COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Daktarin». (15A09038)
Estratto determina n. 2125 del 10 novembre 2015 E' autorizzata l'importazione parallela del medicinale DAKTARIN gel voor oraal gebruik 20 mg/g, 80g gel dall'Olanda con numero di autorizzazione RVG 07490, il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: General Pharma Solutions Spa , Vasil Levski St. 103 - 1000 Sofia. Confezione: Daktarin "2% gel orale" tubo 80 g Codice AIC: 044137014 (in base 10) 1B2YKQ (in base 32) Forma farmaceutica: gel orale Composizione: un grammo di gel orale contiene: Principio attivo: miconazolo 20 mg. Eccipienti: polisorbitan monolaurato, saccarina sodica, acqua purificata, amido di patata pregelatinizzato, aroma di arancio, aroma di cacao, alcool, glicerina. Indicazioni terapeutiche: trattamento curativo e profilattico delle candidosi della cavita' oro-faringea e del tratto gastrointestinale. Come misura terapeutica o profilattica contro altre micosi del tubo digerente, o contro micosi sistemiche, come la candidosi, la blastomicosi sud-americana e la...
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