Approvals/TGA/VYVGART efgartigimod alfa 400 mg/20 mL concentrated injection for intravenous infusion vial

Approved

STANDARD

VYVGART efgartigimod alfa 400 mg/20 mL concentrated injection for intravenous infusion vial

Argenx Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 04e68d9b37144325
Product Name: VYVGART efgartigimod alfa 400 mg/20 mL concentrated injection for intravenous infusion vial
Artg Id: 444955
Artg Name: VYVGART efgartigimod alfa 400 mg/20 mL concentrated injection for intravenous infusion vial
Sponsor: Argenx Australia Pty Ltd
Company Detail Path: /organization/argenx-australia-pty-ltd
Artg Date: 2025-02-24
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-2025-CMI-01269-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01271-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

04e68d9b37144325

Type

Standard