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药品上市许可
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人福医药:咪达唑仑注射液获德国上市许可批准
Zhi Tong Cai Jing· 2025-12-11 08:22
Core Viewpoint - The company has received marketing authorization for midazolam injection from the German Federal Institute for Drugs and Medical Devices (BfArM), indicating a significant regulatory achievement that could enhance its market presence in Europe [1] Group 1: Regulatory Approval - The company's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has been granted marketing authorization for midazolam injection by BfArM [1] - The approved indications for midazolam injection include: 1) conscious sedation before, during, and after diagnostic or therapeutic procedures, with or without local anesthesia; 2) preoperative medication for adult anesthesia induction, anesthesia induction, and use in combination with other anesthetics as a sedative; preoperative medication for pediatric anesthesia induction; 3) sedation in the Intensive Care Unit (ICU) [1]
力生制药: 关于药品氯化钾缓释片通过上市许可申请的公告
Zheng Quan Zhi Xing· 2025-08-26 08:11
Overview - Tianjin Lisheng Pharmaceutical Co., Ltd. has received drug registration certificates for potassium chloride sustained-release tablets in 0.5g and 0.6g specifications from the National Medical Products Administration [1][2] Drug Information - The potassium chloride sustained-release tablets are classified as chemical drugs and are intended for the treatment and prevention of hypokalemia associated or not associated with metabolic alkalosis [1] - The drug registration numbers are 2025S02514 for 0.5g and 2025S02515 for 0.6g [1] Impact on the Company - The approval of this drug will enhance the company's product line for treating digestive system diseases and improve its market competitiveness [2] - The potassium chloride sustained-release tablets are approved under Category 3 of chemical drugs, which is beneficial for expanding market sales and positively impacting future operating performance [2]