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ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet, Juno Pharmaceuticals Pty Ltd, CON-859

Product name
ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet
Sponsor name
Juno Pharmaceuticals Pty Ltd
Batches
226240
Consent start
Consent no.
CON-859
Standard
Section 6, and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
The product packaging does not conform with the requirements of Section 6 'name of an active ingredient'; and Paragraphs 8(1)(b), 8(1)(f), 8(1)(g), 8(1)(i), 9(3)(a) and 11(1)(b) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91) in that The carton labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; the batch number and expiry date prefixes are not preceding the batch number and expiry date; do not include the current sponsor address and updated sponsor logo; do not include the name and quantity of the active ingredient on one line immediately underneath the medicine name; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day. The pouch labels for the products do not include the Australian approved name for the active ingredient Estradiol ; do not include the Australian approved name for Estrogen ; do not indicate the location of the batch number and expiry details; do not include the current sponsor address and updated sponsor logo; and includes the abbreviation μg instead of microgram for the quantity of the active ingredient released per day.
Conditions imposed
          The labels to which this consent applies are those provided with the application in the  email correspondence dated 9  August 2021.      
Therapeutic product type
Prescription medicines

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