COMUNICATO - Autorizzazione dell'importazione parallela del medicinale per uso umano «Nasonex» (19A05271)
Estratto determina IP n. 524 del 10 luglio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NASONEX «50 mcg/spruhstoss nasenspray, suspension» 10G/60 spruhstosse dalla Germania con numero di autorizzazione 40803.00.00, intestato alla societa' MSD Sharp &
Dohme GmbH e prodotto da Schering-Plough Labo N.V., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop S.r.l., con sede legale in CIS di Nola isola 1, torre 1, int. 120 - 80035 Nola (Napoli). Confezione: «Nasonex» 50 microgrammi/erogazione spray nasale, sospensione, flacone da 60 erogazioni, codice A.I.C. n. 045327020 (in base 10), 1C78PD(in base 32). Forma farmaceutica: spray nasale, sospensione. Composizione: ogni spruzzo contiene: principio attivo: 50 microgrammi di mometasone furoato come monoidrato;
eccipienti: cellulosa microcristallina, carmellosa sodica, glicerolo, sodio citrato, acido citrico monoidrato, polisorbato 80, benzalconio cloruro, acqua purificata. Officine di confezionamento secondario: Pharm@Idea S.r.l,. via del Commercio n. 5 - 25039 Travagliato (Brescia);
Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato;
De Salute S.r.l., via Biasini n. 26 - 26015 Soresina (Cremona);
S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago D'Adda (Lodi). Classificazione ai fini della rimborsabilita' Confezione: «Nasonex» 50 microgrammi/erogazione spray nasale, sospensione, flacone da 60 erogazioni, codice A.I.C. n. 045327020, 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...
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