COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Belofran» (09A08716)
Estratto determinazione n. 1308 del 14 luglio 2009
Medicinale: BELOFRAN.
Titolare A.I.C.: Ebewe Italia S.r.l., via Viaggiano n. 90 - 00178 Roma.
Confezioni:
4 mg compresse rivestite con film 6 compresse in blister PVC/AL;
A.I.C. n. 037196108/M (in base 10), 13H4BD (in base 32);
8 mg compresse rivestite con film 6 compresse in blister PVC/AL;
A.I.C. n. 037196110/M (in base 10), 13H4BG (in base 32).
Forma farmaceutica: compresse rivestite con film.
Composizione: ogni compressa rivestita contiene:
principio attivo: 4 mg, 8 mg di ondansetrone (come cloridrato diidrato);
eccipienti: compressa:
Cellulosa microcristallina - Lattosio monoidrato - Amido pregelatinizzato (mais) - Magnesio stearato;
film di rivestimento:
Ipromellosa - Idrossipropilcellulosa - Glicole propilenico - Sorbitan oleato - Acido sorbico - Vanillina - Titanio diossido (E171) - Giallo chinolina (E104).
Produttore responsabile del rilascio dei lotti: Ebewe Pharma Gmbh - Mondseestrasse 11 - A 4866 Unterach - Austria.
Indicazioni terapeutiche: l'ondansetrone e' indicato per il trattamento di nausea e vomito indotti da chemioterapia citotossica e radioterapia, e per la prevenzione della nausea e del vomito postoperatori (NVPO).
(classificazione ai fini della rimborsabilita')
Confezioni:
4 mg compresse rivestite con film 6 compresse in blister PVC/AL;
A.I.C. n. 037196108/M (in base 10), 13H4BD (in base 32).
Classe di rimborsabilita' «A» Nota 57.
Prezzo ex factory (IVA esclusa): € 18,94.
Prezzo al pubblico (IVA inclusa): € 35,52.
8 mg compresse rivestite con film 6 compresse in blister PVC/AL;
A.I.C. n. 037196110/M...
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