当前位置:药药网 / 数据中心 / 儿科标签更改电子表格2021
Injectafer injection
通用名称
ferric carboxymaltose
儿科标签批准日期
2021/11/19 0:00:00
特定指示/秒
Iron deficiency anemia (IDA) in pediatric patients 1 year of age and older
标签更改摘要
- Safety and effectiveness for iron deficiency anemia (IDA) in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established.
- Use or this indication in this age group is supported by evidence from adequate and well-controlled studies of Injectafer in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older.
- Safety and effectiveness have not been established in pediatric patients less than 1 year of age with IDA.
- Information on adverse reactions and PK parameters.
- Postmarketing study.
治疗类别
Parenteral iron replacement drugs