Dossier Portfolio

IN EU CTD FORMAT
October 2015

Dossier Portfolio in EU CTD format

PRODUCT
A

FORM

DOSAGE STRENGTHS

AVAILABILITY

ALIMENTARY TR ACT AND METABOLISM

Esomeprazole

Gastro-resistant Tablets

20 mg, 40 mg

Available

Gliclazide

MR Tablets

30 mg, 60 mg

Available

Glimepiride

Tablets

1 mg, 2 mg, 3 mg, 4 mg, 6 mg

Available

Granisetron

Tablets

1 mg, 2 mg

Available

Nystatin NEW

Oral suspension

100,000 IU / ml

Under development

Pantoprazole

Tablets

20 mg, 40 mg

Available

Pioglitazone

Tablets

15 mg, 30 mg, 45 mg

Available

Rabeprazole

Tablets

10 mg, 20 mg

Available

Repaglinide

Tablets

0.5 mg, 1 mg, 2 mg

Available

Vildagliptin

Tablets

50 mg

Available

Vildagliptin/Metformin

Tablets

50 mg / 850 mg, 50 mg / 1,000 mg

Available

BLOOD AND BLOOD FORMING ORGANS

Acetylsalicylic acid

EC Tablets

50 mg, 75 mg, 100 mg, 150 mg,

160 mg

Available

Clopidogrel Besylate

Tablets

75 mg

Available

Clopidogrel Bisulfate

Tablets

75 mg

Available

Clopidogrel/Acetylsalicylic acid

Tablets

75 mg / 100 mg

Available

Dipyridamole

MR Capsules

150 mg, 200 mg

Available

Prasugrel (copy)

Tablets

5 mg, 10 mg

Available

Prasugrel (novel) NEW

Tablets

5 mg, 10 mg

Under development

Rivaroxaban

Tablets

10 mg, 15 mg, 20 mg

Under development

Ticagrelor NEW

Film coated Tablets

90 mg

Under development

Ambrisentan

Tablets

2.5 mg, 5 mg, 10 mg

Available

Amlodipine/Atorvastatin

Tablets

5 mg / 20 mg, 5 mg / 40 mg, 5 mg /
80 mg, 10 mg / 20 mg, 10 mg /
40 mg, 10 mg / 80 mg

Available

Amlodipine/Atorvastatin

Tablets

5 mg / 10 mg, 10 mg / 10 mg

Available

Amlodipine/Valsartan

Tablets

5 mg / 80 mg, 5 mg / 160 mg,

10 / 160 mg

Available

Amlodipine/Valsartan/HCT

Tablets

5 mg / 160 mg / 12.5 mg, 10 mg /

160 mg / 12.5 mg, 5 mg / 160 mg /
25 mg, 10 mg / 160 mg / 25 mg,
10 mg / 320 mg / 25 mg

Available

Atorvastatin Calcium

Tablets

10 mg, 20 mg, 40 mg

Available

Atorvastatin Calcium

Tablets

80 mg

Available

Bosentan

Tablets

62.5 mg, 125 mg

Available

Enalapril/HCT

Tablets

20 mg / 6 mg

Available **

Enalapril/HCT

Tablets

20 mg / 12.5 mg

Available **

Enalapril/Lercanidipine

Tablets

10 mg / 10 mg, 20 mg / 10 mg

Available

Ezetimibe

Tablets

10 mg

Available

Ezetimibe/Simvastatin

Tablets

10 mg / 10 mg, 10 mg / 20 mg,
10 mg / 40 mg, 10 mg / 80 mg

Available

Fluvastatin

SR Tablets

80 mg

Available

Fosinopril

Tablets

5 mg, 10 mg, 20 mg

Available

Fosinopril/HCT

Tablets

20 mg / 12.5 mg

Available

CARDIOVASCUL AR

* Co-marketing with another party in certain markets

** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October 2015

Strictly Confidential

PRODUCT
C

FORM

DOSAGE STRENGTHS

AVAILABILITY

Irbesartan

Tablets

75 mg, 150 mg, 300 mg

Available

Irbesartan/HCT

Tablets

150 mg / 12.5 mg, 300 mg /

12.5 mg, 300 mg / 25 mg

Available

Ivabradine

Tablets

5 mg, 7.5 mg

Available

Lercanidipine

Tablets

10 mg, 20 mg

Available

Lisinopril

Tablets

2.5 mg, 5 mg, 10 mg, 20 mg

Available

Lisinopril/HCT

Tablets

10 mg / 12.5 mg, 20 mg /
12.5 mg, 20 mg / 25 mg

Available

Losartan

Tablets

12.5 mg, 25 mg, 50 mg, 100 mg

Available

Losartan/HCT

Tablets

50 mg / 12.5 mg, 100 mg / 25 mg

Available

Losartan/HCT

Tablets

100 mg / 12,5 mg

Available

Midodrine

Tablets

2.5 mg

Available

Nebivolol

Tablets

5 mg

Available

Nebivolol NEW

Tablets

1.25 mg, 2.5 mg, 10 mg

Under development

Nebivolol/HCT

Tablets

5 mg / 12.5 mg, 5 mg / 25 mg

Available

Nebivolol/HCT (Generic) NEW

Tablets

5 mg / 12.5 mg, 5 mg / 25 mg

Under development

Olmesartan

Tablets

5 mg, 10 mg, 20 mg, 40 mg

Available

Olmesartan/HCT

Tablets

20 mg / 12.5 mg, 20 mg / 25 mg,

40 mg / 12.5 mg, 40 mg / 25 mg

Available

Perindopril Arginine

Tablets

2.5 mg, 5 mg, 10 mg

Available

Perindopril Arginine/ Amlodipine

Tablets

5 mg / 5 mg, 5 mg / 10 mg, 10 mg /
5 mg, 10 mg / 10 mg

Available

Perindopril erbumine/Amlodipine

Tablets

4 mg / 5 mg, 4 mg / 10 mg, 8 mg /
5 mg, 8 mg / 10 mg

Available

Perindopri Arginine/ Indapamide

Tablets

2.5 mg / 0.625 mg, 5 mg / 1.25 mg,

10 mg / 2.5 mg

Available

Ramipril

Tablets

1.25 mg, 2.5 mg, 5 mg, 10 mg

Available

Ramipril/HCT

Tablets

2.5 mg / 12.5 mg, 5 mg / 25 mg

Available

Ramipril/HCT

Tablets

5 mg / 12.5 mg

Available

Rosuvastatin

Tablets

5 mg, 10 mg, 20 mg, 40 mg

Available

Sildenafil

Tablets

20 mg

Available

Telmisartan

Tablets

20 mg, 40 mg, 80 mg

Available

Telmisartan/HCT

Tablets

40 mg / 12,5 mg, 80 mg / 12,5 mg,

80 mg / 25 mg

Available

Valsartan

Tablets

40 mg, 80 mg, 160 mg

Available

Valsartan

Tablets

320 mg

Available

Valsartan/HCT

Tablets

80 mg / 12.5 mg, 160 mg / 12.5 mg,

160 mg / 25 mg

Available

Valsartan/HCT

Tablets

320 mg / 12.5 mg, 320 mg / 25 mg

Available

Dexpanthenol, Alantoin & Vitamins A, E,

and F

Cream

6% / 0.3%

Available

Finasteride

Tablets

1 mg

Available *

Terbinafine

Cream

1% w / w

Available

CARDIOVASCUL AR

DERMATOLOGICALS

* Co-marketing with another party in certain markets

** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October 2015

Strictly Confidential

Dossier Portfolio in EU CTD format

PRODUCT
G

FORM

DOSAGE STRENGTHS

AVAILABILITY

GENITO -URINARY SYSTEM AND SEX HORMONES

Dutasteride

Soft gel Capsules

0.5 mg

Available **

Finasteride

Tablets

5 mg

Available *

Sildenafil

Tablets

25 mg, 50 mg, 100 mg

Available

Solifenacin

Tablets

5 mg, 10 mg

Available

Tadalafil

Tablets

2.5 mg, 5 mg, 10 mg, 20 mg

Available

Vardenafil

Tablets

5 mg, 10 mg, 20 mg

Under development

SYSTEMIC HORMONAL PREPAR ATIONS

Cinacalcet

Tablets

30 mg, 60 mg, 90 mg

Available

Levothyroxine sodium

Tablets

25 g, 50 g, 75 g, 88 g, 100 g,
112 g, 125 g, 137 g, 150 g,
175 g, 200 g, 300 g

Under development

Prednisolone NEW

Tablets

2.5 mg, 5 mg, 10 mg, 20 mg,

25 mg, 30 mg

Available

Anidulafungin NEW

Powder

100 mg

Under development

Clarithromycin

Tablets

250 mg, 500 mg

Available **

Clindamycin

Capsule

150 mg, 300 mg, 600 mg

Available

Famciclovir

Tablets

125 mg, 250 mg, 500 mg, 750 mg

Available

Fluconazole

Capsules

50 mg, 100 mg, 150 mg, 200 mg

Available

Levofloxacin

Tablets

250 mg, 500 mg

Available

Linezolid

Tablets

600 mg

Available

Lymecycline

Capsules

300 mg

Available

Valaciclovir

Tablets

250 mg, 500 mg, 1,000 mg

Available

Voriconazole

Powder

200 mg

Available

Voriconazole

Tablets

50 mg, 200 mg

Available

ANTIINFECTIVES FOR SYSTEMIC USE

ANTINEOPL ASTIC AND IMMUNOMODUL ATING AGENTS

Azacitidine

Powder

100 mg / 10 ml

Available

Azathioprine

Tablets

50 mg

Available *

Bendamustine

Powder

25 mg, 100 mg

Available

Bicalutamide

Tablets

50 mg, 150 mg

Available

Bortezomib

Powder

3.5 mg

Available

Carboplatin

Concentrate

50 mg / 5 ml, 150 mg / 15 ml,

450 mg / 45 ml, 600 mg / 60 ml

Available **

Cisplatin

Concentrate

10 mg / 10 ml, 50 mg / 50 ml

Available **

Cisplatin

Concentrate

100 mg / 100 ml

Under development
**

Clofarabine

Concentrate

20 mg / 20 ml

Under development

Cytarabine

Solution for infusion

100 mg / ml (100 mg / ml, 500 mg /

5 ml, 1g / 10 ml, 2g / 20 ml)

Available

Dasatinib NEW

Film coated Tablets

20 mg, 50 mg, 70 mg, 80 mg,

100 mg, 140 mg

Under development

Docetaxel - one vial

Concentrate

20 mg / ml (20 mg / ml, 80 mg /
4 ml, 140 mg / 7 ml)

Available

Docetaxel - one vial

Concentrate

20 mg / ml (160 mg / 8 ml)

Available

Docetaxel - two vials

Concentrate

40 mg / ml (20 mg / 0.5 ml, 80 mg

/ 2 ml)

Available

* Co-marketing with another party in certain markets

** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October 2015

Strictly Confidential

PRODUCT
L

FORM

DOSAGE STRENGTHS

AVAILABILITY

ANTINEOPL ASTIC AND IMMUNOMODUL ATING AGENTS

Doxorubicin

Powder

10 mg, 50 mg

Available **

Doxorubicin Solution

Concentrate

2 mg / ml

Available

Epirubicin

Powder

10 mg, 50 mg

Available

Epirubicin

Solution

10 mg / 5 ml, 20 mg / 10 ml, 50 mg
/ 25 ml, 100 mg / 50 ml, 200 mg /
100 ml

Available

Erlotinib

Tablets

25 mg, 100 mg, 150 mg

Available

Exemestane

Tablets

25 mg

Available

Fludarabine

Powder

50 mg

Available

Fludarabine RTU

Concentrate

25 mg / ml

Available

Gefitinib

Tablets

250 mg

Under development

Gemcitabine

Solution

200 mg / 5 ml, 1,000 mg / 25 ml,

2000 mg / 50 ml

Available

Gemcitabine

Powder

200 mg, 1g, 2g

Available

Imatinib

Capsules

50 mg, 100 mg

Available

Imatinib

Capsules

400 mg

Available

Imatinib

Tablets

100 mg, 400 mg

Available

Imatinib New formulation

Tablets

100 mg, 400 mg

Available

Irinotecan

Concentrate

40 mg / 2 ml, 100 mg / 5 ml,

300 mg / 15 ml, 500 mg / 25 ml

Available

Letrozole

Tablets

2.5 mg

Available

Melphalan

Powder

50 mg, 200 mg

Under development

Methotrexate Solution

Pre-filled syringes

7.5 mg / ml, 25 mg / ml

Available

Nilotinib

Capsules

150 mg, 200 mg

Under development

Oxaliplatin

Concentrate

50 mg / 10 ml, 100 mg / 20 ml,

200 mg / 40 ml

Available

Oxaliplatin

Powder

50 mg, 100 mg

Available

Paclitaxel

Concentrate

30 mg / 5 ml, 100 mg / 16.7 ml,

150 mg / 25 ml, 300 mg / 50 ml

Available

Pemetrexed

Powder

100 mg, 500 mg, 1g

Available

Topotecan

Powder

1 mg, 4 mg

Available

Vinorelbine

Concentrate

10 mg / ml, 50 mg / 5 ml

Available

Celecoxib

Capsules

100 mg, 200 mg

Available

Clodronate

Concentrate

300 mg / 5 ml

Available **

Colchicine

Tablets

0.5 mg

Available

Etoricoxib

Tablets

30 mg, 60 mg, 90 mg, 120 mg

Available

Febuxostat

Tablets

80 mg, 120 mg

Under development

Glucosamine/Chondroitin

Oral Solution

1500 mg / 1200 mg

Under development

Ibuprofen

Oral Suspension

100 mg / 5 ml

Available

Ibuprofen NEW

Oral Suspension

20 mg / ml (in stick packs, correct

dose ready)

Under development

Zoledronic Acid

Concentrate

4 mg / 5 ml

Available

MUSCULO -SKELETAL SYSTEM

* Co-marketing with another party in certain markets

** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October 2015

Strictly Confidential

Dossier Portfolio in EU CTD format

PRODUCT
N

FORM

DOSAGE STRENGTHS

AVAILABILITY

Agomelatine

Tablets

25 mg

Under development

Aripiprazole

Orodispersible Tablets

10 mg, 15 mg, 20 mg, 30 mg

Available

Aripiprazole

Tablets

2 mg, 5 mg, 10 mg, 15 mg, 20 mg,

30 mg

Available

Aripiprazole

Oral Solution

1 mg / ml

Available

Atomoxetine

Capsule

10 mg, 18 mg, 25 mg, 40 mg,

60 mg, 80 mg, 100 mg

Available

Buprenorphine

Sublingual Tablets

0.4 mg, 2 mg, 4 mg, 6 mg, 8 mg

Available

Bupropion

ER Tablets

150 mg, 300 mg

Available

Donepezil

Tablets

5 mg, 10 mg

Available

Donepezil

Orodispersible Tablets

5 mg, 10 mg

Available

Duloxetine

DR Capsules

30 mg, 60 mg

Available

Duloxetine

DR Capsules

20 mg, 40 mg

Available

Entacapone Combi

Tablets

50 mg / 12.5 mg / 200 mg, 75 mg /

18.75 mg / 200 mg, 100 mg / 25 mg
/ 200 mg, 125 mg / 31.25 mg /
200 mg, 150 mg / 37.5 mg /
200 mg, 175 mg / 43.75 mg /
200 mg, 200 mg / 50 mg / 200 mg

Available

Escitalopram

Tablets

5 mg, 10 mg, 15 mg, 20 mg

Available

Fentanyl NEW

Sublingual Tablets

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg,

0.6 mg, 0.8 mg

Under development

Lacosamide NEW

Tablets

50 mg, 100 mg, 150 mg, 200 mg

Under development

Lamotrigine

Oro-dispersible Tablets

2 mg, 5 mg, 25 mg, 50 mg, 100 mg,

200 mg

Available *

Levetiracetam

Tablets

250 mg, 500 mg, 750 mg, 1,000 mg

Available

Levetiracetam

Oral Solution

100 mg / ml

Available

Memantine

Tablets

5 mg, 10 mg, 15 mg, 20 mg

Available

Milnacipran

Capsules

25 mg, 50 mg

Available

Mirtazapine

Tablets

15 mg, 30 mg, 45 mg

Available

Mirtazapine

Orodispersible Tablets

15 mg, 30 mg, 45 mg

Available

Olanzapine

Tablets

2.5 mg, 5 mg, 7.5 mg, 10 mg,

15 mg, 20 mg

Available

Olanzapine

Orodispersible Tablets

5 mg, 10 mg, 15 mg, 20 mg

Available

Oxycodone

IR Capsules

5 mg, 10 mg, 20 mg

Available

Oxycodone

PR Tablets

5 mg, 10 mg, 15 mg, 20 mg, 30 mg,

40 mg, 60 mg, 80 mg

Available

Oxycodone/Naloxone

PR Tablets

5 mg / 2.5 mg, 10 mg / 5 mg, 20 mg

/ 10 mg, 40 mg / 20 mg

Under development

Paracetamol

Tablets (Coated)

250 mg, 500 mg, 1,000 mg

Available

Paracetamol

Oral Solution

24 mg / ml

Available

Paracetamol NEW

Oral solution

24 mg / ml (in stick packs, correct

dose ready)

Available

Paracetamol/Codeine

Tablets

500 mg / 10 mg, 500 mg / 30 mg,

1,000 mg / 60 mg

Available

Paracetamol/Diphenhydramine

Tablets

500 mg / 25 mg

Under development

Pramipexole

Tablets

0.125 mg, 0.25 mg, 0.5 mg, 1 mg,

1.5 mg (0.088 mg, 0.18 mg,
0.35 mg, 0.7 mg, 1.1 mg)

Available

NERVOUS SYSTEM

* Co-marketing with another party in certain markets

** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October, 2015. Please be advised that the information on this list is subject to change.

STRICTLY CONFIDENTIAL

PRODUCT
N

FORM

DOSAGE STRENGTHS

AVAILABILITY

Pregabalin

Capsules

25 mg, 50 mg, 75 mg, 100 mg,

150 mg, 200 mg, 225 mg, 300 mg

Available

Quetiapine

Tablets

25 mg, 100 mg, 150 mg, 200 mg,

300 mg

Available

Riluzole

Tablets

50 mg

Available

Risperidone

Tablets

0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg,

4 mg, 6 mg

Available

Rivastigmine

Capsules

1.5 mg, 3 mg, 4.5 mg, 6 mg

Available

Rizatriptan

Tablets

5 mg, 10 mg

Available

Rizatriptan

Orodispersible Tablets

5 mg, 10 mg

Available

Ropinirole

Tablets

0.25 mg, 0.5 mg,1 mg, 2 mg, 3 mg,

4 mg, 5 mg

Available

Ropinirole

SR Tablets

2 mg, 3 mg, 4 mg, 6 mg, 8 mg

Available

Sumatriptan

Tablets

25 mg, 50 mg, 100 mg

Available

Topiramate

Tablets

25 mg, 50 mg, 100 mg, 200 mg

Available

Ziprasidone

Capsules

20 mg, 40 mg, 60 mg, 80 mg

Available

Zolmitriptan

Tablets

2.5 mg, 5 mg

Available

Zolmitriptan

Orodispersible Tablets

2.5 mg, 5 mg

Available

Zonisamide

Capsules

25 mg, 50 mg, 100 mg

Available

Tablets

3 mg

Available

Acetylcysteine

Liquid Sachets

200 mg / 10 ml, 600 mg / 10 ml

Available

Ambroxol

Oral Solution

15 mg / 5 ml

Available

Ambroxol

Oral Solution

30 mg / 5 ml

Available

Butamirate

Oral Solution

7.5 mg / 5 ml

Available

Cetirizine

Tablets

10 mg

Available

Desloratadine

Tablets

5 mg

Available

Desloratadine

Oral Solution

0.5 mg / ml

Available

Loratadine

Tablets

10 mg

Available

Montelukast

Chewable Tablets

4 mg, 5 mg

Available

Montelukast

Tablets

10 mg

Available

Promethazine

Tablets

25 mg, 50 mg

Available

NERVOUS SYSTEM

ANTIPAR ASITICS
Ivermectin

RESPIR ATORY SYSTEMS

For further information please send your enquiry

to [email protected] or contact your local business
development manager.
* Co-marketing with another party in certain markets
** Dossiers with limited production and/or regulatory support
Supply excluded
Not available for all territories
Cosmetic product, dossier not in EU CTD format
Anticipate preparation time for dossier

October, 2015

STRICTLY CONFIDENTIAL

Global R&D Network

27 SITES IN 14 COUNTRIES
By Actavis R&D

Hafnarfjordur Iceland

Lige Belgium
Westport Ireland
Jersey City, NJ USA
Elizabeth, NJ USA

Larne North Ireland

Bucharest Romania
Troyan Bulgaria

Dundalk Ireland
Beijing China

Liverpool UK

Tokyo Japan

London UK
Salt Lake City, UT USA
Irvine, CA USA
Parsippany, NJ USA

Marlow UK

Navi, Mumbai India

Pringy France

Ambernath India
Bangalore India

Nerviano Italy

Chennai India

Bridgewater, NJ USA
Weston, FL USA
Miramar, FL USA

Jakarta Indonesia

Head Office - Iceland

Medis ehf
Reykjavikurvegur 78
220 Hafnarfjordur
Iceland

France
Medis Pharma France SAS
27 rue Ginoux
75015 Paris
France

Spain
Medis Spain
PO Box no 176
08850 Gava, Barcelona
Spain

Medis also has dedicated

regional support elsewhere.
Please contact medis@
medis.is for further
information.

Germany
Medis Pharma GmbH
Knigsberger Strasse 16
55218 Ingelheim
Germany

Australia
Medis Pharma Pty Ltd
Suite 1002 - 53 Walker St.
North Sidney 2060 NSW Australia

Italy
Medis Italy
Via Rodari, 9
22100 Como
Italy

medis.is

Dubai
Medis Dubai
Offices Land Bld. B3-204
Sheikh Rashid Road
Bur Dubai Dubai
UAE

Poland
Medis Poland, Ukraine,
Russia & CIS
111 Marszalkowska Str.
00-102 Warsaw
Poland

Brazil
Medis Brazil
PO Box 410
Jundia, So Paulo
Brazil
13211-620

For further information please send your enquiry

to [email protected] or contact your local business
development manager.

October 2015