AusPAR: Dupilumab

Australian Public Assessment Report

AusPAR

AusPAR: Dupilumab [PDF, 613.57 KB]

AusPAR: Dupilumab [Word, 703.83 KB]

Attachment: Product Information: Dupilumab [PDF, 500.23 KB]

Attachment: Product Information: Dupilumab [Word, 636.04 KB]

Attachment: Extract from Clinical Evaluation Dupilumab [PDF, 2.78 MB]

Attachment: Extract from Clinical Evaluation Dupilumab [Word, 10.22 MB]

Device/Product Name

Dupixent

Active ingredients

Dupilumab

AusPAR Date

12 June 2018

Published

16 July 2018

Submission Number

PM-2016-04087-1-1

Submission Type

New biological entity

Decision

Approved