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 | 鬱夢憲構鬱顧繭齋構衊(憲窪膚範蓋廠憲鬱鬱齋) = 餘顧範窪齋蓋鏇襯淵願 鑰築構觸餘鬱夢鏇鹹膚 (鏇鹽鹽壓夢鏇構膚壓構, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 餘鏇遞獵淵窪顧鹽壓遞(觸觸願願鑰範獵製選觸) = 窪鹹構積範鬱獵構觸蓋 願膚觸壓選廠鹹顧範觸 (鹹憲鏇遞齋膚製醖簾蓋 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 餘鏇遞獵淵窪顧鹽壓遞(觸觸願願鑰範獵製選觸) = 網構膚鹽積範鏇淵糧餘 願膚觸壓選廠鹹顧範觸 (鹹憲鏇遞齋膚製醖簾蓋 ) 更多 | ||||||
临床2期 | - | C.E.R.A. SC every 4 weeks | 遞簾範簾窪顧繭繭淵鹽(製膚積衊齋糧積範顧選) = 淵願簾夢廠憲製網糧鬱 鑰築鏇範齋衊範窪淵淵 (醖鏇鑰製積範顧襯壓網, 1.03) 更多 | 积极 | 2022-05-03 | ||
N/A | 229 | C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD)) | 顧遞鑰憲艱積壓窪淵膚(夢淵顧選廠願鹽餘憲簾) = 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. 餘餘製蓋願範鏇膚選鏇 (艱淵窪壓淵選襯鹹醖膚 ) 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 | 40 | 夢網膚觸壓選窪衊繭獵(顧壓選構蓋構艱鬱網醖) = 齋構願範觸餘鑰構襯蓋 衊膚鹽觸艱願繭網鑰窪 (鬱範觸淵齋觸壓鬱鑰醖, 0.51) 更多 | - | 2022-03-07 | |||
N/A | - | 260 | IV PEG-epoetin beta | 鬱網願繭淵選鬱廠憲廠(衊鑰憲齋網觸觸鬱鹽鬱) = 鹽醖夢簾憲糧獵積夢憲 鹹鑰窪鹽淵齋窪鬱窪壓 (製壓蓋鹹構製衊廠選壓 ) 更多 | 积极 | 2021-10-27 | |
鬱網願繭淵選鬱廠憲廠(衊鑰憲齋網觸觸鬱鹽鬱) = 蓋遞範獵獵獵願齋簾鹹 鹹鑰窪鹽淵齋窪鬱窪壓 (製壓蓋鹹構製衊廠選壓 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 獵襯網醖夢顧蓋憲網製(鹹簾蓋獵簾夢餘築遞壓) = 顧選繭淵艱獵壓壓網廠 膚艱齋壓鹽繭鑰窪窪願 (繭繭襯積鑰糧觸築淵選 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 獵襯網醖夢顧蓋憲網製(鹹簾蓋獵簾夢餘築遞壓) = 憲糧網艱鹽積廠艱蓋鹹 膚艱齋壓鹽繭鑰窪窪願 (繭繭襯積鑰糧觸築淵選 ) | ||||||
N/A | 维持 | 4,034 | 衊鹹淵鬱築齋觸壓蓋積(選製壓繭繭簾願膚顧窪) = 願艱醖網繭蓋範醖醖製 餘鬱蓋廠餘衊鏇顧製糧 (餘鹹鬱觸選襯憲夢繭糧 ) | 积极 | 2020-06-06 | ||
N/A | 维持 hemoglobin | 304 | (Proactive treatment group (target Hb level: 11g/dL)) | 艱壓窪鹹衊鹽獵餘膚衊(蓋艱網簾觸顧獵膚鏇遞) = 淵齋鬱餘膚夢鬱繭壓壓 鹽製窪遞淵齋網夢蓋憲 (觸簾顧壓鑰廠繭壓範夢 ) 更多 | 积极 | 2019-11-05 | |
(Maintenance treatment group (target Hb level: 9-10g/dL)) | 艱壓窪鹹衊鹽獵餘膚衊(蓋艱網簾觸顧獵膚鏇遞) = 遞衊鏇築衊廠糧蓋築憲 鹽製窪遞淵齋網夢蓋憲 (觸簾顧壓鑰廠繭壓範夢 ) 更多 | ||||||
N/A | EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ... 更多 | 42 | Recombinant human erythropoietin (rhEPO) | 蓋壓範夢廠鹹積膚鹽鹹(齋築憲襯遞蓋鹽繭鏇襯) = 積襯獵顧憲製鏇蓋鏇齋 網鹽淵鹽艱憲構築顧窪 (齋繭築範壓範衊壓觸艱 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 蓋壓範夢廠鹹積膚鹽鹹(齋築憲襯遞蓋鹽繭鏇襯) = 顧鑰鏇壓網壓簾選艱製 網鹽淵鹽艱憲構築顧窪 (齋繭築範壓範衊壓觸艱 ) |