| 商品名称 | Ketek |
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| 适用类别 | Human |
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| 治疗领域 | Sinusitis;Tonsillitis;Bronchitis, Chronic;Pharyngitis;Community-Acquired Infections;Pneumonia, Bacterial |
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| 通用名/非专利名称 | telithromycin |
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| 活性成分 | telithromycin |
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| 产品号 | EMEA/H/C/000354 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | J01FA15 |
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| 是否额外监管 | Nei |
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| 是否仿制药或hybrid药物 | Nei |
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| 是否生物类似药 | Nei |
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| 是否附条件批准 | Nei |
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| 是否特殊情形 | Nei |
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| 是否加速审评 | Nei |
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| 是否罕用药 | Nei |
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| 上市许可日期 | 2001/07/09 |
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| 上市许可开发者/申请人/持有人 | Aventis Pharma S.A. |
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| 人用药物治疗学分组 | Antibacterials for systemic use |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2017/02/07 |
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| 修订号 | 25 |
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| 治疗适应症 | When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance. Ketek is indicated for the treatment of the following infections: In patients of 18 years and older community-acquired pneumonia, mild or moderate. when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin: acute exacerbation of chronic bronchitis; acute sinusitis; In patients of 12 years and older tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2017/02/07 |
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| 最后更新日期 | 2019/06/19 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ketek-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ketek |
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