COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Samyr»
Estratto determinazione AIC/N/V n. 1982 del 30 settembre 2008
Medicinale: SAMYR.
Titolare A.I.C.: Abbott S.r.l. con sede legale e domicilio fiscale in Campoverde di Aprilia (Latina), via Pontina km 52 - Campoverde di Aprilia, cap. 04010 - codice fiscale 00076670595.
Variazione A.I.C.: sostituzione/aggiunta sito produttivo del prodotto finito per tutte le fasi di produzione inclusi controlli e rilascio dei lotti.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata.
E' autorizzata la modifica relativa all'aggiunta di un sito di produzione relativo alla fiala di solvente per le fasi di produzione: bulk, confezionamento primario, controllo e rilascio dei lotti presso:
Famar S.A. 63 Agiou Dimitriou str, 17456 Alimos, Athens - Greece...
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