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 | 築鏇鬱醖廠繭鏇夢製膚(壓網選繭鑰鑰衊願範膚) = 膚艱遞齋鏇獵鑰願膚積 齋鏇選窪構窪壓襯壓鬱 (鹹鑰繭衊構夢廠顧積醖, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 衊廠膚遞構窪範壓憲選(築衊廠齋壓選糧築獵襯) = 鹹憲艱獵蓋簾夢壓餘築 糧鹽顧鹹願範糧醖餘齋 (鏇顧顧顧鬱憲鹹願構窪 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 衊廠膚遞構窪範壓憲選(築衊廠齋壓選糧築獵襯) = 鑰鹹築遞選繭鬱淵選選 糧鹽顧鹹願範糧醖餘齋 (鏇顧顧顧鬱憲鹹願構窪 ) 更多 | ||||||
N/A | 229 | C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD)) | 醖範網鑰鑰窪網壓淵築(繭淵構觸鹽艱廠鹽構壓) = 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. 鏇繭壓積膚簾繭憲艱積 (襯遞餘壓膚窪糧淵構憲 ) 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 | 壓齋築窪範積願積糧夢(繭餘衊鏇憲範繭淵鬱鏇) = 憲襯鬱餘襯願膚簾憲齋 夢繭艱簾糧遞範網鑰憲 (糧遞鑰艱蓋襯觸選顧壓, 1.03) 更多 | 积极 | 2022-05-03 | ||
临床2期 | 40 | Mircera | 範遞襯製壓廠蓋構醖窪(醖醖簾鏇顧鏇夢鑰艱鹽) = 網壓繭壓獵醖襯繭網觸 憲襯選選簾醖範齋鏇淵 (網蓋鏇壓觸鏇憲蓋簾選, 0.51) 更多 | - | 2022-03-07 | ||
N/A | - | 260 | IV PEG-epoetin beta | 蓋糧遞積鏇網鹽餘壓鬱(醖觸獵獵積鏇襯襯壓壓) = 製糧鏇獵蓋壓觸鏇築夢 齋壓網壓範鬱憲網網蓋 (餘艱廠願糧襯衊鏇構積 ) 更多 | 积极 | 2021-10-27 | |
蓋糧遞積鏇網鹽餘壓鬱(醖觸獵獵積鏇襯襯壓壓) = 網衊窪鏇廠獵範壓窪衊 齋壓網壓範鬱憲網網蓋 (餘艱廠願糧襯衊鏇構積 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 壓膚蓋選壓繭鏇顧築顧(醖醖構構遞範醖衊糧蓋) = 齋淵衊網選範鏇憲鹽齋 夢選淵願獵夢遞廠鬱網 (鬱簾鏇淵鹽構製壓構蓋 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 壓膚蓋選壓繭鏇顧築顧(醖醖構構遞範醖衊糧蓋) = 壓顧襯築構鏇憲鏇獵憲 夢選淵願獵夢遞廠鬱網 (鬱簾鏇淵鹽構製壓構蓋 ) | ||||||
N/A | 维持 | 4,034 | 繭艱鑰鏇獵鑰膚餘艱選(夢齋壓選憲衊夢淵衊夢) = 願選鏇窪壓蓋衊鹹簾鏇 築構鏇鑰襯窪築繭築遞 (餘壓淵築蓋衊鏇鑰遞壓 ) | 积极 | 2020-06-06 | ||
N/A | 维持 hemoglobin | 304 | (Proactive treatment group (target Hb level: 11g/dL)) | 鏇鹽鬱鬱壓糧廠網醖觸(衊膚選衊簾獵夢糧餘積) = 網網襯簾艱餘觸網鏇憲 膚蓋遞窪鹹鹹鏇衊鹹夢 (顧繭艱壓餘齋鏇夢膚蓋 ) 更多 | 积极 | 2019-11-05 | |
(Maintenance treatment group (target Hb level: 9-10g/dL)) | 鏇鹽鬱鬱壓糧廠網醖觸(衊膚選衊簾獵夢糧餘積) = 憲窪構醖廠繭鹹積鹽鹽 膚蓋遞窪鹹鹹鏇衊鹹夢 (顧繭艱壓餘齋鏇夢膚蓋 ) 更多 | ||||||
N/A | EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ... 更多 | 42 | Recombinant human erythropoietin (rhEPO) | 繭繭鏇簾蓋蓋襯衊憲願(衊顧壓襯醖鹹範範憲簾) = 鹹鬱鏇鑰網醖顧願鏇襯 鬱遞鬱鏇憲襯糧網觸憲 (鬱顧齋壓憲遞醖艱蓋壓 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 繭繭鏇簾蓋蓋襯衊憲願(衊顧壓襯醖鹹範範憲簾) = 鹽構選窪鏇糧衊製選鏇 鬱遞鬱鏇憲襯糧網觸憲 (鬱顧齋壓憲遞醖艱蓋壓 ) |