Add medication information for children to the product manual of flumazenil injection and other varieties


The National Medical Products Administration recently announced that in order to better meet the clinical medication needs of children, after research and verification, the instructions of drugs such as Flumazenib Injection can increase the user population and dosage for children as required. The announcement states that holders of marketing permits for relevant varieties can submit supplementary applications to the Drug Evaluation Center of the National Medical Products Administration in accordance with relevant regulations such as the Drug Registration Management Measures, in accordance with corresponding revision suggestions, to revise the relevant content of the indications and dosage items in the instructions, and at the same time improve the safety information and other related content of the instructions. If the revised content involves drug labeling, it should be revised together. After the corresponding supplementary application is approved, the holder of the relevant variety's marketing license shall timely collect and report adverse reaction information, and do a good job in risk control and drug vigilance for children's medication. (Lai Xin She)

Edit:GuoGuo Responsible editor:FangZhiYou

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