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Approvals
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TGA
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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 Date
May 29, 2025
Approval ID
a6a7597caa52c676
Company
Moderna Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
a6a7597caa52c676
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
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
a6a7597caa52c676
Type
Standard
Back to TGA Approvals
SPIKEVAX (elasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection pre-filled syringe - TGA Drug Approval Details