COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Pantoprazolo Sandoz 40 mg» (16A04828)
Estratto determina n. 804/2016 del 10 giugno 2016 Medicinale: PANTOPRAZOLO SANDOZ 40 mg. Importatore: GMM Farma S.r.l. CIS di Nola Isola 8, Lotti 8105/10 - 80035 Nola. Confezione: Pantoprazolo Sandoz «40 mg compresse gastroresistenti» 14 compresse in blister AL/OPA/AL/PVC - A.I.C. n. 044483016 (in base 10) 1BFJG8 (in base 32). Forma farmaceutica: compresse gastroresistenti. Composizione: ogni compressa gastroresistente contiene: principio attivo: 40 mg di pantoprazolo (come pantoprazolo sodico sesquidrato). Eccipienti: nucleo della compressa. Calcio stearato, Cellulosa microcristallina, Crospovidone, Idrossipropilcellulosa (tipo EXF), Sodio carbonato anidro, Silice colloidale anidra. Rivestimento Ipromellosa, ferro ossido giallo (E172), Macrogol 400, Copolimero dell'acido metacrilico-etil acrilato (1:1), Polisorbato 80, Ponceau 4R lacca di alluminio (E124), Giallo chinolina lacca di alluminio (E104), Sodio lauril solfato, Titanio diossido (E171), Trietilcitrato. Inchiostro di stampa: Macrogol 600 Shellac Povidone ferro ossido nero (E172) ferro ossido rosso (E172) ferro ossido giallo (E172) Officine: De salute S.R.L. via Antonio Biasini, 26 - 26015 Soresina (CR). Fiege Logistics Italia S.p.A., via Amendola 1, 20090 Caleppio di Settala (MI). S.C.F. S.N.C. Di Giovenzana Roberto e Pelizzola Mirko Claudio via F. Barbarossa, 7 26824 Cavenago D'Adda (LO). Pharma Partners S.r.l., via E. Strobino 55/57, 59100 Prato (PO). Indicazioni terapeutiche: Pantoprazolo Sandoz 40 mg viene usato per: adulti e adolescenti a partire dai 12 anni di eta': esofagite da reflusso: un'infiammazione dell'esofago (il tubo che connette la gola allo stomaco) accompagnata da rigurgito di acido dallo stomaco. adulti: un'infezione da batterio chiamato Helicobacter pylori in pazienti con ulcere duodenali e gastriche in combinazione con due antibiotici (terapia di...
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