COMUNICATO - Importazione parallela del medicinale per uso umano «Sinvacor» (15A07475)
Estratto determina n. 1631 del 7 settembre 2015 E' autorizzata l'importazione parallela del medicinale ZOCOR 20 mg comprimidos recubiertos con pelicula blister 28 compr. dalla Spagna con numero di autorizzazione 58846 Codigo Nac. 997189-2, il quale per le motivazioni in premessa espresse puo' essere posto in commercio con la denominazione SINVACOR e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: Farma 1000 S.r.l. Via Camperio Manfredo, 9 - 20123 Milano. Confezione: Sinvacor «20 mg compresse rivestite con film» 28 compresse. Codice A.I.C.: 044011017 (in base 10) 19Z3J9 (in base 32). Forma Farmaceutica : compresse rivestite con film. Ogni compressa contiene: principio attivo: 20 mg di simvastatina;
eccipienti: Lattosio monoidrato, butilidrossianisolo, acido ascorbico, acido citrico monoidrato, cellulosa microcristallina, amido pregelatinizzato, magnesio stearato, ipromellosa, idrossipropilcellulosa, titanio diossido, talco, ferro ossido rosso, ferro ossido giallo. Indicazioni terapeutiche lpercolesterolemia Trattamento della ipercolesterolemia primaria o della dislipidemia mista, come integratore della dieta, quando la risposta alla dieta e ad altri trattamenti non farmacologici (es. esercizio fisico, riduzione del peso corporeo) e' inadeguata. Trattamento della ipercolesterolemia familiare omozigote come integratore della dieta e di altri trattamenti ipolipemizzanti (es. LDL aferesi) o se tali trattamenti non sono appropriati. Prevenzione cardiovascolare Riduzione della mortalita' e della morbilita' cardiovascolare in pazienti con malattia aterosclerotica cardiovascolare manifesta o diabete...
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