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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
Duration
The consent is effective from 2 September 2021 until 31 March 2023 or until the batches are depleted.
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 ?g
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 ?g 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.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines