Viekirax
ombitasvir / paritaprevir / ritonavir
Table of contents
Overview
Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
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List item
Viekirax : EPAR - Medicine overview (PDF/78.63 KB)
First published: 09/03/2015
Last updated: 21/09/2018
EMA/733678/2014 -
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List item
Viekirax : EPAR - Risk-management-plan summary (PDF/69.47 KB)
First published: 09/03/2015
Last updated: 09/03/2015
EMA/775985/2014
Authorisation details
Product details | |
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Name |
Viekirax
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Agency product number |
EMEA/H/C/003839
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Hepatitis C, Chronic
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Anatomical therapeutic chemical (ATC) code |
J05AP53
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Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
AbbVie Deutschland GmbH Co. KG
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Revision |
21
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Date of issue of marketing authorisation valid throughout the European Union |
14/01/2015
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Contact address |
Product information
23/09/2020 Viekirax - EMEA/H/C/003839 - IG/1291
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
For hepatitis C virus (HCV) genotype specific activity.