COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Biodermatin» (17A07064)
Estratto determina AAM/PPA n. 936/2017 del 3 ottobre 2017 Autorizzazione della variazione C.I.4 una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, relativamente al medicinale BIODERMATIN. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto al paragrafo 4.2 e corrispondenti sezioni del foglio illustrativo e l'adeguamento del RCP, FI ed etichette al formato QRD attualmente vigente e al formato richiesto dalla «Guideline on the readability of the labelling and package leaflet of medicinal products for human use»;
vengono apportate modifiche formali ai paragrafi 1, 2, 4.3, 4.4, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.6, 8, 9 e 10 dell'RCP in accordo al DL219/2006 relativamente al medicinale «Biodermatin», nelle forme e confezioni: A.I.C. n. 010130021 - «5 mg compresse» 30 compresse;
A.I.C. n. 010130060 - «20 mg granulato effervescente» 30 bustine. Gli stampati corretti ed approvati sono allegati alla presente determinazione. Titolare A.I.C.: Alliance Pharma S.r.l. (codice fiscale n. 04628980965), con sede legale e domicilio fiscale in viale Restelli n. 5 - 20124 Milano (Italia). 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 2006, n. 219, e successive modificazioni ed integrazioni, il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende avvalersi dell'uso complementare di lingue estere, deve darne preventiva...
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