Clopidogrel / Acetylsalicylic acid Mylan

clopidogrel / acetylsalicylic acid

Opinion

On 14 November 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Clopidogrel/Acetylsalicylic acid Mylan, intended for the secondary prevention of atherothrombotic events. The applicant for this medicinal product is Mylan S.A.S.

Clopidogrel/Acetylsalicylic acid Mylan will be available as film-coated tablets (75 mg clopidogrel with 75 or 100 mg acetylsalicylic acid). The active substances, clopidogrel and acetylsalicylic acid, are antithrombotic agents (ATC code: B01AC30). The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Acetylsalicylic acid also inhibits platelet aggregation by irreversible inhibition of prostaglandin cyclo-oxygenase and thus inhibits the generation of thromboxane A2, an inducer of platelet aggregation and vasoconstriction.

Clopidogrel/Acetylsalicylic acid Mylan is a generic of DuoPlavin, which has been authorised in the EU since 15 March 2010. Studies have demonstrated the satisfactory quality of Clopidogrel/Acetylsalicylic acid Mylan, and its bioequivalence to the reference product DuoPlavin.

The full indication is:

“Clopidogrel/Acetylsalicylic acid Mylan is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Mylan 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“

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Clopidogrel / Acetylsalicylic acid Mylan
Agency product number
EMEA/H/C/004996
International non-proprietary name (INN) or common name
  • clopidogrel / acetylsalicylic acid
Active substance
  • acetylsalicylic acid
  • clopidogrel hydrogen sulfate
Therapeutic area
Acute Coronary Syndrome
Myocardial Infarction
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.

Date opinion adopted
14/11/2019
Company name
Mylan S.A.S.
Status
Positive
Application type
Initial authorisation

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