COMUNICATO - Autorizzazione all''importazione parallela del medicinale per uso umano «Lexotan (20 units)» (12A01578)
Estratto determinazione V & A PC IP n. 686 del 16 gennaio 2012
E' autorizzata l'importazione parallela del medicinale LEXOTAN tablet 20 units dal Portogallo con numero di autorizzazione 4540282 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione.
Importatore: Farma 1000 S.r.l., via Camperio Manfredo n. 9 - 20123 Milano.
Confezione: «Lexotan» «3mg compresse» 20 compresse.
Codice A.I.C.: 041616020 (in base 10) 17Q0NN (in base 32).
Forma farmaceutica: compresse.
Composizione: ogni compressa contiene:
principio attivo: bromazepam 3 mg;
eccipienti: cellulosa microcristallina, lattosio monoidrato, talco, magnesio stearato, ossido di ferro rosso (E 172).
Indicazioni terapeutiche: disturbi emotivi. Stati di tensione e di ansia, senso di insicurezza e paure immotivate anche accompagnate da manifestazioni depressive, nervosismo, agitazione, difficolta' di contatto ed insonnia. Disturbi psicosomatici e funzionali dell'apparato cardiovascolare e respiratorio, dell'apparato gastrointestinale, dell'apparato genito-urinario, cefalea da tensione. Reazioni emotive ad una malattia organica cronica. Le benzodiazepine sono indicate soltanto quando il disturbo e' grave, disabilitante o sottopone il soggetto a grave disagio. Confezionamento secondario
E'...
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