COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Xanax» (19A06617)
Estratto determina IP n. 698 del 2 ottobre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale XANAX 0,50 mg tablets - 30 tablets dalla Grecia con numero di autorizzazione 23876/26-06-1995, intestato alla societa' Pfizer Ellas A.E. e prodotto da Pfizer Italia s.r.l. Italy e da Pfizer Ireland Pharmaceuticals, Kildare, Ireland, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farma 1000 s.r.l. con sede legale in via Camperio Manfredo n. 9 - 20123 Milano. Confezione: XANAX «0,50 mg compresse» 20 compresse - codice A.I.C. n. 041602121 (in base 10) 17PM29 (in base 32). Forma farmaceutica: compresse. Composizione: ogni compressa contiene: principio attivo: alprazolam mg 0,50;
eccipienti: lattosio monoidrato, cellulosa microcristallina, docusato sodico, sodio benzoato, silice colloidale anidra, amido di mais, magnesio stearato, giallo tramonto (E110) lacca di alluminio. Conservazione: conservare a temperatura inferiore a 25°C. Descrizione dell'aspetto di XANAX e contenuto delle confezioni: le compresse di XANAX da 0,5 mg sono compresse ovali di colore arancione chiaro con una linea di incisione su un lato;
le compresse sono disponibili in blister di PVC/PVDC-alluminio in confezione da 20 compresse. Officine di confezionamento secondario: S.C.F. s.r.l. via F. Barbarossa n. 7 - 26824 Cavenago d'Adda - LO;
De Salute s.r.l. via Biasini n. 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: XANAX «0,50 mg compresse» 20 compresse - codice A.I.C. n. 041602121;
classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai...
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