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ANFARM HELLAS S.A. sell "Omeprazole Gr.Cap 20mg & 40mg (EU CTD Available)"

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基本信息

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出售

产品名称

Omeprazole Gr.Cap 20mg & 40mg (EU CTD Available)

规格参数

  • 适应症: 为质子泵抑制剂(PPI),可显著且持久地减少胃酸分泌,参照Losec®/阿斯利康产品。
  • 剂型: 肠溶胶囊,按标签标示的给药途径使用。
  • 储存条件: 存放于25°C以下干燥处,避免阳光直射,保存在原包装密闭容器中。

其他信息

补充描述:

Available as 20 mg and 40 mg gastro-resistant omeprazole capsules, referencing Losec®/AstraZeneca. 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, shelf life of 24 months (20 mg) and 36 months (40 mg), batch sizes of 213,675 capsules (20 mg) and 100,000 capsules (40 mg), and packs of 14 and 28 capsules.
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