通用名称

golimumab

儿科标签批准日期

2020/9/29 0:00:00

特定指示/秒

Active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older and extension of the psoriatic arthritis (PsA) indication to include active PsA in patients 2 years of age and older

标签更改摘要

- Safety and effectiveness for active polyarticular juvenile idiopathic arthritis and PsA have been established in pediatric patients 2 years and older. - Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with RA and PsA, pharmacokinetic data from adult patients with RA and PsA and pediatric patients with JIA with active polyarthritis, and safety data from a clinical study in 127 pediatric patients 2 to < 18 years of age with JIA with active polyarthritis. - Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with golimumab and other TNF-blocking agents - Safety and effectiveness in pediatric patients below the age of 2 years have not been established in pJIA or in PsA. - Safety and effectiveness in pediatric patients with conditions other than pJIA and PsA have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study.

治疗类别

Systemic Juvenile Idiopathic Arthritis

立法类型

PREA Only

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