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Clopidogrel Teva Generics B.V. (clopidogrel hydrochloride) - B01AC04

Updated on site: 06-Oct-2017

Medication nameClopidogrel Teva Generics B.V.
ATC CodeB01AC04
Substanceclopidogrel hydrochloride
ManufacturerTeva Pharma B.V.
EMA/495983/2010
EMEA/H/C/002254
EPAR summary for the public

Clopidogrel Teva Generics B.V.

clopidogrel

This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva

Clopidogrel Teva Generics B.V. is a ‘generic medicine’. This means that Clopidogrel Teva Generics B.V. is similar to a ‘reference medicine’ al eady authorised in the European Union (EU) called Plavix. For

more information on generic medicines, see the question-and-answer document here.

What is ClopidogrelMedicinalTeva Generics B.V. used for?

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

patients who have recently had a myocardial infarction (heart attack). Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. can be started between seven days and six months after the stroke;

patients with peripheral arterial disease (problems with blood flow in the arteries);

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel Teva Generics B.V. can be used in patients who are having a heart attack with ‘ST segment elevation’ (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave’ myocardial infarction.

The medicine can only be obtained with a prescription.

How is Clopidogrel Teva Generics B.V. used?

The standard dose of Clopidogrel Teva Generics B.V. is one 75-mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva Generics B.V. is used tog ther with aspirin and treatment generally starts with a loading dose of four tablets. This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myoca d al infarction) or for up to 12 months (in non-ST segment elevation syndrome).

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 bec ming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or st oke.

no aggregation. This means that it producthelps to prevent blood clots from forming. When the blood clots, this is

How has ClopidogrelMedicinalTeva Generics B.V. been studied?

Because Clopidogrel Teva Generics B.V. is a generic medicine, studies in patients have been limited to tests to determine that t is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent wh n they produce the same levels of the active substance in the body.

What are the benefit and risk of Clopidogrel Teva Generics B.V.?

Because Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. been approved?

The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Generics B.V. 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 Teva Generics B.V. be given marketing authorisation.

Other information about Clopidogrel Teva Generics B.V.:

The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Generics B.V. to Teva Generics B.V. on 28 October 2010. The marketing authorisation is valid for five years, after which it can be renewed.

The full EPAR for Clopidogrel Teva Generics B.V. can be found on the Agency’s website under EMA website/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Clopidogrel Teva Generics B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 08-2010.

 

 

 

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