Approvals/TGA/SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe

Approved

STANDARD

SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe

Moderna Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 065ca94fae95f9cf
Product Name: SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe
Artg Id: 388245
Artg Name: SPIKEVAX (elasomeran) 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: 2022-07-19
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/ee0dbf7623ce1e7da1866b2a6fc11e63.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/214816f7d8dd1fc6ebff0f82f6d4c055.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

065ca94fae95f9cf

Type

Standard