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新華製藥(000756.SZ):收到馬來酸阿伐曲泊帕片的藥品補充申請批准通知書
格隆匯 06-30 17:13

格隆匯6月30日丨新華製藥(000756.SZ)公佈,近日,山東新華製藥股份有限公司收到國家藥品監督管理局核准簽發的馬來酸阿伐曲泊帕片(以下簡稱“本品”)《藥品補充申請批准通知書》,批准本品上市許可持有人轉讓補充申請。

馬來酸阿伐曲泊帕片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。慢性肝病患者不得通過服用本品來恢復正常的血小板計數。本品也適用於既往對糖皮質激素、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,使血小板計數升高並減少或防止出血,僅用於因血小板減少和臨牀條件導致出血風險增加的ITP患者。

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