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Mediator® obtains Marketing Authorisation


Official pharmacovigilance investigation of Mediator® initiated by AFSSAPS (French Agency for the Safety of Health Products) – Opening of the European investigation


First cases of aortic valvulopathy and pulmonary arterial hypertension in two patients treated with Mediator®


In response to the European health agency’s request, Servier proposes a study protocol on Mediator® to the Italian and French authorities.

  • Servier stops marketing Mediator® in Spain and in Italy for commercial and industrial reasons
  • Publication of a case of valvulopathy in Spain
  • According to the National Pharmacovigilance Committee, the number of cases of pulmonary arterial hypertension does not constitute a significant signal of the toxicity of Mediator®
  • 2005-2009: Servier carries out a study of the efficacy and safety of Mediator® in diabetic patients
  • The Marketing Authorisation Committee reassesses the benefit-risk ratio of Mediator® and proposes a change in the indications.

AFSSAPS authorises the marketing of two generics of Mediator®

  • The National Pharmacovigilance Committee identifies and validates the signal of valvulopathies in patients treated with Mediator.
  • The CAMM (Marketing Authorisation Committee) concludes that Benfluorex has a negative benefit-risk ratio
  • Suspension of the marketing authorisation of Mediator® and its generics by AFSSAPS