跳到正文

法规知识库 · EMA 集中审评

Tyenne

tocilizumab · EMEA/H/C/005781 · 已授权

生物类似药

获批上市许可

2023-09-15

欧委会决定日

2026-08-18

持有人 / 申请人

Fresenius Kabi Deutschland GmbH

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

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AC07

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

药理分类:Immunosuppressants

修订号:6 · 最新影响 PI 的程序:VR/0000355576

适应症(原文):Tyenne, 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, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab 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. Tyenne 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. Tyenne 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. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Tyenne 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.Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tyenne 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. Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

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. 2026-08-18 · 欧委会决定

  2. 2023-09-15 · 获批上市许可

  3. 2023-07-20 · 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 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-08-19

    打开官方文件 ↗
  • Tyenne : EPAR - Risk management plan

    rmp · 2026-08-19

    打开官方文件 ↗
  • Tyenne : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-06-17

    打开官方文件 ↗
  • Tyenne : EPAR - Medicine overview

    overview · 2023-10-02 · EMA/358138/2023

    打开官方文件 ↗
  • Tyenne : EPAR - Public assessment report

    assessment-report · 2023-10-02 · EMA/365561/2023

    打开官方文件 ↗

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。