COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura nazionale, del medicinale «Iodoten» (12A09687)
Estratto determinazione V & A n. 1190 del 30 agosto 2012
Medicinale: IODOTEN.
Titolare A.I.C.: Sanitas Lab. chimico farmaceutico S.r.l. (codice fiscale 01799860067) con sede legale e domicilio fiscale in via Guala n. 4 - 15057 Tortona (Alessandria) Italia.
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 del nuovo produttore del principio attivo iodio povidone:
Xian Medicines & Health Products - Imp & Exp Corp Xian (China) - impianto di produzione: Boai Country Kaiyuang Fine Chemical...
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