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法规知识库 · EMA 集中审评

Tosmova (previously Tocilizumab STADA and Tofidence)

tocilizumab · EMEA/H/C/005984 · 已授权

生物类似药

获批上市许可

2024-06-20

欧委会决定日

2026-10-20

持有人 / 申请人

STADA Arzneimittel AG

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

4

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AC07

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

药理分类:Immunosuppressants

修订号:5 · 最新影响 PI 的程序:VR/0000369980

适应症(原文):Tosmova, 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, Tosmova can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tosmova 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. Tosmova 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. Tosmova 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. Tosmova can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Tosmova 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. Tosmova can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

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. 2026-10-20 · 欧委会决定

  2. 2024-06-20 · 获批上市许可

  3. 2024-04-25 · 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 4产品信息 3其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-10-20

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  • Tosmova : EPAR - Risk-management-plan

    rmp-summary · 2026-10-20

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  • Tofidence : EPAR - Medicine overview

    overview · 2026-02-05 · EMA/230842/2024

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  • Tofidence : EPAR - Public assessment report

    assessment-report · 2024-07-10 · EMA/230842/2024

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产品信息

  • Tosmova : EPAR - Product information

    product-information · 2026-10-20

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  • Tosmova : EPAR - All authorised presentations

    all-authorised-presentations · 2026-10-20

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  • Tocilizumab STADA : EPAR - Product information - tracked changes

    product-information-tracked-changes · 2026-01-20

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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。