Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
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).
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.