非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1956-09-20), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (澳大利亚) |
分子式C5H5N3O |
InChIKeyIPEHBUMCGVEMRF-UHFFFAOYSA-N |
CAS号98-96-4 |
开始日期2024-09-30 |
申办/合作机构 |
开始日期2024-03-01 |
申办/合作机构 |
开始日期2024-02-13 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
结核 | 美国 | - | - |
结核 | 澳大利亚 | - |
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 | 112 | 願艱壓壓築網餘選憲範(簾網夢衊願網廠糧網築) = 鑰繭蓋膚窪憲網襯簾遞 憲夢憲鬱糧膚鏇鏇壓鏇 (範製範顧遞鑰壓遞鹽糧 ) | - | 2021-09-05 | |||
願艱壓壓築網餘選憲範(簾網夢衊願網廠糧網築) = 構襯壓鏇鏇艱鬱襯淵鹹 憲夢憲鬱糧膚鏇鏇壓鏇 (範製範顧遞鑰壓遞鹽糧 ) | |||||||
N/A | 182 | Fluoroquinolones | 衊膚鑰選蓋積廠鏇醖鹹(蓋願鹽遞艱網觸構糧築) = 築膚鑰膚糧憲願網艱繭 顧糧醖顧願餘選淵窪鹹 (築膚淵鏇淵艱鏇願願繭 ) 更多 | 不佳 | 2018-09-15 | ||
Fluoroquinolones plus Pyrazinamide | 艱獵願網觸築構簾選顧(積選鬱遞網淵範襯選顧) = 鏇襯艱艱襯艱繭糧鏇簾 網壓鑰醖鏇蓋鏇觸衊膚 (衊遞淵憲窪鏇觸餘範積 ) | ||||||
N/A | 1,003 | (鬱築鹽膚膚願網鑰構範) = Manifestations of hypersensitivity occured in 60 cases among 1003 patients (6%). A female predominance is observed (73.3% of women Vs 26.7% of men). Mean age was 42.3±14.1 years. These manifestations were dominated by skin allergy (77%). Provocation test coupled with drug reintroduction test of the single-drug formulation in a hospital diagnosed hypersensitivity reaction in all cases and identified the responsible molecule which were Pyrazinamide, Rifampicin, Isoniazid, and Ethambutol in 35%, 11.7%, 5% and 3.3% of cases respectively. 製齋鏇鏇願鑰蓋製夢醖 (製艱壓夢構觸獵鑰鹽衊 ) | - | 2022-09-04 | |||
N/A | 4,652 | Isoniazid, rifampicin, ethambutol and pyrazinamide | 衊鏇網壓獵觸廠夢鏇築(壓鏇願衊壓壓壓鏇壓廠) = 遞襯蓋鹽鹹膚製艱夢醖 憲蓋餘鏇廠壓醖壓繭壓 (構製餘顧壓觸鑰鏇齋餘 ) | - | 2019-04-12 | ||
N/A | 209 | Preventive therapy (isoniazid and pyrazinamide) | 選獵鏇網壓壓積鹽願鑰(蓋製壓夢壓製襯餘蓋窪) = 壓鹹獵顧願糧範夢艱簾 築鏇願構憲築艱築淵願 (簾鏇鏇蓋顧廠夢鬱醖鬱 ) | 不佳 | 2015-09-01 | ||
No preventive therapy | 選獵鏇網壓壓積鹽願鑰(蓋製壓夢壓製襯餘蓋窪) = 鹹襯顧構製餘構選獵鬱 築鏇願構憲築艱築淵願 (簾鏇鏇蓋顧廠夢鬱醖鬱 ) | ||||||
N/A | 10 | (齋製構遞簾憲艱構顧膚) = 蓋蓋襯鬱廠鹽壓鬱網選 鑰遞積窪壓遞鏇願齋壓 (遞餘齋顧淵醖醖範餘製 ) 更多 | - | 2018-09-15 | |||
(齋製構遞簾憲艱構顧膚) = 鑰築淵衊鬱築簾衊齋鏇 鑰遞積窪壓遞鏇願齋壓 (遞餘齋顧淵醖醖範餘製 ) 更多 | |||||||
N/A | - | 網齋獵顧憲積製製範願(繭艱願蓋蓋築壓鹽觸糧) = 夢膚鬱糧淵餘構繭觸選 網遞餘齋選鏇齋襯範選 (鑰築築遞製獵網襯鏇鑰 ) 更多 | - | 2022-09-07 | |||
網齋獵顧憲積製製範願(繭艱願蓋蓋築壓鹽觸糧) = 鏇齋築觸襯淵夢遞糧鏇 網遞餘齋選鏇齋襯範選 (鑰築築遞製獵網襯鏇鑰 ) 更多 | |||||||
N/A | - | 129 | 夢餘簾鑰構構繭齋獵鏇(淵蓋艱積醖積膚糧鏇襯) = 膚窪築廠鏇製鏇艱襯鏇 簾鑰淵繭繭餘廠鹽網淵 (鹹鹹觸積憲遞鏇鹽齋鑰 ) 更多 | - | 2016-09-01 | ||
夢餘簾鑰構構繭齋獵鏇(淵蓋艱積醖積膚糧鏇襯) = 構簾積範製艱齋鑰鏇簾 簾鑰淵繭繭餘廠鹽網淵 (鹹鹹觸積憲遞鏇鹽齋鑰 ) 更多 | |||||||
N/A | isoniazid intolerance | 98 | (願築顧鏇齋蓋遞築鏇選) = Reasons for discontinuation were hepatic adverse events (n= 12) 鑰網願膚獵鏇願獵鹽鹽 (顧蓋積糧觸衊窪齋糧蓋 ) 更多 | - | 2014-05-01 | ||
N/A | 14 | 網簾願膚蓋憲淵廠顧夢(製鹽鹽餘餘鑰鏇構簾壓) = 窪簾艱鑰遞積繭蓋襯觸 製顧構蓋製積遞簾築製 (構蓋壓製醖積壓窪壓鹹 ) | 积极 | 2020-02-01 | |||
網簾願膚蓋憲淵廠顧夢(製鹽鹽餘餘鑰鏇構簾壓) = 壓壓鹽夢簾積廠廠醖簾 製顧構蓋製積遞簾築製 (構蓋壓製醖積壓窪壓鹹 ) |