Clopidogrel / Acetylsalicylic acid Mylan
clopidogrel / acetylsalicylic acid
Table of contents
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.
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Clopidogrel / Acetylsalicylic acid Mylan : EPAR - Medicine overview (PDF/178.91 KB)
First published: 24/01/2020
EMA/628773/2019 -
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Clopidogrel / Acetylsalicylic acid Mylan : EPAR - Risk-management-plan summary (PDF/105.5 KB)
First published: 24/01/2020
Authorisation details
Product details | |
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Name |
Clopidogrel / Acetylsalicylic acid Mylan
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Agency product number |
EMEA/H/C/004996
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B01AC30
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Generic |
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 | |
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Marketing-authorisation holder |
Mylan S.A.S.
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
09/01/2020
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Contact address |
Product information
11/01/2021 Clopidogrel / Acetylsalicylic acid Mylan - EMEA/H/C/004996 - IB/0004
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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