Clopidogrel / Acetylsalicylic acid Mylan

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clopidogrel / acetylsalicylic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 24/01/2020

Authorisation details

Product details
Name
Clopidogrel / Acetylsalicylic acid Mylan
Agency product number
EMEA/H/C/004996
Active substance
  • acetylsalicylic acid
  • clopidogrel hydrogen sulfate
International non-proprietary name (INN) or common name
clopidogrel / acetylsalicylic acid
Therapeutic area (MeSH)
  • Acute Coronary Syndrome
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC30
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Date of issue of marketing authorisation valid throughout the European Union
09/01/2020
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

09/01/2020 Clopidogrel / Acetylsalicylic acid Mylan - EMEA/H/C/004996 -

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel/Acetylsalicylic acid Mylan is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).

Clopidogrel/Acetylsalicylic acid Mylan 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

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