通用名称

varenicline

儿科标签批准日期

2019/2/22 0:00:00

特定指示/秒

Aid to smoking cessation treatment

标签更改摘要

- Chantix is not recommended for use in pediatric patients 16 years or younger because its efficacy in this population was not demonstrated. - Efficacy and safety of varenicline were evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years. Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in patients 12 to 19 years. - Varenicline safety profile in this study was consistent with that observed in adult studies. - Information on pharmacokinetics.

治疗类别

N/A

立法类型

PREA + BPCA

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