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

Approved

STANDARD

PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe

Amgen Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 7875101dd8ecd112
Product Name: PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe
Artg Id: 159322
Artg Name: PROLIA denosumab (rch) 60mg/1mL solution for injection prefilled syringe
Sponsor: Amgen Australia Pty Ltd
Company Detail Path: /organization/amgen-australia-pty-ltd
Artg Date: 2010-06-22
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-07242-3

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

7875101dd8ecd112

Type

Standard