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COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.2 mL concentrated suspension for injection multidose vial, Pfizer Australia Pty Ltd, CON-1257
Product name
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.2 mL concentrated suspension for injection multidose vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1257
Duration
The consent is effective from 22 July 2024 until 6 October 2025.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product do not conform to Therapeutic Goods Order No. 91 - Standard for
labels of prescription and related medicines.
Conditions imposed
The products must be supplied with the EU labels that were considered and agreed
to as part of the evaluation under section 25 of the Therapeutic Goods Act 1989.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines