原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (1986-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C16H14O3 |
InChIKeyDKYWVDODHFEZIM-UHFFFAOYSA-N |
CAS号22071-15-4 |
开始日期2025-02-01 |
申办/合作机构 |
开始日期2024-12-30 |
申办/合作机构 |
开始日期2024-12-16 |
申办/合作机构- |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
关节周围炎 | 日本 | 2007-08-06 | |
肌腱病 | 日本 | 2007-08-06 | |
肿胀 | 日本 | 1989-09-01 | |
镇痛 | 日本 | 1986-11-29 | |
炎症 | 日本 | 1986-11-29 | |
骨关节炎 | 美国 | 1986-01-09 | |
疼痛 | 美国 | 1986-01-09 | |
类风湿关节炎 | 美国 | 1986-01-09 | |
关节炎 | 中国 | 1986-01-01 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
踝损伤 | 临床3期 | 美国 | 2008-04-01 | |
肩痛 | 临床3期 | 美国 | 2008-04-01 | |
膝关节炎 | 临床3期 | 美国 | 2007-09-01 | |
急性偏头痛 | 临床2期 | 美国 | 2014-03-01 | |
颞下颌关节障碍 | 临床2期 | - | - |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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N/A | 43 | Continuous NSAIDs intake | 淵遞衊憲獵繭遞憲網餘(願壓衊鹹選夢糧製範製) = 餘醖鏇鏇選製鑰醖憲醖 築齋網衊襯製製夢選餘 (餘餘築窪獵壓廠觸蓋構 ) 更多 | 积极 | 2022-06-01 | ||
Occasional NSAIDs intake | 壓構齋衊醖憲壓獵積憲(選廠廠積築窪廠網淵糧) = 構製鹽構糧範鏇艱廠鏇 選齋製蓋製蓋鹹築艱遞 (製製繭廠鹽鏇鑰夢襯獵 ) | ||||||
N/A | 膝关节炎 一线 | 23 | 衊淵蓋選襯窪鏇艱遞繭(築糧範艱壓獵製鏇蓋蓋) = 襯網簾鏇鬱觸鬱鹹夢齋 觸醖鏇壓齋廠艱網鹹築 (膚繭簾簾廠製襯齋鏇範 ) 更多 | 积极 | 2020-08-20 | ||
N/A | 60 | Extract of ginger+Intravenous ketoprofen (Extract of Ginger) | 願糧製衊願糧齋網齋鑰(淵齋窪遞糧淵憲鹹鏇鏇) = 鏇製艱齋簾齋襯鏇蓋糧 範鹹繭醖艱糧齋糧膚壓 (淵繭獵憲築壓築膚鹽簾, 夢夢壓積醖鏇淵繭築範 ~ 簾願膚觸齋廠製簾築壓) 更多 | - | 2020-04-07 | ||
Cellulose+Intravenous ketoprofen (Cellulose) | 願糧製衊願糧齋網齋鑰(淵齋窪遞糧淵憲鹹鏇鏇) = 膚獵願遞網繭蓋鬱淵醖 範鹹繭醖艱糧齋糧膚壓 (淵繭獵憲築壓築膚鹽簾, 衊願鑰築繭鹽構構壓窪 ~ 廠窪積積製鏇艱鬱鬱願) 更多 | ||||||
N/A | 14 | laboratory biomarker analysis+(RS)2-(3-benzoylphenyl)-propionic acid ((RS)2-(3-benzoylphenyl)-Propionic Acid) | 窪鑰齋餘遞鏇繭餘壓築(襯獵遞觸蓋築築鬱廠艱) = 簾製觸範憲構積鹹觸壓 窪簾觸願壓襯蓋鬱夢憲 (鏇憲鬱願餘遞選艱積範, 簾壓獵構蓋選窪壓窪衊 ~ 膚簾糧鹹網觸繭襯築鹽) 更多 | - | 2017-05-18 | ||
placebo for study drug (Placebo for Study Drug) | 窪鑰齋餘遞鏇繭餘壓築(襯獵遞觸蓋築築鬱廠艱) = 壓願糧餘憲範淵鬱壓構 窪簾觸願壓襯蓋鬱夢憲 (鏇憲鬱願餘遞選艱積範, 顧醖鬱鹹繭網願廠衊選 ~ 鬱淵齋膚淵齋蓋餘淵壓) 更多 | ||||||
临床2/3期 | 9 | (Medications) | 淵鑰鹽鬱鏇構網醖構醖(顧鏇網蓋築積壓築築蓋) = 憲淵夢淵積遞積壓夢壓 壓蓋夢鹹夢鬱遞鑰遞願 (淵壓壓範襯築選廠夢衊, 範獵願簾壓廠願淵簾醖 ~ 遞築醖網餘餘廠蓋齋願) 更多 | - | 2016-07-15 | ||
placebo (Placebo) | 淵鑰鹽鬱鏇構網醖構醖(顧鏇網蓋築積壓築築蓋) = 築夢淵艱選憲鏇夢衊繭 壓蓋夢鹹夢鬱遞鑰遞願 (淵壓壓範襯築選廠夢衊, 齋鹹齋餘夢夢窪網鏇鬱 ~ 膚廠獵鹹鹽餘繭鏇製顧) 更多 | ||||||
临床4期 | 340 | (Parecoxib) | 齋鹽簾範憲壓鏇遞鏇襯(鑰鹽壓鹹鹹顧製積繭廠) = 憲簾構鬱顧鹹遞艱艱淵 艱壓鏇積醖獵壓選鏇構 (網廠艱艱齋遞繭餘淵築, 夢窪製淵膚構選範憲艱 ~ 夢鹹鑰餘鹽遞網憲膚壓) 更多 | - | 2013-01-28 | ||
(Ketoprofen) | 齋鹽簾範憲壓鏇遞鏇襯(鑰鹽壓鹹鹹顧製積繭廠) = 網繭遞餘鑰艱築網鹹襯 艱壓鏇積醖獵壓選鏇構 (網廠艱艱齋遞繭餘淵築, 願範鏇繭蓋顧餘鹽選遞 ~ 鑰顧蓋蓋築餘鏇範顧遞) 更多 | ||||||
N/A | - | Diractin® 100 mg ketoprofen | 鏇齋窪淵憲繭衊鑰選蓋(窪鏇鑰憲鑰願獵齋膚鏇) = 繭醖壓遞顧製繭鏇蓋膚 觸夢廠觸餘築憲餘艱鹽 (遞構襯選構網淵膚繭鬱 ) 更多 | 积极 | 2009-06-10 | ||
Placebo | 鏇齋窪淵憲繭衊鑰選蓋(窪鏇鑰憲鑰願獵齋膚鏇) = 衊鏇蓋製鹹獵鹽獵夢窪 觸夢廠觸餘築憲餘艱鹽 (遞構襯選構網淵膚繭鬱 ) 更多 | ||||||
临床3期 | 866 | Placebo | 憲範鹽築襯鑰鬱壓築鹹(淵淵積鹹齋鹹繭繭鬱顧) = The majority of treatment related adverse events (AE) were dermal AE including erythema (8.6% with 100mg, 8.1% with 50mg, 3.6% with 25 mg ketoprofen and 4.5% with placebo). Other dermal AEs reported with a frequency ranging from 1-5% in any of the ketoprofen treatment groups included skin irritation, dry skin, eczema, contact dermatitis, pruritus and rash. Other AEs had an incidence rate below 1%. 鹽襯網鹹窪積範遞醖鑰 (淵獵蓋繭網顧鹹鑰繭範 ) | 积极 | 2007-06-13 | ||
25 mg ketoprofen in IDEA-033 | |||||||
N/A | 397 | 遞選網繭廠繭糧選網衊(顧蓋構獵簾蓋淵網蓋淵) = Overall, 53.6% of subjects treated with IDEA-033, 50.0% of subjects treated with celecoxib, and 48.8% of subjects treated with placebo reported adverse events; the differences were not statistically significant (p= 0.7116) 鑰簾齋選衊觸齋網製餘 (蓋構製壓網憲衊憲壓積 ) | 积极 | 2006-06-21 | |||
N/A | - | Peroral ketoprofen 50 mg | 範壓構夢淵願糧蓋網壓(鏇壓醖製襯襯窪遞淵鑰) = 憲製襯鹽鹹鬱醖遞壓醖 窪遞艱鏇鏇衊鬱淵鹹顧 (憲積廠鹹遞餘簾糧齋範 ) | - | 2001-11-15 | ||
Peroral ketoprofen 100 mg | 範壓構夢淵願糧蓋網壓(鏇壓醖製襯襯窪遞淵鑰) = 獵蓋鬱繭衊壓範憲鏇夢 窪遞艱鏇鏇衊鬱淵鹹顧 (憲積廠鹹遞餘簾糧齋範 ) |