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Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation
Date:11/30/2009

PARIS, November 30 /PRNewswire-FirstCall/ --

- First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Commission has granted marketing authorization for Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA).

Multaq(R) is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

Multaq(R) discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL as described in the ATHENA trial.

"The approval of Multaq(R) in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach," said Marc Cluzel, MD, Executive Vice President, Research and Development, sanofi-aventis. "The approval of Multaq(R) is the result of more than 15 years of research and development conducted by sanofi-aventis and supported by the commitment of the experts involved in the clinical development program and AF patients participating in the trials."

The use of dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35%, the use o
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SOURCE Sanofi-aventis
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Related medicine technology :

1. Landmark ATHENA Study Findings With Multaq(R) (dronedarone) Shows 24% Reduction In Cardiovascular Hospitalization or Death in Patients With Atrial Fibrillation
2. ATHENA Clinical Results for Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress
3. ATHENA Clinical Results with Dronedarone (Multaq(R)) Highlighted at the World Cardiology Congress
4. Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
5. American Heart Journals Publishes Results From ERATO Trial Showing Dronedarone (Multaq(R)) Improves Ventricular Rate Control in Patients With Permanent Atrial Fibrillation
6. Further Analysis From ATHENA Study Showed That Multaq(R)(Dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
7. Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
8. Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation
9. New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation
10. FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
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