COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Pantorc» (24A01530)
Estratto determina IP n. 138 del 6 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale Pantoloc 20 mg 28 cpr rivestite con film dall'Austria con numero di autorizzazione 1-22885, intestato alla societa' Takeda Pharma GES.M.B.H. Euro Plaza Technologiestrasse 5 A-1 120 Vienna e prodotto da Takeda GMBH Lehnitzstraße 70-98 16515 Oranienburg Germania, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Programmi Sanitari Integrati S.r.l. con sede legale in Via Giovanni Lanza, 3 20121 Milano Confezione: PANTORC «20 mg compresse gastroresistenti» 28 compresse in blister al/al Codice A.I.C.: 039828165 (in base 10) 15ZGQ5 (in base 32) Forma farmaceutica: compressa gastroresistente Composizione: ogni compressa gastroresistente contiene: Principio attivo: 20 mg di pantoprazolo Eccipienti: nucleo: sodio carbonato (anidro), mannitolo, crospovidone, povidone K90, calcio stearato. rivestimento: ipromellosa, povidone K25, titanio diossido(E171), ossido di ferro giallo (E172), glicole propilenico, acido metacrilico-etilacrilato copolimero (1:1), polisorbato 80, sodio laurilsolfato, trietilcitrato. inchiostro di stampa: gommalacca, ossido di ferro rosso, nero e giallo (E172), ammoniaca soluzione concentrata. Officine di confezionamento secondario Falorni S.r.l., Via dei Frilli, 25 - 50019 Sesto Fiorentino (FI) Medezin Sp. z o.o. Ul. Ksiedza Kazimierza Janika 14, Konstantynow Lodzki, 95-050, Polonia Euromed Pharma Services S.r.l. Strada provinciale pianura 2 80078 Pozzuoli (NA) Classificazione ai fini della rimborsabilita' Confezione: Pantorc «20 MG compresse gastroresistenti» 28 compresse in blister al/al Codice A.I.C.: 039828165 Classe di...
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