Ivabradine Zentiva

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ivabradine

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

Overview

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.

This EPAR was last updated on 13/07/2023

Authorisation details

Product details
Name
Ivabradine Zentiva
Agency product number
EMEA/H/C/004117
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Zentiva, k.s.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
11/11/2016
Contact address
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

13/07/2022 Ivabradine Zentiva - EMEA/H/C/004117 - 004117/IB/0015

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Cardiac therapy

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.

Assessment history

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