马来酸依那普利口服溶液说明书增加儿童用药信息

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the inclusion of pediatric usage and dosage for the oral solution of Enalapril Maleate, aiming to better meet the clinical medication needs of children [1] Group 1: Regulatory Changes - The marketing authorization holder can submit a supplementary application to the NMPA's Drug Evaluation Center to revise the instructions for use, including indications and dosage for children [1] - The revisions must also include updates to safety information in the product's labeling [1] Group 2: Post-Approval Requirements - After the supplementary application is approved, the marketing authorization holder is required to collect and report adverse reaction information promptly [1] - There is an emphasis on risk control and pharmacovigilance for pediatric medication use [1]