COMUNICATO - Importazione parallela del medicinale per uso umano «Tobradex». (14A00262)
Estratto determinazione V &
A IP n. 2022 del 15 novembre 2013 E' autorizzata l'importazione parallela del medicinale TOBRADEX colirio en suspension 1 mg/ml + 3 mg/ml fr. de 5 ml dalla Spagna con numero di autorizzazione 61575 Codigo Nac. 670588.9 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: Pharmacyvalue S.r.l. con sede legale e domicilio fiscale in Vicolo del Piede n. 15, 00153 Roma. Confezione: TOBRADEX «0,3% + 0,1% collirio, sospensione» flacone contagocce 5 ml. Codice A.I.C.: 041426053 (in base 10) 17J745 (in base 32). Forma farmaceutica: collirio, sospensione. Composizione: 1 ml contiene Principi attivi: tobramicina 3 mg, desametasone 1 mg. Eccipienti: benzalconio cloruro, disodio edetato, sodio cloruro, sodio solfato anidro, tyloxapol, idrossietilcellulosa, acido solforico e/o idrossido di sodio, acqua depurata. Indicazioni terapeutiche: TobraDex® e' indicato per il trattamento delle infiammazioni oculari quando e' necessario un corticosteroide e quando esista un'infezione oculare o il rischio di infezioni oculari negli adulti e nei bambini da due anni di eta' in poi. Confezionamento secondario E' autorizzato il confezionamento secondario presso le officine De Salute S.r.l., via Antonio Biasini n. 26, 26015 Soresina (Cremona);
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