| 商品名称 | Hulio |
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| 适用类别 | Human |
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| 治疗领域 | Hidradenitis Suppurativa;Psoriasis;Uveitis;Arthritis, Rheumatoid;Spondylitis, Ankylosing;Crohn Disease;Colitis, Ulcerative;Arthritis, Psoriatic |
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| 通用名/非专利名称 | adalimumab |
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| 活性成分 | adalimumab |
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| 产品号 | EMEA/H/C/004429 |
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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 | L04AB04 |
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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 | 2018/09/17 |
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| 上市许可开发者/申请人/持有人 | Biosimilar Collaborations Ireland Limited |
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| 人用药物治疗学分组 | Immunosuppressants;Tumor necrosis factor alpha (TNF-α) inhibitors |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2026/02/17 |
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| 修订号 | 19 |
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| 治疗适应症 | Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Paediatric plaque psoriasis Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric Crohn's disease Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric Uveitis Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy 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 | 2018/09/17 |
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| 最后更新日期 | 2026/02/19 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hulio-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hulio |
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