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科倫藥業(002422.SZ):抗血栓藥阿哌沙班片獲藥品註冊批件
格隆匯 11-11 17:46

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“阿哌沙班片”的《藥品註冊批件》。阿哌沙班片主要用於髖關節或膝關節擇期置換術的成年患者,預防靜脈血栓栓塞事件(VTE)。

阿哌沙班是一種可逆的、高選擇性的直接Xa因子抑制劑,屬於新型口服抗凝藥物。與其他常用的抗凝劑如華法林相比,阿哌沙班的安全性和耐受性好,治療窗寬,能有效地降低腦卒中和全身性栓塞的發生率,同時不增加出血風險。與食物相互作用少,劑量固定,且無需進行常規血液學監測,應用更為方便。

《中國腫瘤相關靜脈血栓栓塞症預防與治療專家指南(2015版)》、《中國骨科大手術靜脈血栓栓塞症預防指南》等國內權威指南,推薦Xa因子抑制劑阿哌沙班等用於預防靜脈血栓栓塞。

公司阿哌沙班片質量與原研(商品名:艾樂妥/Eliquis®,Bristol-MyersSquibb / Pfizer EEIG)等同。

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