法规知识库 · EMA 集中审评
Wegovy
semaglutide · EMEA/H/C/005422 · 已授权
获批上市许可
2022-01-06
欧委会决定日
2026-09-21
持有人 / 申请人
Novo Nordisk A/S
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BJ06
治疗领域：Obesity;Overweight
药理分类：Antiobesity preparations, excl. diet products
修订号：20 · 最新影响 PI 的程序：R/0000336288
适应症（原文）：Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-09-21 · 欧委会决定
2022-01-06 · 获批上市许可
2021-11-11 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Wegovy : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-26
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Wegovy-X-0000296344 : EPAR - Assessment report - Extension
variation-report · 2026-08-26 · EMADOC-1700519818-3184701
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Wegovy : EPAR - Medicine Overview
overview · 2026-08-26 · EMADOC-1829012207-54916
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Wegovy : EPAR - Risk management plan
rmp · 2026-08-26
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Wegovy : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-05-04
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Wegovy-VR-0000284664 : EPAR - Assessment report - Variation
variation-report · 2026-03-13 · EMADOC-1700519818-2317237
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Wegovy-H-C-005422-II-0017 : EPAR - Assessment report - Variation
variation-report · 2024-09-06 · EMEA/400658/2024
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Wegovy-H-C-005422-II-0009 : EPAR - Assessment report - Variation
variation-report · 2024-01-30 · EMA/CHMP/141429/2023
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Wegovy-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-06-09 · EMA/193286/2023
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Wegovy-H-C-5422-II-0009 : EPAR - Assessment Report - Variation
variation-report · 2023-06-09 · EMA/CHMP/141429/2023
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Wegovy : EPAR - Public Assessment Report
assessment-report · 2022-03-10 · EMA/112307/2022
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。