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AusPAR: Ivacaftor

Australian Public Assessment Report

AusPAR

AusPAR: Ivacaftor [PDF, 799.5 KB]

AusPAR: Ivacaftor [Word, 1.6 MB]

Attachment: Product Information: Ivacaftor [PDF, 229.46 KB]

Attachment: Product Information: Ivacaftor [Word, 550 KB]

Attachment: Extract from Clinical Evaluation Report: Ivacaftor [PDF, 1019.92 KB]

Attachment: Extract from Clinical Evaluation Report: Ivacaftor [Word, 4.08 MB]

Device/Product Name

Kalydeco

Active ingredients

Ivacaftor

AusPAR Date

29 November 2013

Published

23 December 2013

Submission Number

PM-2012-01491-3-5

Submission Type

New chemical entity

Decision

Approved