COMUNICATO - Modificazione dell'autorizzazione in commercio del medicinale 'Amoxicillina e acido clavulanico Teva Pharma Italia'
Estratto determinazione AIC/N/V n. 2150 del 3 ottobre 2007
Medicinale: AMOXICILLINA E ACIDO CLAVULANICO TEVA PHARMA ITALIA.
Titolare A.I.C.: Teva Pharma Italia S.r.l. con sede legale e domicilio fiscale in viale G. Richard, 7, 20143 Milano - codice fiscale 11654150157.
Variazione A.I.C.:
32.a Modifica dimensione lotti del prod. finito fino a 10 volte la dimensione originale del lotto approvata con la concessione dell'A.I.C.;
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, modifica delle specifiche relative al medicinale.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato: sono autorizzate le modifiche del tipo "Umbrella variation" come di seguito specificato:
aggiunta dell'officina Reig Jofre' SA sita in Calle Jarama s/n - Poligono Industrial - Toledo (Spagna) per le fasi di produzione, confezionamento primario e secondario (compresa...
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