COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Tobral» (19A04109)
Estratto determina IP n. 180 del 2 aprile 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale TOBREX OCNI MAST - 3,5 g (1 tubo) dalla Repubblica Ceca con numero di autorizzazione 64/128/91-C, intestato alla societa' Novartis S.R.O. (Repubblica Ceca) e prodotto da Alcon Cusi S.A. e da Alcon Couvreur NV, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: General Pharma Solutions S.p.a. con sede legale in via Vasil Levski n. 103 1000 Sofia. Confezione: TOBRAL «0,3 % unguento oftalmico» tubo da 3,5 g. Codice A.I.C. n. 043316088 (in base 10) 199WVS (in base 32). Forma farmaceutica: Unguento oftalmico. Composizione: 100 ml contengono: principio attivo: Tobramicina 0,3 g Eccipienti: clorobutanolo, olio di vaselina, vaselina bianca. Paragrafo 5 del foglio illustrativo 5. Come conservare TOBRAL Non usi il prodotto oltre ventotto giorni dopo la prima apertura del contenitore. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a. via Amendola, 1 - 20090 Caleppio di Settala (MI);
Falorni S.r.l. via Provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (PT);
Pricetag Ead Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria);
S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO. Classificazione ai fini della rimborsabilita' Confezione: TOBRAL «0,3 % unguento oftalmico» tubo da 3,5 g. Codice A.I.C. n. 043316088. 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 legge 24 dicembre 1993, n. 537 e successive...
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