MedPath
EMA Approval

Grepid

B01AC04

clopidogrel

Antithrombotic agents

clopidogrel

Peripheral Vascular DiseasesStrokeMyocardial Infarction

clopidogrel (as besilate)

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeB01AC04
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

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).

Authorisations (2)

EMEA/H/C/001059

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

Authorised

July 27, 2009

EMEA/H/C/001059

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

Authorised

July 27, 2009

Active Substances (1)

clopidogrel (as besilate)

Documents (9)

Grepid : EPAR - Public assessment report

August 4, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Grepid

May 28, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Grepid : EPAR - Summary for the public

August 4, 2009

OVERVIEW_DOCUMENT

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

June 23, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

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

October 12, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Grepid : EPAR - Public assessment report

August 4, 2009

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Grepid

May 28, 2009

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Grepid : EPAR - Product Information

October 12, 2009

DRUG_PRODUCT_INFORMATION

Grepid : EPAR - All Authorised presentations

August 4, 2009

AUTHORISED_PRESENTATIONS

Overview Q&A (8)

Question

How is Grepid used?

Answer

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

Question

How does Grepid work?

Answer

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.

Question

Other information about Grepid

Answer

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

Question

How has Grepid been studied?

Answer

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.

Question

What are the benefit and risk of Grepid?

Answer

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.

Question

Why has Grepid been approved?

Answer

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.

Question

What is Grepid?

Answer

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.

Question

What is Grepid used for?

Answer

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.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.