Neparvis

RSS

sacubitril / valsartan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 21/05/2019

Authorisation details

Product details
Name
Neparvis
Agency product number
EMEA/H/C/004343
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
Additional monitoringAdditional 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
Marketing-authorisation holder
Novartis Europharm Limited
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/05/2016
Contact address

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

11/04/2019 Neparvis - EMEA/H/C/004343 - A31/0020

Contents

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

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.

Assessment history

Changes since initial authorisation of medicine

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