AusPAR: Daclatasvir dihydrochloride

Australian Public Assessment Report

AusPAR

AusPAR Daclatasvir dihydrochloride [PDF, 1.65 MB]

AusPAR Daclatasvir dihydrochloride [Word, 2.25 MB]

Attachment: Product Information: Daclatasvir dihydrochloride [PDF, 413.61 KB]

Attachment: Product Information: Daclatasvir dihydrochloride [Word, 361.5 KB]

Attachment: Extract from Clinical Evaluation Report: Daclatasvir dihydrochloride [PDF, 2.55 MB]

Attachment: Extract from Clinical Evaluation Report: Daclatasvir dihydrochloride [Word, 4.32 MB]

Device/Product Name

Daklinza

Active ingredients

Daclatasvir dihydrochloride

AusPAR Date

14 December 2015

Published

21 December 2015

Submission Number

PM-2014-00647-1-2

Submission Type

New chemical entity

Decision

Approved