COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Siterbon». (14A03950)
Estratto determinazione n. 478/2014 del 14 maggio 2014 Medicinale: SITERBON. Titolare AIC: Laboratorios LICONSA S.A. Gran Via Carlos III, 98, 7th floor 08028 Barcellona, Spagna. Confezione «20 mg compresse» 28 compresse in blister AL/AL - AIC n. 041639016 (in base 10) 17QR38 (in base 32) Confezione «40 mg compresse» 28 compresse in blister AL/AL - AIC n. 041639028 (in base 10) 17QR3N (in base 32) Confezione «80 mg compresse» 28 compresse in blister AL/AL - AIC n. 041639030 (in base 10) 17QR3Q (in base 32). Forma farmaceutica: Compresse. Composizione: Ciascuna compressa contiene: Principio attivo: 20 mg, 40 mg, 80 mg di telmisartan Eccipienti: Povidone Meglumina Idrossido di sodio Mannitolo Magnesio stearato Crospovidone Produzione del Principio attivo: Amino Chemicals Ltd. - A61 Industrial Estate, Marsa LQA06 - Malta Zhejiang Huahai Pharmaceutical Co. Ltd. - Xunqiao China-317 024 Linhai, Zhejiang Province Produzione, confezionamento primario e secondario, controlli e rilascio dei lotti Laboratorios Liconsa, S.A. - Avda. Miralcampo, n. 7, Poligono Industrial Miralcampo - 19200 Azuqueca de Henares (Guadalajara) - Spagna Controllo qualita' Idifarma Desarrollo Farmaceutico, S.L. Poligono Industrial Moncholi', C/Noain, nº 1 - 31110 Noain (Navarra) - Spagna Laboratorio De Analisis DR. Echevarne - C/Provenza 312, bajos, 08037 Barcellona - Spagna Indicazioni terapeutiche: Ipertensione: Trattamento dell'ipertensione essenziale negli adulti. Prevenzione cardiovascolare: Riduzione della morbilita' cardiovascolare in pazienti affetti da: i) malattia cardiovascolare aterotrombotica manifesta (storia di coronaropatia, ictus o malattia arteriosa periferica) o ii) diabete mellito di tipo 2 con danno documentato degli organi bersaglio. Classificazione ai fini della rimborsabilita' Confezione «20 mg compresse» 28 compresse in blister AL/AL - AIC n. 041639016 (in base 10) 17QR38 (in base 32) Classe di rimborsabilita' «A» Prezzo ex factory (IVA esclusa) €
2,28 Prezzo al...
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