COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nasonex» (20A04912)
Estratto determina IP n. 533 dell'11 settembre 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NASONEX 50µg/Sprühstoß Nasenspray, suspension flacone da 60 erogazioni dosate dalla Germania con numero di autorizzazione 40803.00.00, intestato alla societa' MSD Sharp &
Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 85540 Haar Germania e prodotto da Schering-Plough Labo N.V. Industriepark 30 2220 Heist-op-den-Berg Belgio, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Programmi Sanitari Integrati S.r.l. con sede legale in via Giovanni Lanza n. 3 - 20121 Milano MI. Confezione: NASONEX «50 microgrammi/erogazione spray nasale, sospensione» flacone da 60 erogazioni. Codice A.I.C.: 037210061 (in base 10) 13HKYF (in base 32). Forma farmaceutica: spray nasale, sospensione. Composizione: 50 microgrammi/erogazione spray nasale, sospensione. Principio attivo: mometasone furoato (come monoidrato) 50 microgrammi/erogazione. Eccipienti: cellulosa dispersibile (cellulosa microcristallina e carmellosa sodica), glicerolo, sodio citrato, acido citrico monoidrato, polisorbato 80, benzalconio cloruro, acqua purificata. Officine di confezionamento secondario: Falorni S.r.l. - via Provinciale Lucchese, S.n.c. - loc. Masotti - 51100 Serravalle Pistoiese (PT);
Prespack, Jacek Karonski Poland, Skorzewo, UL. Sadowa 38. 60-185;
STM Pharma PRO S.r.l. strada provinciale Pianura 2 - 80078 Pozzuoli (NA). Classificazione ai fini della rimborsabilita' Confezione: NASONEX «50 microgrammi/erogazione spray nasale, sospensione» flacone da 60 erogazioni. Codice A.I.C.: 037210061. 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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