AusPAR: Golimumab (rmc)

Australian Public Assessment Report

AusPAR

AusPAR: Golimumab (rmc) [PDF, 963.46 KB]

AusPAR: Golimumab (rmc) [Word, 2.55 MB]

Attachment: Product Information: Golimumab (rmc) [PDF, 416.37 KB]

Attachment: Product Information: Golimumab (rmc) [Word, 105.63 KB]

Attachment: Extract from Clinical Evaluation Report: Golimumab (rmc) [PDF, 678.01 KB]

Attachment: Extract from Clinical Evaluation Report: Golimumab (rmc) [Word, 914.41 KB]

Device/Product Name

Simponi, Simponi smartject injector

Active ingredients

Golimumab (rmc)

AusPAR Date

19 May 2014

Published

18 June 2014

Submission Number

PM-2013-00215-1-1

Submission Type

Major variation (extension of indications)

Decision

Approved