COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Imodium» (24A01531)
Estratto determina IP n. 137 del 5 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale «Imodium» 2 mg Harde capsules 60 capsules dal Belgio con numero di autorizzazione BE 001215, intestato alla societa' Johnson &Johnson Consumer NV/SA, Antwerpseweg 15-17, B-2340 Beerse e prodotto da JNTL Consumer health (France) SAS, Domaine De Maigremont, 27100 Val De Reuil, Francia, da Johnson &Johnson Consumer NV/SA, Michel De Braeystraat 52, 2000 Antwerpen, Belgio e da Johnson & Johnson Consumer NV/SA Antwerpseweg 15-17, B-2340 Beerse Belgio con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l. con sede legale in via Cavallerizza a Chiaia, 8 80121 Napoli NA. Confezione: IMODIUM «2 mg capsule rigide» 8 capsule. Codice A.I.C.: 047448030 (in base 10) 1F7ZYY(in base 32) Forma farmaceutica: capsula rigida. Composizione: una capsula rigida contiene: principio attivo: 2 mg di loperamide cloridrato eccipienti: lattosio monoidrato, amido di mais, talco, magnesio stearato. Composizione della capsula: eritrosina (E 127) indigotina(E 132)ossido di ferro giallo (E 172) ossido di ferro nero (E 172)titanio diossido e gelatina. Inserire al paragrafo 5 del foglio illustrativo e sul confezionamento secondario: Come conservare «Imodium». Non conservare a temperatura superiore a 25°C. Officine di confezionamento secondario: GXO Logistics Pharma Italy S.p.a., via Amendola, 1 -20049 Caleppio di Settala (MI) Falorni S.r.l., via dei Frilli, 25 -50019 Sesto Fiorentino(FI). Classificazione ai fini della rimborsabilita' Confezione: «Imodium» «2 mg capsule rigide» 8 Capsule Codice A.I.C. : 047448030 Classe di rimborsabilita': C-bis. Classificazione ai fini della fornitura...
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