This is a summary of the European public assessment report (EPAR) for DuoPlavin. 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 DuoPlavin.
- What is DuoPlavin?
DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin). It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
- What is DuoPlavin used for?
DuoPlavin is used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries), such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid. It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome’:
- patients who are having ‘unstable angina’ (a severe type of chest pain) or a myocardial infarction (heart attack) with no ‘ST-segment elevation’ (an abnormal reading on the ECG or electrocardiogram), including in patients having a stent (a short tube) inserted into an artery to prevent it from closing up;
- patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
The medicine can only be obtained with a prescription.
- How is DuoPlavin used?
DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
- How does DuoPlavin work?
Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are ‘inhibitors of platelet aggregation’. This means that they help to prevent blood cells called platelets from aggregating (sticking together) and forming clots. 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. Acetylsalicylic acid stops the platelets aggregating by blocking an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by binding platelets together. When taken together, the two active substances can reduce the risk of blood clots forming, helping to prevent another heart attack.
Both active substances have been available in the European Union (EU) for a number of years. Clopidogrel has been authorised as Plavix and Iscover since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.
- How has DuoPlavin been studied?
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way as the two medicines taken separately. It also presented the results of previous studies involving over 60,000 patients with acute coronary syndrome, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was effective at preventing atherothrombotic events such as heart attacks.
- What benefit has DuoPlavin shown during the studies?
DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
- What is the risk associated with DuoPlavin?
The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured. For the full list of all side effects reported with DuoPlavin, see the package leaflet.
DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells). It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose). DuoPlavin must not be used during the last three months of pregnancy.
- Why has DuoPlavin been approved?
The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets. The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about DuoPlavin
The European Commission granted a marketing authorisation valid throughout the EU for DuoPlavin on 15 March 2010.
For more information about treatment with DuoPlavin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 25/02/2016 .
14/01/2016 DuoPlavin -EMEA/H/C/001143 -WS/0856
- 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.
DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in:
- 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;
- ST-segment-elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.
Changes since initial authorisation of medicine
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|DuoPlavin : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||28/09/2010||25/02/2016|
Initial marketing-authorisation documents
This medicine is approved for use in the European Union