COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Fluimucil» (19A06001)
Estratto determina IP n. 638 del 27 agosto 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale «FLUIMUCIL» 600 mg 10 losliche tabletten (5x2) dall'Austria con numero di autorizzazione 1-20242, intestato alla societa' Zambon S.p.a. e prodotto da Zambon S.p.a., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag S.p.a. con sede legale in via Vasil levski ,103 - 1000 Sofia. Confezione: FLUIMUCIL «600 mg compresse effervescenti» 30 compresse - codice A.I.C. n. 047933027 (in base 10) 1FQTM3 (in base 32). Forma farmaceutica : compressa effervescente. Composizione: una compressa effervescente contiene: principio attivo: 600 mg di N-acetilcisteina;
eccipienti: sodio bicarbonato, acido citrico, aroma limone, aspartame come conservare «Fluimucil»: temperatura di conservazione inferiore a 25°C. Officine di confezionamento secondario Pricetag EAD Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria) S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO. XPO Supply Chain Pharma Italy S.p.a. via Amendola, 1 - 20090 Caleppio di Settala (MI);
Falorni S.r.l. via provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (PT). Classificazione ai fini della rimborsabilita' Confezione: «Fluimucil» 600 mg compresse effervescenti» 30 compresse - codice A.I.C. n. 047933027;
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 farmaci...
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