AusPAR: Armodafinil

Australian Public Assessment Report

AusPAR

AusPAR: Armodafinil [PDF, 2.11 MB]

AusPAR: Armodafinil [Word, 3.32 MB]

Attachment: Product Information: Armodafinil [PDF, 310.62 KB]

Attachment: Product Information: Armodafinil [Word, 166.79 KB]

Attachment: Extract from Clinical Evaluation Report: Armodafinil [PDF, 3.65 MB]

Attachment: Extract from Clinical Evaluation Report: Armodafinil [Word, 6.44 MB]

Device/Product Name

Nuvigil

Active ingredients

Armodafinil

AusPAR Date

26 May 2016

Published

9 June 2016

Submission Number

PM-2014-01922-1-1

Submission Type

New chemical entity

Decision

Approved