COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Epiduo» (17A07448)
Estratto determina PPA n. 967/2017 del 6 ottobre 2017 Autorizzazione delle variazioni e delle nuove confezioni. B.II.b.3.b) B.I.a.1.f) B.II.b.1.a) B.II.b.1.b) B.II.b.1.e) B.II.b.2.a) B.II.b.4.b) B.II.b.5.c) B.II.b.5.z) B.II.d.1.d) B.II.e.1.b.1) Si autorizzano le seguenti variazioni relativamente alla specialita' medicinale EPIDUO: Aggiunta di un sito per il controllo di qualita' di un principio attivo (benzoile perossido): SGS Lab Simon SA, Vieux Chemin du Poete 10, B-1301 Wavre, Belgio Aggiunta di un sito di fabbricazione del prodotto finito (produzione, confezionamento primario, confezionamento secondario, controllo dei lotti): Laboratoires Galderma Zone Industrielle de Montdesir 74540 Alby Sur Cheran Francia Modifiche sostanziali nel procedimento di fabbricazione del prodotto finito, per adeguamento al processo produttivo e alle attrezzature del nuovo sito produttivo (Laboratoires Galderma) Modifica della dimensione del lotto del prodotto finito: aggiunta batch size «500 Kg» e «1000 Kg» Modifiche delle prove in corso di fabbricazione e dei limiti applicati durante la fabbricazione del prodotto finito: soppressione di una prova in corso di fabbricazione non significativa (bulk product testing) e aggiunta del «controllo degli agglomerati» Modifica dei parametri di specifica e/o dei limiti del prodotto finito: soppressione di un parametro di specifica non significativo (minimum filling measurement) Aggiunta di un nuovo confezionamento primario del prodotto finito: contenitore multidose in PP/HDPE/VLDPE con pompa a tenuta d'aria E' autorizzata l'immissione in commercio del medicinale «Epiduo», nelle forme e confezioni (in aggiunta alle confezioni gia' autorizzate): 038261184 - Epiduo 0,3%/ 2,5% gel, 1 contenitore multi dose in PP/HDPE/VLDPE da 15 g con pompa a tenuta d'aria 038261196 - Epiduo 0,3%/ 2,5% gel, 1 contenitore multi dose in PP/HDPE/VLDPE da 30 g con pompa a tenuta d'aria 038261208 - Epiduo 0,3%/ 2,5% gel, 1 contenitore multi dose in PP/HDPE/VLDPE da 45...
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