Clopidogrel / Acetylsalicylic acid Mylan

The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription. The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.

For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist.

Both active substances in the medicine, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help to prevent components in the blood called platelets from sticking together and forming clots, thus helping to prevent another heart attack.

Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming.

Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together. The combination of the two active substances reduces the risk of blood clots forming more than either medicine alone.

Both active substances have been available in the EU for a number of years. Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been available for over 100 years.

Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.

As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin. Therefore, the Agency’s view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored. Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.

Clopidogrel/Acetylsalicylic acid Mylan received a marketing authorisation valid throughout the EU on 09 January 2020.