Maviret

RSS

glecaprevir / pibrentasvir

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

Overview

This is a summary of the European public assessment report (EPAR) for Maviret. 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 Maviret.

For practical information about using Maviret, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/07/2018

Authorisation details

Product details
Name
Maviret
Agency product number
EMEA/H/C/004430
Active substance
  • glecaprevir
  • pibrentasvir
International non-proprietary name (INN) or common name
glecaprevir / pibrentasvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AX
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
AbbVie Deutschland GmbH Co. KG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
26/07/2017
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

15/06/2018 Maviret - EMEA/H/C/004430 - T/0011

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

Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults

Assessment history

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