Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.
Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.
The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.
The main information that researchers will collect in this study:
* Age, gender, and other information about the child and their illness
* Type of VTE treatment given to the child
* Occurrence of medically important bleeding and its severity
Further information that researchers will collect:
* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
* Return of VTE symptoms
* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.
The data for this study will be collected from electronic health records and health insurance claims data until 2026.
Researchers will observe each child during treatment until:
* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
* their information is no longer available, or
* the study ends.

开始日期2025-12-31

申办/合作机构

Bayer AG

[+1]

NCT06580223

/ Not yet recruiting临床3期IIT

Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma: A Prospective, Multicenter, Open-Label, Randomized Trial

The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.

开始日期2025-09-01

申办/合作机构

华中科技大学同济医学院附属协和医院

NCT06965998

/ Recruiting临床2/3期IIT

A Pilot Randomized Double-Blinded Comparison of Full Treatment Dose Rivaroxaban for 90 Days to Prophylactic Dose Rivaroxaban for 45 Days in Patients With Lower Extremity Superficial Vein Thrombosis

The goal of this clinical trial, called a pilot study or a feasibility study, is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. This type of study includes a small number of participants so it is not expected to prove how safe the treatment is or how well the treatment works.
The main question it hopes to answer is:
1.What is the average number of patients that are recruited per month during the 12 month study period?
To test the study plan, adults being treated for a superficial vein thrombosis (SVT), which is a blood clot in the superficial veins of the leg, will be given a type of blood thinner called rivaroxaban. Half of the participants in this study will be given the standard (low-dose) rivaroxaban for 45 days, then 45 days of placebo (a substance that looks like the study medication but does not have any active or medicinal ingredients). The other half of participants will be given full-dose rivaroxaban for a total of 90 days. The placebo in this study is not intended to have any effect on the participants blood clot. A placebo is used to make the results of the study more reliable.

开始日期2025-08-06

申办/合作机构

Ottawa Hospital Research Institute

100 项与利伐沙班相关的临床结果

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100 项与利伐沙班相关的转化医学

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100 项与利伐沙班相关的专利（医药）

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9,511

项与利伐沙班相关的文献（医药）

2025-12-31·PLATELETS

Differential effects of dual antiplatelet and dual antithrombotic therapy on hemostasis in chronic coronary syndrome patients: the DEFINE CCS study

Article

作者: Mehta, Shamir R. ; Grandy, Scott ; Title, Lawrence ; Hillani, Ali ; Kim, Wan Cheol ; Harquail, Hannah ; Sapp, John ; Storey, Robert F. ; Haddad, Tony ; Eichhorn, Finn ; Parker, William ; Sumaya, Wael ; Quraishi, Ata ; Elkhateeb, Osama ; Heinze, Stefan S.

Optimal long term antithrombotic treatment in high-risk chronic coronary syndrome (CCS) patients remains uncertain. Both ticagrelor (60 mg BID) and low-dose rivaroxaban (2.5 mg BID) in addition to low-dose aspirin resulted in significant reductions in major cardiovascular events in high-risk patients at the expense of increased bleeding risk. We aimed to compare the effects of both strategies on bleeding time, fibrin clot lysis time and inflammatory biomarkers in CCS patients with history of acute coronary syndrome. Twenty aspirin-treated patients were recruited into a randomized crossover study to receive ticagrelor 60 mg BID in 1 week and rivaroxaban 2.5 mg BID in the other with a 2-week washout period in between. Outcome measures were determined at the start and end of each treatment week. Two-way ANOVA was used to determine difference in treatment effect. Data are presented as mean ± SD. At baseline, there was no significant difference in any studied outcome measure. Bleeding time was significantly longer with ticagrelor compared to rivaroxaban (Ticagrelor: 897 ± 481secs vs. Rivaroxaban: 440 ± 184 secs; p = .0001). Fibrin clot lysis time was not impacted by ticagrelor but significantly dropped post treatment with rivaroxaban (Ticagrelor: 5743 ± 2590 secs vs. Rivaroxaban: 4309 ± 2308 secs; p = .0049). Neither treatment had an impact on levels of high-sensitivity CRP or white cell count. In conclusion, ticagrelor 60 mg BID has greater impact on bleeding time compared to rivaroxaban 2.5 mg BID. Whereas rivaroxaban, positively modulates fibrin clots, rendering them more prone to lysis.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France

Article

作者: Belhassen, M. ; Lesage, H. ; Moreau, R. ; Guilmet, C. ; Née, M. ; Cotté, F. E. ; Danchin, N. ; Marant Micallef, C. ; Guitard-Dehoux, D.

OBJECTIVES:

Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral Anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban) to VKAs in over 400,000 AF patients in France, showed that DOACs are more effective, safer, and associated with lower total costs. This study evaluates the 10-year budget impact of DOACs in France, focusing on reductions in strokes/SE, MB, and monitoring costs (INRt).

METHODS:

A retrospective budget impact model from 2014 to 2023 compared scenarios with and without DOACs, using clinical and cost data from the NAXOS study. The target population of DOAC-eligible patients ranged from 725,000 in 2014 to 1.4 million in 2023. Market shares trends were derived from the public national drugs database, indicating that VKAs' use decreased from 67% to 11%, while DOACs, especially apixaban, rose sharply (2% to 55%) over the same period. Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs.

RESULTS:

Over a 10-year horizon, the introduction of DOACs is estimated to have prevented 73,009 strokes, 97,234 major bleeding, and 19,567 stroke-related deaths among patients with NVAF. DOAC introduction increased treatment costs by €5.15 billion over 10 years, and reduced costs for strokes/SE (-€4.24 billion), MB (-€3.22 billion), and INRt (-€1.14 billion), leading to €3.45 billion of savings for National Insurance over 10 years, with apixaban contributing 55% of savings.

LIMITATIONS:

This analysis may not account for all contextual variables, such as indirect costs related to productivity losses.

CONCLUSION:

Over 10 years, the introduction of DOACs in France has generated substantial savings in AF-related costs, highlighting their clinical and economic benefits and the importance for authorities to valorise the external effects of therapeutic innovations.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Comparative analysis of all-cause health care resource utilization and costs among patients with non-valvular atrial fibrillation and high risk of gastrointestinal bleeding in France: a nationwide cohort analysis

Article

作者: Subash, Rupesh ; Gusto, Gaelle ; Quignot, Nadia ; Sedjelmaci, Fouad ; Chaves, Jose ; Khachatryan, Artak ; Mokgokong, Ruth ; Pesce, Giancarlo ; Dai, Feng

AIMS:

This population-based cohort study compared healthcare resource utilization (HCRU) and direct HCRU costs (medical and non-medical) in French patients with non-valvular atrial fibrillation (NVAF) and at high-risk of gastrointestinal bleeding (GIB) after initiating an anticoagulant treatment with vitamin-K antagonists (VKAs) or with direct-oral anticoagulants (DOACs).

METHODS:

NVAF patients at high risk of GIB who initiated apixaban, rivaroxaban, dabigatran, or VKAs between 2016 and 2019 were identified from the French National Healthcare Data System (SNDS) database. The first anticoagulant reimbursement set the index date and patients were followed-up until drug discontinuation/switch, death, or study end, whichever came first. Differences in patient characteristics were balanced using 1:1 propensity score matched (PSM) cohorts. Direct (medical and non-medical) HCRU and costs per patient per month (PPPM) were compared using two-part generalized linear models.

RESULTS:

A total of 314,184 patients were identified (mean age 79.0 years; 51.0% female). In PSM cohorts, patients treated with DOACs had less outpatient visits, laboratory tests, and hospitalizations as compared to patients treated with VKAs. Each DOAC was associated with lower direct HCRU costs PPPM than VKAs (apixaban/VKAs: €1,868/€2,082; rivaroxaban/VKA: €1,788/€1,982; dabigatran/VKA: €1,461/€1,665; all p < .001). In DOAC-DOAC comparisons, apixaban was associated with lower direct HCRU costs than rivaroxaban and dabigatran (apixaban/rivaroxaban: €1,424/€1,460; apixaban/dabigatran: €1,444/€1,460), while rivaroxaban was associated with lower direct HCRU costs than dabigatran (rivaroxaban/dabigatran: €1,447/€1,459; all p < .001).

CONCLUSIONS:

In patients at high-risk of GIB, DOACs were associated with reduced direct HCRU costs compared to VKAs. Among DOACs, apixaban was associated with reduced direct HCRU costs.

839

项与利伐沙班相关的新闻（医药）

2025-09-05

·医药经济报

东阳光药：用管线兑现长期主义，第二增长曲线呼之欲出

2025年8月29日，上市不足一个月的东阳光药（06887.HK）如期披露中报业绩。财报数据显示，在研发投入方面，公司上半年投入3.48亿元，与近几年的投入水平基本持平。值得关注的是，8月中旬太保产险、太保寿险发布公告称，被动举牌东阳光药H股股票，合计持有754.6万股，占H股总股本的6.70%。公告中“不排除在后期继续追加投资的可能”这句话，被众多投资者视作“重要信号”。此次险资的被动举牌与潜在追加投资计划，从侧面反映市场对东阳光药长期布局的认可，而这一长期布局的核心落脚点，正是第二增长曲线的构建——通过聚焦高潜力赛道、加速创新药商业化，破解业绩波动难题，打开长期增长空间。第二曲线，三驾马车实际上，东阳光药的业绩一直存在波动，公司对此也有清晰认识，否则也不会推动创新药资产上市。与此同时，公司正积极构建第二增长曲线，加速商业化进程。在肝病领域，东阳光药的丙肝创新药东卫卓®和东英贺®于今年一季度获批。这两款新药适用于治疗初治或干扰素经治的基因1、2、3、6型成人丙型肝炎病毒（HCV）。8月中旬，东阳光药进行了销售架构调整，成立了肝病专线团队，以加速丙肝等创新药商业化。业内人士分析称，依托现有丙肝销售网络的基础，东卫卓®、东英贺®将能极大拓展适应症，迅速提升市场份额，预计在未来5年的销售峰值或达20亿元。在儿童药领域，东阳光药战略性布局具有协同效应的产品组合，新增小儿氨酚黄那敏颗粒（用于儿童感冒对症治疗）、小儿法罗培南颗粒（菲若姆®，口服儿童抗生素药）及儿童退热贴等多款产品，形成“抗感染+对症治疗+护理”儿童健康解决方案。东阳光药表示，借助强大的推广渠道，公司有望迅速打开菲若姆®市场，进一步巩固自身在儿童药领域的领先地位。米内网数据显示，2023年中国三大终端六大市场的全身用抗感染药物销售规模已超过1700亿元，其中儿童用抗生素市场规模超过百亿元。胰岛素领域同样成绩显著。2025年中报显示，甘精、门冬等五款胰岛素产品实现营业额1.22亿元，较去年同期大幅增长148.0%。东阳光药的出海步伐也在稳步迈进，公司瞄准中东、北非和美国等高发病率地区，其生产的胰岛素制剂已在阿联酋获批上市。此外，甘精胰岛素和门冬胰岛素在美国市场的上市准备工作正在进行中，甘精胰岛素预计2026年获批上市。长期主义，做厚里子在创新药行业中，东阳光药的“老实人”特质尤为突出，这一标签源于其上市身份的选择。目前，在资本市场上，biotech（生物科技公司）的估值明显高于传统pharma（制药公司）。东阳光药以pharma的身份上市，从估值角度来看，是一种相对偏低的选择。倘若东阳光药将研发资产单独上市，根据第三方机构给出的300亿元估值，减去其持有的东阳光长江药业股权价值，剩余管线资产的价值约250亿元。参照中慧生物、银诺医药上市后的超100%涨幅计算，东阳光药的总市值可能超500亿港元。然而，东阳光药毅然选择了打通研发、生产、商业化，实现一体化的全链条布局。这一战略决策意味着其体系内存在一些估值偏低的重资产，导致公司整体估值被压低。但从公司整体长远发展来看，这一决策具有诸多稳健之处。其一，东阳光长江药业能够为公司提供稳定的现金流，支持东阳光药开展研发工作；其二，该布局结束了两者的竞业协议，有效打通了国内国外销售网络；其三，减少了关联交易，东阳光长江药业在几年前以超10亿元的对价向东阳光药购买药物专利与授权，如今这种情况将不复存在。在上半年BD（商务拓展）热潮中，东阳光药也错过了炒作节点。据医药魔方统计，2025年上半年，中国创新药License-out（授权许可）总金额已突破600亿美元，其中单笔超10亿美元交易金额的有16笔。而东阳光药去年对英国Apollo公司的授权总金额达9.38亿元，这在今年的BD交易金额中也处于相对靠前的位置。这种“老实”还体现在市值管理上：公司未对标“中国版XX MNC”标签，导致投资者难以迅速理解公司业务和展望其潜在的市值空间。例如，港股上市的科伦博泰生物（06990.HK）因ADC技术路线与第一三共相似，被誉为“中国版第一三共”，上市后快速获得机构关注，股价累计上涨逾7倍，最新总市值约1000亿港元。A股市场也有类似情况，靠一款乙肝创新药被誉为“中国版吉利德”的广生堂（300436.SZ），三个月内从30元涨至188元，股价暴涨6倍。事实上，东阳光药在肝炎领域布局多年，其在研的莫非赛定是国内研发速度最快、也是最早进入三期临床试验的衣壳抑制剂。可以明确的是，东阳光药的“去对标化”使其估值更锚定基本面，如现有产品营收、研发进度等，减少了情绪炒作干扰，当然缺点是需要投资者长时间的陪伴与等待。创新驱动，管线兑现 “老实人”并不是一句情绪化的标签，而是东阳光药在“一体化”与“分拆高估值”两条路径中做出的系统性取舍。公司把短期估值折价换成持续现金流，把一次性BD溢价换成全生命周期的商业化控制，把“对标故事”换成“管线兑现”。因此，衡量东阳光药价值的锚点不再是“下一个XX中国版”，而是管线本身能否在自有商业化体系里快速放量。在研管线的广度和厚度，正是对这一取舍的集中回答——它们既是长期主义的结果，也是检验长期主义的标尺。财报显示，东阳光药已获批药物超过150款，其中创新药3款。在研管线共100款，包括49款1类创新药：1款已提交上市申请，10款处于II/III期临床。在众多在研品种中，三期管线是近期业绩兑现的核心抓手，具体包括克立福替尼片、伊非尼酮片、伏诺拉生注射液、莫非赛定胶囊、莱洛替尼胶囊、利拉鲁肽注射液。其中，克立福替尼与莱洛替尼均为肿瘤管线，承载着东阳光药成为中国领先肿瘤企业的愿景。前者用于治疗复发或难治的携带FLT3-ITD突变的急性髓系白血病（AML），而后者用于治疗食管癌。针对克立福替尼的商业化，东阳光药早在2024年12月就与沈阳三生开展合作，沈阳三生将独家负责该药物在中国大陆的商业化。治疗特发性肺纤维化（IPF）新药盐酸伊非尼酮片更是捷报频传，被投资者视为下一个有望对外授权的重磅品种。2025年5月，国家药品监督管理局药品审评中心同意开展III期临床，伊非尼酮成为该适应症首个获批进入III期临床的国产创新药。8月，东阳光药在官微透露，伊非尼酮II期关键数据亮相2025第九届美国IPF峰会，首席科学家林凯博士表示，II期试验实际入组224例，研究结果显示伊非尼酮组疗效显著。 △东阳光药注册及II、III期临床管线概览，图片来源于2025年中报东阳光药的注册审批成果丰硕。2款创新药（东卫卓®、东英贺®）于国内首次获批上市，2款生物类似药（德谷胰岛素注射液、德谷门冬双胰岛素注射液）申请上市，获得2项创新药临床试验批准，4款新药产品（HEC-007、HEC-301、HECN30227、HEC151）递交临床试验申请；2款仿制药产品（利伐沙班片、奥司他韦干混悬剂）在欧美国家获得药品注册批件。值得注意的是，东阳光药致力于将AI技术应用于药物研发的各个阶段，建立了多个先进的AI驱动模型，以提高研发效率和创新能力。据东阳光药透露，公司建立了覆盖药物研发全周期的HEC药物智能发现平台。该平台以六大自研模型为核心，融合垂直领域大模型与专用工具，构建了从靶点预测到AI蛋白质结构预测与分子模拟的全流程智能化药物研发体系。目前依托HEC药物智能发现平台，已大幅减少了合成化合物数量，PCC筛选时间从2–3年减少至1.5年，稳步推进AI落地生物医药研发的战略目标。 △东阳光药技术平台结语：以长期主义，绘就创新药增长新图景险资的举牌、丙肝新药的商业化加速、胰岛素的出海突破、伊非尼酮的临床捷报，这些信号正逐步验证其战略的有效性。或许东阳光药的估值不会像“对标型企业”那样快速飙升，但当管线中的克立福替尼、莫非赛定等品种相继兑现，当AI研发平台持续产出新候选药物，当“三驾马车”在各自赛道站稳脚跟，这家坚守长期主义的药企，终将在创新药行业的下半场，走出一条以基本面为锚、以价值为核的增长新路——这不仅是东阳光药的未来，更是中国创新药从“概念驱动”迈向“实体驱动”的缩影。数据来源：东阳光药（推广）云顶新耀月销5亿的创新药出圈！诺华、大冢等巨头酣战 A股69家中药企半年报：白云山、云南白药、华润三九等6家净利润超10亿恒瑞双靶点减重新药报产！与信达、礼来等巅峰对决在即 www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

财报上市批准引进/卖出

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-24

·信狐药迅

丹诺医药利福特尼唑、江苏恩华NH600001乳状注射液和爱科百发齐瑞索韦三个1类新药提交上市申请|新受理（8.18-8.24）

本周药品注册受理数据，分门别类呈现，一目了然。(8.18-8.24）新药上市申请药品名称企业注册分类受理号利福特尼唑胶囊丹诺医药(苏州)股份有限公司 1 CXHS2500103 NH600001乳状注射液江苏恩华药业股份有限公司 1 CXHS2500099 齐瑞索韦肠溶胶囊上海爱科百发生物医药技术股份有限公司 1 CXHS2500098 齐瑞索韦肠溶胶囊上海爱科百发生物医药技术股份有限公司 1 CXHS2500097 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500102 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500101 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500100 海曲泊帕乙醇胺片江苏恒瑞医药股份有限公司 2.4 CXHS2500096 贝莫苏拜单抗注射液正大天晴药业集团南京顺欣制药有限公司 2.2 CXSS2500085 新药临床申请药品名称企业注册分类受理号 RNK08954片珃诺生物医药科技(杭州)有限公司 1 CXHL2500886 RNK08954片珃诺生物医药科技(杭州)有限公司 1 CXHL2500885 IN10018片应世生物科技(深圳)有限公司 1 CXHL2500884 IN10018片应世生物科技(深圳)有限公司 1 CXHL2500883 YKYY013注射液北京悦康科创医药科技股份有限公司 1 CXHL2500882 LPM516000152盐酸盐胶囊烟台创和生物科技有限公司 1 CXHL2500881 LPM516000152盐酸盐胶囊烟台创和生物科技有限公司 1 CXHL2500880 BGT-004乳膏博骥源(上海)生物医药有限公司 1 CXHL2500878 BGT-004乳膏博骥源(上海)生物医药有限公司 1 CXHL2500877 HRS-7058片山东盛迪医药有限公司 1 CXHL2500876 HRS-7058片山东盛迪医药有限公司 1 CXHL2500875 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500874 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500873 CG-7321胶囊成都赛璟生物医药科技有限公司 1 CXHL2500872 CG-7321胶囊成都赛璟生物医药科技有限公司 1 CXHL2500871 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500870 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500869 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500868 HRN77片北京华睿鼎信科技有限公司 1 CXHL2500867 HRN77片北京华睿鼎信科技有限公司 1 CXHL2500866 TSN1611片泰励生物医药(苏州)有限公司 1 CXHL2500865 TSN1611片泰励生物医药(苏州)有限公司 1 CXHL2500863 TH202216胶束注射液山东泰合医药科技有限公司 2.2 CXHL2500879 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500864 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500862 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500861 冻干结核病mRNA疫苗瑞佶(北京)生物科技有限公司 1.1 CXSL2500732 吸附无细胞百(二组分)白破联合疫苗(成人及青少年用) 长春百克生物科技股份公司 1.3 CXSL2500724 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) 华普石家庄医药有限公司 1.3 CXSL2500710 LBM801 上海博赛美生物科技有限公司 1 CXSL2500734 SR604注射液上海莱士血液制品股份有限公司 1 CXSL2500733 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500731 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500730 GA001注射液健达九州(北京)生物科技有限公司 1 CXSL2500729 注射用GenSci143 长春金赛药业有限责任公司 1 CXSL2500728 SYS6010 石药集团巨石生物制药有限公司 1 CXSL2500722 注射用CS2009 申石生物医药(上海)有限公司 1 CXSL2500727 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500726 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500725 注射用SHR-A2102 苏州盛迪亚生物医药有限公司 1 CXSL2500718 注射用3H-10000 思康睿奇(上海)药业有限公司 1 CXSL2500717 HCB101注射液广州汉科生物有限公司 1 CXSL2500716 注射用SHR-9839 (sc) 苏州盛迪亚生物医药有限公司 1 CXSL2500713 注射用BL-B01D1 百时美施贵宝(中国)投资有限公司 1 CXSL2500712 注射用BL-B01D1 百时美施贵宝(中国)投资有限公司 1 CXSL2500711 GKL-006RTU注射液北京基因启明生物科技有限公司 1 CXSL2500721 重组人血小板生成素注射液沈阳三生制药有限责任公司 2.2 CXSL2500720 重组人血小板生成素注射液沈阳三生制药有限责任公司 2.2 CXSL2500719 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2500715 贝伐珠单抗注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2500714 仿制药申请药品名称企业注册分类受理号硫酸镁注射液成都华宇制药有限公司 3 CYHS2503089 氯化钾注射液山东新华制药股份有限公司 3 CYHS2503088 注射用氢化可的松琥珀酸钠西藏安星医药有限公司 3 CYHS2503087 注射用氢化可的松琥珀酸钠西藏安星医药有限公司 3 CYHS2503086 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503099 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503098 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503097 利伐沙班口崩片合肥恩瑞特药业有限公司 3 CYHS2503096 利伐沙班口崩片合肥恩瑞特药业有限公司 3 CYHS2503095 复方氨基酸注射液(18AA-X) 远大医学营养科学(武汉)有限公司 3 CYHS2503093 盐酸非索非那定口服混悬液杭州泓友医药科技有限公司 3 CYHS2503082 草酸艾司西酞普兰口服溶液浙江杭康药业有限公司 3 CYHS2503080 注射用哌拉西林钠/氯化钠注射液湖南科伦制药有限公司 3 CYHS2503074 注射用哌拉西林钠/氯化钠注射液湖南科伦制药有限公司 3 CYHS2503073 盐酸非索非那定片植恩生物技术股份有限公司 3 CYHS2503071 盐酸非索非那定片植恩生物技术股份有限公司 3 CYHS2503070 磷酸奥司他韦颗粒湖南欧亚药业有限公司 3 CYHS2503065 氯化钾注射液西安京西双鹤药业有限公司 3 CYHS2503058 硫酸镁注射液山西普恒制药有限公司 3 CYHS2503057 硫酸镁注射液山西普恒制药有限公司 3 CYHS2503055 左乙拉西坦微片海南元盈医药科技有限公司 3 CYHS2503054 左乙拉西坦微片海南元盈医药科技有限公司 3 CYHS2503053 己酮可可碱注射液丹东医创药业有限责任公司 3 CYHS2503052 盐酸伐地那非口崩片江苏东科康德药业有限公司 3 CYHS2503051 硝普钠注射液华润双鹤药业股份有限公司 3 CYHS2503066 聚普瑞锌颗粒北京韩美药品有限公司 3 CYHS2503026 乙酰半胱氨酸颗粒江西仁齐制药有限公司 3 CYHS2503020 复方聚乙二醇(3350)电解质口服溶液四川奇裕医药科技有限公司 3 CYHS2503045 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503040 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503039 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503038 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503037 注射用氯解磷定广州瑞尔医药科技有限公司 3 CYHS2503035 联苯苄唑溶液浙江百代医药科技有限公司 3 CYHS2503029 注射用硫酸艾沙康唑湖北美林药业有限公司 4 CYHS2503091 苹果酸奈诺沙星氯化钠注射液海南广升誉制药有限公司 4 CYHS2503090 氧(液态) 湖南中益邦达能源科技有限公司 4 CYHS2503108 达格列净二甲双胍缓释片(IV) 石药集团欧意药业有限公司 4 CYHS2503107 达格列净二甲双胍缓释片(III) 石药集团欧意药业有限公司 4 CYHS2503106 达格列净二甲双胍缓释片(II) 石药集团欧意药业有限公司 4 CYHS2503105 达格列净二甲双胍缓释片(I) 石药集团欧意药业有限公司 4 CYHS2503104 达格列净二甲双胍缓释片(I) 石药集团欧意药业有限公司 4 CYHS2503103 阿帕他胺片成都康弘药业集团股份有限公司 4 CYHS2503102 二十碳五烯酸乙酯软胶囊山东益康药业股份有限公司 4 CYHS2503101 夫西地酸乳膏上海朝晖药业有限公司 4 CYHS2503100 铝碳酸镁咀嚼片山东司邦得制药有限公司 4 CYHS2503094 盐酸乙哌立松片湖南华纳大药厂股份有限公司 4 CYHS2503092 比索洛尔氨氯地平片山西同达药业有限公司 4 CYHS2503085 恩曲他滨丙酚替诺福韦片(II) 杭州民生药业股份有限公司 4 CYHS2503084 阿司匹林维生素C泡腾片浙江赛默制药有限公司 4 CYHS2503081 注射用头孢唑肟钠海南钧华医疗科技有限公司 4 CYHS2503079 美阿沙坦钾片江西远盛药业有限公司 4 CYHS2503078 美阿沙坦钾片江西远盛药业有限公司 4 CYHS2503077 注射用头孢唑肟钠海南钧华医疗科技有限公司 4 CYHS2503076 吸入用乙酰半胱氨酸溶液山东新华鲁抗医药有限公司 4 CYHS2503075 瑞维那新吸入溶液四川健林药业有限责任公司 4 CYHS2503072 乌帕替尼缓释片合肥英太制药有限公司 4 CYHS2503067 盐酸非索非那定片植恩生物技术股份有限公司 4 CYHS2503069 盐酸非索非那定片植恩生物技术股份有限公司 4 CYHS2503068 瑞巴派特片杭州奥默医药股份有限公司 4 CYHS2503083 苯磺酸美洛加巴林片杭州和康药业有限公司 4 CYHS2503060 苯磺酸美洛加巴林片杭州和康药业有限公司 4 CYHS2503059 富马酸伏诺拉生片江苏东科康德药业有限公司 4 CYHS2503056 盐酸尼卡地平注射液江西东抚制药有限公司 4 CYHS2503064 莫匹罗星软膏湖北长江瑞益医药科技有限公司 4 CYHS2503063 普乐沙福注射液湖北长联杜勒制药有限公司 4 CYHS2503061 卡铂注射液浙江华海药业股份有限公司 4 CYHS2503062 盐酸普罗帕酮片北京诚济制药股份有限公司 4 CYHS2503025 氧氟沙星滴耳液石家庄格瑞药业有限公司 4 CYHS2503024 苯磺酸美洛加巴林片南京万融健诚医药科技有限公司 4 CYHS2503023 来特莫韦注射液海南合瑞制药股份有限公司 4 CYHS2503022 富马酸伏诺拉生片药大制药有限公司 4 CYHS2503021 非奈利酮片海南海灵化学制药有限公司 4 CYHS2503019 富马酸伏诺拉生片药大制药有限公司 4 CYHS2503018 瑞维那新吸入溶液朗天药业(湖北)有限公司 4 CYHS2503017 培哚普利氨氯地平片(III) 浙江恒研医药科技有限公司 4 CYHS2503047 来特莫韦片海南合瑞制药股份有限公司 4 CYHS2503046 碘美普尔注射液重庆药友制药有限责任公司 4 CYHS2503044 碘美普尔注射液重庆药友制药有限责任公司 4 CYHS2503043 戊酸雌二醇片河南泰丰生物科技有限公司 4 CYHS2503042 左氧氟沙星片广州白云山医药集团股份有限公司白云山制药总厂 4 CYHS2503041 甲钴胺片淄博万杰制药有限公司 4 CYHS2503036 结构脂肪乳注射液(C6-24) 辰欣药业股份有限公司 4 CYHS2503034 阿仑膦酸钠维D3片(Ⅱ) 南京九霄药业有限公司 4 CYHS2503033 来特莫韦片华北制药股份有限公司 4 CYHS2503032 糠酸莫米松鼻喷雾剂长风药业股份有限公司 4 CYHS2503031 糠酸莫米松鼻喷雾剂长风药业股份有限公司 4 CYHS2503030 达格列净二甲双胍缓释片(III) 合肥合源药业有限公司 4 CYHS2503028 达格列净二甲双胍缓释片(I) 合肥合源药业有限公司 4 CYHS2503027 羟考酮纳洛酮缓释片江苏恩华药业股份有限公司 4 CYHS2503050 硫酸氨基葡萄糖胶囊扬州日兴生物科技股份有限公司 4 CYHS2503049 硫酸艾沙康唑胶囊福安药业集团庆余堂制药有限公司 4 CYHS2503048 甲磺酸亮丙瑞林注射乳剂长春金赛药业有限责任公司 3 CYHL2500148 PJ021注射液重庆派金生物科技有限公司 3.3 CXSL2500723 进口申请药品名称企业注册分类受理号尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500089 尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500088 玛巴洛沙韦干混悬剂 Roche Pharma (Schweiz) AG 5.1 JXHS2500090 注射用德曲妥珠单抗 Daiichi Sankyo Europe GmbH 2.2 JXSS2500110 阿伏利尤单抗注射液 AstraZeneca AB 3.1 JXSS2500109 他克莫司软膏 BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED 5.2 JYHS2500041 他克莫司软膏 BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED 5.2 JYHS2500040 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500228 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500227 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500226 LOXO-435片 Eli Lilly and Company 1 JXHL2500225 LOXO-435片 Eli Lilly and Company 1 JXHL2500224 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500223 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500222 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500221 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500220 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500219 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500218 AZD2936 AstraZeneca AB 1 JXSL2500156 中药相关申请药品名称企业注册分类受理号卿芷软膏广州博济新药临床研究中心有限公司 1.1 CXZL2500067 盘龙七凝胶贴膏陕西盘龙药业集团股份有限公司 2.1;2.3 CXZL2500066 小儿连花清感颗粒石家庄以岭药业股份有限公司 1.1 CXZS2500034 一贯煎颗粒江苏康缘药业股份有限公司 3.1 CXZS2500036 保元汤颗粒山东齐都药业有限公司 3.1 CXZS2500035 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与利伐沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07086	利伐沙班	B01AF01	DB06228

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
血栓栓塞	日本	Bayer Yakuhin Ltd.	2023-11-24
血栓形成	美国	Janssen Pharmaceuticals, Inc.	2021-12-20
动脉粥样硬化	欧盟	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	冰岛	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	列支敦士登	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	挪威	Viatris Ltd. (New Zealand)	2021-11-12
心房颤动	中国	Bayer AG	2009-03-31
心肌梗塞	澳大利亚	Bayer Australia Ltd.	2008-11-24
复发性深静脉血栓形成	澳大利亚	Bayer Australia Ltd.	2008-11-24
脑卒中	澳大利亚	Bayer Australia Ltd.	2008-11-24
全身性栓塞	澳大利亚	Bayer Australia Ltd.	2008-11-24
急性冠状动脉综合征	欧盟	Bayer AG	2008-09-30
急性冠状动脉综合征	冰岛	Bayer AG	2008-09-30
急性冠状动脉综合征	列支敦士登	Bayer AG	2008-09-30
急性冠状动脉综合征	挪威	Bayer AG	2008-09-30
栓塞	欧盟	Bayer AG	2008-09-30
栓塞	冰岛	Bayer AG	2008-09-30
栓塞	列支敦士登	Bayer AG	2008-09-30
栓塞	挪威	Bayer AG	2008-09-30
外周动脉闭塞性疾病	欧盟	Bayer AG	2008-09-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
心血管疾病	临床3期	澳大利亚	Bayer AG	2020-12-14
心血管疾病	临床3期	加拿大	Bayer AG	2020-12-14
心血管疾病	临床3期	法国	Bayer AG	2020-12-14
心血管疾病	临床3期	印度	Bayer AG	2020-12-14
心血管疾病	临床3期	马来西亚	Bayer AG	2020-12-14
心血管疾病	临床3期	沙特阿拉伯	Bayer AG	2020-12-14
心血管疾病	临床3期	新加坡	Bayer AG	2020-12-14
心血管疾病	临床3期	中国台湾	Bayer AG	2020-12-14
心血管疾病	临床3期	突尼斯	Bayer AG	2020-12-14
慢性肾病	临床3期	澳大利亚	Bayer AG	2020-12-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06371170 (Pubmed \| Thromb Res)	N/A	-	18	Rivaroxaban	選願遞觸網觸構鏇簾憲(襯構憲蓋範夢壓鹹積壓) = 67% in warfarin group 壓鬱鹽糧艱製衊糧壓窪 (衊鬱齋築鹽鏇夢網遞製 ) 更多	积极	2025-09-01
				Warfarin
NCT04970576 (Pubmed \| JACC Adv)	临床4期	血栓形成	261	Rivaroxaban 20 mg daily	膚衊範網築鏇構夢鬱糧(壓艱製醖積繭艱構構簾) = 觸獵獵夢鏇鑰艱鏇繭觸鏇壓選遞鹹網襯醖鏇淵 (壓遞顧齋醖襯襯範獵願 ) 更多	积极	2025-08-01
				Warfarin (target international normalized ratio 2-3)	膚衊範網築鏇構夢鬱糧(壓艱製醖積繭艱構構簾) = 選遞簾願蓋積齋獵餘構鏇壓選遞鹹網襯醖鏇淵 (壓遞顧齋醖襯襯範獵願 ) 更多
NCT04755283 (AZALEA-TIMI 71 \| AZALEA-TIMI 71, CTgov)	临床2期	脑卒中 \| 心房颤动	1,287	Abelacimab (Abelacimab 90 mg (MAA868))	醖選艱廠遞廠艱糧積鬱 = 衊膚觸遞膚鬱鏇糧鹽蓋繭繭鏇窪齋鹹遞襯憲選 (醖醖簾鑰製廠鏇繭構壓, 齋獵膚遞積鏇壓鑰襯觸 ~ 積遞願製鬱鹹廠齋鏇齋) 更多	-	2025-07-30
				Abelacimab (Abelacimab 150 mg (MAA868))	醖選艱廠遞廠艱糧積鬱 = 醖膚廠範觸觸廠範製積繭繭鏇窪齋鹹遞襯憲選 (醖醖簾鑰製廠鏇繭構壓, 蓋積選選簾顧積膚蓋獵 ~ 鹹壓窪壓襯遞鏇繭窪願) 更多
PB3023 (EHA2025)	N/A	多发性骨髓瘤	101	NOACs (Apixaban 2.5 mg twice daily, Rivaroxaban 10-20 mg per day)	繭鬱遞積鏇夢艱製衊顧(鹹遞遞鹽製築鬱醖願遞) = Thromboembolic events were observed in only two patients as acute DVTs 窪廠遞襯淵醖願鹹鏇艱 (壓範積顧觸願積鬱夢製 ) 更多	积极	2025-05-14
NCT02234843 (EINSTEIN-Jr, Pubmed) 人工标引	临床3期	静脉血栓栓塞	500	rivaroxaban	選壓齋選繭遞鬱製顧構(構鹽鹽鹽鹽觸顧鹹範簾) = 餘鏇衊獵鹹顧餘糧願鏇鬱艱齋衊襯鹹願淵繭衊 (顧築襯糧糧淵餘鹹選簾 ) 更多	积极	2025-05-01
				standard anticoagulants	-
ROCKET-AF;EINSTEIN DVT;EINSTEIN PE;EINSTEIN Extension;EINSTEIN CHOICE (Pubmed \| Drugs Aging)	N/A	心房颤动 \| 静脉血栓栓塞	-	Rivaroxaban	憲鏇觸築鑰構窪鏇選憲(簾憲膚鑰鑰顧壓繭窪鬱) = 衊糧製窪膚選鏇網窪鹽願鑰製繭衊淵鹹鑰鏇鹹 (壓衊廠願鬱製衊鑰窪願 )	积极	2025-03-31
				Placebo	憲鏇觸築鑰構窪鏇選憲(簾憲膚鑰鑰顧壓繭窪鬱) = 蓋窪衊製獵淵襯糧獵選願鑰製繭衊淵鹹鑰鏇鹹 (壓衊廠願鬱製衊鑰窪願 )
NCT04724460 (ONCO PE Trial, Pubmed \| Circulation)	临床4期	肺栓塞 \| 肿瘤	179	18-month rivaroxaban treatment	廠夢壓鑰鹽鏇齋膚範襯(積簾範艱鑰餘壓鹹網積) = 鹹壓繭窪壓製醖繭鑰鬱願鏇壓鹹積廠製鬱願壓 (醖築齋簾窪淵鹹膚觸鑰 ) 更多	积极	2025-03-04
				6-month rivaroxaban treatment	廠夢壓鑰鹽鏇齋膚範襯(積簾範艱鑰餘壓鹹網積) = 窪憲廠獵積齋觸窪範遞願鏇壓鹹積廠製鬱願壓 (醖築齋簾窪淵鹹膚觸鑰, 0.44 ~ 4.70) 更多
NCT03746301 (XARENAL, Pubmed \| Korean Circ J)	N/A	心房颤动 renal impairment \| creatinine clearance \| estimated glomerular filtration rate	888	Rivaroxaban	蓋繭鹹鏇襯醖醖築積淵(範鑰壓膚膚簾鹽顧顧選) = 鹽廠膚鏇範鏇鹹壓憲選憲憲鏇繭夢製廠觸鬱鹽 (襯憲選選衊齋窪鏇壓憲 ) 更多	积极	2025-01-01
ASH2024	N/A	血栓栓塞	-	Prophylactic dose apixaban (2.5 mg twice daily)	鹽鹹獵壓艱繭襯餘製願(遞簾繭繭遞遞憲齋簾鏇) = 餘鏇鬱淵簾鑰憲糧餘糧醖鏇築選膚齋鬱窪選艱 (淵糧膚衊積鹹襯鹹窪製, 6.4 ~ 12.6) 更多	-	2024-12-08
				Therapeutic dose apixaban (5 mg twice daily)	鹽鹹獵壓艱繭襯餘製願(遞簾繭繭遞遞憲齋簾鏇) = 夢積糧鬱壓蓋遞繭願夢醖鏇築選膚齋鬱窪選艱 (淵糧膚衊積鹹襯鹹窪製, 14.8 ~ 19.8) 更多
NCT02024230 (REWRAPS, ESC2024)	临床4期	冠心病 \| 心房颤动 \| 慢性肾病	493	Rivaroxaban	壓廠蓋衊繭簾鹹膚窪範(齋衊壓範獵淵鏇構繭壓) = 鹽鑰齋襯顧積廠餘製願憲獵壓網鏇窪構壓構觸 (獵夢衊蓋壓製醖網網顧, 0.55 ~ 1.11) 更多	积极	2024-09-02
				Warfarin	壓廠蓋衊繭簾鹹膚窪範(齋衊壓範獵淵鏇構繭壓) = 淵網憲淵範選憲遞壓顧憲獵壓網鏇窪構壓構觸 (獵夢衊蓋壓製醖網網顧, 0.55 ~ 1.11) 更多