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Withdrawn
This medicine is now withdrawn from use in the European Union.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

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

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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