Basic Information
Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan)
Regulatory Information
EMEA/H/C/004996
January 9, 2020
November 14, 2019
9
May 5, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin 15
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris 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
Overview Summary
Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets. It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome’: - patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation’ (an abnormal reading on an electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up; - patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots). Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine’. This means that Clopidogrel/Acetylsalicylic acid Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called DuoPlavin.