COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Xanax». (24A01765)
Estratto determina IP n. 180 del 25 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale «XANAX» 0,25mg comprimate 30 comp dalla Romania con numero di autorizzazione 7758/2015/01, intestato alla societa' Upjohn Eesv Rivium Westlaan 142, 2909 LD Capelle Aan Den Ijssel, Olanda e prodotto da Pfizer Italia S.r.l. localita' Marino Del Tronto, 63100 Ascoli Piceno (AP), Italia, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l. con sede legale in via Cavallerizza a Chiaia, 8 80121 Napoli Confezione: Xanax «0,25 mg compresse» 20 compresse in blister pvc/al Codice A.I.C.: 045189103 (in base 10) 1C31ZH (in base 32) Forma farmaceutica: compressa Composizione: una compressa contiene: Principio attivo: 0,25 mg di Alprazolam Eccipienti: lattosio monoidrato, cellulosa microcristallina, docusato sodico, sodio benzoato, silice colloidale anidra, amido di mais, magnesio stearato Inserire al paragrafo 5 del foglio illustrativo ed il riferimento sulle etichette: Conservare a temperature inferiori a 25°C, nella confezione originale Officine di confezionamento secondario Pharma Partners S.r.l. Via E. Strobino, 55/57 59100 Prato (PO) GXO Logistics Pharma Italy S.p.a. Via Amendola, 1 - 20049 Caleppio di Settala (MI) De Salute S.r.l. Via Biasini, 26 26015 Soresina (CR) Classificazione ai fini della rimborsabilita' Confezione: XANAX «0,25 mg compresse» 20 compresse in blister pvc/al Codice A.I.C.: 045189103 Classe di rimborsabilita': C. Classificazione ai fini della fornitura Confezione: Xanax «0,25 mg compresse» 20...
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