Victrelis
boceprevir
Table of contents
Overview
The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.
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 |
18/07/2011
|
| Contact address |
Hertford Road
Hoddesdon Hertfordshire EN11 9BU United Kingdom |
Product information
29/06/2017 Victrelis - EMEA/H/C/002332 - II/0042
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.