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海辰藥業(300584.SZ):公司注射用鹽酸蘭地洛爾獲得藥品註冊批件
格隆匯 12-20 17:56

格隆匯 12 月 20日丨海辰藥業(300584.SZ)公佈,公司於近日收到國家藥品監督管理局(以下簡稱"國家藥監局")核准簽發的化學藥品"注射用鹽酸蘭地洛爾"《藥品註冊證書》。

腎上腺素β受體阻滯藥是一類作用廣泛、重要的心血管治療藥物。超短效β受體阻滯藥由於起效快、代謝快、停藥後β受體阻滯作用消失快,在新發生的快速性心律失常的治療中發揮重要且不可替代的作用。蘭地洛爾是一個新型的超短效腎上腺素β受體阻滯藥,具有選擇性高(其對β1受體的阻滯作用約為β2受體的255倍,對β1受體的選擇性為另一個超短效β受體阻滯藥艾司洛爾的8倍)、起效迅速(給藥後1至6分鐘起效)、半衰期短(約為4分鐘)、停藥後失效快、對心臟血流動力學影響小、無明顯負性肌力作用等優點。

注射用鹽酸蘭地洛爾2002年在日本上市,2016年相繼在歐洲多個國家上市,臨牀適用於(1)手術過程中發生的下列快速性心律失常的緊急治療:心房纖顫、心房撲動、竇性心動過速;(2)手術後循環系統動態監護時發生的快速性心律失常的緊急治療:心房纖顫、心房撲動、竇性心動過速;(3)心功能不全患者發生下列快速性心律失常的治療:心房纖顫、心房撲動。

目前該產品原研尚未進口,公司為國內首家批准上市。該產品的上市為國內術中和術後快速性心律失常以及心功能不全患者提供了有效的治療手段。

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