AusPAR: Adalimumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR Adalimumab (rch) [PDF, 733.62 KB]

AusPAR Adalimumab (rch) [Word, 1.09 MB]

Attachment 1: Product Information: Adalimumab (rch) [PDF, 613 KB]

Attachment 1: Product Information: Adalimumab (rch) [Word, 391.81 KB]

Attachment 2: Extract from Clinical Evaluation Report: Adalimumab (rch) [PDF, 2.32 MB]

Attachment 2: Extract from Clinical Evaluation Report: Adalimumab (rch) [Word, 3.96 MB]

Device/Product Name

Humira

Active ingredients

Adalimumab (rch)

AusPAR Date

12 July 2016

Published

22 July 2016

Submission Number

PM–2014-04326-1-4

Submission Type

Major variation; extension of indications

Decision

Approved