Autorizzazione all'immissione in commercio della specialita' medicinale per uso umano
Estratto determinazione n. 375 del 6 febbraio 2007
Medicinale: DEXAMONO.
Titolare A.I.C.: Laboratoires Thea - 12, rue Louis Bleriot, 63017 Clermont Ferrand Cedex 2 (Francia).
Confezioni:
1 mg/ml collirio soluzione 10 contenitori monodose LDPE in bustina - A.I.C. n. 037195017/M (in base 10), 13H389 (in base 32);
1 mg/ml collirio soluzione 20 contenitori monodose LDPE in bustina - A.I.C. n. 037195029/M (in base 10), 13H38P (in base 32);
1 mg/ml collirio soluzione 30 contenitori monodose LDPE in bustina - A.I.C. n. 037195031/M (in base 10), 13H38R (in base 32);
1 mg/ml collirio soluzione 50 contenitori monodose LDPE in bustina - A.I.C. n. 037195043/M (in base 10), 13H393 (in base 32);
1 mg/ml collirio soluzione 100 contenitori monodose LDPE in bustina - A.I.C. n. 037195056/M (in base 10), 13H39J (in base 32).
Forma farmaceutica: collirio soluzione.
Composizione: 1 ml di soluzione contiene:
principio attivo: 1 mg di desametasone fosfato come desametasone sodio fosfato;
eccipienti: edetato disodico, disodio fosfato dodecaidrato, cloruro di sodio, acqua per preparazioni iniettabili.
Produzione, controllo e rilascio dei lotti: Excelvision - Rue de la Lombardiere - 07100 Annonay (Francia).
Indicazioni terapeutiche: stati infiammatori del segmento anteriore dell'occhio, come cheratite marginale, edema stremale nella cheratite, uveite anteriore, episclerite (se i FANS sono controindicati o insufficienti), sclerite, fase acuta della congiuntivite allergica grave che non risponde alla terapia standard.
L'infiammazione non deve essere causata da infezione. L'epitelio corneale deve essere integro.
Questo prodotto deve essere usato solamente sotto stretta supervisione di un oculista.
Classificazione ai fini della rimborsabilita':
Confezioni:
1 mg/ml collirio soluzione 10 contenitori monodose LDPE in bustina - A.I.C. n. 037195017/M (in base 10), 13H389 (in base 32);
classe di rimborsabilita': ´Cª;
1 mg/ml collirio...
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