Clopidogrel / Acetylsalicylic acid Mylan

clopidogrel / acetylsalicylic acid

Overview
Authorisation details
Product information
Assessment history

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.

: The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription. The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist.

: Both active substances in the medicine, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help to prevent components in the blood called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming.
Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together. The combination of the two active substances reduces the risk of blood clots forming more than either medicine alone.
Both active substances have been available in the EU for a number of years. Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.

: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.
As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin. Therefore, the Agency’s view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored. Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.

: Clopidogrel/Acetylsalicylic acid Mylan received a marketing authorisation valid throughout the EU on 09 January 2020.

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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

More detail is available in the summary of product characteristics

This EPAR was last updated on 27/01/2021

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
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
Marketing-authorisation holder	Mylan S.A.S.
Revision	2
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

11/01/2021 Clopidogrel / Acetylsalicylic acid Mylan - EMEA/H/C/004996 - IB/0004

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Clopidogrel / Acetylsalicylic acid Mylan : EPAR - Product information (PDF/753.18 KB) (updated)

First published: 24/01/2020
Last updated: 27/01/2021
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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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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Clopidogrel / Acetylsalicylic acid Mylan : EPAR - All Authorised presentations (PDF/49.8 KB)

First published: 24/01/2020
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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

Assessment history

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Clopidogrel / Acetylsalicylic acid Mylan

Table of contents

Overview