COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Diosmectal» (18A08312)
Estratto determina IP n. 837 del 12 dicembre 2018 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale SMECTA 3G orange-venille, poudre pour suspension buvable en sachet dalla Francia con numero di autorizzazione 3400931923138, intestato alla societa' Ipsen Pharma (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 determinazione. Importatore: SM Pharma S.r.l. con sede legale in Via Santa Maria Segreta 6 20123 Milano. Confezione: DIOSMECTAL «3 g polvere per sospensione orale» 30 bustine. Codice AIC: 047136015 (in base 10) 1DYH8H (in base 32). Forma farmaceutica: polvere per sospensione orale Composizione: un flaconcino contiene: Principio attivo: diosmectite 3 g;
Eccipienti: saccarina sodica, glucosio monoidrato, aroma vaniglia*, aroma arancio**. *composizione dell'aroma vaniglia: maltodestrina, saccarosio, gliceril triacetato (E1518), biossido di silicio (E551), alcool etilico, lecitina di soia (E322), aromatizzanti vaniglia. **composizione dell'aroma arancio: maltodestrina, saccarosio, gomma arabica (E414), esteri mono e diacetiltartarici di mono e digliceridi di acidi grassi (E472e), biossido di silicio (E551), aromatizzanti arancio. Officine di confezionamento secondario S.C.F. S.r.l. Via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO. De Salute S.r.l. Via Biasini, 26 26015 Soresina (CR). Pharma Partners S.r.l. Via E. Strobino, 55/57 59100 Prato (PO). Classificazione ai fini della rimborsabilita' Confezione: Diosmectal «3 g polvere per sospensione orale» 30 bustine. Codice AIC: 047136015. Classe di rimborsabilita': C (nn). La confezione sopradescritta e' collocata in «apposita sezione» della...
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