NEXIUM esomeprazole 20 mg (as magnesium trihydrate) tablet blister pack, AstraZeneca Pty Ltd, CON-728
Product name
NEXIUM esomeprazole 20 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