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西點藥業(301130.SZ):利培酮口崩片獲批新增0.5mg、2mg規格
格隆匯 10-14 08:48

格隆匯10月14日丨西點藥業(301130.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")簽發的利培酮口崩片《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,批准本品新增 0.5mg、2mg 規格,發給藥品批准文號。新增規格的生產工藝和質量標準照所附執行,説明書和包裝標籤做相應修訂,其他按原批准內容執行。相關變更應自獲批之日起 6 個月內實施。

利培酮口崩片用於治療急性和慢性精神分裂症以及其它各種精神病性狀態的明顯陽性症狀(如幻覺、妄想、思維紊亂、敵視、懷疑)和明顯陰性症狀(如反應遲鈍、情緒及社交淡漠、少語),也可用於減輕與精神分裂症有關的情感症狀(如抑鬱、負罪感、焦慮)。對於急性期治療有效的患者,在維持期治療中也可繼續發揮其臨牀療效。

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