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/90.32 KB)
First published: 01/12/2015
Last updated: 07/12/2020
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 |
12
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
Product information
12/11/2020 Entresto - EMEA/H/C/004062 - WS/1830
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.