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RoActemra

tocilizumab · EMEA/H/C/000955 · 已授权

获批上市许可

2009-01-16

欧委会决定日

2026-02-12

持有人 / 申请人

Roche Registration GmbH

终止日期字段

无

从产品到官方文件

文件记录

26

官方索引 26

EPAR / 审评

23

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AC07

治疗领域:Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Cytokine Release Syndrome;Giant Cell Arteritis;COVID-19 virus infection

药理分类:Immunosuppressants

修订号:50 · 最新影响 PI 的程序:VR/0000261482

适应症(原文):RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

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. 2026-02-12 · 欧委会决定

  2. 2009-01-16 · 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 23产品信息 3其他 0

EPAR / 审评资料

  • RoActemra-PAM-0000348681 : EPAR - Assessment report

    variation-report · 2026-08-13 · EMADOC-1700519818-3174543

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

    procedural-steps-after · 2026-04-01

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  • RoActemra : EPAR - Risk-management-plan

    rmp · 2026-04-01

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

    procedural-steps-after · 2025-04-03

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  • RoActemra-H-C-000955-P46-064 : EPAR - Assessment Report

    variation-report · 2025-01-15 · EMA/CHMP/437255/2024

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  • RoActemra-H-C-000955-P46-062 : EPAR - Assessment Report

    variation-report · 2022-10-19 · EMA/727498/2022

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  • RoActemra-H-C-955-II-0101 : EPAR - Assessment Report - Variation

    variation-report · 2021-12-10 · EMA/733881/2021

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  • RoActemra : EPAR - Medicines overview

    overview · 2021-12-10 · EMA/712748/2021

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  • RoActemra-H-C-955-II-0097 : EPAR - Assessment Report - Variation

    variation-report · 2020-09-14 · EMA/429735/2020

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  • RoActemra-PSUSA-00002980-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

    scientific-conclusion · 2019-04-29 · EMA/14506/2019

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  • RoActemra-H-C-955-II-0076 : EPAR - Assessment Report - Variation

    variation-report · 2018-11-28 · EMA/742879/2018

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  • RoActemra : EPAR - Paediatric investigation plan compliance statement

    pip-compliance · 2018-11-28 · EMA/639048/2018

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  • RoActemra-H-C-955-II-0078 : EPAR - Assessment Report - Variation

    variation-report · 2018-10-12 · EMA/491183/2018

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  • RoActemra-H-C-955-II-0072 : EPAR - Assessment Report - Variation

    variation-report · 2018-05-30 · EMA/188997/2018

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  • RoActemra-H-C-955-II-0066 : EPAR - Assessment Report - Variation

    variation-report · 2017-09-29 · EMA/562609/2017

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  • RoActemra-H-C-955-II-0057 : EPAR - Assessment Report - Variation

    variation-report · 2016-08-11 · EMA/CHMP/501514/2016

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  • RoActemra-H-C-955-II-0032 : EPAR - Assessment Report - Variation

    variation-report · 2014-09-29 · EMA/552413/2014

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  • RoActemra-H-C-955-X-0030 : EPAR - Assessment Report - Variation

    variation-report · 2014-05-28 · EMA/CHMP/606295/2013

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  • RoActemra-H-C-955-II-0026 : EPAR - Assessment Report - Variation

    variation-report · 2013-07-03 · EMA/393130/2013

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  • RoActemra-H-C-955-II-0015 : EPAR - Assessment Report - Variation

    variation-report · 2011-08-30

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  • RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

    conditions-member-states · 2011-08-30

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  • RoActemra-H-C-955-II-0007 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2010-07-16

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  • RoActemra : EPAR - Public assessment report

    assessment-report · 2009-02-18

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产品信息

  • RoActemra : EPAR - Product information - tracked changes

    product-information-tracked-changes · 2026-04-01

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  • RoActemra : EPAR - Product Information

    product-information · 2026-04-01

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  • RoActemra : EPAR - All Authorised presentations

    all-authorised-presentations · 2023-10-16

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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。