欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tyenne
适用类别Human
治疗领域Arthritis, Rheumatoid;Cytokine Release Syndrome;Arthritis, Juvenile Rheumatoid;COVID-19 virus infection;Giant Cell Arteritis
通用名/非专利名称tocilizumab
活性成分tocilizumab
产品号EMEA/H/C/005781
患者安全信息No
许可状态Authorised
ATC编码L04AC07
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2023/09/15
上市许可开发者/申请人/持有人Fresenius Kabi Deutschland 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2023/07/20
欧盟委员会决定日期2025/10/02
修订号5
治疗适应症Tyenne, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
适用物种
兽用药物ATC编码
首次发布日期2023/08/07
最后更新日期2025/10/02
产品说明书https://www.ema.europa.eu/en/documents/product-information/tyenne-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tyenne
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