This medicine is authorised for use in the European Union.


Plavix is a medicine used to prevent problems caused by blood clots in adults who have:

  • recently had a myocardial infarction (heart attack). Plavix 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). Plavix 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 placed 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.

Plavix contains the active substance clopidogrel.

This EPAR was last updated on 15/02/2023

Authorisation details

Product details
Agency product number
Active substance
clopidogrel hydrogen sulfate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Stroke
  • Peripheral Vascular Diseases
  • Atrial Fibrillation
  • Myocardial Infarction
  • Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Sanofi Winthrop Industrie
Date of issue of marketing authorisation valid throughout the European Union
Contact address

82 avenue Raspail
94250 Gentilly

Product information

16/12/2022 Plavix - EMEA/H/C/000174 - WS2150

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Product information documents contain:

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 seven days until less than six 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 replacement) 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 and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Assessment history

Changes since initial authorisation of medicine

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