Incivo

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telaprevir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Incivo has expired following the marketing-authorisation holder's decision not to apply for a renewal.

This EPAR was last updated on 06/10/2016

Authorisation details

Product details
Name
Incivo
Agency product number
EMEA/H/C/002313
Active substance
telaprevir
International non-proprietary name (INN) or common name
telaprevir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AE
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
Janssen-Cilag International N.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
19/09/2011
Contact address
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

25/06/2015 Incivo - EMEA/H/C/002313 - II/0035

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

Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):

  • who are treatment naïve;
  • who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Assessment history

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