COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Depakine Chrono» (18A05091)
Estratto determina IP n. 479 del 27 giugno 2018 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale DEPAKINE CHRONO 500 mg comprimate cu eliberare prelungita' 30 comprimate dalla Romania con numero di autorizzazione 1671/2009/01, intestata alla societa' Sanofi-Aventis France e prodotta da Sanofi Winthrop Industries (FR) e da Sanofi Aventis S.A. (ES) con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Programmi Sanitari Integrati S.r.l. con sede legale in Via Giovanni Lanza, 3 20121 Milano. Confezione: Depakin «Chrono 500 mg compresse a rilascio prolungato» 30 compresse in flacone pp. Codice AIC: 040965042 (in base 10) 1724XL (in base 32). Forma farmaceutica: compresse a rilascio prolungato. Una compressa a rilascio prolungato contiene: Principio attivo: sodio valproato 333 mg e acido valproico 145 mg corrispondenti a 500 mg di sodio valproato. Eccipienti: etilcellulosa, ipromellosa, silice colloidale anidra, silice colloidale idrata, saccarina sodica, 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). 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. Condizioni di conservazione: questo medicinale non necessita di particolare condizioni di conservazione. Officine...
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