Approvals/TGA/COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial

Approved

STANDARD

COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial

Roche Products Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: d6bd24ff1f8b1ae8
Product Name: COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial
Artg Id: 389650
Artg Name: COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial
Sponsor: Roche Products Pty Ltd
Company Detail Path: /organization/roche-products-pty-ltd
Artg Date: 2023-08-09
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: REP
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-CMI-02052-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-02041-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

d6bd24ff1f8b1ae8

Type

Standard