MYLAN S.P.A. -
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. Modifica apportata ai sensi del Decreto legislativo 29/12/2007, n. 274. Procedura Europea n. SE/H/0518/001/IB/016 Codice pratica n. C1B/2012/2005 Specialita' Medicinale: FLUOXETINA GENERICS Confezioni: Autorizzazione All'immissione in Commercio n. 037053/M - tutte le confezioni autorizzate Titolare AIC: Mylan s.p.a Tipologia variazione: C.I.3, Tipo IB foreseen. Tipo di Modifica Modifica degli stampati Modifica Apportata: Aggiornamento stampati in linea con il PhVWP riguardo al possibile aumento del rischio di infertilita' maschile, dovuta alla compromissione spermatica, in seguito all'uso di Fluoxacina. E' autorizzata la modifica degli stampati richiesta (paragrafi 4.6 e 5.3...
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