sacubitril / valsartan

This medicine is authorised for use in the European Union.


Entresto is a heart medicine used in adults with chronic (long-term) heart failure who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). The medicine is also used in adolescents and children from 1 year of age with chronic heart failure who have symptoms of the disease and left ventricular systolic dysfunction (a problem affecting the left side of the heart).

Heart failure is the inability of the heart to pump enough blood around the body.

Entresto contains the active substances sacubitril and valsartan.

This EPAR was last updated on 12/09/2023

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

11/09/2023 Entresto - EMEA/H/C/004062 - IG1654/G

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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

Paediatric heart failure
Entresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.

Adult heart failure
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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