| 商品名称 | Cubicin |
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| 适用类别 | Human |
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| 治疗领域 | Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial |
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| 通用名/非专利名称 | daptomycin |
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| 活性成分 | daptomycin |
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| 产品号 | EMEA/H/C/000637 |
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| 患者安全信息 | no |
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| 授权状态 | Authorised |
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| ATC编码 | J01XX09 |
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| 是否额外监管 | no |
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| 是否仿制药 | no |
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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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| 批准上市日期 | 2006/01/19 |
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| 上市许可持有人/公司名称 | Merck Sharp & Dohme B.V. |
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| 人用药物治疗分组 | Antibacterials for systemic use, |
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| 审评意见发布日期 | 2005/11/17 |
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| 决定日期 | 2022/12/06 |
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| 修订号 | 37 |
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| 适应症 | Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
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| 首次发布日期 | 2018/08/08 |
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| 修订日期 | 2022/12/15 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/cubicin-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cubicin |
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