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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
C01EB17
ATC Item
ivabradine
Pharmacotherapeutic Group
Cardiac therapy
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ivabradine hydrochloride | N/A | Ivabradine Hydrochloride |
EMA Name
Ivabradine Zentiva
Medicine Name
Ivabradine Zentiva
Aliases
N/ANo risk management plan link.
