Clopidogrel BGR (previously Zylagren)

Authorised

This medicine is authorised for use in the European Union

clopidogrel

Overview

This is a summary of the European public assessment report (EPAR) for Clopidogrel BGR. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel BGR.

What is Clopidogrel BGR?

Clopidogrel BGR is a medicine that contains the active substance clopidogrel. It is available astablets (75 mg).

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

What is Clopidogrel BGR used for?

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

• patients who have recently had a myocardial infarction (heart attack). Clopidogrel BGR 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 BGR 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 BGR used?

The standard dose of Clopidogrel BGR is one 75 mg tablet once a day.

How does Clopidogrel BGR work?

The active substance in Clopidogrel BGR, 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 BGR been studied?

Because Clopidogrel BGR is a generic medicine, studies in people 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 benefits and risks of Clopidogrel BGR?

Because Clopidogrel BGR 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 BGR been approved?

The CHMP concluded that, in accordance with EU requirements, Clopidogrel BGR 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 BGR be given marketing authorisation.

Other information about Clopidogrel BGR

The European Commission granted a marketing authorisation valid throughout the EU for Zylagren on 21 September 2009. The name of the medicine was changed to Clopidogrel BGR on 14 July 2014.

For more information about treatment with Clopidogrel BGR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Clopidogrel BGR (previously Zylagren) : EPAR - Summary for the public

Reference Number: EMA/658100/2014

Product information

Clopidogrel BGR : EPAR - Product Information

Clopidogrel BGR (previously Zylagren) : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel BGR (previously Zylagren)
• Active substance:
  clopidogrel (as hydrogen sulfate)
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
• Anatomical therapeutic chemical (ATC) code:
  B01AC03

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 7 days until less than 6 months) or established peripheral arterial disease.

Authorisation details

• EMA product number:
  EMEA/H/C/001138
• 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:
  Biogaran

  15, boulevard Charles de Gaulle; 92707 Colombes Cedex; France

• Marketing authorisation issued:
  21/09/2009
• Revision:
  17

Assessment history

Changes since initial authorisation of medicine

Clopidogrel BGR (previously Zylagren) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Clopidogrel BGR (previously Zylagren) : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Zylagren