昂利康(002940.SZ):吸入用七氟烷(120ml和250ml)獲得藥品註冊證書
格隆匯6月29日丨昂利康(002940.SZ)公佈,近日,浙江昂利康製藥股份有限公司收到國家藥品監督管理局簽發的《藥品註冊證書》,為吸入用七氟烷。
吸入用七氟烷以揮發性氣體的形式從呼吸道通過進入人體內形成麻醉作用。吸入用七氟烷由丸石製藥株式會社研發,1990年首次在日本獲批上市,商品名為喜保福寧®、SEVOFRANE®。七氟烷適用於成年人和兒童的全身麻醉的誘導和維持,住院患者和門診患者均適用。
公司於2021年12月分別向國家藥品監督管理局藥品審評中心遞交吸入用七氟烷120ml、250ml的藥品註冊申請,於2022年1月10日獲得受理。公司吸入用七氟烷120ml及250ml註冊分類4類獲批上市,標誌着此產品視同通過仿製藥一致性評價。
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