通用名称

ivabradine

儿科标签批准日期

2019/4/22 0:00:00

特定指示/秒

Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate

标签更改摘要

- Safety and effectiveness have been established in pediatric patients age 6 months to less than 18 years old and are supported by pharmacokinetic and pharmacodynamic trials and evidence from adequate and well-controlled trials of Corlanor in adult patients. - The pediatric study included 116 patients in the following age groups: 17 patients in the 6 months to less than 12 months age group, 36 patients in the 1 year to less than 3 years age group, and 63 patients in the 3 years to less than 18 years age group - Safety and efficacy have not been established in patients less than 6 months of age. - Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor. - Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor, respectively. - Phosphenes were observed in pediatric patients treated with Corlanor. - Information on dosing, adverse reactions, Pk parameters and clinical trial. - New dosage form

治疗类别

N/A

立法类型

BPCA Only

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