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雙鷺藥業(002038.SZ):“利拉魯肽注射液”獲批臨牀試驗
格隆匯 08-17 19:33

格隆匯 8 月 17日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)簽發的關於利拉魯肽注射液的《藥品臨牀試驗批准通知書》。

藥品名稱:利拉魯肽注射液

劑型:注射劑

規格:3ml:18mg(預填充注射筆)

註冊分類:治療用生物製品第15類

藥品生產企業:北京雙鷺藥業股份有限公司

受理號:CXSL2000115

審批結論:根據《中華人民共和國藥品管理法》有關規定,經審查,2020年5月20日受理的利拉魯肽注射液符合藥品註冊的有關要求,同意開展2型糖尿病的臨牀試驗。

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