AusPAR: Idarucizumab

Australian Public Assessment Report

AusPAR

AusPAR Idarucizumab [PDF, 746.64 KB]

AusPAR Idarucizumab [Word, 641.52 KB]

Attachment: Product Information: Idarucizumab [PDF, 356.58 KB]

Attachment: Product Information: Idarucizumab [Word, 982.24 KB]

Attachment: Extract from Clinical Evaluation Report: Idarucizumab [PDF, 1.18 MB]

Attachment: Extract from Clinical Evaluation Report: Idarucizumab [Word, 2.69 MB]

Device/Product Name

Praxbind

Active ingredients

Idarucizumab

AusPAR Date

25 October 2016

Published

8 November 2016

Submission Number

PM-2015-00707-1-3

Submission Type

New biological medicine

Decision

Approved