欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Skyrizi
适用类别Human
治疗领域Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease
通用名/非专利名称risankizumab
活性成分risankizumab
产品号EMEA/H/C/004759
患者安全信息No
许可状态Authorised
ATC编码L04AC18
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2019/04/26
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2019/02/28
欧盟委员会决定日期2025/10/02
修订号30
治疗适应症Plaque PsoriasisSkyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic ArthritisSkyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn’s diseaseSkyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitisSkyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
适用物种
兽用药物ATC编码
首次发布日期2019/06/26
最后更新日期2025/11/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/skyrizi
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