COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Limpidex» (18A02438)
Estratto determina IP n. 247 del 20 marzo 2018 E' autorizzata l'importazione parallela del medicinale AGOPTON 15 mg Kapseln 98 Kaps. dalla Germania con numero di autorizzazione 36286.01.00 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Medifarm S.r.l. con sede legale in via Tiburtina nn. 1166/1168 00156 Roma. Confezione: LIMPIDEX «15 mg capsule rigide» 14 capsule. Codice A.I.C. n. 045746029 (in base 10) 1CN1VF (in base 32). Forma farmaceutica: capsule rigide. Ogni capsula contiene: principio attivo: lansoprazolo 15 mg;
eccipienti: magnesio carbonato basico pesante, saccarosio, amido di mais, idrossipropilcellulosa, copolimero acido metacrilico-etilacrilato (1:1), talco, macrogol 8000, titanio diossido, polisorbato 80, silice colloidale anidra, laurilsolfato di sodio, gelatina, acqua purificata. Indicazioni terapeutiche: trattamento dell'ulcera duodenale e gastrica;
trattamento dell'esofagite da reflusso;
profilassi dell'esofagite da reflusso;
eradicazione dell'Helicobacter pylori (H. pylori) somministrato in concomitanza con appropriata terapia antibiotica per il...
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