FDC INTERNATIONAL LTD -
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano secondo procedura di Mutuo Riconoscimento. Modifica apportata ai sensi del Regolamento (CE) n. 1234/2008. Titolare: FDC International Ltd. Specialita' medicinale: FLOCIX Confezione e numero di A.I.C.: 3 mg/ml gocce auricolari - flacone da 5 ml A.I.C. n. 039722018/M. Variazione Tipo IA C.I.z: Introduzione del fascicolo di riferimento del sistema di farmacovigilanza (PSMF) e sostituzione, nel Modulo 1.8.1, della Descrizione dettagliata del sistema di farmacovigilanza (DDPS), con il Riassunto del sistema di farmacovigilanza. Procedura...
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