海思科(002653.SZ):丙泊酚中/長鏈脂肪乳注射液獲批上市
格隆匯9月15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(簡稱“遼寧海思科”)於近日收到國家藥監局下發的關於丙泊酚中/長鏈脂肪乳注射液的《藥品註冊證書》。
丙泊酚中/長鏈脂肪乳注射液作為一種快速短效的靜脈麻醉藥,具有起效快,誘導平穩,持續時間短,甦醒快而完全的優勢,可以減少注射痛的程度和發生率,呼吸抑制輕,臨牀不良反應少,應用安全快捷,成為當今臨牀上必不可少的靜脈全麻藥。同時採用中鏈甘油三酯和長鏈甘油三酸酯(大豆油)製備的丙泊酚注射液能夠減少大劑量或長期的連續使用長鏈脂肪乳易引起的不良反應,如高脂血症、損害免疫系統和影響網狀內皮系統、肝等重要臟器的功能。
公司同時開展了該製劑與參比製劑的臨牀生物等效性研究以及相關的質量對比研究,證明了公司製劑與參比製劑的質量和療效一致,並獲得批准。
據米內網全國放大數據,該產品2020年城市公立醫院及縣級公立醫院銷售額約為17.7億元。
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