COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio di taluni medicinali per uso umano (14A09822)
Estratto determina V &
A n. 2511/2014 del 2 dicembre 2014 Autorizzazione del worksharing relativamente ai medicinali: IMOVAX POLIO A.I.C. n. 029310;
PENTAVAC A.I.C. n. 034126 (SE/H/153/001/WS/98);
REVAXIS A.I.C. n. 034457 (DE/H/193/001/WS/44);
TETRAVAC A.I.C. n. 034127 (SE/H/154/001/WS/73), ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale e di mutuo riconoscimento. Procedura EU n: DE/H/xxxx/WS/108. Sono autorizzate le seguenti variazioni: l'aumento delle dimensioni del lotto delle colture di propagazione virale presso l'edificio 15 del sito di produzione Marcy L'Etoile: da: 1500 litri;
a: 3000 litri;
l'eliminazione del solfato di streptomicina e polimixina B solfato dai mezzi di coltura delle cellule Vero ( 333 L scale process) presso l'edificio 15 del sito di produzione Marcy L'Etoile;
l'introduzione di un nuovo sistema di filtrazione allo stadio di «crude harvest» presso gli edifici 9 e 15 del sito di produzione Marcy L'Etoile senza l'utilizzo di un adiuvante della filtrazione e basato su un passaggio di prefiltrazione (membrane di cellulosa con pori da 1.0 µm a 0,4 µm) e una filtrazione finale (membrane di polietersulfone...
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