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 |
25
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Date of issue of marketing authorisation valid throughout the European Union |
14/01/2015
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Contact address |
Knollstrasse |
Product information
02/12/2021 Viekirax - EMEA/H/C/003839 - WS2158
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.