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    Public Summary: Summary For ARTG Entry: ARTG Entry For Sponsor Postal Address

    Uploaded by

    SofiaProtopsalti
    TGA Approval for Eye Drops

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

    Public Summary: Summary For ARTG Entry: ARTG Entry For Sponsor Postal Address

    Uploaded by

    SofiaProtopsalti
    64 views1 page
    TGA Approval for Eye Drops

    Original Title

    1524514545373

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    TGA Approval for Eye Drops

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    64 views1 page

    Public Summary: Summary For ARTG Entry: ARTG Entry For Sponsor Postal Address

    Uploaded by

    SofiaProtopsalti
    TGA Approval for Eye Drops

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Public Summary

    Summary for ARTG Entry: 219720 AMO Australia Pty Ltd - Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye

    ARTG entry for Medical Device Included Class III

    Sponsor AMO Australia Pty Ltd


    Postal Address Locked Bag 2005,NORTH RYDE BC, NSW, 1670
    Australia
    ARTG Start Date 30/01/2014
    Product category Medical Device Class III
    Status Active
    Approval area Medical Devices

    Conditions

    - The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
    Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
    2002 for relevant information.
    - Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
    offence; and civil penalties may apply.
    Manufacturers
    Name Address
    Abbott Medical Optics Inc 1700 East Saint Andrew Place
    Santa Ana, CA, 92705

    Public Summary
    United States Of America
    Products

    1. Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye
    Product Type Single Device Product Effective date 30/01/2014

    GMDN 44237 Lubricant, eye


    Functional description A viscous, sterile formulation for installation dropwise, 3-4 times per day into the eyes to lubricate the
    corneal surface, increase tear breakup time and relieve dry, gritty and/or tired strained eyes that result
    from moderate to severe dry eye syndrome. The multi-dose bottle can be used up to 45 days after
    opening.
    Intended purpose To supplement natural tear lubrication of the eyes and provide longer lasting relief from the signs and
    symptoms of moderate to severe dry eye syndrome,such as persistent dryness,scratchiness,burning or
    irritated uncomfortable eyes. It is presented as a viscous gel drop in a multidose bottle. It is available
    over-the-counter (OTC) for home-use. After application, this device cannot be reused.

    Variant information Volume (mL) 2-10 ml

    Specific Conditions
    No Specific Conditions included on Record

    © 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.

    Page 1 of 1 Produced at 24.04.2018 at 06:15:49 AEST


    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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