| 商品名称 | Orencia |
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| 适用类别 | Human |
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| 治疗领域 | Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid |
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| 通用名/非专利名称 | abatacept |
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| 活性成分 | abatacept |
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| 产品号 | EMEA/H/C/000701 |
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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 | L04AA24 |
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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 | No |
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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 | 2007/05/21 |
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| 上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
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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 | 2007/03/22 |
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| 欧盟委员会决定日期 | 2024/06/24 |
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| 修订号 | 41 |
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| 治疗适应症 | Rheumatoid arthritisOrencia, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate. |
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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 | 2017/07/25 |
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| 最后更新日期 | 2025/05/19 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/orencia-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/orencia |
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