Incivo

Withdrawn

This medicine's authorisation has been withdrawn

telaprevir

Overview

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

Incivo : EPAR - Summary for the public

Reference Number: EMA/644234/2011

Product information

Incivo : EPAR - Product Information

Latest procedure affecting product information: II/0035

25/06/2015

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Incivo : EPAR - All Authorised presentations

Incivo : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Incivo
• Active substance:
  telaprevir
• International non-proprietary name (INN) or common name:
  telaprevir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AE

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002313
• Marketing authorisation holder:
  Janssen-Cilag International N.V.

  Turnhoutseweg 30; BE-2340 Beerse; Belgium

• Marketing authorisation issued:
  19/09/2011
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Incivo : EPAR - Procedural steps taken and scientific information after authorisation

Incivo-H-C-2313-P46-023 : EPAR - Assessment Report

AdoptedReference Number: EMA/807529/2015

Incivo-H-C-2313-PSUV-0028 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/648366/2014

Incivo-H-C-2313-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/329265/2014

Incivo-H-C-2313-PSUV-0021 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/14619/2014

Initial marketing authorisation documents

Incivo : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Incivo

AdoptedReference Number: EMA/CHMP/554705/2011