Ivabradine JensonR

Withdrawn

This medicine's authorisation has been withdrawn

ivabradine

Overview

On 6 December 2018, the European Commission withdrew the marketing authorisation for Ivabradine JensonR (ivabradine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, JensonR+ Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Ivabradine JensonR was granted marketing authorisation in the EU on 11 November 2016 for the treatment of angina pectoris and chronic heart failure. The marketing authorisation was initially valid for 5 years. The product had not been marketed in the EU since the marketing authorisation was granted.

Ivabradine JensonR is a generic medicine of ivabradine. Other generic medicinal products of ivabradine are authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Ivabradine JensonR is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Ivabradine JensonR : EPAR - Summary for the public

Reference Number: EMA/624480/2016

Product information

Ivabradine JensonR : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  06/12/2018

Assessment history

Initial marketing authorisation documents

Ivabradine JensonR : EPAR - Public assessment report

Adopted Reference Number: EMA/648588/2016

CHMP summary of positive opinion for Ivabradine JensonR

Adopted Reference Number: EMA/CHMP/605096/2016