Multaq (dronedarone)
- Region
- 🇪🇺 EU
- Active substance
- dronedarone
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Atrial Fibrillation
- CHMP opinion
- Thu 24 Sep 2009
- EU approval
- Wed 25 Nov 2009
- Application
- EMEA/H/C/001043
- ATC
- C01BD07
- Official record
- www.ema.europa.eu
Indication
Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered. Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Multaq Application withdrawn · Sanofi-Aventis
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.