| 商品名称 | Tredaptive |
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| 适用类别 | Human |
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| 治疗领域 | Dyslipidemias |
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| 通用名/非专利名称 | laropiprant;nicotinic acid |
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| 活性成分 | laropiprant;nicotinic acid |
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| 产品号 | EMEA/H/C/000889 |
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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| 许可状态 | Withdrawn |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 | C10AD52 |
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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 | 2008/07/03 |
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| 上市许可开发者/申请人/持有人 | Merck Sharp Dohme Ltd. |
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| 人用药物治疗学分组 | Lipid modifying agents |
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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 | 2013/04/10 |
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| 修订号 | 11 |
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| 治疗适应症 | Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA-reductase inhibitors are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive. |
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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 | 2013/04/10 |
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| 最后更新日期 | 2013/05/16 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tredaptive-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tredaptive |
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