Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel
Table of contents
Overview
Clopidogrel Viatris is a medicine used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in adults who have:
- recently had a myocardial infarction (heart attack). Clopidogrel Viatris can be started between a few days and 35 days after the attack;
- recently had an ischaemic stroke (stroke caused by insufficient blood supply to part of the brain). Clopidogrel Viatris 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 is given with aspirin (another medicine that prevents blood clots). Acute coronary syndrome is a group of heart problems that include heart attack and unstable angina (a severe type of chest pain). Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up.
Clopidogrel Viatris is also used to prevent problems caused by blood clots in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it is given with aspirin. 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.
Clopidogrel Viatris contains the active substance clopidogrel and is a ‘generic medicine’. This means that Clopidogrel Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Plavix. For more information on generic medicines, see the question-and-answer document here.
Authorisation details
| Product details | |
|---|---|
| Name |
Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
|
| Agency product number |
EMEA/H/C/001189
|
| Active substance |
clopidogrel besilate
|
| International non-proprietary name (INN) or common name |
clopidogrel
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
B01AC04
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Viatris Limited
|
| Revision |
26
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/10/2009
|
| Contact address |
Damastown Industrial Park |
Product information
03/08/2022 Clopidogrel Viatris (previously Clopidogrel Taw Pharma) - EMEA/H/C/001189 - IB/0046
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), ischemic 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 medically treated patients eligible for thrombolytic therapy.
In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic 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.
For further information please refer to section 5.1.