Ivabradine JensonR

Withdrawn

This medicine's authorisation has been withdrawn

ivabradine

Overview

The marketing authorisation for Ivabradine JensonR (ivabradine) has been withdrawn at the request of the marketing authorisation holder. 

Ivabradine JensonR : EPAR - Summary for the public

Reference Number: EMA/624480/2016

Product information

Ivabradine JensonR : EPAR - Product Information

Latest procedure affecting product information: -

11/11/2016

This medicine’s product information is available in all official EU languages.
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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).

Ivabradine JensonR : EPAR - All Authorised presentations

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 therapy

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004217
• 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.

• Marketing authorisation holder:
  JensonR+ Limited

  Fishleigh Court ; Fishleigh Road ; Barnstaple EX31 3UD; United Kingdom

• Opinion adopted:
  15/06/2016
• Marketing authorisation issued:
  11/11/2016

Assessment history

Initial marketing authorisation documents

Ivabradine JensonR : EPAR - Public assessment report

AdoptedReference Number: EMA/648588/2016

CHMP summary of positive opinion for Ivabradine JensonR

AdoptedReference Number: EMA/CHMP/605096/2016