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法规知识库 · EMA 集中审评

Kineret

anakinra · EMEA/H/C/000363 · 已授权

获批上市许可

2002-03-08

欧委会决定日

2025-09-04

持有人 / 申请人

Swedish Orphan Biovitrum AB (publ)

终止日期字段

无

从产品到官方文件

文件记录

19

官方索引 19

EPAR / 审评

17

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AC03

治疗领域:Arthritis, Rheumatoid;COVID-19 virus infection

药理分类:Immunosuppressants

修订号:39 · 最新影响 PI 的程序:VR/0000249038

适应症(原文):Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

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. 2025-09-04 · 欧委会决定

  2. 2002-03-08 · 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 17产品信息 2其他 0

EPAR / 审评资料

  • Kineret-PAM-0000335960 : EPAR - Assessment report

    variation-report · 2026-06-09 · EMADOC-1700519818-3226352

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

    procedural-steps-after · 2026-01-30

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  • Kineret : EPAR - Risk-management plan

    rmp · 2026-01-30

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  • Kineret : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-10-15

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  • Kineret-H-C-PSUSA-00000209-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2023-03-29 · EMA/144773/2023

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  • Kineret-H-C-363-II-0087 : EPAR - Assessment Report

    variation-report · 2022-07-20 · EMA/609606/2022

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  • Kineret-H-C-000363-II-0086 : EPAR - Assessment Report - Variation

    variation-report · 2021-12-22 · EMA/772497/2021

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  • Kineret : EPAR - Medicine overview

    overview · 2021-12-22 · EMA/770315/2021

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  • Kineret-H-C-000363-II-0078 : EPAR - Assessment Report - Variation

    variation-report · 2021-07-15 · EMA/385270/2021

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  • Kineret-H-C-363-II-0073 : EPAR - Assessment Report - Variation

    variation-report · 2020-06-26

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  • Kineret-H-C-363-P46-031 : EPAR - Assessment Report

    variation-report · 2020-05-28 · EMA/CHMP/205830/2020

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  • Kineret-H-C-363-II-0070 : EPAR - Assessment Report - Variation

    variation-report · 2020-05-14 · EMA/236936/2020

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  • Kineret-H-C-363-II-0056 : EPAR - Assessment Report - Variation

    variation-report · 2018-05-15 · EMA/CHMP/169769/2018

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  • Kineret-H-C-363-X-0042 : EPAR - Assessment Report - Extension

    variation-report · 2013-12-02 · EMA/CHMP/398765/2013

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  • Kineret : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2006-07-21

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  • Kineret : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2006-07-21

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  • Kineret : EPAR - Scientific Discussion

    scientific-discussion · 2006-07-21

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产品信息

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。