sacubitril / valsartan

This medicine is authorised for use in the European Union.


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 02/09/2022

Authorisation details

Product details
Agency product number
Active substance
  • sacubitril
  • valsartan
International non-proprietary name (INN) or common name
  • sacubitril
  • valsartan
Therapeutic area (MeSH)
Heart Failure
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4

Product information

02/09/2022 Entresto - EMEA/H/C/004062 - IG1544

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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

  • Angiotensin II antagonists, other combinations
  • Agents acting on the renin-angiotensin system

Therapeutic indication

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

Assessment history

Changes since initial authorisation of medicine

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