法规知识库 · EMA 集中审评
Saxenda
liraglutide · EMEA/H/C/003780 · 已授权
获批上市许可
2015-03-23
欧委会决定日
2025-06-25
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
17
官方索引 17
EPAR / 审评
14
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BJ02
治疗领域：Obesity;Overweight
药理分类：Drugs used in diabetes
修订号：19 · 最新影响 PI 的程序：II/0042
适应症（原文）：Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *IOTF BMI cut-off points for obesity by sex between 12-18 years, in accordance with study design of the Trial 4180, see section 5.1. Children (6 to <12 years)Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with - obesity (BMI ≥95th percentile)* and- body weight ≥45 kgTreatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years, in accordance with study design of the Trial 4392, see section 5.1.
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。
2025-06-25 · 欧委会决定
2015-03-23 · 获批上市许可
2015-01-22 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Saxenda-H-C-3780-II-0042 : EPAR - Assessment Report - Variation
variation-report · 2025-07-31
- 打开官方文件 ↗
Saxenda : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-07-31
- 打开官方文件 ↗
Saxenda : EPAR - Summary for the public
overview · 2025-07-31 · EMA/186282/2025
- 打开官方文件 ↗
Saxenda : EPAR - Risk management plan
rmp · 2025-07-31
- 打开官方文件 ↗
Saxenda : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-27
- 打开官方文件 ↗
Saxenda-H-C-PSUSA-00001892-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-10
- 打开官方文件 ↗
Saxenda-H-C-PSUSA-00001892-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-10
- 打开官方文件 ↗
Saxenda-H-C-3780-II-0026 : EPAR - Assessment Report - Variation
variation-report · 2021-06-10
- 打开官方文件 ↗
Saxenda-H-C-PSUSA-00001892-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-02-11 · EMA/85138/2021
- 打开官方文件 ↗
Saxenda-H-C-PSUSA-00001892-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-06 · EMA/429077/2019
- 打开官方文件 ↗
Saxenda-H-C-3780-P46-017 : EPAR - Assessment Report
variation-report · 2018-04-13 · EMA/201755/2018
- 打开官方文件 ↗
Saxenda-H-C-3780-P46-016 : EPAR - Assessment Report
variation-report · 2018-04-13 · EMA/201752/2018
- 打开官方文件 ↗
Saxenda-H-C-PSUSA-00001892-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-09-28 · EMA/516061/2016
- 打开官方文件 ↗
Saxenda : EPAR - Public assessment report
assessment-report · 2015-04-16 · EMA/143005/2015
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。