sacubitril / valsartan

This medicine is authorised for use in the European Union.


Neparvis 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.

Neparvis contains the active substances sacubitril and valsartan.

This medicine is the same as Entresto, which is already authorised in the EU. The company that makes Neparvis has agreed that its scientific data can be used for Neparvis (‘informed consent’).

This EPAR was last updated on 13/09/2023

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
Additional monitoringAdditional 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
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 Neparvis - EMEA/H/C/004343 - 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

Agents acting on the renin-angiotensin system

Therapeutic indication

Paediatric heart failure

Neparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1).

Adult heart failure

Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).

Assessment history

Changes since initial authorisation of medicine

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