Overview

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).

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.

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.

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

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.

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.

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.

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.

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

Grepid : EPAR - Summary for the public

български (BG) (161.48 KB - PDF)
español (ES) (41.93 KB - PDF)
čeština (CS) (154.12 KB - PDF)
dansk (DA) (41.75 KB - PDF)
Deutsch (DE) (42.35 KB - PDF)
eesti keel (ET) (41.47 KB - PDF)
ελληνικά (EL) (170.9 KB - PDF)
français (FR) (41.95 KB - PDF)
italiano (IT) (41.83 KB - PDF)
latviešu valoda (LV) (149.39 KB - PDF)
lietuvių kalba (LT) (150.17 KB - PDF)
magyar (HU) (145.45 KB - PDF)
Malti (MT) (153.77 KB - PDF)
Nederlands (NL) (41.7 KB - PDF)
polski (PL) (159.72 KB - PDF)
português (PT) (41.98 KB - PDF)
română (RO) (143.5 KB - PDF)
slovenčina (SK) (150.23 KB - PDF)
slovenščina (SL) (110.77 KB - PDF)
Suomi (FI) (41.51 KB - PDF)
svenska (SV) (41.6 KB - PDF)

Product information

Grepid : EPAR - Product Information

български (BG) (649.17 KB - PDF)
español (ES) (566.25 KB - PDF)
čeština (CS) (615.92 KB - PDF)
dansk (DA) (550.53 KB - PDF)
Deutsch (DE) (516.15 KB - PDF)
eesti keel (ET) (494.35 KB - PDF)
ελληνικά (EL) (622.04 KB - PDF)
français (FR) (750.8 KB - PDF)
hrvatski (HR) (553.03 KB - PDF)
íslenska (IS) (618.25 KB - PDF)
italiano (IT) (582.3 KB - PDF)
latviešu valoda (LV) (601.06 KB - PDF)
lietuvių kalba (LT) (625.29 KB - PDF)
magyar (HU) (579.44 KB - PDF)
Malti (MT) (625.83 KB - PDF)
Nederlands (NL) (522.38 KB - PDF)
norsk (NO) (517.33 KB - PDF)
polski (PL) (553.89 KB - PDF)
português (PT) (523.3 KB - PDF)
română (RO) (555.05 KB - PDF)
slovenčina (SK) (527.92 KB - PDF)
slovenščina (SL) (576.16 KB - PDF)
Suomi (FI) (543.61 KB - PDF)
svenska (SV) (534.5 KB - PDF)

Latest procedure affecting product information: IB/0057/G

11/01/2024

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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).

Grepid : EPAR - All Authorised presentations

български (BG) (95.48 KB - PDF)
español (ES) (87.04 KB - PDF)
čeština (CS) (91.42 KB - PDF)
dansk (DA) (49.48 KB - PDF)
Deutsch (DE) (50.21 KB - PDF)
eesti keel (ET) (88.72 KB - PDF)
ελληνικά (EL) (92.05 KB - PDF)
français (FR) (92.2 KB - PDF)
hrvatski (HR) (92.97 KB - PDF)
íslenska (IS) (96 KB - PDF)
italiano (IT) (15.68 KB - PDF)
latviešu valoda (LV) (91.49 KB - PDF)
lietuvių kalba (LT) (92.52 KB - PDF)
magyar (HU) (96.63 KB - PDF)
Malti (MT) (93.54 KB - PDF)
Nederlands (NL) (15.72 KB - PDF)
norsk (NO) (49.55 KB - PDF)
polski (PL) (50.79 KB - PDF)
português (PT) (88.37 KB - PDF)
română (RO) (90.75 KB - PDF)
slovenčina (SK) (91.47 KB - PDF)
slovenščina (SL) (90.6 KB - PDF)
Suomi (FI) (88.63 KB - PDF)
svenska (SV) (89.49 KB - PDF)

Product details

Name of medicine
Grepid
Active substance
clopidogrel (as besilate)
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AC04

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.

Authorisation details

EMA product number
EMEA/H/C/001059

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.

Marketing authorisation holder
Pharmathen S.A.

6, Dervenakion str.
Pallini Attiki
Greece

Opinion adopted
29/05/2009
Marketing authorisation issued
27/07/2009
Revision
27

Assessment history

Grepid : EPAR - Procedural steps taken and scientific information after authorisation

Grepid : EPAR - Public assessment report

CHMP summary of positive opinion for Grepid

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