AusPAR: Ivacaftor

Australian Public Assessment Report

AusPAR

AusPAR Ivacaftor [PDF, 1.07 MB]

AusPAR Ivacaftor [Word, 1.89 MB]

Attachment: Product Information: Ivacaftor [PDF, 317.31 KB]

Attachment: Product Information: Ivacaftor [Word, 205.66 KB]

Attachment: Extract from Clinical Evaluation Report: Ivacaftor [PDF, 4.85 MB]

Attachment: Extract from Clinical Evaluation Report: Ivacaftor [Word, 12.46 MB]

Device/Product Name

Kalydeco

Active ingredients

Ivacaftor

AusPAR Date

5 January 2017

Published

19 January 2017

Submission Number

PM-2015-00399-1-5

Submission Type

Extension of indications

Decision

Approved