COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Omeprazen» (18A05699)
Estratto determina AAM/PPA n. 686/2018 del 25 luglio 2018 Si autorizza il seguente grouping di variazioni: tipo II, B.II.b.1c) - aggiunta del sito Alfasigma S.p.A., via Enrico Fermi, 1, 65020 - Alanno (PE) per la produzione del bulk di prodotto finito e per il confezionamento primario di prodotto finito;
tipo II, B.II.b.3b) - modifica della fase di liofilizzazione;
n. 2 tipo IB, B.II.b.3a) - eliminazione della fase di sterilizzazione dei tappi in gomma ed aggiunta di una fase di stoccaggio dopo la prima filtrazione;
tipo IB, B.II.e.4c) - modifica del diametro esterno del tappo in gomma da 13.2 ± 0.2 mm a 12.9 ± 0.15 mm ;
altezza testa da 3.8 mm a 3.2 ± 0.25 mm;
tipo IB, B.II.d.2d) - aggiunta di una procedura di prova sul prodotto finito: contenuto di acqua;
tipo IA, B.II.b.2a) - aggiunta del sito Alfasigma S.p.A, via Enrico Fermi, 1 , 65020 - Alanno (PE) per il controllo dei lotti;
tipo IA, B.II.b.5b) - aggiunta IPC integrita' del filtro dopo la prima filtrazione;
tipo IA, B.II.e.2a) - restringimento del limite di accettabilita' delle endotossine batteriche testate sul tappo in gomma da max 2 EU a 0.25 EU;
n. 2 tipo IA, B.II.e.2b) - aggiunta di un nuovo paramentro di specifica con il relativo limite: sterilita' dei tappi in gomma e dei flip-off caps;
tipo IA, B.II.e.6b) - eliminazione del nome Astrazeneca dal flip-off cap;
tipo IA, B.II.e.3b) - aggiunta di un metodo alternativo per testare la specifica l'identita' del materiale dei tappi in gomma;
tipo IA, A.7 - eliminazione dei seguenti siti di produzione: AstraZeneca AB, Gärtunavägen;
Recipharm Monts;
AstraZeneca GmbH;
Biofabri, S.L.;
AndersonBrecon (UK) Limited;
...
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