COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Mesalazina Mylan Generics» (11A01484)
Estratto determinazione V & A.N/ n. 183 del 24 gennaio 2011
Titolare AIC: MYLAN S.P.A. con sede legale e domicilio fiscale in Via Vittor Pisani, 20 - 20124 Milano - Codice fiscale 13179250157.
Medicinale: MESALAZINA MYLAN GENERICS.
Variazione AIC:
B.II.a.3.b.6 Modifiche nella composizione (eccipienti) del prodotto finito Altri eccipienti Sostituzione di un solo eccipiente con un eccipiente comparabile avente le stesse caratteristiche funzionali e a livello simile.
B.II.a.4.b Modifica del peso dello strato di copertura delle forme di dosaggio orale o del peso dell'involucro delle capsule Forme farmaceutiche gastroresistenti, a liberazione modificata o prolungata, per le quali lo strato di copertura e' un fattore de
B.II.b.3.a Modifica nel procedimento di fabbricazione del prodotto finito Modifica minore nel procedimento di fabbricazione di una forma di dosaggio solida per uso orale o di soluzioni orali a liberazione immediata.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato:
E' autorizzata la modifica, presentata in forma di «Grouping», relativa alla sostituzione dell'eccipiente Sodio carbossimetilcellulosa con l'eccipiente comparabile Sodio croscarmellose, di cui viene aumentata la quantita', in quanto gia'...
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