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AusPAR: Kaldyeco

Australian Public Assessment Report

AusPAR

AusPAR Ivacaftor [PDF, 1.07 MB]

AusPAR Kaldyeco [Word, 1.89 MB]

Attachment: Product Information: Kaldyeco [PDF, 336.09 KB]

Attachment: Product Information: Kaldyeco [Word, 205.42 KB]

Attachment: Extract from Clinical Evaluation Report: Kaldyeco [PDF, 4.76 MB]

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

Device/Product Name

Ivacaftor

Active ingredients

Kaldyeco

AusPAR Date

5 January 2017

Published

19 January 2017

Submission Number

PM-2014-04248-1-5

Submission Type

Extension of indications

Decision

Approved