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COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 15/15 micrograms/0.3 mL suspension for injection vial, Pfizer Australia Pty Ltd, CON-1070
Product name
COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran) COVID-19 VACCINE 15/15 micrograms/0.3 mL suspension for injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1070
Duration
The consent is effective from 27 February 2023 until 20 January 2025.
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The carton labels of the product does not conform to TGO 91.
Conditions imposed
a. The product must be supplied with the carton labels (10 multidose vials) that
were considered and agreed to as part of the evaluation under section 9D(3) of
the Therapeutic Goods Act 1989, being the ‘International Labels’ submitted with
the application on 23 February 2023.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines