Ivabradine Zentiva
ivabradine
Table of contents
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.
Authorisation details
Product details | |
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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) |
|
Anatomical therapeutic chemical (ATC) code |
C01EB17
|
Generic |
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 | |
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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
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.