欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tremfya
适用类别Human
治疗领域Psoriasis;Crohn Disease;Colitis, Ulcerative
通用名/非专利名称guselkumab
活性成分Guselkumab
产品号EMEA/H/C/004271
患者安全信息No
许可状态Authorised
ATC编码L04AC
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2017/11/10
上市许可开发者/申请人/持有人Janssen-Cilag International NV
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2017/09/14
欧盟委员会决定日期2025/10/20
修订号14
治疗适应症Plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya 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 treatment.Crohn’s diseaseTremfya 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 treatment.
适用物种
兽用药物ATC编码
首次发布日期2017/11/10
最后更新日期2025/11/04
产品说明书https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase