COMUNICATO - Importazione parallela del medicinale per uso umano «Depakin» (16A08746)
Estratto determina IP n. 1895 del 15 novembre 2016 E' autorizzata l'importazione parallela del medicinale DEPAKINE CHRONO 500 mg modifikuoto atpalaidavimo tabletės 30 tabs (polipropileno buteliukas su polietileno dangteliu) dalla Lituania con numero di autorizzazione LT/1/94/0818/002 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: Programmi Sanitari Integrati s.r.l., via G. Lanza, 3 - 20121 Milano. Confezione: Depakin «Chrono 500 mg compresse a rilascio prolungato» flacone PP da 30 compresse. Codice AIC: 040965030 (in base 10) 1724X6 (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, silice colloidale idrata, 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). 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...
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