COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Coltowan». (16A03104)
Estratto determina n. 497/2016 del 6 aprile 2016 Medicinale: COLTOWAN Titolare AIC: Gedeon Richter Plc. Gyömrői ut 19-21 H-1103 Budapest Ungheria Confezione: "10 mg compresse" 30 compresse in blister PVC/PE/PVDC/PE/PVC/AL - AIC n. 043851017 (in base 10) 19U789 (in base 32) Forma farmaceutica: compressa Composizione: ogni compressa contiene: Principio attivo: 10 mg di ezetimibe Eccipienti: Lattosio monoidrato Cellulosa microcristallina (tipo 102) Magnesio stearato Povidone (K29-32) Sodio laurilsolfato Croscarmellosa sodica Produttori del principio attivo: Richter Themis Medicare (I) Pvt. Ltd. Plot No. 69/A/2, Gujarat Industrial Development Corporation Vapi 396195 District Valsad Gujarat 396195 India Produttore, responsabili del controllo e del rilascio dei lotti, confezionamento primario e secondario Gedeon Richter România S.A. Cuza Vodă
street 99-105 Târgu-Mures 540306 Romania Indicazioni terapeutiche Ipercolesterolemia primaria Coltowan, somministrato con un inibitore della HMG-CoA reduttasi (statina), e' indicato come terapia aggiuntiva alla dieta in pazienti con ipercolesterolemia primaria (eterozigote familiare e non-familiare) che non sono controllati adeguatamente con le statine da sole. La monoterapia con Coltowan e' indicata come terapia aggiuntiva alla dieta in pazienti con ipercolesterolemia primaria (familiare eterozigote e non-familiare) per i quali le statine sono considerate inappropriate o non sono tollerate. Ipercolesterolemia familiare omozigote (IF omozigote) Coltowan somministrato con una statina, e' indicato come terapia aggiuntiva alla dieta in pazienti con ipercolesterolemia familiare omozigote. Il paziente puo' ricevere anche trattamenti aggiuntivi (per esempio, l'aferesi delle LDL). Sitosterolemia omozigote (Fitosterolemia) Coltowan e' indicato come terapia aggiuntiva alla dieta in pazienti con sitosterolemia familiare omozigote. Non e' stato ancora dimostrato un effetto benefico di ezetimibe sulla morbilita' e sulla mortalita' cardiovascolare. Classificazione ai fini della rimborsabilita' Le confezioni di cui all'art. 1 risultano collocate, in virtu' dell'art. 12, comma 5, del decreto-legge 13 settembre 2012, n. 158, convertito, con modificazioni, dalla legge 8 novembre 2012, n. 189, nell'apposita sezione, dedicata ai farmaci non ancora valutati ai fini della...
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