Entresto
sacubitril / valsartan
Table of contents
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.
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List item
Entresto : EPAR - Summary for the public (PDF/76.78 KB)
First published: 01/12/2015
Last updated: 01/12/2015
EMA/782147/2015 -
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List item
Entresto : EPAR - Risk-management-plan summary (PDF/82.28 KB)
First published: 01/12/2015
Last updated: 11/06/2021
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 |
15
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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
02/09/2022 Entresto - EMEA/H/C/004062 - IG1544
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
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