Clopidogrel Zentiva (previously Clopidogrel Winthrop) - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

clopidogrel

Opinion

On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Clopidogrel Zentiva. The marketing authorisation holder for this medicinal product is Zentiva k.s.

The CHMP adopted an extension to an existing indication to include the secondary prevention of atherothrombotic events in adults with ST segment elevation acute myocardial infarction undergoing percutaneous coronary intervention.

The full indications for Clopidogrel Zentiva will therefore be as follows:¹

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 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.

For further information please refer to section 5.1.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold

CHMP post-authorisation summary of positive opinion for Clopidogrel Zentiva (II-92)

Adopted Reference Number: EMA/CHMP/222151/2025

Key facts

• Name of medicine:
  Clopidogrel Zentiva (previously Clopidogrel Winthrop)
• EMA product number:
  EMEA/H/C/000975
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Stroke
  • Peripheral Vascular Diseases
  • Myocardial Infarction
  • Acute Coronary Syndrome
• Anatomical therapeutical chemical (ATC) code:
  B01AC04
• Marketing authorisation holder:
  Zentiva k.s.
• Date of opinion:
  24/07/2025
• Status:
  Positive