COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Fenofibrato EG». (15A08694)
Estratto determina n. 1457/2015 del 9 novembre 2015 Specialita' medicinale: FENOFIBRATO EG. Titolare A.I.C.: EG S.p.A., via Pavia n. 6, 20136 Milano. Confezione: «145 mg compresse» 30 compresse in blister PVC/PVDC/AL - A.I.C. n. 043837018 (in base 10) 19TTLU (in base 32). Forma farmaceutica: Compressa. Composizione: Ogni compressa contiene: Principio attivo: 145,0 mg di fenofibrato (nanoparticelle). Eccipienti: Lattosio anidro, Ipromellosa, Croscarmellosa sodica Sodio laurilsolfato, Simeticone, Magnesio stearato Produttore del principio attivo Coprima S.L., Pablo Picasso n. 15, 08213 Polinya' (Barcelona) Spagna. Produzione, confezionamento primario e secondario, controllo e rilascio dei lotti: Ethypharm - Zone Industrielle de Saint-Arnoult, 28170 Châteauneuf-en-Thymerais, Francia;
Ethypharm - Chemin de la Poudriere - 76120 Grand Quevilly, Francia. Confezionamento primario e secondario: Famar l'Aigle - Zone industrielle n. 1, Route de Crulai - 61300 L'Aigle, Francia;
Laphal Industries - 248 avenue de la Victoire - 13106 Rousset, Francia. Indicazioni terapeutiche: Fenofibrato EG e' indicato in aggiunta alla dieta e ad altri trattamenti non farmacologici (ad es. esercizio fisico, riduzione ponderale) per: Trattamento dell'ipertrigliceridemia grave con o senza bassi livelli di colesterolo HDL. Iperlipidemia mista quando una statina e' controindicata o non tollerata. Iperlipidemia mista nei pazienti ad alto rischio cardiovascolare, in aggiunta a una statina, quando i livelli di trigliceridi e di colesterolo HDL non sono adeguatamente controllati. Classificazione ai fini della rimborsabilita' Confezione: «145 mg compresse» 30 compresse in blister...
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