erba Ltd PA0236/003/001 Capsule 07/03/1977
DIPHTHERIA ANTITOXIN Wellcome (Ireland) Limited PA0017/025/005 - DIPHTHERIA ANTITOXIN 22/02/1977

Human Medicines Withdrawn Products Page 540 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DIPHTHERIA VACCINE P T Wellcome (Ireland) Limited PA0017/026/001 - DIPHTHERIA TOXOID 22/02/1977
AP
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/036/002 22/02/1977
B&C
TYPHOID-PARATYPHOID A Wellcome (Ireland) Limited PA0017/038/003 22/02/1977
B/TETANUS VACCINE
MANDRAX Roussel Laboratories Limited PA0006/008/001 Capsule - METHAQUALONE 17/02/1977
- DIPHENHYDRAMINE
HYDROCHLORIDE
ALBAMYCIN Pharmacia Limited PA0016/005/001 Capsule 13/01/1977
ALBAMYCIN Pharmacia Limited PA0016/005/002 13/01/1977
ALBAMYCIN Pharmacia Limited PA0016/005/003 Syrup 13/01/1977
ALBAMYCIN GU Pharmacia Limited PA0016/006/001 Tablets 13/01/1977
SULFASUXIDINE Merck Sharp and Dohme PA0035/008/001 Tablets - 23/12/1976
Limited SUCCINYLSULFATHIAZOL
E
MANDRAX Roussel Laboratories Limited PA0006/008/002 Tablets - METHAQUALONE 23/09/1976
- DIPHENHYDRAMINE
HYDROCHLORIDE
DEXASALYL United Drug Distributors PA0182/001/001 Ointment - DEXAMETHASONE 21/09/1976
ACETATE
- SALICYLIC ACID
ALPHACILLIN Merck Sharp and Dohme PA0035/001/004 Capsule - PIVAMPICILLIN 03/09/1976
Limited HYDROCHLORIDE
ALPHACILLIN Merck Sharp and Dohme PA0035/001/006 Tablets - PIVAMPICILLIN 03/09/1976
Limited HYDROCHLORIDE
ALPHACILLIN Merck Sharp and Dohme PA0035/001/007 Tablets - PIVAMPICILLIN 03/09/1976
Limited HYDROCHLORIDE
TUSCALMAN BERNA Capital Pharmaceuticals Ltd PA0249/002/001 - NOSCAPINE 05/08/1976
DIGOXIN Teva UK Limited PA0237/001/001 Tablets 15/04/1976
NANORMON Leo Laboratories Limited PA0046/003/001 26/03/1976
LASIX RETARD Hoechst Ireland Limited PA0023/007/001 Capsule - FUROSEMIDE 19/01/1976
LASIX RETARD Hoechst Ireland Limited PA0023/007/002 Capsule - FUROSEMIDE 19/01/1976
TRH -HOECHST Hoechst Ireland Limited PA0023/002/001 - PROTIRELIN 06/01/1976
TUSS-IONEX Fisons Pharmaceuticals PA0072/001/002 Tablets 26/09/1975
(Ireland)
TUSS-IONEX Fisons Pharmaceuticals PA0072/001/003 Capsule 26/09/1975
(Ireland)
ESKACEF SmithKline and French PA0060/009/001 Capsule 30/03/1975
Laboratories Ltd
SECHOLEX Pharmacia Biosystems PA0107/004/001 - POLIDEXIDE 22/10/1974
Limited
ACOMPLIA Sanofi aventis EU/1/06/344/1-9 Tablets - RIMONABANT N/A
ACTRAPID MC NEUTRAL Novo Nordisk A/S PA0218/003/001 Withdrawn Form N/A
INSULIN
ADRIAMYCIN Farmitalia Carlo Erba Ltd PA0236/008/003 N/A
ADSORBED DIPHTHERIA Sanofi Pasteur MSD Ltd PA0544/004/002 Solution for Injection - DIPHTHERIA TOXOID N/A
AND TETANUS VACCINE - TETANUS TOXOID
BP SYRINGE
AGENERASE- Glaxo Group Limited EU/1/00/148/001 Capsule - AMPRENAVIR N/A
AMPRENAVIR
AGENERASE- Glaxo Group Limited EU/1/00/148/002 Capsule - AMPRENAVIR N/A
AMPRENAVIR
AGENERASE- Glaxo Group Limited EU/1/00/148/003 Capsule - AMPRENAVIR N/A
AMPRENAVIR
AGENERASE- Glaxo Group Limited EU/1/00/148/004 Capsule - AMPRENAVIR N/A
AMPRENAVIR
AIDEX Ovelle Limited PA0206/008/002 Cream N/A
ALBALON LIQUIFILM EYE Allergan Pharmaceuticals PA0148/016/001 Eye Drops Solution - NAPHAZOLINE N/A
DROPS SOLUTION Ireland HYDROCHLORIDE
ALCON Alcon Laboratories (UK) Ltd PA0290/066/001 - SODIUM CHLORIDE N/A
ALLEX Schering Plough Europe EU/1/00/159/001 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/002 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/003 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/004 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/005 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/006 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/007 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/008 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/009 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/010 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/011 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/012 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/013 Tablets - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/014 Syrup - DESLORATIDINE N/A

Human Medicines Withdrawn Products Page 541 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ALLEX Schering Plough Europe EU/1/00/159/015 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/016 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/017 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/018 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/019 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/020 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/021 Syrup N/A
ALLEX Schering Plough Europe EU/1/00/159/022 Oral Lyophilisate - DESLORATIDINE N/A
ALLEX Schering Plough Europe EU/1/00/159/023 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/024 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/025 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/026 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/027 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/028 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/029 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/030 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/031 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/032 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/033 Oral Lyophilisate N/A
ALLEX Schering Plough Europe EU/1/00/159/034 Oral Lyophilisate N/A
ALORBAT (DISPOSABLE Mercury Pharmaceuticals PA0073/003/012 N/A
SYRINGE) (Ireland) Ltd
ALORBAT MULTIDOSE Mercury Pharmaceuticals PA0073/003/013 N/A
(Ireland) Ltd
ALTHESIN Glaxo Laboratories Limited PA0044/064/001 Suspension for Injection - ALFADOLONE N/A
AMINOPLASMAL 10% E B. Braun Medical Limited PA0179/020/001 Solution for Infusion - LEUCINE N/A
WITHOUT - ISOLEUCINE
CARBOHYDRATES - LYSINE
SOLUTION HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- AMINOACETIC ACID
- ALANINE
- PROLINE
- ASPARTIC ACID
- ASPARGINE
MONOHYDRATE
- ACETYLCYSTEINE
- GLUTAMIC ACID
- ORNITHINE
HYDROCHLORIDE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM ACETATE
- MAGNESIUM ACETATE
TETRAHYDRATE
- SODIUM PHOSPHATE
MONOBASIC
- MALIC ACID
- N-ACETYLTYROSINE PH.
EUR.

Human Medicines Withdrawn Products Page 542 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AMINOPLASMAL 5% E B. Braun Medical Limited PA0179/019/001 Solution for Infusion - ISOLEUCINE N/A
WITHOUT - LEUCINE
CARBOHYDRATES - LYSINE
SOLUTION F HYDROCHLORIDE
- DL-METHIONINE
- PHENYLALANINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
- ARGININE
- HISTIDINE
- AMINOACETIC ACID
- ALANINE
- PROLINE
- ASPARTIC ACID
- ASPARGINE
MONOHYDRATE
- ACETYLCYSTEINE
- GLUTAMIC ACID
- ORNITHINE
HYDROCHLORIDE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM ACETATE
- MAGNESIUM ACETATE
TETRAHYDRATE
- SODIUM DIHYDROGEN
PHOSPHATE DIHYDRATE
- MALIC ACID
- N-ACETYLTYROSINE PH.
EUR.
AMOXIL GlaxoSmithKline (Ireland) PA1077/033/002 Capsule - AMOXICILLIN N/A
Limited TRIHYDRATE
AMOXIL PCO Manufacturing PPA0465/008/002B Capsule - AMOXICILLIN N/A
TRIHYDRATE
AMOXIL CAPSULES 250 GlaxoSmithKline (Ireland) PA1077/033/001 Capsule - AMOXICILLIN N/A
MG Limited TRIHYDRATE
AMOXIL FORTE SYRUP 250 GlaxoSmithKline (Ireland) PA1077/033/008 Syrup - AMOXICILLIN N/A
MG/ 5ML Limited TRIHYDRATE
AMOXIL SYRUP 125 MG/ 5 GlaxoSmithKline (Ireland) PA1077/033/007 Syrup - AMOXICILLIN N/A
ML Limited TRIHYDRATE
AMPICILLIN Athlone Laboratories Ltd PA0298/001/001 Capsules Hard - AMPICILLIN TRIHYDRATE N/A

AMPICILLIN Athlone Laboratories Ltd PA0298/001/002 Capsules Hard - AMPICILLIN TRIHYDRATE N/A

AMPICILLIN Company Liquidated M123 PA0432/003/002 Capsule - AMPICILLIN N/A


AMPICILLIN ORAL Athlone Laboratories Ltd PA0298/002/001 Granules for Oral - AMPICILLIN TRIHYDRATE N/A
SUSPENSION BP Suspension
AMPICILLIN ORAL Athlone Laboratories Ltd PA0298/002/002 Granules for Oral - AMPICILLIN TRIHYDRATE N/A
SUSPENSION BP Suspension
AMPICILLIN SYRUP B P C Pinewood Laboratories Ltd, PA0281/009/004 - AMPICILLIN N/A
AMPICILLIN SYRUP Company Liquidated M123 PA0432/003/001 - AMPICILLIN N/A
POWDER
ANATENSOL DECANOATE Bristol-Myers Squibb PA0002/016/001 N/A
Pharmaceuticals uc
ANATENSOL DECANOATE Bristol-Myers Squibb PA0002/016/007 N/A
Pharmaceuticals uc
ANZEMET Sanofi-Aventis Ireland PA0540/029/002 Tablets - DOLASETRON MESYLATE N/A
Limited T/A SANOFI
ANZEMET Sanofi-Aventis Ireland PA0540/029/003 Tablets - DOLASETRON MESYLATE N/A
Limited T/A SANOFI
ANZEMET INJECTION Sanofi-Aventis Ireland PA0540/029/001 Solution for Injection - DOLASETRON MESYLATE N/A
Limited T/A SANOFI
ARDUAN Organon Teknika Ltd PA0374/003/001 - PIPECURONIUM N/A
BROMIDE
AREPANRIX GlaxoSmithKline Biologicals EU/1/10/624/001 Emulsion and suspension for - A/CALIFORNIA/7/2009 N/A
S.A. emulsion for injection (H1N1)V LIKE STRAIN (X-
179A)
ARTEXAL Les Laboratoires Servier PA0568/001/001 Tablets - TERTATOLOL N/A
HYDROCHLORIDE
ASPRO TABLETS Roche Products Limited PA0050/152/001 Tablets - ACETYLSALICYLIC ACID N/A
ATRIDOX Tolmar GmbH PA1501/001/001 Powder and solvent for - DOXYCYCLINE N/A
gingival gel

Human Medicines Withdrawn Products Page 543 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
AUGMENTIN PCO Manufacturing PPA0465/047/001A Film Coated Tablet - AMOXICILLIN N/A
TRIHYDRATE
- CLAVULANIC ACID (IN
THE FORM OF POTASSIUM
CLAVULANATE)

AURALGICIN Fisons Limited PA0018/007/001 - PHENAZONE N/A


- EPHEDRINE
BACTERIOSTATIC WATER Hospira UK Limited PA0437/021/001 Solvent for Parenteral Use - BENZYL ALCOHOL N/A
BACTERIOSTATIC WATER Hospira UK Limited PA0437/021/002 Solvent for Parenteral Use - BENZYL ALCOHOL N/A
BACTERIOSTATIC WATER Hospira UK Limited PA0437/021/003 Solvent for Parenteral Use - BENZYL ALCOHOL N/A
BECONASE AQUEOUS GlaxoSmithKline (Ireland) PA1077/041/001 Nasal Spray Suspension - BECLOMETASONE N/A
Limited DIPROPIONATE
BECOTIDE 100 GlaxoSmithKline (Ireland) PA1077/042/002 Pressurised Inhalation N/A
Limited Suspension
BECOTIDE 250 INHALER PCO Manufacturing PPA0465/041/004B Pressurised Inhalation - BECLOMETASONE N/A
Suspension
BECOTIDE 250 INHALER PCO Manufacturing PPA0465/041/004C Pressurised Inhalation - BECLOMETASONE N/A
Suspension
BECOTIDE 250 INHALER PCO Manufacturing PPA0465/041/004D Pressurised Inhalation Soln - BECLOMETASONE N/A
BECOTIDE INHALER PCO Manufacturing PPA0465/041/002B Pressurised Inhalation - BECLOMETASONE N/A
100MCG Suspension DIPROPIONATE
MONOHYDRATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001B Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001C Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001D Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001E Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001F Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BECOTIDE INHALER PCO Manufacturing PPA0465/041/001G Pressurised Inhalation - BECLOMETASONE N/A
50MCG Suspension DIPROPIONATE
BEGRIVAC GSK Vaccines GmbH PA0877/001/001 Suspension for Injection - A/CALIFORNIA/7/2009 N/A
(H1N1) - DERIVED STRAIN
USED NYMC X-181 REASS
- A/CALIFORNIA/7/2009
(H1N1) - DERIVED STRAIN
USED NYMC X-181 REASS
- B/BRISBANE/60/2008 -
LIKE STRAIN
(B/BRISBANE/60/2008)

BEGRIVAC GSK Vaccines GmbH PA0877/001/002 Suspension for Injection - A/CALIFORNIA/7/2009 N/A
(H1N1) - DERIVED STRAIN
USED NYMC X-181 REASS
- A/CALIFORNIA/7/2009
(H1N1) - DERIVED STRAIN
USED NYMC X-181 REASS
- B/BRISBANE/60/2008

BELLFORMIN BellPharma Limited PA1185/001/001 Tablets - METFORMIN N/A


HYDROCHLORIDE
BELLFORMIN BellPharma Limited PA1185/001/002 Tablets - METFORMIN N/A
HYDROCHLORIDE
BENYLIN WITH CODEINE McNeil Healthcare (Ireland) PA0823/011/001 Syrup - DIPHENHYDRAMINE N/A
Ltd HYDROCHLORIDE
- CODEINE PHOSPHATE
- LEVOMENTHOL
BETAGAN LIQUIFILM Allergan Pharmaceuticals PA0148/040/002 N/A
TOPICAL OPHTHALMIC Ireland
BETALOC AstraZeneca UK Limited PA0970/032/002 Tablets - METOPROLOL TARTRATE N/A

BETALOC AstraZeneca UK Limited PA0970/032/003 Tablets - METOPROLOL TARTRATE N/A

BETNELAN UCB Pharma Limited PA0365/066/001 Tablets - BETAMETHASONE N/A


BETNESOL-N 0.01% W/W, UCB Pharma Limited PA0365/046/002 Eye Ointment - BETAMETHASONE N/A
3500 IU/ML EYE OINTMENT SODIUM PHOSPHATE
- NEOMYCIN SULFATE
BEXTRA Pharmacia-Pfizer EEIG EU/1/02/239/1-24 Tablets - VALDECOXIB N/A
BIDOPLEX ELIXIR Company Liquidated M123 PA0211/018/001 N/A
BIOTRAZEPAM Company Liquidated M123 PA0211/019/001 N/A

Human Medicines Withdrawn Products Page 544 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BIOZINE Company Liquidated M123 PA0211/009/001 Syrup N/A
BIOZINE Company Liquidated M123 PA0211/009/002 Tablets N/A
BIOZINE Company Liquidated M123 PA0211/009/003 Tablets N/A
BIOZINE Company Liquidated M123 PA0211/009/004 Tablets N/A
BLEPH-10 Allergan Pharmaceuticals PA0148/022/001 Eye Drops Solution - SULFACETAMIDE N/A
Ireland SODIUM
BLEPHAMIDE T. P. Whelehan Son & Co. PA0137/018/002 N/A
OPHTHALMIC Limited
(SUSPENSION)
BONDRONAT Roche Registration GmbH EU/1/96/012/005 Concentrate for Soln for Inf - IBANDRONIC ACID N/A
MONOSODIUM
MONOHYDRATE
BRAUNODERM B. Braun Medical Limited PA0179/025/001 Cutaneous Solution - POVIDONE-IODINE N/A
COLOURED - ISOPROPANOL
BRAUNODERM NON- B. Braun Medical Limited PA0179/025/002 Cutaneous Solution - IODINATED POVIDONE N/A
COLOURED PH.EUR.
- ISOPROPANOL
BRAUNOL B. Braun Medical Limited PA0179/027/001 Cutaneous Solution - POVIDONE-IODINE N/A
BRAUNOSAN B. Braun Medical Limited PA0179/026/002 Cutaneous Solution - POVIDONE-IODINE N/A
BRAUNOVIDON B. Braun Medical Limited PA0179/024/001 Ointment - POVIDONE-IODINE N/A
BREVINOR TABLETS Pharmacia Healthcare PA0936/018/001 Tablets - NORETHISTERONE N/A
Ireland - ETHINYLESTRADIOL
BRONCHOTONE MIXTURE T. P. Whelehan Son & Co. PA0137/040/001 - SODIUM SALICYLATE N/A
Limited - CAFFEINE
- SODIUM IODIDE
- EPHEDRINE
HYDROCHLORIDE
- ATROPA BELLADONNA
BRONSECUR SmithKline and French PA0060/004/003 N/A
Laboratories Ltd
BRONSECUR LIQUID SmithKline and French PA0060/004/004 N/A
CONCENTRATE Laboratories Ltd
CALPOL SUGAR/COLOUR McNeil Healthcare (Ireland) PA0823/010/006 Oral Suspension - PARACETAMOL N/A
FREE INFANT Ltd
CALVEPEN DRY POWDER Leo Laboratories Limited PA0046/007/006 N/A
(SUSPENSION)
CALVEPEN DRY POWDER Leo Laboratories Limited PA0046/007/007 N/A
(SUSPENSION)
CAPOZIDE PCO Manufacturing PPA0465/043/001B Tablets - CAPTOPRIL N/A
- HYDROCHLOROTHIAZIDE

CARACE Bristol-Myers Squibb PA0002/072/006 Tablets - LISINOPRIL DIHYDRATE N/A


Pharmaceuticals uc
CARDIAGUTT Karl Engelhard PA0425/003/003 Tablets - VERAPAMIL N/A
CATAFLAM PCO Manufacturing PPA0465/079/001B Tablets - DICLOFENAC N/A
POTASSIUM
CEA-SCAN Immunomedics Inc EU/1/96/023/001 N/A
CHLORACIN 3% Wigglesworth (1982) Limited PA0063/012/001 Withdrawn Form N/A

CHLORAMBID Controlled Medications PA0157/005/001 Capsule - CHLORAMPHENICOL N/A


Limited
CHLORPHENIRAMINE Company Liquidated M123 PA0211/008/001 Tablets N/A
CHYMODIACTIN Aventis Behring Limited PA0010/026/001 - CHYMOPAPAIN N/A
CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/010 Withdrawn Form - GENTAMICIN N/A

CIDOMYCIN GENTAMICIN Roussel Laboratories Limited PA0006/003/011 Withdrawn Form - GENTAMICIN N/A

CIDOMYCIN OINTMENT SmithKline and French PA0006/003/003 - GENTAMICIN N/A


Laboratories Ltd
CIMELDINE Clonmel Healthcare Ltd PA0126/077/003 Tablets - CIMETIDINE N/A
CIMETIDINE Olinka (UK) Limited PA0476/004/001 Tablets - CIMETIDINE N/A
CIMETIDINE Olinka (UK) Limited PA0476/004/002 Tablets - CIMETIDINE N/A
CIPLOX Actavis Group PTC ehf PA1380/049/001 Film Coated Tablet - CIPROFLOXACIN N/A
HYDROCHLORIDE
CIPRAMIL 10 MG FILM- PCO Manufacturing PPA0465/068/001A Tablets - CITALOPRAM N/A
COATED TABLETS
CIPROXIN PCO Manufacturing PPA0465/082/002A Film Coated Tablet - CIPROFLOXACIN N/A
HYDROCHLORIDE
CIPROXIN 250 MG FILM- PCO Manufacturing PPA0465/082/001A Film Coated Tablet - CIPROFLOXACIN N/A
COATED TABLETS HYDROCHLORIDE
CITANEST 3% WITH Dentsply Limited PA1045/001/002 Solution for Injection - PRILOCAINE N/A
OCTAPRESSIN SELF HYDROCHLORIDE
ASPIRATING - FELYPRESSIN
CITANEST 4% DENTAL Dentsply Limited PA1045/002/001 Unknown - PRILOCAINE N/A
INJECTION HYDROCHLORIDE

Human Medicines Withdrawn Products Page 545 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CLINIMIX N9G20E Baxter Healthcare Limited PA0167/098/002 Solution for Infusion - LEUCINE N/A
- PHENYLALANINE
- L-METHIONINE
- L-LYSINE
- ISOLEUCINE
- VALINE
- HISTIDINE
- THREONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
TRIHYDRATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
- GLUCOSE
- CALCIUM CHLORIDE
DIHYDRATE
CLONAMP Clonmel Healthcare Ltd PA0126/015/002 Capsules Hard - AMPICILLIN TRIHYDRATE N/A

CLONAMP Clonmel Healthcare Ltd PA0126/015/003 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE N/A

CLONAMP Clonmel Healthcare Ltd PA0126/015/004 Powder for Oral Suspension - AMPICILLIN TRIHYDRATE N/A

COLSPAN Concept Pharmaceuticals PA0157/002/001 Capsule - CHLORPHENAMINE N/A


Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
COMBIVENT UDVS 500 PCO Manufacturing PPA0465/105/002A Nebuliser Solution - IPRATROPIUM BROMIDE N/A
MICROGRAMS/2.5MG PER MONOHYDRATE
2.5ML NEBU - SALBUTAMOL SULFATE
COMPOUND W SSL International PLC PA0618/043/001 Cutaneous Solution - SALICYLIC ACID N/A
COPTIN Pfizer Limited PA0019/028/001 Tablets N/A
COPTIN (SUSPENSION) Pfizer Limited PA0019/001/006 - SULFADIAZINE N/A
- TRIMETHOPRIM
COPTIN SUSPENSION Pfizer Limited PA0019/028/002 N/A
CORLAN UCB Pharma Limited PA0365/049/001 Buccal Tablet - HYDROCORTISONE N/A
SODIUM SUCCINATE
CORTRIL Pfizer Limited PA0019/018/006 Ointment - HYDROCORTISONE N/A
CO-TRIMOXAZOLE Athlone Laboratories Ltd PA0298/011/001 Oral Suspension - TRIMETHOPRIM N/A
- SULFAMETHOXAZOLE
CO-TRIMOXAZOLE Athlone Laboratories Ltd PA0298/011/002 Unknown - TRIMETHOPRIM N/A
PAEDIATRIC - SULFAMETHOXAZOLE
COTRONAK Schering Plough Europe EU/1/99/106/001 Capsule - RIBAVIRIN N/A
- INTERFERON ALFA-2B
COTRONAK Schering Plough Europe EU/1/99/106/002 Capsule - RIBAVIRIN N/A
- INTERFERON ALFA-2B
COTRONAK Schering Plough Europe EU/1/99/106/003 Capsule - RIBAVIRIN N/A
- INTERFERON ALFA-2B
COVERSYL PCO Manufacturing PPA0465/067/001B Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE SALT
COVERSYL PCO Manufacturing PPA0465/067/001C Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE SALT
CRINONE 4% Serono Limited PA0285/013/001 Vaginal Gel - PROGESTERONE N/A
PROGESTERONE
CRIXIVAN Merck Sharp and Dohme EU/1/96/024/006 Capsule - INDINAVIR SULFATE N/A
Limited
CROOKES SPOT Crookes Healthcare Ltd PA0043/038/001 Cream - SULFUR N/A
TREATMENT CREAM - TRICLOSAN
REGULAR - COLOURLESS
CROOKES SPOT Crookes Healthcare Ltd PA0043/038/002 Cream - SULFUR N/A
TREATMENT CREAM - TRICLOSAN
REGULAR - COVER UP
CYCLABID Controlled Medications PA0157/004/001 - TETRACYCLINE N/A
Limited HYDROCHLORIDE
DAKTARIN Janssen Pharmaceutica PA0045/013/003 Withdrawn Form - MICONAZOLE N/A
DAKTARIN TABLETS Janssen Pharmaceutica PA0045/013/005 Tablets - MICONAZOLE NITRATE N/A
250MG

Human Medicines Withdrawn Products Page 546 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/001 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/002 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/003 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/004 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/005 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/006 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/009 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DAQUIRAN Dr. Karl Thomae GmbH EU/1/97/052/010 Tablets - PRAMIPEXOLE N/A
DIHYDROXHLORIDE
DE- NOLTAB CHEWABLE Yamanouchi Pharma Ltd PA0062/022/001 Tablets N/A
DE WITT POWERFUL E.C. De Witt & Company PA0299/004/001 - PHENOLPHTHALEIN N/A
LAXATIVE Limited - ALOIN
DERMOL Dermal Laboratories Ltd PA0278/011/001 Cream - HYDROCORTISONE N/A
- MENTHOL
DESOXYMETHASONE Hoechst Ireland Limited PA0023/039/001 Cream N/A
DESTARA Roche Registration Limited EU/1/96/013/001 Concentrate for Soln for Inf - IBANDRONIC ACID N/A
DESTARA Roche Registration Limited EU/1/96/013/002 Concentrate for Soln for Inf - IBANDRONIC ACID N/A
DESTARA Roche Registration Limited EU/1/96/013/003 Concentrate for Soln for Inf - IBANDRONIC ACID N/A
DESTARA Roche Registration Limited EU/1/96/013/004 Concentrate for Soln for Inf - IBANDRONIC ACID N/A
DEXTRAN 40 BRAUN IN B. Braun Medical Limited PA0179/011/001 N/A
SODIUM CHLORIDE
DEXTROSE 10% B. Braun Medical Limited PA0179/001/015 Withdrawn Form N/A
DEXTROSE 10% B. Braun Medical Limited PA0179/001/016 Withdrawn Form N/A
DI TI PER ANATOXAL Capital Pharmaceuticals Ltd PA0249/003/002 N/A
BERNA
DIAZEPAM Company Liquidated M123 PA0211/002/001 Tablets N/A
DIAZEPAM Company Liquidated M123 PA0211/002/002 Tablets N/A
DIAZEPAM Company Liquidated M123 PA0211/002/003 Tablets N/A
DIAZEPAM Norton Waterford PA0436/002/001 Tablets - DIAZEPAM N/A
DIAZEPAM Norton Waterford PA0436/002/002 Tablets - DIAZEPAM N/A
DILTIAZEM Norton Healthcare Limited PA0282/049/001 Tablets - DILTIAZEM N/A
HYDROCHLORIDE T/A IVAX Pharmaceuticals HYDROCHLORIDE
UK
DILUENT FOR ONE-ALPHA Leo Laboratories Limited PA0046/038/001 N/A

DIMOTANE A.H. Robins Company PA0086/004/001 Capsule - BROMPHENIRAMINE N/A


Limited MALEATE
- PHENYLEPHRINE
HYDROCHLORIDE
-
PHENYLPROPANOLAMINE
- CODEINE PHOSPHATE
- GUAIFENESIN

DIPARIM 75 Clonmel Healthcare Ltd PA0126/086/002 N/A


DOPERGIN HE Clissmann PA0012/062/001 Tablets - IOPROMIDE N/A
DOXY Mayne Pharma (Ireland) PA0078/047/001 Capsule - DOXYCYCLINE N/A
Limited
DROXARYL Ovelle Limited PA0206/006/003 Suppositories - BUFEXAMAC N/A
DUOVENT INHALER Boehringer Ingelheim Limited PA0007/021/001 Inhalation solution - IPRATROPIUM BROMIDE N/A
- FENOTEROL
HYDROBROMIDE
DYNEPO Aventis Pharma S.A. EU/1/02/211/001 Solution for Injection - EPOETIN DELTA N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/002 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/003 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/004 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/005 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/006 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/007 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/008 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/009 Solution for Injection N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/010 Solution for Injection - EPOETIN DELTA N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/011 Solution for Injection - EPOETIN DELTA N/A
DYNEPO Aventis Pharma S.A. EU/1/02/211/012 Solution for Injection - EPOETIN DELTA N/A
DYSPORT Ipsen Limited PA0583/001/002 Pdr for Soln for Injection - CLOSTRIDIUM N/A
BOTULINUM TYP A-
ANTITOXIN

Human Medicines Withdrawn Products Page 547 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EAREX Pharmalab Limited PA0547/001/001 Ear Drops Solution - SWEET ALMOND OIL N/A
- ARACHIS OIL
- CAMPHOR OIL
ECZENSA Hadensa (Ireland) Limited PA0145/001/001 - DEXAMETHASONE N/A
- RETINOL
- COLECALCIFEROL
- NEOMYCIN SULFATE
- TOCOPHEROL
- NEOMYCIN SULFATE
ECZENSA - S Hadensa (Ireland) Limited PA0145/002/002 Ointment N/A
EFEXOR PCO Manufacturing PPA0465/085/001B Tablets N/A
ELDISINE Eli Lilly and Company Limite PA0047/049/003 Withdrawn Form - VINDESINE SULPHATE N/A

ELUDRIL Pierre Fabre Medicament PA0329/001/001 Mouth Wash - CHLORHEXIDINE N/A


GLUCONATE
EQUAGESIC John Wyeth & Brother PA0022/004/002 Tablets N/A
Limited
ESTRADERM TTS PCO Manufacturing PPA0465/044/002C Transdermal Patch N/A
ESTRADIOL Organon (Ireland) Limited PA0061/015/001 Implant - ESTRADIOL N/A
ESTRADIOL Organon (Ireland) Limited PA0061/015/002 Implant - ESTRADIOL N/A
ESTRADIOL Organon (Ireland) Limited PA0061/015/003 Implant - ESTRADIOL N/A
ESTREVA Belpharma SA PA0908/001/001 Gel - ESTRADIOL N/A
EX-LAX SENNA PILLS Novartis Consumer Health PA0030/055/001 Coated Tablets - CASSIA SENNA N/A
UK Limited
FABLYN Dr. Friedrich Eberth EU/1/08/500/1-4 Film Coated Tablet - LASOFOXIFENE N/A
TARTRATE (00-RS-49750)
FACTORATE HEAT Aventis Behring Limited PA0010/006/004 - HUMAN N/A
TREATED PLASMAFRAKTION
(FACTOR VIII)
FAMEL HONEY & LEMON Optrex Limited PA0275/011/001 Lozenges - CREOSOTE N/A
- MENTHOL
FELDENE Pfizer Limited PA0019/024/004 Suppositories - PIROXICAM N/A
FELDENE TOPIGEL Pfizer Healthcare Ireland PA0822/022/001 Gel - PIROXICAM N/A
FEMINAX Nicholas Laboratories PA0032/002/001 - PARACETAMOL N/A
- SALICYLAMIDE
- CODEINE PHOSPHATE
- CAFFEINE
MONOHYDRATE
- HYOSCINE
HYDROBROMIDE
FENOFIBRATE Ethypharm PA0549/010/002 Capsule - FENOFIBRATE N/A
ETHYPHARM
FENOX (SPRAY) The Boots Company Plc PA0004/022/001 - PHENYLEPHRINE N/A
HYDROCHLORIDE
FERRUM HAUSMANN Clonmel Healthcare Ltd PA0126/030/002 N/A
INTRAMUSCULAR
FLIXONASE AQUEOUS GlaxoSmithKline (Ireland) PA1077/043/001 Nasal Spray Suspension - FLUTICASONE N/A
Limited PROPIONATE
FLUCILLIN Pinewood Laboratories Ltd, PA0281/031/003 Powder for Oral Solution - FLUCLOXACILLIN N/A
SODIUM
FML FORTE LIQUIFILM Allergan Pharmaceuticals PA0148/007/002 Eye Drops Suspension - FLUOROMETHOLONE N/A
Ireland
FML-NEO LIQUIFILM Allergan Pharmaceuticals PA0148/020/001 Eye Drops Suspension - NEOMYCIN SULFATE N/A
Ireland - FLUOROMETHOLONE
FORCALTONIN Unigene UK Limited EU/1/98/093/001 Solution for Injection - CALCITONIN, SALMON N/A
FORCALTONIN Unigene UK Limited EU/1/98/093/002 Solution for Injection - CALCITONIN, SALMON N/A
FORTAGESIC Sanofi-Synthelabo Ireland PA0077/004/002 Tablets N/A
Ltd
FORTOVASE Roche Registration Limited EU/1/98/075/001 Capsule - SAQUINAVIR N/A
FORTOVASE Roche Registration Limited EU/1/98/075/002 Capsule - SAQUINAVIR N/A
FRAMYCORT Fisons Limited PA0018/009/001 - FRAMYCETIN N/A
- HYDROCORTISONE
FRAMYCORT Fisons Limited PA0018/009/002 Ointment - FRAMYCETIN N/A
- HYDROCORTISONE
FRAMYCORT Fisons Limited PA0018/009/003 Ointment - FRAMYCETIN N/A
- HYDROCORTISONE
FRAMYGEN Fisons Limited PA0018/010/001 - FRAMYCETIN N/A
FRAMYGEN Fisons Limited PA0018/010/002 Cream - FRAMYCETIN N/A
FRAMYGEN Fisons Limited PA0018/010/003 Ointment - FRAMYCETIN N/A
FRANOL Sanofi-Synthelabo Ireland PA0077/017/005 Tablets - THEOPHYLLINE N/A
Ltd - EPHEDRINE
HYDROCHLORIDE
FRUSEMIDE Norton Waterford PA0436/003/001 Tablets - FUROSEMIDE N/A
FRUSEMIDE Norton Waterford PA0436/003/002 Tablets - FUROSEMIDE N/A
FRUSEMIDE Company Liquidated M123 PA0211/001/001 Tablets N/A

Human Medicines Withdrawn Products Page 548 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FRUSEMIDE Company Liquidated M123 PA0211/001/002 Tablets N/A
GABAPENTIN 100 MG Lexon (UK) Ltd PA1097/001/001 Capsule - GABAPENTIN N/A
CAPSULES
GABAPENTIN 300MG Lexon (UK) Ltd PA1097/001/002 Capsule - GABAPENTIN N/A
CAPSULES
GABAPENTIN 400MG Lexon (UK) Ltd PA1097/001/003 Capsule - GABAPENTIN N/A
CAPSULES
GABIN 600 MG FILM- Rowex Ltd PA0711/132/004 Tablets - GABAPENTIN N/A
COATED TABLETS
GABIN 800 MG FILM- Rowex Ltd PA0711/132/005 Tablets - GABAPENTIN N/A
COATED TABLETS
GABITRIL Cephalon UK Limited PA0827/003/001 Film Coated Tablet - TIAGABINE N/A
GELOFUSINE B. Braun Medical Limited PA0179/038/001 Solution for Infusion - GELATINE N/A
POLYSUCCINATE
- SODIUM CHLORIDE
- SODIUM HYDROXIDE
GENOPTIC LIQUIFILM Allergan Pharmaceuticals PA0148/035/001 Eye Drops Solution - GENTAMICIN SULFATE N/A
Ireland
GERAMET McDermott Laboratories Ltd PA0577/005/001 Film Coated Tablet - CIMETIDINE N/A
t/a Gerard Laboratories
GERAMET McDermott Laboratories Ltd PA0577/005/002 Film Coated Tablet - CIMETIDINE N/A
t/a Gerard Laboratories
GERAMET McDermott Laboratories Ltd PA0577/005/003 Film Coated Tablet - CIMETIDINE N/A
t/a Gerard Laboratories
GERIFLOX ELIXIR McDermott Laboratories Ltd PA0577/016/001 Powder for Oral Solution - FLUCLOXACILLIN N/A
t/a Gerard Laboratories SODIUM
GLAMIN Fresenius Kabi Limited PA0566/006/001A Solution for Infusion - ALANINE N/A
- ARGININE
- ASPARTIC ACID
- GLUTAMIC ACID
- GLYCYL - GLUTAMINE
MONOHYDRATE
- GLYCYL -TYROSINE
DIHYDRATE
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE ACETATE
- METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
GLAMIN Fresenius Kabi Limited PA0566/006/004 Solution for Infusion - ALANINE N/A
- ARGININE
- ASPARTIC ACID
- GLUTAMIC ACID
- GLYCYL - GLUTAMINE
MONOHYDRATE
- GLYCYL -TYROSINE
DIHYDRATE
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE ACETATE
- METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- VALINE
GLAUBERS SALT Superpac Products Limited PA0552/009/001 N/A
GONADOTRAPHON L.H. Paines and Byrne Limited PA0090/007/002 Solution for Injection N/A
GONAL-F Serono Limited EU/1/95/001/035 Pdr+Solv for Soln for Inj - FOLLITROPIN ALFA N/A
GUANIMYCIN FORTE Glaxo Laboratories Limited PA0044/010/001 - N/A
(SUSPENSION) DIHYDROSTREPTOMYCIN
SULFATE
- SULFAGUANIDINE
GUARINA Norgine Limited PA0102/022/001 - GUAR GUM N/A
H.11 EXTRACT Norland Inter-Trading Co. PA0153/001/001 - POLYPEPTIDE N/A
Ltd.
H.11 OINTMENT Norland Inter-Trading Co. PA0153/001/004 Ointment - POLYPEPTIDE N/A
Ltd.

Human Medicines Withdrawn Products Page 549 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
H.11 ORAL LIQUID Norland Inter-Trading Co. PA0153/001/003 - POLYPEPTIDE N/A
Ltd.
H.11 SUPPOSITORIES Norland Inter-Trading Co. PA0153/001/005 Suppositories - POLYPEPTIDE N/A
Ltd.
H.11 TABLETS Norland Inter-Trading Co. PA0153/001/002 Tablets - POLYPEPTIDE N/A
Ltd.
HALDOL Janssen Pharmaceuticals Lt PA0545/005/003 Oral Solution - HALOPERIDOL N/A

HALF CAPOZIDE Bristol-Myers Squibb PA0002/053/003 Tablets - CAPTOPRIL N/A


Pharmaceuticals uc - HYDROCHLOROTHIAZIDE

HALIBORANGE Seven Seas Ltd PA0417/016/001 Tablets Effervescent - ASCORBIC ACID N/A
HALIBORANGE Seven Seas Ltd PA0417/016/002 Tablets Effervescent - ASCORBIC ACID N/A
HALIBORANGE Reckitt's (Ireland) Limited PA0027/044/002 Tablets - RETINOL N/A
BLACKCURRANT - ASCORBIC ACID
FLAVOURED - VITAMIN D SYNTHETIC
CALCIFEROL
HALIBORANGE ORANGE Reckitt's (Ireland) Limited PA0027/044/001 Tablets - RETINOL N/A
FLAVOURED - ASCORBIC ACID
- VITAMIN D SYNTHETIC
CALCIFEROL
HALIBORANGE VITAMIN C Seven Seas Ltd PA0417/016/004 Tablets Effervescent - ASCORBIC ACID N/A
HALIBORANGE VITAMIN C Seven Seas Ltd PA0417/016/003 Tablets Effervescent - ASCORBIC ACID N/A
ORANGE FLAVOUR
HALOPERIDOL Clonmel Healthcare Ltd PA0126/055/002 Tablets - HALOPERIDOL N/A
HALOPERIDOL Clonmel Healthcare Ltd PA0126/055/003 Tablets - HALOPERIDOL N/A
HEPACARE UCB Pharma Limited EU/1/00/136/002 Suspension for Injection - TRIPLE ANTIGEN N/A
HEPATITIS B VACCINE
HEPACARE 20 UG/ML Amgen Europe B.V. EU/1/00/136/001 Suspension for Injection - TRIPLE ANTIGEN N/A
HEPATITIS B VACCINE
HIBTITER John Wyeth & Brother PA0022/087/001 Solution for Injection - HAEMOPHILUS N/A
Limited INFLUENZAE TYPE B
POLYSACCHARIDE
- DIPHTHERIA TOXOID
HOFELS GARLIC AND Hofels Pure Foods Limited PA0616/002/001 Coated Tablets - ALLIUM SATIVUM N/A
PARSLEY
HOFELS GARLIC PEARLES Hofels Pure Foods Limited PA0616/001/001 Capsules, Soft - ALLIUM SATIVUM N/A
CAPSULES
HOFELS ONE-A-DAY Hofels Pure Foods Limited PA0616/001/002 Capsules, Soft - ALLIUM SATIVUM N/A
GARLIC PEARLES
HOSTACYCLINE DRAGEES Hoechst Ireland Limited PA0023/013/001 - TETRACYCLINE N/A
HYDROCHLORIDE
HUMALOG - HUMAJECT Eli Lilly Nederland B.V. EU/1/97/036/001 Solution for Injection - INSULIN LISPRO N/A
HUMALOG - HUMAPEN Eli Lilly Nederland B.V. EU/1/97/042/001 - INSULIN LISPRO N/A
HUMALOG MIX25 - Eli Lilly Nederland B.V. EU/1/97/036/002 Suspension for Injection - INSULIN LISPRO N/A
HUMAJECT
HUMALOG MIX25 - PEN Eli Lilly Nederland B.V. EU/1/97/042/002 Suspension for Injection - INSULIN LISPRO N/A
HUMALOG MIX50 - Eli Lilly Nederland B.V. EU/1/97/036/003 Suspension for Injection - INSULIN LISPRO N/A
HUMAJECT
HUMALOG MIX50 - PEN Eli Lilly Nederland B.V. EU/1/97/042/003 Suspension for Injection - INSULIN LISPRO N/A
HUMALOG NPL Eli Lilly Nederland B.V. EU/1/97/042/004 Suspension for Injection - INSULIN LISPRO N/A
HUMALOG NPL - Eli Lilly Nederland B.V. EU/1/97/036/004 Suspension for Injection - INSULIN LISPRO N/A
HUMAJECT
HUMAN MIXTARD 30/70 Novo Nordisk A/S PA0218/039/002 - INSULIN HUMAN N/A
HYALGAN VIAL Fidia Farmaceutici S.p.A. PA0814/001/002 Solution for Injection - HYALURONATE SODIUM N/A
HYDROCORTISONE Schering-Plough Limited PA0277/030/001 Cream N/A
HYDROCORTONE Merck Sharp and Dohme PA0035/021/003 Ointment - HYDROCORTISONE N/A
Limited
ILVICO Seven Seas Ltd PA0417/010/001 Tablets - PARACETAMOL N/A
- CALCIUM ASCORBATE
- CAFFEINE
MONOHYDRATE
- BROMPHENIRAMINE
MALEATE
INDORAMIN John Wyeth & Brother PA0022/031/003 Tablets N/A
Limited
INFANRIX HEPB SmithKline Beecham EU/1/97/048/001 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT

Human Medicines Withdrawn Products Page 550 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFANRIX HEPB SmithKline Beecham EU/1/97/048/002 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/003 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/004 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/005 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/006 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/007 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/008 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/009 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/010 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT

Human Medicines Withdrawn Products Page 551 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INFANRIX HEPB SmithKline Beecham EU/1/97/048/011 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFANRIX HEPB SmithKline Beecham EU/1/97/048/012 Suspension for Injection - DIPHTHERIA TOXOID N/A
Biologicals - TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
INFERGEN Yamanouchi Europe B.V. EU/1/98/087/001 Solution for Injection - INTERFERON ALFACON-1 N/A

INFERGEN Yamanouchi Europe B.V. EU/1/98/087/002 Solution for Injection - INTERFERON ALFACON-1 N/A

INFERGEN Yamanouchi Europe B.V. EU/1/98/087/003 Solution for Injection - INTERFERON ALFACON-1 N/A

INFLEXAL BERNA Capital Pharmaceuticals Ltd PA0249/004/003 N/A


INITARD HUMAN 40 IU/ML Nordisk Gentofte A/S PA0217/010/001 N/A
INITARD HUMAN 80 IU/ML Nordisk Gentofte A/S PA0217/010/002 N/A
INNOPRIL TABLETS McDermott Laboratories Ltd PA0577/035/001 Tablets - ENALAPRIL MALEATE N/A
t/a Gerard Laboratories
INNOPRIL TABLETS McDermott Laboratories Ltd PA0577/035/002 Tablets - ENALAPRIL MALEATE N/A
t/a Gerard Laboratories
INNOPRIL TABLETS McDermott Laboratories Ltd PA0577/035/003 Tablets - ENALAPRIL MALEATE N/A
t/a Gerard Laboratories
INNOPRIL TABLETS McDermott Laboratories Ltd PA0577/035/004 Tablets - ENALAPRIL MALEATE N/A
t/a Gerard Laboratories
INSTAT * COLLAGEN Johnson & Johnson (Ireland) PA0330/011/001 - COLLAGEN N/A
ABSORBALBE HEMOSTAT Limited
INSULATED HUMAN 80 Nordisk Gentofte A/S PA0217/009/002 N/A
IU/ML
INSULTARD HUMAN 400 Nordisk Gentofte A/S PA0217/009/001 N/A
IU/ML
INSUMAN Hoechst AG EU/1/97/030/001 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/002 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/003 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/004 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/005 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/006 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/007 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/008 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/009 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/010 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/011 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/012 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/013 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/014 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/015 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/016 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/017 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/018 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/019 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/020 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/021 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/022 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/023 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/024 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/025 Suspension for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/026 Solution for Injection - INSULIN HUMAN N/A
INSUMAN Hoechst AG EU/1/97/030/027 Solution for Injection - INSULIN HUMAN N/A
ISDN/PROPRANOLOL 10/2 Ayerst Laboratories Limited PA0149/017/001 Tablets N/A

ISOPAQUE CORONAR 370 Electramed Ireland Limited PA0161/013/009 N/A


IXENSE Takeda Global R&D Centre EU/1/01/181/001 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/002 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/003 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE

Human Medicines Withdrawn Products Page 552 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
IXENSE Takeda Global R&D Centre EU/1/01/181/004 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/005 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/006 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/007 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
IXENSE Takeda Global R&D Centre EU/1/01/181/03 Tablet Sublingual - APOMORPHINE N/A
Europe Limited HYDROCHLORIDE
LARGACTIL FORTE May & Baker Limited PA0040/031/001 Oral Suspension - CHLORPROMAZINE N/A
EMBONATE
LC-65 DAILY CONTACT Allergan Pharmaceuticals PA0148/025/001 N/A
LENS CLEANER Ireland
LESCOL 20MG CAPSULES PCO Manufacturing PPA0465/090/001A Capsule - FLUVASTATIN N/A
LESCOL 40MG CAPSULES PCO Manufacturing PPA0465/090/002A Capsule - FLUVASTATIN N/A
LEVIUS Farmitalia Carlo Erba Ltd PA0236/006/002 Tablets N/A
LEVOPHED SPECIAL Sanofi-Synthelabo Ireland PA0077/043/001 - NOREPINEPHRINE N/A
Ltd
LEVVIAX Aventis Pharma S.A. EU/1/01/192/001 Tablets N/A
LEVVIAX Aventis Pharma S.A. EU/1/01/192/002 Tablets N/A
LEVVIAX Aventis Pharma S.A. EU/1/01/192/003 Tablets N/A
LEVVIAX Aventis Pharma S.A. EU/1/01/192/004 Tablets N/A
LIPOTRIAD Lewis Laboratories Limited PA0222/001/001 Capsule N/A
LOCAN CREAM Glaxo Laboratories Limited PA0044/080/001 Cream N/A
LOMOTIL G.D. Searle & Company PA0001/001/005 - DIPHENOXYLATE N/A
Limited HYDROCHLORIDE
- ATROPINE SULFATE
- NEOMYCIN SULFATE
LOXAPAC T. P. Whelehan Son & Co. PA0137/004/009 Capsule - LOXAPINE SUCCINATE N/A
Limited
LYPSYL COLD SORE Novartis Consumer Health PA0030/030/001 Gel - LIDOCAINE N/A
UK Limited HYDROCHLORIDE
- ZINC SULFATE
- CETRIMONIUM BROMIDE

MAWS GOLDEN EYE Ashe Laboratories Limited PA0254/004/001 Ointment N/A


MEGACLOR Forest Laboratories UK Ltd PA0100/002/002 Syrup - CLOMOCYCLINE N/A
MEGACLOR Forest Laboratories UK Ltd PA0100/002/003 Syrup N/A
MERBENTYL 20 Marion Merrell Limited PA0041/005/004 Tablets - DICYCLOVERINE N/A
MERIEUX ORAL Merieux UK Limited PA0504/003/003 N/A
POLIOMYELITIS
METOCLOPRAMIDE Company Liquidated M123 PA0211/020/001 Tablets N/A
MFV JECT 0.5 ML Servier Laboratories (Ireland) PA0068/007/006 N/A
Ltd
MFV JECT 5 ML Servier Laboratories (Ireland) PA0068/007/004 N/A
MULTIDOSE Ltd
MFV-JECT Merieux UK Limited PA0504/001/002 Solution for Injection N/A
MFV-JECT 25 ML Servier Laboratories (Ireland) PA0068/007/005 N/A
MULTIDOSE VIAL Ltd
MICANOL Bioglan Laboratories Ltd PA0469/017/001 Cream - DITHRANOL N/A
MICANOL Bioglan Laboratories Ltd PA0469/017/002 Cream - DITHRANOL N/A
MICROPAQUE HD Nicholas Laboratories PA0032/016/003 - BARIUM SULFATE N/A
MIGRIL Wellcome (Ireland) Limited PA0017/051/001 Tablets - ERGOTAMINE TARTRATE N/A
- CYCLIZINE
HYDROCHLORIDE
- CAFFEINE

MIRTAZAPINE MEDIS 15 Medis ehf PA1285/003/001 Film Coated Tablet - MIRTAZAPINE N/A
MG FILM-COATED
TABLETS
MIXTARD 10 PENFILL 3ML Novo Nordisk A/S PA0218/033/004 Suspension for Injection - INSULIN HUMAN N/A
MIXTARD 50 PENFILL 3ML Novo Nordisk A/S PA0218/036/004 Suspension for Injection - INSULIN HUMAN N/A
MIXTARD HUMAN 40 IU/ML Nordisk Gentofte A/S PA0217/011/001 N/A

MIXTARD HUMAN 80 IU/ML Nordisk Gentofte A/S PA0217/011/002 N/A

MOBIFLEX Roche Products Limited PA0050/067/001 Tablets - TENOXICAM N/A


MONOMAX Chiesi Limited PA0743/003/001 Modified-release capsule, - ISOSORBIDE N/A
hard MONONITRATE
MONOMAX Chiesi Limited PA0743/003/002 Modified-release capsule, - ISOSORBIDE N/A
hard MONONITRATE
MONOMAX Chiesi Limited PA0743/003/003 Modified-release capsule, - ISOSORBIDE N/A
hard MONONITRATE
MONOTARD Novo Nordisk A/S EU/1/02/235/1-4 Suspension for Injection - INSULIN HUMAN N/A

Human Medicines Withdrawn Products Page 553 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MST CONTINUS Napp Pharmaceuticals PA0913/005/011 Granules Prolonged Release - MORPHINE SULFATE N/A
Limited
MST CONTINUS Napp Pharmaceuticals PA0913/005/012 Granules Prolonged Release - MORPHINE SULFATE N/A
Limited
MULTIVITAMINS FORMULA Lifeplan Products Ltd PA0354/001/001 Tablets - MULTIVITAMINS N/A
- FERROUS FUMARATE
NAEMIS Merck Serono Limited PA0654/014/001 Tablets - ESTRADIOL N/A
- NOMEGESTROL
ACETATE
NALOXONE Mercury Pharmaceuticals PA0073/111/001 Solution for Inj/Inf - NALOXONE N/A
HYDROCHLORIDE (Ireland) Ltd HYDROCHLORIDE
DIHYDRATE
NARCAN Du Pont De Nemours PA0200/001/004 Withdrawn Form - NALOXONE N/A
Intern.S.A. HYDROCHLORIDE
NEORECORMON Roche Registration GmbH EU/1/97/031/006 Pdr+Solv for Soln for Inj - EPOETIN BETA N/A
NEOSPECT CIS bio International EU/1/00/154/001 Powder for solution for - DEPREOTIDE N/A
infusion TRIFLUOROACETATE
NEOSPECT CIS bio International EU/1/00/154/002 Radio-Pharm Precursor - DEPREOTIDE N/A
TRIFLUOROACETATE
NESPO Amgen Europe B.V. EU/1/01/184/001 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/002 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/003 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/004 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/005 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/006 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/007 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/008 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/009 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/010 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/011 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/012 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/013 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/014 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/015 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/016 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/017 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/018 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/019 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/020 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/021 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/022 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/023 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/024 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/025 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/026 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/027 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/028 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/029 Solution for Injection - DARBEPOETIN ALFA N/A
NESPO Amgen Europe B.V. EU/1/01/184/030 Solution for Injection - DARBEPOETIN ALFA N/A
NEUPOPEG Amgen Europe B.V. EU/1/02/228/001 Solution for Injection - PEGFILGRASTIM N/A
NIFLURIL Mayne Pharma (Ireland) PA0078/039/001 Capsule - NIFLUMIC ACID N/A
Limited
NIGHT NURSE COLD SmithKlineBeecham PA0379/001/001 - PROMETHAZINE N/A
REMEDY Consumer Brand HYDROCHLORIDE
- PHOLCODINE
- PARACETAMOL
NIMBEX GlaxoSmithKline (Ireland) PA1077/072/002 Solution for Injection - CISATRACURIUM N/A
Limited
NITROFURANTOIN Company Liquidated M123 PA0211/006/001 Tablets N/A
NITROFURANTOIN Company Liquidated M123 PA0211/006/002 Tablets N/A
NOOTROPIL UCB (Pharma) Ireland PA0891/001/001 Oral Solution - PIRACETAM N/A
Limited
NOOTROPIL UCB (Pharma) Ireland PA0891/001/002 Film Coated Tablet - PIRACETAM N/A
Limited
NOVAPEN Controlled Medications PA0157/003/002 Syrup - AMPICILLIN N/A
Limited
NU-SEALS PCO Manufacturing PPA0465/074/001A Tablets Gastro-Resistant - ACETYLSALICYLIC ACID N/A
OILATUM EMOLLIENT Eurodrug Ltd DPR1392/037/001 Bath Additive - LIQUID PARAFFIN LIGHT N/A
OPERIDINE Janssen Pharmaceutica PA0045/015/001 - PHENOPERIDINE N/A
HYDROCHLORIDE
OPREN Eli Lilly and Company Limite PA0047/051/001 Tablets - BENOXAPROFEN N/A

OPREN Eli Lilly and Company Limite PA0047/051/002 Tablets - BENOXAPROFEN N/A

Human Medicines Withdrawn Products Page 554 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OPREN Eli Lilly and Company Limite PA0047/051/003 Tablets - BENOXAPROFEN N/A

OPULIS Schering Plough Europe EU/1/00/158/001 Tablets - DESLORATIDINE N/A


OPULIS Schering Plough Europe EU/1/00/158/002 Tablets N/A
OPULIS Schering Plough Europe EU/1/00/158/003 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/004 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/005 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/006 Tablets N/A
OPULIS Schering Plough Europe EU/1/00/158/007 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/008 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/009 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/010 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/011 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/012 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/013 Tablets - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/014 Syrup - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/015 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/016 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/017 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/018 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/019 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/020 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/021 Syrup N/A
OPULIS Schering Plough Europe EU/1/00/158/022 Oral Lyophilisate - DESLORATIDINE N/A
OPULIS Schering Plough Europe EU/1/00/158/023 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/024 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/025 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/026 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/027 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/028 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/029 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/030 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/031 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/032 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/033 Oral Lyophilisate N/A
OPULIS Schering Plough Europe EU/1/00/158/034 Oral Lyophilisate N/A
ORAMORPH Boehringer Ingelheim Limited PA0007/044/008 Oral Solution - MORPHINE SULFATE N/A

ORAMORPH Boehringer Ingelheim Limited PA0007/044/009 Oral Solution - MORPHINE SULFATE N/A

ORAMORPH ORAL Boehringer Ingelheim Limited PA0007/044/007 Oral Solution - MORPHINE SULFATE N/A
SOLUTION
OSSOPAN 800 Sanofi-Synthelabo Ireland PA0077/117/001 Tablets - HYDROXYAPETITE N/A
Ltd COLLAGEN COMPOUND
OXYLIN LIQUIFILM 0.025% Allergan Pharmaceuticals PA0148/039/001 Eye Drops Solution - OXYMETAZOLINE N/A
W/V EYE DROPS, Ireland HYDROCHLORIDE
SOLUTION
PABRINEX IM Paines and Byrne Limited PA0090/010/003 Withdrawn Form N/A
PAEDO-SED Forest Laboratories UK Ltd PA0100/005/002 N/A
PAMERGAN AP100/25 May & Baker Limited PA0040/022/001 N/A
PAMERGAN P100 May & Baker Limited PA0040/023/001 N/A
PARACETAMOL Company Liquidated M123 PA0211/005/001 Tablets N/A
PARACETAMOL ELIXIR Company Liquidated M123 PA0211/005/002 N/A
PAEDIATRIC
PARACETAMOL/CAFFEINE SSL International plc PA1138/023/001 Tablets - PARACETAMOL N/A
/CODEINE AND - CODEINE PHOSPHATE
DOXYLAMINE - DOXYLAMINE
SUCCINATE
- CAFFEINE
PARAREG Amgen Europe B.V. EU/1/04/293/1-12 Coated Tablets - CINACALCET N/A
HYDROCHLORIDE
PAROCETAN Clonmel Healthcare Ltd PA0126/124/001 Coated Tablets - PAROXETINE N/A
HYDROCHLORIDE
PATREX Pfizer Limited EU/1/98/078/001 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/002 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/003 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/004 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/005 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/006 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/007 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/008 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/009 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/010 Tablets - SILDENAFIL N/A
PATREX Pfizer Limited EU/1/98/078/011 Tablets - SILDENAFIL N/A

Human Medicines Withdrawn Products Page 555 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PATREX Pfizer Limited EU/1/98/078/012 Tablets - SILDENAFIL N/A
PAXENE Norton Healthcare Limited EU/1/99/113/001 Concentrate for Soln for Inf - PACLITAXEL N/A
T/A IVAX Pharmaceuticals
UK
PAXENE Norton Healthcare Limited EU/1/99/113/2-4 Concentrate for Soln for Inf - PACLITAXEL N/A
T/A IVAX Pharmaceuticals
UK
PAXT McDermott Laboratories Ltd PA0577/050/001 Film Coated Tablet - PAROXETINE N/A
t/a Gerard Laboratories HYDROCHLORIDE
PAXT McDermott Laboratories Ltd PA0577/050/002 Film Coated Tablet - PAROXETINE N/A
t/a Gerard Laboratories HYDROCHLORIDE
PEROIDIN Larkhall Laboratories Plc PA0288/001/001 Tablets N/A
PETHIDINE International Medication PA0255/024/001 Withdrawn Form N/A
Systems (UK) Ltd
PEVISONE Cilag-Chemie, PA0189/003/001 Cream - ECONAZOLE N/A
- TRIAMCINOLONE
ACETONIDE
PHARMATON KIDDI Boehringer Ingelheim Limited PA0007/061/001 Oral Solution - LYSINE N/A
HYDROCHLORIDE
- CALCIUM
GLYCEROPHOSPHATE
- THIAMINE
HYDROCHLORIDE
- RIBOFLAVIN SODIUM
PHOSPHATE
- PYRIDOXINE
HYDROCHLORIDE
- COLECALCIFEROL
- TOCOPHERYL ACETATE
- NICOTINAMIDE
- DEXPANTHENOL
PHARMORUBICIN 10 MG Pharmacia Healthcare PA0936/043/003 Solution for Injection - EPIRUBICIN N/A
SOLUTION FOR INJECTIO Ireland HYDROCHLORIDE

PHARMORUBICIN 2 MG/ML Pharmacia Healthcare PA0936/043/007 Solution for Inj/Inf - EPIRUBICIN N/A
SOLUTION FOR INJECTION Ireland HYDROCHLORIDE
OR IN
PHARMORUBICIN 2 MG/ML Pharmacia Healthcare PA0936/043/009 Solution for Inj/Inf - EPIRUBICIN N/A
SOLUTION FOR INJECTION Ireland HYDROCHLORIDE
OR IN
PHARMORUBICIN 50 MG Pharmacia Healthcare PA0936/043/004 Solution for Injection - EPIRUBICIN N/A
SOLUTION FOR INJECTIO Ireland HYDROCHLORIDE

PHENOBARBITONE Company Liquidated M123 PA0211/012/001 Tablets - PHENOBARBITAL N/A


PHENOBARBITONE Company Liquidated M123 PA0211/012/002 Tablets - PHENOBARBITAL N/A
PHENOBARBITONE Company Liquidated M123 PA0211/012/003 Tablets - PHENOBARBITAL N/A
PHENSIC 325MG/22MG Seven Seas Ltd PA0417/017/001 Tablets - ACETYLSALICYLIC ACID N/A
TABLETS - CAFFEINE
PHENYLBUTAZONE Company Liquidated M123 PA0211/011/002 Tablets N/A
PHOTOBARR Axcan Pharma International EU/1/04/272/1-2 Pdr for Soln for Injection - HYDROCHLORIC ACID N/A
B.V. - SODIUM HYDROXIDE
PHYLLOCONTIN Napp Laboratories Limited PA0114/007/004 Tablets N/A
PHYTEX PAINT Wynlit Laboratories Limited PA0283/002/001 Cutaneous Solution - TANNIC ACID N/A
- BORIC ACID
- SALICYLIC ACID
- METHYL SALICYLATE
PINAMET Pinewood Laboratories Ltd, PA0281/092/002 Tablets - CIMETIDINE N/A
PINDAC Leo Laboratories Limited PA0046/054/002 Capsule - PINACIDIL N/A
PLACIDEX E.C. De Witt & Company PA0299/001/001 Syrup - PARACETAMOL N/A
Limited
PREDNISOLONE Company Liquidated M123 PA0211/010/001 Tablets N/A
PREMARIN PCO Manufacturing PPA0465/069/001B Tablets - ESTROGENS N/A
CONJUGATED
PRIMAVAX Sanofi Pasteur MSD Ltd EU/1/97/056/001 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
PRIODERM LOTION SSL International plc PA1138/006/002 Cutaneous Solution - MALATHION N/A
PROCHLORPERAZINE Mercury Pharmaceuticals PA0073/129/001 Solution for Injection - PROCHLORPERAZINE N/A
INJECTION BP 12.5MG/ML. (Ireland) Ltd MESILATE

PROCHLORPERAZINE Mercury Pharmaceuticals PA0073/129/002 Solution for Injection - PROCHLORPERAZINE N/A


INJECTION BP 25MG IN (Ireland) Ltd MESILATE
2ML

Human Medicines Withdrawn Products Page 556 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROCOMVAX Pasteur Merieux MSD EU/1/99/104/001 Suspension for Injection - HAEMOPHILUS N/A
INFLUENZAE TYPE B
POLYSACCHARIDE
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- NEISSERIA
MENINGITIDIS, OUTER
MEMBRANE COMPLEX
PROHIBIT VIAL Wellcome (Ireland) Limited PA0017/100/001 - DIPHTHERIA TOXOID N/A
PROPINE-PTM Allergan Pharmaceuticals PA0148/037/002 N/A
Ireland
PROTOPIC Astellas Pharma GmbH EU/1/02/202/001 Ointment - TACROLIMUS N/A
PROTOPY Astellas Pharma GmbH EU/1/02/202/002 Ointment - TACROLIMUS N/A
PROTOPY Astellas Pharma GmbH EU/1/02/202/004 Ointment - TACROLIMUS N/A
PROTOPY Astellas Pharma GmbH EU/1/02/202/005 Ointment - TACROLIMUS N/A
PROTOPY Astellas Pharma GmbH EU/1/02/202/006 Ointment - TACROLIMUS N/A
PROVERA Pharmacia Limited PA0016/023/005 Oral Suspension - N/A
MEDROXYPROGESTERO
NE ACETATE
QUINTANRIX GlaxoSmithKline Biologicals EU/1/04/301/1-5 Powder for suspension for - DIPHTHERIA TOXOID N/A
S.A. injection - TETANUS TOXOID
- BORDETELLA
PERTUSSIS
- HEPATITIS B SURFACE
ANTIGEN, RECOMINANT
- HAEMOPHILUS
INFLUENZAE TYPE B
POLYSACCHARIDE
QUIXIDAR N.V. Organon EU/1/02/207/001 Solution for Injection - FONDAPARINUX SODIUM N/A

QUIXIDAR N.V. Organon EU/1/02/207/002 Solution for Injection - FONDAPARINUX SODIUM N/A

QUIXIDAR N.V. Organon EU/1/02/207/003 Solution for Injection - FONDAPARINUX SODIUM N/A

QUIXIDAR N.V. Organon EU/1/02/207/004 Solution for Injection - FONDAPARINUX SODIUM N/A

QUIXIDAR Glaxo Group Limited EU/1/02/207/09-10 Solution for Injection - FONDAPARINUX SODIUM N/A

QUIXIDAR Sanofi aventis EU/1/02/207/5-8 Solution for Injection - FONDAPARINUX SODIUM N/A

RALGEX LRC Products Ltd PA0197/001/002 - GLYCOL SALICYLATE N/A


- ETHYL SALICYLATE
- METHYL SALICYLATE
- CAPSAICIN
- MENTHOL
RALGEX BALM Gillespie & Company Ltd PA0266/002/003 N/A
RALGEX SPRAY LRC Products Ltd PA0197/001/001 - GLYCOL SALICYLATE N/A
- ETHYL SALICYLATE
- METHYL SALICYLATE
- METHYL NICOTINATE
- ISOPROPANOL
RANTIDINE Rowa Pharmaceuticals PA0074/034/001-3 Unknown N/A
Limited
RAPTIVA Serono Europe Limited EU/1/04/291/1-2 Pdr+Solv for Soln for Inj - EFALIZUMAB N/A
RASITRIO Novartis Europharm Limited EU/1/11/730/001-012 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
- HYDROCHOLOTHIAZIDE
RASITRIO Novartis Europharm Limited EU/1/11/730/013-024 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
- HYDROCHOLOTHIAZIDE
RAYZON Pharmacia Europe EEIG EU/1/02/210/001 Pdr for Soln for Injection - PARECOXIB SODIUM N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/002 Pdr+Solv for Soln for Inj N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/003 Pdr+Solv for Soln for Inj N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/004 Pdr+Solv for Soln for Inj N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/005 Pdr for Soln for Injection N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/006 Pdr for Soln for Injection N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/007 Pdr+Solv for Soln for Inj N/A
RAYZON Pharmacia Europe EEIG EU/1/02/210/008 Pdr+Solv for Soln for Inj N/A
REDOXON Roche Products Limited PA0050/007/001 - ASCORBIC ACID N/A
REDUCTIL Abbott Laboratories Ireland PA0038/075/001 Capsule - SIBUTRAMINE N/A
Ltd HYDROCHLORIDE
MONOHYDRATE

Human Medicines Withdrawn Products Page 557 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
REDUCTIL Abbott Laboratories Ireland PA0038/075/002 Capsule - SIBUTRAMINE N/A
Ltd HYDROCHLORIDE
MONOHYDRATE
RELIGER McDermott Laboratories Ltd PA0577/044/001 Film Coated Tablet - NABUMETONE N/A
t/a Gerard Laboratories
REMEGEL SUMMER FRUIT SSL International plc PA1138/022/002 Tablets Chewable - CALCIUM CARBONATE N/A

RESOLVE SSL International PLC PA0618/034/001 Granules Effervescent - PARACETAMOL N/A


- CITRIC ACID
- SODIUM BICARBONATE
- POTASSIUM
BICARBONATE
- SODIUM CARBONATE
ANHYDROUS
- ASCORBIC ACID
RIMACTANE Sandoz GmbH PA0111/002/002 Capsule - RIFAMPICIN N/A
RISPERDAL PCO Manufacturing PPA0465/078/001A Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/001B Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/001C Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/001D Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/001E Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/002A Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/002B Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/002C Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/002D Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/003A Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/003B Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/003C Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/003D Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/003E Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/004A Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/004B Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/004C Tablets - RISPERIDONE N/A
RISPERDAL PCO Manufacturing PPA0465/078/004D Tablets - RISPERIDONE N/A
RYTHMODAN Roussel Laboratories Limited PA0006/005/001 Solution for Injection - DISOPYRAMIDE N/A
PHOSPHATE
S.T.D. STD Pharmaceutical PA0246/001/001 Withdrawn Form N/A
Products Ltd
S.T.D. STD Pharmaceutical PA0246/001/002 Withdrawn Form N/A
Products Ltd
SAIZEN Serono Limited PA0285/005/001 Pdr+Solv for Soln for Inj - SOMATROPIN N/A
SAIZEN Serono Limited PA0285/005/002 Pdr+Solv for Soln for Inj - SOMATROPIN N/A
SANATOGEN NERVE Fisons Limited PA0018/029/001 N/A
TONIC
SANDOCAL Novartis Consumer Health PA0030/046/001 Tablets Effervescent - CALCIUM LACTATE N/A
UK Limited GLUCONATE
- CALCIUM CARBONATE
SCANDONEST Septodont PA0196/016/001 Solution for Injection - MEPIVACAINE N/A
HYDROCHLORIDE
- EPINEPHRINE
SELEXID Leo Laboratories Limited PA0046/014/004 Withdrawn Form N/A
SEMITARD MC INSULIN Novo Nordisk A/S PA0218/002/002 N/A
ZINC SUSPENSION
SERTRALINE MEDIS Medis ehf PA1285/010/001 Film Coated Tablet - SERTRALINE N/A
HYDROCHLORIDE
SERTRALINE MEDIS Medis ehf PA1285/010/002 Film Coated Tablet - SERTRALINE N/A
HYDROCHLORIDE
SETLERS ANTACID Thornton & Ross Limited PA0610/016/001 Tablets - CALCIUM CARBONATE N/A
PEPPERMINT
SETLERS ANTACID Thornton & Ross Limited PA0610/016/002 Tablets - CALCIUM CARBONATE N/A
SPEARMINT
SMECTA Beaufour Schwabe PA0353/004/001 - FLAVOXATE N/A
HYDROCHLORIDE
SODIUM CHLORIDE Mercury Pharmaceuticals PA0073/105/005A Solution for Injection - SODIUM CHLORIDE N/A
(Ireland) Ltd
SODIUM CHROMATE (51 GE Healthcare Limited PA0240/019/001 Solution for Injection - SODIUM CHROMATE (51 N/A
CR) 37 MBQ/ML CR)
RADIOPHARMACEUTI
SPORANOX 100MG PCO Manufacturing PPA0465/137/001A Capsules Hard - ITRACONAZOLE N/A
CAPSULES
STERAC SODIUM Galen Research Laboratories PA0295/001/001 - SODIUM CHLORIDE N/A
CHLORIDE Ltd
STERAC SODIUM Galen Research Laboratories PA0295/001/002 - SODIUM CHLORIDE N/A
CHLORIDE Ltd

Human Medicines Withdrawn Products Page 558 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
STERISOL SODIUM Galen Research Laboratories PA0295/001/005 - SODIUM CHLORIDE N/A
CHLORIDE Ltd
STRUCTOLIPID Fresenius Kabi Limited PA0566/010/001 Emulsion for Infusion - TRIGLYCERIDES N/A
SULOCTON Ovelle Limited PA0206/005/001 Capsule - SULOCTIDIL N/A
SULPHAMEZATHINE Zeneca Limited PA0051/013/001 Withdrawn Form - SULFADIMIDINE N/A
SURGAM Roussel Laboratories Limited PA0006/023/001 Tablets - TIAPROFENIC ACID N/A

SYNALAR Bioglan Laboratories Ltd PA0469/026/002 Gel - FLUOCINOLONE N/A


ACETONIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/001 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/002 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/003 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/004 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/005 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/006 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/007 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/008 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/009 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TALUVIAN Abbott S.p.A. EU/1/01/182/010 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
TAMOXIFEN B P Norton Healthcare Limited PA0282/032/001 Tablets N/A
T/A IVAX Pharmaceuticals
UK
TANDERIL Novartis Consumer Health PA0030/008/001 Ointment - OXYPHENBUTAZONE N/A
CHLORAMPHENICOL EYE UK Limited - CHLORAMPHENICOL
TANDERIL EYE Novartis Consumer Health PA0030/007/001 Ointment - OXYPHENBUTAZONE N/A
UK Limited
TARACTAN Roche Products Limited PA0050/020/001 Tablets - CHLORPROTHIXENE N/A
TARACTAN Roche Products Limited PA0050/020/002 Tablets - CHLORPROTHIXENE N/A
TEEJEL SSL International plc PA1138/026/001 Oromucosal Gel - CHOLINE SALICYLATE N/A
- CETALKONIUM
CHLORIDE
TEMAZEPAM John Wyeth & Brother PA0022/042/001 Capsule - TEMAZEPAM N/A
Limited
TEMAZEPAM John Wyeth & Brother PA0022/042/002 Capsule - TEMAZEPAM N/A
Limited
TENECTEPLASE Boehringer Ingelheim EU/1/00/168/001 Pdr+Solv for Soln for Inj - TENECTEPLASE N/A
International GmbH
TENECTEPLASE Boehringer Ingelheim EU/1/00/168/002 Pdr+Solv for Soln for Inj - TENECTEPLASE N/A
International GmbH
TENECTEPLASE Boehringer Ingelheim EU/1/00/168/003 Pdr+Solv for Soln for Inj - TENECTEPLASE N/A
International GmbH
TENORMIN PCO Manufacturing PPA0465/023/002B Tablets - ATENOLOL N/A
TENORMIN 100 MG FILM- PCO Manufacturing PPA0465/023/002A Film Coated Tablet - ATENOLOL N/A
COATED TABLETS
TENORMIN 50MG FILM- PCO Manufacturing PPA0465/023/001A Film Coated Tablet - ATENOLOL N/A
COATED TABLETS
TENORMIN LS Zeneca Limited PA0051/052/001 Tablets N/A
TERBINAFINE MEDIS Medis ehf PA1285/009/001 Tablets - TERBINAFINE N/A
HYDROCHLORIDE
THELIN Pfizer Limited EU/1/06/353/001 Tablets - SITAXENTAN SODIUM N/A
THELIN Pfizer Limited EU/1/06/353/002 Film Coated Tablet - SITAXENTAN SODIUM N/A
THELIN Pfizer Limited EU/1/06/353/3-5 Tablets - SITAXENTAN SODIUM N/A
THEOVENT LONG ACTING Schering-Plough Limited PA0277/022/001 Capsule - THEOPHYLLINE N/A

THEOVENT LONG ACTING Schering-Plough Limited PA0277/022/002 Capsule - THEOPHYLLINE N/A

THERYTTREX MDS Nordion S.A. EU/1/02/245/001 Radio-Pharm Precursor - YTTRIUM (90 Y) N/A
TIKOSYN Pfizer Limited EU/1/99/121/001 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/002 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Healthcare Ireland EU/1/99/121/003 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/004 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/005 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/006 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/007 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/008 Capsule - DOFETILIDE N/A

Human Medicines Withdrawn Products Page 559 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TIKOSYN Pfizer Limited EU/1/99/121/009 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/010 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/011 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/012 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/013 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/014 Capsule - DOFETILIDE N/A
TIKOSYN Pfizer Limited EU/1/99/121/015 Capsule - DOFETILIDE N/A
TIMOPTOL OPHTHALMIC Merck Sharp and Dohme PA0035/044/001 N/A
Limited
TIMOPTOL OPHTHALMIC Merck Sharp and Dohme PA0035/044/002 N/A
Limited
TIMOPTOL OPHTHALMIC Merck Sharp and Dohme PA0035/044/003 N/A
Limited
TINADERM-M CREAM Schering-Plough Limited PA0277/003/003 N/A
TINSET Janssen Pharmaceutica PA0045/027/001 Tablets - OXATOMIDE N/A
TOBRAMYCIN Eli Lilly and Company Limite PA0047/003/003 Withdrawn Form N/A

TOBRAMYCIN SULPHATE Eli Lilly and Company Limite PA0047/003/001 Withdrawn Form N/A

TOBRAMYCIN SULPHATE Eli Lilly and Company Limite PA0047/003/002 Withdrawn Form N/A

TOFRANIL Ciba Geigy Plc PA0028/024/002 Tablets N/A


TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/001 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/002 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/003 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/004 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/005 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/006 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/007 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/008 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/009 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/010 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/011 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/012 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/013 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/014 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/015 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/016 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/017 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/018 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/019 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/020 Tablets - NATEGLINIDE N/A
TRAZEC FILM-COATED Novartis Europharm Limited EU/1/01/175/021 Tablets - NATEGLINIDE N/A
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/001 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/002 Solution for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/003 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/004 Solution for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/005 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN

Human Medicines Withdrawn Products Page 560 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/006 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/007 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/008 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRIACELLUVAX GSK Vaccines S.r.l. EU/1/98/088/009 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
- PERTUSSIS TOXOID
- FILAMENTOUS
HAEMAGGLUTININ (FHA)
- PERTACTIN
TRILOBAL Intersan GmbH PA0414/001/001 Oral Drops Solution - GINKGO BILOBA N/A
TRIPTAFEN DA Glaxo Laboratories Limited PA0044/015/002 Tablets - AMITRIPTYLINE N/A
HYDROCHLORIDE
- PERPHENAZINE
TRIPTAFEN M Allen and Hanburys Limited PA0024/006/002 Tablets - AMITRIPTYLINE N/A
HYDROCHLORIDE
- PERPHENAZINE
TRUDEXA Abbott Laboratories Limited EU/1/03/257/1-6 Solution for Injection - MANNITOL N/A
ULTRATARD Novo Nordisk A/S EU/1/02/236/1-4 Suspension for Injection - INSULIN HUMAN N/A
UNIGAM Norgine Limited PA0102/026/001 - OENOTHERA BIENNIS N/A
UNIPHYLLIN CONTINUS Napp Pharmaceuticals PA0913/006/009 Tablets - THEOPHYLLINE N/A
Limited
UNIPHYLLIN SPRINKLE Napp Pharmaceuticals PA0913/006/004 Capsule - THEOPHYLLINE N/A
Limited
UNIPHYLLIN SPRINKLE Napp Pharmaceuticals PA0913/006/005 Capsule - THEOPHYLLINE N/A
Limited
UNIPHYLLIN SPRINKLE Napp Pharmaceuticals PA0913/006/006 Capsule - THEOPHYLLINE N/A
Limited
UNIPHYLLIN SPRINKLE Napp Pharmaceuticals PA0913/006/007 Capsule - THEOPHYLLINE N/A
Limited
UNIPHYLLIN SPRINKLE Napp Pharmaceuticals PA0913/006/008 Capsule - THEOPHYLLINE N/A
Limited
UPRIMA Abbott Laboratories Limited EU/1/01/180/001 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/003 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/004 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/005 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/006 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/007 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/009 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
UPRIMA Abbott Laboratories Limited EU/1/01/180/010 Tablet Sublingual - APOMORPHINE N/A
HYDROCHLORIDE
VALDYN Pharmacia Enterprises S.A. EU/1/02/244/1-24 Tablets - VALDECOXIB N/A
VALTROPIN (SOMATROPIN BioPartners GmbH EU/1/06/335/001 Pdr+Solv for Soln for Inj - SOMATROPIN N/A
BIOPARTNERS)

Human Medicines Withdrawn Products Page 561 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VAMIN 9 GLUCOSE Fresenius Kabi Limited PA0566/012/004 Solution for Infusion - ALANINE N/A
- ARGININE
- ASPARTIC ACID
- CYSTEINE
- GLUTAMIC ACID
- AMINOACETIC ACID
- HISTIDINE
- ISOLEUCINE
- LEUCINE
- LYSINE
- METHIONINE
- PHENYLALANINE
- PROLINE
- SERINE
- THREONINE
- TRYPTOPHAN, L-
- TYROSINE
- VALINE
VANOXIDE Rorer Pharmaceuticals PA0468/028/001 - BENZOYL PEROXIDE N/A
Limited
VARIOTIN Leo Laboratories Limited PA0046/010/001 Ointment - PECILOCIN N/A
VASOGEN Forest Laboratories UK Ltd PA0100/044/001 Cream - DIMETICONE N/A
- ZINC OXIDE
- CALAMINE
VELOSULIN Novo Nordisk A/S EU/1/02/232/1-2 Solution for Injection - INSULIN HUMAN N/A
VELOSULIN HUMAN 40 Nordisk Gentofte A/S PA0217/008/001 N/A
IU/ML
VELOSULIN HUMAN Nordisk Gentofte A/S PA0217/008/002 N/A
80IU/ML
VENTOLIN GlaxoSmithKline (Ireland) PA1077/049/003 N/A
Limited
VENTOLIN ROTAHALER & Glaxo Laboratories Limited PA0044/003/005 N/A
BOX
VICKS LOZENGES Procter & Gamble (Health & PA0441/025/002 Lozenges N/A
BLACKCURRANT Beauty Care) Limited
VICKS LOZENGES LEMON Procter & Gamble (Health & PA0441/028/001 - MENTHOL N/A
Beauty Care) Limited - CAMPHOR
VICKS LOZENGES Procter & Gamble (Health & PA0441/025/001 Lozenges - MENTHOL N/A
REGULAR Beauty Care) Limited - CAMPHOR
VIPEN POWDER Controlled Medications PA0157/011/001 - N/A
(SUSPENSION) Limited PHENOXYMETHYLPENICI
LLIN
VIRAFERON Schering Plough Europe EU/1/99/128/001 Pdr+Solv for Soln for Inj - RECOMBINANT N/A
INTERFERRON ALFA-2B
VIRAFERON Schering Plough Europe EU/1/99/128/002 Pdr+Solv for Susp for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/003 Pdr+Solv for soln for Inf - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/004 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/005 Pdr+Solv for soln for Inf - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/006 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/007 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/008 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/009 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/010 Pdr+Solv for Soln for Inj - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/011 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/012 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/013 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/014 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/016 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/017 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/018 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/019 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/020 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/021 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/022 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/023 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/024 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/025 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/026 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/027 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/028 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/029 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/030 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/031 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/032 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/033 Solution for Injection - INTERFERON ALFA-2B N/A

Human Medicines Withdrawn Products Page 562 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VIRAFERON Schering Plough Europe EU/1/99/128/034 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/035 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/036 Solution for Injection - INTERFERON ALFA-2B N/A
VIRAFERON Schering Plough Europe EU/1/99/128/037 Solution for Injection - INTERFERON ALFA-2B N/A
VITAMIN C PLUS 200 MG Seven Seas Health Care Ltd PA0416/005/001 Capsule - ASCORBIC ACID N/A
SOFT CAPSULE
VITAMIN E Health & Diet Food Company PA0395/004/002 Capsule - TOCOPHEROL N/A
Ltd
VOLTAROL RETARD 100 PCO Manufacturing PPA0465/013/004A Tablets - DICLOFENAC SODIUM N/A
MG FILM-COATED
PROLONGED-RELEA
VOLTAROL RETARD 75 MG PCO Manufacturing PPA0465/013/003A Tablet Prolonged Release - DICLOFENAC SODIUM N/A
FILM-COATED
PROLONGED-RELEAS
WELLCOME BRAND Wellcome (Ireland) Limited PA0017/059/001 N/A
INSULIN ZINC
(SUSPENSION)
WELLCOME Wellcome (Ireland) Limited PA0017/043/002 N/A
POLIOMYELITIS
XENON BOC Gases Ireland Ltd PA0208/007/001 N/A
XIGRIS Eli Lilly Nederland B.V. EU/1/02/225/1-2 Powder for solution for - DROTRECOGIN ALFA N/A
infusion (ACTIVATED)
XYLOCAINE ACCORDION AstraZeneca UK Limited PA0970/054/002 Gel - LIDOCAINE N/A
HYDROCHLORIDE
ZANTAC Blackrock Clinic Limited PA0661/001/002 Tablets - RANITIDINE N/A
ZENAPAX Roche Registration Limited EU/1/99/098/001 Concentrate for Soln for Inf - DACLIZUMAB N/A
ZENAPAX Roche Registration Limited EU/1/99/098/002 Concentrate for Soln for Inf - DACLIZUMAB N/A
ZIMULTI Sanofi aventis EU/1/06/345/01 Coated Tablets - RIMONABANT N/A
ZOTON PCO Manufacturing PPA0465/058/001B Capsule - LANSOPRAZOLE N/A
ABLAVAR TMC Pharma Services Ltd EU/1/05/313/1-9 Solution for Injection - GADOFOSVESET N/A
TRISODIUM
ACERYCAL Profind Wholesale Ltd PPA1500/071/001 Tablets - PERINDOPRIL ARGININE N/A
- AMLODIPINE BESYLATE
ACERYCAL Profind Wholesale Ltd PPA1500/071/002 Tablets - PERINDOPRIL ARGININE N/A
- AMLODIPINE BESYLATE
ACERYCAL Profind Wholesale Ltd PPA1500/071/003 Tablets - PERINDOPRIL ARGININE N/A
- AMLODIPINE BESYLATE
ACERYCAL Profind Wholesale Ltd PPA1500/071/004 Tablets - PERINDOPRIL ARGININE N/A
- AMLODIPINE BESYLATE
ACTONEL ONCE A WEEK McDowell Pharmaceuticals PPA1473/011/001 Film Coated Tablet - RISEDRONATE SODIUM N/A
ACTONEL ONCE A WEEK Eurodrug Ltd DPR1392/028/001 Film Coated Tablet - RISEDRONATE SODIUM N/A
ACTONEL ONCE A WEEK IMED Healthcare Ltd. DPR1463/001/001 Coated Tablets - RISEDRONATE SODIUM N/A
ACTONEL ONCE A WEEK Profind Wholesale Ltd DPR1500/005/001 Film Coated Tablet - RISEDRONATE SODIUM N/A
ACTONEL PLUS CA & D Warner Chilcott UK Limited PA1635/003/002 Film Coated Tablet - RISEDRONATE SODIUM N/A
TABLET 35MG AND - CALCIUM CARBONATE
500MG/400 IU F - CHOLECALCIFEROL
CONCENTRATE
ADCORTYL IN OROBASE B & S Healthcare DPR1328/003/001 Oromucosal Paste - TRIAMCINOLONE N/A
ACETONIDE
ALDOMET McDowell Pharmaceuticals DPR1473/001/001 Tablets - METHYLDOPA N/A
ALPHAGAN Belfast Drug Ltd. DPR1601/003/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN McDowell Pharmaceuticals DPR1473/002/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN Profind Wholesale Ltd DPR1500/010/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN LTT Pharma Limited DPR1562/008/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN Pharma First Limited DPR1592/001/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN B & S Healthcare DPR1328/020/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN MIRAPHARM DPR1400/001/001 Ear Drops Solution - BRIMONIDINE TARTRATE N/A

ALPHAGAN EYE DROPS Clear Pharmacy DPR1596/015/001 Eye Drops Solution - BRIMONIDINE TARTRATE N/A
SOLUTION
AMISULPRIDE ACTAVIS Actavis Group PTC ehf PA1380/089/001 Film Coated Tablet - AMISULPRIDE N/A
ANASTROZOLE PROGEN Progen s.r.l., PA1507/001/001 Film Coated Tablet - ANASTROZOLE N/A
ANTEPSIN McDowell Pharmaceuticals DPR1473/023/001 Oral Suspension - SUCRALFATE N/A
ANTEPSIN McDowell Pharmaceuticals DPR1473/023/002 Tablets - SUCRALFATE N/A
APLIDIN Pharma Mar SA H/C/4354/00/0/0 Powder and solvent for - PLITIDEPSIN N/A
concentrate for solution for
infusion

Human Medicines Withdrawn Products Page 563 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
ARANESP Amgen Europe B.V. H/C/333/X/42 Solution for Injection - DARBEPOETIN ALFA N/A
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
ARCOXIA Profind Wholesale Ltd DPR1500/016/001 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Profind Wholesale Ltd DPR1500/016/002 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Profind Wholesale Ltd DPR1500/016/003 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA G & A Licensing Limited DPR1447/002/001 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/001 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/002 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/003 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/004 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/005 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA B & S Healthcare DPR1328/026/006 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Eurodrug Ltd DPR1392/012/001 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Eurodrug Ltd DPR1392/012/002 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Eurodrug Ltd DPR1392/012/003 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Belfast Drug Ltd. DPR1601/023/001 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Belfast Drug Ltd. DPR1601/023/002 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Belfast Drug Ltd. DPR1601/023/003 Film Coated Tablet - ETORICOXIB N/A
ARCOXIA Chemilines Healthcare PPA1915/011/001 Film Coated Tablet - ETORICOXIB N/A
(Ireland) Limited
ARCOXIA Chemilines Healthcare PPA1915/011/002 Film Coated Tablet - ETORICOXIB N/A
(Ireland) Limited
ARCOXIA FILM COATED Clear Pharmacy DPR1596/022/001 Film Coated Tablet - ETORICOXIB N/A
TABLETS
ARCOXIA FILM COATED Clear Pharmacy DPR1596/022/002 Film Coated Tablet - ETORICOXIB N/A
TABLETS
ARCOXIA FILM COATED Clear Pharmacy DPR1596/022/003 Film Coated Tablet - ETORICOXIB N/A
TABLETS
ARICEPT G & A Licensing Limited PPA1447/010/001 Film Coated Tablet - DONEPEZIL N/A
HYDROCHLORIDE
ARICEPT G & A Licensing Limited PPA1447/010/002 Film Coated Tablet - DONEPEZIL N/A
HYDROCHLORIDE
ARIMIDEX Eurodrug Ltd DPR1392/009/001 Film Coated Tablet - ANASTROZOLE N/A
ARIMIDEX Eurodrug Ltd DPR1392/009/002 Film Coated Tablet - ANASTROZOLE N/A
ARIPIPRAZOLE CHANELLE Chanelle Medical PA0688/049/001 Oral Solution - ARIPIPRAZOLE N/A

ARYTHMOL PCO Manufacturing PPA0465/249/001 Film Coated Tablet - PROPAFENONE N/A


HYDROCHLORIDE
ASASANTIN RETARD LTT Pharma Limited PPA1562/038/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard - ACETYLSALICYLIC ACID
ASASANTIN RETARD 200 B & S Healthcare PPA1328/069/001 Modified-release capsule, - DIPYRIDAMOLE N/A
MG /25 MG MODIFIED- hard - ACETYLSALICYLIC ACID
RELEASE HA
ATACAND Profind Wholesale Ltd PPA1500/033/002 Tablets - CANDESARTAN N/A
CILEXETIL
ATACAND Profind Wholesale Ltd PPA1500/033/003 Tablets - CANDESARTAN N/A
CILEXETIL
ATACAND PLUS Chemilines Healthcare PPA1915/006/001 Tablets - CANDESARTAN N/A
(Ireland) Limited CILEXETIL
- HYDROCHLOROTHIAZIDE

AUDAVAL Auden Mckenzie (Pharma PA1352/020/002 Ointment - BETAMETHASONE N/A


Division) Ltd VALERATE
AUDAVAL RD Auden Mckenzie (Pharma PA1352/020/004 Ointment - BETAMETHASONE N/A
Division) Ltd VALERATE (AS
BETAMETHASONE)
AVODART McDowell Pharmaceuticals PPA1473/046/001 Capsules, Soft - DUTASTERIDE N/A
AZITHROMYCIN ACTAVIS Actavis Group PTC ehf PA1380/138/002 Film Coated Tablet - AZITHROMYCIN N/A
DIHYDRATE
BELLCALCID CALCIUM BellPharma Limited PA1185/003/001 Tablets Effervescent - CALCIUM CARBONATE N/A
CARBONATE 1500MG AND - COLECALCIFEROL
COLECALSIF
BELLPRAV Ranbaxy (UK) Limited PA0967/007/001 Tablets - PRAVASTATIN SODIUM N/A
BELLPRAV Ranbaxy (UK) Limited PA0967/007/002 Tablets - PRAVASTATIN SODIUM N/A
BELLPRAV Ranbaxy (UK) Limited PA0967/007/003 Tablets - PRAVASTATIN SODIUM N/A
BETAGAN LTT Pharma Limited DPR1562/019/001 Eye Drops Solution - LEVOBUNOLOL N/A
HYDROCHLORIDE
BETAGAN Profind Wholesale Ltd DPR1500/021/001 Eye Drops Solution - LEVOBUNOLOL N/A
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 564 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BETAGAN McDowell Pharmaceuticals DPR1473/024/001 Eye Drops Solution - LEVOBUNOLOL N/A
HYDROCHLORIDE
BETAGAN Belfast Drug Ltd. DPR1601/002/001 Eye Drops Solution - LEVOBUNOLOL N/A
HYDROCHLORIDE
BETAGAN UNIT DOSE EYE B & S Healthcare DPR1328/001/001 Eye Drops Solution - LEVOBUNOLOL N/A
DROPS SOLUTION HYDROCHLORIDE
BETOPTIC B & S Healthcare DPR1328/019/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC PCO Manufacturing DPR0465/029/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC Eurodrug Ltd DPR1392/019/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC IMED Healthcare Ltd. DPR1463/002/001 Eye Drops Solution - BETAXOLOL N/A
BETOPTIC G & A Licensing Limited DPR1447/010/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC McDowell Pharmaceuticals DPR1473/003/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC Profind Wholesale Ltd DPR1500/004/001 Ear Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC LTT Pharma Limited DPR1562/002/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC Belfast Drug Ltd. DPR1601/001/001 Eye Drops Solution - BETAXOLOL N/A
HYDROCHLORIDE
BETOPTIC EYE DROPS Clear Pharmacy DPR1596/009/001 Ear Drops Solution - BETAXOLOL N/A
SOLUTION HYDROCHLORIDE
BICALUTAMIDE Gedeon Richter Plc PA1330/004/001 Film Coated Tablet - BICALUTAMIDE N/A
- LACTOSE
MONOHYDRATE
- SODIUM STARCH
GLYCOLLATE
- POVIDONE K30
- SILICA COLLOIDALIS
ANHYDRICA
- MAGNESIUM STEARATE
BICALUTAMIDE Gedeon Richter Plc PA1330/004/002 Film Coated Tablet - BICALUTAMIDE N/A
- LACTOSE
MONOHYDRATE
- SODIUM STARCH
GLYCOLLATE
- POVIDONE K30
- SILICA COLLOIDALIS
ANHYDRICA
- MAGNESIUM STEARATE
BONJELA McDowell Pharmaceuticals DPR1473/004/001 Oromucosal Gel - CHOLINE SALICYLATE N/A
- CETALKONIUM
CHLORIDE
BONJELA IMED Healthcare Ltd. DPR1463/017/001 Gel - CHOLINE SALICYLATE N/A
- CETALKONIUM
CHLORIDE
BONJELA PCO Manufacturing DPR0465/010/001 Oromucosal Gel - CHOLINE SALICYLATE N/A
- CETALKONIUM
CHLORIDE
BONJELA Eurodrug Ltd DPR1392/005/001 Oromucosal Gel - CHOLINE SALICYLATE N/A
- CETALKONIUM
CHLORIDE
BREVOXYL Boots (UK) Limited DPR1465/001/001 Cream - BENZOYL PEROXIDE N/A
BREVOXYL Boots (UK) Limited DPR1465/027/001 Cream - BENZOYL PEROXIDE N/A
BURNEZE Boots (UK) Limited DPR1465/002/001 Cutaneous Spray Solution - BENZOCAINE N/A
BURNEZE SPRAY Boots (UK) Limited DPR1465/028/001 Cutaneous Spray Solution - BENZOCAINE N/A
BUSPAR McDowell Pharmaceuticals DPR1473/034/001 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR McDowell Pharmaceuticals DPR1473/034/002 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR Profind Wholesale Ltd DPR1500/028/001 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR Profind Wholesale Ltd DPR1500/028/002 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR PCO Manufacturing DPR0465/024/001 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR PCO Manufacturing DPR0465/024/002 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR IMED Healthcare Ltd. DPR1463/023/001 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BUSPAR IMED Healthcare Ltd. DPR1463/023/002 Tablets - BUSPIRONE N/A
HYDROCHLORIDE
BYSTAT Sinclair IS Pharma Limited PA0915/032/001 Tablets - PRAVASTATIN SODIUM N/A

Human Medicines Withdrawn Products Page 565 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
BYSTAT Sinclair IS Pharma Limited PA0915/032/002 Tablets - PRAVASTATIN SODIUM N/A
BYSTAT Sinclair IS Pharma Limited PA0915/032/003 Tablets - PRAVASTATIN SODIUM N/A
CALCICHEW PCO Manufacturing DPR0465/001/002 Tablets Chewable - CALCIUM CARBONATE N/A
CALCICHEW D3 FORTE Eurodrug Ltd DPR1392/003/001 Tablets Chewable - CALCIUM CARBONATE N/A
- CHOLECALCIFEROL (02)
400 INTERNATION UNIT
CALCICHEW D3 FORTE B & S Healthcare DPR1328/021/001 Tablets Chewable - CALCIUM CARBONATE N/A
- COLECALCIFEROL
CALCICHEW D3 FORTE IMED Healthcare Ltd. DPR1463/004/001 Tablets - CALCIUM CARBONATE N/A
CALCICHEW D3 FORTE Profind Wholesale Ltd DPR1500/003/001 Tablets Chewable - CALCIUM CARBONATE N/A
- COLECALCIFEROL
CALCICHEW D3 FORTE McDowell Pharmaceuticals DPR1473/005/001 Tablets Chewable - CALCIUM CARBONATE N/A
- COLECALCIFEROL
CALCICHEW D3 FORTE Eurodrug Ltd DPR1392/069/001 Tablets Chewable - CALCIUM CARBONATE N/A
CHEWABLE TABLETS - COLECALCIFEROL
CALCICHEW-D3 FORTE MIRAPHARM DPR1400/002/001 Tablets Chewable - CALCIUM CARBONATE N/A
- COLECALCIFEROL
CALCICHEW-D3 FORTE Primecrown 2010 Ltd DPR1633/002/001 Tablets Chewable - CALCIUM CARBONATE N/A
- COLECALCIFEROL
CALCICHEW-D3 FORTE Belfast Drug Ltd. DPR1601/004/001 Tablets Chewable - CALCIUM CARBONATE N/A
CHEWABLE TABLETS - COLECALCIFEROL
CALCICHEW-D3 FORTE Clear Pharmacy DPR1596/018/001 Tablets Chewable - CALCIUM CARBONATE N/A
TABLETS - COLECALCIFEROL
CALCICHEW-D3 FORTE LTT Pharma Limited DPR1562/011/001 Tablets Chewable - CALCIUM CARBONATE N/A
TABLETS - COLECALCIFEROL
CALCIL 50 Rowex Ltd PA0711/149/001 Cutaneous Solution - CALCIPOTRIOL N/A
MICROGRAMS/ML ANHYDROUS
CUTANEOUS SOLUTION
CALLOUS REMOVAL PADS Boots (UK) Limited DPR1465/023/002 Impregnated Dressing - SALICYLIC ACID N/A

CALLOUS REMOVAL PADS Boots (UK) Limited DPR1465/039/001 Medicated Plaster - SALICYLIC ACID N/A

CAMPRAL EC B & S Healthcare PPA1328/073/001 Tablets Gastro-Resistant - ACAMPROSATE CALCIUM N/A

CAMPTO Pfizer Limited PA0019/053/001 Concentrate for Soln for Inf - IRINOTECAN N/A
HYDROCHLORIDE
TRIHYDRATE
CAMPTO Pfizer Limited PA0019/053/002 Concentrate for Soln for Inf - IRINOTECAN N/A
HYDROCHLORIDE
TRIHYDRATE
CANESTEN McDowell Pharmaceuticals DPR1473/043/001 Cream - CLOTRIMAZOLE N/A
CANESTEN McDowell Pharmaceuticals DPR1473/043/003 Pessary - CLOTRIMAZOLE N/A
CANESTEN Boots (UK) Limited DPR1465/003/001 Pessary - CLOTRIMAZOLE N/A
CANESTEN Boots (UK) Limited DPR1465/003/002 Cream - CLOTRIMAZOLE N/A
CANESTEN LTT Pharma Limited DPR1562/003/001 Cream - CLOTRIMAZOLE N/A
CANESTEN IMED Healthcare Ltd. DPR1463/010/004 Pessary - CLOTRIMAZOLE N/A
CANESTEN CREAM IMED Healthcare Ltd. DPR1463/010/002 Cream - CLOTRIMAZOLE N/A
CANESTEN CREAM Eurodrug Ltd DPR1392/022/001 Cream - CLOTRIMAZOLE N/A
CANESTEN CREAM B & S Healthcare DPR1328/024/001 Cream - CLOTRIMAZOLE N/A
CANESTEN CREAM Profind Wholesale Ltd DPR1500/017/001 Cream - CLOTRIMAZOLE N/A
CANESTEN CREAM Boots (UK) Limited DPR1465/029/001 Cream - CLOTRIMAZOLE N/A
CANESTEN HC McDowell Pharmaceuticals DPR1473/022/001 Cream - CLOTRIMAZOLE N/A
- HYDROCORTISONE
CANESTEN HC PCO Manufacturing DPR0465/004/001 Cream - CLOTRIMAZOLE N/A
- HYDROCORTISONE
CANESTEN HC IMED Healthcare Ltd. DPR1463/010/001 Cream - CLOTRIMAZOLE N/A
- HYDROCORTISONE
CANESTEN HC CREAM B & S Healthcare DPR1328/025/001 Cream - CLOTRIMAZOLE N/A
- HYDROCORTISONE
CANESTEN HC CREAM Profind Wholesale Ltd DPR1500/018/001 Cream - CLOTRIMAZOLE N/A
- HYDROCORTISONE
CANESTEN PESSARY LTT Pharma Limited DPR1562/003/003 Pessary - CLOTRIMAZOLE N/A
CANESTEN PESSARY LTT Pharma Limited DPR1562/003/004 Pessary - CLOTRIMAZOLE N/A
CANESTEN PESSARY Boots (UK) Limited DPR1465/029/002 Pessary - CLOTRIMAZOLE N/A
CANESTEN PESSARY Eurodrug Ltd DPR1392/022/002 Pessary - CLOTRIMAZOLE N/A
CANESTEN PESSARY Belfast Drug Ltd. DPR1601/014/001 Pessary - CLOTRIMAZOLE N/A
CANESTEN THRUSH Eurodrug Ltd DPR1392/022/003 Vaginal Cream - CLOTRIMAZOLE N/A
CANESTEN THRUSH IMED Healthcare Ltd. DPR1463/010/003 Vaginal Cream - CLOTRIMAZOLE N/A
CANESTEN THRUSH Boots (UK) Limited DPR1465/029/003 Vaginal Cream - CLOTRIMAZOLE N/A
CANESTEN THRUSH McDowell Pharmaceuticals DPR1473/043/002 Cream - CLOTRIMAZOLE N/A
CANESTEN THRUSH Boots (UK) Limited DPR1465/003/003 Vaginal Cream - CLOTRIMAZOLE N/A
CANESTEN THRUSH Profind Wholesale Ltd DPR1500/017/002 Vaginal Cream - CLOTRIMAZOLE N/A
CREAM
CANESTEN THRUSH PCO Manufacturing DPR0465/021/001 Vaginal Cream - CLOTRIMAZOLE N/A
VAGINAL CREAM

Human Medicines Withdrawn Products Page 566 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CAPOTEN B & S Healthcare PPA1328/056/003 Tablets - CAPTOPRIL N/A
CARDICOR B & S Healthcare PPA1328/013/001 Film Coated Tablet - BISOPROLOL FUMARATE N/A

CARDICOR B & S Healthcare PPA1328/013/002 Tablets - BISOPROLOL FUMARATE N/A

CARDICOR B & S Healthcare PPA1328/013/003 Tablets - BISOPROLOL FUMARATE N/A

CARDICOR B & S Healthcare PPA1328/013/004 Tablets - BISOPROLOL FUMARATE N/A

CARDICOR B & S Healthcare PPA1328/013/006 Film Coated Tablet - BISOPROLOL N/A


HEMIFUMARATE
CARDICOR G & A Licensing Limited PPA1447/047/001 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR G & A Licensing Limited PPA1447/047/002 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/001 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/002 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/003 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/004 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR PCO Manufacturing DPR0465/005/006 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Eurodrug Ltd DPR1392/001/001 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Eurodrug Ltd DPR1392/001/002 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Eurodrug Ltd DPR1392/001/003 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Eurodrug Ltd DPR1392/001/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Eurodrug Ltd DPR1392/001/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/001 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/002 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/003 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR IMED Healthcare Ltd. DPR1463/006/006 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd DPR1500/002/001 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd DPR1500/002/002 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd DPR1500/002/003 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd DPR1500/002/004 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Profind Wholesale Ltd DPR1500/002/005 Film Coated Tablet - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/001 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/002 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/003 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR LTT Pharma Limited DPR1562/001/006 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Clear Pharmacy DPR1596/001/001 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Clear Pharmacy DPR1596/001/002 Tablets - BISOPROLOL N/A
HEMIFUMARATE

Human Medicines Withdrawn Products Page 567 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CARDICOR Clear Pharmacy DPR1596/001/003 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Clear Pharmacy DPR1596/001/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Clear Pharmacy DPR1596/001/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR Clear Pharmacy DPR1596/001/006 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/001 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/002 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/003 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/005 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR McDowell Pharmaceuticals DPR1473/006/006 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR TABLETS Belfast Drug Ltd. DPR1601/016/001 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR TABLETS Belfast Drug Ltd. DPR1601/016/002 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR TABLETS Belfast Drug Ltd. DPR1601/016/003 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDICOR TABLETS Belfast Drug Ltd. DPR1601/016/004 Tablets - BISOPROLOL N/A
HEMIFUMARATE
CARDURA XL McDowell Pharmaceuticals PPA1473/006/001 Tablets - DOXAZOSIN MESILATE N/A
CARVEDILOL Teva Pharma B.V. PA0749/010/001 Tablets - CARVEDILOL N/A
CARVEDILOL Teva Pharma B.V. PA0749/010/002 Tablets - CARVEDILOL N/A
CARVEDILOL Teva Pharma B.V. PA0749/010/003 Tablets - CARVEDILOL N/A
CARVEDILOL Teva Pharma B.V. PA0749/010/004 Tablets - CARVEDILOL N/A
CASODEX G & A Licensing Limited PPA1447/017/001 Film Coated Tablet - BICALUTAMIDE N/A
CEFALEXIN Actavis Group PTC ehf PA1380/041/001 Capsules Hard - CEFALEXIN N/A
CEFALEXIN Actavis Group PTC ehf PA1380/041/002 Capsules Hard - CEFALEXIN N/A
CEFTAZIDIME Martindale Pharmaceuticals PA0361/033/001 Pdr+Solv for Soln for Inj - CEFTAZIDIME N/A
Ltd PENTAHYDRATE
CEFTAZIDIME Martindale Pharmaceuticals PA0361/033/002 Pdr+Solv for Soln for Inj - CEFTAZIDIME N/A
Ltd PENTAHYDRATE
CEFTAZIDIME Martindale Pharmaceuticals PA0361/033/003 Pdr for Soln Inj/Inf - CEFTAZIDIME N/A
Ltd PENTAHYDRATE
CEFTAZIDIME Martindale Pharmaceuticals PA0361/033/004 Pdr for Soln for Injection - CEFTAZIDIME N/A
Ltd PENTAHYDRATE
CEFUROXIME GLOB Glob Limited PA1675/002/001 Tablets - CEFUROXIME N/A
LIMITED
CEFUROXIME GLOB Glob Limited PA1675/002/002 Tablets - CEFUROXIME N/A
LIMITED
CEFUROXIME GLOB Glob Limited PA1675/002/003 Tablets - CEFUROXIME N/A
LIMITED
CEFUROXIME Martindale Pharmaceuticals PA0361/030/001 Pdr for Soln for Injection - CEFUROXIME SODIUM N/A
MARTINDALE PHARMA Ltd
CEFUROXIME Martindale Pharmaceuticals PA0361/030/002 Pdr for Soln for Injection - CEFUROXIME SODIUM N/A
MARTINDALE PHARMA Ltd
CEFUROXIME TEVA Teva Pharma B.V. PA0749/082/002 Film Coated Tablet - CEFUROXIME AXETIL N/A
CEFUROXIME TEVA Teva Pharma B.V. PA0749/082/003 Film Coated Tablet - CEFUROXIME AXETIL N/A
CELLUVISC LTT Pharma Limited DPR1562/004/001 Eye Drops Solution - CARMELLOSE SODIUM N/A
CELLUVISC Eurodrug Ltd DPR1392/040/001 Eye Drops Solution - CARMELLOSE SODIUM N/A
CELLUVISC EYE DROPS Profind Wholesale Ltd DPR1500/031/001 Ear Drops Solution - CARMELLOSE SODIUM N/A
SOLUTION
CELLUVISC EYE DROPS McDowell Pharmaceuticals DPR1473/052/001 Eye Drops Solution - CARMELLOSE SODIUM N/A
SOLUTION
CELLUVISC EYE DROPS Clear Pharmacy DPR1596/016/001 Eye Drops Solution - CARMELLOSE SODIUM N/A
SOLUTION
CELLUVISC EYE DROPS Belfast Drug Ltd. DPR1601/005/001 Eye Drops Solution - CARMELLOSE SODIUM N/A
SOLUTION
CERUMOL McDowell Pharmaceuticals DPR1473/025/001 Ear Drops Solution - CHLOROBUTANOL N/A
- ARACHIS OIL
CERUMOL PCO Manufacturing DPR0465/026/001 Ear Drops Solution - CHLOROBUTANOL N/A
- ARACHIS OIL
CICLOSPORIN GENFARMA Actavis Group PTC ehf PA1380/030/001 Capsules, Soft - CICLOSPORIN N/A

CICLOSPORIN GENFARMA Actavis Group PTC ehf PA1380/030/002 Capsules, Soft - CICLOSPORIN N/A

Human Medicines Withdrawn Products Page 568 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
CICLOSPORIN GENFARMA Actavis Group PTC ehf PA1380/030/003 Capsules, Soft - CICLOSPORIN N/A

CILEST 250/35 PCO Manufacturing PPA0465/217/001 Tablets - NORGESTIMATE N/A


MICROGRAM TABLETS - ETHINYLESTRADIOL
CIPRAMIL IPS Healthcare Limited PPA1659/022/001 Film Coated Tablet - CITALOPRAM N/A
HYDROBROMIDE
CISPLATIN TEVA Teva Pharma B.V. PA0749/119/001 Concentrate for Soln for Inf - CISPLATIN N/A
CITALOPRAM McDermott Laboratories Ltd PA0577/072/001 Film Coated Tablet - CITALOPRAM N/A
t/a Gerard Laboratories
CLARIE LA Teva Pharma B.V. PA0749/125/001 Tablet Prolonged Release - CLARITHROMYCIN N/A
CLARITHROMYCIN Ranbaxy Ireland Limited PA0408/063/003 Oral Suspension - CLARITHROMYCIN N/A
CLARITHROMYCIN Ranbaxy Ireland Limited PA0408/063/004 Oral Suspension - CLARITHROMYCIN N/A
CLARYL Pinewood Laboratories Ltd, PA0281/131/001 Coated Tablets - CLARITHROMYCIN N/A
CLARYL Pinewood Laboratories Ltd, PA0281/131/002 Coated Tablets - CLARITHROMYCIN N/A
CLOMID McDowell Pharmaceuticals DPR1473/026/001 Tablets - CLOMIFENE CITRATE N/A
CLOPIDOGREL ESP ESP Pharma Limited PA1505/002/001 Film Coated Tablet - CLOPIDOGREL BESILATE N/A
PHARMA
CLOPIDOGREL NUCLEUS Nucleus ehf. PA1369/005/001 Film Coated Tablet - CLOPIDOGREL BESILATE N/A

COPEGUS Roche Products Limited PA0050/153/001 Film Coated Tablet - RIBAVIRIN N/A
COPEGUS 400 MG FILM- Roche Products Limited PA0050/153/002 Film Coated Tablet - RIBAVIRIN N/A
COATED TABLET
CORDARONE X 200 MG B & S Healthcare PPA1328/058/001 Tablets - AMIODARONE N/A
TABLETS HYDROCHLORIDE
CORN REMOVAL Boots (UK) Limited DPR1465/039/002 Medicated Plaster - SALICYLIC ACID N/A
PLASTERS
CORSODYL Boots (UK) Limited DPR1465/004/001 Dental Gel - CHLORHEXIDINE N/A
GLUCONATE
CORSODYL DENTAL GEL Boots (UK) Limited DPR1465/030/001 Dental Gel - CHLORHEXIDINE N/A
GLUCONATE
CORSODYL DENTAL GEL Eurodrug Ltd DPR1392/061/001 Dental Gel - CHLORHEXIDINE N/A
GLUCONATE
COSOPT Eurodrug Ltd DPR1392/018/001 Eye Drops Solution - DORZOLAMIDE N/A
- TIMOLOL
COSOPT IMED Healthcare Ltd. DPR1463/012/001 Eye Drops Solution - DORZOLAMIDE N/A
- TIMOLOL
COSOPT B & S Healthcare DPR1328/029/001 Eye Drops Solution - DORZOLAMIDE N/A
- THYMOL
COSOPT Imbat Limited DPR1151/001/001 Eye Drops Solution - DORZOLAMIDE N/A
- TIMOLOL
COSOPT EYE DROPS Profind Wholesale Ltd DPR1500/019/001 Eye Drops Solution - DORZOLAMIDE N/A
SOLUTION - TIMOLOL
COSOPT EYE DROPS Clear Pharmacy DPR1596/013/001 Eye Drops Solution - DORZOLAMIDE N/A
SOLUTION - TIMOLOL
COSOPT EYE DROPS Belfast Drug Ltd. DPR1601/006/001 Eye Drops Solution - DORZOLAMIDE N/A
SOLUTION - TIMOLOL
COVERSYL Imbat Limited PPA1151/014/001 Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE SALT
COVERSYL Imbat Limited PPA1151/014/002 Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE SALT
COVERSYL ARGININE McDowell Pharmaceuticals PPA1473/027/001 Film Coated Tablet - PERINDOPRIL ARGININE N/A
COVERSYL ARGININE McDowell Pharmaceuticals PPA1473/027/002 Film Coated Tablet - PERINDOPRIL ARGININE N/A
COZAAR McDowell Pharmaceuticals PPA1473/017/002 Film Coated Tablet - LOSARTAN POTASSIUM N/A
CREON McDowell Pharmaceuticals DPR1473/007/001 Capsule - PANCREAS POWDER N/A
CREON IMED Healthcare Ltd. DPR1463/009/001 Capsule - PANCREAS POWDER N/A
CREON Eurodrug Ltd DPR1392/017/001 Capsule - PANCREATIN N/A
CREON 10000 Imbat Limited DPR1151/002/001 Capsules Gastro-Resistant - PANCREATIN N/A
CREON 10000 CAPSULES Belfast Drug Ltd. DPR1601/007/001 Capsule - PANCREAS POWDER N/A
CREON 10000 CAPSULES Clear Pharmacy DPR1596/017/001 Capsule - PANCREAS POWDER N/A
CREON 25000 300 MG Chemilines Healthcare PPA1915/007/001 Capsules Gastro-Resistant - PANCREATIN N/A
GASTRO-RESISTANT (Ireland) Limited
CAPSULES
CRESTOR Eurodrug Ltd DPR1392/062/001 Film Coated Tablet - ROSUVASTATIN N/A
CRESTOR Eurodrug Ltd DPR1392/062/002 Film Coated Tablet - ROSUVASTATIN N/A
CRESTOR Eurodrug Ltd DPR1392/062/003 Film Coated Tablet - ROSUVASTATIN N/A
CRESTOR Eurodrug Ltd DPR1392/062/004 Film Coated Tablet - ROSUVASTATIN N/A
CYMBALTA Eli Lilly Nederland B.V. H/C/572/X/31 Capsules Gastro-Resistant - DULOXETINE N/A
HYDROCHLORIDE
CYMEX Boots (UK) Limited DPR1465/005/001 Cream - UREA N/A
- CETRIMONIUM BROMIDE
- CHLOROCRESOL
- DIMETHICONE

DALBAVANCIN Pfizer Limited H/C/902/00/0/0 Powder for solution for - DALBAVANCIN N/A
infusion

Human Medicines Withdrawn Products Page 569 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DECA DURABOLIN NV Organon PA0964/008/002 Solution for Injection - NANDROLONE N/A
DECANOATE
DERBAC M Boots (UK) Limited DPR1465/006/001 Oral solution - MALATHION N/A
DERBAC-M LIQUID Boots (UK) Limited DPR1465/031/001 Cutaneous Emulsion - MALATHION N/A
DERINIK Actavis Group PTC ehf PA1380/106/001 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
DERINIK Actavis Group PTC ehf PA1380/106/002 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
DERINIK Actavis Group PTC ehf PA1380/106/003 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
DIAMICRON 80MG Servier Laboratories (Ireland) PA0068/002/001 Tablets - GLICLAZIDE N/A
TABLETS Ltd
DIDRONEL PMO PCO Manufacturing DPR0465/006/001 Tablets - ETIDRONATE DISODIUM N/A
DILZEM SR PCO Manufacturing DPR0465/027/001 Capsule - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR PCO Manufacturing DPR0465/027/002 Capsule - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR PCO Manufacturing DPR0465/027/006 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR B & S Healthcare DPR1328/038/001 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Eurodrug Ltd DPR1392/045/001 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Eurodrug Ltd DPR1392/045/002 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Eurodrug Ltd DPR1392/045/003 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR McDowell Pharmaceuticals DPR1473/044/001 Capsules Hard - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR McDowell Pharmaceuticals DPR1473/044/002 Capsules Hard - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR McDowell Pharmaceuticals DPR1473/044/003 Capsules Hard - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR LTT Pharma Limited DPR1562/017/001 Tablet Prolonged Release - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Profind Wholesale Ltd DPR1500/027/001 Capsule - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Profind Wholesale Ltd DPR1500/027/002 Capsule - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM SR Profind Wholesale Ltd DPR1500/027/003 Capsule - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM XL Eurodrug Ltd DPR1392/045/004 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM XL Eurodrug Ltd DPR1392/045/005 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM XL Eurodrug Ltd DPR1392/045/006 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM XL B & S Healthcare DPR1328/038/002 Prolonged Release Capsules - DILTIAZEM N/A
HYDROCHLORIDE
DILZEM XL PROLONGED PCO Manufacturing DPR0465/027/003 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED PCO Manufacturing DPR0465/027/004 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED PCO Manufacturing DPR0465/027/005 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED Profind Wholesale Ltd DPR1500/027/004 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED Profind Wholesale Ltd DPR1500/027/005 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED Profind Wholesale Ltd DPR1500/027/006 Capsule - DILTIAZEM N/A
RELEASE HARD HYDROCHLORIDE
CAPSULES
DILZEM XL PROLONGED- McDowell Pharmaceuticals DPR1473/044/004 Capsules Hard - DILTIAZEM N/A
RELEASE HYDROCHLORIDE
DILZEM XL PROLONGED- McDowell Pharmaceuticals DPR1473/044/005 Capsules Hard - DILTIAZEM N/A
RELEASE HYDROCHLORIDE
DILZEM XL PROLONGED- McDowell Pharmaceuticals DPR1473/044/006 Capsules Hard - DILTIAZEM N/A
RELEASE HYDROCHLORIDE

Human Medicines Withdrawn Products Page 570 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
DITEBOOSTER Statens Serum Institute PA0798/003/001 Suspension for Injection - DIPHTHERIA TOXOID N/A
- TETANUS TOXOID
DOLORITIS AHA Medical Services Ltd PA1780/001/001 Film Coated Tablet - GLUCOSAMINE SULFATE N/A
SODIUM CHLORIDE

DOVONEX B & S Healthcare PPA1328/023/003 Cutaneous Solution - CALCIPOTRIOL N/A


DOVONEX LTT Pharma Limited PPA1562/059/001 Cream - CALCIPOTRIOL N/A
DOVONEX IPS Healthcare Limited PPA1659/045/001 Cream - CALCIPOTRIOL HYDRATE N/A

DOXAPRAM Taro Pharmaceuticals PA1140/005/001 Solution for Injection - DOXAPRAM N/A


(Ireland) Limited HYDROCHLORIDE
DOXAPRAM Taro Pharmaceuticals PA1140/005/002 Solution for Injection - DOXAPRAM N/A
(Ireland) Limited HYDROCHLORIDE
DOXORUBICIN Martindale Pharmaceuticals PA0361/024/001 Concentrate for Soln for Inf - DOXORUBICIN N/A
MARTINDALE PHARMA Ltd HYDROCHLORIDE
DRAPOLENE Boots (UK) Limited DPR1465/007/001 Cream - BENZALKONIUM N/A
CHLORIDE
- CETRIMONIUM BROMIDE

DRAXMIBI DRAXIMAGE (UK) Limited PA1419/001/001 Kit for radiopharmaceutical - TETRAKIS (2-METHOXY N/A
preparation ISOBUTYL ISONITRILE)
COPPER (I)
TETRAFLUOROLBORATE
DUAVIVE Pfizer Limited H/C/2314/00/0/1 Modified-release Tablets - CONJUGATED N/A
ESTROGENS (CE)
- BAZEDOXIFENE
ACETATE
DULCOLAX Boots (UK) Limited DPR1465/032/001 Tablets - BISACODYL N/A
DULCOLAX GASTRO Boots (UK) Limited DPR1465/008/001 Tablets - BISACODYL N/A
RESISTANT
DULCOLAX LIQUID 5 MG/5 McDowell Pharmaceuticals DPR1473/011/001 Oral Solution - SODIUM PICOSULFATE N/A
ML ORAL SOLUTION
DULCOLAX PERLES LTT Pharma Limited DPR1562/006/001 Capsule - SODIUM PICOSULPHATE N/A
MONOHYDRATE

DULCOLAX LTT Pharma Limited DPR1562/007/002 Suppositories - BISACODYL N/A


SUPPOSITORIES
DULCOLAX LTT Pharma Limited DPR1562/007/001 Suppositories - BISACODYL N/A
SUPPOSITORIES FOR
CHILDREN
DULOXETINE Boehringer Ingelheim EU/1/08/471/11-12 Capsules Gastro-Resistant - DULOXETINE N/A
BOEHRINGER INGELHEIM International GmbH HYDROCHLORIDE
DULOXETINE Boehringer Ingelheim EU/1/08/471/1-2 Capsules Gastro-Resistant - DULOXETINE N/A
BOEHRINGER INGELHEIM International GmbH HYDROCHLORIDE
DULOXETINE Boehringer Ingelheim EU/1/08/471/3-5 Capsules Gastro-Resistant - DULOXETINE N/A
BOEHRINGER INGELHEIM International GmbH HYDROCHLORIDE
DULOXETINE Boehringer Ingelheim EU/1/08/471/6-10 Capsules Gastro-Resistant - DULOXETINE N/A
BOEHRINGER INGELHEIM International GmbH HYDROCHLORIDE
DUTREBIS Merck Sharp & Dohme Ltd EU/1/15/995/001 Film Coated Tablet - RALTEGRAVIR N/A
- LAMIVUDINE
EAREX Boots (UK) Limited DPR1465/009/001 Eye Drops Solution - SWEET ALMOND OIL N/A
- ARACHIS OIL
- CAMPHOR OIL
EBASTION Lindopharm GmbH PA1599/001/001 Film Coated Tablet - EBASTINE N/A
EBASTION Lindopharm GmbH PA1599/001/002 Film Coated Tablet - EBASTINE N/A
ELANTAN LA McDowell Pharmaceuticals DPR1473/008/001 Capsule - ISOSORBIDE N/A
MONONITRATE
ELANTAN LA HARD IMED Healthcare Ltd. DPR1463/016/001 Prolonged Release Capsules N/A

ELLEFORE Wyeth Europa Limited H/C/932/00/0/0 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
ELLEFORE Wyeth Europa Limited H/C/932/00/0/1 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
ELLEFORE Wyeth Europa Limited H/C/932/00/0/2 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
ELTROXIN Eurodrug Ltd DPR1392/002/001 Tablets - LEVOTHYROXINE N/A
SODIUM
ELTROXIN Eurodrug Ltd DPR1392/002/002 Tablets - LEVOTHYROXINE N/A
SODIUM
ELTROXIN Eurodrug Ltd DPR1392/002/003 Tablets - LEVOTHYROXINE N/A
SODIUM
ENVIAGE Novartis Europharm Limited EU/1/07/406/1-10 Film Coated Tablet - SPP100 HEMIFUMARATE N/A
ENVIAGE Novartis Europharm Limited EU/1/07/406/11-20 Film Coated Tablet - SPP100 HEMIFUMARATE N/A

Human Medicines Withdrawn Products Page 571 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
EPANUTIN B & S Healthcare DPR1328/031/001 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN B & S Healthcare DPR1328/031/002 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN B & S Healthcare DPR1328/031/003 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN PCO Manufacturing DPR0465/033/001 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN PCO Manufacturing DPR0465/033/002 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN G & A Licensing Limited DPR1447/005/001 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN G & A Licensing Limited DPR1447/005/002 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN G & A Licensing Limited DPR1447/005/003 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN G & A Licensing Limited DPR1447/005/004 Capsules Hard - PHENYTOIN SODIUM N/A
EPANUTIN McDowell Pharmaceuticals DPR1473/009/001 Capsule - PHENYTOIN SODIUM N/A
EPANUTIN McDowell Pharmaceuticals DPR1473/009/002 Capsule - PHENYTOIN SODIUM N/A
EPANUTIN McDowell Pharmaceuticals DPR1473/009/003 Capsule - PHENYTOIN SODIUM N/A
EPANUTIN Profind Wholesale Ltd DPR1500/026/001 Capsules Hard - PHENYTOIN SODIUM N/A
EPIRUBICIN MARTINDALE Martindale Pharmaceuticals PA0361/023/001 Solution for Inj/Inf - EPIRUBICIN N/A
PHARMA Ltd HYDROCHLORIDE
ESCIPREX Rowex Ltd PA0711/153/001 Film Coated Tablet - ESCITALOPRAM N/A
ESCIPREX Rowex Ltd PA0711/153/002 Film Coated Tablet - ESCITALOPRAM N/A
ESCIPREX Rowex Ltd PA0711/153/003 Film Coated Tablet - ESCITALOPRAM N/A
ESCIPREX Rowex Ltd PA0711/153/004 Film Coated Tablet - ESCITALOPRAM N/A
ESTOPAUSE Resource Medical (UK) PA1201/001/001 Film Coated Tablet - ESTRADIOL N/A
Limited - ESTRADIOL
-
MEDROXYPROGESTERO
NE ACETATE
ETHINYLESTRADIOL / Laboratorios Leon Farma, PA1474/002/001 Film Coated Tablet - DROSPIRENONE N/A
DROSPIRENONE LEON S.A. - ETHINYLESTRADIOL
FARMA
ETHINYLESTRADIOL / Laboratorios Leon Farma, PA1474/002/002 Film Coated Tablet - DROSPIRENONE N/A
DROSPIRENONE LEON S.A. - ETHINYLESTRADIOL
FARMA
ETHIRFIN Ethypharm PA0549/015/001 Tablet Prolonged Release - MORPHINE SULFATE N/A
ETHIRFIN Ethypharm PA0549/015/002 Tablet Prolonged Release - MORPHINE SULFATE N/A
ETHIRFIN Ethypharm PA0549/015/003 Tablet Prolonged Release - MORPHINE SULFATE N/A
ETHIRFIN Ethypharm PA0549/015/004 Tablet Prolonged Release - MORPHINE SULFATE N/A
ETHIRFIN Ethypharm PA0549/015/005 Tablet Prolonged Release - MORPHINE SULFATE N/A
EURAX HC Boots (UK) Limited DPR1465/010/001 Cream - CROTAMITON N/A
- HYDROCORTISONE
EURAX HC Boots (UK) Limited DPR1465/033/001 Cream - CROTAMITON N/A
- HYDROCORTISONE
EXOREX LOTION Boots (UK) Limited DPR1465/011/001 Cutaneous Emulsion - COAL TAR, PREPARED N/A
EXTEROL McDowell Pharmaceuticals DPR1473/027/001 Ear Drops Solution - UREA HYDROGEN N/A
PEROXIDE
EXUBERA Aventis/Pfizer EEIG EU/1/05/327/1-17 Inhalation powder - INSULIN HUMAN N/A
EZETROL Primecrown 2010 Ltd DPR1633/007/001 Tablets - EZETIMIBE N/A
EZETROL IMED Healthcare Ltd. DPR1463/027/001 Tablets - EZETIMIBE N/A
EZETROL McDowell Pharmaceuticals DPR1473/039/001 Tablets - EZETIMIBE N/A
EZETROL Profind Wholesale Ltd DPR1500/011/001 Tablets - EZETIMIBE N/A
EZETROL TABLETS Clear Pharmacy DPR1596/020/001 Tablets - EZETIMIBE N/A
FAMCICLOVIR Teva Pharma B.V. PA0749/025/001 Film Coated Tablet - FAMCICLOVIR N/A
FAVERIN McDowell Pharmaceuticals DPR1473/028/001 Tablets - FLUVOXAMINE MALEATE N/A

FAVERIN McDowell Pharmaceuticals DPR1473/028/002 Tablets - FLUVOXAMINE MALEATE N/A

FAVERIN PCO Manufacturing DPR0465/043/001 Film Coated Tablet - FLUVOXAMINE MALEATE N/A

FAVERIN PCO Manufacturing DPR0465/043/002 Film Coated Tablet - FLUVOXAMINE MALEATE N/A

FEMARA PCO Manufacturing PPA0465/243/001 Film Coated Tablet - LETROZOLE N/A


FENTAZIN 4MG COATED Mercury Pharmaceuticals Ltd PA0899/029/002 Coated Tablets - PERPHENAZINE N/A
TABLETS
FINASTERIDE RANBAXY Ranbaxy (UK) Limited PA0967/015/001 Film Coated Tablet - FINASTERIDE N/A
FLIXONASE B & S Healthcare PPA1328/012/001 Nasal Spray Suspension - FLUTICASONE N/A
PROPIONATE
FLIXOTIDE EVOHALER Eurodrug Ltd DPR1392/033/001 Pressurised Inhalation - FLUTICASONE N/A
Suspension PROPIONATE
FLIXOTIDE EVOHALER Chemilines Healthcare PPA1915/003/001 Pressurised Inhalation - FLUTICASONE N/A
(Ireland) Limited Suspension PROPIONATE
FLOTROS Imbat Limited DPR1392/063/001 Film Coated Tablet - TROSPIUM CHLORIDE N/A
FLUCONAZOLE ACTAVIS Actavis Group PTC ehf PA1380/100/002 Capsules Hard - FLUCONAZOLE N/A
FOSAMAX McDowell Pharmaceuticals DPR1473/035/001 Tablets - ALENDRONATE SODIUM N/A
FOSAMAX ONCE WEEKLY Profind Wholesale Ltd DPR1500/007/001 Tablets - ALENDRONATE SODIUM N/A
FOSAMAX ONCE WEEKLY Eurodrug Ltd DPR1392/026/001 Tablets - ALENDRONATE SODIUM N/A
FOSAMAX ONCE WEEKLY IMED Healthcare Ltd. DPR1463/019/001 Tablets - ALENDRONATE SODIUM N/A
FOSAMAX ONCE WEEKLY B & S Healthcare PPA1328/086/001 Tablets - ALENDRONATE SODIUM N/A
TRIHYDRATE

Human Medicines Withdrawn Products Page 572 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
FOSAMAX ONCE WEEKLY Belfast Drug Ltd. DPR1601/008/001 Tablets - ALENDRONATE SODIUM N/A
TABLETS
FOSAMAX ONCE WEEKLY Clear Pharmacy DPR1596/010/001 Tablets - ALENDRONATE SODIUM N/A
TABLETS
FOSTEPOR 10MG McDermott Laboratories Ltd PA0577/086/001 Tablets - ALENDRONIC ACID N/A
TABLETS t/a Gerard Laboratories
GALANTAMINE TEVA Teva Pharma B.V. PA0749/022/001 Tablets - GALANTAMINE N/A
GALANTAMINE TEVA Teva Pharma B.V. PA0749/022/002 Tablets - GALANTAMINE N/A
GALANTAMINE TEVA Teva Pharma B.V. PA0749/022/003 Tablets - GALANTAMINE N/A
GAVISCON ADVANCE McDowell Pharmaceuticals DPR1473/057/001 Tablets Chewable - SODIUM ALGINATE N/A
CHEWABLE TABLETS - POTASSIUM
BICARBONATE
GEMCITABINE Martindale Pharmaceuticals PA0361/022/001 Powder for solution for - GEMCITABINE N/A
MARTINDALE PHARMA Ltd infusion HYDROCHLORIDE
GEMCITABINE Martindale Pharmaceuticals PA0361/022/002 Powder for solution for - GEMCITABINE N/A
MARTINDALE PHARMA Ltd infusion HYDROCHLORIDE
GEMCITABINE TEVA Teva Pharma B.V. PA0749/097/001 Powder for solution for - GEMCITABINE N/A
infusion HYDROCHLORIDE
GEMCITABINE TEVA Teva Pharma B.V. PA0749/097/002 Powder for solution for - GEMCITABINE N/A
infusion HYDROCHLORIDE
GEMCITABINE TEVA Teva Pharma B.V. PA0749/097/003 Powder for solution for - GEMCITABINE N/A
infusion HYDROCHLORIDE
GLUCOSE/GLUCOSE Nektr Technologies CT2312/001/001 Gel - GLUCOSE N/A
OXIDASE/AMOROLFINE - GLUCOSE OXIDASE
HYDROCHLORIDE - AMOROLFINE
HYDROCHLORIDE
GONAL-F Serono Europe Limited EU/1/95/01/027 Pdr+Solv for Soln for Inj - FOLLITROPIN ALFA N/A
GRANISETRON Rowex Ltd PA0711/121/001 Concentrate for Soln for Inf - GRANISETRON N/A
GRANISETRON B. BRAUN B. Braun Melsungen AG PA0736/028/001 Solution for Injection - GRANISETRON N/A
HYDROCHLORIDE
- GRANISETRON
GRANOCYTE 13 Chugai Pharma UK Ltd PA0950/002/004 Pdr+Solv for soln for inf/inj - LENOGRASTIM N/A
GRANOCYTE 34 Chugai Pharma UK Ltd PA0950/002/003 Pdr+Solv for soln for inf/inj - LENOGRASTIM N/A
HALF SINEMET CR McDowell Pharmaceuticals DPR1473/010/001 Tablet Prolonged Release - LEVODOPA N/A
- CARBIDOPA
HYDROCORTISONE Blackrock Pharmaceuticals PA2013/002/001 Tablets - HYDROCORTISONE N/A
Limited
HYDROCORTISONE Blackrock Pharmaceuticals PA2013/002/002 Tablets - HYDROCORTISONE N/A
Limited
HYPERIFORCE ST JOHN'S Bioforce (UK) Ltd TR0725/014/001 Tablets - HYPERICUM N/A
WORT PERFORATUM
IBANDRONATE APOTEX Apotex Europe B.V. PA1513/001/001 Film Coated Tablet - IBANDRONIC ACID N/A
IMATINIB TEVA PHARMA Teva Pharma B.V. PA0749/178/001 Film Coated Tablet - IMATINIB MESILATE N/A
IMATINIB TEVA PHARMA Teva Pharma B.V. PA0749/178/002 Film Coated Tablet - IMATINIB MESILATE N/A
IMMUNINE Baxter Healthcare Limited PA0167/132/001 Pdr+Solv for soln for inf/inj - HUMAN COAGULATION N/A
FACTOR IX
IMMUNOGAM Cangene Europe Limited EU/1/10/613/1-2 Solution for Injection - HUMAN HEPATITIS B N/A
IMMUNOGLOBULIN
IMURAN McDowell Pharmaceuticals PPA1473/007/001 Film Coated Tablet - AZATHIOPRINE N/A
INEGY McDowell Pharmaceuticals DPR1473/042/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Profind Wholesale Ltd DPR1500/020/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Profind Wholesale Ltd DPR1500/020/002 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Profind Wholesale Ltd DPR1500/020/003 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Clear Pharmacy DPR1596/002/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Clear Pharmacy DPR1596/002/002 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Clear Pharmacy DPR1596/002/003 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY IMED Healthcare Ltd. DPR1463/028/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY IMED Healthcare Ltd. DPR1463/028/002 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY IMED Healthcare Ltd. DPR1463/028/003 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY G & A Licensing Limited DPR1447/004/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Eurodrug Ltd DPR1392/023/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY Eurodrug Ltd DPR1392/023/002 Tablets - EZETIMIBE N/A
- SIMVASTATIN

Human Medicines Withdrawn Products Page 573 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
INEGY Eurodrug Ltd DPR1392/023/003 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY TABLETS Belfast Drug Ltd. DPR1601/017/001 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY TABLETS Belfast Drug Ltd. DPR1601/017/002 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INEGY TABLETS Belfast Drug Ltd. DPR1601/017/003 Tablets - EZETIMIBE N/A
- SIMVASTATIN
INNOVACE Eurodrug Ltd DPR1392/013/001 Tablets - ENALAPRIL MALEATE N/A
INSPRA B & S Healthcare DPR1328/016/001 Tablets - EPLERENONE N/A
INSPRA Profind Wholesale Ltd DPR1500/035/001 Film Coated Tablet - EPLERENONE N/A
INSPRA Profind Wholesale Ltd DPR1500/035/002 Film Coated Tablet - EPLERENONE N/A
INSPRA McDowell Pharmaceuticals DPR1473/047/001 Tablets - EPLERENONE N/A
INSULIN HUMAN Sanofi-Aventis Deutschland EU/1/06/368/56-57 Solution for Injection - INSULIN HUMAN GT N/A
WINTHROP INFUSAT GmbH HR1799
INTRINSA Warner Chilcott Deutschland EU/1/06/351/1-3 Transdermal Patch - TESTOSTERONE N/A
GmbH
IRBESARTAN / Ranbaxy Ireland Limited PA0408/085/001 Film Coated Tablet - IRBESARTAN N/A
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE

IRBESARTAN / Ranbaxy Ireland Limited PA0408/085/002 Film Coated Tablet - IRBESARTAN N/A
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE

IRBESARTAN / Ranbaxy Ireland Limited PA0408/085/003 Film Coated Tablet - IRBESARTAN N/A
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE

IRBESARTAN BMS Bristol Myers Squibb Pharma EU/1/06/375/11-15 Tablets - IRBESARTAN N/A
EEIG
IRBESARTAN BMS Bristol Myers Squibb Pharma EU/1/06/375/1-5 Tablets - IRBESARTAN N/A
EEIG
IRBESARTAN BMS Bristol Myers Squibb Pharma EU/1/06/375/22-27 Film Coated Tablet - IRBESARTAN N/A
EEIG
IRBESARTAN BMS Bristol Myers Squibb Pharma EU/1/06/375/28-33 Film Coated Tablet - IRBESARTAN N/A
EEIG
IRBESARTAN BMS Bristol Myers Squibb Pharma EU/1/06/375/6-10 Tablets - IRBESARTAN N/A
EEIG
IRBESARTAN HCT BMS Bristol Myers Squibb Pharma EU/1/06/369/11-16 Tablets - IRBESARTAN N/A
EEIG - HYDROCHLOROTHIAZIDE

IRBESARTAN HCT BMS Bristol Myers Squibb Pharma EU/1/06/369/1-5 Tablets - IRBESARTAN N/A
EEIG - HYDROCHLOROTHIAZIDE

IRBESARTAN HCT BMS Bristol Myers Squibb Pharma EU/1/06/369/6-10 Tablets - IRBESARTAN N/A
EEIG - HYDROCHLOROTHIAZIDE

IRBESARTAN Bristol Myers Squibb Pharma EU/1/06/369/17-22 Tablets - IRBESARTAN N/A


HYDROCHLOROTHIAZIDE EEIG - HYDROCHLOROTHIAZIDE
BMS
IRINOTECAN MARTINDALE Martindale Pharmaceuticals PA0361/028/001 Concentrate for Soln for Inf - IRINOTECAN N/A
PHARMA Ltd HYDROCHLORIDE
TRIHYDRATE
IRINOTECAN TEVA Teva Pharma B.V. PA0749/044/001 Concentrate for Soln for Inf - IRINOTECAN N/A
HYDROCHLORIDE
TRIHYDRATE
ISTIN IMED Healthcare Ltd. PPA1463/010/002 Tablets - AMLODIPINE BESYLATE N/A
ISTIN G & A Licensing Limited PPA1447/067/001 Tablets - AMLODIPINE AS N/A
AMLODIPINE BESILATE
ISTIN G & A Licensing Limited PPA1447/067/002 Tablets - AMLODIPINE AS N/A
AMLODIPINE BESILATE
IVY LEAF Chanelle Medical TR0688/001/001 Suppositories - IVY LEAF DRY EXTRACT N/A
(DER 4-8:1)
KLACID LA McDowell Pharmaceuticals PPA1473/040/001 Modified-release Tablets - CLARITHROMYCIN N/A
KLACID LA B & S Healthcare PPA1328/014/001 Modified-release Tablets - CLARITHROMYCIN N/A
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/0 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/1 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/2 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/3 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/4 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA
LACOSAMIDE PAIN UCB Pharma GmbH H/C/894/00/0/5 Film Coated Tablet - LACOSAMIDE N/A
SCHWARZ PHARMA

Human Medicines Withdrawn Products Page 574 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LACTUGAL Intrapharm Laboratories PA0997/008/001 Unknown - LACTULOSE N/A
Limited
LAMOTRIGINE Ranbaxy Ireland Limited PA0408/071/001 Dispersable Tablet - LAMOTRIGINE N/A
LANACANE Boots (UK) Limited DPR1465/034/001 Cream - BENZOCAINE N/A
LANACANE Boots (UK) Limited DPR1465/012/001 Cream - BENZOCAINE N/A
LANZIOP Norton Waterford PA0436/041/001 Capsules Gastro-Resistant - LANSOPRAZOLE N/A
LANZIOP Norton Waterford PA0436/041/002 Capsules Gastro-Resistant - LANSOPRAZOLE N/A
LANZIOP WPR Healthcare Limited PPA0565/045/001 Capsules Gastro-Resistant - LANSOPRAZOLE N/A
LANZIOP WPR Healthcare Limited PPA0565/045/002 Capsules Gastro-Resistant - LANSOPRAZOLE N/A
LATANOPROST / TIMOLOL Yes Pharmaceutical PA1372/005/001 Eye Drops Solution - LATANOPROST N/A
YES Development Services - TIMOLOL MALEATE
GmbH
LERCANIDIPINE ESP Pharma Limited PA1505/001/001 Film Coated Tablet - LERCANIDIPINE N/A
HYDROCHLORIDE
LERCANIDIPINE ESP Pharma Limited PA1505/001/002 Film Coated Tablet - LERCANIDIPINE N/A
HYDROCHLORIDE
LESCOL XL PCO Manufacturing PPA0465/090/003 Tablet Prolonged Release - FLUVASTATIN SODIUM N/A
LEVOFLOXACIN Actavis Group PTC ehf PA1380/071/001 Solution for Infusion - LEVOFLOXACIN N/A
HEMIHYDRATE
LEVOFLOXACIN ACTAVIS Actavis Group PTC ehf PA1380/069/001 Film Coated Tablet - LEVOFLOXACIN N/A
LEVOFLOXACIN ACTAVIS Actavis Group PTC ehf PA1380/069/002 Film Coated Tablet - LEVOFLOXACIN N/A
LIPITOR G & A Licensing Limited PPA1447/044/001 Film Coated Tablet - ATORVASTATIN-CALCIUM N/A

LIPITOR G & A Licensing Limited PPA1447/044/002 Film Coated Tablet - ATORVASTATIN-CALCIUM N/A

LIPITOR G & A Licensing Limited PPA1447/044/003 Film Coated Tablet - ATORVASTATIN-CALCIUM N/A

LIPITOR McDowell Pharmaceuticals PPA1473/002/004 Film Coated Tablet - ATORVASTATIN-CALCIUM N/A

LIPOSTAT McDowell Pharmaceuticals DPR1473/036/001 Tablets - PRAVASTATIN SODIUM N/A


LIPOSTAT Profind Wholesale Ltd DPR1500/012/001 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT LTT Pharma Limited DPR1562/015/001 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT PCO Manufacturing DPR0465/018/001 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT PCO Manufacturing DPR0465/018/002 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT Eurodrug Ltd DPR1392/024/001 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT IMED Healthcare Ltd. DPR1463/014/001 Tablets - PRAVASTATIN SODIUM N/A
LIPOSTAT IMED Healthcare Ltd. DPR1463/014/002 Tablets - PRAVASTATIN SODIUM N/A
LIVENSA Procter & Gamble EU/1/06/351/001-003 Transdermal Patch - TESTOSTERONE N/A
Pharmaceuticals UK Limited
LUVINSTA Actavis Group PTC ehf PA1380/005/001 Capsules Hard - FLUVASTATIN SODIUM N/A
LUVINSTA Actavis Group PTC ehf PA1380/005/002 Capsules Hard - FLUVASTATIN SODIUM N/A
LUVINSTA XL Actavis Group PTC ehf PA1380/006/001 Tablet Prolonged Release - FLUVASTATIN SODIUM N/A
LYCLEAR CREAM RINSE Boots (UK) Limited DPR1465/013/001 Cutaneous Solution - PERMETHRIN N/A
LYPSYL COLD SORE GEL Boots (UK) Limited DPR1465/014/001 Gel - LIDOCAINE N/A
HYDROCHLORIDE
- ZINC SULFATE
- CETRIMONIUM BROMIDE

LYRINEL XL McDowell Pharmaceuticals DPR1473/012/001 Tablet Prolonged Release - OXYBUTYNIN N/A


HYDROCHLORIDE
LYRINEL XL McDowell Pharmaceuticals DPR1473/012/002 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL Profind Wholesale Ltd DPR1500/025/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL Profind Wholesale Ltd DPR1500/025/002 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL IMED Healthcare Ltd. DPR1463/015/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL IMED Healthcare Ltd. DPR1463/015/002 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL Eurodrug Ltd DPR1392/021/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL Eurodrug Ltd DPR1392/021/002 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL PCO Manufacturing DPR0465/020/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL PCO Manufacturing DPR0465/020/002 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL B & S Healthcare DPR1328/018/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL Primecrown 2010 Ltd DPR1633/006/001 Tablet Prolonged Release - OXYBUTYNIN N/A
HYDROCHLORIDE
LYRINEL XL PROLONGED Belfast Drug Ltd. DPR1601/018/001 Tablet Prolonged Release - OXYBUTYNIN N/A
RELEASE TABLETS HYDROCHLORIDE

Human Medicines Withdrawn Products Page 575 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
LYRINEL XL PROLONGED Belfast Drug Ltd. DPR1601/018/002 Tablet Prolonged Release - OXYBUTYNIN N/A
RELEASE TABLETS HYDROCHLORIDE
LYRINEL XL PROLONGED Clear Pharmacy DPR1596/023/001 Tablet Prolonged Release - OXYBUTYNIN N/A
RELEASE TABLETS HYDROCHLORIDE
LYRINEL XL PROLONGED Clear Pharmacy DPR1596/023/002 Tablet Prolonged Release - OXYBUTYNIN N/A
RELEASE TABLETS HYDROCHLORIDE
MABCAMPATH ILEX Pharmaceuticals Ltd EU/1/01/193/001 Concentrate for Soln for Inf - ALEMTUZUMAB N/A
MADOPAR Clear Pharmacy DPR1596/004/001 Capsules Hard - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR Clear Pharmacy DPR1596/004/002 Capsules Hard - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR Clear Pharmacy DPR1596/004/003 Capsules Hard - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR McDowell Pharmaceuticals DPR1473/013/001 Capsules Hard - BENSERAZIDE N/A
HYDROCHLORIDE
- LEVODOPA
MADOPAR McDowell Pharmaceuticals DPR1473/013/002 Capsules Hard - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR McDowell Pharmaceuticals DPR1473/013/003 Capsule - BENSERAZIDE N/A
HYDROCHLORIDE
- LEVODOPA
MADOPAR PCO Manufacturing DPR0465/034/001 Capsules Hard - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR CR McDowell Pharmaceuticals DPR1473/013/004 Prolonged Release Capsules - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR CR Clear Pharmacy DPR1596/004/004 Prolonged Release Capsules - LEVODOPA N/A
- BENSERAZIDE
HYDROCHLORIDE
MADOPAR HARD B & S Healthcare DPR1328/022/001 Capsules Hard - BENSERAZIDE N/A
CAPSULES HYDROCHLORIDE
- LEVODOPA
MADOPAR HARD B & S Healthcare DPR1328/022/002 Capsules Hard - BENSERAZIDE N/A
CAPSULES HYDROCHLORIDE
- LEVODOPA
MADOPAR HARD B & S Healthcare DPR1328/022/003 Capsules Hard - BENSERAZIDE N/A
CAPSULES HYDROCHLORIDE
- LEVODOPA
MASSAGE BALM WITH Weleda (UK) Limited TR0407/004/001 Oral solution - ARNICA MONTANA N/A
ARNICA
MEDRONATE DRAXIMAGE DRAXIMAGE (UK) Limited PA1419/002/001 Kit for radiopharmaceutical - MEDRONIC ACID N/A
preparation
MEGACE IMED Healthcare Ltd. DPR1463/036/001 Tablets - MEGESTROL ACETATE N/A
MEMANTINE Ratiopharm GmbH H/C/2671/00/0/2 Film Coated Tablet - MEMANTINE N/A
HYDROCHLORIDE HYDROCHLORIDE
MEMANTINE MERZ Merz Pharmaceuticals Gmb H/C/2711/00/0/2 Film Coated Tablet - MEMANTINE N/A
HYDROCHLORIDE
- MEMANTINE (FREE
BASE)
MEMANTINE TEVA Teva Pharma B.V. PA0749/193/001 Film Coated Tablet - MEMANTINE N/A
HYDROCHLORIDE
MENINGITEC Nuron Biotech B.V. PA1886/001/001 Solution for Injection - NEISSERIA MENINGITIDIS N/A
SEROGROUP C (STRAIN
C11) POLYSACCHARIDE
- CORYNEBACTERIUM
DIPHTHERIAE CRM197
CARRIER PROTEIN
- ALUMINIUM PHOSPHATE

MEROCAINE Boots (UK) Limited DPR1465/015/001 Lozenges - CETYLPYRIDINIUM N/A


CHLORIDE
- BENZOCAINE
MEROCAINE IMED Healthcare Ltd. DPR1463/031/001 Lozenges - CETYLPYRIDINIUM N/A
CHLORIDE
- BENZOCAINE
MEROCAINE McDowell Pharmaceuticals DPR1473/029/001 Lozenges - CETYLPYRIDINIUM N/A
CHLORIDE
MEROCAINE LTT Pharma Limited DPR1562/018/001 Lozenges - CETYLPYRIDINIUM N/A
CHLORIDE
- BENZOCAINE

Human Medicines Withdrawn Products Page 576 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
MEROCAINE LOZENGES Boots (UK) Limited DPR1465/035/001 Lozenges - CETYLPYRIDINIUM N/A
CHLORIDE
- BENZOCAINE
MEROCAINE LOZENGES Eurodrug Ltd DPR1392/060/001 Lozenges - CETYLPYRIDINIUM N/A
CHLORIDE
- BENZOCAINE
MIRTAZ Pinewood Laboratories Ltd, PA0281/134/001 Orodispersible Tablet - MIRTAZAPINE N/A
MIRTAZAPINE MEDIS 30 Medis ehf PA1285/003/002 Film Coated Tablet - MIRTAZAPINE N/A
MG FILM-COATED
TABLETS
MIRTAZAPINE MEDIS 45 Medis ehf PA1285/003/003 Film Coated Tablet - MIRTAZAPINE N/A
MG FILM-COATED
TABLETS
MIRTAZIPINE GLOB Glob Limited PA1675/001/001 Film Coated Tablet - MIRTAZAPINE N/A
MIRTAZIPINE GLOB Glob Limited PA1675/001/002 Film Coated Tablet - MIRTAZAPINE N/A
MIRTAZIPINE GLOB Glob Limited PA1675/001/003 Film Coated Tablet - MIRTAZAPINE N/A
MITOXANTRONE Generics (UK) Limited PA0405/084/001 Concentrate for Soln for Inf - MITOXANTRONE N/A
MOBIC B & S Healthcare PPA1328/003/001 Tablets - MELOXICAM N/A
MOVICOL PAEDIATRIC Profind Wholesale Ltd DPR1500/032/001 Powder for Oral Solution - MACROGOL 3350 N/A
- SODIUM CHLORIDE
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
MOVICOL PLAIN SACHET B & S Healthcare DPR1328/037/001 Powder for Oral Solution - MACROGOL 3350 N/A
- SODIUM CHLORIDE
PH.EUR.
- SODIUM BICARBONATE
- POTASSIUM CHLORIDE
MUCINEX Reckitt Benckiser Ireland Ltd PA0979/052/001 Modified-release Tablets - GUAIFENESIN DC N/A

MYCIL Eurodrug Ltd DPR1392/058/001 Ointment - TOLNAFTATE N/A


- BENZALKONIUM
CHLORIDE
MYCIL Eurodrug Ltd DPR1392/047/001 Cutaneous Powder - TOLNAFTATE N/A
- CHLORHEXIDINE
HYDROCHLORIDE
MYCIL LTT Pharma Limited DPR1562/009/001 Cutaneous Powder - TOLNAFTATE N/A
- CHLORHEXIDINE
HYDROCHLORIDE
MYCIL LTT Pharma Limited DPR1562/010/001 Cutaneous Spray Solution - TOLNAFTATE N/A
MYCIL ATHLETE'S FOOT Eurodrug Ltd DPR1392/048/001 Cutaneous Spray Solution - TOLNAFTATE N/A
SPRAY
MYCLOVEAR McDermott Laboratories Ltd PA0577/109/001 Film Coated Tablet - FAMCICLOVIR N/A
t/a Gerard Laboratories
NAGERINE McDermott Laboratories Ltd PA0577/070/001 Tablets - CINNARIZINE N/A
t/a Gerard Laboratories
NASACORT G & A Licensing Limited DPR1447/009/001 Nasal Spray Suspension - TRIAMCINOLONE N/A
ACETONIDE
NASACORT Profind Wholesale Ltd DPR1500/009/001 Nasal Spray Suspension - TRIAMCINOLONE N/A
ACETONIDE
NASACORT McDowell Pharmaceuticals DPR1473/014/001 Nasal Spray Suspension - TRIAMCINOLONE N/A
ACETONIDE
NASEPTIN NASAL McDowell Pharmaceuticals DPR1473/015/001 Cream - CHLORHEXIDINE N/A
HYDROCHLORIDE
- NEOMYCIN SULFATE
NASEPTIN NASAL CREAM B & S Healthcare DPR1328/023/001 Cream - CHLORHEXIDINE N/A
HYDROCHLORIDE
- NEOMYCIN SULFATE
NASONEX Eurodrug Ltd DPR1392/004/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A

NASONEX G & A Licensing Limited DPR1447/003/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A

NASONEX Profind Wholesale Ltd DPR1500/008/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A

NASONEX 50 Clear Pharmacy DPR1596/021/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A
MICROGRAMS/ACTUATION
NASAL SPRAY SUSPEN

NASONEX AQUEOUS B & S Healthcare DPR1328/036/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A

NASONEX AQUEOUS Belfast Drug Ltd. DPR1601/009/001 Nasal Spray Suspension - MOMETASONE FUROATE N/A
NASAL SPRAY
SUSPENSION
NEBILET McDowell Pharmaceuticals PPA1473/045/001 Tablets - NEBIVOLOL N/A
HYDROCHLORIDE
NEOFORDEX Laboratoires CTRS H/C/2418/00/0/0 Tablets - DEXAMETHASONE N/A
ACETATE

Human Medicines Withdrawn Products Page 577 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
NESPO DOMPE BIOTEC S.p.A. H/C/333/X/43 Solution for Injection - DARBEPOETIN ALFA N/A
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
- DARBEPOETIN ALFA
NEXIUM MIRAPHARM DPR1400/003/001 Tablets - ESOMEPRAZOLE N/A
NEXIUM MIRAPHARM DPR1400/003/002 Tablets - ESOMEPRAZOLE N/A
NEXIUM McDowell Pharmaceuticals PPA1473/001/001 Tablets Gastro-Resistant - ESOMEPRAZOLE N/A
NEXIUM McDowell Pharmaceuticals PPA1473/001/002 Tablets Gastro-Resistant - ESOMEPRAZOLE N/A
NEXIUM Chemilines Healthcare PPA1915/002/001 Tablets Gastro-Resistant - ESOMEPRAZOLE N/A
(Ireland) Limited MAGNESIUM
NEXIUM Chemilines Healthcare PPA1915/002/002 Tablets Gastro-Resistant - ESOMEPRAZOLE N/A
(Ireland) Limited
NICORETTE McNeil Healthcare (Ireland) PA0823/049/011 Transdermal Patch - NICOTINE N/A
Ltd
NICORETTE McNeil Healthcare (Ireland) PA0823/049/012 Transdermal Patch - NICOTINE N/A
Ltd
NICORETTE McNeil Healthcare (Ireland) PA0823/049/013 Transdermal Patch - NICOTINE N/A
Ltd
NICORETTE MICROTAB McNeil Healthcare (Ireland) PA0823/049/019 Tablet Sublingual - NICOTINE BITARTRATE N/A
LEMON SUBLINGUAL Ltd DIHYDRATE
TABLETS 2MG
NICORETTE MICROTAB McNeil Healthcare (Ireland) PA0823/049/020 Tablet Sublingual - NICOTINE BITARTRATE N/A
LEMON SUBLINGUAL Ltd DIHYDRATE
TABLETS 4MG
NICORETTE SPICEMINT McNeil Healthcare (Ireland) PA0823/049/017 Medicated Chewing Gum - NICOTINE RESIN N/A
2MG MEDICATED Ltd
CHEWING GUM
NICORETTE SPICEMINT McNeil Healthcare (Ireland) PA0823/049/018 Medicated Chewing Gum - NICOTINE RESIN N/A
4MG MEDICATED Ltd
CHEWING GUM
NIQUITIN MINI MINT Chefaro Ireland DAC PA1186/018/002A Lozenges - NICOTINE N/A
NITROLINGUAL PUMP Eurodrug Ltd DPR1392/006/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
NITROLINGUAL PUMP B & S Healthcare DPR1328/039/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP PCO Manufacturing DPR0465/015/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP IMED Healthcare Ltd. DPR1463/022/001 Sublingual spray, solution - GLYCEROL TRIACETATE N/A
SPRAY
NITROLINGUAL PUMP Profind Wholesale Ltd DPR1500/022/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP LTT Pharma Limited DPR1562/014/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP Clear Pharmacy DPR1596/012/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP Belfast Drug Ltd. DPR1601/010/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
SPRAY
NITROLINGUAL PUMP G & A Licensing Limited DPR1447/006/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
STRAY
NITROLINGUAL McDowell Pharmaceuticals DPR1473/045/001 Sublingual spray, solution - GLYCERYL TRINITRATE N/A
PUMPSPRAY
NOCTISSIN Actavis Group PTC ehf PA1380/033/001 Tablets - DESMOPRESSIN N/A
ACETATE
NOCTISSIN Actavis Group PTC ehf PA1380/033/002 Tablets - DESMOPRESSIN N/A
ACETATE
NUROFEN MAXIMUM Reckitt Benckiser Ireland Ltd PA0979/032/019 Tablets - IBUPROFEN N/A
STRENGTH 400MG
TABLETS
OILATUM Eurodrug Ltd DPR1392/036/001 Cream - LIQUID PARAFFIN LIGHT N/A
- WHITE SOFT PARAFFIN
OILATUM EMOLLIENT McDowell Pharmaceuticals DPR1473/049/001 Bath Additive - LIQUID PARAFFIN LIGHT N/A
OLANZAPINE ACTAVIS Actavis Group PTC ehf PA1380/043/006 Film Coated Tablet - OLANZAPINE N/A
OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/001 Coated Tablets - OLANZAPINE N/A

OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/002 Coated Tablets - OLANZAPINE N/A

OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/003 Coated Tablets - OLANZAPINE N/A

OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/004 Coated Tablets - OLANZAPINE N/A

OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/005 Coated Tablets - OLANZAPINE N/A

OLANZAPINE LILLY Eli Lilly and Company Limite PA0047/096/006 Coated Tablets - OLANZAPINE N/A

Human Medicines Withdrawn Products Page 578 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
OLANZAPINE LILLY 10 MG Eli Lilly and Company Limite PA0047/096/008 Orodispersible Tablet - OLANZAPINE N/A
ORODISPERSIBLE
TABLETS
OLANZAPINE LILLY 10 MG Eli Lilly and Company Limite PA0047/096/011 Pdr for Soln for Injection - OLANZAPINE N/A
POWDER FOR SOLUTION
FOR INJ
OLANZAPINE LILLY 15 MG Eli Lilly and Company Limite PA0047/096/009 Orodispersible Tablet - OLANZAPINE N/A
ORODISPERSIBLE
TABLETS
OLANZAPINE LILLY 20 MG Eli Lilly and Company Limite PA0047/096/010 Orodispersible Tablet - OLANZAPINE N/A
ORODISPERSIBLE
TABLETS
OLANZAPINE LILLY 5 MG Eli Lilly and Company Limite PA0047/096/007 Orodispersible Tablet - OLANZAPINE N/A
ORODISPERSIBLE
TABLETS
OMEPRAZOLE Rowa Pharmaceuticals PA0074/057/001 Tablets Gastro-Resistant - OMEPRAZOLE N/A
Limited
ONDANSETRON Martindale Pharmaceuticals PA0361/019/002 Solution for Inj/Inf - ONDANSETRON N/A
Ltd HYDROCHLORIDE
DIHYDRATE
ONDANSETRON B.BRAUN B. Braun Melsungen AG PA0736/027/001 Solution for Injection - ONDANSETRON N/A
HYDROCHLORIDE
DIHYDRATE
OPOSTAF Astellas Pharma Europe BV H/C/864/00/0/0 Solution for Infusion - TELAVANCIN N/A
HYDROCHLORIDE
OPOSTAF Astellas Pharma Europe BV H/C/864/00/0/1 Solution for Infusion - TELAVANCIN N/A
HYDROCHLORIDE
OPXIL-EU Novocat Farma S.A. PA1952/003/001 Capsule - CEFALEXIN N/A
MONOHYDRATE
- CEFALEXIN
OSBONELLE Actavis Group PTC ehf PA1380/117/001 Film Coated Tablet - IBANDRONATE SODIUM N/A
MONOHYDRATE
OSPIZAN Sigillata Ltd PA1493/003/001 Orodispersible Tablet - OLANZAPINE N/A
OSPIZAN Sigillata Ltd PA1493/003/002 Orodispersible Tablet - OLANZAPINE N/A
OSPIZAN Sigillata Ltd PA1493/003/003 Orodispersible Tablet - OLANZAPINE N/A
OSPIZAN Sigillata Ltd PA1493/003/004 Orodispersible Tablet - OLANZAPINE N/A
OTELUS Arrow Generics Limited PA1130/036/003W Film Coated Tablet - MONTELUKAST SODIUM N/A
OTELUS Arrow Generics Limited PA1130/036/002W Tablets Chewable - MONTELUKAST SODIUM N/A
OTELUS Arrow Generics Limited PA1130/036/001W Tablets Chewable - MONTELUKAST SODIUM N/A
OTRIVINE Boots (UK) Limited DPR1465/016/001 Eye Drops Solution - XYLOMETAZOLINE N/A
HYDROCHLORIDE
- ANTAZOLINE SULFATE
OXALIPLATIN Martindale Pharmaceuticals PA0361/026/001 Powder for solution for - OXALIPLATIN (20ML) N/A
Ltd infusion - OXALIPLATIN (50ML)
OXALIPLATIN 5 MG/ML, Pharmachemie BV PA0937/007/002 Powder for solution for - OXALIPLATIN N/A
POWDER FOR SOLUTION infusion
FOR INFUS
OXCARBAZEPINE TEVA Teva Pharma B.V. PA0749/073/001 Film Coated Tablet - OXCARBAZEPINE N/A
PALLADONE Napp Pharmaceuticals PA0913/015/012 Solution for Inj/Inf - HYDROMORPHONE N/A
Limited HYDROCHLORIDE
PALLADONE Napp Pharmaceuticals PA0913/015/013 Solution for Inj/Inf - HYDROMORPHONE N/A
Limited HYDROCHLORIDE
PALLADONE Napp Pharmaceuticals PA0913/015/014 Solution for Inj/Inf - HYDROMORPHONE N/A
Limited HYDROCHLORIDE
PALLADONE Napp Pharmaceuticals PA0913/015/015 Solution for Inj/Inf - HYDROMORPHONE N/A
Limited HYDROCHLORIDE
PANADOL ACTIFAST PCO Manufacturing PPA0465/158/002 Film Coated Tablet - PARACETAMOL N/A
TABLETS 500MG
PANTOPRAZOLE Ranbaxy (UK) Limited PA0967/013/002 Tablets Gastro-Resistant - PANTOPRAZOLE N/A
PANTOPRAZOLE Ranbaxy (UK) Limited PA0967/014/001 Tablets Gastro-Resistant - PANTOPRAZOLE N/A
RANBAXY
PANTOPRAZOLE Ranbaxy (UK) Limited PA0967/014/002 Tablets Gastro-Resistant - PANTOPRAZOLE N/A
RANBAXY
PARICALCIMED Medice Arzneimittel Putter PA1555/002/004 Solution for Injection - PARICALCITOL N/A
GmbH & Co. K.G
PARIET McDowell Pharmaceuticals PPA1473/035/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM N/A
PARIET McDowell Pharmaceuticals PPA1473/035/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM N/A
PENTASA McDowell Pharmaceuticals PPA1473/038/001 Tablet Prolonged Release - MESALAZINE N/A
PEPCID B & S Healthcare DPR1328/004/001 Film Coated Tablet - FAMOTIDINE N/A
PEPCID B & S Healthcare PPA1328/117/001 Film Coated Tablet - FAMOTIDINE N/A
PERINDOPRIL- Les Laboratoires Servier PA0568/009/001 Tablets - PERINDOPRIL TERT- N/A
INDAPAMIDE BUTYLAMINE SALT
- INDAPAMIDE
PERSANTIN REGARD IMED Healthcare Ltd. DPR1463/033/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard

Human Medicines Withdrawn Products Page 579 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PERSANTIN RETARD McDowell Pharmaceuticals DPR1473/017/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
PERSANTIN RETARD Profind Wholesale Ltd DPR1500/036/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
PERSANTIN RETARD PCO Manufacturing DPR0465/014/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
PERSANTIN RETARD B & S Healthcare DPR1328/013/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
PERSANTIN RETARD G & A Licensing Limited DPR1447/007/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
PERSANTIN RETARD Eurodrug Ltd DPR1392/051/001 Modified-release capsule, - DIPYRIDAMOLE N/A
hard
POLYFAX OINTMENT, McDowell Pharmaceuticals DPR1473/030/001 Ointment - POLYMYXIN B SULFATE N/A
(POLYMYXIN B SULPHATE) - BACITRACIN ZINC
& (BACITR
POSACONAZOLE SP SP Europe EU/1/05/321/001 Oral Suspension - POSACONAZOLE N/A
PRAMIPEXOLE ORION Orion Corporation PA1327/012/001 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE ORION Orion Corporation PA1327/012/002 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE ORION Orion Corporation PA1327/012/003 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE ORION Orion Corporation PA1327/012/004 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
PRAMIPEXOLE ORION Orion Corporation PA1327/012/005 Tablets - PRAMIPEXOLE N/A
DIHYDROCHLORIDE
MONOHYDRATE
PRAVASTATIN SODIUM Primecrown 2010 Ltd DPR1633/010/001 Tablets - PRAVASTATIN SODIUM N/A
PRAVASTATIN SODIUM Primecrown 2010 Ltd DPR1633/010/002 Tablets - PRAVASTATIN SODIUM N/A
PRAVASTATIN SODIUM Primecrown 2010 Ltd DPR1633/010/003 Tablets - PRAVASTATIN SODIUM N/A
PREVENTEX OVULE Aromapharm Ireland Ltd PA1164/001/001 Pessary - BENZALKONIUM N/A
CHLORIDE
PREVIFECT Rowex Ltd PA0711/185/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM N/A
SESQUIHYDRATE

PRIODERM LOTION Boots (UK) Limited DPR1465/036/001 Cutaneous Solution - MALATHION N/A
PRIODERM LOTION Boots (UK) Limited DPR1465/017/001 Cutaneous Solution - MALATHION N/A
PRISTIQS Wyeth Europa Limited H/C/794/00/0/0 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
PRISTIQS Wyeth Europa Limited H/C/794/00/0/1 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
PRISTIQS Wyeth Europa Limited H/C/794/00/0/2 Tablet Prolonged Release - DESVENLAFAXINE N/A
SUCCINATE
MONOHYDRATE
PROMETAX Novartis Europharm Limited H/C/225/X/078/G Transdermal Patch - RIVASTIGMINE N/A
PROPOFOL Techno-Pharm Limited PA0754/005/001 Emulsion for Inj/Inf - PROPOFOL N/A
TECHNOPHARM AMPOULE

PROPOFOL Techno-Pharm Limited PA0754/005/002 Emulsion for Inj/Inf - PROPOFOL N/A


TECHNOPHARM VIAL
PROSTAP 3 PCO Manufacturing PPA0465/258/001 Pdr+Solv for Susp for Inj - LEUPRORELIN ACETATE N/A
PROTIUM LTT Pharma Limited PPA1562/005/001 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM N/A
SESQUIHYDRATE

PROTIUM LTT Pharma Limited PPA1562/005/002 Tablets Gastro-Resistant - PANTOPRAZOLE SODIUM N/A
SESQUIHYDRATE

PROTIUM IPS Healthcare Limited PPA1659/008/002 Tablets Gastro-Resistant - PANTOPRAZOLE N/A


PROVIGIL PCO Manufacturing PPA0465/233/001 Tablets - MODAFINIL N/A
PROVIGIL PCO Manufacturing PPA0465/233/002 Tablets - MODAFINIL N/A
PROZAC Belfast Drug Ltd. DPR1601/011/001 Capsules Hard - FLUOXETINE N/A
HYDROCHLORIDE
PROZAC McDowell Pharmaceuticals DPR1473/037/001 Capsules Hard - FLUOXETINE N/A
HYDROCHLORIDE
PROZAC LTT Pharma Limited DPR1562/012/001 Capsules Hard - FLUOXETINE N/A
HYDROCHLORIDE
PROZAC Profind Wholesale Ltd DPR1500/006/001 Capsules Hard - FLUOXETINE N/A
HYDROCHLORIDE
PROZAC Eurodrug Ltd DPR1392/008/001 Capsules Hard - FLUOXETINE N/A

Human Medicines Withdrawn Products Page 580 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
PROZAC B & S Healthcare DPR1328/034/001 Capsules Hard - FLUOXETINE N/A
HYDROCHLORIDE
PULMICORT AstraZeneca UK Limited PA0970/050/008 Pressurised Inhalation - BUDESONIDE N/A
Suspension
PULMICORT AstraZeneca UK Limited PA0970/050/009 Pressurised Inhalation - BUDESONIDE N/A
Suspension
PULMICORT TURBOHALER G & A Licensing Limited PPA1447/023/001 Inhalation powder - BUDESONIDE N/A

PULMICORT TURBOHALER G & A Licensing Limited PPA1447/023/002 Inhalation powder - BUDESONIDE N/A

PULMICORT TURBOHALER PCO Manufacturing PPA0465/100/003 Inhalation powder - BUDESONIDE N/A


400 MICROGRAMS
INHALATION POW

RABEPRAZOLE SODIUM Teva Pharma B.V. PA0749/080/001 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM N/A
TEVA
RABEPRAZOLE SODIUM Teva Pharma B.V. PA0749/080/002 Tablets Gastro-Resistant - RABEPRAZOLE SODIUM N/A
TEVA
RALGEX LTT Pharma Limited DPR1562/005/001 Cream - GLYCOL N/A
MONOSALICYLATE
- CAPSAICIN
RALGEX Boots (UK) Limited DPR1465/018/001 Cream - GLYCOL N/A
MONOSALICYLATE
- METHYL NICOTINATE
- CAPSAICIN
RALGEX Eurodrug Ltd DPR1392/054/001 Cream - GLYCOL N/A
MONOSALICYLATE
- METHYL NICOTINATE
- CAPSAICIN
RALGEX Eurodrug Ltd DPR1392/057/001 Cutaneous Spray Solution - GLYCOL N/A
MONOSALICYLATE
- METHYL NICOTINATE
RALGEX HEAT SPRAY Boots (UK) Limited DPR1465/019/001 Cutaneous Spray Solution - GLYCOL N/A
MONOSALICYLATE
- METHYL NICOTINATE
RALGEX HEAT SPRAY Boots (UK) Limited DPR1465/037/001 Cutaneous Spray Solution - GLYCOL N/A
MONOSALICYLATE
- METHYL NICOTINATE
RAMELTEON Takeda Global R&D Centre H/C/838/00/0/0 Film Coated Tablet - RAMELTEON N/A
Europe Limited
RAMELTEON Takeda Global R&D Centre H/C/838/00/0/1 Film Coated Tablet - RAMELTEON N/A
Europe Limited
RANITIDINE CLARIS Claris Lifesciences (UK) PA1389/011/001 Solution for Inj/Inf - RANITIDINE N/A
Limited HYDROCHLORIDE
RASILAMLO Novartis Europharm Limited EU/1/11/686/001-014 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
RASITRIO Novartis Europharm Limited EU/1/11/730/025-036 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
- HYDROCHOLOTHIAZIDE
RASITRIO Novartis Europharm Limited EU/1/11/730/037-048 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
- HYDROCHOLOTHIAZIDE
RASITRIO Novartis Europharm Limited EU/1/11/730/049-060 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- AMLODIPINE BESYLATE
- HYDROCHOLOTHIAZIDE
REACTINE McNeil Healthcare (Ireland) PA0823/041/003 Capsule - CETIRIZINE N/A
Ltd DIHYDROCHLORIDE
RECOMBINANT GlaxoSmithKline Biologicals PIP1408/003/001 Not assigned N/A
VARICELLA ZOSTER
VIRUS (VZV) GLYCOPROT
RECTOGESIC IMED Healthcare Ltd. DPR1463/037/001 Rectal Ointment - GLYCERYL TRINITRATE N/A
REDUCTIL Imbat Limited PPA1151/019/001 Capsules Hard - SIBUTRAMINE N/A
HYDROCHLORIDE
MONOHYDRATE
REDUCTIL Imbat Limited PPA1151/019/002 Capsules Hard - SIBUTRAMINE N/A
HYDROCHLORIDE
MONOHYDRATE
REFLUDAN Pharmion Limited EU/1/97/035/001 Powder for solution for - LEPIRUDIN N/A
infusion
REFLUDAN Pharmion Limited EU/1/97/035/002 Powder for solution for - LEPIRUDIN N/A
infusion
REGURIN IMED Healthcare Ltd. DPR1463/040/001 Coated Tablets - TROSPIUM CHLORIDE N/A

Human Medicines Withdrawn Products Page 581 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RELESTAT B & S Healthcare DPR1328/008/001 Eye Drops Solution - EPINASTINE N/A
HYDROCHLORIDE
RELTEBON Actavis Group PTC ehf PA1380/129/006 Tablet Prolonged Release - OXYCODONE N/A
HYDROCHLORIDE
REMEGEL Boots (UK) Limited DPR1465/020/001 Tablets Chewable - CALCIUM CARBONATE N/A
REMINYL XL McDowell Pharmaceuticals DPR1473/046/001 Prolonged Release Capsules - GALANTAMINE N/A

REMINYL XL McDowell Pharmaceuticals DPR1473/046/002 Prolonged Release Capsules - GALANTAMINE N/A

REMINYL XL McDowell Pharmaceuticals DPR1473/046/003 Prolonged Release Capsules - GALANTAMINE N/A

REMINYL XL B & S Healthcare DPR1328/010/001 Tablet Prolonged Release - GALANTAMINE N/A


REMINYL XL B & S Healthcare DPR1328/010/002 Tablet Prolonged Release - GALANTAMINE N/A
REMINYL XL B & S Healthcare DPR1328/010/003 Tablet Prolonged Release - GALANTAMINE N/A
REMINYL XL G & A Licensing Limited DPR1447/008/001 Prolonged Release Capsules - GALANTAMINE N/A
HYDROBROMIDE
REMINYL XL G & A Licensing Limited DPR1447/008/002 Prolonged Release Capsules - GALANTAMINE N/A
HYDROBROMIDE
REMINYL XL G & A Licensing Limited DPR1447/008/003 Prolonged Release Capsules - GALANTAMINE N/A
HYDROBROMIDE
REMINYL XL PROLONGED Profind Wholesale Ltd DPR1500/033/001 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

REMINYL XL PROLONGED Profind Wholesale Ltd DPR1500/033/002 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

REMINYL XL PROLONGED Profind Wholesale Ltd DPR1500/033/003 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

REMINYL XL PROLONGED Belfast Drug Ltd. DPR1601/019/001 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

REMINYL XL PROLONGED Belfast Drug Ltd. DPR1601/019/002 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

REMINYL XL PROLONGED Belfast Drug Ltd. DPR1601/019/003 Prolonged Release Capsules - GALANTAMINE N/A
RELEASE CAPSULES

RESDAL Niche Generics Limited PA1063/026/001 Orodispersible Tablet - RISPERIDONE N/A


RESDAL Niche Generics Limited PA1063/026/002 Orodispersible Tablet - RISPERIDONE N/A
RESDAL Niche Generics Limited PA1063/026/003 Orodispersible Tablet - RISPERIDONE N/A
RESDAL Niche Generics Limited PA1063/026/004 Orodispersible Tablet - RISPERIDONE N/A
RESDAL Niche Generics Limited PA1063/026/005 Orodispersible Tablet - RISPERIDONE N/A
RIBAVIRIN BIOPARTNERS BioPartners GmbH EU/1/10/626/1-4 Film Coated Tablet - RIBAVIRIN N/A
RIENSO Takeda Pharma A/S EU/1/12/774/001-002 Solution for Injection - FERUMOXYTOL (USAN) N/A
RIMENDIA Bayer Limited PA1410/057/001 Film Coated Tablet - ETHINYLESTRADIOL (AS N/A
BETADEX-CLATHRATE)
- DROSPIRENONE
RINOPREX Pinewood Laboratories Ltd, PA0281/133/001 Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE
RINOPREX Pinewood Laboratories Ltd, PA0281/133/002 Tablets - PERINDOPRIL TERT- N/A
BUTYLAMINE
RISDONE 6 MG FILM- Arrow Generics Limited PA1130/008/006 Film Coated Tablet - RISPERIDONE N/A
COATED TABLETS
RISEDRONATE SODIUM Actavis Group PTC ehf PA1380/053/002 Film Coated Tablet - RISEDRONATE SODIUM N/A
ACTAVIS 30 MG FILM-
COATED TABLETS
RISEDRONATE SODIUM Actavis Group PTC ehf PA1380/053/001 Film Coated Tablet - RISEDRONATE SODIUM N/A
ACTAVIS 5 MG FILM-
COATED TABLETS
RISESEUS Caduceus Pharma Ltd PA1399/004/002 Film Coated Tablet - RISEDRONATE SODIUM N/A
AMORPHOUS
RISESEUS 5 MG FILM- Caduceus Pharma Ltd PA1399/004/001 Film Coated Tablet - RISEDRONATE SODIUM N/A
COATED TABLETS AMORPHOUS
RISESEUS ONCE WEEKLY Caduceus Pharma Ltd PA1399/004/003 Film Coated Tablet - RISEDRONATE SODIUM N/A
AMORPHOUS
RISPERDAL Imbat Limited PPA1151/091/001 Film Coated Tablet - RISPERIDONE N/A
RISPERDAL Imbat Limited PPA1151/091/002 Film Coated Tablet - RISPERIDONE N/A
RISPERDAL Imbat Limited PPA1151/091/003 Film Coated Tablet - RISPERIDONE N/A
RISPERDAL CONSTA Clear Pharmacy DPR1596/026/001 Suspension for Injection - RISPERIDONE N/A
RISPERDAL CONSTA Clear Pharmacy DPR1596/026/002 Suspension for Injection - RISPERIDONE N/A
RISPERDAL CONSTA Clear Pharmacy DPR1596/026/003 Suspension for Injection - RISPERIDONE N/A
RISPERDAL CONSTA IMED Healthcare Ltd. DPR1463/035/001 Suspension for Injection - RISPERIDONE N/A
RISPERDAL CONSTA IMED Healthcare Ltd. DPR1463/035/002 Suspension for Injection - RISPERIDONE N/A
RISPERDAL CONSTA IMED Healthcare Ltd. DPR1463/035/003 Suspension for Injection - RISPERIDONE N/A

Human Medicines Withdrawn Products Page 582 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
RISPERIDONE McDowell Pharmaceuticals DPR1473/060/001 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/001 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/002 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/003 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/004 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/005 Film Coated Tablet - RISPERIDONE N/A
RISPERIDONE GENTIAN Gentian Generics Limited PA1469/003/006 Film Coated Tablet - RISPERIDONE N/A
RISPEVA Teva Pharma B.V. PA0749/049/003 Orodispersible Tablet - RISPERIDONE N/A
RISPEVA Teva Pharma B.V. PA0749/049/004 Orodispersible Tablet - RISPERIDONE N/A
RISPEVA Teva Pharma B.V. PA0749/049/005 Orodispersible Tablet - RISPERIDONE N/A
RISPEVA Teva Pharma B.V. PA0749/049/006 Orodispersible Tablet - RISPERIDONE N/A
RIVASTIGMINE ORION Orion Corporation PA1327/013/004 Capsules Hard - RIVASTIGMINE N/A
RONI Rowex Ltd PA0711/116/001 Film Coated Tablet - ROPINIROLE N/A
RONI Rowex Ltd PA0711/116/002 Film Coated Tablet - ROPINIROLE N/A
RONI Rowex Ltd PA0711/116/003 Film Coated Tablet - ROPINIROLE N/A
RONI Rowex Ltd PA0711/116/004 Film Coated Tablet - ROPINIROLE N/A
RONI Rowex Ltd PA0711/116/005 Film Coated Tablet - ROPINIROLE N/A
ROPINIROLE McDermott Laboratories Ltd PA0577/094/003 Film Coated Tablet - ROPINIROLE N/A
t/a Gerard Laboratories HYDROCHLORIDE
SALOFALK ENEMA Eurodrug Ltd DPR1392/038/001 Enema - MESALAZINE N/A
SALOFALK GASTRO- B & S Healthcare DPR1328/005/001 Granules Prolonged Release - MESALAZINE N/A
RESISTANT
SALOFALK GRANULES Eurodrug Ltd DPR1392/038/002 Granules - MESALAZINE N/A
SALOFALK GRANULES McDowell Pharmaceuticals DPR1473/053/001 Granules - MESALAZINE N/A
SALOFALK TABLETS Eurodrug Ltd DPR1392/038/003 Tablets - MESALAZINE N/A
SAVLON Boots (UK) Limited DPR1465/021/001 Cream - CETRIMONIUM BROMIDE N/A
- CHLORHEXIDINE
GLUCONATE

SAVLON Boots (UK) Limited DPR1465/022/001 Cutaneous Spray Powder - POVIDONE-IODINE N/A
SAVLON DRY ANTISEPTIC Boots (UK) Limited DPR1465/038/001 Cutaneous Spray Powder - POVIDONE-IODINE N/A

SAVLON DRY ANTISEPTIC PCO Manufacturing DPR0465/037/001 Cutaneous Spray Powder - POVIDONE-IODINE N/A

SDFF test company 2 99999/999/992 Not assigned N/A


SERC Eurodrug Ltd DPR1392/020/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC Clear Pharmacy DPR1596/007/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC Clear Pharmacy DPR1596/007/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-16 McDowell Pharmaceuticals DPR1473/038/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-16 Profind Wholesale Ltd DPR1500/015/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-16 IMED Healthcare Ltd. DPR1463/025/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-16 TABLETS Belfast Drug Ltd. DPR1601/020/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-8 Eurodrug Ltd DPR1392/020/002 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-8 Profind Wholesale Ltd DPR1500/015/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-8 McDowell Pharmaceuticals DPR1473/038/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-8 IMED Healthcare Ltd. DPR1463/025/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERC-8 TABLETS Belfast Drug Ltd. DPR1601/020/001 Tablets - BETAHISTINE N/A
HYDROCHLORIDE
SERETIDE 100 DISKUS Eurodrug Ltd DPR1392/030/001 Inhalation powder - SALMETEROL N/A
XINAFOATE
- FLUTICASONE
PROPIONATE
SERETIDE 250 DISKUS Eurodrug Ltd DPR1392/030/002 Inhalation powder - SALMETEROL N/A
XINAFOATE
- FLUTICASONE
PROPIONATE
SEROQUEL Eurodrug Ltd DPR1392/065/001 Film Coated Tablet - QUETIAPINE FUMARATE N/A
SEROQUEL Chemilines Healthcare PPA1915/001/001 Film Coated Tablet - QUETIAPINE FUMARATE N/A
(Ireland) Limited
SEROQUEL Chemilines Healthcare PPA1915/001/002 Film Coated Tablet - QUETIAPINE FUMARATE N/A
(Ireland) Limited
SEROQUEL Chemilines Healthcare PPA1915/001/003 Film Coated Tablet - QUETIAPINE FUMARATE N/A
(Ireland) Limited

Human Medicines Withdrawn Products Page 583 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SEROXAT B & S Healthcare PPA1328/002/002 Film Coated Tablet - PAROXETINE N/A
HYDROCHLORIDE
HEMIHYDRATE
SIBUTRAMINE TEVA Teva Pharma B.V. PA0749/050/001 Capsule - SIBUTRAMINE HCI N/A
MONOHYDRATE
SIBUTRAMINE TEVA Teva Pharma B.V. PA0749/050/002 Capsule - SIBUTRAMINE HCI N/A
MONOHYDRATE
SILKIS OINTMENT McDowell Pharmaceuticals DPR1473/058/001 Ointment - CALCITRIOL N/A
SIMCOVAS Actavis Group PTC ehf PA1380/062/004 Film Coated Tablet - SIMVASTATIN N/A
SINEMET IMED Healthcare Ltd. DPR1463/029/004 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET McDowell Pharmaceuticals DPR1473/018/002 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET McDowell Pharmaceuticals DPR1473/018/003 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET McDowell Pharmaceuticals DPR1473/018/004 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET IMED Healthcare Ltd. DPR1463/029/001 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET IMED Healthcare Ltd. DPR1463/029/002 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET 110 Profind Wholesale Ltd DPR1500/024/002 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET 275 Profind Wholesale Ltd DPR1500/024/003 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET 62.5 Profind Wholesale Ltd DPR1500/024/001 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET CR Eurodrug Ltd DPR1392/007/002 Tablet Prolonged Release - CARBIDOPA N/A
- LEVODOPA
SINEMET CR McDowell Pharmaceuticals DPR1473/018/001 Prolonged Release Capsules - LEVODOPA N/A
- CARBIDOPA
SINEMET CR IMED Healthcare Ltd. DPR1463/029/005 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET PLUS IMED Healthcare Ltd. DPR1463/029/003 Tablets - CARBIDOPA N/A
- LEVODOPA
SINEMET-PLUS McDowell Pharmaceuticals DPR1473/018/005 Tablets - CARBIDOPA N/A
- LEVODOPA
SINGULAIR McDowell Pharmaceuticals DPR1473/040/003 Film Coated Tablet - MONTELUKAST SODIUM N/A
SINGULAIR Profind Wholesale Ltd DPR1500/023/002 Film Coated Tablet - MONTELUKAST SODIUM N/A
SINGULAIR IMED Healthcare Ltd. DPR1463/024/001 Film Coated Tablet - MONTELUKAST SODIUM N/A
SINGULAIR Novalus Healthcare Limited PPA1925/001/001 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR Novalus Healthcare Limited PPA1925/001/002 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR Novalus Healthcare Limited PPA1925/001/003 Film Coated Tablet - MONTELUKAST SODIUM N/A
SINGULAIR 10 MG FILM Belfast Drug Ltd. DPR1601/021/003 Film Coated Tablet - MONTELUKAST SODIUM N/A
COATED TABLETS
SINGULAIR PAEDIATRIC IMED Healthcare Ltd. DPR1463/024/002 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC IMED Healthcare Ltd. DPR1463/024/003 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC IMED Healthcare Ltd. DPR1463/024/004 Granules - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC Profind Wholesale Ltd DPR1500/023/003 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC Profind Wholesale Ltd DPR1500/023/001 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC Clear Pharmacy DPR1596/005/001 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC Clear Pharmacy DPR1596/005/002 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC Clear Pharmacy DPR1596/005/003 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC McDowell Pharmaceuticals DPR1473/040/004 Granules - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC McDowell Pharmaceuticals DPR1473/040/001 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC McDowell Pharmaceuticals DPR1473/040/002 Tablets Chewable - MONTELUKAST SODIUM N/A
SINGULAIR PAEDIATRIC 4 Belfast Drug Ltd. DPR1601/021/001 Tablets Chewable - MONTELUKAST SODIUM N/A
MG CHEWABLE TABLETS
SINGULAIR PAEDIATRIC 5 Belfast Drug Ltd. DPR1601/021/002 Tablets Chewable - MONTELUKAST SODIUM N/A
MG CHEWABLE TABLETS
SOFT CORN REMOVAL Boots (UK) Limited DPR1465/023/001 Impregnated Dressing - SALICYLIC ACID N/A
PADS
SONOVUE Bracco International B.V. EU/1/01/177/001 Pdr for Soln for Injection - SULPHUR N/A
HEXAFLUORIDE
SPIRIVA RESPIMAT B & S Healthcare PPA1328/154/001 Inhalation solution - TIOTROPIUM BROMIDE N/A
SPIRIVA RESPIMAT IMED Healthcare Ltd. DPR1463/030/001 Inhalation solution - TIOTROPIUM N/A
SPIRIVA RESPIMAT Profind Wholesale Ltd DPR1500/034/001 Inhalation solution - TIOTROPIUM N/A
SPIRIVA RESPIMAT McDowell Pharmaceuticals DPR1473/050/001 Inhalation solution - TIOTROPIUM N/A
SPIRIVA RESPIMAT Belfast Drug Ltd. DPR1601/012/001 Inhalation solution - TIOTROPIUM N/A
SOLUTION FOR
INHALATION
SPIRIVA RESPIMAT Clear Pharmacy DPR1596/019/001 Inhalation solution - TIOTROPIUM N/A
SOLUTION FOR
INHALATION

Human Medicines Withdrawn Products Page 584 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SPRIMEO HCT Novartis Europharm Limited EU/1/11/683/001-020 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

SPRIMEO HCT Novartis Europharm Limited EU/1/11/683/021-40 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

SPRIMEO HCT Novartis Europharm Limited EU/1/11/683/041-060 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

SPRIMEO HCT Novartis Europharm Limited EU/1/11/683/061-80 Film Coated Tablet - ALISKIREN N/A
HEMIFUMARATE
- HYDROCHLOROTHIAZIDE

SUDOCREM Boots (UK) Limited DPR1465/024/001 Cream - ZINC OXIDE N/A


- LANOLIN
- BENZYL BENZOATE
- BENZYL CINNAMATE
- BENZYL ALCOHOL
SYMBICORT TURBOHALE McDowell Pharmaceuticals PPA1473/028/002 Inhalation powder - BUDESONIDE N/A
- FORMOTEROL
FUMARATE
SYMBICORT TURBOHALE McDowell Pharmaceuticals PPA1473/028/003 Inhalation powder - BUDESONIDE N/A
- FORMOTEROL
FUMARATE
SYMTUZA (FORMERLY Janssen-Cilag International H/C/4391/00/0/1 Film Coated Tablet - DARUNAVIR N/A
DARUNAVIR COBICISTAT NV ETHANOLATE
EMTRICITABINE - COBICISTAT
TENOFOVIR
ALAFENAMIDE)
SYMTUZA (FORMERLY Janssen-Cilag International H/C/4391/00/0/2 Film Coated Tablet - DARUNAVIR N/A
DARUNAVIR COBICISTAT NV ETHANOLATE
EMTRICITABINE - COBICISTAT
TENOFOVIR
ALAFENAMIDE)
SYMTUZA (FORMERLY Janssen-Cilag International H/C/4391/00/0/3 Film Coated Tablet - DARUNAVIR N/A
DARUNAVIR COBICISTAT NV ETHANOLATE
EMTRICITABINE - COBICISTAT
TENOFOVIR
ALAFENAMIDE)
SYNTHAMIN 14 Baxter Healthcare Limited PA0167/091/004 Solution for Infusion - LEUCINE N/A
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- VALINE
- PHENYLALANINE
- HISTIDINE
- THREONINE
- DL-METHIONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE

Human Medicines Withdrawn Products Page 585 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
SYNTHAMIN 17 Baxter Healthcare Limited PA0167/091/007 Solution for Infusion - LEUCINE N/A
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- VALINE
- PHENYLALANINE
- HISTIDINE
- THREONINE
- DL-METHIONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
SYNTHAMIN 9 Baxter Healthcare Limited PA0167/091/001 Solution for Infusion - LEUCINE N/A
- ISOLEUCINE
- LYSINE
HYDROCHLORIDE
- VALINE
- PHENYLALANINE
- HISTIDINE
- THREONINE
- DL-METHIONINE
- TRYPTOPHAN, L-
- ALANINE
- ARGININE
- AMINOACETIC ACID
- PROLINE
- SERINE
- TYROSINE
- SODIUM ACETATE
- POTASSIUM PHOSPHATE
DIBASIC
- SODIUM CHLORIDE
- MAGNESIUM CHLORIDE
HEXAHYDRATE
TAGAMET Primecrown Ltd. PPA1071/012/002A Tablets - CIMETIDINE N/A
TAMBOCOR McDowell Pharmaceuticals DPR1473/048/001 Tablets - FLECAINIDE ACETATE N/A
TAMBOCOR Profind Wholesale Ltd DPR1500/013/001 Tablets - FLECAINIDE ACETATE N/A
TAMBOCOR B & S Healthcare DPR1328/009/001 Tablets - FLECAINIDE ACETATE N/A
TAMBOCOR Eurodrug Ltd DPR1392/043/001 Tablets - FLECAINIDE ACETATE N/A
TAMBOCOR Eurodrug Ltd DPR1392/043/002 Tablets - FLECAINIDE ACETATE N/A
TANDEMACT Takeda Global R&D Centre EU/1/06/366/003-004 Tablets - PIOGLITAZONE N/A
Europe Limited - GLIMEPIRIDE
TAVANIC PCO Manufacturing PPA0465/237/001 Film Coated Tablet - LEVOFLOXACIN N/A
TAVANIC McDowell Pharmaceuticals DPR1473/031/001 Film Coated Tablet - LEVOFLOXACIN N/A
HEMIHYDRATE
TAVANIC McDowell Pharmaceuticals DPR1473/031/003 Film Coated Tablet - LEVOFLOXACIN N/A
TEBONEVA Teva Pharma B.V. PA0749/166/001 Tablets - ALENDRONIC ACID N/A
- ALFACALCIDOL
TEKTURNA Novartis Europharm Limited EU/1/07/408/1-10 Film Coated Tablet - SPP100 HEMIFUMARATE N/A
TEKTURNA Novartis Europharm Limited EU/1/07/408/11-20 Film Coated Tablet - SPP100 HEMIFUMARATE N/A
TELFAST Belfast Drug Ltd. DPR1601/022/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST Belfast Drug Ltd. DPR1601/022/002 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST McDowell Pharmaceuticals DPR1473/019/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST McDowell Pharmaceuticals DPR1473/019/002 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST Profind Wholesale Ltd DPR1500/001/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST Profind Wholesale Ltd DPR1500/001/002 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST LTT Pharma Limited DPR1562/013/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST IMED Healthcare Ltd. DPR1463/013/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST IMED Healthcare Ltd. DPR1463/013/002 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST Eurodrug Ltd DPR1392/014/001 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE
TELFAST Eurodrug Ltd DPR1392/014/002 Film Coated Tablet - FEXOFENADINE N/A
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 586 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
TENORMIN G & A Licensing Limited PPA1447/014/001 Tablets - ATENOLOL N/A
TENORMIN 25 MG FILM- PCO Manufacturing PPA0465/023/003 Film Coated Tablet - ATENOLOL N/A
COATED TABLETS
TEST PRODUCT 20 New Test Company LTD PA13340/001/001 Capsule - TEST 29999234 N/A
TETRALYSAL Eurodrug Ltd DPR1392/067/001 Capsules Hard - LYMECYCLINE N/A
TETRALYSAL IMED Healthcare Ltd. DPR1463/041/001 Capsules Hard - LYMECYCLINE N/A
TEVETEN Chemilines Healthcare PPA1915/004/001 Film Coated Tablet - EPROSARTAN MESYLATE N/A
(Ireland) Limited
THERALOC ONCOSCIENCE AG H/C/931/00/0/0 Concentrate for Soln for Inf - NIMOTUZUMAB N/A
TIMOPTOL McDowell Pharmaceuticals DPR1473/032/001 Eye Drops Solution - TIMOLOL MALEATE N/A
TIMOPTOL Profind Wholesale Ltd DPR1500/030/001 Eye Drops Solution - TIMOLOL MALEATE N/A
TIMOPTOL B & S Healthcare DPR1328/011/002 Eye Drops Solution - TIMOLOL MALEATE N/A
TIMOPTOL EYE DROPS Eurodrug Ltd DPR1392/052/001 Eye Drops Solution - TIMOLOL MALEATE N/A
SOLUTION
TIMOPTOL EYE DROPS Clear Pharmacy DPR1596/011/001 Eye Drops Solution - TIMOLOL MALEATE N/A
SOLUTION
TIMOPTOL EYE DROPS Belfast Drug Ltd. DPR1601/013/001 Eye Drops Solution - TIMOLOL MALEATE N/A
SOLUTION
TIMOPTOL LA GEL- B & S Healthcare DPR1328/011/001 Eye Drops Solution - TIMOLOL MALEATE N/A
FORMING
TIRLOR Rowex Ltd PA0711/148/001 Tablets N/A
TIRLOR ALLERGY 10MG Rowex Ltd PA0711/148/002 Tablets N/A
TABLETS
TOPIRAMATE ACTAVIS Actavis Group PTC ehf PA1380/074/001 Tablets - TOPIRAMATE N/A
TOPIRAMATE ACTAVIS Actavis Group PTC ehf PA1380/074/002 Tablets - TOPIRAMATE N/A
TOPIRAMATE ACTAVIS Actavis Group PTC ehf PA1380/074/003 Tablets - TOPIRAMATE N/A
TOPIRAMATE ACTAVIS Actavis Group PTC ehf PA1380/074/004 Tablets - TOPIRAMATE N/A
TOPOTECAN MARTINDALE Martindale Pharmaceuticals PA0361/032/001 Powder for concentrate for - TOPOTECAN N/A
PHARMA Ltd solution for infusion HYDROCHLORIDE
TOPOTECAN MARTINDALE Martindale Pharmaceuticals PA0361/032/002 Powder for concentrate for - TOPOTECAN N/A
PHARMA Ltd solution for infusion HYDROCHLORIDE
TOSTRAN Eurodrug Ltd DPR1392/029/001 Gel - TESTOSTERONE N/A
TRAJENTAMET Boehringer Ingelheim H/C/2279/00/0/0 Film Coated Tablet - LINAGLIPTIN N/A
International GmbH - METFORMIN
TRAXAM MIRAPHARM DPR1400/004/001 Gel - FELBINAC N/A
TRAXAM IMED Healthcare Ltd. DPR1463/011/001 Gel - FELBINAC N/A
TRAXAM Eurodrug Ltd DPR1392/015/001 Gel - FELBINAC N/A
TRAXAM PCO Manufacturing DPR0465/007/001 Gel - FELBINAC N/A
TRAXAM McDowell Pharmaceuticals DPR1473/020/001 Gel - FELBINAC N/A
TRIAPIN 5MG/5MG PCO Manufacturing PPA0465/232/001 Tablet Prolonged Release - FELODIPINE N/A
PROLONGED RELEASE - RAMIPRIL
TABLET
TRUSOPT McDowell Pharmaceuticals DPR1473/021/001 Eye Drops Solution - DORZOLAMIDE N/A
TRUSOPT Profind Wholesale Ltd DPR1500/029/001 Eye Drops Solution - DORZOLAMIDE N/A
TRUSOPT B & S Healthcare DPR1328/015/001 Eye Drops Solution - DORZOLAMIDE N/A
TRUSOPT EYE DROPS Clear Pharmacy DPR1596/014/001 Eye Drops Solution - DORZOLAMIDE N/A
SOLUTION
TRUSOPT EYE DROPS Belfast Drug Ltd. DPR1601/015/001 Eye Drops Solution - DORZOLAMIDE N/A
SOLUTION
TYROZETS Boots (UK) Limited DPR1465/040/001 Lozenges - TYROTHRICIN N/A
- BENZOCAINE
TYROZETS Boots (UK) Limited DPR1465/025/001 Lozenges - TYROTHRICIN N/A
- BENZOCAINE
VELOSULIN Novo Nordisk A/S EU/1/02/232/3 Solution for Injection - INSULIN HUMAN N/A
VENOFUNDIN B. Braun Melsungen AG PA0736/020/001 Solution for Infusion - POLY(O-2- N/A
HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

VENOFUNDIN B. Braun Melsungen AG PA0736/020/002 Solution for Infusion - POLY(O-2- N/A


HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

VENOFUNDIN B. Braun Melsungen AG PA0736/020/003 Solution for Infusion - POLY(O-2- N/A


HYDROXYETHYL)STARCH
- SODIUM CHLORIDE

VENTOLIN EVOHALER Chemilines Healthcare PPA1915/005/001 Pressurised Inhalation - SALBUTAMOL SULFATE N/A
(Ireland) Limited Suspension
VICKS INHALER Boots (UK) Limited DPR1465/026/001 Inhalation Vapour Solution - MENTHOL N/A
- CAMPHOR
- SIBERIAN FIR OIL
VICKS INHALER Boots (UK) Limited DPR1465/041/001 Inhalation Vapour Solution - MENTHOL N/A
- CINNAMOMUM
CAMPHORA
- SIBERIAN FIR OIL

Human Medicines Withdrawn Products Page 587 of 588


Trade Name Licence Holder Licence Number Dosage Form Active Ingredients Withdrawal Date
VILGENDRA Actavis Group PTC ehf PA1380/097/001 Film Coated Tablet - SILDENAFIL BASE (AS N/A
CITRATE)
VILGENDRA Actavis Group PTC ehf PA1380/097/002 Film Coated Tablet - SILDENAFIL BASE (AS N/A
CITRATE)
VILGENDRA Actavis Group PTC ehf PA1380/097/003 Film Coated Tablet - SILDENAFIL BASE (AS N/A
CITRATE)
VINORELBINE Cardinal Health UK 434 PA1348/016/001 Concentrate for Soln for Inf - VINORELBINE TARTRATE N/A
MARTINDALE PHARMA Limited
VIVAGLOBIN CSL Behring GmbH PA0800/004/002 Solution for Injection - HUMAN N/A
IMMUMOGLOBULINS
VOLTAROL 1% W/W PCO Manufacturing PPA0465/013/005 Gel - DICLOFENAC N/A
EMULGEL DIETHYLAMINE
VOLTAROL RETARD G & A Licensing Limited PPA1447/062/001 Film Coated Tablet - DICLOFENAC SODIUM N/A
VORINOSTAT MSD Merck Sharp & Dohme Ltd H/C/947/00/0/0 Capsules Hard - VORINOSTAT N/A
WARTICON Eurodrug Ltd DPR1392/034/001 Cream - PODOPHYLLOTOXIN N/A
XATRAL Chemilines Healthcare PPA1915/008/001 Tablet Prolonged Release - ALFUZOSIN N/A
(Ireland) Limited HYDROCHLORIDE
YOSQIERO Rowex Ltd PA0711/201/001 Film Coated Tablet - DESLORATIDINE N/A
ZANAFLEX Eurodrug Ltd DPR1392/025/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX Eurodrug Ltd DPR1392/025/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX IMED Healthcare Ltd. DPR1463/026/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX IMED Healthcare Ltd. DPR1463/026/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX B & S Healthcare DPR1328/017/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX B & S Healthcare DPR1328/017/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX Clear Pharmacy DPR1596/003/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX Clear Pharmacy DPR1596/003/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX Profind Wholesale Ltd DPR1500/014/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX Profind Wholesale Ltd DPR1500/014/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX TABLETS McDowell Pharmaceuticals DPR1473/055/001 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANAFLEX TABLETS McDowell Pharmaceuticals DPR1473/055/002 Tablets - TIZANIDINE N/A
HYDROCHLORIDE
ZANIDIP Chemilines Healthcare PPA1915/009/001 Film Coated Tablet - LERCANIDIPINE N/A
(Ireland) Limited
ZANOPRO PLUS Clonmel Healthcare Ltd PA0126/200/001 Eye Drops Solution - LATANOPROST N/A
- TIMOLOL MALEATE
ZANTAC 75 PCO Manufacturing PPA0465/033/003 Coated Tablets - RANITIDINE N/A
ZIMOVANE B & S Healthcare PPA1328/043/001 Film Coated Tablet - ZOPICLONE N/A
ZINBRYTA Biogen Idec Research EU/1/16/1107/001-002 Solution for injection in pre- - DACLIZUMAB N/A
Limited filled syringe
ZISPIN SOLTAB PCO Manufacturing PPA0465/207/001 Orodispersible Tablet - MIRTAZAPINE N/A
ZISPIN SOLTAB PCO Manufacturing PPA0465/207/002 Orodispersible Tablet - MIRTAZAPINE N/A
ZISPIN SOLTAB PCO Manufacturing PPA0465/207/003 Orodispersible Tablet - MIRTAZAPINE N/A
ZISPIN SOLTABS McDowell Pharmaceuticals PPA1473/025/002 Orodispersible Tablet - MIRTAZAPINE N/A
ZISPIN SOLTABS McDowell Pharmaceuticals PPA1473/025/003 Orodispersible Tablet - MIRTAZAPINE N/A
ZOCOR G & A Licensing Limited PPA1447/024/001 Film Coated Tablet - SIMVASTATIN N/A
ZOCOR G & A Licensing Limited PPA1447/024/002 Film Coated Tablet - SIMVASTATIN N/A
ZOLADEX IMPLANT Eurodrug Ltd DPR1392/011/001 Implant - GOSERELIN ACETATE N/A
ZOLMITRIPTAN ACTAVIS Actavis Group PTC ehf PA1380/114/001 Orodispersible Tablet - ZOLMITRIPTAN N/A
ZOLMITRIPTAN ACTAVIS Actavis Group PTC ehf PA1380/035/002 Film Coated Tablet - ZOLMITRIPTAN N/A
ZOMIG McDowell Pharmaceuticals PPA1473/039/001 Film Coated Tablet - ZOLMITRIPTAN N/A
ZOMIG G & A Licensing Limited PPA1447/009/002 Film Coated Tablet - ZOLMITRIPTAN N/A
ZOMIG RAPIMELT McDowell Pharmaceuticals PPA1473/039/002 Orodispersible Tablet - ZOLMITRIPTAN N/A
ZONTIVITY Merck Sharp & Dohme Ltd EU/1/14/976/001-006 Film Coated Tablet - VORAPAXAR N/A
ZOTON FASTAB Chemilines Healthcare PPA1915/010/001 Orodispersible Tablet - LANSOPRAZOLE N/A
(Ireland) Limited
ZOTON FASTAB Chemilines Healthcare PPA1915/010/002 Orodispersible Tablet - LANSOPRAZOLE N/A
(Ireland) Limited
ZOVIRAX B & S Healthcare PPA1328/067/001 Eye Ointment - ACICLOVIR N/A
ZYBAN B & S Healthcare PPA1328/063/001 Tablet Prolonged Release - AMFEBUTAMONE N/A
HYDROCHLORIDE

Human Medicines Withdrawn Products Page 588 of 588

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