COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Surolan», sospensione oleosa per uso topico per cani e gatti. (19A06768)
Estratto decreto n. 128 del 30 settembre 2019 La societa' New Pharmashop CIS di Nola IS1 Torre 1 int 120, 80035 NA Nola P.I. 07260261214, e' autorizzata all'importazione parallela dalla Polonia del veterinario SUROLAN sospensione oleosa per uso topico per cani e gatti flacone da 15 ml, di cui all'autorizzazione n. 68/94, con le specificazioni di seguito indicate, a condizione che siano valide ed efficaci al momento dell'entrata in vigore del presente decreto. Confezione da commercializzare: «Surolan» sospensione oleosa per uso topico per cani e gatti flacone da 15 ml. Codice autorizzazione importazione parallela: 105448017. Forma farmaceutica: sospensione oleosa per uso topico. Principi attivi: 1 ml di sospensione contiene: principio attivo: miconazolo nitrato: 23 mg;
polimixina B solfato: 0,5293 mg;
prednisolone acetato: 5 mg. Eccipienti: silice precipitata;
paraffina liquida. Medicinale importato, composizione quali-quantitativa acquisita dalla Polonia: 1. Qualitative and quantitative composition in terms of active ingredients and excipients: 1 ml contains: - Name of active substance(s): miconazolo nitrato: 23 mg;
polimixina B solfato: 0,5293 mg;
prednisolone acetato: 5 mg. - Name of excipient (s): silice colloidale anidra;
paraffina liquida. Specie di destinazione: cani e gatti. Indicazioni terapeutiche: «Surolan», nei cani e nei gatti, e' indicato nel trattamento delle otiti esterne e delle dermatiti sostenute da...
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