Viekirax

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ombitasvir / paritaprevir / ritonavir

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 29/01/2019

Authorisation details

Product details
Name
Viekirax
Agency product number
EMEA/H/C/003839
Active substance
  • Ombitasvir
  • paritaprevir
  • ritonavir
International non-proprietary name (INN) or common name
ombitasvir / paritaprevir / ritonavir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AP53
Accelerated assessmentAccelerated 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 monitoringAdditional 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
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

13/12/2018 Viekirax - EMEA/H/C/003839 - WS/1473

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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