COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Fluimucil» (20A01123)
Estratto determina IP n. 837 del 26 novembre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale LYSOMUCIL 600 mg comprimes effervescents - 30 comprimes arome citron dal Belgio con numero di autorizzazione BE150202, intestato alla societa' Zambon S.A. e prodotto da Zambon NV (BE) e 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: General Pharma Solutions 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. 043993031 (in base 10) 19YKY7 (in base 32). Forma farmaceutica: compresse effervescenti. Composizione: ogni compressa contiene: principio attivo: N-acetilcisteina mg 600;
eccipienti: sodio bicarbonato, acido citrico anidro, aroma limone, aspartame. Officine di confezionamento secondario: Xpo Supply Chain Pharma Italy S.p.a., via Amendola, 1 - 20090 Caleppio di Settala (MI);
Pricetag EAD Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria);
Falorni S.r.l., via Provinciale Lucchese, s.n.c. - loc. Masotti - 51034 Serravalle Pistoiese (PT);
S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda - LO. Classificazione ai fini della rimborsabilita' Confezione: «600 mg compresse effervescenti» 30 compresse. Codice A.I.C. n. 043993031. 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 non ancora...
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