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海思科(002653.SZ):獲得環泊酚注射液《藥品補充申請批准通知書》
格隆匯 03-24 16:04

格隆匯3月24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核准簽發的關於環泊酚注射液的《藥品補充申請批准通知書》。

經審查,該藥品此次申請事項符合藥品註冊的有關要求,同意該藥品修訂説明書有關內容。同意在該藥品已批准的適應症“消化道內鏡檢查中的鎮靜”和“支氣管鏡檢查中的鎮靜”基礎上,將説明書【適應症】修訂為“非氣管插管手術/操作中的鎮靜和麻醉”。

環泊酚注射液(以下簡稱“環泊酚”)屬於靜脈麻醉藥,其活性成分環泊酚是(R)-構型異構體小分子藥物,為GABAA受體激動劑,通過作用於GABAA受體介導的氯離子通道,增加電流的傳導,引起神經元的超極化。這種超極化引起了神經信號傳遞一致,降低了動作電位產生的成功率,從而抑制中樞神經系統,產生麻醉的作用。

環泊酚整體安全性耐受性良好,藥效活性約為丙泊酚的5倍,快速平穩起效,甦醒迅速且完全,注射痛發生率極低,對呼吸的影響優於丙泊酚,對心率和血壓的影響不劣於丙泊酚,脂質輸入量小於丙泊酚。

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。目前已獲得藥監局批准上市的適應症為“消化道內鏡檢查中的鎮靜”、“支氣管鏡檢查中的鎮靜”及“全身麻醉誘導和維持”,尚在上市申請審批中的適應症為“重症監護期間的鎮靜”和“婦科門診手術的鎮靜及麻醉”。

該次補充申請是將環泊酚已批准的適應症“消化道內鏡檢查中的鎮靜”和“支氣管鏡檢查中的鎮靜”進行了合併,將説明書適應症擴大修訂為“非氣管插管手術/操作中的鎮靜和麻醉”。

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