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EMA Product

Ivabradine Accord

Product approved by European Medicines Agency (EU)

Basic Information

Ivabradine Accord

Regulatory Information

EMEA/H/C/004241

Authorised

May 22, 2017

March 23, 2017

7

September 6, 2024

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

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. (see section 5.1)

Overview Summary

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.

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