| 商品名称 | Myalepta |
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| 适用类别 | Human |
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| 治疗领域 | Lipodystrophy, Familial Partial |
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| 通用名/非专利名称 | metreleptin |
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| 活性成分 | Metreleptin |
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| 产品号 | EMEA/H/C/004218 |
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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 | A16AA |
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| 是否额外监管 | Yes |
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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 | Yes |
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| 是否加速审评 | No |
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| 是否罕用药 | Yes |
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| 上市许可日期 | 2018/07/30 |
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| 上市许可开发者/申请人/持有人 | Chiesi Farmaceutici S.p.A. |
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| 人用药物治疗学分组 | Other alimentary tract and metabolism products |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2018/05/31 |
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| 欧盟委员会决定日期 | 2025/11/03 |
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| 修订号 | 15 |
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| 治疗适应症 | Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. |
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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 | 2018/07/30 |
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| 最后更新日期 | 2025/11/03 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/myalepta-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/myalepta |
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