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PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack, Pfizer Australia Pty Ltd, CON-1178
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-1178
Duration
The consent is effective from 14 November 2023 until 30 June 2024.
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product is supplied with international labels
Conditions imposed
1. The product must be supplied with the labels that were considered and agreed to as part of the submission dated 13 October 2023, being:
a. Carton labels for AUST R 377572
b. Blister label for AUST R 377572
c. Carton labels for AUST R 389801
d. Blister label for AUST R 389801
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines