COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Betadine» (18A00282)
Estratto determina IP n. 659 del 30 novembre 2017 E' autorizzata l'importazione parallela del medicinale BETADINE DERMIQUE 10 pour cent solution pour application locale, 1 flacon de 125 ml dalla Francia con numero di autorizzazione 314 997 8 ou 34009 314 997 8 7, 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: Farmaroc S.r.l., viale Pio XI n. 48 - 70056 Molfetta (Bari);
Confezione: Betadine «10% soluzione cutanea» flacone 125 ml;
Codice A.I.C. n. 045462013 (in base 10) 1CCDHX (in base 32);
Forma farmaceutica: soluzione;
Composizione: 1 ml di soluzione contiene: principio attivo: Iodopovidone (al 10% di iodio) 0,1 g;
eccipienti: glicerolo, macrogol 9 lauryl ether, sodio fosfato bibasico biidrato, acido citrico monoidrato, sodio idrossido, acqua depurata;
Indicazioni terapeutiche: disinfezione e pulizia della cute lesa (ferite, piaghe ecc.). Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a. - via Amendola n. 1 - 20090 Caleppio di Settala (Milano);
S.C.F. S.n.c. di Giovenzana Roberto e...
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