Community register of medicinal products for human use
Product information
| Invented name: | Plavix |
| INN : | Clopidogrel |
| ATC: | |
| 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 myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.. |
| Marketing Authorisation Holder: | Sanofi Pharma Bristol-Myers Squibb SNC |
Package presentations
| EU Number | Presentation | Authorisation date |
| EU/1/98/069/001a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 28 | 15 Jul 1998 |
| EU/1/98/069/001b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 28 | 15 Jul 1998 |
| EU/1/98/069/002a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 50 | 15 Jul 1998 |
| EU/1/98/069/002b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 50 | 15 Jul 1998 |
| EU/1/98/069/003a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 84 | 15 Jul 1998 |
| EU/1/98/069/003b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 84 | 15 Jul 1998 |
| EU/1/98/069/004a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 100 | 24 Mar 2003 |
| EU/1/98/069/004b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 100 | 24 Mar 2003 |
| EU/1/98/069/005a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 30 | 15 May 2007 |
| EU/1/98/069/005b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 30 | 15 May 2007 |
| EU/1/98/069/006a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 90 | 15 May 2007 |
| EU/1/98/069/006b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 90 | 15 May 2007 |
| EU/1/98/069/007a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 14 | 22 Jun 2007 |
| EU/1/98/069/007b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 14 | 22 Jun 2007 |
| EU/1/98/069/008 | Plavix - 300 mg - Film-coated tablet - Oral use - blister (alu/alu) - 4 x 1 | 14 Apr 2008 |
| EU/1/98/069/009 | Plavix - 300 mg - Film-coated tablet - Oral use - blister (alu/alu) - 30 x 1 | 14 Apr 2008 |
| EU/1/98/069/010 | Plavix - 300 mg - Film-coated tablet - Oral use - blister (alu/alu) - 100 x 1 | 14 Apr 2008 |
| EU/1/98/069/011a | Plavix - 75 mg - Film-coated tablet - Oral use - blister (PVC/PVDC/alu) - 7 | 26 Jan 2009 |
| EU/1/98/069/011b | Plavix - 75 mg - Film-coated tablet - Oral use - blister (alu/alu) - 7 | 26 Jan 2009 |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 16/07/1998 | Centralised - Autorisation | EMEA/H/C/174 | C(1998)2002 of 15/07/1998 | |||
| 2/04/1999 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/1 | C(1999)192 of 1/02/1999 | |||
| 21/06/1999 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/3 | C(1999)1626 of 16/06/1999 | |||
| 25/06/1999 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/2 | C(1999)1606 of 11/06/1999 | |||
| 19/07/1999 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/5 | C(1999)1962 of 8/07/1999 | |||
| 14/09/1999 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/7 | C(1999)2867 of 7/09/1999 | |||
| 22/02/2000 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/11 | ||||
| 9/05/2000 | Centralised - Notification - (Art. 61(2) Dir 2001/82) | EMEA/H/C/174/N/13 | C(2000)1186 of 3/05/2000 | |||
| 16/05/2000 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/14 | ||||
| 20/07/2000 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/12 | C(2000)2029 of 13/07/2000 | |||
| 26/09/2000 | Centralised - Notification - (Art. 61(2) Dir 2001/82) | EMEA/H/C/174/N/16 | C(2000)2598 of 25/09/2000 | |||
| 17/01/2001 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/15 | C(2001)16 of 15/01/2001 | |||
| 13/03/2001 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/17 | C(2001)320 of 13/03/2001 | |||
| 15/03/2001 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/19 | ||||
| 15/03/2001 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/20 | ||||
| 17/07/2001 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/18 | C(2001)2014 of 16/07/2001 | |||
| 25/07/2001 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/21 | ||||
| 20/12/2001 | Centralised - Notification - (Art. 61(2) Dir 2001/82) | EMEA/H/C/174/N/23 | C(2001)4320 of 17/12/2001 | |||
| 30/01/2002 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/22 | C(2002)397 of 28/01/2002 | |||
| 21/02/2002 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/25 | C(2002)629 of 19/02/2002 | |||
| 30/05/2002 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/27 | ||||
| 21/06/2002 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/26 | C(2002)2358 of 19/06/2002 | |||
| 11/09/2002 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/24 | C(2002)3373 of 9/09/2002 | |||
| 16/01/2003 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/30 | ||||
| 5/02/2003 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/174/I/28 | C(2003)469 of 3/02/2003 | |||
| 3/03/2003 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/29 | ||||
| 27/03/2003 | Centralised - Variation Type I - (Additional pack size) | EMEA/H/C/174/I/33 | C(2003)1034 of 24/03/2003 | |||
| 1/04/2003 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/32 | ||||
| 1/04/2003 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/174/I/31 | ||||
| 2/10/2003 | Centralised - Variation Type II - No decision, letter of acceptance only | EMEA/H/C/174/II/36 | ||||
| 10/10/2003 | Centralised - Renewal after maximum 5 years | EMEA/H/C/174/R/35 | C(2003)3740 of 8/10/2003 | |||
| 24/12/2003 | Centralised - Notification - (Art. 61(3) Dir 2001/83) normal | EMEA/H/C/174/N/37 | C(2003)5317 of 22/12/2003 | |||
| Will be updated later | ||||||
| 14/06/2004 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/39 | ||||
| Updated with Decision C(2005)18 of 5/01/2005 |
|
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| 4/08/2004 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/38 | C(2004)3055 of 2/08/2004 | |||
| 8/11/2004 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/43 | ||||
| 23/11/2004 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/42 | ||||
| 28/11/2004 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/41 | ||||
| 7/01/2005 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/40 | C(2005)18 of 5/01/2005 | |||
| 1/03/2005 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/45 | ||||
| Updated with Decision C(2005)3654 of 22/09/2005 |
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| 15/04/2005 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/46 | ||||
| 15/08/2005 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/47 | ||||
| 18/08/2005 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/49 | ||||
| Updated with Decision C(2005)3654 of 22/09/2005 |
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| 10/09/2005 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/48 | ||||
| 26/09/2005 | Centralised - Update Type IA - (Acceptance modification) | - | C(2005)3654 of 22/09/2005 | |||
| 24/01/2006 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/50 | C(2006)156 of 20/01/2006 | |||
| 24/03/2006 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/52 | ||||
| 28/06/2006 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/53 | C(2006)3008 of 26/06/2006 | |||
| 6/09/2006 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/51 | C(2006)4081 of 1/09/2006 | |||
| 13/10/2006 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/60 | ||||
| 13/10/2006 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/56 | ||||
| 13/10/2006 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/55 | ||||
| 13/10/2006 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/57 | ||||
| 17/10/2006 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/54 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 27/10/2006 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/58 | ||||
| 27/10/2006 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/59 | ||||
| 12/01/2007 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/62 | ||||
| 9/02/2007 | Centralised - Notification 61(3) - (Acceptance modification) | EMEA/H/C/174/N/63 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 16/03/2007 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/66 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 16/03/2007 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/65 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 16/03/2007 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/64 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 16/03/2007 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/174/IA/67 | ||||
| Updated with Decision C(2007)2194 of 15/05/2007 |
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| 11/05/2007 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/174/IB/68 | ||||
| Updated with Decision C(2007)3159 of 22/06/2007 |
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| 11/05/2007 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/174/IB/69 | ||||
| Updated with Decision C(2007)3159 of 22/06/2007 |
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| 21/05/2007 | Centralised - Update Type IA - (Acceptance modification) | - | C(2007)2194 of 15/05/2007 | |||
| 26/06/2007 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/61 | C(2007)3159 of 22/06/2007 | |||
| 10/10/2007 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/71 | ||||
| 4/12/2007 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/72 | ||||
| 16/04/2008 | Centralised - Annex II extension adding new number | EMEA/H/C/174/X/70 | C(2008)1524 of 14/04/2008 | |||
| 23/06/2008 | Centralised - Renewal after maximum 5 years | EMEA/H/C/174/R/73 | C(2008)3087 of 19/06/2008 | |||
| 30/06/2008 | Centralised - Variation Type II - No decision, letter of acceptance only | EMEA/H/C/174/II/74 | ||||
| 21/07/2008 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/75 | ||||
| 21/07/2008 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/76 | ||||
| 3/11/2008 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/174/IB/78 | ||||
| Updated with Decision C(2009)559 of 26/01/2009 |
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| 4/11/2008 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/174/IB/80 | ||||
| Updated with Decision C(2009)559 of 26/01/2009 |
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| 4/11/2008 | Centralised - Variation Type IB - (Acceptance modification) | EMEA/H/C/174/IB/79 | ||||
| Updated with Decision C(2009)559 of 26/01/2009 |
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| 22/01/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/81 | ||||
| 28/01/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/77 | C(2009)559 of 26/01/2009 | |||
| 11/08/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/85 | ||||
| 11/08/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/84 | ||||
| 11/08/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/83 | ||||
| 1/09/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/174/II/82 | C(2009)6723 of 28/08/2009 | |||
| 21/10/2009 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/174/IA/86 | ||||
| 10/11/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/88 | ||||
| 17/11/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/90 | ||||
| 17/11/2009 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/174/IB/89 |
