AusPAR: Tezacaftor/Ivacaftor and Ivacaftor

Australian Public Assessment Report

AusPAR

AusPAR Tezacaftor/ivacaftor and ivacaftor [PDF, 1.13 MB]

AusPAR Tezacaftor/ivacaftor and ivacaftor [Word, 1.53 MB]

Attachment Product information Tezacaftor/ivacaftor and ivacaftor [PDF, 438.12 KB]

Attachment Product information Tezacaftor/ivacaftor and ivacaftor [Word, 782.12 KB]

Device/Product Name

Symdeko

Active ingredients

Tezacaftor/Ivacaftor and Ivacaftor

AusPAR Date

16 October 2019

Published

28 October 2019

Submission Number

PM-2017-04765-1-5

Submission Type

New chemical entity

Decision

Approved