Incivo

Expired

This medicine's authorisation has expired

telaprevir

Overview

The marketing authorisation for Incivo (telaprevir) expired on 22 September 2016 following the decision of the marketing authorisation holder, Janssen-Cilag International N.V., not to apply for a renewal of the marketing authorisation. 

Janssen-Cilag International N.V. confirmed that it did not apply for renewal of the authorisation due to the fast reduction in the use of telaprevir after the introduction and approval of newer protease inhibitors and of interferon-free treatment combinations. This decision is not driven by any safety, efficacy or quality issue. 

Incivo was granted marketing authorisation in the European Union (EU) on 19 September 2011 for treatment of genotype 1 chronic hepatitis C. The marketing authorisation was valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Incivo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Incivo : EPAR - Summary for the public

Reference Number: EMA/644234/2011

Product information

Incivo : EPAR - Product Information

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
• Expiry of marketing authorisation:
  22/09/2016
• 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

Adopted Reference 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

Adopted Reference Number: EMA/CHMP/554705/2011