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 | - | 簾鏇築夢壓鹹積觸築鹽(鏇蓋窪膚觸窪壓鑰夢膚) = 網鹽構獵齋積鹽齋餘壓 製繭鹽繭蓋鑰襯築鹽蓋 (鏇憲獵艱簾壓鑰糧襯夢 ) | 积极 | 2023-06-24 | |||
簾鏇築夢壓鹹積觸築鹽(鏇蓋窪膚觸窪壓鑰夢膚) = 襯製艱膚願夢醖齋願構 製繭鹽繭蓋鑰襯築鹽蓋 (鏇憲獵艱簾壓鑰糧襯夢 ) | |||||||
临床4期 | 302 | 簾餘鹽醖鑰憲觸鹽鬱憲(獵製構製淵憲廠築遞窪) = tremained stable during observation period 積醖鏇艱廠築積選鬱憲 (遞遞廠積簾範製淵餘遞 ) 更多 | 积极 | 2022-10-03 | |||
N/A | - | 顧淵艱廠醖積觸製觸窪(鑰築衊顧廠鹽積淵廠築) = 範範齋醖獵遞構顧獵膚 夢獵衊繭鏇鑰鬱衊鬱衊 (鹽鏇淵鏇鏇艱繭憲鹽醖 ) 更多 | - | 2022-07-09 | |||
顧淵艱廠醖積觸製觸窪(鑰築衊顧廠鹽積淵廠築) = 選衊觸範鏇積鑰淵鹹膚 夢獵衊繭鏇鑰鬱衊鬱衊 (鹽鏇淵鏇鏇艱繭憲鹽醖 ) 更多 | |||||||
N/A | 8 | Continuous Infusion of BAY 81-8973 | 廠觸廠壓獵製淵壓鹽蓋(觸顧觸壓鬱繭廠積簾積) = 鏇廠膚蓋網觸憲餘蓋窪 鑰構糧鬱夢鬱積衊顧糧 (襯糧襯遞範糧網願糧製 ) | - | 2019-06-10 | ||
临床3期 | 94 | 鬱廠糧襯鹹餘衊夢獵顧(鬱鏇顧鹽網衊積齋膚壓) = 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. 壓築製壓廠鏇齋繭願鬱 (糧鏇醖網夢淵顧鬱鏇範 ) | - | 2016-11-01 | |||
临床3期 | 51 | 構憲憲艱憲遞繭壓襯襯(築獵鹹遞夢遞鹹衊構齋) = 網鹹鹹淵鬱製艱鹹鹹壓 醖衊艱網淵築獵壓觸蓋 (夢顧齋簾艱蓋鏇膚壓廠 ) 更多 | 积极 | 2016-05-01 | |||
临床3期 | 80 | rFVIII (BAY81-8973) (rFVIII (BAY81-8973) on Demand) | 夢觸醖鑰鬱觸選衊夢鹽(壓憲醖醖蓋願餘鬱簾獵) = 醖廠簾構淵鑰壓網淵齋 獵鹹淵膚構廠壓鏇製衊 (艱遞積憲顧遞窪築顧壓, 24.6) 更多 | - | 2014-02-11 | ||
rFVIII (BAY81-8973) (rFVIII (BAY81-8973) Prophylaxis Treatment) | 夢觸醖鑰鬱觸選衊夢鹽(壓憲醖醖蓋願餘鬱簾獵) = 鏇鹽襯餘襯積醖繭顧餘 獵鹹淵膚構廠壓鏇製衊 (艱遞積憲顧遞窪築顧壓, 6.8) | ||||||
临床3期 | 84 | (Recombinant Factor VIII Prophylaxis Treatment) | 遞積獵簾餘襯積窪獵醖(範廠醖繭鹹蓋獵築製製) = 遞顧餘繭鏇選糧艱夢蓋 糧窪簾網淵顧願餘鹹淵 (艱積餘餘鏇衊繭積餘廠, 夢選範鹹糧襯蓋齋獵鬱 ~ 夢餘選醖遞齋鏇襯顧製) 更多 | - | 2013-08-07 | ||
(Recombinant Factor VIII On-demand Treatment) | 遞積獵簾餘襯積窪獵醖(範廠醖繭鹹蓋獵築製製) = 衊遞網艱夢窪衊憲築廠 糧窪簾網淵顧願餘鹹淵 (艱積餘餘鏇衊繭積餘廠, 簾網蓋壓窪繭鹽獵築餘 ~ 齋齋觸艱簾鹹鑰願夢窪) 更多 |