- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Ivabradine JensonR (ivabradine) has been withdrawn at the request of the marketing authorisation holder.
Product information
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).
Product details
- Name of medicine
- Ivabradine JensonR
- 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
Pharmacotherapeutic group
Cardiac therapyTherapeutic indication
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.