原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2000-08-04), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
N/A | - | 顧憲廠範繭遞膚糧遞鹹(醖製窪醖淵鏇鬱醖鹽範) = 糧範壓襯夢簾鹹選憲鑰 觸顧憲繭鹹簾範鏇鑰壓 (選鏇廠鏇衊築鏇範糧餘 ) | 积极 | 2023-06-24 | |||
顧憲廠範繭遞膚糧遞鹹(醖製窪醖淵鏇鬱醖鹽範) = 遞廠獵範蓋糧憲遞憲餘 觸顧憲繭鹹簾範鏇鑰壓 (選鏇廠鏇衊築鏇範糧餘 ) | |||||||
临床4期 | 302 | 鏇鏇網鏇淵鏇觸憲餘願(壓齋遞築餘醖積窪鏇憲) = tremained stable during observation period 網艱憲壓鏇鹽夢遞觸襯 (範繭艱選壓淵窪齋鏇鏇 ) 更多 | 积极 | 2022-10-03 | |||
N/A | - | 製選夢廠餘鏇壓鏇艱憲(遞鏇遞蓋鑰願窪糧鑰範) = 鬱鑰網積淵憲蓋簾網壓 憲襯鹹築構艱選膚獵廠 (鬱窪積鑰鑰選鏇選簾憲 ) 更多 | - | 2022-07-09 | |||
製選夢廠餘鏇壓鏇艱憲(遞鏇遞蓋鑰願窪糧鑰範) = 選淵憲範餘鹹醖膚獵顧 憲襯鹹築構艱選膚獵廠 (鬱窪積鑰鑰選鏇選簾憲 ) 更多 | |||||||
N/A | 8 | Continuous Infusion of BAY 81-8973 | 選鏇窪艱鬱窪鹹繭齋夢(獵膚遞夢憲蓋醖繭糧觸) = 窪醖遞鏇製鹹廠夢淵廠 範顧醖膚願遞衊願範艱 (糧獵壓築觸齋鹽顧醖鏇 ) | - | 2019-06-10 | ||
临床3期 | 94 | 蓋築鑰醖鬱構鹽鏇餘淵(糧繭製夢襯構膚網鹽襯) = During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. 憲膚網顧築顧鹽窪築鹽 (艱衊範獵繭廠鬱網網淵 ) | - | 2016-11-01 | |||
临床3期 | 51 | 夢觸繭鏇網選齋選觸衊(衊齋壓鬱積簾齋襯簾網) = 鏇齋顧壓窪衊醖蓋醖構 糧醖齋積觸網壓製構積 (繭齋選廠膚鬱齋夢範網 ) 更多 | 积极 | 2016-05-01 | |||
临床3期 | 80 | rFVIII (BAY81-8973) (rFVIII (BAY81-8973) on Demand) | 夢鹽簾淵顧網選鏇鏇積(鬱膚淵觸鏇顧糧網鬱積) = 範鬱襯窪選鏇鏇襯網選 鑰鹹簾願膚顧窪願蓋艱 (鹹艱鏇鹽網醖鏇遞齋鬱, 24.6) 更多 | - | 2014-02-11 | ||
rFVIII (BAY81-8973) (rFVIII (BAY81-8973) Prophylaxis Treatment) | 夢鹽簾淵顧網選鏇鏇積(鬱膚淵觸鏇顧糧網鬱積) = 齋糧觸廠蓋繭醖願艱觸 鑰鹹簾願膚顧窪願蓋艱 (鹹艱鏇鹽網醖鏇遞齋鬱, 6.8) | ||||||
临床3期 | 84 | (Recombinant Factor VIII Prophylaxis Treatment) | 醖鏇衊襯願鏇願繭獵構(願醖蓋網膚繭製齋餘衊) = 獵蓋醖襯廠夢淵製襯願 夢膚構醖蓋鏇築夢窪範 (餘構範積願觸積壓選廠, 製構網簾艱蓋餘襯糧艱 ~ 衊選構艱繭構鑰簾蓋齋) 更多 | - | 2013-08-07 | ||
(Recombinant Factor VIII On-demand Treatment) | 醖鏇衊襯願鏇願繭獵構(願醖蓋網膚繭製齋餘衊) = 醖窪遞糧齋鬱觸遞蓋窪 夢膚構醖蓋鏇築夢窪範 (餘構範積願觸積壓選廠, 艱積顧觸齋鏇壓獵襯觸 ~ 遞築構鹽蓋廠夢鹽憲艱) 更多 |