通用名称

tenofovir disoproxil fumarate

儿科标签批准日期

2018/12/11 0:00:00

特定指示/秒

Chronic hepatitis B (CHB) in pediatric patients 2 years and older weighing at least 10 kg

标签更改摘要

- Safety and effectiveness in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials in which Viread was administered to HBV-infected treatment-experienced patients. - Safety and effectiveness in chronic HBV-infected pediatric patients younger than 2 years and weighing less than 10 kg have not been established. - The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in chronic HBV-infected pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown. - Information on dosing, adverse reactions, and clinical trials. - New indication.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接