欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Eksunbi
适用类别Human
治疗领域Crohn Disease;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic
通用名/非专利名称ustekinumab
活性成分ustekinumab
产品号EMEA/H/C/006448
患者安全信息No
许可状态Authorised
ATC编码L04AC05
是否额外监管No
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2024/09/12
上市许可开发者/申请人/持有人Samsung Bioepis NL B.V.
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2024/07/25
修订号
治疗适应症Crohn’s DiseaseEksunbi 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 or have medical contraindications to such therapies.Ulcerative colitisEksunbi 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 or have medical contraindications to such therapies (see section 5.1).Plaque psoriasisEksunbi 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 psoriasisEksunbi 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)Eksunbi, 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2024/07/26
最后更新日期2024/09/24
产品说明书https://www.ema.europa.eu/en/documents/product-information/eksunbi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/eksunbi
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