CHMP meeting to discuss Multaq on Friday 2 September

News 01/09/2011

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) is meeting on 2 September 2011 to discuss the ongoing review of the benefits and risks of Multaq (dronedarone).

The current review of Multaq began in January 2011 on the request of the European Commission, following reports of liver damage in two patients taking the medicine. In July 2011, the scope of the review was extended to also look at new data related to the effects of the medicine on the heart, blood vessels and lungs.

The Committee is holding this additional meeting outside of its normal schedule because the new information on the safety of Multaq only became available shortly before the Committee's last plenary meeting of 18-21 July 2011. The assessors have now analysed the new data in depth, as well as additional information requested from the marketing-authorisation holder, in preparation for Friday's meeting.

Multaq has been authorised in the European Union since November 2009 for use in patients with atrial fibrillation, a condition where the upper chambers of the heart contract rapidly and in an irregular fashion.

After Friday's meeting, the Agency will announce the outcome of the Committee's discussions and explain the next steps.

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