COMUNICATO - Importazione parallela del medicinale per uso umano «Sortis» (15A00539)
Estratto determina V&A IP n. 2743 del 30 dicembre 2014 E' autorizzata l'importazione parallela del medicinale SORTIS 20 mg potahovane' tablety 100 tablet dalla Repubblica Ceca con numero di autorizzazione 31/234/99-C, il quale deve essere posto in commercio 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: SORTIS «20» 30 compresse 20 mg, Codice AIC: 043648017 (in base 10) 18N10K (in base 32) Forma Farmaceutica: compresse rivestite con film Composizione: una compressa rivestita contiene: Principio attivo: atorvastatina 20 mg (come atorvastatina-calcio triidrato). Nucleo della compressa: Calcio carbonato (E170), Cellulosa microcristallina (E460), Lattosio monoidrato, Croscarmellosa sodica, Polisorbato 80 (E433), Iprolosa (E463), Magnesio stearato (E572);
Film di rivestimento: Ipromellosa (E464), Macrogol 8000, Titanio diossido (E171), Talco (E553b), Simeticone, Emulsionanti stearati, Agenti addensanti (metilcellulosa, gomma xantana), Acido benzoico, Acido sorbico. Indicazioni terapeutiche: Ipercolesterolemia SORTIS e' indicato in aggiunta alla dieta per ridurre i livelli elevati di colesterolo totale, colesterolo LDL, apolipoproteina B e trigliceridi in soggetti adulti, adolescenti e bambini di eta' uguale o superiore ai 10 anni affetti da ipercolesterolemia primaria inclusa ipercolesterolemia familiare (variante eterozigote) o iperlipemia mista (corrispondente ai Tipi IIa e IIb della classificazione di Fredrickson) quando la risposta alla dieta e ad altre misure non farmacologiche e' inadeguata. SORTIS e' anche indicato per ridurre il colesterolo totale ed il colesterolo LDL in soggetti adulti con ipercolesterolemia familiare omozigote in aggiunta ad altri trattamenti ipolipemizzanti (ad esempio, LDL aferesi) o se tali trattamenti non...
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