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

Approved

STANDARD

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

Celltrion Healthcare Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: eb0621f270603aa2
Product Name: OMLYCLO omalizumab (rch) 75 mg/0.5 mL solution for injection in a pre-filled syringe with needle guard
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
Company Detail Path: /organization/celltrion-healthcare-australia-pty-ltd
Artg Date: 2024-11-26
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/4a02a641f6e1915bcfce269fb67fa988.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/37b6bc6a49bda9137cdcff417cf7ef38.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

eb0621f270603aa2

Type

Standard