Victrelis
boceprevir
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.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 |
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
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
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.