Approvals/TGA/Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe

Approved

STANDARD

Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe

Approval Id: fc4dc7db3dc80e1e
Product Name: Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe
Artg Id: 330617
Artg Name: Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe
Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/novartis-pharmaceuticals-australia-pty-ltd
Artg Date: 2021-03-04
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-01288-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01279-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

fc4dc7db3dc80e1e

Type

Standard