| 商品名称 | Tigecycline Accord |
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| 适用类别 | Human |
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| 治疗领域 | Soft Tissue Infections;Intraabdominal Infections;Bacterial Infections;Skin Diseases, Infectious |
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| 通用名/非专利名称 | tigecycline |
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| 活性成分 | tigecycline |
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| 产品号 | EMEA/H/C/005114 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J01AA12 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2020/04/17 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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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 | 2025/09/25 |
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| 修订号 | 7 |
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| 治疗适应症 | Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4) Complicated intra-abdominal infections (cIAI) Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
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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 | 2020/04/24 |
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| 最后更新日期 | 2025/09/26 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tigecycline-accord-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tigecycline-accord |
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