通用名称

methylphenidate

儿科标签批准日期

2018/8/8 0:00:00

特定指示/秒

Attention Deficit Hyperactivity Disorder

标签更改摘要

- Safety and effectiveness have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical studies in pediatric patients 6 to 12 years, pharmacokinetic data in adults, and safety information from other methylphenidate-containing products. - Safety and effectiveness in pediatric patients less than 6 years have not been established. - The long-term efficacy of methylphenidate in pediatric patients has not been established. - Growth should be monitored during treatment with stimulants, including JORNAY PM. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted - Information on dosing, adverse reactions, clinical trials - New dosage form

治疗类别

CNS Stimulants

立法类型

PREA Only

产品说明书链接

书号

3.0 2.0 1.0

研究年龄

6 YEARS - 12 YEARS 6 YEARS - 12 YEARS 6 YEARS - 12 YEARS

学习类型

Efficacy,Safety Efficacy,Safety Efficacy,Safety

研究设计

Placebo,Single-Blind,Parallel Group Placebo,Single-Blind,Parallel Group,Open-Label Placebo,Single-Blind,Parallel Group,Open-Label

登记的患者

163 161 43

患者分析

N/A N/A N/A

中心的数量

21 7 4

国家数量

1 1 1

西班牙裔拉美裔/拉丁裔总计

N/A N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A N/A

总数#种族不明

N/A N/A N/A

亚裔学生总数

N/A N/A N/A

黑人总数

N/A N/A N/A

白人总数

N/A N/A N/A

夏威夷或太平洋岛民总数

N/A N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A N/A

其他种族总计

N/A N/A N/A

未知种族总数

N/A N/A N/A

国家

N/A N/A N/A