Zepatier

RSS

elbasvir / grazoprevir

Authorised
This medicine is authorised for use in the European Union.

Overview

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 20/06/2018

Authorisation details

Product details
Name
Zepatier
Agency product number
EMEA/H/C/004126
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
J05A
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
21/07/2016
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

15/06/2018 Zepatier - EMEA/H/C/004126 - T/0015

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Treatment of chronic hepatitis C (CHC) in adults.

For hepatitis C virus genotype-specific activity.

Assessment history

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