Approvals/TGA/OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe

Approved

STANDARD

OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe

Samsung Bioepis AU Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: d5689e911e1b8d04
Product Name: OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe
Artg Id: 445963
Artg Name: OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe
Sponsor: Samsung Bioepis AU Pty Ltd
Company Detail Path: /organization/samsung-bioepis-au-pty-ltd
Artg Date: 2025-07-09
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

d5689e911e1b8d04

Type

Standard