Victrelis

Withdrawn

This medicine's authorisation has been withdrawn

boceprevir

Overview

On 29 June 2018, the European Commission withdrew the marketing authorisation for Victrelis (boceprevir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Victrelis was granted marketing authorisation in the EU on 18 July 2011 for treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016.

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Assessment Report (EPAR) for Victrelis is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Victrelis : EPAR - Summary for the public

Product information

Victrelis: EPAR - Product Information

Victrelis : EPAR - All Authorised presentations

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

Product details

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

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Authorisation details

• EMA product number:
  EMEA/H/C/002332
• Marketing authorisation holder:
  Merck Sharp Dohme Ltd

  Hertford Road; Hoddesdon; Hertfordshire; EN11 9BU; United Kingdom

• Marketing authorisation issued:
  18/07/2011
• Withdrawal of marketing authorisation:
  29/06/2018
• Revision:
  22

Assessment history

Changes since initial authorisation of medicine

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

Victrelis-H-C-2332-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/768663/2014

Victrelis-H-C-2332-P46-0035 : EPAR - Assessment Report

Adopted Reference Number: EMA/594074/2014

Victrelis-H-C-2332-PSUV-0028 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Victrelis-H-C-2332-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/CHMP/99097/2014

Victrelis-H-C-2332-PSU-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/CHMP/547111/2013

Victrelis-H-C-2332-II-0005: EPAR - Assessment Report - Variation

Adopted

Initial marketing authorisation documents

Victrelis: EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Victrelis

Adopted Reference Number: EMA/CHMP/354114/2011