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CHRONOLOGY



1974

Mediator® obtains Marketing Authorisation

1998

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

1999

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

2001

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

2003
  • Servier stops marketing Mediator® in Spain and in Italy for commercial and industrial reasons
  • Publication of a case of valvulopathy in Spain
2005
  • 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
2007
  • The Marketing Authorisation Committee reassesses the benefit-risk ratio of Mediator® and proposes a change in the indications.
2008

AFSSAPS authorises the marketing of two generics of Mediator®

2009
  • 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