COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Prontobario Colon». (14A09950)
Estratto determina V &
A n. 2546/2014 del 2 dicembre 2014 Autorizzazione della variazione relativamente al medicinale PRONTOBARIO COLON. E' autorizzata la seguente variazione: B.II.a.5 Modifica nella concentrazione di un prodotto monodose per uso parenterale, utilizzazione totale, quando la quantita' di sostanza attiva per dose unitaria (vale a dire il dosaggio) rimane la stessa, relativamente al medicinale Prontobario Colon, nelle forme e confezioni, numeri A.I.C.: A.I.C. n. 028557015 - "94,015 g polvere per sospensione rettale" sacca 400 g: =============================================== | Da | A | +=============================+===============+ |Documentazione chimica | | |autorizzata | 3.2.P.1 | +-----------------------------+---------------+ | | Bario Solfato | |Bario Solfato 94,015 (% w/w) | 96,48 (% w/w) | +-----------------------------+---------------+ E' autorizzata la rettifica dello standard terms e della descrizione della confezione A.I.C. n. 028557015 da: "94,015 g polvere per sospensione rettale" sacca 400 g a: "96,48 % P/P polvere per sospensione rettale" sacca 400 g. Titolare A.I.C.: Bracco Imaging Italia s.r.l. con sede legale e domicilio fiscale in via Folli Egidio n. 50 - 20134 Milano (MI) - Italia;
(codice fiscale n. 05501420961). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determinazione, al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura. 2. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile...
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