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常山藥業(300255.SZ)獲得藥品補充申請批件
格隆匯 12-31 16:37

格隆匯12月31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:達肝素鈉注射液;劑型:注射劑;規格:0.2ml:5000IU;原藥品批准文號:國藥準字H20143110;藥品標準:國家藥品監督管理局標準YBH01622014;藥品生產企業:河北常山生化藥業股份有限公司;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,本品符合藥品註冊的有關要求,接受本品與參比製劑(原研進口產品,商品名:法安明)具有生物等效性的結論。

2014年5月,公司達肝素鈉注射液獲得國家藥監局頒發的《藥品註冊批件》,此次公司達肝素鈉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,對公司經營業績將產生積極影響。

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