欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tofidence
适用类别Human
治疗领域Arthritis, Rheumatoid;COVID-19 virus infection;Arthritis, Juvenile Rheumatoid
通用名/非专利名称tocilizumab
活性成分tocilizumab
产品号EMEA/H/C/005984
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2024/06/20
上市许可开发者/申请人/持有人STADA Arzneimittel AG
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2024/04/25
欧盟委员会决定日期2025/10/09
修订号3
治疗适应症Rheumatoid arthritis (RA): the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination 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 tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): 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 (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).
适用物种
兽用药物ATC编码
首次发布日期2024/07/10
最后更新日期2025/10/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/tofidence-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tofidence
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