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AusPAR: Evolocumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Evolocumab (rch) [PDF, 2.01 MB]

AusPAR: Evolocumab (rch) [Word, 4.32 MB]

Attachment: Product Information: Evolocumab (rch) [PDF, 421.72 KB]

Attachment: Product Information: Evolocumab (rch) [Word, 517.92 KB]

Attachment: Extract from Clinical Evaluation Report: Evolocumab (rch) [PDF, 5.6 MB]

Attachment: Extract from Clinical Evaluation Report: Evolocumab (rch) [Word, 11.81 MB]

Device/Product Name

Repatha

Active ingredients

Evolocumab (rch)

AusPAR Date

3 May 2016

Published

16 May 2016

Submission Number

PM-2014-03144-1-3

Submission Type

New biological entity

Decision

Approved