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TGA
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ANDEXXA andexanet alfa 200 mg powder for injection vial
Approved
STANDARD
ANDEXXA andexanet alfa 200 mg powder for injection vial
AstraZeneca Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
67ba005f21f59b21
Company
AstraZeneca Pty Ltd
Type
Standard
Approval Details
Approval Id
67ba005f21f59b21
Product Name
ANDEXXA andexanet alfa 200 mg powder for injection vial
Artg Id
388713
Artg Name
ANDEXXA andexanet alfa 200 mg powder for injection vial
Sponsor
AstraZeneca Pty Ltd
Company Detail Path
/organization/astrazeneca-pty-ltd
Artg Date
2023-07-03
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
REP
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/10305de01bb8192a3642dfe06fac749c.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/9b50f57d9da40b351b11cf14b8c52b6d.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
67ba005f21f59b21
Type
Standard
Back to TGA Approvals
ANDEXXA andexanet alfa 200 mg powder for injection vial - TGA Drug Approval Details