Approvals/TGA/PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe with automatic needle guard

Approved

STANDARD

PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe with automatic needle guard

Amgen Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 7ff7cf86b78fdc3d
Product Name: PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe with automatic needle guard
Artg Id: 159323
Artg Name: PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe with automatic needle guard
Sponsor: Amgen Australia Pty Ltd
Company Detail Path: /organization/amgen-australia-pty-ltd
Artg Date: 2010-06-07
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/3c8f8912596ac0a2c71f35394bc13021.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ef7cace48dc2fd872cd2301591e36c19.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

7ff7cf86b78fdc3d

Type

Standard