COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Stilnox» (15A02709)
Estratto determina V&A IP n. 583 del 20 marzo 2015 E' autorizzata l'importazione parallela del medicinale STILNOCT 10 mg film-coated tablets 28 Tablets dalla Gran Bretagna con numero di autorizzazione PL 04425/0619, il quale, per le motivazioni espresse in premessa, deve essere posto in commercio con la denominazione Stilnox e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: Gekofar S.r.l. con sede legale in Piazza Duomo, 16 - 20122 Milano. Confezione: STILNOX «10 mg compresse rivestite con film» 30 compresse. Codice A.I.C.: 041252053 (in base 10) 17BX6P (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: zolpidem tartrato 10 mg;
eccipienti: compressa: lattosio monoidrato;
cellulosa microcristallina;
ipromellosa;
carbossimetilamido sodico, magnesio stearato;
rivestimento: ipromellosa;
titanio diossido;
macrogol 400. Indicazioni terapeutiche: trattamento a breve termine dell'insonnia. Le benzodiazepine o le sostanze simil-benzodiazepiniche sono indicate solamente nei casi di insonnia grave, debilitante o tale da causare profondo malessere. Confezionamento secondario E' autorizzato il confezionamento secondario presso l'officine Fiege Logistics Italia S.p.A., via Amendola 1, 20090 Caleppio di Settala (MI);
S.C.F. S.n.c. di Giovenzana Roberto e...
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