通用名称

leuprolide acetate

儿科标签批准日期

2020/5/1 0:00:00

特定指示/秒

Treatment of central precocious puberty (CPP) in pediatric patients 2 years and older

标签更改摘要

- Safety and effectiveness for the treatment of CPP has been established in pediatric patients 2 years and older. - Use for this indication is supported by evidence from an adequate and uncontrolled open-label, single-arm study of 64 pediatric patients with CPP with an age range of 4 to 9 years. - Safety and effectiveness have not been established in pediatric patients less than 2 years old. - Information on dosing, adverse reactions, and clinical trials. - New dosing regimen.

治疗类别

Developmental Disorders

立法类型

PREA Only

产品说明书链接

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