法规知识库 · EMA 集中审评
Jylamvo
methotrexate · EMEA/H/C/003756 · 已授权
获批上市许可
2017-03-29
欧委会决定日
2026-08-27
持有人 / 申请人
Oresund Pharma ApS
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AX03
治疗领域：Arthritis, Psoriatic;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Psoriasis;Arthritis, Rheumatoid;Arthritis
药理分类：Antineoplastic agents
修订号：16 · 最新影响 PI 的程序：PSUR/0000327873
适应症（原文）：In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
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。
2026-08-27 · 欧委会决定
2017-03-29 · 获批上市许可
2017-01-26 · 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
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Jylamvo : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-07
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Jylamvo-PSUSA-00002014-202510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-09-07 · EMADOC-1700519818-3435345
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Jylamvo : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-09-07
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Jylamvo-H-C-PSUSA-00002014-202310 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-09-02 · EMA/407130/2024
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Jylamvo : EPAR - Risk management plan
rmp · 2024-06-24
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Jylamvo-H-C-PSUSA-00002014-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-08-21 · EMA/405776/2020
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Jylamvo : EPAR - Medicine overview
overview · 2019-10-31
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Jylamvo-H-C-PSUSA-00002014-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-09-18 · EMA/506249/2019
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Jylamvo : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-06-01 · EMA/357560/2018
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Jylamvo : EPAR - Public assessment report
assessment-report · 2017-04-19 · EMA/78284/2017
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。