AusPAR: Acalabrutinib

Australian Public Assessment Report

AusPAR

AusPAR: Acalabrutinib [PDF, 547.21 KB]

AusPAR: Acalabrutinib [Word, 557.99 KB]

Attachment: Product Information for Acalabrutinib [PDF, 206.9 KB]

Attachment: Product Information for Acalabrutinib [Word, 100.29 KB]

Device/Product Name

Calquence

Active ingredients

Acalabrutinib

AusPAR Date

17 February 2020

Published

3 March 2020

Submission Number

PM-2019-03536-1-6

Submission Type

New chemical entity

Decision

Approved for provisional registration