COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso veterinario Dextroquillan 0,1 mg/ml soluzione iniettabile e Dextroquillan 0,5 mg/ml soluzione iniettabile. (17A00009)
Estratto provvedimento n. 797 del 30 novembre 2016 Medicinali veterinari: - Dextroquillan 0,1 mg/ml soluzione iniettabile - confezione: flacone da 15 ml A.I.C. n. 104874019 - Dextroquillan 0,5 mg/ml soluzione iniettabile - confezione: flacone da 10 ml A.I.C. n. 104875012 Titolare A.I.C.: Fatro S.p.a. con sede in Via Emilia, 285 - 40064 Ozzano Emilia (BO) Oggetto del provvedimento: variazioni raggruppate di tipo IB B.II.f.1.b.1 modifica della durata di conservazione o delle condizioni di magazzinaggio del prodotto finito: estensione della durata di conservazione del prodotto finito cosi' come confezionato per la vendita (sulla base dei dati in tempo reale) B.II.f.1.b.2 modifica della durata di conservazione o delle condizioni di magazzinaggio del prodotto finito: estensione della durata di conservazione del prodotto finito dopo prima apertura (sulla base dei dati in tempo reale) Si autorizzano, per i medicinali veterinari indicati in oggetto, le modifiche come di seguito descritte: - estensione del periodo di validita' dei medicinale cosi' come confezionati per la...
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