This is a summary of the European public assessment report (EPAR) for Ivabradine Zentiva. 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 Zentiva.
For practical information about using Ivabradine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Ivabradine Zentiva : EPAR - Summary for the public (PDF/94.12 KB)
First published: 08/02/2017
Last updated: 08/02/2017
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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.
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U kabelovny 130
102 37 Prague 10
06/02/2020 Ivabradine Zentiva - EMEA/H/C/004117 - IB/0006/G
- 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.
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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
- 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.