AusPAR: Elexacaftor/tezacaftor/ivacaftor and ivacaftor

Australian Public Assessment Report

AusPAR

AusPAR Elexacaftor/tezacaftor/ivacaftor and ivacaftor [PDF, 872.35 KB]

AusPAR: Elexacaftor/tezacaftor/ivacaftor and ivacaftor [Word, 1.51 MB]

Attachment 1: Product Information for Elexacaftor/tezacaftor/ivacaftor and ivacaftor [PDF, 525.06 KB]

Attachment 1: Product Information for Elexacaftor/tezacaftor/ivacaftor and ivacaftor [Word, 286.21 KB]

Device/Product Name

Trikafta

Active ingredients

Elexacaftor/tezacaftor/ivacaftor and ivacaftor

AusPAR Date

18 June 2021

Published

8 July 2021

Submission Number

PM-2020-00642-1-5

Submission Type

New chemical entity in a fixed dose combination

Decision

Approved