COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Naxiglo» (19A06632)
Estratto determina AAM/PPA n. 795 del 7 ottobre 2019 Autorizzazione delle variazioni: variazione di tipo II: B.II.b.4.d) modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito;
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la modifica riguarda tutte le altre forme farmaceutiche fabbricate secondo procedimenti di fabbricazione complessi;
e delle variazioni di tipo IB: B.I.a.3.e) modifica della dimensione del lotto (comprese le classi di dimensione del lotto) del principio attivo o del prodotto intermedio utilizzato nel procedimento di fabbricazione del principio attivo;
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la scala per un principio attivo biologico/immunologico e' aumentata/diminuita senza modifica del procedimento (ad esempio duplicazione di una linea), relativamente al medicinale NAXIGLO;
Codice pratica: VN2/2019/153. E' autorizzato l'aumento del batch size dell'intermedio (frazione II) e quindi del principio attivo (bulk) e del prodotto finito, relativamente al medicinale «Naxiglo», nella forma e confezione: A.I.C. n. 043396023 - «160 mg/ml soluzione per infusione sottocutanea» flaconcino in vetro da 25 ml...
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