欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Trudexa
适用类别Human
治疗领域Spondylitis, Ankylosing;Arthritis, Rheumatoid;Arthritis, Psoriatic;Crohn Disease
通用名/非专利名称adalimumab
活性成分adalimumab
产品号EMEA/H/C/000482
患者安全信息No
许可状态Withdrawn
ATC编码L04AA17
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2003/09/01
上市许可开发者/申请人/持有人Abbott Laboratories Ltd.
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
欧盟委员会决定日期2007/06/29
修订号8
治疗适应症Rheumatoid arthritisTrudexa in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Psoriatic arthritisTrudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Ankylosing spondylitisTrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's diseaseTrudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Trudexa should be given in combination with cortiocosteroids. Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
适用物种
兽用药物ATC编码
首次发布日期2007/06/29
最后更新日期2008/02/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/trudexa-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa
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