常山藥業(300255.SZ):那屈肝素鈣注射液獲藥品補充申請批件
格隆匯5月6日丨常山藥業(300255.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的藥品補充申請批件,藥品名稱:那屈肝素鈣注射液;劑型:注射劑;規格:0.4ml:4100AXaIU、0.6ml:6150AXaIU;申請內容:提交那屈肝素鈣注射液的人體藥效動力學等效性試驗資料;審批結論:申請人上市後依照批件要求完成了人體藥效動力學等效性試驗,符合現行技術要求。
2016年3月,公司那屈肝素鈣注射液獲得國家藥監局頒發的《藥品註冊批件》,此次公司那屈肝素鈣注射液通過生物等效性研究,有助於提升該產品的市場競爭力。
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