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

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Australian Public Assessment Report

26 April 2017
AusPAR Details
AusPAR
AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (pdf, 3 MB)
AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (docx, 5 MB)
Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (pdf, 716 KB)
Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (docx, 303 KB)
Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (pdf, 3 MB)
Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin (docx, 6 MB)
Active Ingredient
Ritonavir / Paritaprevir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin
Product Name
Viekira Pak-RBV
Sponsor
AbbVie Pty Ltd
Submission Number
PM-2014-01438-1-2
Submission Type
New chemical entity in a fixed dose combination
Decision
Approved
AusPAR Date
24 March 2017
Publication Date

26 April 2017
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/755331