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REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD - TGA Drug Approval Details
Approvals
/
TGA
/
REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD
Approved
STANDARD
REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD
Amgen Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
b8794f6c9fe7e9f7
Company
Amgen Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
b8794f6c9fe7e9f7
Product Name
REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD
Artg Id
348651
Artg Name
REPATHA evolocumab (rch) 420 mg/3.5 mL injection solution automated mini-doser AMD
Sponsor
Amgen Australia Pty Ltd
Company Detail Path
/organization/amgen-australia-pty-ltd
Artg Date
2020-12-03
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/2d412539cc5f1c444776f6dae07f7fa8.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/de0e5ab92a5811514383dae8f0f63a34.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
b8794f6c9fe7e9f7
Type
Standard
Back to TGA Approvals