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人福医药:咪达唑仑注射液获法国上市许可
news flash· 2025-06-30 09:42
人福医药(600079)公告,近日控股子公司宜昌人福药业收到法国国家药品和健康产品安全局核准签发 的咪达唑仑注射液上市许可批准信。咪达唑仑注射液被批准的适应症包括清醒镇静、成人麻醉诱导前的 术前用药、儿童麻醉诱导前的术前用药以及重症监护病房中的镇静。宜昌人福于2023年12月提交上市许 可申请并获得受理,现获得上市批准,有效期五年。本项目累计研发投入约为800万元人民币。根据 IQVIA数据统计,2024年咪达唑仑注射液在法国市场的年销售额约为3300万美元。 ...
力生制药:替格瑞洛分散片通过上市许可申请
news flash· 2025-06-06 07:48
Core Viewpoint - The announcement indicates that the company has received a drug registration certificate from the National Medical Products Administration for Ticagrelor dispersible tablets (90mg), which has been approved for market licensing. This drug is intended for use in patients with acute coronary syndrome or a history of myocardial infarction, along with at least one high-risk factor for atherosclerotic thrombotic events, to reduce the incidence of cardiovascular death, myocardial infarction, and stroke [1] Company Impact - The launch of Ticagrelor dispersible tablets will enhance the company's product line for treating circulatory system diseases, thereby increasing its market competitiveness [1] - The introduction of this drug is expected to have a positive impact on the company's future operating performance [1]
新天地:硫酸氢氯吡格雷原料药获准上市
news flash· 2025-05-07 08:08
Core Viewpoint - The company has received approval from the National Medical Products Administration for the raw material drug Sulfhydryl Clopidogrel, indicating compliance with Chinese drug review standards and enhancing the company's product portfolio [1] Group 1: Regulatory Approval - The company received the approval notice for Sulfhydryl Clopidogrel on May 6, 2025 [1] - The approval allows the raw material to be used in domestic formulations, expanding the company's product offerings [1] - The approval notice is valid until May 5, 2030 [1] Group 2: Product Information - Sulfhydryl Clopidogrel is a commonly used antiplatelet drug [1] - It is primarily used for the prevention and treatment of cardiovascular diseases related to atherosclerotic thrombosis [1] - The drug works by inhibiting platelet aggregation to reduce the risk of thrombosis [1]