COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Tobradex» (24A01785)
Estratto determina IP n. 203 del 28 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale TOBRADEX AUGENTROPFEN 1 flacone da 5 ml dall'Austria con numero di autorizzazione 1-22591, intestato alla societa' Novartis Pharma GmbH Jakov-Lind-Straße 5, Top 3.05 1020 Wien Austria e prodotto da Siegfried El Masnou S.A. Camil Fabra 58 08320 El Masnou, Barcelona Spain, da S.A. Alcon - Couvreur N.V. Rijksweg 14 2870 Puurs Belgium, da Novartis Pharma GmbH Roonstraße 25 90429 Nürnberg Germany e da Novartis Farmaceutica S.A. Gran Via de Les Corts Catalanes 764 08013 Barcelona Spain, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: BB Farma S.r.l. con sede legale in viale Europa n. 160 - 21017 Samarate (VA). Confezione: TOBRADEX «0,3% + 0,1% collirio, sospensione» flacone contagocce 5 ml - codice A.I.C. n. 041683095 (in base 10) 17S24R (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/o idrossido di sodio, acqua depurata. Inserire al paragrafo 5 del foglio illustrativo e sulle etichette: 5. Come conservare TobraDex Collirio: Conservare il flacone nella confezione originale per proteggere dalla luce. Tenere il flacone ben chiuso. Non usi il medicinale oltre ventotto giorni dopo la prima apertura del contenitore. Officine di confezionamento secondario: Falorni S.r.l., via dei Frilli n. 25 - 50019 Sesto Fiorentino(FI) GXO Logistics Pharma Italy S.p.a., via Amendola n. 1 - 20049 Caleppio di Settala (MI) Pricetag AD Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria) S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago d'Adda(LO). Classificazione ai fini della rimborsabilita'...
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