AusPAR: Ocrelizumab

Australian Public Assessment Report

AusPAR

AusPAR: Ocrelizumab [PDF, 1.6 MB]

AusPAR: Ocrelizumab [Word, 3.89 MB]

Product Information: Ocrelizumab [PDF, 310.85 KB]

Product Information: Ocrelizumab [Word, 450.83 KB]

Extract from Clinical Evaluation Ocrelizumab [PDF, 7.49 MB]

Attachment: Extract from Clinical Evaluation Ocrelizumab [Word, 17.32 MB]

Device/Product Name

Ocrevus

Active ingredients

Ocrelizumab

AusPAR Date

8 August 2018

Published

6 September 2018

Submission Number

PM-2016-01580-1-1

Submission Type

New chemical (biological) entity

Decision

Approved