COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Influvac S» e «Batrevac». (15A03351)
Estratto determina V&A n. 658/2015 del 2 aprile 2015 Autorizzazione della variazione relativamente ai medicinali INFLUVAC S - BATREVAC. E' autorizzata la seguente variazione: trasferimento della produzione di bulk monovalenti dei vaccini influenzali presso il sito Abbott Biologicals BV, Weesp, Netherlands: da: l'edificio «WNW-1» a: agli edifici: «WWY e WWP». Le modifiche minori conseguenti al trasferimento della produzione e all'aumento delle dimensioni del lotto del bulk monovalente riguardo a: contenitore per la conservazione dell'intermedio «concentrato del virus attivo»: da: bottiglie di vetro a: sacche flessibili in Polietilene a bassa densita' [(U)LDPE];
contenitori utilizzati durante il processo di solubilizzazione: da: 16 bottiglie in vetro a: 1 contenitore in acciaio inossidabile;
soluzione di lavaggio dell'ago della macchina inoculatrice: da: 0.01% Polysorbate 20 in 50 mM NaOH a: 75-100 mM NaOH;
volume del bulk monovalente: da: 70-150L a: 70-160L;
numero delle uova inoculate al giorno: da: 110.000-125.000 a: 110.000-150.000, relativamente alle specialita' medicinali ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Procedura...
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