COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Buscopan» (20A03247)
Estratto determina IP n. 347 del 15 giugno 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale BUSCOPAN RX 10 MG COATED TEBLET 56 TABS dall'Irlanda con numero di autorizzazione PA 0540/190/001, intestato alla societa' Sanofi-Aventis Ireland Ltd t/a Sanofi, Citywest Business Campus, Dublino 24 - Irlanda e prodotto da Delpharm Reims S.A.S, 10 Rue Colonel Charbonneaux, France e Istituto De Angeli S.r.1., loc. Prulli 103/C, Italia, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop S.r.l. con sede legale in CIS di Nola Isola 1, Torre 1, int. 120 - 80035 Nola (Napoli). Confezione: BUSCOPAN «10 mg compresse rivestite» 30 compresse rivestite - codice A.I.C. n. 048518017 (in base 10), 1G8NW1 (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: N-butilbromuro di joscina 10 mg;
eccipienti: nucleo: calcio idrogenofosfato anidro, amido di mais, amido solubile, silice colloidale anidra, acido tartarico, acido stearico/palmitico;
rivestimento: povidone, saccarosio, talco, gomma arabica, titanio diossido (E171), macrogol 6000, cera carnauba, cera bianca. Condizioni di conservazione: non conservare a temperatura superiore ai 30°C. Officine di confezionamento secondario: Pharm@Idea S.r.l., via del Commercio, 5 - 25039 Travagliato (Brescia);
S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda (Lodi). Classificazione ai fini della rimborsabilita' Confezione...
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