COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Depo Medrol». (14A00586)
Estratto determinazione V &
A/54 del 20 gennaio 2014 Titolare AIC: Pfizer Italia S.r.l. (codice fiscale 06954380157) con sede legale e domicilio fiscale in Via Isonzo, 71, 04100 - Latina - Italia Medicinale: DEPO MEDROL Variazione AIC: C.I.4) Modifiche concernenti la sicurezza, l'efficacia e la farmacovigilanza medicinali per uso umano e veterinario Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica degli stampati relativamente alle...
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