法规知识库 · EMA 集中审评
Jakavi
ruxolitinib phosphate · EMEA/H/C/002464 · 已授权
获批上市许可
2012-08-23
欧委会决定日
2025-11-10
持有人 / 申请人
Novartis Europharm Limited
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
17
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EJ01
治疗领域：Myeloproliferative Disorders;Polycythemia Vera;Graft vs Host Disease
药理分类：Antineoplastic agents
修订号：38 · 最新影响 PI 的程序：VR/0000310678
适应症（原文）：Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (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。
2025-11-10 · 欧委会决定
2012-08-23 · 获批上市许可
2012-04-19 · 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 ↗
Jakavi : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-10
- 打开官方文件 ↗
Jakavi-PAM-0000250368 : EPAR - Assessment report
variation-report · 2025-09-10 · EMADOC-1700519818-2427323
- 打开官方文件 ↗
Jakavi : EPAR - Risk management plan
rmp · 2025-08-29
- 打开官方文件 ↗
Jakavi-H-C-002464-X-0070-G : EPAR - Assessment report - Variation
variation-report · 2025-02-11 · EMA/553041/2024
- 打开官方文件 ↗
Jakavi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-11
- 打开官方文件 ↗
Jakavi : EPAR - Medicine overview
overview · 2025-02-11 · EMA/46877/2025
- 打开官方文件 ↗
Jakavi-H-C-002464-P46-021 : EPAR - Assessment report
variation-report · 2024-07-02 · EMA/223194/2024
- 打开官方文件 ↗
Jakavi-H-C-2464-P46-020: EPAR - Assessment report
variation-report · 2023-12-21 · EMA/527931/2023
- 打开官方文件 ↗
Jakavi-H-C-831-P46-019: EPAR - Assessment report
variation-report · 2023-07-31 · EMA/345111/2023
- 打开官方文件 ↗
Jakavi-H-C-2464-II-0053 : EPAR - Assessment report - Variation
variation-report · 2022-11-04 · EMA/231935/2022
- 打开官方文件 ↗
Jakavi-H-C-831-P46-018: EPAR - Assessment report
variation-report · 2022-05-18 · EMA/74208/2022
- 打开官方文件 ↗
Jakavi-H-C-PSUSA-00010015-202002 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-01-04 · EMA/704721/2020
- 打开官方文件 ↗
Jakavi-H-C-PSUSA-00010015-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-03-05 · EMA/136195/2018
- 打开官方文件 ↗
Jakavi-H-C-PSUSA-00010015-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-11-29 · EMA/789757/2016
- 打开官方文件 ↗
Jakavi-H-C-2464-II-0016: EPAR - Assessment Report - Variation
variation-report · 2015-04-15 · EMA/139813/2015
- 打开官方文件 ↗
Jakavi-H-C-2464-PSUV-0009 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-01-08 · EMA/CHMP/801864/2013
- 打开官方文件 ↗
Jakavi : EPAR - Public assessment report
assessment-report · 2012-10-04 · EMA/465846/2012
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。