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Atrial Fibrillation

Sanofi Aventis : Multaq(R) (dronedarone) Recommended for Approval in the European Union

Published in Drug Week, October 16th, 2009

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that 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 Multaq® (dronedarone - 400mg Tablets).

The CHMP has recommended the approval of Multaq® in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

In the Summary of Positive Opinion, the CHMP has acknowledged that dronedarone has been shown, in addition to its rhythm and rate...

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