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
授权状态Authorised
ATC编码L04AC07
是否额外监管no
是否仿制药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
批准上市日期2023/09/15
上市许可持有人/公司名称Fresenius Kabi Deutschland GmbH
人用药物治疗分组Immunosuppressants
审评意见发布日期2023/07/20
修订号
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.
首次发布日期2023/08/07
修订日期2023/10/02
产品信息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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