May 27, 2008- The European Medicines Agency (EMEA) has been formally notified by Sanofi Pharma Bristol- Myers Squibb SNC of its decision to withdraw its application for a centralised marketing authorisation for the medicine DuoPlavin (fixed-dose combination tablets of 75 mg clopidogrel/75 mg acetylsalicylic acid and 75 mg clopidogrel/100 mg acetylsalicylic acid). DuoPlavin was expected to be used by patients already taking clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome.
The application for marketing authorisation for DuoPlavin was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP)
The details can be read here.
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