COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Enterogermina» 10a10 Normaflore (12A11579)
Estratto Determinazione V & A IP n. 1429 del 27 settembre 2012
E' autorizzata l'importazione parallela del medicinale NORMAFLORE belsoleges szuszpenzio 10x5 ml dall'UNGHERIA con numero di autorizzazione OGYI-T-10357/01, il quale, per le motivazioni espresse in premessa, deve essere posto in commercio con la denominazione Enterogermina e 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., Via Tiburtina nn. 1166/1168, 00156 - Roma.
Confezione: Enterogermina «2 miliardi/5 ml sospensione orale» 10 flaconcini 5 ml.
Codice A.I.C.: 042209015 (in base 10) 1883RR (in base 32)
Forma Farmaceutica: sospensione orale
Composizione: ogni flaconcino contiene:
Principio attivo: 2 miliardi di spore di Bacillus clausii poliantibiotico resistente;
Eccipienti: acqua depurata.
Indicazioni Terapeutiche:
Enterogermina si usa per curare e prevenire le alterazioni della flora batterica intestinale.
Enterogermina ripristina l'equilibrio della flora intestinale alterato nel corso di terapie con antibiotici o chemioterapici, contribuendo a correggere le conseguenti disvitaminosi (cioe' gli squilibri di produzione e di assimilazione delle vitamine).
Enterogermina 2 miliardi/ 5 ml sospensione orale si puo' impiegare anche nei lattanti per curare disturbi gastrointestinali acuti e cronici, sia...
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