Exviera

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dasabuvir

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

Overview

This is a summary of the European public assessment report (EPAR) for Exviera. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Exviera.

For practical information about using Exviera, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Exviera
Agency product number
EMEA/H/C/003837
Active substance
dasabuvir sodium
International non-proprietary name (INN) or common name
dasabuvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AP09
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 Ltd
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire SL6 4UB
United Kingdom

Product information

03/10/2018 Exviera - EMEA/H/C/003837 - 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

Exviera 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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