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