欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Erelzi
适用类别Human
治疗领域Arthritis, Psoriatic;Psoriasis;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid;Spondylitis, Ankylosing
通用名/非专利名称etanercept
活性成分etanercept
产品号EMEA/H/C/004192
患者安全信息No
许可状态Authorised
ATC编码L04AB01
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2017/06/23
上市许可开发者/申请人/持有人Sandoz GmbH
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2017/04/21
欧盟委员会决定日期2025/12/16
修订号19
治疗适应症Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease?modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis?related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease?modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non?radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C?reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non?steroidal anti?inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet?A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
适用物种
兽用药物ATC编码
首次发布日期2018/03/28
最后更新日期2025/12/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/erelzi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/erelzi
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