ESTALIS CONTINUOUS 50/140 estradiol 50 mcg/day norethisterone acetate 140 mcg/day patch sachet, Novartis Pharmaceuticals Australia Pty Ltd, CON-522
Product name
ESTALIS CONTINUOUS 50/140 estradiol 50 mcg/day norethisterone acetate 140 mcg/day patch sachet
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
ARTG
Consent start
Consent no.
CON-522
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform to the requirements of Therapeutic Goods Order No.
91, in that they do not meet the requirements stipulated in Paragraph 8(1)(j) -
The following statement is missing Consumer Medicine Information (CMI) is
available from your pharmacist or doctor, or go to novartis.com.au. The CMI
contains a full list of ingredients including possible allergens.Subsection 8(2)
- The following is missing 70 x 30 mm black bordered box with no fill inside,
with text inside Please attach pharmacy dispensing label here. Subsection 9(2) -
The name of the medicine on the main label is not presented in a continuous,
uninterrupted manner and is broken up by additional text.Subsection 9(3) - The
ingredients and strengths are not directly below tradename.
Therapeutic product type
Prescription medicines