AusPAR: Baricitinib

Australian Public Assessment Report

AusPAR

AusPAR: Baricitinib [PDF, 1.36 MB]

AusPAR: Baricitinib [Word, 3.3 MB]

Attachment: Product Information: Baricitinib [PDF, 584.31 KB]

Attachment: Product Information: Baricitinib [Word, 218.23 KB]

Attachment: Extract from Clinical Evaluation: Baricitinib [PDF, 3.23 MB]

Attachment: Extract from Clinical Evaluation: Baricitinib [Word, 9.99 MB]

Device/Product Name

Olumiant

Active ingredients

Baricitinib

AusPAR Date

21 March 2019

Published

17 July 2019

Submission Number

PM-2016-01468-1-3

Submission Type

New chemical entity

Decision

Approved