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PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack, Pfizer Australia Pty Ltd, CON-925
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-925
Duration
The consent is effective for all batches released for supply from the 20 April 2022 until 18 January 2024.
Standard
Does not conform with the requirements of the 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 carton and blister labels that were considered and agreed to as part of the submission dated 19 April 2022.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines