AusPAR: Bendamustine hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Bendamustine hydrochloride [PDF, 1.54 MB]

AusPAR: Bendamustine hydrochloride [Word, 2.6 MB]

Attachment: Product Information: Bendamustine hydrochloride [PDF, 672.09 KB]

Attachment: Product Information: Bendamustine hydrochloride [Word, 192.61 KB]

Attachment: Extract from the Clinical Evaluation Report: Bendamustine hydrochloride [PDF, 4.68 MB]

Attachment: Extract from the Clinical Evaluation Report: Bendamustine hydrochloride [Word, 8.52 MB]

Device/Product Name

Ribomustin

Active ingredients

Bendamustine hydrochloride

AusPAR Date

6 January 2015

Published

25 February 2015

Submission Number

PM-2013-01517-1-4

Submission Type

New chemical entity

Decision

Approved