ENTRESTO 97/103 sacubitril/valsartan (combined as a sodium salt hydrate complex) 97.2/102.8 mg film-coated tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-876
Product name
ENTRESTO 97/103 sacubitril/valsartan (combined as a sodium salt hydrate complex) 97.2/102.8 mg film-coated tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-876
Standard
Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product(s) do not conform to the requirements of Paragraph 10(10)(a) and
Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 '“ Standard for labels of
prescription and related medicines (TGO 91), in that the product(s) sample pack
carton labels do not include a space for the prescriber to provide dispensing
details and the batch number/expiry date prefixes on blister foil labels do not
precede the batch number/expiry date.
Conditions imposed
1. The product labels to which this consent applies are those provided with
the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23
February 2021.
Therapeutic product type
Prescription medicines