普利製藥(300630.SZ):特利加壓素注射液在德獲批上市
格隆匯6月9日丨普利製藥(300630.SZ)宣佈,公司於近日收到了德國聯邦藥物和醫療器械管理局簽發的特利加壓素注射液的上市許可。
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,屬於共線產品。該藥品已獲得荷蘭藥物評價委員會(CBG)的批准,在中國藥品審評中心(CDE)也已進入審評程序。
近日,公司收到了德國聯邦藥物和醫療器械管理局簽發的上市許可,標誌着普利製藥具備了在德國銷售特利加壓素注射液的資格,將對公司拓展市場帶來積極的影響。
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