COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Lansoprazolo Aristo Pharma». (19A05608)
Estratto determina n. 1319/2019 del 30 agosto 2019 Medicinale: LANSOPRAZOLO ARISTO PHARMA (lansoprazolo) Titolare A.I.C.: Aristo Pharma GmbH - Wallenroder Straße 8-10 - 13435 Berlino - Germania. Confezioni: «15 mg compresse orodispersibili» 14 compresse in blister AL/AL - A.I.C. n. 046037014 (in base 10);
15 mg compresse orodispersibili
28 compresse in blister AL/AL - A.I.C. n. 046037026 (in base 10);
15 mg compresse orodispersibili
56 compresse in blister AL/AL - A.I.C. n. 046037038 (in base 10);
30 mg compresse orodispersibili
14 compresse in blister AL/AL - A.I.C. n. 046037040 (in base 10);
30 mg compresse orodispersibili
28 compresse in blister AL/AL - A.I.C. n. 046037053 (in base 10);
30 mg compresse orodispersibili
56 compresse in blister AL/AL - A.I.C. n. 046037065 (in base 10). Forma farmaceutica: compressa orodispersibile. Validita' prodotto integro: due anni. Condizioni particolari di conservazione: non conservare a temperatura superiore a 25 °C. Conservare nella confezione originale. Composizione: principio attivo: «Lansoprazolo Aristo Pharma» 15 mg compresse orodispersibili: ogni compressa orodispersibile contiene 15 mg di lansoprazolo. «Lansoprazolo Aristo Pharma» 30 mg compresse orodispersibili: ogni compressa orodispersibile contiene 30 mg di lansoprazolo. Eccipienti: microgranuli gastro-resistenti cellulosa microcristallina carbonato di magnesio leggero idrossipropil cellulosa a bassa sostituzione idrossipropil cellulosa ipromellosa titanio diossido talco mannitolo copolimero acido metacrilico etil acrilato (1:1) 30% poliacrilato dispersione 30% glicerolo monostearato polietilenglicole 6000 trietil citrato polisorbato 80 acido citrico anidro ossido di ferro giallo (E172) ossido di ferro rosso (E172). Altri eccipienti: mannitolo xilitolo cellulosa microcristallina crospovidone calcio fosfato dibasico anidro magnesio stearato aroma di fragola e aspartame. Officine di produzione: Produttore del principio attivo Lupin Limited T-142, M.I.D.C. Tarapur, via Boisar Maharashtra 401 506 India. Produttore prodotto finito, confezionamento primario e secondario Lupin Limited Plot no. 2, SEZ Phase - II, Misc. Zone Apparel Park, Pithampur - 454 775 Dist. - Dhar, M.P. India. Controllo lotti Lupin Healthcare (UK) Limited The urban Building, 2nd Floor, 3-9 Albert Street Slough SL1 2BE Regno Unito;
Source Bioscience PLC 4 Michaelson Square, Livingson, EH54 7DP Regno Unito;
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