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普利製藥(300630.SZ):地氯雷他定片獲得德國聯邦藥物和醫療器械管理局上市許可
格隆匯 02-02 17:54

格隆匯2月2日丨普利製藥(300630.SZ)公佈,公司於近日收到了德國聯邦藥物和醫療器械管理局(BfArM)所簽發的地氯雷他定片的上市許可。

地氯雷他定為非鎮靜性的長效三環類抗組膠藥,為氯雷他定的活性代謝物,可通過選擇性地阻斷外周H1受體,抑制各種過敏性致炎的化學介質的釋放,緩解過敏性鼻炎或慢性特發性蕁麻疹的相關症狀。地氯雷他定由Sepracor公司研製,Schering-Plough公司開發並在全球53個國家上市。地氯雷他定片2001年首次在歐洲上市,2002年在美國上市,在國內,目前地氯雷他定片已獲批進口,商品名:恩理思,規格:5mg。

公司的地氯雷他定片於2016年啟動研發,後分別遞交了歐盟和中國一致性評價補充申請,屬共線生產產品。本品於2019年11月獲得了中國一致性評價批准,於2019年12月獲得了荷蘭藥物評價委員會(CBG)批准的上市許可。近日,公司獲得德國聯邦藥物和醫療器械管理局(BfArM)所簽發的上市許可,標誌着普利製藥具備了在德國銷售地氯雷他定片的資格,將對公司拓展德國市場帶來積極影響。

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