Multaq inches closer to EU approval
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.
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.