AusPAR: Sofosbuvir / Velpatasvir

Australian Public Assessment Report

AusPAR

AusPAR Sofosbuvir / Velpatasvir [PDF, 1.05 MB]

AusPAR Sofosbuvir / Velpatasvir [Word, 1.83 MB]

Attachment: Product Information: Sofosbuvir / Velpatasvir [PDF, 386.92 KB]

Attachment: Product Information: Sofosbuvir / Velpatasvir [Word, 163.21 KB]

Attachment: Extract from Clinical Evaluation Report: Sofosbuvir/Velpatasvir [PDF, 3.37 MB]

Attachment: Extract from Clinical Evaluation Report: Sofosbuvir/Velpatasvir [Word, 8.04 MB]

Device/Product Name

Epclusa

Active ingredients

Sofosbuvir / Velpatasvir

AusPAR Date

8 November 2017

Published

20 November 2017

Submission Number

PM-2015-03984-1-2

Submission Type

New chemical entity

Decision

Approved