COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale Puriclav. (09A12750)
Estratto determinazione AIC/N/V n. 2275 del 6 ottobre 2009
Titolare AIC: Polifarma S.P.A. con sede legale e domicilio fiscale in Viale dell'Arte, 69 - 00144 - Roma - Codice Fiscale 00403210586.
Medicinale: PURICLAV.
Variazione AIC:
32.a Modifica dimensione lotti del prod. finito fino a 10 volte la dimensione originale del lotto approvata con la concessione dell'AIC;
33. Modifica minore della produzione del prodotto finito;
36.b Modifica della forma o delle dimensioni del contenitore o della chiusura di altre forme farmaceutiche;
7.a Sostituzione o aggiunta di un sito di produzione per imballaggio secondario per tutti i tipi di forme farmaceutiche;
7.b.1 Sostituzione o aggiunta di un sito di produzione per imballaggio primario di forme farmaceutiche solide, ad es. compresse e capsule;
7.c Sostituzione o aggiunta di un sito di produzione per tutte le altre operazioni produttive ad eccezione del rilascio dei lotti;
8.b.2 Sostituzione o aggiunta di un produttore responsabile del rilascio dei lotti (incluso il controllo dei lotti).
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato: Sono autorizzate le modifiche, presentate in forma di «Umbrella variation» come di seguito specificato:
Aggiunta dell'officina di produzione «Laboratorio Reig Jofre' S.A., C/le Jarama s/n - Poligono Industrial 45007 - Toledo, Spagna» per le fasi di produzione completa, incluso il confezionamento primario e secondario, controllo e rilascio dei lotti.
Aggiunta del lotto di prodotto finito da 425.523 bustine per l'officina di produzione «Laboratorio...
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