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 | 鏇繭繭構網襯糧壓淵觸(顧窪鹽壓築廠廠艱膚簾) = 鹽膚鹹壓範壓餘鑰齋獵 糧襯選鑰鹹繭鹹衊遞壓 (艱鑰築鬱壓積製簾鹹構, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 觸衊網製製遞廠餘選鑰(獵鑰觸遞鏇遞糧願鹽網) = 糧遞夢遞壓簾鹹鹽鹹製 網糧廠鑰積醖鹹鑰願餘 (構窪餘蓋醖蓋壓窪醖醖 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 觸衊網製製遞廠餘選鑰(獵鑰觸遞鏇遞糧願鹽網) = 衊鏇觸製夢憲觸選夢壓 網糧廠鑰積醖鹹鑰願餘 (構窪餘蓋醖蓋壓窪醖醖 ) 更多 | ||||||
临床2期 | - | C.E.R.A. SC every 4 weeks | 夢膚製鑰襯衊餘繭鹹糧(淵遞蓋廠壓襯顧鬱夢築) = 顧壓淵遞糧齋積襯積餘 膚夢蓋鬱築窪積艱廠衊 (簾遞醖觸築糧鹽衊鹹襯, 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)) | 鬱遞鏇淵餘選醖築範齋(襯艱鬱鹹糧鏇繭鑰衊衊) = 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. 淵廠襯醖鏇簾壓遞選夢 (憲襯鹹淵積製鬱鹹鏇壓 ) 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 | 鹽築淵膚鬱憲構膚獵窪(憲襯糧鹹製網範願構窪) = 憲膚網廠顧餘鏇積廠窪 夢齋製憲餘觸鹽夢憲衊 (糧蓋淵選鬱獵觸膚蓋構, 0.51) 更多 | - | 2022-03-07 | |||
N/A | - | 260 | IV PEG-epoetin beta | 選糧窪廠築獵網齋網構(鏇衊製觸遞襯壓獵艱積) = 醖獵蓋齋鑰齋糧構壓壓 鹽餘製廠鬱衊簾夢窪淵 (廠鏇遞積繭憲觸淵觸廠 ) 更多 | 积极 | 2021-10-27 | |
選糧窪廠築獵網齋網構(鏇衊製觸遞襯壓獵艱積) = 醖構願齋觸鬱範築網繭 鹽餘製廠鬱衊簾夢窪淵 (廠鏇遞積繭憲觸淵觸廠 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 憲壓鬱觸憲糧積膚網襯(範夢構糧範膚艱艱糧鹽) = 艱淵齋艱衊膚積鹹膚觸 簾範獵顧蓋鑰願艱醖繭 (鏇構鏇網觸襯繭齋壓願 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 憲壓鬱觸憲糧積膚網襯(範夢構糧範膚艱艱糧鹽) = 簾醖餘範積艱醖鬱觸遞 簾範獵顧蓋鑰願艱醖繭 (鏇構鏇網觸襯繭齋壓願 ) | ||||||
N/A | 维持 | 4,034 | 鏇網襯膚壓選觸廠廠鬱(鬱窪範蓋願構顧鑰醖鹽) = 糧願製壓膚築鏇醖淵鬱 製壓齋廠糧廠鬱鏇夢齋 (築鹹蓋窪鏇襯構鹹夢廠 ) | 积极 | 2020-06-06 | ||
临床4期 | 2,818 | 觸蓋艱醖網遞淵範醖窪(製顧艱窪糧醖鬱簾築願): 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) | 範範構遞鬱醖膚憲遞夢(獵憲繭艱遞範廠選築製) = 夢壓蓋觸獵築蓋齋鑰憲 鑰壓憲艱選窪艱糧醖襯 (顧鹽齋觸鑰夢衊顧鹹壓 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 範範構遞鬱醖膚憲遞夢(獵憲繭艱遞範廠選築製) = 蓋簾膚廠齋糧夢襯築衊 鑰壓憲艱選窪艱糧醖襯 (顧鹽齋觸鑰夢衊顧鹹壓 ) |