COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Tobradex» (20A01125)
Estratto determina IP n. 31 del 15 gennaio 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale TOBRADEX eye drops suspension 0,1% + 0,3% 1 bottle × 5 ml dalla Grecia con numero di autorizzazione 43179/12-05-2011, intestato alla societa' Novartis (Hellas) A.E.B.E., con sede in 12° km. Ethn. Odoy N°1, 144 51, Metamorfosi Attikis, Greece e prodotto da Alcon Couvreur N.V. S.A. Belgium - Rijksweg 14, B- 2870 e da Alcon Cusi S.A., Barcelona, Spain - Camil Fabra 58, 08320 El Masnou, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop S.r.l., con sede legale in Cis di Nola Isola 1, Torre 1, Int. 120 - 80035 Nola NA. Confezione: TOBRADEX «0,3% + 0,1% collirio, sospensione» flacone contagocce 5 ml. Codice A.I.C. n. 043319021 (in base 10) 199ZRF(in base 32). Forma farmaceutica: collirio, sospensione. Composizione: 1 ml di collirio contiene: principio attivo: tobramicina 3 mg, desametasone 1 mg;
eccipienti: benzalconio cloruro, disodio edetato, sodio cloruro, sodio solfato, tyloxapol, idrossietilcellulosa, acido solforico e idrossido di sodio (per l'aggiustamento del pH), acqua depurata. Come conservare TOBRADEX: non usi il prodotto oltre ventotto giorni dopo la prima apertura del contenitore. Officine di confezionamento secondario: S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda - Lo;
Pharma Partners S.r.l., via E. Strobino, 55/57 - 59100 Prato (PO);
De Salute S.r.l., via Biasini, 26 - 26015 Soresina (CR);
Pharm@idea S.r.l., via del Commercio, 5 - 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: TOBRADEX «0,3% + 0,1% collirio, sospensione» flacone contagocce 5 ml. Codice A.I.C. n. 043319021. Classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della...
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