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恆瑞醫藥(01276.HK):公司布比卡因脂質體注射液新增適應症獲批

格隆匯6月30日丨恆瑞醫藥(01276.HK)公佈,近日,公司收到國家藥品監督管理局(以下簡稱"國家藥監局")的通知,批準公司布比卡因脂質體注射液新增適應症。

藥品名稱:布比卡因脂質體注射液

劑型:注射劑

規格:20ml:266mg

註冊分類:化學藥品 3 類

受理號:CYHS2401989

處方藥/非處方藥:處方藥

批準的適應症:成人膕窩坐骨神經阻滯產生術後區域鎮痛;成人收肌管阻滯產生術後區域鎮痛。

布比卡因脂質體注射液於 2022 年 12 月於國內首仿獲批上市,用於 12 歲及以上的患者單劑量浸潤產生術後局部鎮痛,也適用於成人肌間溝臂叢神經阻滯產生術後區域鎮痛。該產品已於 2024 年 7 月在美國首仿獲批上市。

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