Multaq inches closer to EU approval

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Sanofi-Aventis’ atrial fibrillation (AF) drug Multaq (dronedarone–400mg tablets).

The CHMP recommended the approval of Multaq in adult clinically stable patients with history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate, according to the Paris-based company.

The positive opinion from the CHMP needs now to be ratified by the European Commission.