Approvals/TGA/OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guard

Approved

STANDARD

OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guard

Celltrion Healthcare Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 22d6ca59d7ad401c
Product Name: OMLYCLO omalizumab (rch) 150 mg/ mL solution for injection in a pre-filled syringe with needle guard
Artg Id: 427224
Artg Name: OMLYCLO omalizumab (rch) 150 mg/ 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: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-CMI-03053-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-03052-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

22d6ca59d7ad401c

Type

Standard