科倫藥業(002422.SZ):丙泊酚中/長鏈脂肪乳注射液獲得藥品註冊證書
格隆匯11月11日丨科倫藥業(002422.SZ)宣佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“丙泊酚中/長鏈脂肪乳注射液”的《藥品註冊證書》,規格為20ml:0.2g。
丙泊酚中/長鏈脂肪乳注射液為德國費森尤斯卡比開發,目前已在德國、奧地利、日本等10餘個國家獲批上市,2006年中國批准進口,用於成人和1個月以上兒童的全身麻醉誘導和維持,診斷性操作和手術過程中的鎮靜,以及16歲以上重症監護患者輔助通氣治療時的鎮靜。
公司已有6個脂肪乳相關產品獲批上市,丙泊酚中/長鏈脂肪乳注射液採用公司優勢脂肪乳技術平台,工藝成熟,產品質量穩定,且具有規模化生產優勢。此外,丙泊酚中/長鏈脂肪乳注射液也為公司繼注射用帕瑞昔布鈉、鹽酸右美託咪定注射液後第三個獲批上市的麻醉鎮痛藥,將進一步豐富公司的麻醉鎮痛產品線。
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