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

立法类型

PREA Only

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