AusPAR: Ivacaftor

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Australian Public Assessment Report

19 January 2017
AusPAR Details
AusPAR
AusPAR Ivacaftor (pdf, 1 MB)
AusPAR Ivacaftor (docx, 2 MB)
Attachment: Product Information: Ivacaftor (pdf, 317 KB)
Attachment: Product Information: Ivacaftor (docx, 206 KB)
Attachment: Extract from Clinical Evaluation Report: Ivacaftor (pdf, 5 MB)
Attachment: Extract from Clinical Evaluation Report: Ivacaftor (docx, 12 MB)
Active Ingredient
Ivacaftor
Product Name
Kalydeco
Sponsor
Vertex Pharmaceuticals Australia
Submission Number
PM-2015-00399-1-5
Submission Type
Extension of indications
Decision
Approved
AusPAR Date
5 January 2017
Publication Date

19 January 2017
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/734707