Victrelis

Withdrawn

This medicine's authorisation has been withdrawn

boceprevir

Overview

The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.

Victrelis : EPAR - Summary for the public

Product information

Victrelis: EPAR - Product Information

Latest procedure affecting product information: II/0042

29/06/2017

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).

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
• 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

AdoptedReference 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

AdoptedReference 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

AdoptedReference 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

AdoptedReference Number: EMA/CHMP/354114/2011