Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zyllt   
Auth. number : EU/1/09/553
INN : 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: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
30/09/2009 Centralised - Authorisation EMEA/H/C/1058 (2009)7559 of 28/09/2009
17/11/2009 Centralised - Variation EMEA/H/C/1058/IB/1
Updated with Decision(2010)4707 of 02/07/2010
07/07/2010 Centralised - Variation (2010)4707 of 02/07/2010
27/07/2010 Centralised - Variation EMEA/H/C/1058/IB/2
Updated with Decision(2011)974 of 11/02/2011
21/12/2010 Centralised - Variation EMEA/H/C/1058/IA/3
15/02/2011 Centralised - Variation (2011)974 of 11/02/2011
20/04/2011 Centralised - Variation EMEA/H/C/1058/IB/4
Updated with Decision(2011)8958 of 28/11/2011
31/08/2011 Centralised - Variation EMEA/H/C/1058/IB/5/G
Updated with Decision(2011)8958 of 28/11/2011
30/11/2011 Centralised - Variation (2011)8958 of 28/11/2011
14/05/2012 Centralised - Variation EMEA/H/C/1058/N/6
Updated with Decision(2014)3369 of 14/05/2014
18/07/2013 Centralised - Variation EMEA/H/C/1058/N/9
Updated with Decision(2014)3369 of 14/05/2014
15/08/2013 Centralised - Variation EMEA/H/C/1058/IB/10/G
Updated with Decision(2014)3369 of 14/05/2014
21/10/2013 Centralised - Variation EMEA/H/C/1058/IB/11/G
Updated with Decision(2014)3369 of 14/05/2014
13/12/2013 Centralised - Variation EMEA/H/C/1058/IA/13
Updated with Decision(2014)3369 of 14/05/2014
20/02/2014 Centralised - Variation EMEA/H/C/1058/IB/17
Updated with Decision(2014)3369 of 14/05/2014
25/04/2014 Centralised - Variation EMEA/H/C/1058/IB/19/G
16/05/2014 Centralised - Renewal EMEA/H/C/1058/R/16 (2014)3369 of 14/05/2014