Ivabradine Accord

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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 Accord. 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 Accord.

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

This EPAR was last updated on 08/05/2018

Authorisation details

Product details
Name
Ivabradine Accord
Agency product number
EMEA/H/C/004241
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 medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/05/2017
Contact address
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

23/03/2018 Ivabradine Accord - EMEA/H/C/004241 - IB/0001

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

CARDIAC THERAPY

Therapeutic indication

Symptomatic treatment of chronic stable angina pectoris

Ivabradine is indicated for the 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. (see section 5.1)

Assessment history

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