Procoralan

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ivabradine

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

Overview

An overview of Procoralan and why it is authorised in the EU

Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute. It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.

Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute. It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.

Procoralan contains the active substance ivabradine.

This EPAR was last updated on 04/05/2018

Authorisation details

Product details
Name
Procoralan
Agency product number
EMEA/H/C/000597
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
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
Marketing-authorisation holder
Les Laboratoires Servier
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
24/10/2005
Contact address
50, rue Carnot
F-92284 Suresnes Cedex
France

Product information

10/01/2018 Procoralan - EMEA/H/C/000597 - WS/1180

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

Treatment of coronary-artery disease

Symptomatic treatment of chronic stable angina pectoris in coronary-artery-disease patients with normal sinus rhythm. Ivabradine is indicated:

- in patients 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 and whose heart rate is > 60 beats per minute (bpm).

Treatment of chronic heart failure

Ivabradine is indicated in chronic heart failure New York Heart Association 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

Changes since initial authorisation of medicine

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