AusPAR: Darolutamide

Australian Public Assessment Report

AusPAR

AusPAR: Darolutamide [PDF, 516.29 KB]

AusPAR: Darolutamide [Word, 1.32 MB]

Attachment: Product Information Darolutamide [PDF, 186.49 KB]

Attachment: Product Information Darolutamide [Word, 115.8 KB]

Device/Product Name

Nubeqa

Active ingredients

Darolutamide

AusPAR Date

2 July 2020

Published

3 August 2020

Submission Number

PM-2019-01420-1-4

Submission Type

New chemical entity

Decision

Approved