COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Gentagil Fortius». (10A00370)
Estratto provvedimento n. 238 del 27 novembre 2009
Specialita' medicinale per uso veterinario GENTAGIL FORTIUS nelle confezioni:
flacone da 250 ml - A.I.C. n. 102076054;
flacone da 500 ml - A.I.C. n. 102076027.
Titolare A.I.C.: Intervet Productions S.r.l. con sede e domicilio fiscale in Aprilia (Latina), via Nettunense km. 20,300 - codice fiscale 02059910592
Oggetto del provvedimento: variazione Tipo II - aggiornamento parte II del dossier di registrazione.
Si autorizza l'aggiornamento della parte II del dossier di registrazione che comporta le seguenti modifiche:
1) modifica della composizione quantitativa degli eccipienti. La composizione ora autorizzata e' la seguente:
principio attivo: gentamicina solfato 10.000.000 UI (pari a gentamicina base a 10 g) (invariato);
eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti;
2) introduzione del periodo di validita' dopo prima apertura del condizionamento primario pari a 28 giorni a 25 ±2°C. La...
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