Press Release: European Medicines Agency recommends suspension of all buflomedil-containing medicines

The European Medicines Agency, on 17 November 2011, recommended the suspension of all buflomedil-containing medicines.

Buflomedil is used to treat the symptoms of peripheral arterial occlusive disease (PAOD). This is a condition where the body’s large arteries become obstructed causing symptoms such as pain and weakness, particularly in the legs. The review of buflomedil was initiated by the European Medicines Agency (EMA) following the suspension of the marketing authorisation in France by the French regulatory authority in February 2011. Buflomedil-containing medicines have been authorised in the EU since the 1970s via national procedures.

Buflomedil is authorised in the form of tablets, an oral solution or a solution for injection in Austria, Belgium, Cyprus, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Poland, Portugal and Spain under the invented name Loftyl and other trade names.

EMA: Press Release: EMA/CHMP/570796/2011 (17.11.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/11/WC500117792.pdf

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