AusPAR: Suvorexant

Australian Public Assessment Report

AusPAR

AusPAR: Suvorexant [PDF, 1.61 MB]

AusPAR: Suvorexant [Word, 2.11 MB]

Attachment: Product Information: Suvorexant [PDF, 291.59 KB]

Attachment: Product Information: Suvorexant [Word, 502.15 KB]

Attachment: Product Information: Suvorexant [PDF, 290.86 KB]

Attachment: Product Information: Suvorexant [Word, 502.67 KB]

Device/Product Name

Belsomra / Silumbra

Active ingredients

Suvorexant

AusPAR Date

1 June 2018

Published

5 July 2018

Submission Number

PM-2013-00325-1-1

Submission Type

New chemical entity

Decision

Approved (doses of 15 and 20 mg)