欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Apremilast Accord
适用类别Human
治疗领域Arthritis, Psoriatic;Psoriasis;Behcet Syndrome;Oral Ulcer
通用名/非专利名称apremilast
活性成分apremilast
产品号EMEA/H/C/006208
患者安全信息No
许可状态Authorised
ATC编码L04AA32
是否额外监管No
是否仿制药或hybrid药物Yes
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2024/04/19
上市许可开发者/申请人/持有人Accord Healthcare S.L.U.
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2024/02/22
欧盟委员会决定日期2025/06/23
修订号1
治疗适应症Psoriatic arthritisApremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).PsoriasisApremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).Behçet’s diseaseApremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
适用物种
兽用药物ATC编码
首次发布日期2024/02/23
最后更新日期2025/07/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/apremilast-accord-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/apremilast-accord
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