Epclusa

RSS

sofosbuvir / velpatasvir

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

Overview

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

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

This EPAR was last updated on 30/07/2018

Authorisation details

Product details
Name
Epclusa
Agency product number
EMEA/H/C/004210
Active substance
  • Sofosbuvir
  • velpatasvir
International non-proprietary name (INN) or common name
sofosbuvir / velpatasvir
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
Gilead Sciences Ireland UC
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
06/07/2016
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

14/06/2018 Epclusa - EMEA/H/C/004210 - WS/1391

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

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Assessment history

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