Iscover
clopidogrel
Table of contents
Overview
Iscover is a medicine used to prevent problems caused by blood clots in adults who have:
- recently had a myocardial infarction (heart attack). Iscover can be started between a few days and 35 days after the attack;
- recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Iscover can be started between seven days and six months after the stroke;
- peripheral arterial disease (problems with blood flow in the arteries);
- a condition known as ‘acute coronary syndrome’, when it should be given with acetylsalicylic acid (also known as aspirin). Acute coronary syndrome is a group of heart problems that includes heart attacks and unstable angina (a severe type of chest pain).
Some of these patients may be undergoing percutaneous coronary intervention (a procedure that unblocks blood vessels of the heart to restore its blood supply) and may have had a stent inserted (a short tube in an artery to prevent it closing up). Others may benefit from thrombolytic or fibrinolytic treatment (treatments to dissolve blood clots). - atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with acetylsalicylic acid. It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Iscover contains the active substance clopidogrel.
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List item
Iscover : EPAR - Medicine Overview (PDF/116.8 KB)
First published: 09/11/2009
Last updated: 16/02/2023
EMA/902533/2022 -
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List item
Iscover : EPAR - Risk-management-plan summary (PDF/189.02 KB)
First published: 12/02/2021
Last updated: 16/02/2023
Authorisation details
Product details | |
---|---|
Name |
Iscover
|
Agency product number |
EMEA/H/C/000175
|
Active substance |
clopidogrel
|
International non-proprietary name (INN) or common name |
clopidogrel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B01AC04
|
Publication details | |
---|---|
Marketing-authorisation holder |
Sanofi Winthrop Industrie
|
Revision |
49
|
Date of issue of marketing authorisation valid throughout the European Union |
14/07/1998
|
Contact address |
82 Avenue Raspail |
Product information
16/12/2022 Iscover - EMEA/H/C/000175 - WS2150
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antithrombotic agents
Therapeutic indication
Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.
In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:
- Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.