Clopidogrel Viatris (previously Clopidogrel Taw Pharma)

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clopidogrel

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 19/01/2022

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)
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC04
GenericGeneric

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
Taw Pharma (Ireland) Limited
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
16/10/2009
Contact address

104 Baggot Street Lower
Dublin 2
Co. Dublin
D02 Y940
Ireland
 

Product information

25/10/2021 Clopidogrel Viatris (previously Clopidogrel Taw Pharma) - EMEA/H/C/001189 - IAIN/0041

Contents

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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.

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