Neparvis
sacubitril / valsartan
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Neparvis. 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 Neparvis.
For practical information about using Neparvis, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Neparvis : EPAR - Summary for the public (PDF/76.18 KB)
First published: 13/06/2016
Last updated: 13/06/2016
EMA/262203/2016 -
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List item
Neparvis : EPAR - Risk-management-plan summary (PDF/90.63 KB)
First published: 07/12/2020
Authorisation details
Product details | |
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Name |
Neparvis
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Agency product number |
EMEA/H/C/004343
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Heart Failure
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Anatomical therapeutic chemical (ATC) code |
C09DX04
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Additional 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 | |
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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 |
26/05/2016
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Contact address |
Vista Building |
Product information
02/09/2022 Neparvis - EMEA/H/C/004343 - 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
Agents acting on the renin-angiotensin system
Therapeutic indication
Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.