BLUEFISH PHARMACEUTICALS AB - Modifica secondaria di un'autorizzazione all'immissione in commercio di medicinali per uso umano. (Modifiche apportate ai sensi del Regolamento 1234/2008 e s.m.i.).
Modifica secondaria di un'autorizzazione all'immissione in commercio di medicinali per uso umano. (Modifiche apportate ai sensi del Regolamento 1234/2008 e s.m.i.). Specialita' Medicinale: DONEPEZIL BLUEFISH 5 mg compresse rivestite con film DONEPEZIL BLUEFISH 10 mg compresse rivestite con film Confezioni: 041009010 - 041009059 -041009022 - 041009046 - 041009061 - 041009073-041009034 - 041009085 - 041009097- 041009123 - 041009109 - 041009135 - 041009111 Titolare AIC: BLUEFISH PHARMACEUTICALS AB N° e Tipologie variazioni: C.I.3.a IB foreseen Codice Pratica N°ClB/2012/2741 (SE/H/779/001-002/IB/03) Tipo di modifica: Modifica stampati Modifica apportata: Modifica degli stampati per inserire una avvertenza riguardante il rischio di sindrome neurolettica maligna E' autorizzata la modifica degli stampati richiesta (paragrafi 4.4 e 4.8 del Riassunto delle Caratteristiche del Prodotto e corrispondenti paragrafi del Foglio Illustrativo) relativamente alle confezioni sopra elencate e la responsabilita' si ritiene affidata alla Azienda titolare dell' AIC. I lotti gia' prodotti non possono piu' essere dispensati al pubblico a decorrere dal 120° giorno successivo a quello della pubblicazione della presente determinazione nella Gazzetta Ufficiale della Repubblica Italiana. Trascorso il suddetto termine non potranno piu' essere dispensate al pubblico confezioni che non rechino le modifiche indicate dal presente provvedimento. E' approvata, altresi', secondo la lista dei termini standard della Farmacopea Europea, la...
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