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AusPAR: Sofosbuvir

Australian Public Assessment Report

AusPAR

AusPAR: Sofosbuvir [PDF, 2.25 MB]

AusPAR: Sofosbuvir [DOCX, 2.86 MB]

Attachment: Product Information: Sofosbuvir [PDF, 510.67 KB]

Attachment: Product Information: Sofosbuvir [DOCX, 280.29 KB]

Attachment: Extract from Clinical Evaluation Report: Sofosbuvir [PDF, 5.75 MB]

Attachment: Extract from Clinical Evaluation Report: Sofosbuvir [DOCX, 6.18 MB]

Device/Product Name

Sovaldi

Active ingredients

Sofosbuvir

AusPAR Date

5 August 2014

Published

1 September 2014

Submission Number

PM-2013-01283-1-2

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines