Multaq (dronedarone) - Restriction of use and new monitoring requirements
01 November 2011
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has completed its benefit-risk assessment of Multaq (see IMB Drug Safety Newsletters February 2011 and August 2011). As a result of the emergence of safety issues in the post marketing period (hepatic, lung and the negative inotropic effect), new restrictions for the use of Multaq have been introduced to maintain a positive benefit-risk balance.
Multaq (dronedarone) - Restriction of use and new monitoring requirements