COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Pantorc» (17A07361)
Estratto determina IP n. 494 del 22 settembre2017 E' autorizzata l'importazione parallela del medicinale CONTROLOC 20 mg por. tabl. enter. 28 tabl. Al/Al blister dalla Repubblica Ceca con numero di autorizzazione 09/380/00-C, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: Importatore: Pricetag S.p.a., Vasil Levski St. 103 - 1000 Sofia. Confezione: PANTORC 14 cpr gastroresistenti 20 mg blister. Codice A.I.C. n. 043516020 (in base 10) 19J03N (in base 32). Forma farmaceutica: compresse. Ogni compressa gastroresistente contiene: principio attivo: Pantoprazolo 20 mg (come sodio sesquidrato). 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 «Pantorc» e' usato per il trattamento di adulti ed adolescenti di 12 anni ed oltre per Sintomi (es. pirosi, rigurgito acido, dolore nella deglutizione) associati alla malattia da reflusso gastroesofageo causata da reflusso di acido dallo stomaco. Trattamento a lungo termine dell'esofagite da reflusso (infiammazione dell'esofago accompagnata da rigurgito di acido dallo stomaco) e prevenzione del suo ripresentarsi. «Pantorc» e' usato per il trattamento di adulti per prevenzione delle ulcere duodenali e dello stomaco causate da farmaci antinfiammatori...
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