AusPAR: Bezlotoxumab

Australian Public Assessment Report

AusPAR

AusPAR: Bezlotoxumab [PDF, 1.15 MB]

AusPAR: Bezlotoxumab [Word, 2.72 MB]

Attachment: Product Information: Bezlotoxumab [PDF, 167 KB]

Attachment: Product Information: Bezlotoxumab [Word, 67.03 KB]

Attachment: Extract from Clinical Evaluation: Bezlotoxumab [PDF, 1.63 MB]

Attachment: Extract from Clinical Evaluation: Bezlotoxumab [Word, 2.48 MB]

Device/Product Name

Zinplava

Active ingredients

Bezlotoxumab

AusPAR Date

24 September 2018

Published

21 November 2018

Submission Number

PM-2016-03738-1-2

Submission Type

New biological entity

Decision

Approved