通用名称

mesalamine

儿科标签批准日期

2020/6/26 0:00:00

特定指示/秒

Mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg

标签更改摘要

- Safety and effectiveness have been established for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. - Use in this population is supported by evidence from adequate and well-controlled trials in adults, a multicenter, randomized, double-blind, parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. - Safety profile in pediatric patients was similar to that observed in adults. - Safety and effectiveness have not been established in patients weighing less than 24 kg. - Information on dosing, adverse reactions and clinical trial. - New indication.

治疗类别

Ulcerative Colitis

立法类型

PREA Only

产品说明书链接