COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Soluzione per emodiafiltrazione Baxter». (14A03741)
Estratto determinazione V &
A 883 del 5 maggio 2014 Medicinale: SOLUZIONE PER EMODIAFILTRAZIONE BAXTER. Titolare A.I.C.: Baxter S.p.a. con sede legale e domicilio fiscale in piazzale dell'Industria, 20 - 00144 Roma - Codice fiscale 00492340583. Variazione A.I.C.: B.I.a.1.c 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 - Il fabbricante proposto utilizza un procedimento di sintesi o condizioni di fabbricazione sostanzialmente diversi e tali da modificare caratteristiche qualitative importanti del principio attivo, come il profilo di impurita' qualitativo e/o quantitativo che necessita di una qualificazione o proprieta' fisico-chimiche aventi un impatto sulla biodisponibilita'. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata. E' autorizzata la modifica relativa all'aggiunta del produttore Church &
Dwight Co. Inc., 2501 East County Road #34, Old Fort, Ohio 44861 per il principio attivo sodio bicarbonato relativamente al medicinale indicato in oggetto e alle confezioni sotto elencate: 031510124 - «Bicarbonato 45 MMOL/L» 4 sacche clear-flex 3000 ml con connettore standard;
031510136 - «Bicarbonato 40 MMOL/L» 4 sacche clear-flex 3000 ml con connettore standard;
031510148 - «Bicarbonato 60 MMOL/L» 4 sacche clear-flex 3000 ml con connettore standard;
031510151 - «Bicarbonato 20 MMOL/L» 4 sacche clear-flex 3000 ml con connettore standard;
031510163 - «Bicarbonato 60 MMOL/L» 4 sacche clear-flex 3000 ml con connettore emoluer;
031510175 - «Bicarbonato 40 MMOL/L» 4 sacche clear-flex 3000 ml...
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