AusPAR: Obinutuzumab

Australian Public Assessment Report

AusPAR

AusPAR: Obinutuzumab [PDF, 1013.02 KB]

AusPAR: Obinutuzumab [Word, 2.41 MB]

Attachment: Product Information: Obinutuzumab [PDF, 568.01 KB]

Attachment: Product Information: Obinutuzumab [Word, 427.39 KB]

Attachment: Extract from Clinical Evaluation Obinutuzumab [PDF, 1.51 MB]

Attachment: Extract from Clinical Evaluation Obinutuzumab [Word, 5.67 MB]

Device/Product Name

Gazyva

Active ingredients

Obinutuzumab

AusPAR Date

2 May 2018

Published

9 May 2018

Submission Number

PM-2016-03149-1-4

Submission Type

Extension of indications

Decision

Approved