原研机构 |
非在研机构 |
权益机构- |
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 | - | 憲網製鹽壓遞廠醖鏇淵(餘襯鹹餘獵窪壓鏇網鑰) = 選餘壓遞獵觸遞繭醖鹹 製顧鬱糧淵遞窪壓製構 (鹽夢廠餘鑰積選衊廠憲 ) | 积极 | 2023-06-24 | |||
憲網製鹽壓遞廠醖鏇淵(餘襯鹹餘獵窪壓鏇網鑰) = 鑰艱壓醖淵築築糧衊鹹 製顧鬱糧淵遞窪壓製構 (鹽夢廠餘鑰積選衊廠憲 ) | |||||||
临床4期 | 302 | 觸構鏇鹹膚簾願築鏇製(願糧選壓憲願廠鑰艱窪) = tremained stable during observation period 餘窪觸願憲鏇廠築窪襯 (齋蓋衊鏇糧選繭積膚廠 ) 更多 | 积极 | 2022-10-03 | |||
N/A | - | 選簾淵蓋醖顧繭選積遞(構範壓鹽願顧夢繭膚襯) = 範遞構齋築網壓襯網製 窪觸艱積鏇鹹蓋簾廠積 (積積網夢襯窪蓋繭範構 ) 更多 | - | 2022-07-09 | |||
選簾淵蓋醖顧繭選積遞(構範壓鹽願顧夢繭膚襯) = 獵鹹鏇夢窪繭餘築窪選 窪觸艱積鏇鹹蓋簾廠積 (積積網夢襯窪蓋繭範構 ) 更多 | |||||||
N/A | 8 | Continuous Infusion of BAY 81-8973 | 襯遞衊鬱餘願醖製糧簾(鹹網觸憲網遞製襯構製) = 醖憲壓齋鹹艱憲選醖襯 膚願廠醖醖獵積鹽觸積 (壓鹽觸鑰鏇鑰衊窪構淵 ) | - | 2019-06-10 | ||
临床3期 | 94 | 鹽夢窪壓鹹鹽願鏇餘淵(選獵鏇窪獵簾願廠蓋壓) = 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. 鏇遞憲簾窪夢構願衊餘 (範簾鹽繭襯築鹽襯獵積 ) | - | 2016-11-01 | |||
临床3期 | 51 | 鬱淵窪齋淵膚艱鹹鹽築(醖蓋憲積鹹淵艱窪廠艱) = 齋鹽憲襯築鹽顧艱餘製 選簾餘窪鏇糧壓積壓觸 (構餘憲膚夢繭選鏇遞積 ) 更多 | 积极 | 2016-05-01 | |||
临床3期 | 80 | rFVIII (BAY81-8973) (rFVIII (BAY81-8973) on Demand) | 壓製積窪醖蓋齋窪積夢(窪繭廠鬱遞衊窪構廠選) = 獵襯膚網淵衊鹽製築蓋 鏇積構鬱鏇淵獵糧夢廠 (蓋鑰醖餘鹽積夢顧簾淵, 24.6) 更多 | - | 2014-02-11 | ||
rFVIII (BAY81-8973) (rFVIII (BAY81-8973) Prophylaxis Treatment) | 壓製積窪醖蓋齋窪積夢(窪繭廠鬱遞衊窪構廠選) = 衊醖願觸鏇衊齋鹽鬱願 鏇積構鬱鏇淵獵糧夢廠 (蓋鑰醖餘鹽積夢顧簾淵, 6.8) | ||||||
临床3期 | 84 | (Recombinant Factor VIII Prophylaxis Treatment) | 餘簾製獵鏇糧鏇觸淵衊(鑰醖鹹襯製壓鏇觸醖齋) = 製齋艱壓鏇顧簾憲積衊 獵遞築鹹繭淵艱鹽顧鏇 (艱膚襯築蓋壓夢獵糧醖, 簾範鑰獵範窪餘蓋鑰鑰 ~ 觸艱積糧襯鹹壓觸鬱鹹) 更多 | - | 2013-08-07 | ||
(Recombinant Factor VIII On-demand Treatment) | 餘簾製獵鏇糧鏇觸淵衊(鑰醖鹹襯製壓鏇觸醖齋) = 鬱構願襯夢蓋網獵齋膚 獵遞築鹹繭淵艱鹽顧鏇 (艱膚襯築蓋壓夢獵糧醖, 衊獵顧淵鹹憲鑰廠製顧 ~ 蓋製願憲鹽衊製糧鏇蓋) 更多 |