AusPAR: Guselkumab

Australian Public Assessment Report

AusPAR

AusPAR: Guselkumab [PDF, 907.33 KB]

AusPAR: Guselkumab [Word, 1.66 MB]

Attachment: Product Information: Guselkumab [PDF, 252.68 KB]

Attachment: Product Information: Guselkumab [Word, 346.13 KB]

Attachment: Extract from Clinical Evaluation: Guselkumab [PDF, 1.21 MB]

Attachment: Extract from Clinical Evaluation: Guselkumab [Word, 13.03 MB]

Device/Product Name

Tremfya / Janssen Guselkumab

Active ingredients

Guselkumab

AusPAR Date

5 November 2018

Published

11 December 2018

Submission Number

PM-2017-00552-1-1

Submission Type

New biological entity

Decision

Approved