COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Dulcolax» (19A07941)
Estratto determina IP n. 838 del 26 novembre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale DULCOLAX 5 mg gastro-resistant tablets (5×20) dall'Irlanda con numero di autorizzazione 540/184/3, intestato alla societa' Sanofi-Aventis Ireland LTD (IE) e prodotto da Delpharm Reims S.A.S. 10 Rue Colonel Charbonneaux 51100 Reims (Francia), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag Spa con sede legale in via Vasil Levski, 103 - 1000 Sofia. Confezione: DULCOLAX «5 mg compresse rivestite» 40 compresse in blister pvc/pvdc;
Codice A.I.C. : 048035024 (in base 10) 1FTX6J (in base 32);
Forma farmaceutica: compressa rivestita;
Composizione: una compressa rivestita contiene: principio attivo: bisacodile 5 mg;
eccipienti: lattosio monoidrato, saccarosio, olio di ricino amido di mais, amido modificato, glicerolo, magnesio stearato, talco, gomma arabica, titanio diossido (E171), acido metacrilico/metile metacrilato copolimero (1:1), acido metacrilico/metile metacrilato copolimero (1:2), macrogol 6000, ferro ossido giallo (E172), cera bianca, cera carnauba, gomma lacca. Condizioni di conservazione: non conservare a temperatura superiore a 25°C. Officine di confezionamento secondario Falorni S.r.l., via provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (PT). XPO Supply Chain Pharma Italy S.p.a., via Amendola, 1 - 20090 Caleppio di Settala (MI). S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO;
Pricetag EAD Business Center Serdica, 2E Ivan Geshov blvd. - 1000 Sofia (Bulgaria);
Classificazione ai fini della rimborsabilita'...
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