AusPAR: Macitentan

Australian Public Assessment Report

AusPAR

AusPAR: Macitentan [PDF, 868.3 KB]

AusPAR: Macitentan [Word, 762.11 KB]

Attachment: Product Information: Macitentan [PDF, 359.05 KB]

Attachment: Product Information: Macitentan [Word, 313.77 KB]

Attachment: Extract from Clinical Evaluation Report: Macitentan [PDF, 4.47 MB]

Attachment: Extract from Clinical Evaluation Report: Macitentan [Word, 6.23 MB]

Device/Product Name

Opsumit

Active ingredients

Macitentan

AusPAR Date

28 April 2014

Published

4 August 2014

Submission Number

PM-2012-04112-1-3

Submission Type

New chemical entity

Decision

Approved