AusPAR: Cariprazine hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Cariprazine hydrochloride [PDF, 750.27 KB]

AusPAR: Cariprazine hydrochloride [Word, 314.76 KB]

Attachment: Product Information for Cariprazine hydrochloride [PDF, 479.52 KB]

Attachment: Product Information for Cariprazine hydrochloride [Word, 345.26 KB]

Device/Product Name

Reagila

Active ingredients

Cariprazine hydrochloride

AusPAR Date

24 May 2021

Published

28 June 2021

Submission Number

PM-2019-04790-1-1

Submission Type

New chemical entity

Decision

Approved