AusPAR: Romidepsin

Australian Public Assessment Report

AusPAR

AusPAR: Romidepsin [PDF, 794.76 KB]

AusPAR: Romidepsin [Word, 1.36 MB]

Attachment: Product Information: Romidepsin [PDF, 231.87 KB]

Attachment: Product Information: Romidepsin [Word, 62.63 KB]

Attachment: Extract from Clinical Evaluation Report: Romidepsin [PDF, 1.59 MB]

Attachment: Extract from Clinical Evaluation Report: Romidepsin [Word, 3.78 MB]

Device/Product Name

Istodax

Active ingredients

Romidepsin

AusPAR Date

20 November 2013

Published

6 December 2013

Submission Number

PM-2012-01446-3-4

Submission Type

New chemical entity

Decision

Approved