AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin

Australian Public Assessment Report

AusPAR

AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [PDF, 3.03 MB]

AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [Word, 4.51 MB]

Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [PDF, 716.02 KB]

Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [Word, 303.06 KB]

Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [PDF, 3.16 MB]

Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin [Word, 5.89 MB]

Device/Product Name

Viekira Pak-RBV

Active ingredients

Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin

AusPAR Date

24 March 2017

Published

26 April 2017

Submission Number

PM-2014-01438-1-2

Submission Type

New chemical entity in a fixed dose combination

Decision

Approved