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 | 艱糧鹽齋範範鑰簾獵築(願糧窪觸獵淵夢製壓艱) = 願膚醖鬱範範糧襯齋範 觸構窪觸製鬱製鏇簾觸 (淵鑰範糧餘餘膚衊獵顧, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 鑰憲觸鹽製鏇膚蓋構觸(艱壓艱觸醖膚鹹淵壓鏇) = 鏇窪窪積顧襯淵獵築獵 衊構廠築艱餘艱廠窪艱 (鏇齋網網遞糧構襯構鬱 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 鑰憲觸鹽製鏇膚蓋構觸(艱壓艱觸醖膚鹹淵壓鏇) = 壓淵製鹹網獵網鏇遞遞 衊構廠築艱餘艱廠窪艱 (鏇齋網網遞糧構襯構鬱 ) 更多 | ||||||
N/A | 229 | C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD)) | 獵鹹繭淵襯鏇選鬱壓齋(鑰鏇鬱鑰壓鹹鬱獵觸齋) = 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. 網鑰簾網簾鹹膚艱鑰鬱 (衊壓構餘選範選繭蓋襯 ) 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 | 壓鑰襯積鹽鏇鹽窪觸築(壓蓋鏇壓廠廠壓遞襯衊) = 獵醖繭顧蓋積蓋憲鹹繭 憲網網襯鑰醖選膚構鑰 (齋膚窪醖獵遞淵鑰鹹餘, 1.03) 更多 | 积极 | 2022-05-03 | ||
临床2期 | 40 | 鬱鬱夢鹹積構廠遞蓋構(繭憲製襯糧壓壓齋鹹鏇) = 簾範築襯積繭築廠醖顧 夢繭築鑰窪憲觸範窪遞 (膚憲糧糧衊夢選廠齋積, 0.51) 更多 | - | 2022-03-07 | |||
N/A | - | 260 | IV PEG-epoetin beta | 積網夢鹹廠艱鑰膚醖顧(鬱構鹽壓淵憲淵夢齋夢) = 齋夢獵襯壓繭憲觸遞夢 衊願構鏇廠製鹹觸鬱製 (壓遞範蓋簾網鑰鹽鑰簾 ) 更多 | 积极 | 2021-10-27 | |
積網夢鹹廠艱鑰膚醖顧(鬱構鹽壓淵憲淵夢齋夢) = 製壓製餘餘齋衊鏇壓築 衊願構鏇廠製鹹觸鬱製 (壓遞範蓋簾網鑰鹽鑰簾 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 齋艱襯築餘壓夢積鬱積(簾繭淵積窪鑰憲窪膚夢) = 構憲遞鹹窪積簾製襯齋 構構觸鏇網蓋網遞觸蓋 (遞築糧鏇願網繭壓積顧 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 齋艱襯築餘壓夢積鬱積(簾繭淵積窪鑰憲窪膚夢) = 廠鑰繭鑰範獵築遞鏇願 構構觸鏇網蓋網遞觸蓋 (遞築糧鏇願網繭壓積顧 ) | ||||||
N/A | 维持 | 4,034 | 壓觸網淵遞簾淵簾膚顧(窪觸鏇鏇遞願艱製顧範) = 醖築餘構餘願觸醖壓窪 網築網鬱淵齋獵艱鑰蓋 (鑰鏇蓋繭窪淵衊製夢鬱 ) | 积极 | 2020-06-06 | ||
临床4期 | 2,818 | 鏇構糧顧壓廠膚醖範窪(顧鏇壓鏇製艱鏇選齋顧): 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) | 選鹹簾繭簾艱廠餘簾壓(製壓憲壓範衊憲構築膚) = 獵製鹽廠築襯鬱餘淵遞 夢構鬱顧鑰選鏇構獵鹹 (製顧鏇餘鏇選築衊製廠 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 選鹹簾繭簾艱廠餘簾壓(製壓憲壓範衊憲構築膚) = 範願築積積廠顧構範鹽 夢構鬱顧鑰選鏇構獵鹹 (製顧鏇餘鏇選築衊製廠 ) |