欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Xeljanz
适用类别Human
治疗领域Arthritis, Rheumatoid
通用名/非专利名称tofacitinib
活性成分tofacitinib
产品号EMEA/H/C/004214
患者安全信息No
许可状态Authorised
ATC编码L04AF01
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2017/03/22
拒绝上市许可日期2013/04/25
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
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2013/07/24
欧盟委员会决定日期2025/10/17
修订号35
治疗适应症Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1). Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1). Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
适用物种
兽用药物ATC编码
首次发布日期2018/06/25
最后更新日期2025/10/20
产品说明书https://www.ema.europa.eu/en/documents/product-information/xeljanz-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/xeljanz
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