AusPAR: Migalastat

Australian Public Assessment Report

AusPAR

AusPAR: Migalastat [PDF, 1.09 MB]

AusPAR: Migalastat [Word, 756.49 KB]

Attachment: Product Information: Migalastat [PDF, 570.75 KB]

Attachment: Product Information: Migalastat [Word, 177.16 KB]

Attachment: Extract from Clinical Evaluation: Migalastat [PDF, 4.73 MB]

Attachment: Extract from Clinical Evaluation: Migalastat [Word, 9.81 MB]

Device/Product Name

Galafold

Active ingredients

Migalastat

AusPAR Date

30 August 2018

Published

18 September 2018

Submission Number

PM-2016-01191-1-3

Submission Type

New chemical entity

Decision

Approved