中生製藥(01177.HK)附屬口服抗凝血藥物獲國家藥監局註冊批件
中國生物製藥(01177.HK)公布,公司附屬正大天晴藥業開發的新型口服抗凝血藥物「達比加群酯膠囊」,已獲中國國家藥品監督管理局頒發藥品註冊批件,為該品種國內首家獲批,且視同通過仿製藥質量和療效一致性評價。該產品有兩個規格獲批(75mg、110mg),劑型與原研藥一致。
達比加群酯屬於β-丙氨酸類凝血(酉每)抑制劑,是達比加群的前體藥物;用於預防非瓣膜性房顫患者的卒中和全身性栓塞,治療急性深靜脈血拴形成和/或肺栓塞以及預防其復發。
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