商品名称 | Sapropterin Dipharma |
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适用类别 | Human |
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治疗领域 | Phenylketonurias |
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通用名/非专利名称 | sapropterin |
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活性成分 | Sapropterin dihydrochloride |
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产品号 | EMEA/H/C/005646 |
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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 | A16AX07 |
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是否额外监管 | no |
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是否仿制药 | 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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批准上市日期 | 2022/02/16 |
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上市许可持有人/公司名称 | Dipharma Arzneimittel GmbH |
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人用药物治疗分组 | Other alimentary tract and metabolism products, |
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审评意见发布日期 | 2021/12/16 |
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决定日期 | 2023/01/30 |
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修订号 | 3 |
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适应症 | Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment. |
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首次发布日期 | 2021/12/14 |
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修订日期 | 2023/02/20 |
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产品信息 | https://www.ema.europa.eu/en/documents/product-information/sapropterin-dipharma-epar-product-information_en.pdf |
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公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma |
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