September 28, 2011
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of Multaq. The anti-arrhythmic medicine should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation (AF) for the maintenance of sinus rhythm after successful cardioversion, they say.
September 20, 2010
The National Institute for Health and Clinical Excellence (NICE) has published final guidance on the use of Multaq® (dronedarone) for the treatment of atrial fibrillation (AF).
April 9, 2010
The National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document (ACD)1 for Multaq® (dronedarone) indicating its intention to recommend its use for the management of patients with atrial fibrillation (AF).
October 14, 2009
Sanofi-aventis has 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).
July 7, 2009
It has recently been announced that the U.S. Food and Drug Administration (FDA) has approved the use of dronaderone (Multaq®) for patients with atrial fibrillation (AF) or atrial flutter (AFL). Multaq® is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.
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