欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Jylamvo
适用类别Human
治疗领域Arthritis, Psoriatic;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Psoriasis;Arthritis, Rheumatoid;Arthritis
通用名/非专利名称methotrexate
活性成分methotrexate
产品号EMEA/H/C/003756
患者安全信息No
许可状态Authorised
ATC编码L04AX03
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2017/03/29
上市许可开发者/申请人/持有人Oresund Pharma ApS
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2017/01/26
欧盟委员会决定日期2024/10/21
修订号15
治疗适应症In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
适用物种
兽用药物ATC编码
首次发布日期2018/05/22
最后更新日期2024/10/24
产品说明书https://www.ema.europa.eu/en/documents/product-information/jylamvo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/jylamvo
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