The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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-1078
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-1078
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 product will be supplied with International labels.
Conditions imposed
The product must be supplied with the labels 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’ evaluated in submission.
Therapeutic product type
Prescription medicines