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.
Procoralan : EPAR - Summary for the public (PDF/78.96 KB)
First published: 18/07/2006
Last updated: 04/05/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Les Laboratoires Servier
|Date of issue of marketing authorisation valid throughout the European Union||
10/01/2018 Procoralan - EMEA/H/C/000597 - WS/1180
- 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 201421/11/2014
European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)21/11/2014
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 201116/12/2011