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金城醫藥(300233.SZ)子公司蒙脱石散獲一致性評價
格隆匯 12-23 15:51

格隆匯12月23日丨金城醫藥(300233.SZ)公佈,山東金城醫藥集團股份有限公司收到全資子公司北京金城泰爾製藥有限公司(“金城泰爾”)的通知,金城泰爾於近日收到國家藥品監督管理局下發的蒙脱石散《藥品補充申請批件》,經審查,該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。

藥品通用名稱:蒙脱石散;英文名/拉丁名:Montmorillonite Powder;劑型:散劑;註冊分類:化學藥品規格:每袋含蒙脱石3g;藥品標準:YBH07682019;原藥品批准文號:國藥準字H20093355;申請內容:一致性評價申請;受理號:CYHB1850324;批件號:2019B04577;藥品生產企業名稱:北京金城泰爾製藥有限公司;審批結論主要內容:經審查,本品通過仿製藥質量和療效一致性評價。質量標準照所附執行,有效期為18個月。

蒙脱石散由IPSEN PHARMA(益普生藥業)研發,於1980年3月在法國上市。目前蒙脱石散在國內主要用於成人及兒童急、慢性腹瀉;食道、胃、十二指腸疾病引起的相關疼痛症狀的輔助治療。

該品通過一致性評價,有利於提高市場競爭力,併為後續產品開展仿製藥一致性評價工作積累寶貴經驗。

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