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AusPAR: Ceritinib

Australian Public Assessment Report

AusPAR

AusPAR: Ceritinib [PDF, 1.13 MB]

AusPAR: Ceritinib [DOCX, 1.33 MB]

Attachment: Product Information: Ceritinib [PDF, 327.45 KB]

Attachment: Product Information: Ceritinib [DOCX, 84.03 KB]

Attachment: Extract from Clinical Evaluation Report: Ceritinib [PDF, 2.11 MB]

Attachment: Extract from Clinical Evaluation Report: Ceritinib [DOCX, 4.23 MB]

Device/Product Name

Zykadia

Active ingredients

Ceritinib

AusPAR Date

27 February 2018

Published

13 March 2018

Submission Number

PM-2015-00418-1-4

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines