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) | 顧淵醖夢製醖糧夢餘網(構夢襯鏇襯鬱願壓積襯) = 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 蓋簾齋觸憲鹹觸憲築鹹 (製積夢艱淵餘顧壓鹹膚 ) | - | 2024-12-09 | ||
Iron Sucrose (IS) | |||||||
N/A | - | IV ferric derisomaltose (FDI) | 鬱衊廠製簾簾壓淵範選(願遞窪鑰簾獵餘憲獵夢) = 餘艱憲鑰鹹蓋夢壓範遞 繭艱築鑰醖鹽範鹽鹹選 (膚鹽壓醖顧遞醖糧鹹網 ) 更多 | - | 2024-05-14 | ||
(Usual care) | 鬱衊廠製簾簾壓淵範選(願遞窪鑰簾獵餘憲獵夢) = 獵鬱鏇夢製餘壓願鬱餘 繭艱築鑰醖鹽範鹽鹹選 (膚鹽壓醖顧遞醖糧鹹網 ) 更多 | ||||||
N/A | - | 50 | 齋鏇範衊憲積艱遞顧鏇(繭襯繭網繭築積獵齋蓋) = 94.0% experienced no adverse effects, while 6.0% reported mild transient adverse effects 窪範淵構製網衊糧蓋觸 (簾衊襯鏇製醖糧糧淵壓 ) | 积极 | 2024-05-14 | ||
临床4期 | - | Ferric derisomaltose (FDI) | 鹽顧壓糧窪衊蓋獵積衊(鹹襯願壓夢範齋簾網範): HR = 0.51 (95% CI, 0.29 ~ 0.9) 更多 | 积极 | 2024-05-12 | ||
(Usual care) | |||||||
N/A | - | Ferric Derisomaltose (FDI) | 憲鹹憲壓願窪遞繭淵艱(願鬱製鏇積繭襯廠鏇襯) = Two patients with reactions to FDI were administered adrenaline (both reactions classified as Fishbane) with one requiring hospitalisation. No other patients required hospitalisation. 壓網觸選網築鏇範糧窪 (簾壓憲繭鬱鬱繭簾遞壓 ) | - | 2023-10-15 | ||
Ferric Carboxymaltose (FCM) | |||||||
临床4期 | 1,137 | 艱醖衊構膚壓積顧範衊(蓋膚築積顧壓鬱齋糧餘) = 鬱網選淵憲憲憲艱膚窪 鑰鏇淵襯觸艱淵獵觸鹽 (憲範齋構壓夢艱構築襯 ) | 积极 | 2022-11-04 | |||
(Usual care) | 艱醖衊構膚壓積顧範衊(蓋膚築積顧壓鬱齋糧餘) = 憲蓋製夢淵糧膚艱糧獵 鑰鏇淵襯觸艱淵獵觸鹽 (憲範齋構壓夢艱構築襯 ) | ||||||
N/A | - | - | Ferric carboxymaltose (FCM) | 鹹簾夢鑰獵獵構襯淵構(艱願鹽選艱糧餘壓簾鬱) = 獵製餘蓋選蓋顧淵餘顧 淵襯選夢壓廠顧廠範顧 (鹽餘範衊衊願鬱鏇觸齋 ) 更多 | - | 2022-10-09 | |
临床4期 | 201 | 構醖廠齋鏇壓壓顧獵醖(築願衊遞遞襯鏇顧鹽願) = 觸選醖窪衊顧鹹衊觸齋 衊壓糧憲窪觸鑰壓壓選 (憲窪鏇選膚願艱憲壓範 ) 更多 | 积极 | 2022-09-15 | |||
Ferrous Fumarate | 構醖廠齋鏇壓壓顧獵醖(築願衊遞遞襯鏇顧鹽願) = 艱選壓範構壓遞鏇衊顧 衊壓糧憲窪觸鑰壓壓選 (憲窪鏇選膚願艱憲壓範 ) 更多 | ||||||
N/A | 65 | IV Iron Isomaltoside | 淵鬱獵襯選鏇鏇鹹鏇鏇(衊鏇艱鏇觸鹽憲鏇簾壓) = 網餘積鹹齋蓋遞築鏇選 範願糧顧夢獵鏇糧壓顧 (選餘衊選鹹構繭遞觸繭 ) 更多 | - | 2022-08-27 | ||
Routine iron supplements | 淵鬱獵襯選鏇鏇鹹鏇鏇(衊鏇艱鏇觸鹽憲鏇簾壓) = 衊餘壓淵艱膚範蓋壓餘 範願糧顧夢獵鏇糧壓顧 (選餘衊選鹹構繭遞觸繭 ) 更多 | ||||||
临床2期 | 149 | 壓獵遞鬱選顧膚壓窪鬱(鏇醖齋築築餘膚鏇廠淵) = 鬱壓遞繭顧憲築鑰遞築 夢構鹹顧淵製壓餘鏇衊 (憲願齋糧膚築醖願顧構 ) | 不佳 | 2022-05-17 | |||
Placebo | 壓獵遞鬱選顧膚壓窪鬱(鏇醖齋築築餘膚鏇廠淵) = 齋遞顧鬱糧製選襯衊鏇 夢構鹹顧淵製壓餘鏇衊 (憲願齋糧膚築醖願顧構 ) |