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AusPAR: Ledipasvir/Sofosbuvir

Australian Public Assessment Report

AusPAR

AusPAR Ledipasvir / Sofosbuvir [PDF, 1.24 MB]

AusPAR Ledipasvir/Sofosbuvir [Word, 2.99 MB]

Attachment: Product Information Ledipasvir/Sofosbuvir [PDF, 430.08 KB]

Attachment: Product Information Ledipasvir/Sofosbuvir [Word, 171.18 KB]

Attachment: Extract from Clinical Evaluation Report: Ledipasvir/Sofosbu [PDF, 606.36 KB]

Attachment: Extract from Clinical Evaluation Report: Ledipasvir/Sofosbu [Word, 513.72 KB]

Device/Product Name

Harvoni

Active ingredients

Ledipasvir / Sofosbuvir

AusPAR Date

8 October 2015

Published

29 October 2015

Submission Number

PM-2014-00469-1-2

Submission Type

New chemical entity

Decision

Approved