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AusPAR: Sofosbuvir / Ledipasvir

Australian Public Assessment Report

AusPAR

AusPAR: Sofosbuvir / Ledipasvir [PDF, 1004.48 KB]

AusPAR: Sofosbuvir / Ledipasvir [Word, 1.1 MB]

Attachment: Product Information: Sofosbuvir / Ledipasvir [PDF, 482.75 KB]

Attachment: Product Information: Sofosbuvir / Ledipasvir [Word, 165.66 KB]

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Sofosbuvir / Ledipasvir [PDF, 2 MB]

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Sofosbuvir / Ledipasvir [Word, 2.98 MB]

Device/Product Name

Harvoni

Active ingredients

Sofosbuvir / Ledipasvir

AusPAR Date

20 October 2017

Published

16 November 2017

Submission Number

PM-2015-03086-1-2

Submission Type

Major variation; extension of indications

Decision

Approved