COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Textazo». (15A05790)
Estratto determina V&A n. 1366/2015 del 14 luglio 2015 E' autorizzata la seguente variazione: A.5 Modifica del nome e/o dell'indirizzo del fabbricante/importatore del prodotto finito (compresi il rilascio dei lotti e i siti di controllo della qualita'), A.4 Modifiche del nome e/o dell'indirizzo: del fabbricante (compresi eventualmente i siti di controllo della qualita');
o del titolare di un ASMF;
o del fornitore di un principio attivo, di una materia prima, di un reattivo o di una sostanza intermedia utilizzata nella fabbricazione del principio attivo (se specificati nel fascicolo del prodotto) per i quali non si dispone di un certificato di conformita' alla farmacopea europea;
o del fabbricante di un nuovo eccipiente (se specificato nel fascicolo tecnico), B.I.a.1.b Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (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 fabbricante del principio attivo avente il sostegno di un ASMF (Master File del principio attivo), relativamente al medicinale "TEXTAZO", nelle forme e confezioni: AIC n. 038558019 - " 2 g + 250mg/4 ml polvere e solvente per soluzione iniettabileper uso intramuscolare" 1 flaconcino polvere + 1 fiala solvente AIC n. 038558021 - " 4 g + 500 mg polvere per soluzione per infusione " 1 flaconcino polvere Modifica del nome e dell'indirizzo della sede legale del produttore di tazobactam: da Ribbon s.r.l., Via G. Prati 4, 20145 Milano a Fresenius Kabi Anti-Infectives s.r.l., Piazza Maestri del Lavoro 7, 20063 Cernusco sul Naviglio (MI). Il sito di produzione rimane invariato, ossia Fresenius Kabi Anti-Infectives s.r.l., Via San leonardo 23, 45010 Villadose...
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