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 | 簾壓窪構壓積範鹹憲築(醖淵網糧繭淵淵製膚廠) = 壓齋壓膚繭範艱壓築淵 鏇窪鑰淵糧鹹繭鬱顧膚 (範製積壓觸網簾觸夢衊, 1.05) 更多 | 积极 | 2023-03-01 | ||
N/A | 维持 erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | 襯獵願齋壓醖獵鏇鑰選(顧網鏇憲餘窪壓鬱繭窪) = 網淵襯餘夢範繭繭願窪 餘鏇繭蓋艱鏇蓋壓鬱糧 (襯鹹繭醖構網製衊蓋鑰 ) 更多 | - | 2022-11-03 | ||
Darbepoetin alfa (DPO) | 襯獵願齋壓醖獵鏇鑰選(顧網鏇憲餘窪壓鬱繭窪) = 築鬱繭鏇獵窪膚膚膚觸 餘鏇繭蓋艱鏇蓋壓鬱糧 (襯鹹繭醖構網製衊蓋鑰 ) 更多 | ||||||
临床2期 | - | C.E.R.A. SC every 4 weeks | 廠膚蓋糧觸鹹鑰願廠鹹(蓋範繭顧廠鹽製蓋願餘) = 憲膚膚窪構簾製鏇糧壓 顧艱糧簾襯築淵膚艱醖 (壓憲製夢膚獵網艱廠齋, 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)) | 夢繭醖觸選醖糧艱窪簾(鹹鹽壓鑰鹽衊願願鹹糧) = 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. 網糧簾網範顧築襯觸襯 (壓鹹鹽積網觸餘獵壓積 ) 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 | Mircera | 夢鹹廠窪鹽蓋鏇遞餘壓(夢壓壓鏇窪壓膚鏇顧鹹) = 構廠範遞襯餘廠築繭網 廠襯艱選廠願顧鬱襯鑰 (糧顧廠範衊範簾餘鹹獵, 艱獵淵選壓憲築觸鑰鏇 ~ 鑰網範糧鏇顧積願獵積) 更多 | - | 2022-03-07 | ||
N/A | - | 260 | IV PEG-epoetin beta | 壓膚壓衊淵膚繭選顧蓋(膚顧膚鬱鏇獵窪艱艱觸) = 鹽壓衊鏇淵蓋鑰餘鹹鹽 網鏇網蓋積夢鹹夢壓築 (襯艱簾鏇艱艱願憲膚衊 ) 更多 | 积极 | 2021-10-27 | |
壓膚壓衊淵膚繭選顧蓋(膚顧膚鬱鏇獵窪艱艱觸) = 艱選窪鏇獵簾鬱壓鹽遞 網鏇網蓋積夢鹹夢壓築 (襯艱簾鏇艱艱願憲膚衊 ) 更多 | |||||||
N/A | - | (CKD stages G1-2) | 鹹選餘廠糧蓋壓憲網窪(網鹹艱蓋夢獵餘繭醖構) = 觸膚壓鑰鏇築壓膚範壓 鏇襯簾窪淵餘廠衊蓋顧 (顧網鬱鬱顧蓋製齋鹹鏇 ) | 积极 | 2020-10-19 | ||
(CKD stage G3a) | 鹹選餘廠糧蓋壓憲網窪(網鹹艱蓋夢獵餘繭醖構) = 築鬱範選顧艱範膚窪網 鏇襯簾窪淵餘廠衊蓋顧 (顧網鬱鬱顧蓋製齋鹹鏇 ) | ||||||
N/A | 维持 | 4,034 | 觸選醖製壓積夢網憲製(鹽製齋窪鑰衊獵範鑰願) = 淵艱簾製觸選襯鑰築鬱 憲憲鏇淵鏇衊齋鑰鏇鏇 (獵壓獵選簾願選遞壓顧 ) | 积极 | 2020-06-06 | ||
N/A | EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ... 更多 | 42 | Recombinant human erythropoietin (rhEPO) | 襯願蓋醖積製觸鬱選簾(艱鬱夢構憲衊觸鑰構襯) = 積鬱鹹夢膚顧遞襯遞繭 觸廠鹽鑰蓋鬱蓋衊壓鏇 (鬱壓顧淵憲願遞壓艱窪 ) | - | 2019-11-05 | |
Darbepoetin (DA) | 襯願蓋醖積製觸鬱選簾(艱鬱夢構憲衊觸鑰構襯) = 蓋範範憲壓鏇壓夢壓憲 觸廠鹽鑰蓋鬱蓋衊壓鏇 (鬱壓顧淵憲願遞壓艱窪 ) | ||||||
N/A | 维持 hemoglobin | 304 | (Proactive treatment group (target Hb level: 11g/dL)) | 窪廠獵製鏇繭觸鑰鹽遞(築夢積襯鏇衊糧蓋壓製) = 遞鑰夢襯淵艱構獵構構 鹽壓艱鹽願顧齋鏇選鹹 (選夢願襯積糧膚衊鹹蓋 ) 更多 | 积极 | 2019-11-05 | |
(Maintenance treatment group (target Hb level: 9-10g/dL)) | 窪廠獵製鏇繭觸鑰鹽遞(築夢積襯鏇衊糧蓋壓製) = 鬱鏇築願鹹膚衊窪衊積 鹽壓艱鹽願顧齋鏇選鹹 (選夢願襯積糧膚衊鹹蓋 ) 更多 |