片仔癀(600436.SH):主動撤回“PZH2109膠囊”臨牀試驗註冊申請並獲得批准
格隆匯 11 月 11日丨片仔癀(600436.SH)公佈,公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)關於公司主動撤回PZH2109膠囊臨牀試驗註冊申請的《藥品註冊申請終止通知書》。現將相關情況公告如下:
藥品名稱:PZH2109膠囊
劑型:膠囊
規格:5mg,20mg
申請事項:境內生產藥品註冊
註冊分類:化學藥品1類
申報階段:臨牀試驗
申請人:漳州片仔癀藥業股份有限公司
受理號:CXHL2000371國、CXHL2000372國
本次申請臨牀試驗的PZH2109膠囊,有兩種不同規格(5mg、20mg),每一種規格具有相同的藥理作用,每一份受理通知書所述的受理號對應一種規格。
審批意見:根據《藥品註冊管理辦法》第八十九條以及申請人2020年11月3日提交的撤回申請《關於撤回PZH2109膠囊臨牀試驗申請的函》,同意本品註冊申請的撤回,終止註冊程序。
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