Navigation path

Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Clopidogrel / Acetylsalicylic acid Teva   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Клопидогрел/Ацетилсалицилова киселина Teva (BG)
   - Clopidogrel/Acetylsalicylic acid Teva (CS)
   - Clopidogrel/Acetylsalicylsyre Teva (DA)
   - Clopidogrel/Acetylsalicylsäure Teva (DE)
   - Clopidogrel/Acetylsalicylic acid Teva (EL)
   - Clopidogrel/Ácido acetilsalicílico Teva (ES)
   - Clopidogrel/Acetylsalicylic acid Teva (ET)
   - Clopidogrel/Acetylsalicylic acid Teva (FI)
   - Clopidogrel/Acide acétylsalicylique Teva (FR)
   - Klopidogrel/acetilsalicilatna kiselina Teva (HR)
   - Clopidogrel/Acetylsalicylic acid Teva (HU)
   - Clopidogrel/Acido acetilsalicilico Teva (IT)
   - Clopidogrel/Acetylsalicylic acid Teva (LT)
   - Clopidogrel/Acetylsalicylic acid Teva (LV)
   - Clopidogrel/Acetylsalicylic acid Teva (MT)
   - Clopidogrel/Acetylsalicylzuur Teva (NL)
   - Clopidogrel/Acetylsalicylic acid Teva (PL)
   - Clopidogrel/Ácido acetilsalicílico Teva (PT)
   - Clopidogrel/Acid acetilsalicilic Teva (RO)
   - Clopidogrel/kyselina acetylsalicylová Teva (SK)
   - Klopidogrel/acetilsalicilna kislina Teva (SL)
   - Clopidogrel/Acetylsalicylic acid Teva (SV)
Auth. number : EU/1/14/942
INN : 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 Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva 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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

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
03/09/2014 Centralised - Authorisation EMEA/H/C/2272 (2014)6269 of 01/09/2014