COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Finasteride RK» (10A01799)
Estratto determinazione n. 1545 del 2 febbraio 2010
Medicinale: FINASTERIDE RK.
Titolare A.I.C.: Errekappa Euroterapici S.p.A., via Ciro Menotti n. 1/A - 20129 Milano.
Confezioni:
5 mg compresse rivestite con film 15 compresse in blister PVC/PE/PVDC/AL - A.I.C. n. 039417011/M (in base 10) 15LX5M (in base 32);
5 mg compresse rivestite con film 30 compresse in blister PVC/PE/PVDC/AL - A.I.C. n. 039417023/M (in base 10) 15LX5Z (in base 32);
5 mg compresse rivestite con film 100 compresse in blister PVC/PE/PVDC/AL - A.I.C. n. 039417035/M (in base 10) 15LX6C (in base 32).
Forma farmaceutica: compressa rivestita con film.
Composizione: ogni compressa contiene:
principio attivo: 5 mg di finasteride;
eccipienti:
nucleo della compressa: cellulosa microcristallina, amido di mais pregelatinizzato, sodio amido glicolato, ossido di ferro giallo (E172), sodio docusato, magnesio stearato;
film di rivestimento: ipromellosa, titanio diossido (E171), talco, glicole propilenico, indigotina (E132), giallo di crinolina FCF (E104), giallo tramonto FCF (E110).
Produzione, confezionamento e controllo: Famar S.A. - 7, Anthoussa Ave. 153 44 Anthoussa - Grecia.
Controllo e rilascio lotti: Pharmathen S.A. - 6 Dervenakion str. - Pallini 15351 Attiki - Grecia.
Indicazioni terapeutiche: «Finasteride RK» e' indicata per il trattamento ed il controllo della iperplasia benigna della prostata (IPB) nei pazienti con prostata ingrossata:
determina una regressione della prostata ingrossata, migliora il flusso urinario e migliora i sintomi associati alla IPB;
riduce l'incidenza di ritenzione acuta urinaria e la necessita' di intervento chirurgico, inclusa la resezione transuretrale della prostata (TURP) e la prostatectomia.
Finasteride RK
5 mg compresse puo' essere...
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