Ivabradine JensonR

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ivabradine

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

Overview

This is a summary of the European public assessment report (EPAR) for Ivabradine JensonR. 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 Ivabradine JensonR.

For practical information about using Ivabradine JensonR, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/02/2017

Authorisation details

Product details
Name
Ivabradine JensonR
Agency product number
EMEA/H/C/004217
Active substance
ivabradine hydrochloride
International non-proprietary name (INN) or common name
ivabradine
Therapeutic area (MeSH)
  • Angina Pectoris
  • Heart Failure
Anatomical therapeutic chemical (ATC) code
C01EB17
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
JensonR+ Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
10/11/2016
Contact address
Fishleigh Court
Fishleigh Road
Barnstaple EX31 3UD
United Kingdom

Product information

11/11/2016 Ivabradine JensonR - EMEA/H/C/004217 - -

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic indication

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Assessment history

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