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 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 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/19
15/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/20
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/32
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/174/I/31
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/60
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/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/67
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/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