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AusPAR: Fidaxomicin

Australian Public Assessment Report

AusPAR

AusPAR: Fidaxomicin [PDF, 757.72 KB]

AusPAR: Fidaxomicin [Word, 834.86 KB]

Attachment: Product Information: Fidaxomicin [PDF, 303.01 KB]

Attachment: Product Information: Fidaxomicin [Word, 95.1 KB]

Attachment: Extract from Clinical Evaluation Report: Fidaxomicin [PDF, 763.73 KB]

Attachment: Extract from Clinical Evaluation Report: Fidaxomicin [Word, 1.25 MB]

Device/Product Name

Dificid

Active ingredients

Fidaxomicin

AusPAR Date

26 September 2013

Published

29 October 2013

Submission Number

PM-2012-04269-3-2

Submission Type

New chemical entity

Decision

Approved