Ivabradine Accord
·
- Prescription status not stated
- Heart, blood pressure and circulation
- Active substance
- Ivabradine
- Made by
- Accord Healthcare S.L.U.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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)
EMA’s data export replaced some characters it could not represent (for example “≥”) with “?”. The text is shown exactly as exported; the wording on the EMA page is authoritative.
From the official label · 2026-09-30 · European Medicines Agency
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (ivabradine). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Ivabradine blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker I f current, which regulates heart rate.
In clinical electrophysiology studies, the cardiac effects were most pronounced in the sinoatrial (SA) node, but prolongation of the AH interval has occurred as has PR interval prolongation.
Ivabradine is extensively metabolized in the liver and intestines by CYP3A4-mediated oxidation.
The total clearance of ivabradine is 24 L/h, and renal clearance is approximately 4.2 L/h, with ~ 4% of an oral dose excreted unchanged in urine.
Food delays absorption by approximately 1 hour and increases plasma exposure by 20% to 40%.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-24
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Accord Healthcare S.L.U. |
|---|---|
| Active substance | Ivabradine |
| Used in | Heart, blood pressure and circulation |
| Classification | C01EB17 · Heart, blood pressure and circulation |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2017-05-22 |
| Last updated by the regulator | 2024-09-06 |
| EMA product number | EMEA/H/C/004241 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.