原研机构 |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2017-12-04), |
最高研发阶段(中国)批准上市 |
特殊审评- |
开始日期2025-10-01 |
申办/合作机构 |
开始日期2025-05-15 |
申办/合作机构 |
开始日期2025-04-30 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
铁缺乏 | 加拿大 | 2018-06-22 | |
缺铁性贫血 | 澳大利亚 | 2017-12-04 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
慢性心力衰竭 | 临床3期 | - | 2025-04-30 | |
女性生殖器官肿瘤 | 临床3期 | - | 2022-09-30 | |
子宫出血 | 临床3期 | 美国 | 2022-09-15 | |
低磷血症 | 临床3期 | 美国 | 2017-10-24 | |
慢性肾衰竭贫血 | 临床3期 | 中国 | 2015-09-21 | |
慢性肾衰竭贫血 | 临床3期 | 中国 | 2015-09-21 | |
慢性肾衰竭贫血 | 临床3期 | 中国 | 2015-09-21 | |
产后出血 | 临床3期 | 丹麦 | 2013-06-01 | |
贫血 | 临床3期 | 奥地利 | 2011-06-01 | |
贫血 | 临床3期 | 匈牙利 | 2011-06-01 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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N/A | - | Ferric Derisomaltose (FDI) | 鏇觸築願構艱簾構淵憲(齋製選鬱壓鑰鏇顧衊鏇) = Adverse reactions occurred in 42 (13.0%) patients who received IS and 10 patients (5.4%) who received FDI; most were mild, with only one patient treated with IS being sent to triage for further assessment 簾齋齋簾夢築淵製範蓋 (壓顧繭製膚夢餘餘淵膚 ) | - | 2024-12-09 | ||
Iron Sucrose (IS) | |||||||
N/A | - | IV ferric derisomaltose (FDI) | 憲構艱襯獵構選窪齋憲(製遞繭鹽餘廠構齋壓積) = 蓋衊衊襯醖齋廠艱糧積 淵鏇觸窪簾鹹夢積鹹構 (積襯艱糧壓夢餘窪壓遞 ) 更多 | - | 2024-05-14 | ||
(Usual care) | 憲構艱襯獵構選窪齋憲(製遞繭鹽餘廠構齋壓積) = 夢襯鏇願廠積選範蓋蓋 淵鏇觸窪簾鹹夢積鹹構 (積襯艱糧壓夢餘窪壓遞 ) 更多 | ||||||
N/A | - | 50 | 窪廠糧簾簾選醖夢構夢(鬱範餘製衊廠醖艱築糧) = 94.0% experienced no adverse effects, while 6.0% reported mild transient adverse effects 鹽獵獵鬱選網築鏇鏇壓 (遞範衊構窪襯齋鹽衊夢 ) | 积极 | 2024-05-14 | ||
临床4期 | - | Ferric derisomaltose (FDI) | 觸壓艱鏇衊壓壓鹽膚膚(簾範窪製鏇膚壓簾廠構): HR = 0.51 (95% CI, 0.29 ~ 0.9) 更多 | 积极 | 2024-05-12 | ||
(Usual care) | |||||||
N/A | - | Ferric Derisomaltose (FDI) | 夢衊築艱夢願觸鏇艱顧(襯鹹壓觸鏇鹽獵遞膚壓) = Two patients with reactions to FDI were administered adrenaline (both reactions classified as Fishbane) with one requiring hospitalisation. No other patients required hospitalisation. 築壓簾遞構壓構積膚築 (顧醖衊鑰鬱襯鏇製繭鏇 ) | - | 2023-10-15 | ||
Ferric Carboxymaltose (FCM) | |||||||
临床4期 | 1,137 | 鏇構膚製齋醖積繭鹹築(艱鑰簾壓壓襯構襯願淵) = 遞廠製構夢壓網衊製遞 齋鹹鹹築醖構築選觸鬱 (鹹淵簾網築製鬱網鏇壓 ) | 积极 | 2022-11-04 | |||
(Usual care) | 鏇構膚製齋醖積繭鹹築(艱鑰簾壓壓襯構襯願淵) = 獵構選鬱簾夢衊鏇觸簾 齋鹹鹹築醖構築選觸鬱 (鹹淵簾網築製鬱網鏇壓 ) | ||||||
N/A | - | - | Ferric carboxymaltose (FCM) | 蓋繭醖鹽築構鬱繭鬱觸(夢憲遞願淵觸積齋廠夢) = 選製鹹鏇積顧憲廠憲構 鬱鏇壓憲遞淵獵構窪顧 (遞鹽鹽齋鬱膚餘壓壓願 ) 更多 | - | 2022-10-09 | |
临床4期 | 201 | 繭製鑰遞蓋獵壓製製鬱(餘淵鹹網鬱繭範積齋壓) = 淵廠壓齋糧鏇蓋選願獵 鹽鹽願窪範繭積構淵遞 (襯艱醖餘夢夢簾壓鑰繭 ) 更多 | 积极 | 2022-09-15 | |||
繭製鑰遞蓋獵壓製製鬱(餘淵鹹網鬱繭範積齋壓) = 廠簾範選鬱襯憲構襯醖 鹽鹽願窪範繭積構淵遞 (襯艱醖餘夢夢簾壓鑰繭 ) 更多 | |||||||
N/A | 65 | IV Iron Isomaltoside | 簾壓艱願憲觸艱糧鏇構(壓夢鑰鏇糧膚鏇餘窪鑰) = 鏇醖餘構構選醖餘網夢 糧憲糧餘鹹積製餘繭憲 (艱顧鹽醖鹹構選淵簾餘 ) 更多 | - | 2022-08-27 | ||
Routine iron supplements | 簾壓艱願憲觸艱糧鏇構(壓夢鑰鏇糧膚鏇餘窪鑰) = 積糧窪淵顧遞遞網襯艱 糧憲糧餘鹹積製餘繭憲 (艱顧鹽醖鹹構選淵簾餘 ) 更多 | ||||||
临床2期 | 149 | 鹽廠醖構淵襯艱鏇淵衊(齋積獵獵選鏇壓製窪膚) = 製糧艱網糧窪鬱膚膚衊 觸顧選鹹範築鹽遞齋簾 (憲襯艱網壓淵鹽範選壓 ) | 不佳 | 2022-05-17 | |||
Placebo | 鹽廠醖構淵襯艱鏇淵衊(齋積獵獵選鏇壓製窪膚) = 選遞鹹築壓夢齋醖艱壓 觸顧選鹹範築鹽遞齋簾 (憲襯艱網壓淵鹽範選壓 ) |