COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Xanax» (18A01937)
Estratto determina CIP IP n. 130 del 21 febbraio 2018 E' autorizzata l'importazione parallela del medicinale XANAX 0,25 mg tablets 30 tabs dalla Grecia con numero di autorizzazione 23875/26-6-1995, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione. Importatore: GMM Farma s.r.l. con sede legale in via Lambretta n. 2 - 20090 Segrate (Milano). Confezione: «Xanax» - «0,25 mg compresse» 20 compresse. Codice A.I.C.: 043881135 (in base 10) 19V4PH (in base 32). Forma farmaceutica: compresse. Ogni compressa contiene: principio attivo: alprazolam mg 0,25;
eccipienti: silice colloidale anidra, magnesio stearato, sodio docusato, sodio benzoato, amido di mais, cellulosa microcristallina, lattosio monoidrato. Indicazioni terapeutiche. Ansia, tensione ed altre manifestazioni somatiche o psichiatriche associate con sindrome ansiosa. Attacchi di panico con o senza agorafobia. Le benzodiazepine sono indicate soltanto quando il disturbo e' grave, disabilitante e sottopone il soggetto a grave disagio. Officine di confezionamento secondario: XPO Supply Chian Pharma Italy S.p.A., via Amendola n. 1 - 20090 Caleppio di Settala (Milano);
De Salute S.r.l., via Antonio Biasini n. 26 - 26015...
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