elbasvir / grazoprevir

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 21/11/2022

Authorisation details

Product details
Agency product number
Active substance
  • elbasvir
  • grazoprevir
International non-proprietary name (INN) or common name
  • elbasvir
  • grazoprevir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

21/11/2022 Zepatier - EMEA/H/C/004126 - IAIN/0038

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Product information documents contain:

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

  • Direct acting antivirals

  • Antivirals for systemic use

  • Antivirals for treatment of HCV infections

Therapeutic indication

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.

Assessment history

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