AusPAR: Alirocumab

Australian Public Assessment Report

AusPAR

AusPAR: Alirocumab [PDF, 2.55 MB]

AusPAR: Alirocumab [Word, 4.32 MB]

Attachment: Product Information: Alirocumab [PDF, 582.19 KB]

Attachment: Product Information: Alirocumab [Word, 369.42 KB]

Attachment: Extract from Clinical Evaluation Report: Alirocumab [PDF, 3.12 MB]

Attachment: Extract from Clinical Evaluation Report: Alirocumab [Word, 4.47 MB]

Device/Product Name

Praluent

Active ingredients

Alirocumab

AusPAR Date

18 September 2018

Published

13 November 2018

Submission Number

PM-2016-01950-1-3

Submission Type

Major variation: extension of indications and new dose regimen

Decision

Approved