COMUNICATO - Importazione parallela del medicinale per uso umano «Pantorc». (13A09697)
Estratto determinazione V &
A IP n. 1861 del 4 novembre 2013 E' autorizzata l'importazione parallela del medicinale CONTROLOC 40 mg po. tablet ent. 100 Tablets dalla Repubblica Ceca con numero di autorizzazione 09/714/95-C, il quale per le motivazioni espresse in premessa, deve essere posto in commercio con la denominazione PANTORC e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione: IMPORTATORE: BB FARMA s.r.l., Viale Europa 160 - 21017 SAMARATE (VA);
Confezione: PANTORC 14 compresse gastroresistenti da 40 mg in blister AL/AL Codice AIC: 041972047 (in base 10) 180WBH (in base 32) Forma Farmaceutica : compresse Ogni compressa gastroresistente contiene: Principio attivo: Pantoprazolo 40 mg;
Eccipienti: Nucleo: sodio carbonato, mannitolo, crospovidone, povidone 360, calcio stearato. Rivestimento: ipromellosa, povidone K25, titanio diossido (E171), ossido di ferro giallo (E172), 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 batteri in modo da ridurre la possibilita' che queste ulcere ritornino. Ulcere dello stomaco e del duodeno. Sindrome di Zollinger-Ellison ed altre condizioni...
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