AusPAR: Ivacaftor

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Australian Public Assessment Report

23 December 2013
AusPAR Details
AusPAR
AusPAR: Ivacaftor (pdf, 799 KB)
AusPAR: Ivacaftor (docx, 2 MB)
Attachment: Product Information: Ivacaftor (pdf, 229 KB)
Attachment: Product Information: Ivacaftor (doc, 550 KB)
Attachment: Extract from Clinical Evaluation Report: Ivacaftor (pdf, 1020 KB)
Attachment: Extract from Clinical Evaluation Report: Ivacaftor (docx, 4 MB)
Active Ingredient
Ivacaftor
Product Name
Kalydeco
Sponsor
Vertex Pharmaceuticals Australia Pty Ltd
Submission Number
PM-2012-01491-3-5
Submission Type
New chemical entity
Decision
Approved
AusPAR Date
29 November 2013
Publication Date

23 December 2013
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/837