A Multicentre, Open Label, Randomized, Single-Dose, Two-Treatment, Parallel Arm Bioequivalence Study of Ferric Carboxymaltose Intravenous Injection (750 mg Iron/15 mL) of Dr. Reddy’s Laboratories Ltd, India, with that of Injectafer® [Ferric Carboxymaltose Injection (750 mg Iron/15 mL)] of American Regent Inc., USA Under Fasting Condition in Adult Patients with Iron Deficiency Anaemia, for whom Oral Iron Supplementation Alone was Not Adequate or is Not Appropriate - NIL

开始日期2024-11-10

申办/合作机构

Dr. Reddy's Laboratories Ltd.

CTRI/2024/09/074184 / Not yet recruiting临床3期IIT

Iron isomaltoside versus Ferric carboxymaltose in Iron Deficiency Anemia: A randomized clinical trial - Nil

开始日期2024-10-04

申办/合作机构-

100 项与羧基麦芽糖铁相关的临床结果

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100 项与羧基麦芽糖铁相关的转化医学

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100 项与羧基麦芽糖铁相关的专利（医药）

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项与羧基麦芽糖铁相关的文献（医药）

2024-12-31·Future Science OA

Ferric carboxymaltose for iron deficiency in patients with heart failure: a systematic review and meta-analysis

Review

作者: Rehman, Faizan ur ; Fatima Zaidi, Syeda Mahrukh ; Zuhair, Varisha ; Rangwala, Burhanuddin Sohail ; Danish, Fnu ; Mussarat, Abdullah ; Shafique, Muhammad Ashir ; Mustafa, Muhammad Saqlain ; Khan, Aimen Waqar

Aim: Iron deficiency (ID) is associated with heart failure (HF) in a considerable proportion of patients. To improve the quality of life, lower the frequency of hospitalizations, and lower mortality rates of chronic HF patients (HF), this meta-analysis will look into the role of iron supplementation using ferric carboxymaltose (FCM). Methods & results: From inception until 1 October 2023, we conducted a thorough literature search of electronic databases for peer-reviewed publications. Around 5229 HF patients were included, of which 2691 received FCM while 2538 received placebo. Conclusion: FCM reduces HF-related hospitalizations but doesn't improve overall or cardiovascular mortality in those with HF and ID. The overall results support FCM's role in managing iron deficiency in heart failure.

2024-12-01·EUROPEAN JOURNAL OF HAEMATOLOGY

Perinatal Outcomes Following Intravenous Iron for Treatment of Iron Deficiency With and Without Anemia

Article

作者: Deloughery, Thomas G. ; Hedges, Madeline A. ; Shatzel, Joseph J. ; Chobrutskiy, Boris I. ; Ryan, Kimberly S. ; Martens, Kylee L. ; Benson, Ashley E. ; Tuuli, Methodius G. ; Sabile, Jean M. G. ; Hagen, Olivia L. ; Garg, Bharti ; Lewkowitz, Adam K. ; Lo, Jamie O.

ABSTRACT:

Objective:

To determine maternal and neonatal outcomes in individuals with iron deficiency receiving antepartum intravenous (IV) iron supplementation, stratified by the degree of anemia.

Study Design:

Retrospective cohort study of iron‐deficient pregnant patients who received at least one IV infusion of iron (iron sucrose, low molecular weight iron dextran [LMWID], or ferric carboxymaltose) during their pregnancy from January 1, 2011 through June 16, 2022. Our primary outcomes included both neonatal composite morbidity and maternal composite morbidity in the context of maternal anemia.

Results:

Patients who received LMWID had fewer infusion visits, received higher total doses of iron and had a more substantial correction of hemoglobin compared to those who received iron sucrose (p < 0.01). Maternal anemia at the time of admission was not associated with neonatal composite morbidity. However, there was a significant association between anemia status and maternal composite outcome (p = 0.05). Anemia at time of delivery was associated with the likelihood of requiring a blood transfusion (p = 0.01).

Conclusion:

This study reinforces previous findings emphasizing the adverse effects of iron deficiency on maternal health and the role of IV iron in reducing these risks.

2024-12-01·Blood Research

Functional iron deficiency anemia in patients with cancer

Review

作者: Koh, Jeong Suk ; Song, Ik-Chan

Abstract:

Anemia is frequently observed in patients with cancer owing to anticancer chemotherapy, radiation therapy, and inflammatory responses. This often leads to functional iron deficiency, characterized by adequate iron stores but impaired use of iron for red blood cell production. This condition, termed functional iron deficiency anemia (IDA), is identified by a ferritin level of 30–500 µg/dL and a transferrin saturation < 50%. Functional iron deficiency often develops with the prolonged use of erythropoiesis-stimulating agents, leading to a diminished response to anemia treatment. Although oral iron supplementation is common, intravenous iron is more effective and recommended in such cases. Recent studies have shown that ferric carboxymaltose (FCM) is effective in treating functional IDA in patients with cancer. However, because of its potential to induce asymptomatic severe phosphate deficiency, it is important to closely monitor phosphate levels in patients receiving FCM.

项与羧基麦芽糖铁相关的新闻（医药）

2024-09-06

·微信

欧盟委员会接受Vifor（瑞士维福药业）纠正其对Monofer（莫诺菲®）散布潜在误导信息行为的承诺，并监督其履行承诺

近日，根据欧盟竞争法，欧盟委员会对Vifor（瑞士维福药业）公司在静脉铁剂市场竞争的承诺赋予法律效力。此前，欧盟委员会担忧多年来Vifor公司可能通过传播有关Monofer（在中国称莫诺菲®）的安全性误导信息限制了Monofer在注射铁剂市场的竞争，可能过度阻碍了Monofer在欧洲经济区（EEA）的更广应用。 Vifor公司的Ferinject(在中国称菲新捷®)和Pharmacosmos（丹麦科思莫斯）公司的Monofer是两种高剂量注射铁剂，用于治疗口服铁剂无效、无法口服补铁或临床上需要快速补铁的缺铁患者。欧盟委员会认定，Vifor公司可能在几个国家的静脉注射铁剂市场占据主导地位，如奥地利、芬兰、德国、爱尔兰、葡萄牙、罗马尼亚、西班牙、瑞典和荷兰。Monofer是Ferinject在欧洲最相似且可能唯一的竞争产品，Vifor公司针对医疗卫生专业人士发布误导信息，以保护Ferinject免受竞争。欧盟委员会在收到Pharmacosmos公司提交的投诉后，于2022年6月对Vifor的行为展开正式反垄断调查。2024年4月，欧盟委员会通过了一份评估报告，总结了该案的主要事实，委员会判定，Vifor公司由于其不适当的行为，可能滥用了其支配地位，违反了《欧盟运行条约》（TFEU）第102条和《欧洲经济区协定》第54条。为此，为解决欧盟委员会的担忧，Vifor 公司作出改正承诺。2024年4月22日至5月22日期间，委员会对这些改正承诺进行了市场测试，以核实这些改正承诺是否会消除其发布误导信息可能带来的限制市场竞争后果。根据市场测验的结果，Vifor 公司调整了最初改正承诺方案并作出如下承诺： Vifor 公司将发起全面的多渠道沟通活动，以纠正和消除Vifor 此前散布的有关Monofer 安全性的潜在误导性信息所造成的影响：（i）通过电子邮件、信函和面对面会议的形式，向欧盟委员会认定的Vifor 可能占主导地位的九个成员国中众多医疗卫生专业人士发送澄清函；（ii）在其网站显著位置发布该澄清函；（iii）在每个相关成员国的权威医学期刊上发布该澄清函；（iv）允许第三方（包括Pharmacosmos丹麦科思莫斯）与医疗卫生专业人士沟通时使用该澄清函。 Vifor 承诺，进行外部宣传和医学交流时（无论是书面还是口头形式），不得沟通非源于Monofer 说明书中的信息或未正式发表的临床研究信息，特别是整个欧洲经济区内未发表的Ferinject 和Monofer 的比较性研究的信息。 Vifor 将实施一系列措施和保障体系以确保合规性，包括建立内部机制确保所有相关的外部推广资料、医学沟通信息、内部培训材料在使用前均符合承诺，以及每年对员工进行内部培训和合规认证制度。欧盟委员会的结论是Vifor 公司的最终承诺将解决其对Vifor 可能贬低Monofer的竞争担忧。因此，欧盟委员会决定这些改正承诺对Vifor具有法律效力。 Vifor做出的改正承诺的履行将由其指定的监督受托人进行监督，为期10年。 “ 缺铁是一种影响欧洲数百万人的疾病。因此，获得安全、有效且负担得起的药物至关重要。Vifor 已承诺消除其对最接近的静脉铁治疗竞争药物安全性的潜在误导性宣传的影响。今天的决定使这些承诺对 Vifor 具有法律约束力，并重新建立了公平的竞争环境，使消费者受益。”玛格丽特·维斯塔格 (Margrethe Vestager)，负责竞争政策的执行副总裁 ‑ 2024 年 7 月 22 日背景 Vifor（瑞士维福药业）隶属于生物科技集团CSL，该公司在全球范围内开发、生产和销售治疗缺铁、肾病等药品。 Pharmacosmos（丹麦科思莫斯）是一家丹麦专业制药公司，专注于治疗铁缺乏症。《欧盟运行条约》（TFEU）第102条禁止可能影响欧盟内部贸易并阻止或限制竞争的滥用支配地位的行为。有关该条款的实施细则在第1/2003号条例中进行了规定。第1/2003号条例第9(1)条允许接受欧盟委员会检查的公司作出改正承诺，并授权欧盟委员会通过决定，使此类承诺对公司具有约束力。如果相关公司不履行承诺，欧盟委员会可在无需证明其违反欧盟反垄断规则的基础上对其处以最高相当于其全球年度总营业额10%的罚款；此外，欧盟委员会还可对其处以每日营业额5%的定期罚款，直至其停止违规行为。这是欧盟委员会第二次调查医药行业中与排他性诋毁竞争产品相关的潜在滥用行为。另一个案例则是2022年10月，欧盟委员会向Teva发出异议声明，指控其滥用专利制度并诋毁竞争对手的多发性硬化症药物，以阻碍其进入市场和推广。澄清重要内容与Monofer相比，没有科学证据表明Ferinject具有更高的安全性。从Monofer的上市许可和欧洲药品管理局对静脉注射铁剂的连续审查中可以明显看出，没有证据表明Monofer的证据基础有限，无法对其安全性提出质疑。根据监管机构批准的Monofer产品说明书，Monofer不是右旋糖酐，右旋糖酐衍生物或基于右旋糖酐的药品。且与Ferinject相比，Monofer不增加超敏反应(HSR)的风险。更多信息更多信息（包括决定的全文和承诺的完整版本）可在欧盟委员会竞争网站的公共案件登记册中查阅，案件编号为AT.40577。免责声明：本文仅作最新前沿信息交流之目的，文中所有观点不代表梅斯医学立场，亦不代表梅斯医学支持或反对文中观点。如需获得治疗方案指导，请前往正规医院就诊！

2024-05-06

·信狐药迅

常山凯捷健GLP-1激动剂艾本那肽、轩竹生物达希替尼、贝达CDK4/6抑制剂泰贝西利提交上市申请| 新受理（4.22-5.5）

本周药品注册受理数据，分门别类呈现，一目了然。(4.22-5.5）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号艾本那肽注射液常山凯捷健生物药物研发(河北)有限公司1CXHS2400034达希替尼片轩竹生物科技股份有限公司1CXHS2400036达希替尼片轩竹生物科技股份有限公司1CXHS2400035莫米司特片赣州和美药业股份有限公司1CXHS2400033氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2400032甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400031甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400030鼻喷流感减毒活疫苗长春百克生物科技股份公司3.2CXSS2400043卡度尼利单抗注射液中山康方生物医药有限公司2.2CXSS2400042酒石酸泰贝西利胶囊贝达药业股份有限公司1CXHS2400039苹果酸司妥吉仑片上海上药信谊药厂有限公司1CXHS2400037司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400045利多卡因凝胶贴膏北京泰德制药股份有限公司2.4CXHS2400038新药临床申请药品名称企业注册分类受理号HS-10370片江苏豪森药业集团有限公司1CXHL2400420TYK-01054胶囊浙江同源康医药股份有限公司1CXHL2400419TYK-01054胶囊浙江同源康医药股份有限公司1CXHL2400418TQB3911片正大天晴药业集团南京顺欣制药有限公司1CXHL2400413TQB3911片正大天晴药业集团南京顺欣制药有限公司1CXHL2400412注射用IPG浙江仙琚制药股份有限公司2.2CXHL2400417艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ)海南灵康制药有限公司2.2CXHL2400416艾司奥美拉唑镁碳酸氢钠干混悬剂(Ⅰ)海南灵康制药有限公司2.2CXHL2400415TRD303溶液北京泰德制药股份有限公司2.2CXHL2400407CP006吸入粉雾剂上海新黄河制药有限公司2.3CXHL2400414甲磺酸伏美替尼片上海艾力斯医药科技股份有限公司2.4CXHL2400411羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400410羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400409羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400408枸橼酸西地那非注射液合肥科大生物技术有限公司3CYHL2400079冻干b型流感嗜血杆菌结合疫苗远大赛威信生命科学(南京)有限公司1.2CXSL2400257ZHB110舌下片江苏众红生物工程创药研究院有限公司1CXSL2400266ZHB110舌下片江苏众红生物工程创药研究院有限公司1CXSL2400265CEL001注射液广州希灵生物科技有限公司1CXSL2400262BC008-1A注射液四川泸州步长生物制药有限公司1CXSL2400261HB0046注射液上海华奥泰生物药业股份有限公司1CXSL2400260MRG006A乐普生物科技股份有限公司1CXSL2400256BC008-1A注射液四川泸州步长生物制药有限公司1CXSL2400255人羊膜间充质干细胞注射液源品细胞生物科技集团有限公司1CXSL2400258注射用重组A型肉毒毒素重庆誉颜制药有限公司2.2CXSL2400259司美格鲁肽注射液重庆宸安生物制药有限公司3.3CXSL2400264司美格鲁肽注射液重庆宸安生物制药有限公司3.3CXSL2400263注射用sacituzumab tirumotecan默沙东研发(中国)有限公司1CXSL2400283SGB-3908注射液苏州圣因生物医药有限公司1CXHL2400426CNK-UT002细胞注射液羿尊生物医药(浙江)有限公司1CXSL2400284TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400422TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400421PM8002注射液普米斯生物技术(珠海)有限公司1CXSL2400277PM1009注射液普米斯生物技术(珠海)有限公司1CXSL2400276SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400275SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400274SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400273SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400272SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400282SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400281SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400279SQ-22031滴眼液沈阳兴齐眼药股份有限公司1CXSL2400278ZX-7101A片南京征祥医药有限公司1CXHL2400424注射用sacituzumab tirumotecan默沙东研发(中国)有限公司1CXSL2400280注射用TRS005浙江特瑞思药业股份有限公司1CXSL2400269ART001注射液锐正基因(苏州)有限公司1CXSL2400271AFN0328注射液合肥阿法纳生物科技有限公司1CXSL2400268四价流感病毒亚单位疫苗江苏中慧元通生物科技股份有限公司1.4CXSL2400267HZ031口溶膜浙江和泽医药科技股份有限公司2.2CXHL2400425环孢素眼用凝胶兆科(广州)眼科药物有限公司2.2CXHL2400423聚乙二醇干扰素α-2b注射液厦门特宝生物工程股份有限公司2.2CXSL2400270阿奇霉素滴眼液深圳欣祺医药科技有限公司3CYHL2400080仿制药申请药品名称企业注册分类受理号米诺地尔搽剂江苏天士力帝益药业有限公司3CYHS2401276米诺地尔搽剂江苏天士力帝益药业有限公司3CYHS2401275西咪替丁注射液四川汇宇制药股份有限公司3CYHS2401262氯化钾口服溶液四川天杏汇医药科技有限公司3CYHS2401260盐酸布比卡因注射液山东诚创蓝海医药科技有限公司3CYHS2401258盐酸布比卡因注射液山东诚创蓝海医药科技有限公司3CYHS2401257盐酸布比卡因注射液山东诚创蓝海医药科技有限公司3CYHS2401256福多司坦口服溶液东阳祥昇医药科技有限公司3CYHS2401253福多司坦口服溶液东阳祥昇医药科技有限公司3CYHS2401252吲哚布芬片石家庄四药有限公司3CYHS2401248醋酸钙口服溶液北京远方通达医药技术有限公司3CYHS2401247法莫替丁注射液河北智恒医药科技股份有限公司3CYHS2401244氨氯地平贝那普利胶囊成都倍特药业股份有限公司3CYHS2401242多索茶碱片杭州沐源生物医药科技有限公司3CYHS2401241多索茶碱片杭州沐源生物医药科技有限公司3CYHS2401240乙酰半胱氨酸注射液四川天杏汇医药科技有限公司3CYHS2401238维生素B6注射液河南合智医药科技有限公司3CYHS2401259洛索洛芬钠细粒剂湖南埃威格林医药科技有限公司3CYHS2401234氨溴特罗口服溶液石家庄宇惠制药有限公司3CYHS2401233复方聚乙二醇电解质散(II)东阳祥昇医药科技有限公司3CYHS2401228米诺地尔搽剂浙江浙北药业有限公司3CYHS2401225米诺地尔搽剂浙江浙北药业有限公司3CYHS2401224德昔度司他片康哲(湖南)制药有限公司3CYHS2401213甲氧氯普胺片浙江赛默制药有限公司3CYHS2401212甲氧氯普胺片浙江赛默制药有限公司3CYHS2401211眼用丝裂霉素溶液用粉末浙江长典药物技术开发有限公司3CYHS2401210注射用盐酸罗沙替丁醋酸酯安徽省先锋制药有限公司3CYHS2401209盐酸替罗非班氯化钠注射液安徽双鹤药业有限责任公司3CYHS2401208乙酰半胱氨酸注射液苏州弘森药业股份有限公司3CYHS2401207盐酸替罗非班氯化钠注射液安徽双鹤药业有限责任公司3CYHS2401206地氯雷他定口服溶液万特制药(海南)有限公司3CYHS2401202吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401222吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401221吸入用盐酸氨溴索溶液四川普锐特药业有限公司3CYHS2401220碳酸氢钠血滤置换液上海峰林生物科技有限公司3CYHS2401218复合磷酸氢钾注射液嘉亨(珠海横琴)医药科技有限公司3CYHS2401217腺苷钴胺胶囊舒美奇成都生物科技有限公司3CYHS2401215盐酸布比卡因注射液广东鼎信医药科技有限公司3CYHS2401201地氯雷他定口服溶液石家庄凯达生物工程有限公司3CYHS2401200地氯雷他定口服溶液石家庄凯达生物工程有限公司3CYHS2401199贝那普利氢氯噻嗪片维生原(厦门)生物科技有限公司3CYHS2401197吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2401191西格列汀二甲双胍片(II)南昌立健药业有限公司4CYHS2401284他达拉非片重庆康刻尔制药股份有限公司4CYHS2401283他达拉非片重庆康刻尔制药股份有限公司4CYHS2401282玻璃酸钠滴眼液武汉五景药业有限公司4CYHS2401281枸橼酸西地那非口腔崩解片山东新华制药股份有限公司4CYHS2401280依折麦布阿托伐他汀钙片南京海纳制药有限公司4CYHS2401279依折麦布阿托伐他汀钙片南京海纳制药有限公司4CYHS2401278注射用头孢他啶阿维巴坦钠安徽威尔曼制药有限公司4CYHS2401277富马酸伏诺拉生片常州四药制药有限公司4CYHS2401274甲巯咪唑片山东华铂凯盛生物科技有限公司4CYHS2401273富马酸伏诺拉生片常州四药制药有限公司4CYHS2401272甲巯咪唑片山东华铂凯盛生物科技有限公司4CYHS2401271磷酸奥司他韦胶囊山东鲁抗三叶制药有限公司4CYHS2401270酒石酸美托洛尔片山东新时代药业有限公司4CYHS2401269酒石酸美托洛尔片山东新时代药业有限公司4CYHS2401268盐酸屈他维林注射液北京新美泰克医药科技有限公司4CYHS2401267乳果糖口服溶液江西远超医药科技有限公司4CYHS2401266乳果糖口服溶液江西远超医药科技有限公司4CYHS2401265兰索拉唑肠溶胶囊北京福元医药股份有限公司4CYHS2401264兰索拉唑肠溶胶囊北京福元医药股份有限公司4CYHS2401263盐酸氨溴索注射液多多药业有限公司4CYHS2401261恩格列净片深圳奥萨制药有限公司4CYHS2401255磷酸芦可替尼片昆山龙灯瑞迪制药有限公司4CYHS2401254盐酸阿莫罗芬搽剂江苏盈科生物制药有限公司4CYHS2401251氧(液态)荆州华尔文气体有限公司4CYHS2401250克立硼罗软膏扬子江药业集团江苏制药股份有限公司4CYHS2401249洛索洛芬钠贴剂北京福元医药股份有限公司4CYHS2401246洛索洛芬钠贴剂北京福元医药股份有限公司4CYHS2401245蒙脱石混悬液四川天杏汇医药科技有限公司4CYHS2401243羧基麦芽糖铁注射液四川汇宇制药股份有限公司4CYHS2401239羧基麦芽糖铁注射液四川汇宇制药股份有限公司4CYHS2401237卡格列净片沐邦(北京)医药科技有限公司4CYHS2401236氯化钾氯化钠注射液石家庄四药有限公司4CYHS2401230氯化钾氯化钠注射液石家庄四药有限公司4CYHS2401229丙氨酰谷氨酰胺注射液赤峰源生药业有限公司4CYHS2401227丙氨酰谷氨酰胺注射液赤峰源生药业有限公司4CYHS2401226盐酸乌拉地尔注射液湖南恒生制药股份有限公司4CYHS2401235达肝素钠注射液辰欣药业股份有限公司4CYHS2401232达肝素钠注射液辰欣药业股份有限公司4CYHS2401231美沙拉秦肠溶片江西山香药业有限公司4CYHS2401219阿卡波糖片山东普瑞曼药业有限公司4CYHS2401214培哚普利氨氯地平片(III)上海安必生制药技术有限公司4CYHS2401205马来酸氟伏沙明片安徽金太阳生化药业有限公司4CYHS2401204马来酸氟伏沙明片安徽金太阳生化药业有限公司4CYHS2401203培哚普利氨氯地平片(III)成都硕德药业有限公司4CYHS2401223米氮平片湖南洞庭药业股份有限公司4CYHS2401216注射用氟氧头孢钠广州艾奇西新药研究有限公司4CYHS2401198氧(液态)吉林杭氧气体有限公司4CYHS2401196苯磺酸氨氯地平片吉林省益浦生物科技有限公司4CYHS2401195棕榈酸帕利哌酮注射液湖南科伦制药有限公司4CYHS2401194棕榈酸帕利哌酮注射液湖南科伦制药有限公司4CYHS2401193棕榈酸帕利哌酮注射液湖南科伦制药有限公司4CYHS2401192吸附破伤风疫苗北京科兴中维生物技术有限公司3.3CXSS2400044普瑞巴林口服溶液海南斯达制药有限公司3CYHS2401314普瑞巴林口服溶液海南斯达制药有限公司3CYHS2401312普瑞巴林口服溶液海南斯达制药有限公司3CYHS2401311肾上腺素注射液武汉久安药物研究院有限公司3CYHS2401310盐酸溴己新注射液辰欣药业股份有限公司3CYHS2401309复方聚乙二醇电解质散(II)陕西丽彩药业有限公司3CYHS2401308复方聚乙二醇电解质散(II)陕西丽彩药业有限公司3CYHS2401307头孢克肟颗粒浙江昂利康制药股份有限公司3CYHS2401322盐酸利多卡因注射液南京泽恒医药技术开发有限公司3CYHS2401319盐酸氨溴索滴剂南京海纳制药有限公司3CYHS2401318比拉斯汀口服溶液深圳市贝美药业有限公司3CYHS2401313硫酸沙丁胺醇糖浆海南万玮制药有限公司3CYHS2401315腺苷钴胺胶囊桂林华信制药有限公司3CYHS2401296氯化钾颗粒四川天杏汇医药科技有限公司3CYHS2401287盐酸甲氧氯普胺注射液仁合益康汇泽药业河北有限公司3CYHS2401300硫酸镁注射液山东齐都药业有限公司3CYHS2401298复方聚乙二醇(3350)电解质散哈尔滨葵花药业有限公司3CYHS2401295盐酸乌拉地尔注射液广州万正药业有限公司4CYHS2401327培哚普利氨氯地平片(I)江西施美药业股份有限公司4CYHS2401326培哚普利氨氯地平片(II)江西施美药业股份有限公司4CYHS2401325培哚普利氨氯地平片(III)江西施美药业股份有限公司4CYHS2401324培哚普利氨氯地平片(I)江西施美药业股份有限公司4CYHS2401323枸橼酸托瑞米芬片重庆圣华曦药业股份有限公司4CYHS2401306盐酸莫西沙星滴眼液珠海联邦制药股份有限公司中山分公司4CYHS2401305盐酸莫西沙星滴眼液珠海联邦制药股份有限公司中山分公司4CYHS2401304富马酸依美斯汀滴眼液浙江视方极医药科技有限公司4CYHS2401321氟比洛芬钠滴眼液扬州中宝药业股份有限公司4CYHS2401320注射用头孢比罗酯钠深圳华润九新药业有限公司4CYHS2401317硫酸镁钠钾口服用浓溶液河北华晨药业集团有限公司4CYHS2401316马来酸氟伏沙明片石家庄龙泽制药股份有限公司4CYHS2401294多巴丝肼片重庆华邦制药有限公司4CYHS2401293盐酸达泊西汀片苏州特瑞药业股份有限公司4CYHS2401292氯吡格雷阿司匹林片辰欣药业股份有限公司4CYHS2401291他达拉非片辽宁鑫善源药业有限公司4CYHS2401290他达拉非片辽宁鑫善源药业有限公司4CYHS2401289他达拉非片辽宁鑫善源药业有限公司4CYHS2401288伊曲康唑口服液嘉实(湖南)医药科技有限公司4CYHS2401303氧(液态)吉林省宏拓气体分离设备有限公司4CYHS2401302盐酸贝尼地平片北京福元医药股份有限公司4CYHS2401301地夸磷索钠滴眼液福建博悦医药科技有限公司4CYHS2401299布南色林片山东京卫制药有限公司4CYHS2401297马来酸氟伏沙明片石家庄四药有限公司4CYHS2401286注射用盐酸地尔硫䓬山东豪瑞恩制药有限公司4CYHS2401285进口申请药品名称企业注册分类受理号注射用ASP5354Astellas Pharma Global Development, Inc.1JXHL2400095AZD8205AstraZeneca AB1JXSL2400082AZD2936AstraZeneca AB1JXSL2400081Efgartigimod注射液argenx BV2.2JXSL2400080MM09舌下喷雾剂Inmunotek S.L.3.1JXSL2400079ASP2138注射液Astellas Pharma Global Development, Inc1JXSL2400083PembrolizumabMerck Sharp & Dohme LLC2.2JXSL2400084中药相关申请药品名称企业注册分类受理号一贯煎颗粒上海凯宝药业股份有限公司3.1CXZS2400014苓桂术甘颗粒上海凯宝药业股份有限公司3.1CXZS2400013百苓止咳颗粒苏州中药研究所有限公司1.1CXZL2400021清降和胃颗粒黑龙江珍宝岛药业股份有限公司1.1CXZL2400022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。

申请上市疫苗

2024-03-19

·PRNewswire

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

ST. GALLEN, SWITZERLAND, March 19, 2024 /PRNewswire/ -- CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III* 1 to improve exercise capacity.2 Ferinject has now received marketing authorization in 87 countries worldwide. Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4. "While iron deficiency and associated anemia are some of the most prevalent medical conditions on a global scale, it is easily diagnosed and treatable," said Prof. Dr. Justin Ezekowitz, Director of Cardiovascular Research and Cardiologist at the University of Alberta, Canada. "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency." Iron deficiency affects one in every two hospitalized patients with heart failure5. Iron deficiency is often accompanied by reduced exercise tolerance and untreated iron deficiency may result in anemia and worsening NYHA class, with reduced quality of life and eventually increased risk of hospitalization 6,7,8 "The approval by Health Canada marks an important step forward for the treatment of iron deficiency anemia as well as iron deficiency in heart failure and supports our promise to patients and public health," said Dr. Vinicius Gomes de Lima, Head of Global Medical Affairs, CSL Vifor. "We are confident that our now approved IV iron therapy can make a meaningful contribution to achieve key therapeutic goals in the treatment of these patients." Marketing authorization in Canada is based on a comprehensive clinical data package and totality of evidence from CSL Vifor's cardiology studies. In Canada, Ferinject® is commercialized through CSL Behring Canada, Inc., with availability expected in the second half of 2024. * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.9 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor, visit . About Ferinject Ferinject (ferric carboxymaltose) is an IV iron therapy with marketing authorization in 87 countries as of March 2024. Ferinject has historically delivered significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure10. In Canada, Ferinject is indicated for the treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and NYHA class II/III to improve exercise capacity. The diagnosis of iron deficiency must be based on laboratory tests.2 Important Information for Canada For more information and a complete risk/benefit profile, please refer to the Product Monograph available here. About iron deficiency and associated anemia Iron plays a vital role in many bodily processes, including the production of red blood cells, effective heart and brain function, and the prevention of infection and illness. Without enough iron, the body is unable to function properly. Common symptoms include fatigue, dizziness, and shortness of breath. Iron deficiency and iron deficiency anemia are estimated to affect one in three people worldwide11, yet despite the serious consequences and high prevalence12, the conditions remain under-recognized. The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being13. Iron deficiency and iron deficiency anemia can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality13. Common symptoms include fatigue 13,14,15 pale skin14, brittle nails14, 16, craving non-food items such as dirt, clay and ice17, and an inability to concentrate13, 18. In children, iron deficiency anemia can significantly impair cognitive and motor development19,20,21. Multiple organizations, including the World Health Organization (WHO), UNICEF and the U.S. Agency for International Development (USAID) have called for a comprehensive anemia monitoring framework. Find more information on the global burden of anemia in the report published in the Lancet in July 2023: . References Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994. Ferinject Product Monograph. CSL Vifor, St. Gallen, Switzerland. Chang V et al. J Nutr 2022 ; 153 : 781–797. doi.org/10.1016/j.tjnut.2022.10.011; Cochrane K et al. J Nutr 2022;152:2238–2244. Tahir E et al. 2020 Can J Public Health 111, 682–693 (2020). doi.org/10.17269/s41997-020-00304-7; Abdullah K et al Canadian Paediatric Surveillance program, 2011 . Del Pinto et al. Eur Heart J Suppl. 2022 Nov; 24(Suppl I): I96–I99). Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013;5(9):3730-9. doi:10.3390/nu5093730. Klip IT, Comin-Colet J, Voors A a, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013;165(4):575-582.e3. doi:10.1016/j.ahj.2013.01.017. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268–275. Classes of Heart Failure. American Heart Association. May 2017. Data on file. PSUR report. CSL Vifor, St. Gallen, Switzerland. Peyrin-Biroulet L, et al. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: E0C7?sequence=1. Last accessed: November 2023. Fernando B, et al. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive diseases. World J Gastroenterol. 2009 Oct 7; 15(37): 4638-4643. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38. Favrat, B., et al. (2014). Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One 9(4): e94217. eCollection 2014. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5. Barton JC, et al. Pica associated with iron deficiency or depletion: clinical and laboratory correlates in 262 non-pregnant adult outpatients. BMC Blood Disord. 2010;10:9. doi:10.1186/1471-2326-10-9. Patterson A et al. Iron deficiency, general health and fatigue: Results from the Australian Longitudinal Study on Women's Health. Qual Life Res. 2000;9:491-497. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: . Last accessed: November 2023. Sant-Rayn S, et al. Diagnosis and management of iron deficiency anaemia: a clinical update. Med J Aust 2010; 193 (9): 525-532. doi: 10.5694/j.1326-5377.2010.tb04038.x. Özdemir N. Iron deficiency anemia from diagnosis to treatment in children. Turk Pediatri Ars. 2015 Mar 1;50(1):11-9. doi: 10.5152/tpa.2015.2337. PMID: 26078692; PMCID: PMC4462328. CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] SOURCE Vifor International AG (CSL Vifor)

上市批准AHA会议

100 项与羧基麦芽糖铁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08920	羧基麦芽糖铁	B03A	DB08917

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
铁缺乏	美国	American Regent, Inc.	2023-05-31
缺铁性贫血	欧盟	Vifor SA	2007-06-26
缺铁性贫血	冰岛	Vifor SA	2007-06-26
缺铁性贫血	列支敦士登	Vifor SA	2007-06-26
缺铁性贫血	挪威	Vifor SA	2007-06-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
收缩性心力衰竭	临床3期	巴西	Vifor Pharma AG	2024-05-24
肿瘤	临床3期	美国	American Regent, Inc.	2015-05-23
不宁腿综合征	临床3期	美国	American Regent, Inc.	2015-01-01
2型糖尿病	临床3期	德国	Vifor Pharma AG	2012-08-01
淋巴瘤	临床3期	德国	Vifor Pharma AG	2010-05-01
淋巴瘤	临床3期	瑞典	Vifor Pharma AG	2010-05-01
炎症性肠病	临床3期	俄罗斯	Vifor Pharma AG	2009-02-01
溃疡性结肠炎	临床3期	奥地利	Vifor Pharma AG	2008-10-01
克罗恩病	临床3期	奥地利	Vifor Pharma AG	2008-10-01
月经过多	临床3期	美国	American Regent, Inc.	2007-10-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03037931 (HEART-FID, CTgov)	临床3期	铁缺乏 \| 心脏衰竭	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	獵鹽構艱壓築夢鏇鹹築(醖願憲糧鹽廠製製餘簾) = 願衊壓繭醖願構壓壓構廠繭憲鹹鑰餘願鑰齋鹹 (構餘膚鏇艱淵積糧鹽鑰, 鏇壓鏇窪製壓夢遞鬱獵 ~ 遞蓋憲淵艱範鏇淵繭窪) 更多	-	2024-07-03
				Placebo (Placebo)	獵鹽構艱壓築夢鏇鹹築(醖願憲糧鹽廠製製餘簾) = 鹽獵網壓構鏇鏇鏇鹹選廠繭憲鹹鑰餘願鑰齋鹹 (構餘膚鏇艱淵積糧鹽鑰, 鬱壓艱鏇膚鬱築願膚齋 ~ 觸積齋襯網淵築蓋壓醖) 更多
EHA2024	N/A	缺铁性贫血	-	Ferric Carboxymaltose	鹹壓積製範艱醖範餘鏇(顧鏇遞積獵積簾選獵襯): RR = 2.75 (95% CI, 2.29 ~ 3.3), P-Value = <0.0001 更多	不佳	2024-05-14
				Iron Sucrose
NCT01690585 (Pubmed \| Age Ageing) 人工标引	临床3期	消化道出血	59	Ferric carboxymaltose	獵簾醖襯鏇選餘構網簾(網鹽簾艱網簾遞醖衊鏇) = 構艱網積衊餘糧淵積鹽網糧鏇壓鏇衊構襯廠鹹 (鹽夢鹽鹽鹹觸夢蓋築膚 ) 更多	积极	2024-05-01
				Placebo	獵簾醖襯鏇選餘構網簾(網鹽簾艱網簾遞醖衊鏇) = 網遞膚積醖廠遞膚願齋網糧鏇壓鏇衊構襯廠鹹 (鹽夢鹽鹽鹹觸夢蓋築膚 ) 更多
ASH2023	N/A	-	289	Ferric Carboxymaltose (FCM)	觸鏇獵築積淵範鹽襯淵(憲鹽範獵蓋製鏇範顧齋) = 艱廠願壓夢蓋鹽壓網顧範襯鹹構餘鏇餘蓋顧範 (範遞餘鏇鏇構齋遞鹽餘 )	-	2023-12-11
				Ferric Derisomaltose (FDI)	觸鏇獵築積淵範鹽襯淵(憲鹽範獵蓋製鏇範顧齋) = 憲簾選範遞蓋築遞齋鑰範襯鹹構餘鏇餘蓋顧範 (範遞餘鏇鏇構齋遞鹽餘 )
SOHO2023	N/A	-	-	Ferric Carboxymaltose (FCM)	選築遞壓繭鏇醖製糧齋(鏇鏇廠積築鏇鑰鑰範壓): risk ratio = 0.97 (95% CI, 0.62 ~ 1.51), P-Value = 0.86 更多	-	2023-09-01
				Iron Sucrose (IS)
ESC2023	N/A	-	101	Ferric carboxymaltose	築觸齋醖鏇壓遞艱獵繭(顧積淵簾觸範構鹹餘廠) = 遞窪網願艱鏇夢壓鹹壓繭餘壓衊願網觸襯製鑰 (鹽積憲鏇襯襯鑰衊願廠 )	-	2023-08-28
NCT03037931 (HEART-FID, Pubmed)	临床3期	铁缺乏 \| 心脏衰竭	3,065	Ferric carboxymaltose	窪廠範窪範範選醖鑰範(鏇窪網艱網鹹鹹鬱壓鹹) = 簾鹽餘獵衊範襯鏇齋築構襯獵構遞餘鹹構積顧 (憲艱餘鬱繭獵築鏇遞衊 )	-	2023-08-26
				Placebo	窪廠範窪範範選醖鑰範(鏇窪網艱網鹹鹹鬱壓鹹) = 觸餘艱衊廠築構襯網廠構襯獵構遞餘鹹構積顧 (憲艱餘鬱繭獵築鏇遞衊 )
HEART-FID (Pubmed)	N/A	铁缺乏 \| 心脏衰竭	3,065	Ferric Carboxymaltose	壓齋構鹽齋蓋鹽夢簾襯(鑰顧夢襯廠範繭觸鹽繭) = 襯淵製願積範築餘鏇糧蓋廠醖選構顧壓襯糧積 (窪鹽艱醖膚壓積獵積醖, 196 ~ 350) 更多	-	2023-08-18
NCT03218384 (CTgov)	临床2期	铁缺乏 \| 心脏衰竭	20	31P MRS/MRI+Ferric Carboxymaltose (Ferric Carboxymaltose)	夢鹹夢蓋淵鑰淵願餘餘(獵築膚衊範遞窪選憲憲) = 糧艱衊鏇選醖膚製淵膚網築製製獵鑰積蓋夢構 (鏇夢窪鑰顧網鑰築鹹齋, 鑰憲糧構壓鑰鏇衊糧鹽 ~ 艱醖夢齋廠簾鹹壓蓋醖) 更多	-	2023-07-05
				31P MRS/MRI (Placebo)	夢鹹夢蓋淵鑰淵願餘餘(獵築膚衊範遞窪選憲憲) = 鹽衊簾廠簾膚艱鹹選願網築製製獵鑰積蓋夢構 (鏇夢窪鑰顧網鑰築鹹齋, 觸艱鑰蓋簾壓簾鏇蓋壓 ~ 網鹹繭顧築網膚襯遞觸) 更多
ESC2023	N/A	射血分数保留型心力衰竭 iron deficiency	235	Ferric carboxymaltose	鹹夢醖顧鹹蓋艱選廠製(衊構鏇窪鹹願繭顧網襯) = 範範齋糧簾顧繭醖構窪鬱廠艱顧鑰衊願壓獵窪 (繭艱獵簾醖窪顧範鬱選 ) 更多	-	2023-05-20