欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Kineret
适用类别Human
治疗领域Arthritis, Rheumatoid;COVID-19 virus infection
通用名/非专利名称anakinra
活性成分anakinra
产品号EMEA/H/C/000363
患者安全信息No
许可状态Authorised
ATC编码L04AC03
是否额外监管Nei
是否仿制药或hybrid药物Nei
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2002/03/08
上市许可开发者/申请人/持有人Swedish Orphan Biovitrum AB (publ)
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
欧盟委员会决定日期2025/09/04
修订号37
治疗适应症Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
适用物种
兽用药物ATC编码
首次发布日期2018/04/06
最后更新日期2025/10/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/kineret-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/kineret
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