COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Buscopan» (19A02040)
Estratto determina IP n. 152 del 5 marzo 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale BUSCOPAN RX 10 mg coated tablets, 56 tablets dall'Irlanda con numero di autorizzazione PA 0540/190/001, intestato alla societa' Sanofi Aventis Ireland Ltd e prodotto da Delpharm Reims S.a.s. e da Istituto De Angeli S.r.l., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta n. 2 - 20090 Segrate (MI). Confezione: BUSCOPAN «10 mg compresse rivestite» 30 compresse rivestite. Codice A.I.C.: 043962024 (in base 10) 19XMP8 (in base 32). Forma farmaceutica: compresse rivestite. Composizione: una compressa rivestita contiene: principio attivo: N-butilbromuro di joscina 10 mg;
eccipienti: nucleo: calcio idrogeno fosfato anidro, amido di mais, amido solubile, silice colloidale anidra, acido tartarico, acido stearico/palmitico;
rivestimento: povidone, saccarosio, talco, acacia, titanio diossido (E171), macrogol 6000, cera carnauba, cera d'api bianca. Conservazione: non conservare a temperatura superiore ai 30°C. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala (MI);
S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago d'Adda (LO). Classificazione ai fini della rimborsabilita' Confezione: BUSCOPAN «10 mg compresse rivestite» 30 compresse rivestite. Codice A.I.C.: 043962024. Classe di rimborsabilita': C-bis. Classificazione ai fini...
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