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AusPAR: Enzalutamide

Australian Public Assessment Report

AusPAR

AusPAR Enzalutamide [PDF, 1.45 MB]

AusPAR Enzalutamide [Word, 3.68 MB]

Attachment: Product Information: Enzalutamide [PDF, 591.23 KB]

Attachment: Product Information: Enzalutamide [Word, 1.36 MB]

Attachment: Extract from Clinical Evaluation Report: Enzalutamide [PDF, 2.79 MB]

Attachment: Extract from Clinical Evaluation Report: Enzalutamide [Word, 8.36 MB]

Device/Product Name

Xtandi

Active ingredients

Enzalutamide

AusPAR Date

23 March 2016

Published

31 March 2016

Submission Number

PM-2014-03154-1-4

Submission Type

Extension of indications

Decision

Approved