Approvals/TGA/COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial

Approved

STANDARD

COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial

Pfizer Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 5e9ec4daf72295cc
Product Name: COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial
Artg Id: 419371
Artg Name: COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial
Sponsor: Pfizer Australia Pty Ltd
Company Detail Path: /organization/pfizer-australia-pty-ltd
Artg Date: 2023-10-09
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/6e393674caf909bb76d5374335ba9e63.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/a3a7c889e756272030f6c7533576b6f9.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

5e9ec4daf72295cc

Type

Standard