COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Pantorc» (17A01948)
Estratto determina IP n. 157 del 21 febbraio 2017 E' autorizzata l'importazione parallela del medicinale CONTROLOC 40 mg tabletki dojelitowe 28 tablets Al/Al blister dalla Polonia con numero di autorizzazione R/6898, il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione: importatore: Mediwin Limited, Unit 11-13 Martello Enterprise Centre Courtwick Lane - Littlehampton West Sussex BN17 7PA;
confezione: PANTORC 14 compresse gastroresistenti da 40 mg in blister Al/Al;
codice A.I.C.: n. 045086030 (in base 10) 1BZXBG (in base 32). Forma farmaceutica: compresse Ogni compressa gastroresistente contiene: Principio attivo: Pantoprazolo 40 mg;
Eccipienti: Nucleo: sodio carbonato anidro, mannitolo (E421), crospovidone, povidone K90, calcio stearato. Rivestimento: ipromellosa, povidone K25, titanio diossido (E171), ossido di ferro giallo (E 172), glicole propilenico, acido metacrilico-etilacrilato copolimero (1:1), polisorbato 80, sodio laurilsolfato, trietilcitrato. Inchiostro di stampa: gommalacca, ossido di ferro rosso, nero e giallo (E172), ammoniaca soluzione concentrata. Indicazioni terapeutiche. Adulti ed adolescenti di 12 anni ed oltre: esofagite da reflusso. Un'infiammazione dell'esofago (il tubo che unisce la gola con lo stomaco) accompagnata da rigurgito di acido gastrico. Adulti: un'infezione con un batterio denominato Helicobacter pylori nei pazienti con ulcera duodenale e ulcera gastrica in combinazione con due antibiotici (Terapia di eradicazione). Lo scopo e' di liberarsi dei...
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