🇪🇺 P2Y12 inhibitor in European Union

EMA authorised P2Y12 inhibitor on 14 July 1998

Marketing authorisations

EMA — authorised 14 July 1998

  • Application: EMEA/H/C/000175
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Iscover
  • 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 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 acut
  • Status: approved

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EMA — authorised 15 July 2008

  • Application: EMEA/H/C/000975
  • Marketing authorisation holder: Zentiva k.s.
  • Local brand name: Clopidogrel Zentiva (previously Clopidogrel Winthrop)
  • 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-elevatio
  • Status: approved

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EMA — authorised 16 July 2008

  • Application: EMEA/H/C/000974
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Clopidogrel BMS
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: - 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. - 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
  • Status: withdrawn

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EMA — authorised 21 July 2009

  • Application: EMEA/H/C/001132
  • Marketing authorisation holder: Mylan dura GmbH
  • Local brand name: Clopidogrel DURA
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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.
  • Status: withdrawn

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EMA — authorised 27 July 2009

  • Application: EMEA/H/C/001053
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Clopidogrel Teva (hydrogen sulphate)
  • Indication: Secondary prevention of atherothrombotic eventsClopidogrel 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 acut
  • Status: approved

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EMA — authorised 27 July 2009

  • Application: EMEA/H/C/001059
  • Marketing authorisation holder: Pharmathen S.A.
  • Local brand name: Grepid
  • Indication: 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 my
  • Status: approved

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EMA — authorised 28 July 2009

  • Application: EMEA/H/C/001139
  • Marketing authorisation holder: Acino Pharma GmbH
  • Local brand name: Clopidogrel Hexal
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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; 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 my
  • Status: withdrawn

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EMA — authorised 28 July 2009

  • Application: EMEA/H/C/001054
  • Marketing authorisation holder: Acino Pharma GmbH
  • Local brand name: Clopidogrel 1A Pharma
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. 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
  • Status: withdrawn

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EMA — authorised 28 July 2009

  • Application: EMEA/H/C/001165
  • Marketing authorisation holder: Archie Samiel s.r.o.
  • Local brand name: Clopidogrel ratiopharm GmbH
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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; 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 my
  • Status: withdrawn

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EMA — authorised 28 July 2009

  • Application: EMEA/H/C/001166
  • Marketing authorisation holder: Acino AG
  • Local brand name: Clopidogrel Acino
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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 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 medi
  • Status: withdrawn

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EMA — authorised 20 September 2009

  • Application: EMEA/H/C/001137
  • Marketing authorisation holder: Norpharm Regulatory Services Ltd
  • Local brand name: Clopidogrel Krka d.d. (previously Zopya)
  • Indication: Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) 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 my
  • Status: approved

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001175
  • Marketing authorisation holder: Acino Pharma GmbH
  • Local brand name: Clopidogrel Acino Pharma GmbH
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. For further information please refer to section 5.1.
  • Status: withdrawn

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001174
  • Marketing authorisation holder: Acino Pharma GmbH
  • Local brand name: Clopidogrel Sandoz
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. For further information please refer to section 5.1.
  • Status: withdrawn

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001138
  • Marketing authorisation holder: Biogaran
  • Local brand name: Clopidogrel BGR (previously Zylagren)
  • Indication: 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 7 days until less than 6 months) or established peripheral arterial disease.
  • Status: approved

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001133
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Clopidogrel Teva Pharma (previously Clopidogrel HCS)
  • 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
  • Status: withdrawn

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001134
  • Marketing authorisation holder: Taw Pharma (Ireland) Limited
  • Local brand name: Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
  • 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 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
  • Status: approved

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EMA — authorised 21 September 2009

  • Application: EMEA/H/C/001172
  • Marketing authorisation holder: Acino Pharma GmbH
  • Local brand name: Clopidogrel Acino Pharma
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. For further information please refer to section 5.1.
  • Status: withdrawn

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EMA — authorised 23 September 2009

  • Application: EMEA/H/C/001173
  • Marketing authorisation holder: Archie Samuel s.r.o.
  • Local brand name: Clopidogrel ratiopharm
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. For further information please refer to section 5.1.
  • Status: withdrawn

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EMA — authorised 23 September 2009

  • Application: EMEA/H/C/001056
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Clopidogrel Krka
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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.
  • Status: approved

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EMA — authorised 23 September 2009

  • Application: EMEA/H/C/001135
  • Marketing authorisation holder: Qualimed
  • Local brand name: Clopidogrel Qualimed
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. For further information please refer to section 5.1.
  • Status: withdrawn

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EMA — authorised 23 September 2009

  • Application: EMEA/H/C/001136
  • Marketing authorisation holder: Tad Pharma GmbH
  • Local brand name: Clopidogrel TAD
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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.
  • Status: approved

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EMA — authorised 28 September 2009

  • Application: EMEA/H/C/001058
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Zyllt
  • Indication: Prevention 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 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
  • Status: approved

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EMA — authorised 16 October 2009

  • Application: EMEA/H/C/001189
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
  • 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
  • Status: approved

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000875
  • Marketing authorisation holder: Bristol Myers Squibb Pharma EEIG
  • Local brand name: DuoCover
  • Status: withdrawn

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/001052
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Clopidogrel Teva Pharma
  • Status: withdrawn

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000874
  • Marketing authorisation holder: Sanofi Pharma Bristol-Myers Squibb
  • Local brand name: DuoPlavin
  • Status: withdrawn

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EMA — authorised 14 March 2010

  • Application: EMEA/H/C/001144
  • Marketing authorisation holder: Sanofi-Aventis Groupe
  • Local brand name: Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
  • Indication: Acute Coronary Syndrome Myocardial Infarction
  • Status: approved

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EMA — authorised 14 March 2010

  • Application: EMEA/H/C/001143
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: DuoPlavin
  • Indication: DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: 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 (PCI); ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for throm
  • Status: approved

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EMA — authorised 28 October 2010

  • Application: EMEA/H/C/002254
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Clopidogrel Teva Generics B.V.
  • Indication: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 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. 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 my
  • Status: withdrawn

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EMA — authorised 28 October 2010

  • Application: EMEA/H/C/002255
  • Marketing authorisation holder: HCS bvba
  • Local brand name: Clopidogrel HCS
  • 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 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 acut
  • Status: approved

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EMA — authorised 3 December 2010

  • Application: EMEA/H/C/002303
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Possia
  • Indication: Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
  • Status: withdrawn

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EMA — authorised 16 June 2011

  • Application: EMEA/H/C/001226
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Clopidogrel Teva Pharma B.V.
  • Indication: 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 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 myocardi
  • Status: withdrawn

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EMA — authorised 1 September 2014

  • Application: EMEA/H/C/002272
  • Marketing authorisation holder: Teva Pharma B.V.
  • Local brand name: Clopidogrel/Acetylsalicylic acid Teva
  • Indication: Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixed?dose combination medicinal product for continuation of therapy in: 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 ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic th
  • Status: withdrawn

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EMA — authorised 18 February 2015

  • Application: EMEA/H/C/004006
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Clopidogrel ratiopharm
  • 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 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 acut
  • Status: approved

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EMA — authorised 15 May 2018

  • Application: EMEA/H/C/004644
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Prasugrel Viatris (previously Prasugrel Mylan)
  • Indication: Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
  • Status: approved

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EMA — authorised 9 January 2020

  • Application: EMEA/H/C/004996
  • Marketing authorisation holder: Mylan Pharmaceuticals Limited
  • Local brand name: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan)
  • Indication:  Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris is a fixed-dose combination medicinal product for continuation of therapy in: - 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 - ST segment elevation acute myocardial infarction in medically treated patients elig
  • Status: approved

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P2Y12 inhibitor in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is P2Y12 inhibitor approved in European Union?

Yes. EMA authorised it on 14 July 1998; EMA authorised it on 15 July 2008; EMA authorised it on 16 July 2008.

Who is the marketing authorisation holder for P2Y12 inhibitor in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.