AusPAR: Nalmefene (as hydrochloride dihydrate)

Australian Public Assessment Report

AusPAR

AusPAR: Nalmefene (as hydrochloride dihydrate) [PDF, 2.72 MB]

AusPAR: Nalmefene (as hydrochloride dihydrate) [Word, 4.56 MB]

Attachment: Product Information: Nalmefene (as hydrochloride dihydrate) [PDF, 221.21 KB]

Attachment: Product Information: Nalmefene (as hydrochloride dihydrate) [Word, 70.3 KB]

Attachment: Extract from Clinical Evaluation Report: Nalmefene (as hydrochloride dihydrate) [PDF, 8.29 MB]

Attachment: Extract from Clinical Evaluation Report: Nalmefene (as hydrochloride dihydrate) [Word, 15.17 MB]

Device/Product Name

Selincro

Active ingredients

Nalmefene (as hydrochloride dihydrate)

AusPAR Date

9 August 2016

Published

2 September 2016

Submission Number

PM-2013-02690-1-1

Submission Type

New chemical entity

Decision

Approved