| 商品名称 | Tuzulby |
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| 适用类别 | Human |
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| 治疗领域 | Attention Deficit Disorder with Hyperactivity |
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| 通用名/非专利名称 | methylphenidate hydrochloride |
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| 活性成分 | methylphenidate hydrochloride |
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| 产品号 | EMEA/H/C/005975 |
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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 | N06BA04 |
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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 | 2025/02/28 |
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| 上市许可开发者/申请人/持有人 | Neuraxpharm Pharmaceuticals S.L. |
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| 人用药物治疗学分组 | Psychoanaleptics |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2024/12/12 |
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| 修订号 | |
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| 治疗适应症 | Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms. |
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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 | 2024/12/13 |
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| 最后更新日期 | 2025/05/08 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tuzulby-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tuzulby |
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