AusPAR: Nivolumab

Australian Public Assessment Report

AusPAR

AusPAR: Nivolumab [PDF, 930.79 KB]

AusPAR: Nivolumab [Word, 1.99 MB]

Attachment: Product Information: Nivolumab [PDF, 752.33 KB]

Attachment: Product Information: Nivolumab [Word, 1.58 MB]

Attachment: Extract from Clinical Evaluation Report: Nivolumab [PDF, 3.97 MB]

Attachment: Extract from Clinical Evaluation Report: Nivolumab [Word, 11.17 MB]

Device/Product Name

Opdivo

Active ingredients

Nivolumab

AusPAR Date

26 October 2017

Published

15 November 2017

Submission Number

2015-03579-1-4

Submission Type

New biological entity

Decision

Approved