AusPAR: Ibrutinib

Australian Public Assessment Report

AusPAR

AusPAR: Ibrutinib [PDF, 1.46 MB]

AusPAR: Ibrutinib [Word, 1.58 MB]

Attachment: Product Information: Ibrutinib [PDF, 430.72 KB]

Attachment: Product Information: Ibrutinib [Word, 701 KB]

Attachment: Extract from Clinical Evaluation Report: Ibrutinib [PDF, 2.68 MB]

Attachment: Extract from Clinical Evaluation Report: Ibrutinib [Word, 11.54 MB]

Device/Product Name

Imbruvica

Active ingredients

Ibrutinib

AusPAR Date

2 February 2016

Published

5 April 2016

Submission Number

PM-2014-02780-1-4

Submission Type

New chemical entity

Decision

Approved