欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Taltz
适用类别Human
治疗领域Psoriasis;Arthritis, Psoriatic;Axial Spondyloarthritis;Arthritis, Juvenile
通用名/非专利名称ixekizumab
活性成分ixekizumab
产品号EMEA/H/C/003943
患者安全信息No
许可状态Authorised
ATC编码L04AC13
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2016/04/25
上市许可开发者/申请人/持有人Eli Lilly and Company (Ireland) 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2016/02/25
欧盟委员会决定日期2025/08/22
修订号20
治疗适应症Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Paediatric plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies. Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis)Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Juvenile idiopathic arthritis (JIA)Juvenile psoriatic arthritis (JPsA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.Enthesitis-related arthritis (ERA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.
适用物种
兽用药物ATC编码
首次发布日期2018/07/30
最后更新日期2025/09/11
产品说明书https://www.ema.europa.eu/en/documents/product-information/taltz-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/taltz
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