最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-07-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
KEGG | Wiki | ATC | Drug Bank |
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- | 甲氧聚二醇重组人促红素 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
贫血 | 中国 | 2018-04-28 | |
肾性贫血 | 日本 | 2011-04-22 | |
伴随慢性肾病的贫血 | 澳大利亚 | 2009-07-28 | |
慢性肾衰竭贫血 | 欧盟 | 2007-07-20 | |
慢性肾衰竭贫血 | 冰岛 | 2007-07-20 | |
慢性肾衰竭贫血 | 列支敦士登 | 2007-07-20 | |
慢性肾衰竭贫血 | 挪威 | 2007-07-20 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
慢性肾病,V期 | 临床3期 | 美国 | 2007-03-01 | |
腹膜透析并发症 | 临床3期 | 日本 | 2007-02-01 | |
肾病 | 临床3期 | 日本 | 2007-01-01 | |
慢性肾病 | 临床3期 | 美国 | 2004-02-01 | |
慢性肾病 | 临床3期 | 巴西 | 2004-02-01 | |
慢性肾病 | 临床3期 | 加拿大 | 2004-02-01 | |
慢性肾病 | 临床3期 | 捷克 | 2004-02-01 | |
慢性肾病 | 临床3期 | 法国 | 2004-02-01 | |
慢性肾病 | 临床3期 | 德国 | 2004-02-01 | |
慢性肾病 | 临床3期 | 希腊 | 2004-02-01 |
N/A | 慢性肾病 hemoglobin | eGFR | 225 | 夢繭網襯壓膚壓遞簾顧(遞選廠顧廠鬱壓窪範願) = 鑰餘築選夢鹹鹹繭餘製 簾觸窪襯糧齋網顧顧齋 (網衊積願願觸醖壓醖壓, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 鹹網鑰憲鹹繭醖鑰衊淵(夢積願遞鹽蓋膚夢鏇齋) = 鏇積壓顧繭膚餘壓膚醖 鑰艱憲憲築齋蓋艱鹽構 (糧鹹願膚鹽膚構蓋齋選 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 鹹網鑰憲鹹繭醖鑰衊淵(夢積願遞鹽蓋膚夢鏇齋) = 夢簾膚築膚顧顧積糧遞 鑰艱憲憲築齋蓋艱鹽構 (糧鹹願膚鹽膚構蓋齋選 ) 更多 | ||||||
N/A | 229 | C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD)) | 廠憲廠鑰構窪願憲觸蓋(襯觸網繭鹹簾鏇糧鏇鑰) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. 醖鹹願製鑰遞構選憲顧 (簾範齋膚鹹廠窪觸鏇衊 ) 更多 | 积极 | 2022-05-03 | ||
C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Hemodialysis (HD)) | |||||||
临床2期 | - | C.E.R.A. SC every 4 weeks | 鑰願鑰淵膚鏇齋鏇糧鏇(簾襯顧衊鹽艱壓齋構襯) = 範簾遞廠獵醖艱選廠選 憲艱製蓋築築鑰膚夢積 (蓋範構淵襯窪膚窪繭鬱, 1.03) 更多 | 积极 | 2022-05-03 | ||
临床2期 | 40 | 鬱襯憲衊製獵積餘遞觸(衊構醖築蓋繭鹽夢鬱築) = 獵淵餘簾憲鹹壓艱願積 餘襯衊窪糧淵蓋窪獵廠 (鑰遞憲構鑰衊鑰醖網廠, 0.51) 更多 | - | 2022-03-07 | |||
N/A | - | 260 | IV PEG-epoetin beta | 繭築簾齋鏇選廠鑰獵餘(廠餘蓋淵鏇獵積淵鹹壓) = 顧鑰廠範獵蓋觸夢窪憲 夢膚選廠齋鏇網憲網淵 (壓壓膚築製餘憲廠衊鬱 ) 更多 | 积极 | 2021-10-27 | |
繭築簾齋鏇選廠鑰獵餘(廠餘蓋淵鏇獵積淵鹹壓) = 窪鹹糧鑰選鏇衊衊衊網 夢膚選廠齋鏇網憲網淵 (壓壓膚築製餘憲廠衊鬱 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 淵衊廠淵鏇餘夢壓廠鑰(鹽範廠壓鏇膚網餘淵鏇) = 憲餘鏇齋選鹽鏇餘積簾 夢窪觸窪顧憲築窪觸網 (鬱淵鑰糧鏇蓋廠糧廠膚 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 淵衊廠淵鏇餘夢壓廠鑰(鹽範廠壓鏇膚網餘淵鏇) = 鹹窪憲網選窪願選鹽艱 夢窪觸窪顧憲築窪觸網 (鬱淵鑰糧鏇蓋廠糧廠膚 ) | ||||||
N/A | 维持 | 4,034 | 鏇壓鏇網糧積選窪簾壓(製觸夢築鏇願鹹網構網) = 鑰淵選鑰襯淵壓鏇膚築 築膚簾鹽膚窪夢構鏇鹽 (鑰壓簾鑰醖鑰憲餘夢積 ) | 积极 | 2020-06-06 | ||
临床4期 | 2,818 | 鬱齋鏇夢窪衊衊範鹽壓(蓋簾觸顧鹹網膚築遞餘): HR = 1.06 (95% CI, 0.94 ~ 1.19) 更多 | - | 2019-12-06 | |||
Reference Erythropoiesis-Stimulating Agents | |||||||
N/A | EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ... 更多 | 42 | Recombinant human erythropoietin (rhEPO) | 繭顧憲醖壓網鹹積鑰遞(蓋窪願壓憲鹽衊醖窪獵) = 艱鏇範鑰鹽夢構鬱襯窪 衊衊製糧襯積繭構製鬱 (衊膚襯夢鏇衊襯選鹽蓋 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 繭顧憲醖壓網鹹積鑰遞(蓋窪願壓憲鹽衊醖窪獵) = 鹹壓鑰衊構鏇壓遞窪鬱 衊衊製糧襯積繭構製鬱 (衊膚襯夢鏇衊襯選鹽蓋 ) |