Entresto

sacubitril / valsartan

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

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.

: Entresto is a heart medicine that contains the active substances sacubitril and valsartan. It is used in adults with long-term heart failure who have symptoms of the disease. Heart failure is the inability of the heart to pump enough blood around the body.

: Entresto is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan). Entresto can only be obtained with a prescription.
Entresto tablets are taken twice a day. The recommended starting dose is one tablet of Entresto 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day. The doctor may choose lower doses for certain patients. For further information, see the summary of product characteristic (also part of the EPAR).

: The two active substances in Entresto, sacubitril and valsartan, work in different ways. Sacubitril blocks the breakdown of natriuretic peptides produced in the body. Natriuretic peptides cause sodium and water to pass into the urine thereby reducing the strain on the heart. Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissues) that occurs in heart failure.
Valsartan is an ‘angiotensin-II-receptor antagonist’, which means that it blocks the action of a hormone called angiotensin II. The effects of angiotensin II can be harmful in patients with heart failure. By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone’s harmful effects on the heart and it also reduces blood pressure by allowing blood vessels to widen.

: In the main study, Entresto was compared to enalapril, another medicine used for heart failure. Patients in the study had long-term heart failure with symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart). In the group treated with Entresto, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril. In general, patients were monitored for about 27 months, during which they took the medicine for about 24 months on average. The study was stopped early because there was compelling evidence that Entresto was more effective than enalapril.

: The most common side effects with Entresto (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well. A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people). For the full list of all side effects reported with Entresto, see the package leaflet.
Entresto must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure). It must not be taken by patients who have suffered angioedema, those who have severe liver disease or by women who are pregnant. For the full list of restrictions see the package leaflet.

: The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Entresto’s benefits are greater than its risks and recommended that it be approved for use in the EU. The main study found that Entresto reduced deaths from heart and circulation problems or hospital admissions for heart failure.
Entresto’s serious side effects in the main study were similar to those of enalapril, which is already authorised for use in heart failure. Valsartan, one of the active substances in the medicine, is well established for the treatment of high blood pressure and heart failure; its side effects are well known.

: A risk management plan has been developed to ensure that Entresto is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entresto, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the summary of the risk management plan .

: The European Commission granted a marketing authorisation valid throughout the European Union for Entresto on 19 November 2015.
For more information about treatment with Entresto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Entresto : EPAR - Summary for the public (PDF/76.78 KB)

First published: 01/12/2015
Last updated: 01/12/2015
EMA/782147/2015
- Bulgarian
  (PDF/103.74 KB)
- Croatian
  (PDF/96.99 KB)
- Czech
  (PDF/101.61 KB)
- Danish
  (PDF/74.95 KB)
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  (PDF/75.77 KB)
- Estonian
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- Finnish
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- French
  (PDF/76.61 KB)
- German
  (PDF/77.27 KB)
- Greek
  (PDF/106.88 KB)
- Hungarian
  (PDF/94.17 KB)
- Italian
  (PDF/97.21 KB)
- Latvian
  (PDF/99.62 KB)
- Lithuanian
  (PDF/99.35 KB)
- Maltese
  (PDF/102.13 KB)
- Polish
  (PDF/102.73 KB)
- Portuguese
  (PDF/76.46 KB)
- Romanian
  (PDF/97.72 KB)
- Slovak
  (PDF/101.27 KB)
- Slovenian
  (PDF/95.8 KB)
- Spanish
  (PDF/75.5 KB)
- Swedish
  (PDF/75.7 KB)
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Entresto : EPAR - Risk-management-plan summary (PDF/82.28 KB)

First published: 01/12/2015
Last updated: 11/06/2021

This EPAR was last updated on 02/09/2022

Authorisation details

Product details
Name	Entresto
Agency product number	EMEA/H/C/004062
Active substance	sacubitril valsartan
International non-proprietary name (INN) or common name	sacubitril valsartan
Therapeutic area (MeSH)	Heart Failure
Anatomical therapeutic chemical (ATC) code	C09DX04

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	15
Date of issue of marketing authorisation valid throughout the European Union	19/11/2015
Contact address	Vista Building Elm Park Merrion Road Dublin 4 Ireland

Product information

02/09/2022 Entresto - EMEA/H/C/004062 - IG1544

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Entresto : EPAR - Product Information (PDF/420.43 KB)

First published: 01/12/2015
Last updated: 02/09/2022
- Bulgarian
  (PDF/590.13 KB)
- Croatian
  (PDF/497.57 KB)
- Czech
  (PDF/595.09 KB)
- Danish
  (PDF/408.34 KB)
- Dutch
  (PDF/468.88 KB)
- Estonian
  (PDF/487.99 KB)
- Finnish
  (PDF/411.25 KB)
- French
  (PDF/541.01 KB)
- German
  (PDF/437.46 KB)
- Greek
  (PDF/647.08 KB)
- Hungarian
  (PDF/568.53 KB)
- Icelandic
  (PDF/401.46 KB)
- Italian
  (PDF/465.61 KB)
- Latvian
  (PDF/561.99 KB)
- Lithuanian
  (PDF/589.6 KB)
- Maltese
  (PDF/607.05 KB)
- Norwegian
  (PDF/411.48 KB)
- Polish
  (PDF/592.08 KB)
- Portuguese
  (PDF/422.17 KB)
- Romanian
  (PDF/590.17 KB)
- Slovak
  (PDF/594.67 KB)
- Slovenian
  (PDF/562.24 KB)
- Spanish
  (PDF/421.11 KB)
- Swedish
  (PDF/423.04 KB)

Other EU languages available icon 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.

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Entresto : EPAR - All Authorised presentations (PDF/97.24 KB)

First published: 01/12/2015
Last updated: 11/12/2019
- Bulgarian
  (PDF/99.17 KB)
- Croatian
  (PDF/101.17 KB)
- Czech
  (PDF/98.99 KB)
- Danish
  (PDF/99.65 KB)
- Dutch
  (PDF/98.12 KB)
- Estonian
  (PDF/99.31 KB)
- Finnish
  (PDF/98.48 KB)
- French
  (PDF/97 KB)
- German
  (PDF/100.59 KB)
- Greek
  (PDF/105.75 KB)
- Hungarian
  (PDF/104.08 KB)
- Icelandic
  (PDF/99.37 KB)
- Italian
  (PDF/99.09 KB)
- Latvian
  (PDF/103.11 KB)
- Lithuanian
  (PDF/105.9 KB)
- Maltese
  (PDF/102.34 KB)
- Norwegian
  (PDF/96.42 KB)
- Polish
  (PDF/99.63 KB)
- Portuguese
  (PDF/99.08 KB)
- Romanian
  (PDF/101.15 KB)
- Slovak
  (PDF/102.54 KB)
- Slovenian
  (PDF/102.52 KB)
- Spanish
  (PDF/99.9 KB)
- Swedish
  (PDF/96.62 KB)

Pharmacotherapeutic group

Angiotensin II antagonists, other combinations
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

Changes since initial authorisation of medicine

List item

Entresto : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1.9 MB)

First published: 17/03/2016
Last updated: 02/09/2022
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Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Adopted

First published: 05/07/2021
- Bulgarian
  (PDF/145.18 KB)
- Croatian
  (PDF/142.87 KB)
- Czech
  (PDF/139.02 KB)
- Danish
  (PDF/126.81 KB)
- Dutch
  (PDF/127.53 KB)
- Estonian
  (PDF/123.85 KB)
- Finnish
  (PDF/125.84 KB)
- French
  (PDF/127.12 KB)
- German
  (PDF/131.05 KB)
- Greek
  (PDF/139.5 KB)
- Hungarian
  (PDF/137.17 KB)
- Italian
  (PDF/126.56 KB)
- Latvian
  (PDF/147.7 KB)
- Lithuanian
  (PDF/148.34 KB)
- Maltese
  (PDF/151.21 KB)
- Polish
  (PDF/137.7 KB)
- Portuguese
  (PDF/128.87 KB)
- Romanian
  (PDF/143.59 KB)
- Slovak
  (PDF/135.07 KB)
- Slovenian
  (PDF/149.74 KB)
- Spanish
  (PDF/125.85 KB)
- Swedish
  (PDF/126.99 KB)
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Entresto : EPAR - EMEA/H/C/PSUSA/00010438/202007 - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (s) (PDF/119.1 KB)

First published: 11/06/2021
Last updated: 11/06/2021
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Adopted

First published: 02/03/2021
EMA/47245/2021
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Entresto : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

First published: 27/05/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
  (PDF/96.12 KB)
- Dutch
  (PDF/99.3 KB)
- Estonian
  (PDF/94.4 KB)
- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
  (PDF/100.2 KB)
- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
  (PDF/130.84 KB)
- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
  (PDF/128.25 KB)
- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
List item

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019

Entresto

Table of contents

Overview

Entresto : EPAR - Summary for the public (PDF/76.78 KB)

Entresto : EPAR - Risk-management-plan summary (PDF/82.28 KB)

Authorisation details

Product information

Entresto : EPAR - Product Information (PDF/420.43 KB)

Entresto : EPAR - All Authorised presentations (PDF/97.24 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Entresto : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1.9 MB)

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Entresto : EPAR - EMEA/H/C/PSUSA/00010438/202007 - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (s) (PDF/119.1 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Entresto : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Initial marketing-authorisation documents

Entresto : EPAR - Public assessment report (PDF/1.5 MB)

CHMP summary of positive opinion Entresto (PDF/67.84 KB)

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