欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Olumiant
适用类别Human
治疗领域Arthritis, Rheumatoid
通用名/非专利名称baricitinib
活性成分Baricitinib
产品号EMEA/H/C/004085
患者安全信息No
许可状态Authorised
ATC编码L04AA37
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2017/02/13
上市许可开发者/申请人/持有人Eli Lilly Nederland B.V.
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2016/12/14
欧盟委员会决定日期2024/11/21
修订号23
治疗适应症Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1). Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: - Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), - Enthesitis related arthritis, and - Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate.
适用物种
兽用药物ATC编码
首次发布日期2018/01/25
最后更新日期2025/07/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/olumiant-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/olumiant
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