Approvals/TGA/COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial

Approved

STANDARD

COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial

Roche Products Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 101960db05ea7e24
Product Name: COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial
Artg Id: 392331
Artg Name: COLUMVI glofitamab (rch) 10 mg/10 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: https://medical-cdn.nocode.com/drug_tga/df402656a64cae3b69a2827bde5fc554.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/100854c67b23fa8a63c87dc201d52142.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

101960db05ea7e24

Type

Standard