COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Trosyd». (16A02405)
Estratto determina n. 425 del 1° marzo 2016 E' autorizzata l'importazione parallela del medicinale TROSYD 280 mg/ml solução cutânea Frasco de vidro âmbar contendo 12 ml de solução cutânea e com tampa que inclui um pincel para aplicação dal Portogallo con numero di autorizzazione 8620401, 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: Medifarm S.r.l. Via Tiburtina 1166/1168, 00156 - Roma. Confezione: TROSYD «28% soluzione cutanea per uso ungueale» flaconcino 12 ml. Codice AIC: 044536011 (in base 10) 1BH46C (in base 32). Forma farmaceutica: soluzione cutanea per uso ungueale. Composizione: 100 g di soluzione contengono: Principo attivo: Tioconazolo 28 g;
Eccipienti: acido undecilenico, acetato di etile. Indicazioni terapeutiche: Onicomicosi causate da dermatofiti e lieviti. Per la concomitante attivita' antibatterica...
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