LOSEC omeprazole 20 mg (as magnesium) tablet blister pack, AstraZeneca Pty Ltd, CON-728
Product name
LOSEC omeprazole 20 mg (as magnesium) tablet blister pack
Sponsor name
AstraZeneca Pty Ltd
Consent start
Consent no.
CON-728
Duration
The consent is effective for all batches of the product released from 12 January 2021 until 31 August 2021.
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.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines