According to the website of the National Medical Products Administration, in order to better meet the clinical medication needs of children, after research and demonstration, the instructions for enalapril maleate oral solution can increase the number of pediatric users and dosage according to requirements. According to the announcement, the holder of the marketing authorization for this product may, in accordance with relevant regulations such as the "Measures for the Administration of Drug Registration", submit a supplementary application to the Drug Evaluation Center of the National Medical Products Administration in accordance with the corresponding revision suggestions, revise the relevant content of the "Indications" and "Usage and Dosage" items in the instruction manual, and at the same time improve the safety information and other related content of the instruction manual. If the revised content involves drug labels, it should be revised together. After the corresponding supplementary application is approved, the marketing authorization holder of the product shall promptly collect and report adverse reaction information, and do a good job in risk control and drug vigilance for children's medication. (New Society)
Edit:Wang Shu Ying Responsible editor:Li Jie
Source:people.cn
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