COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale per uso veterinario «Sulfadimetossina 20% Filozoo». (12A12918)
Estratto provvedimento n. 843 del 31 ottobre 2012
Specialita' medicinale per uso veterinario SULFADIMETOSSINA 20% FILOZOO.
Confezioni: sacco da 5 kg - A.I.C. n. 102657020.
Titolare A.I.C: Filozoo S.r.l., con sede legale in via del Commercio n. 28/30 - 41012 Carpi (Modena) - codice fiscale 0277084067.
Oggetto: variazioni tipo II ridotta: aggiornamento del dossier di tecnica farmaceutica.
E' autorizzata, per il medicinale per uso veterinario indicato in oggetto, la variazione tipo II concernente l'aggiornamento di tecnica farmaceutica.
La modifica, apportata al dossier di tecnica farmaceutica che impatta sugli stampati e' la seguente:
aumento del periodo di validita' dopo prima apertura del confezionamento primario: da 1 mese a 2 mesi;
aumento del periodo di validita' dopo diluizione o ricostituzione in acqua da bere, conformemente alle istruzioni, da 12 ore a 24 ore.
Pertanto il periodo di validita' ora autorizzato e' il seguente:
periodo di validita' del medicinale veterinario...
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