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李氏大藥廠(00950.HK)附屬藥物獲國家藥監局藥品註冊批件
阿思達克 08-06 12:13
李氏大藥廠(00950.HK)公布,全資附屬兆科藥業(合肥)的低分子量肝素,注射用那屈肝素鈣已獲中國國家藥監局藥品註冊批件。

集團為藥品註冊批件申請進行了一項立邁青生物等效研究。審批結論為根據《中華人民共和國藥品管理法》及有關規定,經審查立邁青符合藥品註冊的有關要求,接受立邁青與那屈肝素鈣注射液原研進口產品(商品名:速碧林)生物等效的結論,批准立邁青增加以下2個規格:0.6ml:6150IU及0.4ml:4100IU,核發藥品批准文號。

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