Victrelis

RSS

boceprevir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 31/07/2018

Authorisation details

Product details
Name
Victrelis
Agency product number
EMEA/H/C/002332
Active substance
Boceprevir
International non-proprietary name (INN) or common name
boceprevir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AE
Publication details
Marketing-authorisation holder
Merck Sharp Dohme Ltd
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
17/07/2011
Contact address
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

28/06/2017 Victrelis - EMEA/H/C/002332 - II/0042

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

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