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    Public Summary: 1. Co Enzyme Q10 150mg With Fish Oil

    Uploaded by

    Rado
    dietary supplement

    Copyright:

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

    Public Summary: 1. Co Enzyme Q10 150mg With Fish Oil

    Uploaded by

    Rado
    29 views2 pages
    dietary supplement

    Original Title

    coq10 with omega

    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
    29 views2 pages

    Public Summary: 1. Co Enzyme Q10 150mg With Fish Oil

    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: 266147 Co Enzyme Q10 150mg with Fish Oil

    ARTG entry for Medicine Listed

    Sponsor Greensvich Pty Ltd


    Postal Address Suite 1605 Level 16 1 Alfred Street,Sydney, NSW, 2000
    Australia
    ARTG Start Date 15/12/2015
    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. Co Enzyme Q10 150mg with Fish Oil


    Product Type Single Medicine Product Effective date 15/12/2015

    Warnings

    Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.
    Do not take while on warfarin therapy without medical advice.

    Standard Indications

    Aids, assists or helps in the maintenance or improvement of general well-being.

    Specific Indications

    Greensvich Co-Enzyme Q10 150mg with Fish Oil Soft Gelatin Capsule contains Fish Oil and Co Emzyme Q10 (Ubidecarenone) , designed to improves
    and maintains a healthy cardiovascular system. Fish Oil contains Omega-3 fatty acids Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) to
    promote healthy heart and circulatory system, while Co Enzyme Q10 is a powerful antioxidant and is essential for cellular energy production.
    No added lactose, gluten, yeast, preservatives or artificial flavours

    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

    natural fish oil 500 mg


    Ubidecarenone 150 mg

    Page 1 of 2 Produced at 31.12.2017 at 10:26:06 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
    © Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
    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 10:26:06 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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