COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Paxabel». (20A00372)
Estratto determina IP n. 893 del 16 dicembre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale FORLAX poudre pour solution buvable 10 g 20 sachets dalla Francia con numero di autorizzazione 34009 338 997 8 3, intestato alla societa' Ipsen Consumer Healthcare (FR) e prodotto da Beaufour Ipsen Industrie (FR), 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, 2 - 20090 Segrate (Milano). Confezione: PAXABEL «10 g polvere per soluzione orale» 20 bustine - codice A.I.C. n. 048164014 (in base 10), 1FXV5G (in base 32). Forma farmaceutica: polvere per soluzione orale. Composizione: ogni bustina contiene: principio attivo: 10 g di macrogol 4000;
eccipienti: saccarina sodica (E954), aroma di arancio-pompelmo che contiene oli di arancia e pompelmo, succo d'arancia concentrato, citrale, acetaldeide, linalolo, etilbutirrato, alfaterpineolo, ottanale, beta e gamma esenolo, maltodestrina, gomma arabica, sorbitolo (E420), BHA (E320) e biossido di zolfo (E220). Officine di confezionamento secondario: De Salute S.r.l., via Biasini, 26 - 26015 Soresina (Cremona);
Pharma Partners S.r.l., via E. Strobino, 55/57 - 59100 Prato;
S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda (Lodi). Classificazione ai fini della rimborsabilita' Confezione: PAXABEL «10 g polvere per soluzione orale» 20 bustine - codice A.I.C. n...
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