COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Blopress» (15A05064)
Estratto determina V&A IP n. 1117 del 12 giugno 2015 E' autorizzata l'importazione parallela del medicinale AMIAS 16 mg tablets 28 Tablets dalla Gran Bretagna con numero di autorizzazione PL 16189/0004 il quale deve essere posto in commercio con la denominazione Blopress e con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente Determinazione. Importatore: GMM Farma S.r.l. CIS di Nola Isola 8, Lotti 8105/10 - 80035 Nola. Confezione: Blopress 28 compresse 16 mg. Codice AIC: 043896012 (in base 10) 19VM6D (in base 32). Forma farmaceutica: compresse. Ogni compressa contiene: principio attivo: candesartan cilexetil 16 mg. Eccipienti: carmellosa calcica, idrossipropilcellulosa, lattosio monoidrato, magnesio stearato, amido di mais, macrogol, ossido di ferro rosso (E172). Indicazioni terapeutiche: Blopress e' indicato per il: trattamento dell'ipertensione essenziale negli adulti;
trattamento dell'ipertensione in bambini e adolescenti di eta' compresa tra 6 e 18 anni;
il trattamento di pazienti adulti con insufficienza cardiaca e compromissione della funzione sistolica ventricolare sinistra (frazione di eiezione ventricolare sinistra ≤
40%) quando gli ACE-inibitori non sono tollerati o come terapia aggiuntiva agli ACE-inibitori in pazienti con insufficienza cardiaca sintomatica, nonostante la terapia ottimale, quando gli antagonisti del recettore dei mineralcorticoidi non sono tollerati. Officine di...
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