AusPAR: Perampanel (as hemisesquihydrate)

Australian Public Assessment Report

AusPAR

AusPAR: Perampanel (as hemisesquihydrate) [PDF, 1.22 MB]

AusPAR: Perampanel (as hemisesquihydrate) [DOCX, 2.24 MB]

Attachment: Product Information: Perampanel (as hemisesquihydrate) [PDF, 378.3 KB]

Attachment: Product Information: Perampanel (as hemisesquihydrate) [DOCX, 92.24 KB]

Attachment: Extract from the Clinical Evaluation Report: Perampanel (as hemisesquihydrate) [PDF, 5.25 MB]

Attachment: Extract from the Clinical Evaluation Report: Perampanel (as hemisesquihydrate) [DOCX, 10.7 MB]

Device/Product Name

Fycompa

Active ingredients

Perampanel (as hemisesquihydrate)

AusPAR Date

14 October 2014

Published

19 November 2014

Submission Number

PM-2013-00324-1-1

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines