AusPAR: Paliperidone palmitate

Australian Public Assessment Report

AusPAR

AusPAR: Paliperidone palmitate [PDF, 942.98 KB]

AusPAR: Paliperidone palmitate [Word, 1.3 MB]

Attachment: Product Information: Paliperidone palmitate [PDF, 564.99 KB]

Attachment: Product Information: Paliperidone palmitate [Word, 1.75 MB]

Attachment: Extract from Clinical Evaluation Report: Paliperidone palmitate [PDF, 3.49 MB]

Attachment: Extract from Clinical Evaluation Report: Paliperidone palmitate [Word, 6.57 MB]

Device/Product Name

Invega Trinza and Trevicta

Active ingredients

Paliperidone palmitate

AusPAR Date

13 October 2017

Published

10 November 2017

Submission Number

2015-02788-1-1

Submission Type

Major variation (extension of indications new dose form and strength)

Decision

Approved