COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Lipitor» (17A08079)
Estratto determina IP n. 633 del 14 novembre 2017 E' autorizzata l'importazione parallela del medicinale LIPITOR 40 mg film coated tablets 28 film coated tablets dalla Gran Bretagna con numero di autorizzazione PL 39933/0003, 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: Programmi Sanitari Integrati s.r.l., via G. Lanza, 3 - 20121 Milano. Confezione: Lipitor «40» 30 compresse 40 mg. Codice AIC: 045039029 (in base 10) 1BYHFP (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. Lipitor 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. Lipitor e' anche indicato per ridurre il colesterolo totale ed il colesterolo LDL...
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