AusPAR: Aripiprazole monohydrate

Australian Public Assessment Report

AusPAR

AusPAR: Aripiprazole monohydrate [PDF, 838.77 KB]

AusPAR: Aripiprazole monohydrate [Word, 780.33 KB]

Attachment: Product information: Aripiprazole monohydrate [PDF, 452.41 KB]

Attachment: Product information: Aripiprazole monohydrate [Word, 2.35 MB]

Attachment: Extract from the Clinical Evaluation Report: Aripiprazole monohydrate [PDF, 1.64 MB]

Attachment: Extract from the Clinical Evaluation Report: Aripiprazole monohydrate [Word, 2.16 MB]

Device/Product Name

Abilify maintena

Active ingredients

Aripiprazole monohydrate

AusPAR Date

25 November 2014

Published

14 January 2015

Submission Number

PM-2013-01100-1-1

Submission Type

Major variation (new strength, new dosage form)

Decision

Approved