Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel Acino   
Auth. number : EU/1/09/532
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: 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.
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: Acino AG
Am Windfeld 35, 83714 D-Miesbach, Deutschland
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
31/07/2009 Centralised - Authorisation EMEA/H/C/1166 (2009)6149 of 28/07/2009
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1166/IA/1
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1166/II/3
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1166/II/2
30/03/2010 Referral EMEA/H/C/1166/A-20/4 (2010)2203 of 29/03/2010
06/08/2010 Centralised - Variation EMEA/H/C/1166/IB/5
Updated with Decision(2011)1786 of 14/03/2011
20/09/2010 Referral EMEA/H/C/1166/A-20/4 (2010)6434 of 16/09/2010
16/03/2011 Centralised - Variation (2011)1786 of 14/03/2011
12/05/2011 Centralised - Variation EMEA/H/C/1166/IB/6
Updated with Decision(2011)9175 of 05/12/2011
26/07/2011 Centralised - Variation EMEA/H/C/1166/IB/7
Updated with Decision(2011)9175 of 05/12/2011
07/12/2011 Centralised - Variation (2011)9175 of 05/12/2011
08/03/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1166/T/8 (2014)1556 of 06/03/2012
13/08/2013 Centralised - Variation EMEA/H/C/1166/IB/10/G
Updated with Decision(2014)2056 of 21/03/2014
10/10/2013 Centralised - Variation EMEA/H/C/1166/IB/11/G
Updated with Decision(2014)2056 of 21/03/2014
26/11/2013 Centralised - Variation EMEA/H/C/1166/IB/13
Updated with Decision(2014)2056 of 21/03/2014
26/03/2014 Centralised - Renewal EMEA/H/C/1166/R/12 (2014)2056 of 21/03/2014
24/04/2014 Centralised - Variation EMEA/H/C/1166/IB/15
Updated with Decision(2015)2466 of 09/04/2015
27/05/2014 Rectificative Decision EMEA/H/C/1166/T/8 (2014)3624 of 23/05/2014
13/04/2015 Centralised - Yearly update (2015)2466 of 09/04/2015
28/05/2015 Centralised - Variation EMEA/H/C/1166/IB/17
Updated with Decision(2016)630 of 28/01/2016
01/02/2016 Centralised - 2-Monthly update EMEA/H/C/1166/IB/18/G (2016)630 of 28/01/2016