Approvals/TGA/COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled plastic syringe

Approved

STANDARD

COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled plastic syringe

Pfizer Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 8118226db35d235e
Product Name: COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled plastic syringe
Artg Id: 442811
Artg Name: COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 30 micrograms/0.3 mL suspension for injection prefilled plastic syringe
Sponsor: Pfizer Australia Pty Ltd
Company Detail Path: /organization/pfizer-australia-pty-ltd
Artg Date: 2024-08-12
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-02414-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-02409-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

8118226db35d235e

Type

Standard