COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aliflus» (18A04308)
Estratto determina PPA n. 489/2018 del 21 maggio 2018 E' autorizzata la seguente variazione: C.I.z) Introduzione dell'Environmental Risk Assessment (ERA) ed aggiornamento dell'overview non-clinica, relativamente alla specialita' medicinale ALIFLUS ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: SE/H/170/01-03/II/91. Titolare AIC: Menarini International Operations Luxembourg S.A., codice SIS 0734. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in...
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