COMUNICATO - Importazione parallela del medicinale per uso umano «Sinvacor» (15A00541)
Estratto determina V&A IP n. 2752 del 30 dicembre 2014 E' autorizzata l'importazione parallela del medicinale ZOCOR 20 mg por. tablet film. 28 tabl. dalla Repubblica Ceca con numero di autorizzazione 31/155/92-B/C il quale per le motivazioni in premessa espresse deve 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: GMM Farma S.r.l. CIS di Nola Isola 8, Lotti 8105/10 - 80035 Nola;
Confezione: SINVACOR «20 mg compresse rivestite con film» 28 compresse Codice AIC: 043655012 (in base 10) 19N7V4 (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: 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...
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