NeLM news service
European CHMP convenes meeting to discuss ongoing review of safety of dronedarone (Multaq)

Source: European Medicines Agency

Date published: 01/09/2011 17:25

Summary
by: Yuet Wan

The Committee on Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is meeting on 2 September 2011 to discuss the ongoing review of the benefits and risks of dronedarone (Multaq). The current review began in January 2011 following reports of liver damage in two patients. In July 2011, the scope of the review was extended to examine new data related to effects on the heart, blood vessels and lungs. The additional meeting is being held because the new safety information only became available shortly before the last meeting in July. The new data have now been analysed as well as additional information requested from the manufacturers. After the meeting, the EMA will announce the outcome of the Committee's discussions and explain the next steps to be taken.

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