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AusPAR: Armodafinil

Australian Public Assessment Report

AusPAR

AusPAR: Armodafinil [PDF, 2.11 MB]

AusPAR: Armodafinil [DOCX, 3.32 MB]

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

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

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

Attachment: Extract from Clinical Evaluation Report: Armodafinil [DOCX, 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

Product types

Prescription medicines