NEXIUM esomeprazole 40 mg (as magnesium trihydrate) tablet blister pack, AstraZeneca Pty Ltd, CON-728
Product name
NEXIUM esomeprazole 40 mg (as magnesium trihydrate) tablet blister pack
Sponsor name
AstraZeneca Pty Ltd
Consent start
Consent no.
CON-728
Standard
Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not conform with the requirements of paragraph
8(1)(j) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription
and related medicines (TGO 91) in that the products do not include declaration
for the Schedule 1 substances - 'Sugars and sorbates' on the carton labels.
Therapeutic product type
Prescription medicines