| 商品名称 | Obodence |
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| 适用类别 | Human |
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| 治疗领域 | Osteoporosis, Postmenopausal;Osteoporosis;Bone Resorption |
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| 通用名/非专利名称 | denosumab |
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| 活性成分 | denosumab |
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| 产品号 | EMEA/H/C/006424 |
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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 | M05BX04 |
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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 | Yes |
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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 | 2025/02/12 |
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| 上市许可开发者/申请人/持有人 | Samsung Bioepis NL B.V. |
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| 人用药物治疗学分组 | Drugs for treatment of bone diseases |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2024/11/14 |
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| 欧盟委员会决定日期 | 2025/05/06 |
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| 修订号 | 1 |
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| 治疗适应症 | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1). |
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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 | 2024/11/15 |
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| 最后更新日期 | 2025/05/06 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/obodence-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/obodence |
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