Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.

AusPAR: Obinutuzumab

Australian Public Assessment Report

AusPAR

AusPAR: Obinutuzumab [PDF, 3.23 MB]

AusPAR: Obinutuzumab [Word, 2.78 MB]

Attachment: Product Information: Obinutuzumab [PDF, 526.96 KB]

Attachment: Product Information: Obinutuzumab [Word, 400.17 KB]

Attachment: Extract from Clinical Evaluation Report: Obinutuzumab [PDF, 5.71 MB]

Attachment: Extract from Clinical Evaluation Report: Obinutuzumab [Word, 5.11 MB]

Device/Product Name

Gazyva

Active ingredients

Obinutuzumab

AusPAR Date

26 August 2014

Published

30 September 2014

Submission Number

PM-2013-01148-1-4

Submission Type

New biological entity

Decision

Approved