AusPAR: Golimumab (rmc)

Australian Public Assessment Report

AusPAR

AusPAR: Golimumab (rmc) [PDF, 1.45 MB]

AusPAR: Golimumab (rmc) [Word, 1.54 MB]

Attachment: Product Information: Golimumab (rmc) [PDF, 225.06 KB]

Attachment: Product Information: Golimumab (rmc) [Word, 118.39 KB]

Attachment: Extract from Clinical Evaluation Report: Golimumab (rmc) [PDF, 1.5 MB]

Attachment: Extract from Clinical Evaluation Report: Golimumab (rmc) [Word, 1.84 MB]

Device/Product Name

Simponi and Simponi Smartject Injector

Active ingredients

Golimumab (rmc)

AusPAR Date

16 August 2013

Published

11 October 2013

Submission Number

PM-2012-01202-3-3

Submission Type

Extension of indications, Changes to Product Information

Decision

Approved