Approvals/TGA/REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector

Approved

STANDARD

REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector

Amgen Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 3e7af97e20c39503
Product Name: REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector
Artg Id: 231152
Artg Name: REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector
Sponsor: Amgen Australia Pty Ltd
Company Detail Path: /organization/amgen-australia-pty-ltd
Artg Date: 2015-12-09
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

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

3e7af97e20c39503

Type

Standard