COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Pantoprazolo Bluefish» (11A06522)
Estratto determinazione n. 2267 / 2011
Medicinale PANTOPRAZOLO BLUEFISH
Titolare AIC:
Bluefish Pharmaceuticals AB
Torsgatan 11
111 23 Stoccolma
Svezia
Confezione
20 mg compresse gastroresistenti
14 compresse in blister ALU/ALU
AIC n. 040100024/M (in base 10) 167S5S (in base 32)
Confezione
20 mg compresse gastroresistenti
28 compresse in blister ALU/ALU
AIC n. 040100036/M (in base 10) 167S64 (in base 32)
Confezione
20 mg compresse gastroresistenti
56 compresse in blister ALU/ALU
AIC n. 040100048/M (in base 10) 1676JS (in base 32)
Confezione
20 mg compresse gastroresistenti
100 compresse in blister ALU/ALU
AIC n. 040100051/M (in base 10) 167S6M (in base 32)
Confezione
40 mg compresse gastroresistenti
7 compresse in blister ALU/ALU
AIC n. 040100063/M (in base 10) 167S6Z (in base 32)
Confezione
40 mg compresse gastroresistenti
14 compresse in blister ALU/ALU
AIC n. 040100075/M (in base 10) 167S7C (in base 32)
Confezione
40 mg compresse gastroresistenti
28 compresse in blister ALU/ALU
AIC n. 040100087/M (in base 10) 167S7R (in base 32)
Confezione
40 mg compresse gastroresistenti
56 compresse in blister ALU/ALU
AIC n. 040100099/M (in base 10) 167S83 (in base 32)
Confezione
40 mg compresse gastroresistenti
100 compresse in blister ALU/ALU
AIC n. 040100101/M (in base 10) 167S85 (in base 32)
Forma farmaceutica:
Compressa gastroresistente
Composizione:
Ogni compressa gastroresistente contiene:
Principio attivo:
Pantoprazolo Bluefish 20 mg:
20 mg, di pantoprazolo (come pantoprazolo sodico sesquidrato 22,55 mg)
Pantoprazolo Bluefish 40 mg:
40 mg, di pantoprazolo (come pantoprazolo sodico sesquidrato 45,10 mg)
Eccipienti:
Disodio fosfato anidro
Mannitolo
Cellulosa microcristallina
Croscarmellosa sodica
Magnesio stearato
Ipromellosa
Trietilcitrato
Sodio amido glicolato (Tipo A)
Acido metacrilico-Etilacrilato copolimero (1: 1)
Ossido di ferro giallo (E172)
Produzione del principio attivo:
Natco Pharma Limited
Chemical Division Mekaguda Village, Kothur Mandal, Mahaboob Nagar District
Andhra Pradesh
India
Produzione, confezionamento, controllo di qualita':
Laboratorios Belmac S.A.
Poligono Malpica, 4 - 50016 Zaragoza
Spain
Confezionamento (primario e secondario):
MPF B.V.
Neptunus 12, 8448 CN Heerenveeen
The Netherlands
Controllo di qualita':
Astron Research Limited
Sage House, 319 Pinner Road, North Harrow - Middlesex, HAI 4UF
UK
Zeta Analytical Limited
Unit 3...
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