- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions

European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
- European Commission
- Public health
- Register
- Human not active centr
- Clopidogrel Teva Pharma
Pharmaceuticals - Community Register
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
Invented name: | Clopidogrel Teva Pharma |
Auth. number : | EU/1/09/561 |
Active substance : | 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: | Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland |
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 procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
23/09/2009 | Centralised - Authorisation | EMEA/H/C/1133 | (2009)7415 of 21/09/2009 | |||
20/10/2009 | Centralised - Variation | EMEA/H/C/1133/IB/2 | ||||
Updated with Decision(2009)9247 of 19/11/2009 | ||||||
23/11/2009 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/1133/T/3 | (2009)9247 of 19/11/2009 | |||
08/12/2009 | Centralised - Variation | EMEA/H/C/1133/IA/4 | ||||
Updated with Decision(2010)1831 of 15/03/2010 | ||||||
04/01/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/1133/II/1 | ||||
18/01/2010 | Centralised - Variation | EMEA/H/C/1133/IB/5 | ||||
Updated with Decision(2010)1831 of 15/03/2010 | ||||||
17/03/2010 | Centralised - Variation | (2010)1831 of 15/03/2010 | ||||
09/08/2010 | Centralised - Variation | EMEA/H/C/1133/IB/6 | ||||
Updated with Decision(2011)1716 of 10/03/2011 | ||||||
16/09/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/1133/IB/7/G | ||||
08/02/2011 | Centralised - Variation | EMEA/H/C/1133/IB/8 | ||||
Updated with Decision(2011)1716 of 10/03/2011 | ||||||
14/03/2011 | Centralised - Variation | (2011)1716 of 10/03/2011 | ||||
10/05/2011 | Centralised - Variation | EMEA/H/C/1133/IB/9 | ||||
Updated with Decision(2011)9287 of 07/12/2011 | ||||||
29/07/2011 | Centralised - Variation | EMEA/H/C/1133/IB/11/G | ||||
Updated with Decision(2011)9287 of 07/12/2011 | ||||||
20/09/2011 | Centralised - Variation | EMEA/H/C/1133/IB/13 | ||||
Updated with Decision(2011)9287 of 07/12/2011 | ||||||
21/10/2011 | Centralised - Variation | EMEA/H/C/1133/IA/10/G | ||||
Updated with Decision(2011)9287 of 07/12/2011 | ||||||
09/12/2011 | Centralised - Variation | (2011)9287 of 07/12/2011 | ||||
04/04/2012 | Centralised - Variation | EMEA/H/C/1133/IB/14 | ||||
Updated with Decision(2012)7710 of 25/10/2012 | ||||||
29/10/2012 | Centralised - Variation | (2012)7710 of 25/10/2012 | ||||
15/08/2013 | Centralised - Variation | EMEA/H/C/1133/IB/17/G | ||||
Updated with Decision(2014)3175 of 08/05/2014 | ||||||
21/10/2013 | Centralised - Variation | EMEA/H/C/1133/IB/18/G | ||||
Updated with Decision(2014)3175 of 08/05/2014 | ||||||
07/01/2014 | Centralised - Variation | EMEA/H/C/1133/IB/20 | ||||
Updated with Decision(2014)3175 of 08/05/2014 | ||||||
24/04/2014 | Centralised - Variation | EMEA/H/C/1133/IB/23/G | ||||
Updated with Decision(2014)7870 of 21/10/2014 | ||||||
14/05/2014 | Centralised - Renewal | EMEA/H/C/1133/R/19 | (2014)3175 of 08/05/2014 | |||
23/10/2014 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/1133/T/24 | (2014)7870 of 21/10/2014 | |||
28/05/2015 | Centralised - Variation | EMEA/H/C/1133/IB/26 | ||||
Updated with Decision(2016)417 of 22/01/2016 | ||||||
26/01/2016 | Centralised - 2-Monthly update | EMEA/H/C/1133/IB/27/G | (2016)417 of 22/01/2016 | |||
19/06/2017 | Centralised - Withdrawal | (2017)4264 of 15/06/2017 |