Buflomedil (LOFTYL): confirmation of the suspension of the marketing authorisation

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended in May 2011 to suspend the marketing authorisation (MA) of the buflomedil-containing medicines, awaiting of the completion of the reassessment of their benefit / risk balance. In Belgium LOFTYL 150 mg (single presentation still marketed in May 2011) has since been withdrawn. CHMP has finished the review of buflomedil and confirms the recommendation of May 2011. Buflomedil-containing medicines can no longer be marketed.

See EMA website .

Contact: vig@fagg-afmps.be

Last updated on 30/11/2011