仙琚製藥(002332.SZ):戊酸雌二醇片境內生產藥品註冊申請獲受理
格隆匯 2 月 22日丨仙琚製藥(002332.SZ)公佈,公司於近日收到國家藥品監督管理局下發的戊酸雌二醇片境內生產藥品註冊受理通知書。
戊酸雌二醇最早由德國先靈公司(ScheringAG)研究開發,其製劑戊酸雌二醇片(商品名:補佳樂®/Progynova®)最早於1969年在意大利上市,規格為2mg,用於補充主要與自然或人工絕經相關的雌激素缺乏。1991年Progynova在澳大利亞批准上市,規格1mg和2mg。目前主要在歐洲各國(如:比利時、德國、法國、新西蘭、意大利、英國等國家)上市。
戊酸雌二醇片原研(商品名:補佳樂)已於1997年在中國獲得進口註冊許可,規格1mg。此次浙江仙琚製藥股份有限公司申報的戊酸雌二醇片(1mg)規格與原研已批准上市的規格一致,按化學藥品4類進行申報。
戊酸雌二醇片被國家藥品監督管理局藥品審評中心受理,標誌着該品種境內生產藥品註冊工作進入了審評階段,公司將積極推進後續相關工作,如順利通過審評審批將豐富公司的產品線,有利於提升公司的市場競爭力。
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