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Effects of the European restrictive actions concerning nimesulide prescription: a simulation study on hepatopathies and gastrointestinal bleedings in Italy
Annali dell'Istituto Superiore di Sanità
In 2002 and 2007 the European Medicines Agency (EMA) examined the signals of a greater risk of hepatopathies related to nimesulide use. In 2007 restrictive actions were adopted in Europe. Moreover, EMA initiated a new referral in February 2010. The objective of this paper is to evaluate the effects of the 2007 regulatory measures concerning nimesulide and to estimate the potential effect of further actions. Specifically, we carried out a simulation on the expected number of hospitalisations forpmid:20567066 fatcat:i47rcg5u5zcw3eblf6exofqqfu