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Referencing Losec®/AstraZeneca, this is a powder for solution for infusion. Omeprazole belongs to the proton-pump inhibitor (PPI) class, which markedly and durably reduces stomach acid production; PPIs' potent acid-suppressing effect supports approval for numerous indications, including short-term management of GERD, erosive esophagitis, H. pylori, and duodenal and gastric ulcers, as well as long-term use for NSAID-associated gastric ulcers, hypersecretory conditions, and maintaining healed erosive esophagitis. An EU CTD dossier is available, with stability studies for Zone II/IVb, a two-year shelf life, batch sizes of 24,000 and 32,500 vials, and packs of 1 or 5 vials.
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