法规知识库 · EMA 集中审评
Mounjaro
tirzepatide · EMEA/H/C/005620 · 已授权
获批上市许可
2022-09-15
欧委会决定日
2026-09-21
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
13
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BX16
治疗领域：Diabetes Mellitus, Type 2;Obesity;Overweight
药理分类：Drugs used in diabetes
修订号：22 · 最新影响 PI 的程序：VR/0000369537
适应症（原文）：Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro 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 comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), 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。
2026-09-21 · 欧委会决定
2022-09-15 · 获批上市许可
2022-07-21 · 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 ↗
Mounjaro : EPAR - Risk management plan
rmp · 2026-10-08
- 打开官方文件 ↗
Mounjaro-H-C-005620-VR-0000310637 : EPAR - Assessment report - Variation
variation-report · 2026-10-08 · EMADOC-1700519818-2639821
- 打开官方文件 ↗
Mounjaro : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-21
- 打开官方文件 ↗
Mounjaro-VR-0000281937 : EPAR - Assessment report - Variation
variation-report · 2026-08-18 · EMADOC-1700519818-2704504
- 打开官方文件 ↗
Mounjaro-H-C-005620-II-0038 : EPAR - Assessment report - Variation
variation-report · 2026-08-18 · EMA/39652/2026
- 打开官方文件 ↗
Mounjaro : EPAR - Medicine Overview
overview · 2026-08-18 · EMADOC-1829012207-38696
- 打开官方文件 ↗
Mounjaro : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-02-26
- 打开官方文件 ↗
Mounjaro-H-C-PSUSA-00011019-202405 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-03-20 · EMA/101887/2025
- 打开官方文件 ↗
Mounjaro-H-C-005620-II-0027 : EPAR - Assessment report - Variation
variation-report · 2025-02-06 · EMA/14848/2025
- 打开官方文件 ↗
Mounjaro-H-C-PSUSA-00011019-202311 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-10-23 · EMA/495656/2024
- 打开官方文件 ↗
Mounjaro-H-C-005620-II-0007 : EPAR - Assessment report - Variation
variation-report · 2024-03-06 · EMA/539700/2023
- 打开官方文件 ↗
Mounjaro-H-C-PSUSA-00011019-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-02-21 · EMA/342202/2023
- 打开官方文件 ↗
Mounjaro : EPAR - Public assessment report
assessment-report · 2022-11-25 · EMA/791310/2022
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。