Clopidogrel Teva Pharma (previously Clopidogrel HCS)

clopidogrel

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The marketing authorisation for Clopidogrel Teva Pharma has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Clopidogrel Teva Pharma : EPAR - Summary for the public BG = bălgarski 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public ES = español 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public CS = čeština 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public DA = dansk 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public DE = Deutsch 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public ET = eesti keel 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public EL = elliniká 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public EN = English 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public FR = français 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public IT = italiano 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public LV = latviešu valoda 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public LT = lietuvių kalba 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public HU = magyar 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public MT = Malti 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public NL = Nederlands 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public PL = polski 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public PT = português 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public RO = română 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public SK = slovenčina 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public SL = slovenščina 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public FI = suomi 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public SV = svenska 2009-10-14 2016-04-19
Clopidogrel Teva Pharma : EPAR - Summary for the public HR = Hrvatski 2009-10-14 2016-04-19

This EPAR was last updated on 24/10/2017 .

Authorisation details

Product details

Product details for Clopidogrel Teva Pharma (previously Clopidogrel HCS)
NameClopidogrel Teva Pharma (previously Clopidogrel HCS)
Agency product numberEMEA/H/C/001133
Active substance

clopidogrel hydrochloride

International non-proprietary name (INN) or common name

clopidogrel

Therapeutic area Peripheral Vascular DiseasesStrokeMyocardial Infarction
Anatomical therapeutic chemical (ATC) code B01AC04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Clopidogrel Teva Pharma (previously Clopidogrel HCS)
Marketing-authorisation holder

Teva B.V.
 

Revision9
Date of issue of marketing authorisation valid throughout the European Union21/09/2009

Contact address:

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

Product information

Product information

22/01/2016  Clopidogrel Teva Pharma (previously Clopidogrel HCS) -EMEA/H/C/001133 -IB/0027/G

Name Language First published Last updated
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26
Clopidogrel Teva Pharma : EPAR - Product Information HR = Hrvatski 2009-10-14 2016-02-26

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11
Clopidogrel Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 2009-10-14 2010-06-11

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Clopidogrel Teva Pharma: EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-06-11 2016-02-26

Initial marketing-authorisation documents

Name Language First published Last updated
Clopidogrel HCS : EPAR - Public assessment report HR = Hrvatski 2009-10-14  
Committee for medicinal products for human use summary of positive opinion for Clopidogrel HCS HR = Hrvatski 2009-06-25  

Withdrawn

This medicine is now withdrawn from use in the European Union

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