COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Sortis» (17A01927)
Estratto determina IP n. 148 del 21 febbraio 2017 E' autorizzata l'importazione parallela del medicinale SORTIS 40 mg potahovane' tablety 30 tablet blister 3×10 dalla Repubblica Ceca con numero di autorizzazione 31/235/99-C, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: importatore: General Pharma Solutions Spa, Vasil Levski St. 103 - 1000 Sofia. Confezione: Sortis «40» 30 compresse 40 mg, codice A.I.C.: 045096017 (in base 10) 1C072K (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: una compressa rivestita contiene: principio attivo: atorvastatina 40 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, acido solforico. 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...
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