欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cosentyx
适用类别Human
治疗领域Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing
通用名/非专利名称secukinumab
活性成分secukinumab
产品号EMEA/H/C/003729
患者安全信息No
许可状态Authorised
ATC编码L04AC10
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2015/01/14
上市许可开发者/申请人/持有人Novartis Europharm Limited
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2014/11/20
欧盟委员会决定日期2025/10/16
修订号43
治疗适应症Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
适用物种
兽用药物ATC编码
首次发布日期2018/06/07
最后更新日期2025/12/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx
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