COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Ramilich» (18A03276)
Estratto determina IP n. 283 del 10 aprile 2018 E' autorizzata l'importazione parallela del medicinale Ramilich 5 mg 100 tabletten (5×20) dalla Germania con numero di autorizzazione 56526.01.00 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag Spa con sede legale in via Vasil Levski 103 - 1000 Sofia Bulgaria. Confezione: RAMILICH «5 mg compresse» 14 compresse divisibili. Codice AIC: 045636053 (in base 10) 1CJQGP (in base 32). Forma farmaceutica: compressa. Ogni compressa contiene: principio attivo: ramipril 5 mg;
eccipienti: ipromellosa, amido di mais pregelatinizzato, cellulosa microcristallina, sodio stearilfumarato, ferro ossido rosso E 172. Indicazioni terapeutiche: Trattamento dell'ipertensione. Prevenzione cardiovascolare: riduzione della morbilita' e mortalita' cardiovascolare in pazienti con: patologie cardiovascolari aterotrombotiche conclamate (pregresse patologie coronariche o ictus, o patologie vascolari periferiche) o diabete con almeno un fattore di rischio cardiovascolare (vedere paragrafo 5.1) Trattamento delle patologie renali: nefropatia glomerulare diabetica incipiente, definita dalla presenza di microalbuminuria;
nefropatia glomerulare diabetica conclamata, definita da macroproteinuria in pazienti con almeno un fattore di rischio cardiovascolare (vedere paragrafo 5.1);
nefropatia glomerulare non diabetica conclamata definita da macroproteinuria ≥
3g/die (vedere paragrafo 5.1). Trattamento dell'insufficienza cardiaca sintomatica. Prevenzione secondaria dopo infarto miocardico acuto: riduzione della mortalita' dopo la fase acuta dell'infarto miocardico in...
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