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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover)   
Auth. number : EU/1/10/623
Active substance : clopidogrel / acetylsalicylic acid
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: B01AC30 - Combinations
(See WHO ATC Index)
Indication: Clopidogrel/Acetylsalicylic acid Zentiva is indicated for the prevention of atherothrombotic events in
adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).
Clopidogrel/Acetylsalicylic acid Zentiva is a fixed-dose combination medicinal product for
continuation of therapy in:
• 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
• ST segment elevation acute myocardial infarction in medically treated patients eligible for
thrombolytic therapy
Marketing Authorisation Holder: Sanofi-Aventis groupe
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
17/03/2010 Centralised - Authorisation EMEA/H/C/1144 (2010)1816 of 15/03/2010
18/05/2010 Centralised - Variation EMEA/H/C/1144/IA/1
Updated with Decision(2010)5395 of 28/07/2010
24/05/2010 Centralised - Variation EMEA/H/C/1144/IA/4/G
Updated with Decision(2010)5395 of 28/07/2010
01/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1144/IB/3/G
30/07/2010 Centralised - Variation EMEA/H/C/1144/II/2 (2010)5395 of 28/07/2010
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1144/IB/5
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1144/IB/4
23/12/2010 Centralised - Variation EMEA/H/C/1144/II/6 (2010)9623 of 20/12/2010
08/09/2011 Centralised - Notification EMEA/H/C/1144/N/8
Updated with Decision(2012)3566 of 25/05/2012
30/05/2012 Centralised - Variation EMEA/H/C/1144/II/11 (2012)3566 of 25/05/2012
04/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1144/T/15 (2013)1254 of 28/02/2013
26/03/2013 Corrigendum (2013)1845 of 22/03/2013
29/05/2013 Centralised - 2-Monthly update EMEA/H/C/1144/WS/365, 366, 367, 368, 369 (2013)3228 of 27/05/2013
31/07/2013 Centralised - 2-Monthly update EMEA/H/C/1144/WS/378, 397 (2013)5012 of 26/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/1144/WS/409
Updated with Decision(2014)6259 of 01/09/2014
15/11/2013 Corrigendum (2013)8069 of 13/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/1144/WS/476
Updated with Decision(2014)6259 of 01/09/2014
23/01/2014 Centralised - Variation EMEA/H/C/1144/WS/477
Updated with Decision(2014)6259 of 01/09/2014
24/07/2014 Centralised - Variation EMEA/H/C/1144/WS/538
Updated with Decision(2014)6259 of 01/09/2014
24/07/2014 Centralised - Variation EMEA/H/C/1144/WS/554
Updated with Decision(2014)6259 of 01/09/2014
24/07/2014 Centralised - Variation EMEA/H/C/1144/WS/572
Updated with Decision(2014)6259 of 01/09/2014
03/09/2014 Centralised - Yearly update (2014)6259 of 01/09/2014
21/11/2014 Centralised - Renewal EMEA/H/C/1144/R/33 (2014)8883 of 19/11/2014
26/02/2015 Centralised - Variation EMEA/H/C/1144/WS/682
Updated with Decision(2016)1335 of 26/02/2016
26/02/2015 Centralised - Variation EMEA/H/C/1144/WS/686
Updated with Decision(2016)1335 of 26/02/2016
26/02/2015 Centralised - Variation EMEA/H/C/1144/WS/685
Updated with Decision(2016)1335 of 26/02/2016
21/05/2015 Centralised - Variation EMEA/H/C/1144/II/WS/707
Updated with Decision(2016)1335 of 26/02/2016
24/09/2015 Centralised - Variation EMEA/H/C/1144/WS/809
Updated with Decision(2016)1335 of 26/02/2016
24/09/2015 Centralised - Variation EMEA/H/C/1144/WS/815
Updated with Decision(2016)1335 of 26/02/2016
19/11/2015 Centralised - Variation EMEA/H/C/1144/WS/813
Updated with Decision(2016)1335 of 26/02/2016
14/01/2016 Centralised - Variation EMEA/H/C/1144/WS/856
Updated with Decision(2016)1335 of 26/02/2016
15/01/2016 Centralised - Variation EMEA/H/C/1144/IB/44
Updated with Decision(2016)1335 of 26/02/2016
01/03/2016 Centralised - Yearly update (2016)1335 of 26/02/2016
26/05/2016 Centralised - Variation EMEA/H/C/1144/WS/930