通用名称

ustekinumab

儿科标签批准日期

2020/7/29 0:00:00

特定指示/秒

Moderate to severe plaque psoriasis in pediatric patients 6 to 11 years

标签更改摘要

- Expanded indication to 6 years and older; previously approved down to 12 years. - Use in children 6 to 11 years with moderate to severe plaque psoriasis is supported by evidence from an open-label, single-arm, efficacy, safety and pharmacokinetics study in 44 patients. - Safety and effectiveness for pediatric patients less than 6 years with psoriasis have not been established. - Safety profile in pediatric patients similar to that observed in adults. - Information on adverse reactions, clinical trial, PK parameters. - Postmarketing study.

治疗类别

Psoriasis Agents

立法类型

PREA Only

产品说明书链接