欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Eliquis
适用类别Human
治疗领域Arthroplasty;Venous Thromboembolism
通用名/非专利名称apixaban
活性成分apixaban
产品号EMEA/H/C/002148
患者安全信息No
许可状态Authorised
ATC编码B01AF02
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2011/05/18
上市许可开发者/申请人/持有人Bristol-Myers Squibb / Pfizer EEIG
人用药物治疗学分组Antithrombotic agents
兽用药物治疗学分组
审评意见日期2011/03/17
欧盟委员会决定日期2025/11/26
修订号38
治疗适应症Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. 
适用物种
兽用药物ATC编码
首次发布日期2018/08/03
最后更新日期2025/11/26
产品说明书https://www.ema.europa.eu/en/documents/product-information/eliquis-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/eliquis
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