Entresto

RSS

sacubitril / valsartan

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

Overview

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

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

This EPAR was last updated on 16/08/2018

Authorisation details

Product details
Name
Entresto
Agency product number
EMEA/H/C/004062
Active substance
  • sacubitril
  • valsartan
International non-proprietary name (INN) or common name
sacubitril / valsartan
Therapeutic area (MeSH)
Heart Failure
Anatomical therapeutic chemical (ATC) code
C09DX04
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
Novartis Europharm Limited
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

22/06/2018 Entresto - EMEA/H/C/004062 - IG/0948

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

  • Angiotensin II antagonists
  • other combinations

Therapeutic indication

Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Assessment history

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