Approvals/TGA/REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen

Approved

STANDARD

REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen

Celltrion Healthcare Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 30bb668a48e8b7d6
Product Name: REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen
Artg Id: 326188
Artg Name: REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen
Sponsor: Celltrion Healthcare Australia Pty Ltd
Company Detail Path: /organization/celltrion-healthcare-australia-pty-ltd
Artg Date: 2020-11-12
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-2021-CMI-01619-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-02540-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

30bb668a48e8b7d6

Type

Standard