COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Dulcolax» (19A03855)
Estratto determina IP n. 344 del 29 aprile 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale DULCOLAX GASTRO-RESISTANT TABLET 5 mg/tab 40 tablets dalla Grecia con numero di autorizzazione 36881/28-07-2008, intestato alla societa' Sanofi-Aventis Aebe e prodotto da Delpharm Reims, France e da Boehringer Ingelheim Hellas (S.A.), AE, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l. con sede legale in via Cavallerizza a Chiaia, 8 - 80121 Napoli. Confezione: DULCOLAX «5 mg compresse rivestite» 40 compresse in blister PVC/PVDC. Codice A.I.C.: 047449018 (in base 10) 1F80XU (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: bisacodile 5 mg;
eccipienti: lattosio monoidrato, saccarosio, olio di ricino (vedere paragrafo 2. «Dulcolax contiene lattosio, saccarosio e olio di ricino»), amido di mais, amido modificato, glicerolo, magnesio stearato, talco, acacia, titanio diossido (E171), eudragit L, eudragit S, macrogol 6000, ferro ossido giallo (E172), cera bianca, cera carnauba, gomma lacca. Conservazione: conservare a temperatura inferiore a 25°C. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a. via Amendola, 1 - 20090 Caleppio di Settala (MI);
FALORNI S.r.l. via Provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (PT);
CIT S.r.l. via Primo Villa n. 17 - 20875 Burago di Molgora (MB). Classificazione ai fini della...
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