NeLM news service
European Medicines Agency recommends suspension of all buflomedil-containing medicines

Source: European Medicines Agency

Date published: 18/11/2011 17:07

Summary
by: Yuet Wan

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded a review of the safety and efficacy of buflomedil, a vasoactive agent, used to treat the symptoms of peripheral arterial occlusive disease. The Committee stated that the risks of these medicines, particularly the risks of severe cardiological and neurological adverse reactions, are greater than their limited benefits, therefore the marketing authorisations of all buflomedil-containing medicines are to be suspended in all EU Member States where they are currently authorised. The CHMP’s recommendation will be sent to the EC for the adoption of a decision.

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