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天宇股份(300702.SZ):馬來酸阿伐曲泊帕片、甲苯磺酸艾多沙班片獲得藥品註冊證書
格隆匯 03-10 20:59

格隆匯3月10日丨天宇股份(300702.SZ)公佈,公司全資子公司浙江諾得藥業有限公司(簡稱“諾得藥業”)於近日收到國家藥品監督管理局覈準簽發的關於馬來酸阿伐曲泊帕片、甲苯磺酸艾多沙班片的《藥品註冊證書》。

馬來酸阿伐曲泊帕片是血小板生成素受體激動劑,適用於擇期行診斷性操作或者手術的慢性肝病相關血小板減少症的成年患者和既往對糖皮質激素、免疫球蛋白等治療反應不佳的慢性原發免疫性血小板減少症(ITP)成人患者。

根據國家藥監局網站數據查詢,截至公告日,該製劑除諾得藥業外,國內生產商另有南京正大天晴製藥有限公司、桂林南藥股份有限公司等13家企業。

諾得藥業甲苯磺酸艾多沙班片於2023年12月獲得國家藥監局受理,截至目前公司及子公司累計研發投入約1,208.39萬元。

甲苯磺酸艾多沙班片適應症爲:1.用於伴有一個或多個風險因素(如充血性心力衰竭、高血壓、年齡≥75歲、糖尿病、既往卒中或短暫性腦缺血發作(TIA)病史)的非瓣膜性房顫(NVAF)成人患者,預防卒中和體循環栓塞。2.用於治療成人深靜脈血栓(DVT)和肺栓塞(PE),以及預防成人深靜脈血栓和肺栓塞復發。

諾得藥業甲苯磺酸艾多沙班片於2023年12月獲得國家藥監局受理,截至目前公司及子公司累計研發投入約1,208.39萬元。

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