Entresto
sacubitril / valsartan
Table of contents
Overview
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.
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List item
Entresto : EPAR - Summary for the public (PDF/96.43 KB)
First published: 01/12/2015
Last updated: 22/06/2023
EMA/275352/2023 -
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List item
Entresto : EPAR - Risk-management-plan summary (PDF/86.91 KB)
First published: 01/12/2015
Last updated: 07/09/2023
Authorisation details
Product details | |
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Name |
Entresto
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Agency product number |
EMEA/H/C/004062
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Heart Failure
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Anatomical therapeutic chemical (ATC) code |
C09DX04
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
18
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
Vista Building |
Product information
11/09/2023 Entresto - EMEA/H/C/004062 - IG1654/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Angiotensin II antagonists, other combinations
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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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 202331/03/2023
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01/04/2016
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25/09/2015
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25/09/2015