Grepid

clopidogrel

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About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Grepid?

Grepid is a medicine that contains the active substance clopidogrel. It is available as pink tablets (75 mg).

Grepid is a ‘generic medicine’. This means that Grepid is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.

What is Grepid used for?

Grepid is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Grepid can be given to the following groups of patients:

  • patients who have recently had a myocardial infarction (heart attack). Grepid can be started between a few days and 35 days after the attack;
  • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Grepid can be started between seven days and six months after the stroke;
  • patients with peripheral arterial disease (problems with blood flow in the arteries).

The medicine can only be obtained with a prescription.

How is Grepid used?

The standard dose of Grepid is one 75 mg tablet once a day, taken with or without food.

How does Grepid work?

The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).

Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

How has Grepid been studied?

Because Grepid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Grepid?

Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Grepid been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Grepid be given marketing authorisation.

Other information about Grepid

The European Commission granted a marketing authorisation valid throughout the EU for Grepid to Pharmathen S.A. on 28 July 2009.

Name Language First published Last updated
Grepid : EPAR - Summary for the public BG = bălgarski 05/08/2009  
Grepid : EPAR - Summary for the public ES = español 05/08/2009  
Grepid : EPAR - Summary for the public CS = čeština 05/08/2009  
Grepid : EPAR - Summary for the public DA = dansk 05/08/2009  
Grepid : EPAR - Summary for the public DE = Deutsch 05/08/2009  
Grepid : EPAR - Summary for the public ET = eesti keel 05/08/2009  
Grepid : EPAR - Summary for the public EL = elliniká 05/08/2009  
Grepid : EPAR - Summary for the public EN = English 05/08/2009  
Grepid : EPAR - Summary for the public FR = français 05/08/2009  
Grepid : EPAR - Summary for the public IT = italiano 05/08/2009  
Grepid : EPAR - Summary for the public LV = latviešu valoda 05/08/2009  
Grepid : EPAR - Summary for the public LT = lietuvių kalba 05/08/2009  
Grepid : EPAR - Summary for the public HU = magyar 05/08/2009  
Grepid : EPAR - Summary for the public MT = Malti 05/08/2009  
Grepid : EPAR - Summary for the public NL = Nederlands 05/08/2009  
Grepid : EPAR - Summary for the public PL = polski 05/08/2009  
Grepid : EPAR - Summary for the public PT = português 05/08/2009  
Grepid : EPAR - Summary for the public RO = română 05/08/2009  
Grepid : EPAR - Summary for the public SK = slovenčina 05/08/2009  
Grepid : EPAR - Summary for the public SL = slovenščina 05/08/2009  
Grepid : EPAR - Summary for the public FI = suomi 05/08/2009  
Grepid : EPAR - Summary for the public SV = svenska 05/08/2009  

This EPAR was last updated on 22/01/2016 .

Authorisation details

Product details

Product details for Grepid
NameGrepid
Agency product numberEMEA/H/C/001059
Active substance

clopidogrel besilate

International non-proprietary name (INN) or common name

clopidogrel

Therapeutic area Peripheral Vascular DiseasesStrokeMyocardial Infarction
Anatomical therapeutic chemical (ATC) code B01AC04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Grepid
Marketing-authorisation holder

Pharmathen S.A.

Revision12
Date of issue of marketing authorisation valid throughout the European Union28/07/2009

Contact address:

Pharmathen S.A.
6, Dervenakion str.
Pallini Attiki
Greece

Product information

Product information

09/12/2015  Grepid -EMEA/H/C/001059 -IB/0037/G

Name Language First published Last updated
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016
Grepid : EPAR - Product Information SV = svenska 13/10/2009 22/01/2016

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

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.


Name Language First published Last updated
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010
Grepid : EPAR - All Authorised presentations SV = svenska 05/08/2009 05/03/2010

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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 seven days until less than six 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.

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 and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Grepid : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 13/10/2009 22/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Grepid : EPAR - Public assessment report SV = svenska 05/08/2009  
Committee for medicinal products for human use, summary of positive opinion for Grepid SV = svenska 29/05/2009  

Authorised

This medicine is approved for use in the European Union

More information on Grepid