COMUNICATO - Comunicato relativo alla determina V & A n. 260/2013 di autorizzazione all'immissione in commercio del medicinale per uso umano «Drytec» (13A04405)
Estratto determinazione V &
A/703 del 3 maggio 2013 Titolare AIC: GE Healthcare S.r.l. con sede legale e domicilio fiscale in via Galeno, 36 - 20126 Milano - codice fiscale 01778520302. Medicinale: DRYTEC. Variazione AIC: richiesta rettifica determinazione. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato: All'estratto della determinazione V &
A n. 260/2013 del 21 febbraio 2013 pubblicato nel supplemento ordinario n. 19 alla Gazzetta Ufficiale della Repubblica italiana, serie generale n. 69 del 22 marzo 2013 concernente "l'Autorizzazione all'immissione in commercio" del medicinale: "DRYTEC" e' apportata la seguente modifica: a pagina 1 della pubblicazione sulla Gazzetta Ufficiale, alla colonna di destra al paragrafo "Principio attivo" invece di: «Principio attivo: sodio molibdato (99 Mo) 2,5-40 GBq che produce l'isotopo figlio sodio pertecnetato (99m Tc) 2,08-41,58 GBq alla data e ora di calibrazione», leggasi: «Principio attivo: sodio molibdato (99 Mo) 2,5-40 GBq che produce l'isotopo figlio sodio pertecnetato (99m Tc) 2,0-31,7 GBq alla data e ora di calibrazione»;
a pagina 3 della pubblicazione sulla Gazzetta Ufficiale, alle ultime tre righe dell'estratto invece di: «Decorrenza di efficacia della determinazione: dal giorno successivo a quello della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana», leggasi: «Decorrenza di efficacia della determinazione: dal giorno successivo a quello della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana, fatto salvo un periodo transitorio della durata di 90 giorni, a decorrere da tale data, al fine di provvedere all'adeguamento di tutte le confezioni ed alla predisposizione degli stampati con riferimento in particolare al riassunto delle caratteristiche del prodotto, al foglio illustrativo ed alle etichette del generatore. Per le etichette dei flaconcini di soluzione salina e dei flaconcini sottovuoto, facenti parte dei kit di eluizione, il periodo transitorio di cui sopra e' di 180 giorni. La stessa determinazione...
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