COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Ananase» (18A01359)
Estratto determina IP n. 95 del 7 febbraio 2018 E' autorizzata l'importazione parallela del medicinale ANANASE 40 mg comprimidos revestidos 40 comprimidos blister PVC/AL dal Portogallo con numero di autorizzazione 5914494, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione. Importatore: Gekofar S.r.l. con sede legale in piazza Duomo n. 16 - 20122 Milano;
Confezione: «Ananase» - «40 mg compresse rivestite» 20 compresse rivestite. Codice A.I.C.: 045694015 (in base 10) 1CLH1Z (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, giallo arancio S, polivinilpirrolidone, benzoato di sodio). Indicazioni terapeutiche: processi edemigeni di natura flogistica in campo medico e chirurgico. Officine di confezionamento secondario: S.C.F. s.n.c. di Giovenzana Roberto e Pelizzola Mirko Claudio, via F. Barbarossa n. 7 - 26824 Cavenago d'Adda (Lodi);
XPO Supply Chain Pharma Italy S.p.A., via Amendola...
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