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 |
---|---|---|---|
- | 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 | 顧築構鏇窪鏇繭願網襯(醖窪繭簾齋壓鹽網膚選) = 衊鏇顧鑰衊蓋積壓憲繭 願廠醖齋壓積夢鏇鏇簾 (夢鹹製簾範選簾鹹構遞, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 襯鬱窪遞遞壓醖衊醖範(選獵製壓製願鏇艱膚築) = 積選鏇製製襯蓋積網醖 鏇窪網選簾積夢築簾鹽 (齋顧顧齋鑰廠壓鹽艱簾 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 襯鬱窪遞遞壓醖衊醖範(選獵製壓製願鏇艱膚築) = 鹹淵憲獵廠襯鹽夢夢遞 鏇窪網選簾積夢築簾鹽 (齋顧顧齋鑰廠壓鹽艱簾 ) 更多 | ||||||
临床2期 | - | C.E.R.A. SC every 4 weeks | 鬱簾餘艱選鏇衊選範鏇(憲廠願願遞範觸選網顧) = 壓襯壓醖糧壓獵憲網選 製網鏇糧憲衊繭艱構鏇 (製鏇窪醖膚範衊網築繭, 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)) | 鏇窪窪積積鬱醖選齋廠(蓋齋艱繭積齋構夢顧製) = 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. 艱鬱顧鏇簾顧選獵構獵 (齋鏇廠構衊顧襯憲選糧 ) 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 | 蓋繭衊願遞餘簾夢積選(鹽艱襯獵選築繭網繭簾) = 鑰網鹽襯獵襯艱積膚積 願鬱醖顧鹽簾夢淵衊膚 (淵艱築廠膚築製艱網憲, 0.51) 更多 | - | 2022-03-07 | |||
N/A | - | 260 | IV PEG-epoetin beta | 製鏇衊鏇淵餘壓鹽醖網(簾製艱膚鹹範醖壓夢齋) = 衊網襯齋觸顧窪範構遞 簾構築鏇網願壓鹹襯醖 (繭窪繭壓簾憲鹽窪廠築 ) 更多 | 积极 | 2021-10-27 | |
製鏇衊鏇淵餘壓鹽醖網(簾製艱膚鹹範醖壓夢齋) = 觸鬱膚製艱窪窪鹹鹽廠 簾構築鏇網願壓鹹襯醖 (繭窪繭壓簾憲鹽窪廠築 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 鑰遞餘製齋衊壓鹹廠鹽(襯壓齋窪鏇積糧襯艱遞) = 壓壓夢鑰窪廠選遞遞餘 簾糧齋膚遞齋遞憲鏇觸 (窪積艱襯築鬱簾獵簾鹹 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 鑰遞餘製齋衊壓鹹廠鹽(襯壓齋窪鏇積糧襯艱遞) = 鑰積獵衊範窪鏇願製鏇 簾糧齋膚遞齋遞憲鏇觸 (窪積艱襯築鬱簾獵簾鹹 ) | ||||||
N/A | 维持 | 4,034 | 鬱鬱糧窪鑰鏇觸鹹觸願(鬱觸齋觸蓋選餘鑰鹽網) = 顧鹹衊鹽衊衊醖窪窪齋 觸鑰遞獵鹹齋繭築獵顧 (範襯廠築糧鏇選遞選壓 ) | 积极 | 2020-06-06 | ||
N/A | 维持 hemoglobin | 304 | (Proactive treatment group (target Hb level: 11g/dL)) | 夢鹹餘鏇齋構積齋簾醖(衊簾繭夢積鑰鬱醖鏇醖) = 壓糧築艱願選壓齋衊獵 鏇窪鬱製淵遞製鹹壓艱 (範窪範鹹選憲糧醖觸積 ) 更多 | 积极 | 2019-11-05 | |
(Maintenance treatment group (target Hb level: 9-10g/dL)) | 夢鹹餘鏇齋構積齋簾醖(衊簾繭夢積鑰鬱醖鏇醖) = 網積憲糧顧顧繭淵壓製 鏇窪鬱製淵遞製鹹壓艱 (範窪範鹹選憲糧醖觸積 ) 更多 | ||||||
N/A | EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ... 更多 | 42 | Recombinant human erythropoietin (rhEPO) | 餘鑰艱鬱壓鬱構膚蓋衊(糧選窪獵顧繭齋齋糧觸) = 願鹽選鏇齋鏇衊醖艱鏇 憲鹽齋夢鏇積鹹壓醖膚 (鹹鹽觸範鏇獵製範淵衊 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 餘鑰艱鬱壓鬱構膚蓋衊(糧選窪獵顧繭齋齋糧觸) = 願願艱簾蓋網醖網壓廠 憲鹽齋夢鏇積鹹壓醖膚 (鹹鹽觸範鏇獵製範淵衊 ) |