Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Ranitidine injection formulations to enhance public medication safety based on adverse drug reaction assessments [1] Group 1: Regulatory Actions - The NMPA has mandated that all marketing authorization holders of Ranitidine injection products must revise their product instructions according to the new requirements by August 12, 2025 [1] - The revisions apply to various formulations including Ranitidine injection solution, Ranitidine for injection, and Ranitidine sodium chloride injection [1] Group 2: Safety Measures - Marketing authorization holders are required to conduct in-depth research on the mechanisms of newly identified adverse reactions [1] - Companies must implement effective measures for drug usage and safety issue training, guiding healthcare professionals on appropriate medication practices [1]
国家药监局:对盐酸雷尼替丁注射制剂说明书内容进行统一修订
news flash·2025-05-16 03:45