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AusPAR: Simeprevir (as sodium)

Australian Public Assessment Report

AusPAR

AusPAR: Simeprevir (as sodium) [PDF, 1.9 MB]

AusPAR: Simeprevir (as sodium) [Word, 913.68 KB]

Attachment: Product Information: Simeprevir (as sodium) [PDF, 899.15 KB]

Attachment: Product Information: Simeprevir (as sodium) [Word, 320.61 KB]

Attachment: Extract from the Clinical Evaluation Report: Simeprevir (as sodium) [PDF, 4.13 MB]

Attachment: Extract from the Clinical Evaluation Report: Simeprevir (as sodium) [Word, 3.9 MB]

Device/Product Name

Olysio / Janssen Simeprevir

Active ingredients

Simeprevir (as sodium)

AusPAR Date

27 October 2014

Published

20 November 2014

Submission Number

PM-2013-01557-1-2

Submission Type

New chemical entity

Decision

Approved