COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Nicorette». (20A01791)
Estratto determina IP n. 204 del 4 marzo 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale NICORETTE ICEMINT 105 chewable tablet 4 mg dalla Grecia con numero di autorizzazione 27792-29-04-2010, intestato alla societa' Johnson &Johnson Hellas Consumer Ae Epidayroy 4 Kai Aigialeias, 151 25 Maroysi Grrece e prodotto da McNeil AB Norrbroplasten 2, Bunkagardsgatan 19 Helsingborg Sweden, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Gekofar S.r.l. con sede legale in piazza Duomo, 16 - 20122 Milano. Confezione: NICORETTE «4 mg gomme da masticare medicate gusto menta forte» 105 gomme - codice A.I.C. n. 048180018 (in base 10), 1FYBTL (in base 32). Forma farmaceutica: gomma da masticare medicata. Composizione: una gomma contiene: principio attivo: 20 mg di complesso di resina nicotinica contenente il 20% di nicotina, corrispondente a 4 mg di nicotina;
eccipienti: gomma da masticare base, xilitolo, peppermint oil, acesulfame di potassio, sodio carbonato anidro, levomentolo, ossido di magnesio leggero, amido pregelatinizzato, titanio biossido, cera di carnauba, giallo chinolina laccato (E 104), ipromellosa, sucralosio, polisorbato 80, menta glaciale, acqua purificata. Officine di confezionamento secondario: 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 - 20090 Caleppio di Settala (Milano);
De Salute S.r.l., via Biasini, 26 - 26015 Soresina (Cremona). Classificazione ai fini della rimborsabilita'...
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