COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.3 mL concentrated suspension for injection multidose vial, Pfizer Australia Pty Ltd, CON-1229
Product name
COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 3 micrograms/0.3 mL concentrated suspension for injection multidose vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1229
Standard
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product has international labels
Conditions imposed
- The products must be supplied with the international labels that were
considered and agreed to
as part of the evaluation under section 25 of the Therapeutic Goods Act 1989.
- Ongoing commitment: a Dear Healthcare Professional Letter will be distributed,
providing
information to the prescribers of different presentations of the vaccine
available, including
how to differentiate them and what each is for.
Therapeutic product type
Prescription medicines