Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Iscover   
Auth. number : EU/1/98/070
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 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 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.
Marketing Authorisation Holder: Sanofi-Aventis groupe
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/175 (1998)2003 of 15/07/1998
21/06/1999 Centralised - Variation EMEA/H/C/175/I/1 (1999)1608 of 11/06/1999
23/06/1999 Centralised - Variation EMEA/H/C/175/I/2 (1999)1630 of 16/06/1999
19/07/1999 Centralised - Variation EMEA/H/C/175/I/4 (1999)1963 of 08/07/1999
14/09/1999 Centralised - Variation EMEA/H/C/175/II/6 (1999)2969 of 07/09/1999
22/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/10
16/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/12
20/07/2000 Centralised - Variation EMEA/H/C/175/II/11 (2000)2030 of 13/07/2000
26/09/2000 Centralised - Notification EMEA/H/C/175/N/14 (2000)2599 of 25/09/2000
17/01/2001 Centralised - Variation EMEA/H/C/175/II/13 (2001)17 of 15/01/2001
08/03/2001 Centralised - Variation EMEA/H/C/174/II/15 (2001)316 of 06/03/2001
15/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/17
15/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/18
17/07/2001 Centralised - Variation EMEA/H/C/175/II/16 (2001)2016 of 16/07/2001
25/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/19
07/02/2002 Centralised - Variation EMEA/H/C/175/II/20 (2002)417 of 29/01/2002
19/02/2002 Centralised - Variation EMEA/H/C/175/I/21 (2002)644 of 19/02/2002
22/02/2002 Centralised - Variation EMEA/H/C/175/I/23 (2002)630 of 19/02/2002
30/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/26
21/06/2002 Centralised - Variation EMEA/H/C/175/I/25 (2002)2357 of 19/06/2002
11/09/2002 Centralised - Variation EMEA/H/C/175/II/22 (2002)3372 of 09/09/2002
16/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/29
05/02/2003 Centralised - Variation EMEA/H/C/175/I/27 (2003)468 of 03/02/2003
03/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/28
24/03/2003 Centralised - Variation EMEA/H/C/175/I/32 (2003)954 of 20/03/2003
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/30
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/31
14/05/2003 Centralised - Notification EMEA/H/C/175/N/34 (2003)1620 of 12/05/2003
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/II/36
10/10/2003 Centralised - Renewal EMEA/H/C/175/R/35 (2003)3732 of 08/10/2003
24/12/2003 Centralised - Notification EMEA/H/C/175/N/37 (2003)5320 of 22/12/2003
14/06/2004 Centralised - Variation EMEA/H/C/175/IA/39
Updated with Decision(2004)5620 of 22/12/2004
04/08/2004 Centralised - Variation EMEA/H/C/175/II/38 (2004)3056 of 02/08/2004
08/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/43
23/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/42
28/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/41
04/01/2005 Centralised - Variation EMEA/H/C/175/II/40 (2004)5620 of 22/12/2004
01/03/2005 Centralised - Variation EMEA/H/C/175/IA/45
Updated with Decision(2005)3653 of 22/09/2005
15/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/46
15/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/48
18/08/2005 Centralised - Variation EMEA/H/C/175/IA/50
Updated with Decision(2005)3653 of 22/09/2005
10/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/49
26/09/2005 Centralised - Variation (2005)3653 of 22/09/2005
08/11/2005 Centralised - Notification EMEA/H/C/175/N/52
Updated with Decision(2006)155 of 20/01/2006
16/11/2005 Centralised - Variation EMEA/H/C/175/IA/51
Updated with Decision(2006)155 of 20/01/2006
24/01/2006 Centralised - Variation EMEA/H/C/175/II/53 (2006)155 of 20/01/2006
24/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/55
28/06/2006 Centralised - Variation EMEA/H/C/175/II/56 (2006)3005 of 26/06/2006
11/09/2006 Centralised - Variation EMEA/H/C/175/II/54 (2006)4053 of 01/09/2006
13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/60
13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/63
13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/58
13/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/59
17/10/2006 Centralised - Variation EMEA/H/C/175/IA/57
Updated with Decision(2007)2192 of 15/05/2007
27/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/61
27/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/62
12/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/65
19/03/2007 Centralised - Variation EMEA/H/C/175/IA/66
Updated with Decision(2007)2192 of 15/05/2007
19/03/2007 Centralised - Variation EMEA/H/C/175/IA/67
Updated with Decision(2007)2192 of 15/05/2007
19/03/2007 Centralised - Variation EMEA/H/C/175/IA/69
Updated with Decision(2007)2192 of 15/05/2007
19/03/2007 Centralised - Variation EMEA/H/C/175/IA/68
Updated with Decision(2007)2192 of 15/05/2007
11/05/2007 Centralised - Variation EMEA/H/C/175/IB/71
Updated with Decision(2007)3136 of 21/06/2007
11/05/2007 Centralised - Variation EMEA/H/C/175/IB/70
Updated with Decision(2007)3136 of 21/06/2007
17/05/2007 Centralised - Variation (2007)2192 of 15/05/2007
25/06/2007 Centralised - Variation EMEA/H/C/175/II/64 (2007)3136 of 21/06/2007
10/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/73
04/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/74
18/04/2008 Centralised - Variation EMEA/H/C/175/X/72 (2008)1591 of 16/04/2008
23/06/2008 Centralised - Renewal EMEA/H/C/175L/R/75 (2008)3088 of 19/06/2008
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/II/76
21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/78
21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/77
30/10/2008 Centralised - Variation EMEA/H/C/175/IB/82
Updated with Decision(2008)588 of 27/01/2009
30/10/2008 Centralised - Variation EMEA/H/C/175/IB/81
Updated with Decision(2008)588 of 27/01/2009
03/11/2008 Centralised - Variation EMEA/H/C/175/IB/80
Updated with Decision(2008)588 of 27/01/2009
22/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/83
29/01/2009 Centralised - Variation EMEA/H/C/175/II/79 (2008)588 of 27/01/2009
09/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/9
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/87
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/I/B/86
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/85
01/09/2009 Centralised - Variation EMEA/H/C/175/II/84 (2009)6712 of 27/08/2009
21/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/89
10/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/91
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/9
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/92
14/12/2009 Centralised - Variation EMEA/H/C/175/IA/95
Updated with Decision(2010)1806 of 15/03/2010
21/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/90
17/03/2010 Centralised - Variation (2010)1806 of 15/03/2010
04/05/2010 Centralised - Variation EMEA/H/C/175/II/96 (2010)2938 of 29/04/2010
25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IA/97
27/05/2010 Centralised - Variation EMEA/H/C/175/IG/4/G
Updated with Decision(2010)5320 of 27/07/2010
29/07/2010 Centralised - Variation (2010)5320 of 27/07/2010
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/100
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/175/IB/99
31/12/2010 Centralised - Variation EMEA/H/C/175/II/94, 98 (2011)184 of 13/01/2011
01/06/2011 Centralised - Variation EMEA/H/C/175/II/101 (2011)3868 of 27/05/2011
08/09/2011 Centralised - Notification EMEA/H/C/175/N/102
Updated with Decision(2013)1646 of 13/03/2013
15/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/175/T/109 (2013)1646 of 13/03/2013
03/06/2013 Centralised - 2-Monthly update EMEA/H/C/175/WS/365, 366 (2013)3376 of 30/05/2013
19/07/2013 Centralised - 2-Monthly update EMEA/H/C/175/WS/378 (2013)4694 of 17/07/2013
31/07/2013 Centralised - 2-Monthly update EMEA/H/C/175/WS/397 (2013)5001 of 26/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/175/WS/409
Updated with Decision(2014)7187 of 01/10/2014
23/01/2014 Centralised - Variation EMEA/H/C/175/WS/477
Updated with Decision(2014)7187 of 01/10/2014
23/01/2014 Centralised - Variation EMEA/H/C/175/WS/476
Updated with Decision(2014)7187 of 01/10/2014
03/10/2014 Centralised - Yearly update (2014)7187 of 01/10/2014