TGA Approval

OSENVELT denosumab (rch) 70 mg/mL solution for injection vial (442990)

ARTG ID

442990

ARTG Name

OSENVELT denosumab (rch) 70 mg/mL solution for injection vial

Sponsor

Celltrion Healthcare Australia Pty Ltd

ARTG Date

April 4, 2025

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

Celltrion Healthcare Australia Pty Ltd.

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01505-1

Ingredient Name

Denosumab

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OSENVELT denosumab (rch) 70 mg/mL solution for injection vial (442990) - TGA 批准文号 | MedPath