Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 22 October 2018

Indication(s)

Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults
-For non-surgery patients: atrial fibrillation ≤ 7 days duration
-For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration.

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Category Value
Agency product number EMEA/H/C/001215
Orphan designation No
Date First Approved 01-09-2010
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Cardiome UK Limited