| 商品名称 | Selincro |
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| 适用类别 | Human |
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| 治疗领域 | Alcohol-Related Disorders |
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| 通用名/非专利名称 | nalmefene |
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| 活性成分 | nalmefene hydrochloride dihydrate |
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| 产品号 | EMEA/H/C/002583 |
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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 | N07BB05 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | 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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| 上市许可日期 | 2013/02/24 |
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| 上市许可开发者/申请人/持有人 | H. Lundbeck A/S |
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| 人用药物治疗学分组 | Drugs used in alcohol dependence |
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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 | 2025/10/07 |
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| 修订号 | 15 |
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| 治疗适应症 | Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment. |
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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 | 2017/12/08 |
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| 最后更新日期 | 2025/10/07 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/selincro-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/selincro |
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