Approvals/TGA/DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen

Approved

STANDARD

DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen

Sanofi-Aventis Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: fbc4f2cd25dff8a5
Product Name: DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen
Artg Id: 382593
Artg Name: DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen
Sponsor: Sanofi-Aventis Australia Pty Ltd
Company Detail Path: /organization/sanofi-aventis-australia-pty-ltd
Artg Date: 2022-06-03
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-2018-CMI-01171-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-01199-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

fbc4f2cd25dff8a5

Type

Standard