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SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial - TGA Drug Approval Details
Approvals
/
TGA
/
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Approved
STANDARD
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Moderna Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
abbb7a7a1f739066
Company
Moderna Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
abbb7a7a1f739066
Product Name
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Artg Id
399552
Artg Name
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
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 29, 2025
Approval ID
abbb7a7a1f739066
Type
Standard
Back to TGA Approvals