AusPAR: Defibrotide

Australian Public Assessment Report

AusPAR

Australian Public Assessment Report for Defibrotide [PDF, 580.28 KB]

Australian Public Assessment Report for Defibrotide [Word, 235.59 KB]

AusPAR Attachment 1: Product Information for Defibrotide [PDF, 425.93 KB]

AusPAR Attachment 1: Product Information for Defibrotide [Word, 128.73 KB]

Device/Product Name

Defitelio

Active ingredients

Defibrotide

AusPAR Date

3 December 2020

Published

11 December 2020

Submission Number

PM-2019-01763-1-3

Submission Type

New biological entity

Decision

Approved