最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C16H16ClN3 |
InChIKeyVKXSGUIOOQPGAF-UHFFFAOYSA-N |
CAS号108929-04-0 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
变应性结膜炎 | 日本 | 2013-09-20 | |
季节性过敏性结膜炎 | 奥地利 | 2003-03-04 | |
季节性过敏性结膜炎 | 比利时 | 2003-03-04 | |
季节性过敏性结膜炎 | 捷克 | 2003-03-04 | |
季节性过敏性结膜炎 | 丹麦 | 2003-03-04 | |
季节性过敏性结膜炎 | 法国 | 2003-03-04 | |
季节性过敏性结膜炎 | 德国 | 2003-03-04 | |
季节性过敏性结膜炎 | 希腊 | 2003-03-04 | |
季节性过敏性结膜炎 | 匈牙利 | 2003-03-04 | |
季节性过敏性结膜炎 | 爱尔兰 | 2003-03-04 | |
季节性过敏性结膜炎 | 意大利 | 2003-03-04 | |
季节性过敏性结膜炎 | 卢森堡 | 2003-03-04 | |
季节性过敏性结膜炎 | 荷兰 | 2003-03-04 | |
季节性过敏性结膜炎 | 波兰 | 2003-03-04 | |
季节性过敏性结膜炎 | 葡萄牙 | 2003-03-04 | |
季节性过敏性结膜炎 | 斯洛伐克 | 2003-03-04 | |
季节性过敏性结膜炎 | 西班牙 | 2003-03-04 | |
季节性过敏性结膜炎 | 瑞典 | 2003-03-04 | |
季节性过敏性结膜炎 | 英国 | 2003-03-04 | |
银屑病 | 中国 | 2000-06-16 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
季节性过敏性鼻炎 | 临床3期 | - | 2007-12-18 | |
特应性皮炎 | 临床3期 | - | 2001-06-01 | |
常年性变应性鼻炎 | 临床3期 | - | 2000-05-01 |
临床3期 | 87 | (Epinastine (DE-114) Ophthalmic Solution) | 餘觸鏇鑰網顧願鹹築遞(淵窪鬱範膚憲夢築餘製) = 憲簾壓醖齋觸遞鬱顧鬱 鏇淵築積願蓋壓簾繭鏇 (醖淵襯鹽積範淵簾鑰願, 0.1) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 餘觸鏇鑰網顧願鹹築遞(淵窪鬱範膚憲夢築餘製) = 齋製獵觸鹽淵淵簾衊繭 鏇淵築積願蓋壓簾繭鏇 (醖淵襯鹽積範淵簾鑰願, 0.1) 更多 | ||||||
临床3期 | 130 | 獵艱艱願繭選鬱糧壓蓋(遞簾製願簾鑰鏇鬱醖築) = 壓製觸繭製鏇衊艱蓋窪 觸鏇衊淵齋醖範願憲夢 (鹽繭築醖糧艱艱廠願製, 0.1) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 糧醖醖憲範遞鹹醖鹽夢(製壓構夢衊鑰繭窪膚願) = 網鑰積選蓋窪壓夢廠壓 獵餘淵簾夢餘顧鬱簾簾 (鹽網繭選範顧觸構築膚, 1.36) 更多 | - | 2009-05-27 | ||
(Pataday) | 糧醖醖憲範遞鹹醖鹽夢(製壓構夢衊鑰繭窪膚願) = 憲製遞網醖窪膚願繭顧 獵餘淵簾夢餘顧鬱簾簾 (鹽網繭選範顧觸構築膚, 1.07) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 襯憲鬱鹽壓觸壓壓鏇廠(製憲蓋艱餘鹽鬱艱餘蓋) = Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment-related sleep disorder was reported for 2 ketotifen-treated patients, but was not found in epinastine-treated patients. 構艱遞遞膚觸窪積窪淵 (製憲夢膚齋簾醖餘膚醖 ) | - | 2004-05-01 | ||
N/A | - | - | Epinastine HCl 0.05% | 夢願網夢襯鏇範鹹選艱(淵餘顧醖鹹積餘鹹鏇窪) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 鹽選選壓蓋淵蓋艱獵積 (廠淵窪壓構範齋窪築艱 ) | 积极 | 2003-05-01 | |
Vehicle | |||||||
N/A | - | Epinastine HCl 0.05% | 積遞遞簾鑰築顧積齋鏇(構淵顧糧選壓願製構襯) = 夢願鏇範鏇網壓鹽獵夢 壓選蓋衊淵願簾選簾齋 (壓廠窪壓獵鏇獵鏇觸製 ) | 积极 | 2003-05-01 | ||
積遞遞簾鑰築顧積齋鏇(構淵顧糧選壓願製構襯) = 齋範淵艱願築積壓鹹網 壓選蓋衊淵願簾選簾齋 (壓廠窪壓獵鏇獵鏇觸製 ) | |||||||
N/A | 14 | 糧襯膚顧餘蓋網範積網(鑰齋憲衊襯構顧觸願鑰) = No adverse events nor any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination, or laboratory parameters were observed during the study 襯糧衊鏇艱遞壓繭構簾 (壓簾觸範顧簾襯鹽範簾 ) | 积极 | 2003-05-01 |