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海思科(002653.SZ):創新藥環泊酚注射液新適應症註冊申請獲受理
格隆匯 02-07 16:20

格隆匯2月7日丨海思科(002653.SZ)公佈,公司之全資子公司遼寧海思科製藥有限公司於近日收到國家藥監局下發的關於環泊酚注射液的《受理通知書》。環泊酚注射液(簡稱“環泊酚”)是公司開發的全新的具有自主知識產權的靜脈麻醉藥物,擬用於手術全麻誘導、內鏡診療的鎮靜/麻醉、重症監護期間的鎮靜等適應症。

其中,環泊酚的“消化道內鏡檢查中的鎮靜”適應症於2020年12月獲得國家藥監局批准上市。“全身麻醉誘導”適應症於2021年2月獲得國家藥監局批准上市。“支氣管鏡檢查中的鎮靜”適應症於2021年12月獲得國家藥監局批准上市。“全身麻醉誘導和維持”適應症及“重症監護期間的鎮靜”適應症分別於2021年6月和2021年11月獲得國家藥監局受理。“婦科門診手術的鎮靜及麻醉”適應症上市申請於近日獲得國家藥監局受理,按我國新化學藥品註冊分類規定,該次上市許可申請的類別藥品註冊分類為化藥2.4類。

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