TGA Approval

OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard (427223)

ARTG ID

427223

ARTG Name

OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard

Sponsor

Celltrion Healthcare Australia Pty Ltd

ARTG Date

November 26, 2024

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.

https://medical-cdn.nocode.com/drug_tga/4a02a641f6e1915bcfce269fb67fa988.pdf

https://medical-cdn.nocode.com/drug_tga/37b6bc6a49bda9137cdcff417cf7ef38.pdf

Ingredient Name

Omalizumab

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OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard (427223) - TGA 批准文号 | MedPath