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AusPAR: Alirocumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR Alirocumab (rch) [PDF, 1.01 MB]

AusPAR Alirocumab (rch) [Word, 666.35 KB]

Attachment: Product Information: Alirocumab (rch) [PDF, 485.13 KB]

Attachment: Product Information: Alirocumab (rch) [Word, 434.82 KB]

Attachment: Extract from Clinical Evaluation Report: Alirocumab (rch) [PDF, 2.68 MB]

Attachment: Extract from Clinical Evaluation Report: Alirocumab (rch) [Word, 3.91 MB]

Device/Product Name

Praluent (Golyra/Eliriduc)

Active ingredients

Alirocumab (rch)

AusPAR Date

13 December 2016

Published

22 December 2016

Submission Number

PM-2015-00764-1-3

Submission Type

New biological entity

Decision

Approved