Ivabradine Accord

ivabradine

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This is a summary of the European public assessment report (EPAR) for Ivabradine Accord. 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 Accord.

For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.

What is Ivabradine Accord and what is it used for?

Ivabradine Accord is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle). The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute. It is used either in patients who cannot take beta‑blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by beta-blockers alone.

Ivabradine Accord is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute. It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.

Ivabradine Accord contains the active substance ivabradine. It is a ‘generic medicine’. This means that Ivabradine Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Procoralan.

How is Ivabradine Accord used?

Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription. The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient’s heart rate and symptoms. In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used. Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue. When used for angina, treatment should be stopped if symptoms do not improve after 3 months. Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.

How does Ivabradine Accord work?

The symptoms of angina are caused by the heart muscle not receiving enough oxygenated blood. In stable angina, these symptoms occur during physical effort. The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current’ in the sinus node, the natural ‘pacemaker’ that regulates the heart rate. When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood. Ivabradine Accord therefore reduces or prevents the symptoms of angina.

The symptoms of heart failure are caused by the heart not pumping enough blood around the body. By lowering the heart rate, Ivabradine Accord reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.

How has Ivabradine Accord been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Procoralan, and do not need to be repeated for Ivabradine Accord.

As for every medicine, the company provided studies on the quality of Ivabradine Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Ivabradine Accord?

Because Ivabradine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Ivabradine Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Accord has been shown to have comparable quality and to be bioequivalent to Procoralan. Therefore, the CHMP’s view was that, as for Procoralan, the benefit outweighs the identified risk. The Committee recommended that Ivabradine Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Ivabradine Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Accord have been included in the summary of product characteristics and the package leaflet.

Other information about Ivabradine Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Ivabradine Accord on 22 May 2017.

For more information about treatment with Ivabradine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ivabradine Accord : EPAR - Summary for the public BG = bălgarski 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public ES = español 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public CS = čeština 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public DA = dansk 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public DE = Deutsch 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public ET = eesti keel 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public EL = elliniká 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public EN = English 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public FR = français 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public IT = italiano 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public LV = latviešu valoda 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public LT = lietuvių kalba 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public HU = magyar 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public MT = Malti 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public NL = Nederlands 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public PL = polski 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public PT = português 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public RO = română 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public SK = slovenčina 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public SL = slovenščina 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public FI = suomi 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public SV = svenska 2017-06-01  
Ivabradine Accord : EPAR - Summary for the public HR = Hrvatski 2017-06-01  

This EPAR was last updated on 01/06/2017 .

Authorisation details

Product details

Product details for Ivabradine Accord
NameIvabradine Accord
Agency product numberEMEA/H/C/004241
Active substance

ivabradine hydrochloride

International non-proprietary name (INN) or common name

ivabradine

Therapeutic area Heart FailureAngina Pectoris
Anatomical therapeutic chemical (ATC) code C01EB17
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Ivabradine Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/05/2017

Contact address:

Accord Healthcare Ltd
Sage House
319 Pinner Road North
Harrow Middlesex
HA1 4HF
United Kingdom

Product information

Product information

22/05/2017  Ivabradine Accord -EMEA/H/C/004241 --

Name Language First published Last updated
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - Product Information HR = Hrvatski 2017-06-01  

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  
Ivabradine Accord : EPAR - All Authorised presentations HR = Hrvatski 2017-06-01  

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. (see section 5.1)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Ivabradine Accord : EPAR - Public assessment report HR = Hrvatski 2017-06-07  
CHMP summary of positive opinion for Ivabradine Accord HR = Hrvatski 2017-03-24  

Authorised

This medicine is approved for use in the European Union

More information on Ivabradine Accord