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

2024-05-29

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

Source:People.cn

Special statement: if the pictures and texts reproduced or quoted on this site infringe your legitimate rights and interests, please contact this site, and this site will correct and delete them in time. For copyright issues and website cooperation, please contact through outlook new era email:lwxsd@liaowanghn.com

Return to list

Recommended Reading Change it

Links

Submission mailbox:lwxsd@liaowanghn.com Tel:020-817896455

粤ICP备19140089号 Copyright © 2019 by www.lwxsd.com.all rights reserved

>