欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Usgena
适用类别Human
治疗领域Crohn Disease;Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative
通用名/非专利名称ustekinumab
活性成分ustekinumab
产品号EMEA/H/C/006667
患者安全信息No
许可状态Authorised
ATC编码L04AC05
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
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2025/11/17
上市许可开发者/申请人/持有人Stada Arzneimittel AG
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2025/09/18
修订号
治疗适应症Crohn’s DiseaseUsgena is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.Ulcerative colitisUsgena is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasisUsgena is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisUsgena is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).Psoriatic arthritis (PsA)Usgena, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
适用物种
兽用药物ATC编码
首次发布日期2025/09/19
最后更新日期2025/11/21
产品说明书https://www.ema.europa.eu/en/documents/product-information/usgena-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/usgena
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