elbasvir / grazoprevir
This is a summary of the European public assessment report (EPAR) for Zepatier. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zepatier.
For practical information about using Zepatier, patients should read the package leaflet or contact their doctor or pharmacist.
Zepatier : EPAR - Summary for the public (PDF/119.14 KB)
First published: 28/07/2016
Last updated: 09/02/2022
Zepatier : EPAR - Risk management plan summary (PDF/138.54 KB)
First published: 09/02/2022
|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 B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
21/11/2022 Zepatier - EMEA/H/C/004126 - IAIN/0038
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).
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.
Direct acting antivirals
Antivirals for systemic use
Antivirals for treatment of HCV infections
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.