| 商品名称 | Tocilizumab STADA (previously Tofidence) |
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| 适用类别 | Human |
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| 治疗领域 | Arthritis, Rheumatoid;COVID-19 virus infection;Arthritis, Juvenile Rheumatoid |
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| 通用名/非专利名称 | tocilizumab |
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| 活性成分 | tocilizumab |
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| 产品号 | EMEA/H/C/005984 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L04AC07 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | Yes |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2024/06/20 |
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| 上市许可开发者/申请人/持有人 | STADA Arzneimittel AG |
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| 人用药物治疗学分组 | Immunosuppressants |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2024/04/25 |
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| 欧盟委员会决定日期 | 2026/01/15 |
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| 修订号 | 4 |
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| 治疗适应症 | Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination 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 tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): 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 (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): 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 (monotherapy or in combination with MTX). |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2024/07/10 |
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| 最后更新日期 | 2026/02/05 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tocilizumab-stada-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tocilizumab-stada |
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