欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Inhixa
适用类别Human
治疗领域Venous Thromboembolism
通用名/非专利名称enoxaparin sodium
活性成分enoxaparin sodium
产品号EMEA/H/C/004264
患者安全信息No
许可状态Authorised
ATC编码B01AB05
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2016/09/15
上市许可开发者/申请人/持有人Techdow Pharma Netherlands B.V. 
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2016/07/21
欧盟委员会决定日期2025/11/15
修订号30
治疗适应症Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis.
适用物种
兽用药物ATC编码
首次发布日期2018/06/22
最后更新日期2025/11/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/inhixa-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/inhixa
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase