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新華製藥(000756.SZ):艾司奧美拉唑鎂獲得化學原料藥上市申請批准通知書
格隆匯 09-02 17:01

格隆匯9月2日丨新華製藥(000756.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的艾司奧美拉唑鎂("本品")《化學原料藥上市申請批准通知書》。

艾司奧美拉唑鎂產品用於治療胃食管反流病(GERD),包括反流性食管炎的治療、已經治癒的食管炎患者預防復發的長期治療、GERD的症狀控制;與適當的抗菌療法聯合用藥根除幽門螺桿菌;需要持續非甾體抗炎藥(NSAID)治療的患者。本品作為治療消化性潰瘍病和胃食道反流病的質子泵抑制劑類藥物,其製劑屬於《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》乙類品種。據相關數據庫統計顯示,艾司奧美拉唑鎂相關製劑2023年全球銷售額約31.64億美元,消耗原料藥約424噸。

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