COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio, mediante procedura di mutuo riconoscimento, del medicinale «Novynette».
Estratto provvedimento UPC/II/10 del 9 gennaio 2008
Specialita' medicinale: NOVYNETTE.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Finderm farmaceutici S.r.l.
Numero procedura mutuo riconoscimento: DK/H/0308/001/II/019.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: cambio del produttore degli intermedi, del processo di produzione della sostanza attiva Destrogel, del ´batch sizeª degli intermedi e del ´batch sizeª della sostanza...
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