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PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack, Pfizer Australia Pty Ltd, CON-908
Product name
PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack
Sponsor name
Pfizer Australia Pty Ltd
ARTG
Consent start
Consent no.
CON-908
Duration
The consent is effective for all batches released for supply from 18 January 2022 until 18 January 2024.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Conditions imposed
The product must be supplied with the labels that were considered and agreed to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989, being
a. The international label as follows
i. Carton label (submitted 15 November 2021)
ii. Blister label (submitted 15 November 2021)
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines