COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Lexotan» (19A02064)
Estratto determina IP n. 144 del 26 febbraio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale LEXOTAN 1,5 mg comprimidos, 60 comprimidos dal Portogallo con numero di autorizzazione 5470083, intestato alla societa' Roche Farmaceutica Quimica, LDA e prodotto da Roche Pharma A.G., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag Spa, con sede legale in via Vasil Levski 103 1000 Sofia. Confezione: LEXOTAN «1,5 mg compresse» 20 compresse. Codice A.I.C.: 043989021 (in base 10) 19YG0X (in base 32). Forma farmaceutica: compressa. Composizione: ogni compressa contiene: principi attivi: Bromazepam 1,5 mg;
eccipienti: cellulosa microcristallina, lattosio monoidrato, talco, magnesio stearato. Conservazione: non conservare a temperatura superiore ai 30 °C. Officine di confezionamento secondario: 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);
Xpo Supply Chain Pharma Italy S.p.a. via Amendola n. 1 - 20090 Caleppio di Settala (MI);
S.C.F. S.r.l. via F. Barbarossa n. 7 - 26824 Cavenago D'Adda (LO). Classificazione ai fini della rimborsabilita' Confezione: LEXOTAN «1,5 mg compresse» 20 compresse. Codice A.I.C.: 043989021. 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 modificazioni, dedicata ai farmaci non ancora valutati ai...
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