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

Approved

STANDARD

SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe

Moderna Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 30, 2025
Approval ID: 2a130a41fed4eceb
Company: Moderna Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 2a130a41fed4eceb
Product Name: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe
Artg Id: 399553
Artg Name: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe
Sponsor: Moderna Australia Pty Ltd
Company Detail Path: /organization/moderna-australia-pty-ltd
Artg Date: 2023-02-20
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE

Active Ingredients

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

2a130a41fed4eceb

Type

Standard

Back to TGA Approvals