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 their 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 Clopidogrel ratiopharm?
Clopidogrel ratiopharm is a medicine that contains the active substance clopidogrel. It is available as white, round tablets (75 mg).
Clopidogrel ratiopharm is a ‘generic medicine’. This means that Clopidogrel ratiopharm is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.
- What is Clopidogrel ratiopharm used for?
Clopidogrel ratiopharm is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel ratiopharm can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel ratiopharm 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). Clopidogrel ratiopharm 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 Clopidogrel ratiopharm used?
The standard dose of Clopidogrel ratiopharm is one 75 mg tablet once a day, taken with or without food.
- How does Clopidogrel ratiopharm work?
The active substance in Clopidogrel ratiopharm, 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 Clopidogrel ratiopharm been studied?
Because Clopidogrel ratiopharm 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 Clopidogrel ratiopharm?
Because Clopidogrel ratiopharm 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 Clopidogrel ratiopharm been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel ratiopharm 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 Clopidogrel ratiopharm be given marketing authorisation.
- Other information about Clopidogrel ratiopharm
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel ratiopharm to Acino Pharma GmbH on 23 September 2009.
This EPAR was last updated on 30/03/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
16/09/2010 Clopidogrel ratiopharm -EMEA/H/C/001173 -A20/0008
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.
Pharmacotherapeutic group
Antithrombotic agents
Therapeutic indication
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
* 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.
* 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.
For further information please refer to section 5.1.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Clopidogrel Ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 01/12/2009 | 30/03/2011 |
| Clopidogrel ratiopharm-H-C-1173-A-20-8 : EPAR - Assessment Report - Article 20 | (English only) | 30/03/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Clopidogrel Ratiopharm : EPAR - Public assessment report | (English only) | 16/10/2009 |
Authorised
This medicine is approved for use in the European Union
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