COMUNICATO - Importazione parallela del medicinale per uso umano «Zocor 40 mg». (13A05009)
Estratto determinazione V &
A IP n. 575 del 15 aprile 2013 E' autorizzata l'importazione parallela del medicinale ZOCOR FORTE 40 mg comprimidos recubiertos con pelicula 28 compr. dalla Spagna con numero di autorizzazione 61497 Codigo Nac. 672253-4, il quale per le motivazioni in premessa espresse deve essere posto in commercio con la denominazione «Zocor» e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione: importatore: BB Farma S.r.l., viale Europa n. 160 - 21017 Samarate (Varese);
confezione: «Zocor» 40 mg compresse rivestite con film - 28 compresse;
codice A.I.C. n. 038478020 (in base 10), 14Q864 (in base 32). Forma farmaceutica : compresse rivestite con film. Ogni compressa contiene: principio attivo: 40 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: ipercolesterolemia;
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 mellito, con livelli di colesterolo normali o aumentati, come coadiuvante per la correzione di altri fattori di rischio e di altre terapie...
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