Overview

The marketing authorisation for Clopidogrel Teva Pharma has been withdrawn at the request of the marketing authorisation holder.

Clopidogrel Teva Pharma : EPAR - Summary for the public

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Product information

Clopidogrel Teva Pharma : EPAR - Product Information

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Latest procedure affecting product information: IB/0027/G

22/01/2016

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This medicine’s product information is available in all official EU languages.
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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).

Clopidogrel Teva Pharma : EPAR - All Authorised presentations

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español (ES) (155.58 KB - PDF)
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lietuvių kalba (LT) (218.99 KB - PDF)
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português (PT) (150.89 KB - PDF)
română (RO) (215.15 KB - PDF)
slovenčina (SK) (185.5 KB - PDF)
slovenščina (SL) (155.75 KB - PDF)
Suomi (FI) (150.77 KB - PDF)
svenska (SV) (150.46 KB - PDF)

Product details

Name of medicine
Clopidogrel Teva Pharma (previously Clopidogrel HCS)
Active substance
clopidogrel (as hydrochloride)
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Myocardial Infarction
  • Peripheral Vascular Diseases
  • Stroke
Anatomical therapeutic chemical (ATC) code
B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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 medically treated patients eligible for thrombolytic therapy.

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.

Authorisation details

EMA product number
EMEA/H/C/001133

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.

Marketing authorisation holder
Teva B.V. 

Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Marketing authorisation issued
21/09/2009
Revision
9

Assessment history

Clopidogrel Teva Pharma: EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel HCS : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel HCS

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