COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso umano «Finasteride Germed» (10A06555)
Estratto determinazione n. 1720 /2010 del 19 maggio 2010
Medicinale: FINASTERIDE GERMED.
Titolare A.I.C.: Germed Pharma S.p.a. - via Cesare Cantu', 11 - 20092 Cinisello Balsamo (Milano).
Confezioni:
5 mg compresse rivestite con film 14 compresse compresse in blister PVC/PVDC/AL - A.I.C. n. 039262011/M (in base 10), 15G5TV (in base 32);
5 mg compresse rivestite con film 15 compresse compresse in blister PVC/PVDC/AL - A.I.C. n. 039262023/M (in base 10), 15G5U7 (in base 32);
5 mg compresse rivestite con film 28 compresse compresse in blister PVC/PVDC/AL - A.I.C. n. 039262035/M (in base 10), 15G5UM (in base 32);
5 mg compresse rivestite con film 500 compresse compresse in blister PVC/PVDC/AL - A.I.C. n. 039262047/M (in base 10), 15G5UZ (in base 32).
Forma farmaceutica: compressa rivestita con film.
Composizione: ogni compressa rivestita con film contiene:
principio attivo: 5 mg di finasteride;
eccipienti: nucleo della compressa:
povidone K29-32, croscarmellosa sodica, lattosio monoidrato, sodio laurilsolfato, magnesio stearato (E470b);
rivestimento: alcool polivinilico, titanio diossido (E171), macrogol talco (E533b), indigotina (E132).
Produzione, confezionamento, controllo: EMS S/A Rodovia SP 101 Km 08, Parque Odimar - Hortolandia - Sao Paulo CEP 13186-901 (Brasile).
Controllo, rilascio: Sofarimex - Industria Quimica e Farmacêutica, Lda - Av. Das Industrias, Alto do Colaride, Agualva - 2735-213 Cacem (Portogallo).
Controllo, rilascio: Monteresearch S.r.l. - IV Novembre, 94 - 20021 Bollate (Milano) - Italia.
Indicazioni terapeutiche: la finasteride e' indicata per il trattamento e il controllo dell'iperplasia benigna (IPB) per:
causare una regressione dell'ipertrofia prostatica, migliorare il flusso urinario e alleviare i sintomi associati a IPB;
ridurre l'incidenza di ritenzione urinaria acuta e la necessita' di intervento chirurgico, inclusa la resezione...
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