通用名称

bictegravir/emtricitabine/tenofovir alafenamide

儿科标签批准日期

2019/6/18 0:00:00

特定指示/秒

HIV-1 infected pediatric patients weighing at least 25 kg

标签更改摘要

- Safety and effectiveness were established in pediatric patients with body weight greater than or equal to 25 kg. - Use in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg is supported by trials in adults and by an open-label trial of 100 pediatric patients. - Safety and effectiveness in pediatric patients weighing less than 25 kg have not been established. - There was no clinically significant change in exposure for the components of Biktarvy. - Adverse reactions in pediatric patients were similar to those observed in adults. - Information on dosing, adverse reactions, clinical trials, and PK parameters. - Postmarketing study.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

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西班牙裔拉美裔/拉丁裔总计

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