TGA Approval

OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe (445963)

ARTG ID

445963

ARTG Name

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

Sponsor

Samsung Bioepis AU Pty Ltd

ARTG Date

July 9, 2025

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

Samsung Bioepis AU Pty Ltd

Ingredient Name

Denosumab

Empowering clinical research with data-driven insights and AI-powered tools.

OSPOMYV denosumab 60mg/1mL solution for injection pre-filled syringe (445963) - TGA 批准文号 | MedPath