Approvals/TGA/SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial-single dose

Approved

STANDARD

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial-single dose

Moderna Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 39fd06010e72be72
Product Name: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial-single dose
Artg Id: 406730
Artg Name: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial-single dose
Sponsor: Moderna Australia Pty Ltd
Company Detail Path: /organization/moderna-australia-pty-ltd
Artg Date: 2023-06-08
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

39fd06010e72be72

Type

Standard