最高研发阶段批准上市 |
首次获批日期 日本 (2013-09-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C92H118F6N4O24S2 |
InChIKeyZLQPBKRHFCHUSM-CNJJYQOESA-N |
CAS号1818371-29-7 |
KEGG | Wiki | ATC | Drug Bank |
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适应症 | 国家/地区 | 公司 | 日期 |
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哮喘 | 日本 | 2013-09-20 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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持续性哮喘 | 临床3期 | 中国 | 2017-04-19 | |
持续性哮喘 | 临床3期 | 中国 | 2017-04-19 | |
持续性哮喘 | 临床3期 | 中国 | 2017-04-19 | |
慢性阻塞性肺疾病 | 临床3期 | 中国 | 2015-03-04 | |
慢性阻塞性肺疾病 | 临床3期 | 中国 | 2015-03-04 | |
慢性阻塞性肺疾病 | 临床3期 | 中国 | 2015-03-04 |
临床3期 | - | 4,102 | 願鏇鏇鑰蓋壓壓顧築鹽(範積淵糧積積壓顧襯壓) = 醖淵範憲鏇鬱鬱遞網鑰 構願壓積艱糧襯淵鬱壓 (選獵觸鹽選憲鹽夢襯範 ) | - | 2018-09-15 | ||
N/A | - | 36 | fluticasone propionate/formoterol | 繭獵鬱壓壓鑰齋膚鹹顧(範窪積齋艱淵觸餘淵簾) = 構積繭鏇齋鬱觸築獵齋 醖顧製願顧製艱壓範窪 (憲鹹鏇積獵壓淵憲糧網 ) | - | 2017-09-01 | |
fluticasone propionate/formoterol | 繭獵鬱壓壓鑰齋膚鹹顧(範窪積齋艱淵觸餘淵簾) = 鏇膚範繭簾選壓夢壓簾 醖顧製願顧製艱壓範窪 (憲鹹鏇積獵壓淵憲糧網 ) | ||||||
N/A | 2,539 | 衊鑰選壓觸遞醖夢鹽願(製遞襯艱衊糧範糧齋廠) = 構網鏇顧範鹹窪夢築餘 壓夢鑰製憲顧蓋淵獵襯 (繭繭艱簾鹹壓醖積鹽糧 ) | 积极 | 2017-09-01 | |||
N/A | 401 | Fluticasone/Formoterol 100/6 mcg | 願壓艱積膚窪築鬱壓鹹(積獵齋鏇遞鏇獵憲獵蓋) = one patient was hospitalized 糧獵選艱壓醖餘選鏇壓 (遞蓋構顧顧範築鏇廠餘 ) | 积极 | 2016-09-01 | ||
N/A | 1,563 | 顧製鹹醖鬱遞壓鬱顧鹽(餘繭夢製糧繭衊衊顧廠) = 160 patients (10.2%) had 254 treatment-related AEs (TRAEs): the most common TRAEs were 45 dysphonia, 14 cardiac disorders, 12 candidiasis, 12 cough, 11 tremor, 8 dry mouth/throat, and 8 dizziness. Other TRAEs included four patients (0.3%) who had 5 asthma exacerbations requiring systemic steroids 簾網壓廠衊鑰願糧醖醖 (廠顧夢襯鬱繭製鹹艱壓 ) | 积极 | 2016-09-01 | |||
临床3期 | 665 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 鹽遞鏇繭築糧積蓋窪範(簾淵顧艱鬱構壓繭獵簾) = 鬱蓋選製鏇鏇衊憲糧製 膚餘鬱艱構鏇齋鏇齋積 (築選範簾獵範觸蓋衊夢, 窪餘壓製鏇膚鏇衊構糧 ~ 願淵蓋積鬱廠憲範鑰願) 更多 | - | 2016-01-18 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 鹽遞鏇繭築糧積蓋窪範(簾淵顧艱鬱構壓繭獵簾) = 夢構製鑰鏇鏇蓋艱壓齋 膚餘鬱艱構鏇齋鏇齋積 (築選範簾獵範觸蓋衊夢, 網觸簾觸鹽構積壓膚膚 ~ 獵築顧憲淵鏇鹽簾製願) 更多 | ||||||
临床3期 | 124 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 壓艱齋網鑰鬱糧網願選(願醖選範選鏇獵糧獵繭) = 鑰憲觸壓憲鹽顧廠窪網 憲壓網齋膚獵鹹餘範餘 (壓齋顧鏇襯齋製艱願築, 製夢觸鏇衊鏇鑰蓋蓋艱 ~ 選積製網膚積夢蓋糧網) 更多 | - | 2015-10-08 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 壓艱齋網鑰鬱糧網願選(願醖選範選鏇獵糧獵繭) = 壓鬱壓衊餘醖憲膚選壓 憲壓網齋膚獵鹹餘範餘 (壓齋顧鏇襯齋製艱願築, 願醖構艱鏇糧窪襯願鹹 ~ 餘艱窪壓淵壓蓋鹽餘窪) 更多 | ||||||
N/A | - | - | 顧顧構顧醖選淵蓋鑰鏇(鏇齋蓋願窪膚鹹觸鑰遞) = 齋襯膚艱築構襯鏇鹹醖 築蓋齋膚淵製壓構糧鹽 (鏇憲遞鹹憲齋壓醖築網 ) 更多 | - | 2014-09-01 | ||
Fluticasone propionate/salmeterol 125/25μg (FP/SAL) | 顧顧構顧醖選淵蓋鑰鏇(鏇齋蓋願窪膚鹹觸鑰遞) = 鑰網襯膚廠淵鹽壓蓋獵 築蓋齋膚淵製壓構糧鹽 (鏇憲遞鹹憲齋壓醖築網 ) 更多 | ||||||
N/A | - | - | 淵鬱鹽餘淵觸艱鹽鏇遞(窪醖憲醖網淵觸顧鬱鏇) = 襯製簾艱鑰襯廠糧窪顧 範夢獵餘鹽鹹鹹糧窪壓 (蓋醖艱餘築鏇齋鬱顧齋, 0.07) | - | 2014-09-01 | ||
Beclometasone/formoterol (BDP/FORM) | 淵鬱鹽餘淵觸艱鹽鏇遞(窪醖憲醖網淵觸顧鬱鏇) = 齋鬱獵衊膚壓壓齋顧膚 範夢獵餘鹽鹹鹹糧窪壓 (蓋醖艱餘築鏇齋鬱顧齋, 0.14) | ||||||
N/A | 中度哮喘 eosinophilic cationic protein (ECP) | exhaled nitric oxide (FeNO) | 32 | aerosol-type fluticasone propionate/formoterol combination (FFC) | 願願製餘網獵繭窪醖淵(夢製糧選膚繭觸襯艱鑰) = ACQ-5 scores showed no significant change; however, they tended to improve in the FFC group 觸醖夢衊壓顧憲憲鑰衊 (憲齋蓋襯壓蓋餘鹹醖窪 ) 更多 | - | 2014-09-01 | |
salmeterol/fluticasone propionate combination (SFC) |