Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Plavix   
Auth. number : EU/1/98/069
INN : Clopidogrel
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding Heparin
Chemical substance: B01AC04 - Clopidogrel
(See WHO ATC Index)
Indication: 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 acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
  • Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn 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.
    Marketing Authorisation Holder: Sanofi Clir SNC
    54 rue La Boétie, F-75008 Paris, France

      EPAR and active package presentations

    Package presentations

    Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
    Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

     

    European Commission proceduresGoto top of the page

    Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
    16/07/1998 Centralised - Authorisation EMEA/H/C/174 (1998)2002 of 15/07/1998
    02/04/1999 Centralised - Variation EMEA/H/C/174/I/1 (1999)192 of 01/02/1999
    21/06/1999 Centralised - Variation EMEA/H/C/174/I/3 (1999)1626 of 16/06/1999
    25/06/1999 Centralised - Variation EMEA/H/C/174/I/2 (1999)1606 of 11/06/1999
    19/07/1999 Centralised - Variation EMEA/H/C/174/I/5 (1999)1962 of 08/07/1999
    14/09/1999 Centralised - Variation EMEA/H/C/174/II/7 (1999)2867 of 07/09/1999
    22/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/11
    09/05/2000 Centralised - Notification EMEA/H/C/174/N/13 (2000)1186 of 03/05/2000
    16/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/14
    20/07/2000 Centralised - Variation EMEA/H/C/174/II/12 (2000)2029 of 13/07/2000
    26/09/2000 Centralised - Notification EMEA/H/C/174/N/16 (2000)2598 of 25/09/2000
    17/01/2001 Centralised - Variation EMEA/H/C/174/II/15 (2001)16 of 15/01/2001
    13/03/2001 Centralised - Variation EMEA/H/C/174/II/17 (2001)320 of 13/03/2001
    15/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/20
    15/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/19
    17/07/2001 Centralised - Variation EMEA/H/C/174/II/18 (2001)2014 of 16/07/2001
    25/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/21
    20/12/2001 Centralised - Notification EMEA/H/C/174/N/23 (2001)4320 of 17/12/2001
    30/01/2002 Centralised - Variation EMEA/H/C/174/II/22 (2002)397 of 28/01/2002
    21/02/2002 Centralised - Variation EMEA/H/C/174/I/25 (2002)629 of 19/02/2002
    30/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/27
    21/06/2002 Centralised - Variation EMEA/H/C/174/I/26 (2002)2358 of 19/06/2002
    11/09/2002 Centralised - Variation EMEA/H/C/174/II/24 (2002)3373 of 09/09/2002
    16/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/30
    05/02/2003 Centralised - Variation EMEA/H/C/174/I/28 (2003)469 of 03/02/2003
    03/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/29
    27/03/2003 Centralised - Variation EMEA/H/C/174/I/33 (2003)1034 of 24/03/2003
    01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/31
    01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/32
    02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/II/36
    10/10/2003 Centralised - Renewal EMEA/H/C/174/R/35 (2003)3740 of 08/10/2003
    24/12/2003 Centralised - Notification EMEA/H/C/174/N/37 (2003)5317 of 22/12/2003
    14/06/2004 Centralised - Variation EMEA/H/C/174/IA/39
    Updated with Decision(2005)18 of 05/01/2005
    04/08/2004 Centralised - Variation EMEA/H/C/174/II/38 (2004)3055 of 02/08/2004
    08/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/43
    23/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/42
    28/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/41
    07/01/2005 Centralised - Variation EMEA/H/C/174/II/40 (2005)18 of 05/01/2005
    01/03/2005 Centralised - Variation EMEA/H/C/174/IA/45
    Updated with Decision(2005)3654 of 22/09/2005
    15/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/46
    15/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/47
    18/08/2005 Centralised - Variation EMEA/H/C/174/IA/49
    Updated with Decision(2005)3654 of 22/09/2005
    10/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/48
    26/09/2005 Centralised - Variation (2005)3654 of 22/09/2005
    24/01/2006 Centralised - Variation EMEA/H/C/174/II/50 (2006)156 of 20/01/2006
    24/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/52
    28/06/2006 Centralised - Variation EMEA/H/C/174/II/53 (2006)3008 of 26/06/2006
    06/09/2006 Centralised - Variation EMEA/H/C/174/II/51 (2006)4081 of 01/09/2006
    13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/56
    13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/57
    13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/60
    13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/55
    17/10/2006 Centralised - Variation EMEA/H/C/174/IA/54
    Updated with Decision(2007)2194 of 15/05/2007
    27/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/58
    27/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/59
    12/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/62
    09/02/2007 Centralised - Notification EMEA/H/C/174/N/63
    Updated with Decision(2007)2194 of 15/05/2007
    16/03/2007 Centralised - Variation EMEA/H/C/174/IA/66
    Updated with Decision(2007)2194 of 15/05/2007
    16/03/2007 Centralised - Variation EMEA/H/C/174/IA/65
    Updated with Decision(2007)2194 of 15/05/2007
    16/03/2007 Centralised - Variation EMEA/H/C/174/IA/67
    Updated with Decision(2007)2194 of 15/05/2007
    16/03/2007 Centralised - Variation EMEA/H/C/174/IA/64
    Updated with Decision(2007)2194 of 15/05/2007
    11/05/2007 Centralised - Variation EMEA/H/C/174/IB/68
    Updated with Decision(2007)3159 of 22/06/2007
    11/05/2007 Centralised - Variation EMEA/H/C/174/IB/69
    Updated with Decision(2007)3159 of 22/06/2007
    21/05/2007 Centralised - Variation (2007)2194 of 15/05/2007
    26/06/2007 Centralised - Variation EMEA/H/C/174/II/61 (2007)3159 of 22/06/2007
    10/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/71
    04/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/72
    16/04/2008 Centralised - Variation EMEA/H/C/174/X/70 (2008)1524 of 14/04/2008
    23/06/2008 Centralised - Renewal EMEA/H/C/174/R/73 (2008)3087 of 19/06/2008
    30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/II/74
    21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/76
    21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/75
    03/11/2008 Centralised - Variation EMEA/H/C/174/IB/78
    Updated with Decision(2009)559 of 26/01/2009
    04/11/2008 Centralised - Variation EMEA/H/C/174/IB/80
    Updated with Decision(2009)559 of 26/01/2009
    04/11/2008 Centralised - Variation EMEA/H/C/174/IB/79
    Updated with Decision(2009)559 of 26/01/2009
    22/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/81
    28/01/2009 Centralised - Variation EMEA/H/C/174/II/77 (2009)559 of 26/01/2009
    11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/85
    11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/84
    11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/83
    01/09/2009 Centralised - Variation EMEA/H/C/174/II/82 (2009)6723 of 28/08/2009
    21/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/86
    10/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/88
    17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/90
    17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/89
    14/12/2009 Centralised - Variation EMEA/H/C/174/IA/92
    Updated with Decision(2010)1807 of 15/03/2010
    21/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/87
    17/03/2010 Centralised - Variation (2010)1807 of 15/03/2010
    03/05/2010 Centralised - Variation EMEA/H/C/174/II/93 (2010)2939 of 29/04/2010
    25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IA/94
    27/05/2010 Centralised - Variation EMEA/H/C/174/IG/4
    Updated with Decision(2010)5321 of 27/07/2010
    29/07/2010 Centralised - Variation (2010)5321 of 27/07/2010
    10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/96
    10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/IB/97
    31/12/2010 Centralised - Variation EMEA/H/C/174/II/91, 95 (2011)186 of 13/01/2011
    01/06/2011 Centralised - Variation EMEA/H/C/174/II/98 (2011)3867 of 27/05/2011
    11/04/2012 Centralised - Variation EMEA/H/C/174/II/98rev (2012)2411 of 04/04/2012
    18/04/2012 Centralised - Variation EMEA/H/C/174/IG/171
    Updated with Decision(2012)7901 of 29/10/2012
    02/11/2012 Centralised - Variation (2012)7901 of 29/10/2012
    03/06/2013 Centralised - 2-Monthly update EMEA/H/C/174/WS/365, 366 (2013)3375 of 30/05/2013
    19/07/2013 Centralised - 2-Monthly update EMEA/H/C/174/WS/378 (2013)4696 of 17/07/2013
    30/07/2013 Centralised - 2-Monthly update EMEA/H/C/174/WS/397 (2013)5002 of 26/07/2013
    19/09/2013 Centralised - Variation EMEA/H/C/174/WS/409
    Updated with Decision(2014)7188 of 01/10/2014
    07/10/2013 Centralised - Variation EMEA/H/C/174/IG/325
    Updated with Decision(2014)7188 of 01/10/2014
    23/01/2014 Centralised - Variation EMEA/H/C/174/WS/477
    Updated with Decision(2014)7188 of 01/10/2014
    23/01/2014 Centralised - Variation EMEA/H/C/174/WS/476
    Updated with Decision(2014)7188 of 01/10/2014
    25/02/2014 Corrigendum (2013)5002 of 26/07/2013
    25/02/2014 Corrigendum (2013)3375 of 30/05/2013
    25/02/2014 Corrigendum (2013)4696 of 17/07/2013
    03/10/2014 Centralised - Yearly update (2014)7188 of 01/10/2014