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

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Australian Public Assessment Report

3 May 2017
AusPAR Details
AusPAR
AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (pdf, 3 MB)
AusPAR: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (docx, 4 MB)
Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (pdf, 632 KB)
Attachment: Product Information: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (docx, 293 KB)
Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (pdf, 3 MB)
Attachment: Extract from Clinical Evaluation Report: Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) (docx, 6 MB)
Active Ingredient
Ritonavir / Ombitasvir / Paritaprevir and Dasabuvir (as sodium salt)
Product Name
Viekira Pak
Sponsor
AbbVie Pty Ltd
Submission Number
PM-2014-01436-1-2
Submission Type
New chemical entity in a fixed dose combination
Decision
Approved
AusPAR Date
24 March 2017
Publication Date

3 May 2017
Category: 
Prescription medicines
Tags: 
AusPARs
URL: 
https://www.tga.gov.au/node/755494