法规知识库 · EMA 集中审评
Imcivree
setmelanotide · EMEA/H/C/005089 · 已授权
获批上市许可
2021-07-16
欧委会决定日
2026-04-30
持有人 / 申请人
Rhythm Pharmaceuticals Netherlands B.V.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A08AA
治疗领域：Obesity
药理分类：Antiobesity preparations, excl. diet products
修订号：15 · 最新影响 PI 的程序：VR/0000288021
适应症（原文）：Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.
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。
2026-04-30 · 欧委会决定
2021-07-16 · 获批上市许可
2021-05-20 · 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 ↗
Imcivree : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-02
- 打开官方文件 ↗
Imcivree-VR-0000288021 : EPAR - Assessment report - Variation
variation-report · 2026-05-27 · EMADOC-1700519818-3004862
- 打开官方文件 ↗
Imcivree : Orphan maintenance assessment report (post authorisation)
orphan-maintenance-report-post · 2026-05-27 · EMADOC-1700519818-3040248
- 打开官方文件 ↗
Imcivree : EPAR - Medicine overview
overview · 2026-05-27 · EMADOC-1829012207-48183
- 打开官方文件 ↗
Imcivree : EPAR - Risk management plan
rmp · 2026-05-27
- 打开官方文件 ↗
Imcivree : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-27
- 打开官方文件 ↗
Imcivree-H-C-005089-II-0018 : EPAR - Assessment report - Variation
variation-report · 2024-09-30 · EMA/402097/2024
- 打开官方文件 ↗
Imcivree-H-C-005089-P46-009 : EPAR - Assessment report
variation-report · 2024-09-18 · EMA/438147/2024
- 打开官方文件 ↗
Imcivree-H-C-005089-II-0002-G : EPAR - Assessment report - Variation
variation-report · 2022-09-28 · EMA/677091/2022
- 打开官方文件 ↗
Imcivree : EPAR - Orphan maintenance assessment report (post authorisation)
orphan-maintenance-report-post · 2022-09-28 · EMA/OD/0000074865
- 打开官方文件 ↗
Imcivree : EPAR - Public assessment report
assessment-report · 2021-07-22 · EMA/CHMP/319064/2021
- 打开官方文件 ↗
Imcivree : EPAR - Orphan maintenance assessment report (initial authorisation)
orphan-maintenance-report · 2021-07-22 · EMADOC-1700519818-687119
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。