COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Colifoam» (18A06067)
Estratto determina AAM/PPA n. 739/2018 del 31 agosto 2018 Si autorizzano le seguenti variazioni: VN2/2017/182, Tipo II, C.I.4): aggiornamento degli stampati sulla base di nuove informazioni di sicurezza, in linea con l'ultima versione del CCDS aziendale (gennaio 2017) e con i dati di letteratura;
N1B/2015/3118, Tipo IB, C.I.z): aggiornamento del Foglio illustrativo in seguito ai risultati del Readability User Test e adeguamento del Riassunto delle caratteristiche del prodotto e delle etichette al QRD template;
N1B/2017/1212, Tipo IB, C.I.z): aggiornamento degli stampati in linea con le conclusioni della procedura PSUSA 00000449-201604. Si modificano i paragrafi 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.4, 6.5 e 6.6 del Riassunto delle caratteristiche del prodotto (RCP) e l'intero Foglio illustrativo ed etichette. Le presenti variazioni si applicano alla specialita' medicinale COLIFOAM, nella seguente forma e confezione autorizzata all'immissione in commercio in Italia, cosi' come di seguito indicato: A.I.C. n. 027000013 - «10 g /100 g schiuma rettale». Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Codici pratica: VN2/2017/182 - N1B/2015/3118 - N1B/2017/1212. Titolare AIC: Meda Pharma S.p.a. (Codice fiscale n. 00846530152). Stampati 1. Il titolare dell'Autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina 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...
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