COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Nettacin collirio» (11A12404)
Estratto determinazione V & A.N n. 1036 del 22 luglio 2011
Titolare A.I.C.: S.I.F.I. S.p.A., con sede legale e domicilio fiscale in 95020 - Lavinaio Aci S. Antonio - Catania, via Ercole Patti n. 36 - codice fiscale 00122890874.
Medicinale: NETTACIN COLLIRIO.
Variazione A.I.C.: B.I.a.1.b Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzato nel procedimento di fabbricazione di una sostanza attiva o modifica del fabbricante della sostanza attiva (compresi, eventualmente, i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Introduzione di un nuovo fabbricante della sostanza attiva che ha il sostegno di un ASMF (master file della sostanza attiva)
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: e' autorizzata la modifica relativa all'introduzione di un nuovo produttore (che possiede un ASMF) per il principio attivo: «netilmicina solfato», come da tabella allegata:
Parte di provvedimento in formato grafico
La sostanza attiva del nuovo produttore Wuxi Fortune Pharmaceutical Co., Ltd e' controllata conformemente alla pertinente monografia (n. 1351) della F.E. edizione corrente.
Il periodo di re-test dell'attivo netilmicina solfato del produttore Wuxi Fortune Pharmaceutical Co., Ltd e' di 36...
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