Dronedarone is indicated for treating and preventing a number of types of cardiac dysrhythmias.
Being the newer version of Amiodarone, Unipharm’s generic Dronedarone Tablets were launched in Israel in 2020.
Dronedarone Tablets are available for EU submission with an early launch. The Dossier includes a new EU bioequivalence study compared to the EU Reference Listed Drug, Multaq.