COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Desferal» (19A01822)
Estratto determina AAM/PPA n. 194 del 6 marzo 2019 Autorizzazione delle variazioni: variazioni di tipo II: A.7), B.II.f.1.a.1), B.II.b.1.b), B.II.b.4.z), B.II.b.4.d), B.II.b.5.c), B.II.d.1.a), B.II.d.1.c), B.II.d.2.e), B.II.d.2.a), B.II.d.2.d), B.II.d.2.z), B.II.b.2.a), B.II.b.3.a), relativamente al medicinale DESFERAL;
Codice pratica: VN2/2018/16 Si approvano le seguenti variazioni: aggiunta di due nuovi batch sizes del prodotto finito presso il sito Wasserburger Arzneimittelwerk GmbH;
modifiche minori nel processo di produzione del prodotto finito presso il sito Novartis Pharma Stein AG;
modifiche minori nel processo di produzione del prodotto finito presso il sito Wasserburger Arzneimittelwerk GmbH;
eliminazione di un IPC dai controlli in-process presso il sito Novartis Pharma Stein AG;
riduzione della shelf-life del prodotto finito da 48 mesi a 36 mesi;
eliminazione del sito alternativo Wasserburger Arzneimittelwerk GmbH per il controllo qualita' del prodotto finito;
aggiunta del sito alternativo Wasserburger Arzneimittelwerk GmbH per il confezionamento primario del prodotto finito;
aggiunta di due nuovi parametri con i corrispondenti metodi di prova;
aggiunta di 8 impurezze identificate e specificate;
restrizione del limite per impurezze non specificate;
aggiunta di un nuovo test per il prodotto finito;
aggiunta di un test alternativo per il prodotto finito;
eliminazione di un test per il prodotto finito;
modifica minore di tre procedure di prova approvate per il prodotto finito;
aggiornamento di una procedura di prova per renderla conforme alla monografia generale aggiornata della Ph.Eur.;
aggiornamento di una procedura di prova per conformarsi agli standards interni;
aggiunta del sito Novartis...
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