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AusPAR: Enzalutamide

Australian Public Assessment Report

AusPAR

AusPAR: Enzalutamide [PDF, 1.03 MB]

AusPAR: Enzalutamide [Word, 1.68 MB]

Attachment: Product information: Enzalutamide [PDF, 315.73 KB]

Attachment: Product information: Enzalutamide [Word, 359.22 KB]

Attachment: Extract from the Clinical Evaluation Report: Enzalutamide [PDF, 1.01 MB]

Attachment: Extract from the Clinical Evaluation Report: Enzalutamide [Word, 1.95 MB]

Device/Product Name

Xtandi

Active ingredients

Enzalutamide

AusPAR Date

24 November 2014

Published

14 January 2015

Submission Number

PM-2013-01155-1-4

Submission Type

New chemical entity

Decision

Approved