COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Daflon» (19A03133)
Estratto detrmina IP n. 169 dell'11 marzo 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale DAFLON «500 mg filmtabletten» 30 tabletten dall'Austria con numero di autorizzazione 1-20685, intestato alla societa' Servier Austria GmbH e prodotto da Les Laboratoires Servier Industrie, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag S.p.a. con sede legale in via Vasil Levski 103, 1000 Sofia. Confezione: DAFLON «500 mg compresse rivestite con film» 60 compresse. Codice AIC: 047408012 (in base 10) 1F6SWD(in base 32). Forma farmaceutica: compressa rivestita. Composizione: ogni compressa rivestita con film contiene: Principio attivo: 500 mg di frazione flavonoica purificata, micronizzata costituita da 450 mg di diosmina e 50 mg di flavonoidi espressi in esperidina. Eccipienti: Carbossimetilamido sodico, cellulosa microcristallina, gelatina, glicerina, ipromellosa, sodio laurilsolfato, ossido di ferro giallo E172, ossido di ferro rosso E 172, titanio diossido, macrogol 6000, magnesio stearato, talco. Officine di confezionamento secondario XPO Supply Chain Pharma Italy S.p.a., via Amendola n. 1, 20090 Caleppio di Settala (MI);
Falorni S.r.l., via Provinciale Lucchese, localita' Masotti 51030 Serravalle Pistoiese (PT);
S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago D'Adda - LO;
Pricetag EAD Business Center Serdica, 2E Ivan Geshov blvd., 1000 Sofia (Bulgaria). Classificazione ai fini della rimborsabilita'...
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