COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Movicol» (18A08310)
Estratto determina IP n. 763 del 20 novembre 2018 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale MOVICOL PLAIN 13.7 g sachet, powder for oral solution - 30 sachets dal Regno Unito con numero di autorizzazione 20142/0004, intestato alla societa' Norgine BV e prodotto da Norgine Limited (GB), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag Spa con sede legale in Via Vasil Levski 103 1000 Sofia. Confezione: Movicol «13,7 g polvere per soluzione orale Senza Aroma» 20 bustine ldpe/al/ldpe/carta. Codice AIC: 046765018 (in base 10) 1DM4YU (in base 32). Forma farmaceutica: polvere per soluzione orale. Composizione: ogni bustina da 13,7 g di Movicol Senza Aroma contiene: macrogol 3350 13,125 g sodio cloruro 0,3508 g sodio idrogenocarbonato 0,1786 g potassio cloruro 0,0502 g. Officine di confezionamento secondario Pricetag Ead Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria). S.C.F. S.r.l. Via F. Barbarossa,7 26824 Cavenago D'Adda Lodi. XPO Supply Chain Pharma Italy S.p.a. Via Amendola, 1 Settala loc. Caleppio 20090 Milano. Falorni S.r.l. Via Provinciale Lucchese, localita' Masotti 51030 Serravalle Pistoiese (PT). Classificazione ai fini della rimborsabilita' Confezione: Movicol «13,7 g polvere per soluzione orale senza aroma» 20 bustine ldpe/al/ldpe/carta. Codice AIC: 046765018. Classe di rimborsabilita': C (nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive...
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