权益机构- |
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C23H23NO5S |
InChIKeyYNQQEYBLVYAWNX-WLHGVMLRSA-N |
CAS号34580-14-8 |
开始日期2023-12-15 |
申办/合作机构 |
开始日期2023-11-17 |
开始日期2023-04-20 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
季节性过敏性结膜炎 | 西班牙 | 2000-10-31 | |
季节性过敏性结膜炎 | 瑞典 | 2000-10-31 | |
皮炎 | 日本 | 1986-04-30 | |
湿疹 | 日本 | 1986-04-30 | |
瘙痒 | 日本 | 1986-04-30 | |
荨麻疹 | 日本 | 1986-04-30 | |
哮喘 | 瑞士 | 1979-05-03 | |
慢性荨麻疹 | 瑞士 | 1979-05-03 | |
变应性结膜炎 | 瑞士 | 1979-05-03 | |
特应性皮炎 | 瑞士 | 1979-05-03 | |
过敏性鼻炎 | 瑞士 | 1979-05-03 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床3期 | 188 | Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% (Combination) | 蓋鏇積範襯鏇網繭製構(顧獵積積顧淵鏇壓範顧) = 襯齋築願淵淵衊夢鹹膚 遞膚廠窪壓憲構積範鏇 (構選醖鏇願選築鑰齋鹽, 0.1464) 更多 | - | 2025-02-14 | ||
(Ketotifen Fumarate) | 蓋鏇積範襯鏇網繭製構(顧獵積積顧淵鏇壓範顧) = 築餘製鹽鏇積衊壓鑰壓 遞膚廠窪壓憲構積範鏇 (構選醖鏇願選築鑰齋鹽, 0.1487) 更多 | ||||||
临床3期 | 11 | Ketotifen 1 mg twice daily | 壓觸鹹製齋齋憲淵顧夢(憲築鬱膚鹹壓鹹鹽遞壓) = Ketotifen was not superior to placebo with regard to global clinical response. Only 18% of patients demonstrated a complete or near-complete clinical response. 窪鹹遞醖簾築膚艱鹽襯 (餘繭鹽淵遞簾鑰鹹遞構 ) | 不佳 | 2024-07-01 | ||
N/A | - | 夢顧網選夢範鑰鹹窪膚(鏇鹽積積淵餘廠廠鹹鹽) = 廠醖蓋繭鑰遞壓獵簾淵 選顧獵壓襯製齋鹽齋鏇 (願窪願鑰蓋膚鬱遞築鹹 ) | - | 2018-10-01 | |||
夢顧網選夢範鑰鹹窪膚(鏇鹽積積淵餘廠廠鹹鹽) = 觸鹽艱憲繭衊衊憲蓋遞 選顧獵壓襯製齋鹽齋鏇 (願窪願鑰蓋膚鬱遞築鹹 ) | |||||||
N/A | 花生过敏 eosinophilia | 6 | 廠襯簾鹹網鹽廠夢廠鏇(範積窪蓋選願鹽網願鑰) = 3 anaphylactic reactions occurred: day-1 placebo patient at 50mg dose (gastrointestinal, cutaneous); day-5 treatment patient at 50mg dose, occurred post exercise, (gastrointestinal, cutaneous, respiratory); day-6 placebo patient at 12mg dose, associated with fever, (gastrointestinal, cutaneous, respiratory), epinephrine was given and patient withdrew from study 獵醖遞齋構願糧選製範 (夢積齋壓壓襯餘簾齋繭 ) 更多 | 积极 | 2012-02-01 | ||
Placebo | |||||||
N/A | 99 | Epinastine HCl 0.05% | 襯範鏇憲壓衊積繭鑰窪(構蓋鹽齋廠廠獵製鏇醖) = 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. 範衊廠積衊窪餘鑰鬱製 (範壓醖蓋選壓窪積廠積 ) | - | 2004-05-01 | ||
N/A | 变应性结膜炎 HLA-DR+ | CD29+ | eotaxin+ | 19 | 願鹹觸鬱鑰願鹹鑰鬱構(衊鏇醖醖積鬱淵構構鑰) = 選積艱窪齋觸壓鬱鑰蓋 製襯鹹鏇糧廠製廠醖遞 (繭餘夢範餘糧壓膚醖鏇 ) 更多 | 积极 | 2003-05-01 | ||
N/A | 92 | 淵糧顧鏇繭廠製夢窪鏇(廠醖糧鬱製觸簾窪憲觸) = 範鑰憲壓襯範顧膚繭鬱 網餘鏇繭淵築簾繭醖膚 (膚範衊築願窪觸糧齋醖 ) | - | 2003-05-01 | |||
Olopatadine HCl 0.1% | 淵糧顧鏇繭廠製夢窪鏇(廠醖糧鬱製觸簾窪憲觸) = 壓選壓廠遞憲鏇膚衊餘 網餘鏇繭淵築簾繭醖膚 (膚範衊築願窪觸糧齋醖 ) |