COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Pantoprazolo Sandoz 20 mg» (16A04819)
Estratto determina n. 803/2016 del 10 giugno 2016 Medicinale: PANTOPRAZOLO SANDOZ 20 mg Importatore: GMM Farma S.r.l. CIS di Nola Isola n. 8, Lotti 8105/10 - 80035 Nola Confezione: Pantoprazolo Sandoz «20 mg compresse gastroresistenti» 14 compresse in blister AL/OPA/AL/PVC - A.I.C. n. 044483028 (in base 10) 1BFJGN (in base 32). Forma farmaceutica: compresse gastroresistenti Composizione: ogni compressa gastroresistente contiene: Principio attivo: 20 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 n. 26 - 26015 Soresina (CR);
Fiege Logistics Italia S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala (MI);
S.C.F. S.N. C. di Giovenzana Roberto e Pelizzola Mirko Claudio, via F. Barbarossa n. 7 - 26824 Cavenago D'Adda (LO);
Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato (PO). Indicazioni terapeutiche: Pantoprazolo Sandoz 20 mg viene usato per: adulti e adolescenti a partire dai 12 anni di eta' trattamento dei sintomi (come bruciore di stomaco, rigurgito acido, dolore all'atto della deglutizione) associati a reflusso gastroesofageo, causato da reflusso di acido dallo stomaco;
gestione a lungo termine dell'esofagite da reflusso (infiammazione dell'esofago accompagnata da rigurgito di acido gastrico) e prevenzione...
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