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華潤雙鶴(600062.SH):維格列汀片獲得藥品註冊批件
格隆匯 08-03 16:53

格隆匯 8 月 3日丨華潤雙鶴(600062.SH)公佈,近日,公司全資子公司華潤賽科藥業有限責任公司(華潤賽科”)收到了國家藥品監督管理局(“國家藥監局”)核准簽發維格列汀片(50mg)(該藥品”)《藥品註冊批件》,批准該藥品生產。

維格列汀片適用於治療2型糖尿病。當飲食和運動不能有效控制血糖時,可作為單藥治療;當二甲雙胍作為單藥治療用至最大耐受劑量仍不能有效控制血糖時,可與二甲雙胍聯合使用;當穩定劑量的胰島素不能有效控制血糖時,可與胰島素(合用或不合用二甲雙胍)聯合使用;當穩定劑量的磺脲類藥物仍不能有效控制血糖,可與磺脲類藥物聯合使用。

華潤賽科2018830向國家藥監局提交該藥品的上市申請,920日獲得受理通知書,並於2020729獲得國家藥監局批准。

截至公告日,華潤賽科針對該藥品研發投入約為人民幣1801萬元(未經審計)

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