PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack, Pfizer Australia Pty Ltd, CON-971
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-971
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product is non-compliant in that the labels are international labels. The
main deficiencies with regards to compliance with TGO 91 are with the carton
labels and are as follows ' The quantity of the drug substances are not closely
associated with their names in a cohesive unit on the main label ' Signal words
and cautionary statement required by the Poison Standard for a prescription only
medicine are absent ' The ARTG number is absent ' The contact details for the
Australian sponsor are absent
Conditions imposed
1. The product must be supplied with the labels that were considered and agreed
to as part of the submission, being
* Carton label
* Blister label
Therapeutic product type
Prescription medicines