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泰恩康(301263.SZ):利多卡因丙胺卡因氣霧劑臨牀試驗申請獲得受理
格隆匯 05-10 17:38

格隆匯5月10日丨泰恩康(301263.SZ)公佈,公司全資子公司山東華鉑凱盛生物科技有限公司於近日收到國家藥品監督管理局簽發的境內生產藥品註冊臨牀試驗《受理通知書》,國家藥監局根據《中華人民共和國行政許可法》第三十二條的規定,對上述藥品的註冊臨牀試驗申請進行了審查,決定予以受理。

利多卡因丙胺卡因氣霧劑是一種局部麻醉藥物,主要用於治療成年男性原發性早泄問題,臨牀療效明確,使用方便。原研藥物由英國Plethora公司開發,2013年在歐盟批准上市,已在歐洲主要市場商業推出,2020年獲得歐盟委員會批准,由處方藥轉為非處方藥,目前國內尚未進口。

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