Clopidogrel Taw Pharma (previously Clopidogrel Mylan)

clopidogrel

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Clopidogrel Taw Pharma is a medicine used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in adults who have:

recently had a myocardial infarction (heart attack). Clopidogrel Taw Pharma can be started between a few days and 35 days after the attack;
recently had an ischaemic stroke (stroke caused by insufficient blood supply to part of the brain). Clopidogrel Taw Pharma can be started between seven days and six months after the stroke;
peripheral arterial disease (problems with blood flow in the arteries);
a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots). Acute coronary syndrome is a group of heart problems that include unstable angina (a severe type of chest pain) and certain types of heart attack. Some of these patients may have had a stent (a short tube) inserted into an artery to prevent it from closing up.

Clopidogrel Taw Pharma is also used to prevent problems caused by blood clots in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. It is used in patients who have at least one risk factor for events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.

Clopidogrel Taw Pharma contains the active substance clopidogrel and is a ‘generic medicine’. This means that Clopidogrel Taw Pharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Plavix. For more information on generic medicines, see the question-and-answer document here.

: Clopidogrel Taw Pharma is available as tablets. The standard dose is 75 mg once a day.
In acute coronary syndrome, treatment generally starts with a loading dose of 300 mg. This is then followed by the standard 75 mg dose once a day for between 4 weeks and up to 12 months.
Clopidogrel Taw Pharma can only be obtained with a prescription.
For more information about using Clopidogrel Taw Pharma, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Clopidogrel Taw Pharma, clopidogrel, is an antiplatelet medicine. This means that it helps to prevent components in the blood called platelets from sticking together and forming clots. 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 and helping to prevent another heart attack or stroke.

: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Plavix, and do not need to be repeated for Clopidogrel Taw Pharma.
As for every medicine, the company provided data on the quality of Clopidogrel Taw Pharma. 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.

: Because Clopidogrel Taw Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel Taw Pharma has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the Agency’s view was that, as for Plavix, the benefits of Clopidogrel Taw Pharma 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 Taw Pharma have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Clopidogrel Taw Pharma are continuously monitored. Suspected side effects reported with Clopidogrel Taw Pharma are carefully evaluated and any necessary action taken to protect patients.

: Clopidogrel Mylan received a marketing authorisation valid throughout the EU on 21 September 2009. The name of the medicine was changed to Clopidogrel Taw Pharma on 1 October 2021.

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Clopidogrel Taw Pharma (previously Clopidogrel Mylan) : EPAR - Summary for the public (PDF/166.24 KB)

First published: 14/10/2009
Last updated: 22/02/2022
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This EPAR was last updated on 01/07/2022

Authorisation details

Product details
Name	Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
Agency product number	EMEA/H/C/001134
Active substance	clopidogrel hydrochloride
International non-proprietary name (INN) or common name	clopidogrel
Therapeutic area (MeSH)	Peripheral Vascular Diseases Stroke Myocardial Infarction Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code	B01AC04
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	Taw Pharma (Ireland) Limited
Revision	20
Date of issue of marketing authorisation valid throughout the European Union	21/09/2009
Contact address	104 Baggot Street Lower Dublin 2 Co. Dublin D02 Y940 Ireland

Product information

29/06/2022 Clopidogrel Taw Pharma (previously Clopidogrel Mylan) - EMEA/H/C/001134 - IB/0048

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Clopidogrel Taw Pharma (previously Clopidogrel Mylan) : EPAR - Product information (PDF/472.23 KB)

First published: 15/12/2009
Last updated: 01/07/2022
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Clopidogrel Taw Pharma (previously Clopidogrel Mylan) : EPAR - All Authorised presentations (PDF/85.73 KB)

First published: 15/12/2009
Last updated: 22/02/2022
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- Slovenian
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- Spanish
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- Swedish
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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Secondary prevention of atherothrombotic events

Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- 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, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:
- Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event.

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

For further information please refer to section 5.1.

Assessment history

Changes since initial authorisation of medicine

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Clopidogrel Taw Pharma (previously Clopidogrel Mylan) : EPAR - Procedural steps taken and scientific information after authorisation (PDF/205.92 KB)

First published: 15/12/2009
Last updated: 01/07/2022

Clopidogrel Taw Pharma (previously Clopidogrel Mylan)

Table of contents

Overview