Ivabradine JensonR
ivabradine
Table of contents
Overview
The marketing authorisation for Ivabradine JensonR (ivabradine) has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Ivabradine JensonR
|
| Agency product number |
EMEA/H/C/004217
|
| 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 | |
|---|---|
| Marketing-authorisation holder |
JensonR+ Limited
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
11/11/2016
|
| Contact address | |
Product information
11/11/2016 Ivabradine JensonR - EMEA/H/C/004217 - -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Therapeutic 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.