Viekirax

RSS

ombitasvir / paritaprevir / ritonavir

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

Overview

An overview of Viekirax and why it is authorised in the EU

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 21/09/2018

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
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
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

31/08/2018 Viekirax - EMEA/H/C/003839 - WS/1348

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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