COMUNICATO - Importazione parallela del medicinale per uso umano «Daflon» (14A01861)
Estratto determinazione V &
A IP n. 329 del 13 febbraio 2014 E' autorizzata l'importazione parallela del medicinale DAFLON 500 mg comprimidos recubiertos 60 compr. dalla Spagna con numero di autorizzazione 59080 Cod. Nac. 655365-7, 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: Farmavox S.r.l. con sede legale in via Giuseppe Parini, 9 - 20121 Milano. Confezione: «Daflon» «500 mg compresse rivestite con film» 30 compresse. Codice A.I.C.: 042989020 (in base 10) 18ZXGV (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa contiene: principio attivo: frazione flavonoica purificata micronizzata 500 mg, corrispondenti a diosmina 450 mg , flavonoidi espressi in esperidina 50 mg;
eccipienti: carbossimetilamido sodico, cellulosa microcristallina, gelatina, magnesio stearato, talco, glicerina, idrossipropilmetilcellulosa (ipromellosa), macrogol 6000, sodio laurilsolfato, ossido di ferro giallo E 172, ossido di ferro rosso E 172, titanio biossido E 171. Indicazioni terapeutiche Sintomi attribuibili ad insufficienza venosa;
stati di fragilita' capillare. Confezionamento secondario E' autorizzato il confezionamento secondario presso l'officine Fiege Logistics Italia S.p.A., via Amendola, 1 - 20090 Caleppio di Settala (Milano);
CIT S.r.l., via Primo Villa, 17 - 20875 Burago di Molgora (Monza-Brianza);
Pharma Partners S.r.l. via V. Locchi, 112 - 50141 Firenze;
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