Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale .
Estratto provvedimento UPC/II/2265 del 22 marzo 2006
Specialita' medicinale: PROLEUKIN.
Confezione A.I.C. n. 027131010 - iniettabile 1 flacone 18.000.000 UI 1 ml.
Titolare A.I.C.: Chiron B.V.
Numero procedura mutuo riconoscimento: NL/H/0005/001/W/017.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: modifica del terreno di coltura precedentemente utilizzato per la preparazione del master e working cell banks con il peptone di soia.
I lotti gia' prodotti, possono essere mantenuti...
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