AusPAR: Inotuzumab ozogamicin

Australian Public Assessment Report

AusPAR

AusPAR: Inotuzumab ozogamicin [PDF, 2.24 MB]

AusPAR: Inotuzumab ozogamicin [Word, 4.02 MB]

Attachment: Product Information: Inotuzumab ozogamicin [PDF, 417.23 KB]

Attachment: Product Information: Inotuzumab ozogamicin [Word, 393.74 KB]

Device/Product Name

Besponsa

Active ingredients

Inotuzumab ozogamicin

AusPAR Date

4 July 2019

Published

12 August 2019

Submission Number

PM-2017-01455-1-4

Submission Type

New biological entity

Decision

Approved