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  • Uji Terapeutik Calcifediol Approval - 19 June 2019

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    Ferdian Iwank Iriyanto
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    The Therapeutic Goods Administration updated the list of permissible ingredients for medicines in June 2019. The update included adding 4 new ingredients and making 19 existing ingredient entries less restrictive based on safety reviews. The changes ensure the list of allowable ingredients is clear and up-to-date.

    Original Description:

    calcifediol

    Original Title

    Uji Terapeutik Calcifediol approval_19 June 2019 (2)

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    The Therapeutic Goods Administration updated the list of permissible ingredients for medicines in June 2019. The update included adding 4 new ingredients and making 19 existing ingredient entries less restrictive based on safety reviews. The changes ensure the list of allowable ingredients is clear and up-to-date.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    16 views3 pages

    Uji Terapeutik Calcifediol Approval - 19 June 2019

    Uploaded by

    Ferdian Iwank Iriyanto
    The Therapeutic Goods Administration updated the list of permissible ingredients for medicines in June 2019. The update included adding 4 new ingredients and making 19 existing ingredient entries less restrictive based on safety reviews. The changes ensure the list of allowable ingredients is clear and up-to-date.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    of 3

    Update to listed medicine ingredients in June 2019 | Therapeutic Goods Administratio...

    Page 1 of 3

    Update to listed medicine ingredients in June 2019

    Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019

    19 June 2019

    An updated version of the Therapeutic Goods (Permissible Ingredients) Determination


    (//www.tga.gov.au/therapeutic-goods-determinations#pi) was registered on the Federal Register of
    Legislation (FRL) in June 2019. The updated determination is titled the Therapeutic Goods
    (Permissible Ingredients) Determination (No. 2) 2019. A total of 23 changes have been made in
    the updated Determination. These changes include:

    • Addition of 4 new ingredient entries; and

    • Changes to 19 existing ingredient entries to make requirements clearer and less


    restrictive.

    A complete list of changes to ingredient is below.

    New ingredients

    • Calcifediol Monohydrate

    • Hexyl Propionate

    • Omega-3-Acid Ethyl Esters 60

    • VP/Acrylates/Lauryl Methacrylate Copolymer

    Changed ingredients

    Ingredient Reason for update

    MENTHA AQUATICA Safety review, Less restrictive


    requirements

    MENTHA ARVENSIS Safety review, Less restrictive


    requirements

    MENTHA ARVENSIS LEAF OIL Safety review, Less restrictive


    requirements

    https://www.tga.gov.au/update-listed-medicine-ingredients-june-2019 4/17/2020
    Update to listed medicine ingredients in June 2019 | Therapeutic Goods Administratio... Page 2 of 3

    Ingredient Reason for update

    MENTHA ARVENSIS OIL Safety review, Less restrictive


    requirements

    MENTHA HAPLOCALYX Safety review, Less restrictive


    requirements

    MENTHA PULEGIUM Safety review, Less restrictive


    requirements

    MENTHA SPICATA Safety review, Less restrictive


    requirements

    MENTHA X CARDIACA Safety review, Less restrictive


    requirements

    MENTHA X PIPERITA Safety review, Less restrictive


    requirements

    MENTHOL Safety review, Less restrictive


    requirements

    MENTHOL OIL DEMENTHOLISED Safety review, Less restrictive


    requirements

    PEPPERMINT AMERICAN EXT. Safety review, Less restrictive


    requirements

    PEPPERMINT LEAF DRY Safety review, Less restrictive


    requirements

    PEPPERMINT LEAF POWDER Safety review, Less restrictive


    requirements

    PEPPERMINT OIL Safety review, Less restrictive


    requirements

    PEPPERMINT OIL TERPENELESS Safety review, Less restrictive


    requirements

    PEPPERMINT OIL TERPENES AND Safety review, Less restrictive


    TERPENOIDS requirements

    SPEARMINT OIL Safety review, Less restrictive


    requirements

    SPEARMINT OIL TERPENELESS Safety review, Less restrictive


    requirements

    https://www.tga.gov.au/update-listed-medicine-ingredients-june-2019 4/17/2020
    Update to listed medicine ingredients in June 2019 | Therapeutic Goods Administratio... Page 3 of 3

    Category: Complementary medicines


    Tags: ingredients/substances
    URL: https://www.tga.gov.au/node/712722 (https://www.tga.gov.au/node/712722)

    https://www.tga.gov.au/update-listed-medicine-ingredients-june-2019 4/17/2020

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