COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Pulmozyme».
Estratto Provvedimento UPC/II/593 del 21 ottobre 2008
Specialita' medicinale: PULMOZYME.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: ROCHE S.p.a.
Numero procedura mutuo riconoscimento: UK/H/0060/001/II/046.
Tipo di modifica: modifica relativa al processo di produzione del principio attivo.
Modifica apportata: modifica alle specifiche dei materiale di partenza usati nella cultura cellulare e nel processo di purificazione di dornase alfa.
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