COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Depakin». (17A03724)
Estratto determina n. 243 del 12 maggio 2017 E' autorizzata l'importazione parallela del medicinale DEPAKINE Chrono 500 mg 30 modifikuoto atapalaidavimo Tab. bottle PP dalla Lituania con numero di autorizzazione LT/1/94/0818/002, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: importatore: Gekofar S.r.l. con sede legale in piazza Duomo n. 16 - 20122 Milano;
confezione: DEPAKIN CHRONO «500 mg compresse a rilascio prolungato» 30 compresse in flacone PP;
codice A.I.C.: 043478027 (in base 10) 19GV0C (in base 32). Forma farmaceutica: compresse a rilascio prolungato. Ogni compressa contiene: principio attivo: 333,0 mg sodio valproato - 145,0 mg acido valproico (corrispondenti a 500 mg di sodio valproato);
nucleo: etilcellulosa, ipromellosa, diossido di silice colloidale idrata, diossido di silice colloidale anidra, saccarina sodica. Film: ipromellosa, poliacrilato dispersione 30%, macrogol 6000, talco, titanio diossido. Indicazioni terapeutiche Nel trattamento dell'epilessia generalizzata, in particolare in attacchi di tipo: assenza;
mioclonico;
tonico-clonico;
atonico;
misto, e nell'epilessia parziale: semplice o complessa;
secondariamente generalizzata. Nel trattamento di sindromi specifiche (West, Lennox-Gastaut). Officine di confezionamento secondario: S.C.F. S.n.c. Di Giovenzana Roberto e Pelizzola Mirko Claudio via F. Barbarossa n. 7 - 26824 Cavenago d'Adda - LO;
XPO Supply Chain Pharma Italy S.p.A., via Amendola n. 1...
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