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    CPR - Reax Syrup - DRP-5405 (02-23-2027)

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    zulitabernard3
    The document is a certificate of product registration from the Philippines Food and Drug Administration certifying that Reax 5 mg/5 mL Syrup, an antihistamine produced by LifeSquare Laboratories Inc., has been authorized for marketing in the Philippines until February 2027 subject to certain conditions.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    CPR - Reax Syrup - DRP-5405 (02-23-2027)

    Uploaded by

    zulitabernard3
    7 views2 pages
    The document is a certificate of product registration from the Philippines Food and Drug Administration certifying that Reax 5 mg/5 mL Syrup, an antihistamine produced by LifeSquare Laboratories Inc., has been authorized for marketing in the Philippines until February 2027 subject to certain conditions.

    Original Title

    CPR_Reax Syrup_DRP-5405 (02-23-2027) (2)

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    The document is a certificate of product registration from the Philippines Food and Drug Administration certifying that Reax 5 mg/5 mL Syrup, an antihistamine produced by LifeSquare Laboratories Inc., has been authorized for marketing in the Philippines until February 2027 subject to certain conditions.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    7 views2 pages

    CPR - Reax Syrup - DRP-5405 (02-23-2027)

    Uploaded by

    zulitabernard3
    The document is a certificate of product registration from the Philippines Food and Drug Administration certifying that Reax 5 mg/5 mL Syrup, an antihistamine produced by LifeSquare Laboratories Inc., has been authorized for marketing in the Philippines until February 2027 subject to certain conditions.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Republic of the Philippines

    Department of Health
    Food and Drug Administration
    Civic Drive, Filinvest Corporate City
    Alabang, Muntinlupa City

    CERTIFICATE OF PRODUCT REGISTRATION

    Pursuant to the provisions of Republic Act (R.A.) No. 3720 as amended, known as the Foods, Drugs, Devices and
    Cosmetics Act, and consistent with R.A. No. 6675, known as the Generics Act of 1988 and R.A. No. 9711, otherwise
    known as the Food and Drug Administration Act of 2009, the product described hereunder has been found to conform
    with the requirements and standards for marketing authorization of pharmaceutical products per existing regulations in
    force as of date hereof.

    Registration Number: DRP-5405

    Generic Name: Cetirizine Dihydrochloride


    Brand Name: Reax
    Dosage Strength & Form: 5 mg/5 mL Syrup
    Pharmacologic Category: Antihistamine
    Classification: Prescription Drug (Rx)
    Approved Shelf-life: 24 months
    Storage Condition: Store at temperatures not exceeding 30 C.
    Packaging: Boston Round Amber Bottle x 60 mL (Box of 1's)
    Packaging: Boston Round Amber Bottle x 30 mL (Box of 1's)

    Manufacturer: LifeSquare Laboratories Inc.


    Blk 2 Lot 10-11 Mount View Industrial Park II, Brgy. Bancal, Carmona,
    Cavite

    The marketing authorization shall be valid until 23 February 2027 subject to the conditions listed on the reverse side.
    No change in the formulation, labelling and commercial presentation of this product shall be made at any time during
    the effectivity of this registration without prior written approval of this Office.

    This marketing authorization is subject to suspension, cancellation or recall should any violation of R.A. No. 3720, R.A.
    No. 6675 and R.A. No. 9711 and/or regulations issued thereunder involving the product be committed.

    Witness My Hand and Seal of this Office, this 14 March 2022

    By the Authority of the Director-General Per FDA Order No. 2016-005:

    Jesusa Joyce N. Cirunay, RPh

    Director IV, Center for Drug Regulation and Research

    This electronic-CPR (eCPR) is computer generated and does not require signature
    Registration Number: DRP-5405

    SPECIAL CONDITION:

    Provided that nothing in the registration of the product herein granted shall be interpreted or construed as an
    endorsement or representation by FDA, that registrant has the right or privilege to the use of the name or brand so
    registered, Registrant hereby agrees and affirms to indemnify and/or hold FDA free and harmless against any and all
    third-party claims on infringement of patent, trademark or intellectual property right arising from the registration of the
    product.

    Subject to post-marketing surveillance of the marketing authorization holder’s strict compliance to the Generic
    Labeling Requirements following the applicable provisions of A.O No. 2016-0008 for drug products for human use and
    A.O. No. 105 s. 1991 for veterinary drug products.

    REMARKS:

    This Certificate of Product Registration (CPR) is revalidated to reflect the full validity until 23 February 2027.

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