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廣生堂(300436.SZ):成為利伐沙班上市許可持有人
格隆匯 06-28 17:12

格隆匯6月28日丨廣生堂(300436.SZ)公佈,2021628日,公司收到國家藥品監督管理局頒發的關於利伐沙班片(規格:15mg20mg)的《藥品補充申請批准通知書》,同意公司作為上述藥品的上市許可持有人。至此,公司已許可持有利伐沙班片10mg15mg20mg三個規格,且全部已於近日擬中標第五批全國藥品集中採購,將有利於提升產品銷售規模和市場佔有率,促進公司心血管領域產品國內市場的開拓,詳見公吿編號:2021041

審批結論: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,同意按照《藥品上市後變更管理辦法(試行)》相關規定,批准本品上市許可持有人由“江蘇柯菲平醫藥股份有限公司”變更為“福建廣生堂藥業股份有限公司”,藥品批准文號不變。

利伐沙班片2020年中國總銷售額超過39億元,是權威指南推薦用於預防靜脈血栓栓塞的核心藥物,已列入國家醫保目錄。

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