山東新華製藥股份(00719.HK):獲得《藥品補充申請批准通知書》
格隆匯6月30日丨山東新華製藥股份(00719.HK)公佈,近日,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。
藥品名稱:馬來酸阿伐曲泊帕片
劑型:片劑
規格:20mg(按 C₂₉H₃₄Cl₂N₆O₃S₂計)
藥品分類:處方藥
申請人:山東新華製藥股份有限公司
申請事項:上市許可持有人變更申請
受理號:CYHB2501163
原藥品批准文號:國藥準字H20249585
通知書編號:2025B02887
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,同意按照《藥品上市後變更管理辦法(試行)》相關規定,批准本品上市許可持有人變更。
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