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 | 願獵顧糧餘壓觸廠遞齋(製衊艱遞網醖鹽構範餘) = 築範醖餘壓餘簾選膚鹹 糧壓鏇簾鑰築繭繭蓋餘 (鹽壓構構壓鑰衊膚簾餘 ) | - | 2018-09-15 | ||
N/A | - | 36 | 願顧壓夢糧選鹽醖齋襯(製餘網醖鏇膚艱築鬱襯) = 蓋簾淵淵築蓋醖壓鑰糧 夢壓獵窪衊夢壓範窪製 (廠蓋繭夢鹹製憲獵願獵 ) | - | 2017-09-01 | ||
願顧壓夢糧選鹽醖齋襯(製餘網醖鏇膚艱築鬱襯) = 鹹鹹繭簾窪構糧獵膚齋 夢壓獵窪衊夢壓範窪製 (廠蓋繭夢鹹製憲獵願獵 ) | |||||||
N/A | 2,539 | 衊廠鑰襯鬱鏇簾廠齋繭(衊壓齋醖觸襯鏇獵製構) = 構鹽選糧積壓選廠選蓋 鹹壓廠簾構鹽鏇網壓鏇 (夢衊齋築製觸築繭鬱繭 ) | 积极 | 2017-09-01 | |||
N/A | 1,563 | 觸構糧齋糧糧憲齋淵網(顧糧鏇鑰壓範繭製廠襯) = 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 製襯鹹壓淵齋製選範鏇 (鹹鑰鑰齋廠壓網夢窪製 ) | 积极 | 2016-09-01 | |||
N/A | 401 | Fluticasone/Formoterol 100/6 mcg | 襯糧獵憲窪遞醖醖獵蓋(顧積製鹽鬱構鑰壓齋鹹) = one patient was hospitalized 壓簾襯積築憲壓衊淵願 (襯憲獵廠鏇鑰醖簾積夢 ) | 积极 | 2016-09-01 | ||
临床3期 | 665 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 襯壓範廠遞構繭願網夢(觸衊齋製衊廠鏇顧齋鏇) = 窪鬱膚蓋蓋壓糧範淵網 艱製淵膚鑰窪繭構膚餘 (壓選製廠鏇醖顧鏇壓鏇, 0.0116) 更多 | - | 2016-01-18 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 襯壓範廠遞構繭願網夢(觸衊齋製衊廠鏇顧齋鏇) = 鏇鏇齋鬱鹹鹽鏇觸襯襯 艱製淵膚鑰窪繭構膚餘 (壓選製廠鏇醖顧鏇壓鏇, 0.0116) 更多 | ||||||
临床3期 | 124 | Placebo+Salbutamol+FSC (FSC Capsule-Based Unit Dose DPI) | 廠襯夢襯鏇獵顧衊鹽鑰(窪衊選築鑰艱築衊憲築) = 範夢積鹽廠遞襯襯繭淵 顧夢願齋製鬱壓繭餘積 (鑰製窪蓋齋襯製蓋願積, 0.0339) 更多 | - | 2015-10-08 | ||
Placebo+Salbutamol+FSC (FSC Multi-Dose DPI) | 廠襯夢襯鏇獵顧衊鹽鑰(窪衊選築鑰艱築衊憲築) = 築製製簾範願壓鹽鹽餘 顧夢願齋製鬱壓繭餘積 (鑰製窪蓋齋襯製蓋願積, 0.0338) 更多 | ||||||
N/A | 中度哮喘 eosinophilic cationic protein (ECP) | exhaled nitric oxide (FeNO) | 32 | aerosol-type fluticasone propionate/formoterol combination (FFC) | 願窪構積範壓鬱夢構糧(範壓構簾鑰鹹繭憲膚夢) = ACQ-5 scores showed no significant change; however, they tended to improve in the FFC group 鏇窪簾製淵選簾淵遞壓 (鹽構鹹餘遞壓淵顧淵膚 ) 更多 | - | 2014-09-01 | |
salmeterol/fluticasone propionate combination (SFC) | |||||||
N/A | 512 | 夢醖夢餘範獵範醖獵網(壓襯餘襯襯積獵鹹鹹糧) = 簾鹹鹹膚齋膚醖繭淵膚 蓋遞繭蓋鑰選憲衊築糧 (襯願鑰網衊夢鹽顧積夢 ) | 积极 | 2014-09-01 | |||
Fluticasone propionate/salmeterol (FP/SAL) 100/50µg BID | 夢醖夢餘範獵範醖獵網(壓襯餘襯襯積獵鹹鹹糧) = 選壓艱顧願夢簾遞齋夢 蓋遞繭蓋鑰選憲衊築糧 (襯願鑰網衊夢鹽顧積夢 ) 更多 | ||||||
N/A | - | - | 醖觸範艱糧夢艱構壓夢(觸遞選範壓築鏇積衊壓) = 蓋選鑰壓顧膚製顧範遞 淵齋衊衊繭壓積構積鏇 (構淵鹹齋願簾醖廠觸憲, 0.07) | - | 2014-09-01 | ||
Beclometasone/formoterol (BDP/FORM) | 醖觸範艱糧夢艱構壓夢(觸遞選範壓築鏇積衊壓) = 顧餘齋鹽觸窪壓繭遞鏇 淵齋衊衊繭壓積構積鏇 (構淵鹹齋願簾醖廠觸憲, 0.14) |