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    Public Summary: 1. Super Calcium Supplement With Cod Liver Oil 1000mg

    Uploaded by

    Rado
    dietary supplement

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

    Public Summary: 1. Super Calcium Supplement With Cod Liver Oil 1000mg

    Uploaded by

    Rado
    57 views2 pages
    dietary supplement

    Original Title

    cod liver with calcium

    Copyright

    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    dietary supplement

    Copyright:

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

    Public Summary: 1. Super Calcium Supplement With Cod Liver Oil 1000mg

    Uploaded by

    Rado
    dietary supplement

    Copyright:

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

    Public Summary

    Summary for ARTG Entry: 115128 Super Calcium supplement with Cod liver Oil 1000mg

    ARTG entry for Medicine Listed

    Sponsor Careline Australia Pty Ltd


    Postal Address 41-43 Bellona Avenue,REGENTS PARK, NSW, 2143
    Australia
    ARTG Start Date 13/12/2004
    Product category Medicine
    Status Active
    Approval area Listed Medicines

    Conditions

    Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in
    the list of 'Colourings permitted in medicines for oral use'.

    The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,
    (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is
    sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be
    kept.

    The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records
    to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

    The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted
    in relation to the inclusion of the medicine in the Register.

    All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

    Public Summary
    of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors
    of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified
    of the report or reports.

    The sponsor shall not supply the listed medicine after the expiry date of the goods.

    Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine
    outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National
    Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

    Products

    1. Super Calcium supplement with Cod liver Oil 1000mg


    Product Type Single Medicine Product Effective date 28/06/2013

    Warnings

    No Warnings included on Record


    Standard Indications
    Specific Indications

    Super Calcium supplement with Cod liver oil 1000mg is formulated containing sufficient amount of Calcium, Vitamin A and D3. Vitamin A is essential for
    maintaining good eyesight and is neccessary for the maintainance of healthy skin. vitamin D3 helps in the absorption of calcium and is essential for
    strong teeth and bones.

    Additional Product information

    Pack Size/Poison information


    Pack Size Poison Schedule
    Components
    1. Formulation 1

    Dosage Form Capsule, soft


    Route of Administration Oral
    Visual Identification

    Active Ingredients

    Calcium carbonate 300 mg


    Cod-liver oil 700 mg

    © Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

    Page 1 of 2 Produced at 31.12.2017 at 10:32:30 AEDT


    This is not an ARTG Certificate document.
    The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
    Visit www.tga.gov.au for contact information
    written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

    Public Summary

    Page 2 of 2 Produced at 31.12.2017 at 10:32:30 AEDT


    This is not an ARTG Certificate document.
    The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
    Visit www.tga.gov.au for contact information

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