AusPAR: Lumacaftor / ivacaftor

Australian Public Assessment Report

AusPAR

AusPAR: Lumacaftor / Ivacaftor [PDF, 2.19 MB]

AusPAR: Lumacaftor / Ivacaftor [Word, 5.2 MB]

AusPAR: Product Information: Lumacaftor / Ivacaftor [PDF, 466.1 KB]

AusPAR: Lumacaftor / Ivacaftor [Word, 5.2 MB]

AusPAR: Extract from Clinical Evaluation Report: Lumacaftor / Ivacaftor [PDF, 6.01 MB]

AusPAR: Extract from Clinical Evaluation Report: Lumacaftor / Ivacaftor [Word, 11.47 MB]

Device/Product Name

Orkambi 200/125

Active ingredients

Lumacaftor / ivacaftor

AusPAR Date

8 September 2016

Published

21 September 2016

Submission Number

PM-2015-00424-1-5

Submission Type

New chemical entity in a fixed dose combination

Decision

Approved