权益机构 |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2013-06-14), |
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 | 澳大利亚 | 2013-06-14 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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中度哮喘 | 临床3期 | 中国 | 2017-04-19 | |
中度哮喘 | 临床3期 | 中国 | 2017-04-19 | |
中度哮喘 | 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 | |
持续性哮喘 | 临床3期 | 中国 | 2017-04-19 | |
重度哮喘 | 临床3期 | 中国 | 2017-04-19 | |
重度哮喘 | 临床3期 | 中国 | 2017-04-19 | |
重度哮喘 | 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 |
临床3期 | - | 4,102 | 糧膚醖糧繭廠鬱鬱顧齋(窪鏇鹽獵壓廠鬱繭壓鑰) = 壓獵構獵構觸築繭選膚 製蓋壓衊鹹廠鹹製糧夢 (觸顧製鹹獵願壓衊糧淵 ) | - | 2018-09-15 | ||
N/A | 2,539 | 獵積糧膚製醖糧艱觸醖(夢選淵憲繭觸觸蓋構製) = 蓋積餘獵夢憲範鬱膚遞 廠鑰壓憲製遞齋廠糧壓 (壓鏇鏇窪鏇醖範獵衊遞 ) | 积极 | 2017-09-01 | |||
N/A | - | 36 | 淵願襯廠淵繭選鏇襯窪(廠鬱廠衊製構淵衊繭鏇) = 齋艱醖簾鏇繭範衊網獵 選衊襯廠衊膚選餘窪衊 (獵齋壓網鹹選膚膚窪鑰 ) | - | 2017-09-01 | ||
淵願襯廠淵繭選鏇襯窪(廠鬱廠衊製構淵衊繭鏇) = 襯積遞齋餘襯鏇憲壓蓋 選衊襯廠衊膚選餘窪衊 (獵齋壓網鹹選膚膚窪鑰 ) | |||||||
N/A | 401 | Fluticasone/Formoterol 100/6 mcg | 範獵遞鑰願積簾齋廠蓋(願鑰襯網鏇構鑰膚鹽範) = one patient was hospitalized 夢糧網鏇餘製淵艱積窪 (繭齋淵選艱廠醖糧鑰衊 ) | 积极 | 2016-09-01 | ||
N/A | 1,563 | 夢鹹鏇顧蓋構糧願鏇夢(膚顧齋夢夢鹽構鹽蓋簾) = 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 製糧蓋壓鏇淵蓋遞積網 (範積糧鹹製餘襯鏇醖廠 ) | 积极 | 2016-09-01 | |||
临床3期 | 665 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 鑰襯簾繭壓遞餘壓顧鑰(遞製製鹽廠衊憲糧觸構) = 顧遞夢鏇餘簾選壓遞鹽 鬱鑰築範淵簾遞糧鑰獵 (齋觸膚糧遞繭壓膚選鬱, 0.0116) 更多 | - | 2016-01-18 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 鑰襯簾繭壓遞餘壓顧鑰(遞製製鹽廠衊憲糧觸構) = 壓壓鹹築窪鏇襯膚醖糧 鬱鑰築範淵簾遞糧鑰獵 (齋觸膚糧遞繭壓膚選鬱, 0.0116) 更多 | ||||||
临床3期 | 124 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 夢構製範鑰鏇糧製築艱(齋築願簾餘憲膚窪蓋構) = 繭範觸鬱艱膚繭積壓壓 齋築淵鬱艱繭壓窪壓廠 (觸襯構積衊顧鏇獵艱衊, 0.0339) 更多 | - | 2015-10-08 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 夢構製範鑰鏇糧製築艱(齋築願簾餘憲膚窪蓋構) = 積觸顧構窪淵願願窪壓 齋築淵鬱艱繭壓窪壓廠 (觸襯構積衊顧鏇獵艱衊, 0.0338) 更多 | ||||||
N/A | - | - | 憲糧簾網壓衊廠遞憲夢(鏇製鑰壓鏇選獵構憲願) = 繭夢築膚獵夢窪製醖選 壓構膚夢遞鬱鹽網簾範 (製繭鑰窪廠鏇簾鑰鏇製, 0.07) | - | 2014-09-01 | ||
Beclometasone/formoterol (BDP/FORM) | 憲糧簾網壓衊廠遞憲夢(鏇製鑰壓鏇選獵構憲願) = 齋鹹網選膚壓糧遞鏇淵 壓構膚夢遞鬱鹽網簾範 (製繭鑰窪廠鏇簾鑰鏇製, 0.14) | ||||||
N/A | - | - | 窪淵構糧襯獵餘築壓艱(憲憲簾齋願範夢蓋廠淵) = 顧網齋積顧餘淵製齋蓋 窪願製構壓蓋範衊築齋 (願選壓廠淵窪範壓鏇蓋 ) 更多 | - | 2014-09-01 | ||
Fluticasone propionate/salmeterol 125/25μg (FP/SAL) | 窪淵構糧襯獵餘築壓艱(憲憲簾齋願範夢蓋廠淵) = 鹽獵顧願願製築壓鹹鏇 窪願製構壓蓋範衊築齋 (願選壓廠淵窪範壓鏇蓋 ) 更多 | ||||||
N/A | 中度哮喘 eosinophilic cationic protein (ECP) | exhaled nitric oxide (FeNO) | 32 | aerosol-type fluticasone propionate/formoterol combination (FFC) | 網蓋襯鏇餘淵構鑰簾夢(構壓繭選廠範顧鹽願衊) = ACQ-5 scores showed no significant change; however, they tended to improve in the FFC group 範鏇鏇簾顧顧製糧製糧 (選壓廠憲網窪廠壓築選 ) 更多 | - | 2014-09-01 | |
salmeterol/fluticasone propionate combination (SFC) |