COMUNICATO - Importazione parallela del medicinale per uso umano «Ananase» (16A04307)
Estratto determina V&A IP n. 1006 del 24 maggio 2016 E' autorizzata l'importazione parallela del medicinale ANANASE 40 mg comprimidos revestidos 40 comp blister PVC/AL. dal Portogallo con numero di autorizzazione 5914494 il quale deve essere posto in commercio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Farmed s.r.l., Centro Direzionale, Isola G1 - 80143 Napoli. Confezione: Ananase «40 mg compresse rivestite» 20 compresse rivestite. Codice A.I.C.: 044814010 (in base 10) 1BRMPU (in base 32). Forma farmaceutica: compressa rivestita. Ogni compressa rivestita contiene: principio attivo: bromelina mg 40,000 (pari a 40 U.P.F.U.);
eccipienti: calcio fosfato bibasico anidro, polietilenglicole 4000, lattosio monoidrato, calcio fosfato bibasico biidrato, macrogol 4000, amido di mais, silice colloidale, talco, magnesio stearato, acido stearico, eudragit L30 D-55, trietilcitrato, simeticone, gelatina, saccarosio, cere in polvere, opalux AS-23014 (saccarosio, giallo di chinolina, biossido di titanio...
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