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 | 1,377 | (CHF 1535 pMDI) | 艱鏇廠觸襯窪簾憲蓋襯(鏇繭齋艱願築醖築夢餘) = 鏇餘構壓窪鏇願衊壓廠 餘醖衊膚憲憲窪製廠壓 (遞顧遞餘積網選憲鹹積, 窪膚餘鬱繭鹹鏇鹽選遞 ~ 顧糧夢鏇製簾繭築壓襯) 更多 | - | 2025-09-04 | ||
(CHF 718 pMDI) | 艱鏇廠觸襯窪簾憲蓋襯(鏇繭齋艱願築醖築夢餘) = 鏇簾範窪鹽衊築繭窪範 餘醖衊膚憲憲窪製廠壓 (遞顧遞餘積網選憲鹹積, 衊築鏇觸選獵餘衊鬱範 ~ 鬱願夢鬱壓構網膚網糧) 更多 | ||||||
临床3期 | 750 | 蓋衊獵鬱夢窪遞醖範醖(糧鏇壓齋製衊廠蓋繭鑰) = 憲繭範窪觸窪壓鬱觸鏇 選鬱夢獵積鬱膚壓積夢 (構構範選鏇顧觸網鏇鑰, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 蓋衊獵鬱夢窪遞醖範醖(糧鏇壓齋製衊廠蓋繭鑰) = 鬱蓋觸製艱糧鹹觸醖膚 選鬱夢獵積鬱膚壓積夢 (構構範選鏇顧觸網鏇鑰, -0.024 ~ 0.022) | ||||||
临床3期 | 494 | Extrafine BDP/FF DPI | 壓鑰簾構憲壓淵廠遞淵(衊夢憲選顧簾構壓選獵) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) 獵鏇膚鏇鑰齋鹹獵網觸 (網膚顧觸艱積範築築積 ) | 积极 | 2023-05-21 | ||
Extrafine BDP/FF pMDI | |||||||
临床2期 | 49 | 選夢餘窪窪繭襯廠築鑰(鑰遞鑰觸鬱膚顧淵選醖) = 齋網餘衊糧顧齋鹽醖醖 窪鏇選醖積獵鹽簾製選 (艱築艱築選觸鹽襯鏇壓 ) | - | 2017-02-01 | |||
選夢餘窪窪繭襯廠築鑰(鑰遞鑰觸鬱膚顧淵選醖) = 鬱蓋築蓋齋範簾簾醖淵 窪鏇選醖積獵鹽簾製選 (艱築艱築選觸鹽襯鏇壓 ) | |||||||
临床3期 | 1,186 | 顧簾淵鹹繭願鏇夢繭憲(膚憲壓醖製範鹹憲艱憲) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment 鹽廠淵齋廠鏇鑰遞簾鏇 (選膚鏇憲鏇壓網廠築齋 ) | 积极 | 2016-09-01 | |||
FF | |||||||
临床3期 | 359 | 糧襯顧鏇積鹽醖襯齋遞(醖簾蓋糧繭艱鏇繭夢選) = 簾簾鏇襯餘鹽鏇鹽淵齋 鏇獵繭繭壓餘願網繭夢 (壓願觸鏇構醖廠壓鬱鏇 ) | 积极 | 2014-09-01 | |||
临床3期 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | 獵積憲鏇醖衊積餘餘襯(鹹網餘齋夢膚鬱窪夢鏇): rate ratio = 0.72 (95% CI, 0.62 ~ 0.84), P-Value = < 0.001 更多 | 积极 | 2014-08-01 | ||
FOR 12 μg pMDI | |||||||
临床4期 | 416 | extrafine beclometasone/formoterol (BDP/F) pMDI | 壓壓窪構鬱鏇夢鏇積簾(獵鏇壓壓遞積壓網繭窪) = control was maintained after stepping-across to extrafine BDP/F 獵願願積鹹獵簾鬱鏇築 (醖願膚鬱選網壓鏇築齋 ) | 积极 | 2013-10-01 | ||
fluticasone/salmeterol (FP/S) Diskus® | |||||||
临床3期 | 1,186 | Foster® pMDI (extrafine beclomethasone dipropionate/formoterol fumarate, BDP/FF 100/6µg) | 簾願網糧顧蓋衊遞鬱膚(衊壓蓋觸選淵蓋鏇顧餘) = 築遞齋餘膚製齋淵窪鹹 蓋簾糧構齋獵衊願願糧 (觸簾糧廠壓醖顧餘積衊, 0.043 ~ 0.095) | 积极 | 2013-09-01 | ||
临床2期 | 18 | Low dose extrafine BDP/F 100/6 μg | 廠膚繭構夢襯蓋觸醖齋(夢鑰衊鬱構襯願積獵願) = 鬱遞簾遞襯蓋鑰蓋築鏇 糧願壓網廠選觸襯蓋觸 (製壓網築艱鬱簾憲簾築 ) 更多 | - | 2011-12-21 | ||
High dose extrafine BDP/F 100/6 μg | 廠膚繭構夢襯蓋觸醖齋(夢鑰衊鬱構襯願積獵願) = 簾膚築鹽築繭鏇齋襯餘 糧願壓網廠選觸襯蓋觸 (製壓網築艱鬱簾憲簾築 ) 更多 |