法规知识库 · EMA 集中审评
Otezla
apremilast · EMEA/H/C/003746 · 已授权
获批上市许可
2015-01-15
欧委会决定日
2026-01-13
持有人 / 申请人
Amgen Europe B.V.
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA32
治疗领域：Arthritis, Psoriatic;Psoriasis;Behcet Syndrome
药理分类：Immunosuppressants
修订号：25 · 最新影响 PI 的程序：PSUR/0000282235
适应症（原文）：Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric psoriasisOtezla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.Behçet’s diseaseOtezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
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。
2026-01-13 · 欧委会决定
2015-01-15 · 获批上市许可
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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Otezla : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-14
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Otezla : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-14
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Otezla : EPAR - Medicine overview
overview · 2025-07-16 · EMEA/H/C/003746
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Otezla-H-C-003746-II-0044-G : EPAR - Assessment report
variation-report · 2024-10-22 · EMA/484631/2024
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Otezla : EPAR - Risk management plan
rmp · 2024-10-22
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Otezla-H-C-003746-P46-010 : EPAR - Assessment report
variation-report · 2023-12-01 · EMA/548921/2023
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Otezla-H-C-003746-II-0029 : EPAR - Assessment report - Variation
variation-report · 2020-04-16 · EMA/135313/2020
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Otezla-H-C-PSUSA-00010338-201603 : EPAR - Scientific Conclusion
scientific-conclusion · 2017-03-13 · EMA/CHMP/53286/2017
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Otezla-H-C-PSUSA-10338-201509 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-07-19 · EMA/496344/2016
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Otezla : EPAR - Public assessment report
assessment-report · 2015-02-16 · EMA/CHMP/476353/2014
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。