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普利製藥(300630.SZ):特利加壓素注射液通過荷蘭藥物評價委員會(CBG)技術審評
格隆匯 01-19 16:07

格隆匯1月19日丨普利製藥(300630.SZ)公佈,公司於近日收到了荷蘭藥物評價委員會(“CBG”)批准特利加壓素注射液的技術審評報吿通知。

藥品名稱:特利加壓素注射液;劑型:注射劑;規格:0.1mg/mL(8.5mL);適應症:1、食管靜脈曲張出血,特利加壓素可用於食管靜脈曲張急性出血的緊急治療,其後再使用內窺鏡治療。此後,特利加壓素通常被用於內鏡下止血治療的食管靜脈曲張出血。2、肝腎綜合徵,特利加壓素可用於嚴重肝硬化伴腹水的1型肝腎綜合徵(以自發性急性腎功能不全為特徵)的緊急治療。

特利加壓素化學名為三甘氨酰賴氨酸加壓素,是一種人工合成的長效血管加壓素。特利加壓素注射液最早於2010年9月23日在歐洲獲批上市,上市的國家包括德國、荷蘭、英國、西班牙、意大利等,上市許可持有人為Ferring公司。

普利製藥的特利加壓素注射液成功研發後,分別遞交歐洲和中國的仿製藥註冊申請。於近日,公司收到了荷蘭藥物評價委員會的批准通知,該產品的技術審評已於2021年01月18日結束,結論為批准。目前進入荷蘭和德國國家階段的產品特性概要,説明書和標籤的審核和批件發放階段。之後該產品即可在荷蘭、德國市場進行上市銷售,將對公司拓展市場帶來積極的影響。

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