| 商品名称 | Rinvoq |
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| 适用类别 | Human |
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| 治疗领域 | Arthritis, Rheumatoid;Arthritis, Psoriatic;Axial Spondyloarthritis;Spondylitis, Ankylosing;Giant Cell Arteritis;Dermatitis, Atopic;Colitis, Ulcerative;Crohn Disease |
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| 通用名/非专利名称 | upadacitinib |
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| 活性成分 | upadacitinib |
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| 产品号 | EMEA/H/C/004760 |
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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 | L04AA44 |
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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 | 2019/12/16 |
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| 上市许可开发者/申请人/持有人 | AbbVie Deutschland GmbH & Co. KG |
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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 | 2019/10/17 |
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| 欧盟委员会决定日期 | 2026/06/04 |
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| 修订号 | 31 |
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| 治疗适应症 | Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. |
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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 | 2019/10/18 |
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| 最后更新日期 | 2026/06/09 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq |
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