COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio della premiscela per alimenti medicamentosi «Ossibiotic 200 Premix» per suini, conigli e pesci. (13A04752)
Provvedimento n. 352 del 10 maggio 2013 Premiscela per alimenti medicamentosi OSSIBIOTIC 200 PREMIX per suini, conigli e pesci. Confezione: sacco da 25 Kg da 200 g/Kg - A.I.C. n. 102773013. Titolare A.I.C.: Industria Italiana Integratori Trei S.p.A. con sede in viale Corassori, 62 - 41124 Modena - Cod. Fisc. 04515040964. Oggetto del provvedimento: variazione tipo IB: modifica della denominazione del medicinale;
variazione tipo II: estensione di concentrazione e nuova confezione;
variazione: modifica tempi di attesa. Si autorizzano, per la premiscela per alimenti medicamentosi indicata in oggetto, le seguenti modifiche: 1) modifica della denominazione del medicinale da «Ossibiotic 200 premix» a «Ossibiotic premix»;
2) estensione di concentrazione con conseguente nuova confezione: sacco da 25 Kg da 400 g/Kg - A.I.C. n. 102773025. La composizione della nuova confezione e' la seguente: ossitetraciclina (come diidrato) 400 mg;
olio di soia 80 mg;
tutolo di mais q.b.a. 1 g. La validita' della nuova confezione e' la stessa di quella autorizzata per la confezione da 200 mg/g...
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