COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Movicol» (19A01031)
Estratto determina IP N. 24 del 10 gennaio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale Movicol Liquid Orange Flavour, concentrate for oral solution 500 ml dal Regno Unito con numero di autorizzazione PL20011/0007, intestato alla societa' Norgine Pharmaceutical Limited e prodotto da Norgine Pharma Dreux (FR) e da Norgine Limited (UK), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: General Pharma Solutions S.p.a. con sede legale in via Vasil Levki 103 - 1000 Sofia. Confezione: MOVICOL «13,9 G/25 ml concentrato per soluzione orale gusto arancio» 1 flacone in PE da 500 ml. Codice A.I.C. n.: 043382023 (in base 10) 19CX87(in base 32). Forma farmaceutica: concentrato per soluzione orale. Composizione: 25 ml di Movicol concentrato per soluzione orale contengono: Macrogol 3350 13,125 g, Sodio cloruro 0,3507 g, Sodio idrogenocarbonato 0,1785 g, Potassio cloruro 0,0466 g. Movicol concentrato per soluzione orale contiene anche acqua depurata, aroma di arancio, acesulfame potassio (E950) e sucralosio (E955) come dolcificanti. Contiene inoltre un conservante che contiene alcool benzilico, metil paraidrossibenzoato (E218) ed etil paraidrossibenzoato (E214). L'aroma di arancio contiene i seguenti ingredienti: sostanze aromatizzanti, preparati aromatizzanti ed etanolo (alcool). Officine di confezionamento secondario XPO Supply Chain Pharma Italy S.p.a. via Amendola, 1 - 20090 Caleppio di Settala (MI);
Falorni S.RL. via provinciale lucchese, localita' Masotti 51030 Serravalle Pistoiese (PT);
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 - LO. Classificazione ai fini della rimborsabilita' Confezione: MOVICOL «13,9 g/25 ml concentrato per soluzione orale gusto arancio» 1 flacone in pe da 500 ml. Codice A.I.C. n...
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