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法规知识库 · EMA 集中审评

Apremilast Accord

apremilast · EMEA/H/C/006208 · 已授权

仿制药

获批上市许可

2024-04-19

欧委会决定日

2026-06-11

持有人 / 申请人

Accord Healthcare S.L.U.

终止日期字段

无

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

5

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;Oral Ulcer

药理分类:Immunosuppressants

修订号:5 · 最新影响 PI 的程序:VR/0000355526

适应症(原文):Psoriatic arthritis Apremilast Accord, 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 (see section 5.1).Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis 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).Behçet’s disease Apremilast Accord 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。

  1. 2026-06-11 · 欧委会决定

  2. 2024-04-19 · 获批上市许可

  3. 2024-02-22 · 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 5产品信息 3其他 0

EPAR / 审评资料

  • Apremilast Accord : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-06-12

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  • Apremilast Accord : EPAR - Procedural steps taken and scientific information after authorisation (archived)

    procedural-steps-after · 2025-07-18

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  • Apremilast Accord : EPAR - Medicine overview

    overview · 2024-05-21 · EMA/91614/2024

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  • Apremilast Accord : EPAR - Risk management plan

    rmp · 2024-05-21

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  • Apremilast Accord : EPAR - Public assessment report

    assessment-report · 2024-05-21 · EMA/96125/2024

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产品信息

  • Apremilast Accord : EPAR - Product information - tracked changes

    product-information-tracked-changes · 2026-06-12

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  • Apremilast Accord : EPAR - Product information

    product-information · 2026-06-12

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  • Apremilast Accord : EPAR - All authorised presentations

    all-authorised-presentations · 2025-07-18

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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。