TGA Approval

Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe (330617)

ARTG ID

330617

ARTG Name

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

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

ARTG Date

March 4, 2021

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

Novartis Pharmaceuticals Australia Pty Ltd.

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-CMI-01288-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01279-1

Ingredient Name

Ofatumumab

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Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe (330617) - TGA 批准文号 | MedPath