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普利製藥(300630.SZ):注射用伏立康唑獲得哥斯達黎加衞生部上市許可
格隆匯 10-31 17:01

格隆匯10月31日丨普利製藥(300630.SZ)公佈,公司於近日收到了哥斯達黎加衞生部簽發的注射用伏立康唑200 mg的上市許可。

注射用伏立康唑由輝瑞公司研發,於2002年3月獲歐洲藥物管理局(EMA)批准上市,2002年5月獲美國食品藥品監督管理局(FDA)批准上市,2004年10月獲國家藥品監督管理局批准上市,商品名為VFEND(威凡)。

公司的注射用伏立康唑成功研發後,分別遞交美國、歐盟、中國、澳大利亞、哥斯達黎加等多個國家和地區的仿製藥註冊申請,屬共線生產產品。本品已於2018年11月獲得美國FDA的批准;於2019年3月獲得荷蘭藥物評價委員會(CBG)的上市許可;於2019年4月獲得德國聯邦藥物和醫療器械管理局(BfArM)的上市許可;於2021年9月獲得澳大利亞藥物管理局(TGA)的上市許可。

該上市許可的獲得,標誌着普利製藥具備了在哥斯達黎加銷售注射用伏立康唑的資格,將對公司拓展哥斯達黎加市場帶來積極影響。同時,公司的注射用伏立康唑其他市場的註冊工作正在持續推進中。

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