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AusPAR: Crizotinib

Australian Public Assessment Report

AusPAR

AusPAR: Crizotinib [PDF, 841.19 KB]

AusPAR: Crizotinib [DOCX, 1.56 MB]

Attachment: Product Information: Crizotinib [PDF, 449.95 KB]

Attachment: Product Information: Crizotinib [DOCX, 679.72 KB]

Attachment: Extract from Clinical Evaluation: Crizotinib [PDF, 2.1 MB]

Attachment: Extract from Clinical Evaluation: Crizotinib [DOCX, 2.93 MB]

Device/Product Name

Xalkori

Active ingredients

Crizotinib

AusPAR Date

18 October 2018

Published

6 December 2018

Submission Number

PM-2016-03535-1-4

Submission Type

Extension of indications

Decision

Approved

Product types

Prescription medicines