AusPAR: Niraparib tosilate monohydrate

Australian Public Assessment Report

AusPAR

AusPAR: Niraparib tosilate monohydrate [PDF, 548.03 KB]

AusPAR: Niraparib tosilate monohydrate [Word, 548.06 KB]

Attachment: Product Information for Niraparib tosilate monohydrate [PDF, 223.28 KB]

Attachment: Product Information for Niraparib tosilate monohydrate [Word, 85.75 KB]

Device/Product Name

Zejula

Active ingredients

Niraparib tosilate monohydrate

AusPAR Date

26 November 2020

Published

2 December 2020

Submission Number

PM-2018 02496 1 4

Submission Type

New chemical entity

Decision

Approved