AusPAR: Crizotinib

Australian Public Assessment Report

AusPAR

AusPAR: Crizotinib [PDF, 1.9 MB]

AusPAR: Crizotinib [Word, 3.57 MB]

Attachment: Product Information: Crizotinib [PDF, 323.49 KB]

Attachment: Product Information: Crizotinib [Word, 272.2 KB]

Attachment: Extract from Clinical Evaluation Report: Crizotinib [PDF, 1.95 MB]

Attachment: Extract from Clinical Evaluation Report: Crizotinib [Word, 3.94 MB]

Attachment: Extract from Clinical Evaluation Report: Study A8081007 [PDF, 844.63 KB]

Attachment: Extract from Clinical Evaluation Report: Study A8081007 [Word, 1.48 MB]

Device/Product Name

Xalkori

Active ingredients

Crizotinib

AusPAR Date

12 March 2014

Published

15 April 2014

Submission Number

PM-2011-02752-3-4

Submission Type

New chemical entity

Decision

Approved