TGA Approval

DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen (382593)

ARTG ID

382593

ARTG Name

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

Sponsor

Sanofi-Aventis Australia Pty Ltd

ARTG Date

June 3, 2022

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

SANOFI-AVENTIS AUSTRALIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-CMI-01171-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-01199-1

Ingredient Name

dupilumab

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DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen (382593) - TGA 批准文号 | MedPath