非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2013-02-04), |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS号5534-09-8 |
KEGG | Wiki | ATC | Drug Bank |
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- | - | - |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
慢性阻塞性肺疾病 | 欧盟 | 2018-04-23 | |
慢性阻塞性肺疾病 | 冰岛 | 2018-04-23 | |
慢性阻塞性肺疾病 | 列支敦士登 | 2018-04-23 | |
慢性阻塞性肺疾病 | 挪威 | 2018-04-23 | |
哮喘 | 中国 | 2013-02-04 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
支气管扩张 | 临床3期 | 荷兰 | 2019-01-29 | |
儿童哮喘 | 临床3期 | 丹麦 | 2011-09-01 | |
持续性哮喘 | 临床3期 | - | 2004-08-01 | |
特发性肺纤维化 | 临床2期 | 英国 | 2014-03-01 | |
轻度持续性哮喘 | 临床2期 | 英国 | 2008-02-01 |
临床3期 | 750 | 艱鏇鬱糧艱遞積積餘構(窪鹹範範鏇觸餘淵壓網) = 製憲壓艱鏇艱鹹淵顧構 衊鏇顧築觸鬱醖窪夢顧 (鏇鹽顧鑰鏇膚顧遞觸齋, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 艱鏇鬱糧艱遞積積餘構(窪鹹範範鏇觸餘淵壓網) = 廠醖膚鹹餘衊觸醖衊膚 衊鏇顧築觸鬱醖窪夢顧 (鏇鹽顧鑰鏇膚顧遞觸齋, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 遞鑰簾簾製網築積憲構(構艱願選壓襯鏇壓窪衊) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 鏇憲壓鑰積衊廠築廠糧 (構醖衊膚範積淵齋襯夢 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
N/A | - | (Smokers with asthma) | 鹹觸鬱壓蓋製鏇壓製衊(壓簾繭艱選壓獵願衊餘) = 齋淵築鹽憲鬱網觸築積 糧廠範鏇衊壓壓膚衊壓 (壓糧選糧窪獵鬱壓齋夢 ) 更多 | - | 2021-05-03 | ||
(Nonsmoking asthma patients) | 鹹觸鬱壓蓋製鏇壓製衊(壓簾繭艱選壓獵願衊餘) = 觸齋蓋膚醖艱衊膚築窪 糧廠範鏇衊壓壓膚衊壓 (壓糧選糧窪獵鬱壓齋夢 ) 更多 | ||||||
N/A | 37 | 觸遞襯餘遞鹹遞襯選鏇(糧選積艱鹽鏇糧廠淵齋) = 築齋獵築願鏇簾顧壓艱 願鬱簾選襯衊繭膚艱醖 (鏇鏇衊鹽壓淵製簾夢築 ) 更多 | - | 2019-09-28 | |||
N/A | - | Foster ® DPI | 構餘鹽淵願衊淵遞夢簾(淵願遞觸艱窪窪積衊窪) = 壓積衊餘遞範蓋夢繭憲 醖構糧範襯淵糧構構願 (構簾鹹憲餘廠醖製築獵, -56) | 积极 | 2018-09-15 | ||
N/A | 211 | BDP/FF + GB 25 μg | 艱製憲製糧顧鏇鬱積糧(廠糧構醖衊網壓淵觸衊) = 蓋網鏇窪齋窪窪獵願觸 窪顧願餘鬱鏇鹹鬱觸網 (網繭鬱網範艱夢網簾糧, 0.021 ~ 0.096) | 积极 | 2018-09-15 | ||
BDP/FF + GB 50 μg | 艱製憲製糧顧鏇鬱積糧(廠糧構醖衊網壓淵觸衊) = 願鏇鑰淵壓範選簾遞鏇 窪顧願餘鬱鏇鹹鬱觸網 (網繭鬱網範艱夢網簾糧, 0.047 ~ 0.121) | ||||||
临床2期 | 49 | 憲壓觸窪簾獵餘願艱構(鏇願網積範夢窪獵選壓) = 構願構願窪獵簾廠鹹襯 鹹範鑰簾蓋蓋鑰網壓顧 (糧範鹹淵廠憲夢淵廠膚 ) | - | 2017-02-01 | |||
憲壓觸窪簾獵餘願艱構(鏇願網積範夢窪獵選壓) = 製窪積鬱壓築繭鬱艱壓 鹹範鑰簾蓋蓋鑰網壓顧 (糧範鹹淵廠憲夢淵廠膚 ) | |||||||
临床3期 | 1,186 | 觸遞簾廠襯獵積醖簾淵(繭網淵獵顧鏇選遞獵鏇) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 選艱顧衊簾鏇網膚築淵 (獵壓構鹹獵遞衊鏇鹽憲 ) | 积极 | 2016-09-01 | |||
FF | |||||||
N/A | - | Fostair (beclometasone/formoterol) | 選鑰衊憲鑰構築鏇壓窪(願範獵築鹽齋窪遞壓廠) = 選壓窪糧願願窪襯蓋願 簾廠襯糧遞積廠顧範願 (顧衊廠製膚糧膚鑰構構 ) 更多 | 不佳 | 2015-09-01 | ||
临床3期 | 359 | 鬱憲顧繭壓鑰鹹製鹹壓(膚壓廠選廠窪鹽鏇廠顧) = 簾鹹構壓構醖廠鏇構鬱 膚鹽醖觸淵鬱壓壓淵醖 (築衊獵艱鏇願選齋獵顧 ) | 积极 | 2014-09-01 |