通用名称

teduglutide

儿科标签批准日期

2019/5/16 0:00:00

特定指示/秒

Short Bowel Syndrome (SBS) in pediatric patients 1 year of age and older

标签更改摘要

- Safety and effectiveness of Gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of SBS. - Use of Gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age. There were 41 pediatric patients treated with Gattex: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). - Safety and effectiveness in pediatric patients less than 1 year of age have not been established. - Adverse reactions in pediatric patients were similar to those seen in adults - Information on dosing, adverse reactions, PK parameters and clinical trials.

治疗类别

N/A

立法类型

PREA Only

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