通用名称

nitisinone

儿科标签批准日期

2020/9/2 0:00:00

特定指示/秒

Treatment of HT-1 in combination with dietary restriction of tyrosine and phenylalanine in adults and pediatric patients

标签更改摘要

- Safety and effectiveness have been established in pediatric patients for the treatment of HT-1 in combination with dietary restriction of tyrosine and phenylalanine. - Use in pediatric patients is supported by evidence from one open-label, uncontrolled clinical study conducted with another oral formulation of nitisinone in 207 patients with HT-1 ages 0 to 22 years (median age 9 months) - Information on dosing, maintenance regimen, PK parameters, and clinical trial - New dosage regimen.

治疗类别

Inborn Errors

立法类型

PREA Only

产品说明书链接