| 商品名称 | DaTSCAN |
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| 适用类别 | Human |
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| 治疗领域 | Tomography, Emission-Computed, Single-Photon;Lewy Body Disease;Parkinson Disease;Alzheimer Disease |
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| 通用名/非专利名称 | ioflupane (123l) |
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| 活性成分 | ioflupane (123l) |
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| 产品号 | EMEA/H/C/000266 |
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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 | V09AB03 |
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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 | 2000/07/27 |
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| 上市许可开发者/申请人/持有人 | GE Healthcare B.V. |
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| 人用药物治疗学分组 | Diagnostic radiopharmaceuticals |
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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 | 2024/05/16 |
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| 修订号 | 25 |
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| 治疗适应症 | This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain Parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. DaTSCAN is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia. |
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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 | 2018/07/19 |
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| 最后更新日期 | 2024/07/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/datscan-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/datscan |
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