AusPAR: Fidaxomicin

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Australian Public Assessment Report

29 October 2013
AusPAR Details
AusPAR
AusPAR: Fidaxomicin (pdf, 758 KB)
AusPAR: Fidaxomicin (docx, 835 KB)
Attachment: Product Information: Fidaxomicin (pdf, 303 KB)
Attachment: Product Information: Fidaxomicin (docx, 95 KB)
Attachment: Extract from Clinical Evaluation Report: Fidaxomicin (pdf, 764 KB)
Attachment: Extract from Clinical Evaluation Report: Fidaxomicin (docx, 1 MB)
Active Ingredient
Fidaxomicin
Product Name
Dificid
Sponsor
Specialised Therapeutics Australia Pty Ltd
Submission Number
PM-2012-04269-3-2
Submission Type
New chemical entity
Decision
Approved
AusPAR Date
26 September 2013
Publication Date

29 October 2013
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/781