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Evekeo ODT orally disintegrating tablets
儿科标签批准日期
2021/4/16 0:00:00
特定指示/秒
Attention Deficit Hyperactivity Disorder in pediatric patients 3 to 5 years of age
标签更改摘要
- Safety and effectiveness have been established in pediatric patients 3 years and older.
- Use is based on one adequate and well-controlled study with another immediate-release amphetamine sulfate product in pediatric patients 6 to 12 years, along with dosing and safety information for other amphetamine products.
- Safety and efficacy in pediatric patients below the age of 3 years have not been established.
- Information on dosing.