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濟川藥業(600566.SH):宮瘤清片獲藥品補充申請批准通知書
格隆匯 02-28 15:54

格隆匯2月28日丨濟川藥業(600566.SH)公佈,近日,公司全資子公司陝西東科製藥有限責任公司(“東科製藥”)收到了國家藥品監督管理局(“國家藥監局”)核准簽發的宮瘤清片藥品補充申請批准通知書。

根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,批准本品藥品技術轉讓的補充申請,同將宮瘤清片生產技術轉讓陝西東科製藥有限責任公司,發給藥品批准文號,同時註銷原藥品批准文號。規格每片重0.37g(相當於飲片2g)。有效期:24個月。

建議在下次註冊之前,完成以下提高質量標準的研究:繼續研究完善含量測定方法,確定含量測定指標的含量範圍(上下限)

宮瘤清片功能與主治:活血逐瘀,消癥破積,用於瘀血內停所致的婦女癥瘕,症見小腹脹痛、經色紫黯有塊、經行不爽;子宮肌瘤見上述證候者。宮瘤清片是《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020)》甲類品種。

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