欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Rinvoq
适用类别Human
治疗领域Arthritis, Rheumatoid
通用名/非专利名称upadacitinib
活性成分upadacitinib
产品号EMEA/H/C/004760
患者安全信息No
许可状态Authorised
ATC编码L04AA44
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2019/12/16
上市许可开发者/申请人/持有人AbbVie Deutschland GmbH & Co. KG
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
审评意见日期2019/10/17
欧盟委员会决定日期2025/11/17
修订号29
治疗适应症Rheumatoid arthritisRINVOQ 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 arthritisRINVOQ 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 arteritisRINVOQ is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitisRINVOQ 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 colitisRINVOQ 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 diseaseRINVOQ 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.
适用物种
兽用药物ATC编码
首次发布日期2019/10/18
最后更新日期2025/11/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq
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