The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.
Victrelis : EPAR - Summary for the public (PDF/513.73 KB)
First published: 03/08/2011
Last updated: 31/07/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis C, Chronic
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp Dohme Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
29/06/2017 Victrelis - EMEA/H/C/002332 - II/0042
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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).
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Antivirals for systemic use
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.