COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Depakin». (18A01966)
Estratto determina CIP IP n. 168 del 28 febbraio 2018 E' autorizzata l'importazione parallela del medicinale DEPAKINE Chrono 300 mg tabletten met verlengde afgifte/Retardtabletten 50 (divisible) Tabs Blister PVC/ALU dal Belgio con numero di autorizzazione BE166512 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag S.p.a. con sede legale in Vasil Levski St. 103 - 1000 Sofia;
Confezione: DEPAKIN «Chrono 300 mg compresse a rilascio prolungato» blister da 30 compresse. Codice: 045699016 (in base 10) 1CLMY8 (in base 32) Forma farmaceutica: compresse a rilascio prolungato Ogni compressa contiene: principio attivo: 200 mg sodio valproato-87 mg acido valproico (corrispondenti a 300 mg di sodio valproato). eccipienti: etilcellulosa, ipromellosa, silice colloidale idrata, poliacrilato dispersione 30%, macrogol 6000, talco, titanio diossido, saccarina sodica. 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). Nel trattamento degli episodi di mania correlati al disturbo bipolare quando il litio e' controindicato o non tollerato. La continuazione della terapia dopo l'episodio di mania puo' essere presa in considerazione nei pazienti che hanno risposto al valproato per la mania acuta. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.A. - Via Amendola, 1, 20090...
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