COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Sandimmun Neoral» (17A07299)
Estratto determina IP n. 487 del 20 settembre 2017 E' autorizzata l'importazione parallela del medicinale NEORAL-SANDIMMUN 100 mg capsule, soft 50 capsules blister Al/Al dal Belgio con numero di autorizzazione BE 170676, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: Importatore: Pricetag SPA , Vasil Levski St. 103 - 1000 Sofia. Confezione: Sandimmun Neoral «100 mg capsule molli» 30 capsule. Codice A.I.C.: 045335015 (in base 10) 1C7JH7 (in base 32). Forma farmaceutica: capsule molli. Ogni capsula molle contiene: principio attivo: ciclosporina 100 mg;
eccipienti: contenuto della capsula: alfa-tocoferolo, etanolo assoluto, glicole propilenico, mono-di-trigliceridi di olio di mais, macrogolglicerolo idrossistearato/olio di ricino poliossile-40 idrogenato. involucro della capsula: ossido di ferro nero (E172), titanio diossido (E 171), glicerolo 85%, glicole propilenico, gelatina;
impressione: acido carminico (E 120). Indicazioni terapeutiche: Indicazioni per il trapianto Trapianto d'organo Prevenzione del rigetto del trapianto d'organo solido. Trattamento del rigetto cellulare di trapianto in pazienti che hanno ricevuto precedentemente altre terapie immunosoppressive. Trapianto di midollo osseo Prevenzione del rigetto del trapianto allogenico di midollo osseo e di cellule staminali. Profilassi o trattamento della malattia da trapianto verso ospite (graft-versus-host disease, GVHD). Indicazioni diverse dal trapianto Uveite endogena Trattamento dell'uveite posteriore o intermedia di origine non infettiva a rischio di grave perdita della funzione visiva, in pazienti nei quali le terapie convenzionali non sono risultate efficaci o provocano effetti indesiderati inaccettabili. Trattamento dell'uveite di Behçet con ripetuti attacchi infiammatori a carico della retina nei pazienti senza manifestazioni neurologiche. Sindrome nefrosica Sindrome nefrosica steroido-dipendente e steroido-resistente dovuta a glomerulopatie primarie quali nefropatia a lesioni minime, glomerulosclerosi focale e segmentaria o glomerulonefrite membranosa...
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