Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

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 proceduresGoto top of the page
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