| 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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| 授权状态 | 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 | 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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| 批准上市日期 | 2007/05/21 |
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| 上市许可持有人/公司名称 | Bristol-Myers Squibb Pharma EEIG |
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| 人用药物治疗分组 | Immunosuppressants |
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| 审评意见发布日期 | 2007/03/22 |
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| 决定日期 | 2023/06/26 |
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| 修订号 | 38 |
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| 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 arthritisOrencia, 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 arthritisOrencia 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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| 首次发布日期 | 2017/07/25 |
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| 修订日期 | 2023/06/27 |
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| 产品信息 | 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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