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CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial - TGA Drug Approval Details
Approvals
/
TGA
/
CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial
Approved
STANDARD
CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial
Kyowa Kirin Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
b4ba316dfa0e8bf3
Company
Kyowa Kirin Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
b4ba316dfa0e8bf3
Product Name
CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial
Artg Id
340796
Artg Name
CRYSVITA burosumab 20 mg/mL solution for injection in a 5 mL vial
Sponsor
Kyowa Kirin Australia Pty Ltd
Company Detail Path
/organization/kyowa-kirin-australia-pty-ltd
Artg Date
2021-09-10
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/ce0f9a83d0a7e28f35c6022384ecae10.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/433b86bf68f23f23d67bc637b6aa518e.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
b4ba316dfa0e8bf3
Type
Standard
Back to TGA Approvals