| 商品名称 | Fablyn |
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| 适用类别 | Human |
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| 治疗领域 | Osteoporosis, Postmenopausal |
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| 通用名/非专利名称 | lasofoxifene |
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| 活性成分 | Lasofoxifene tartrate |
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| 产品号 | EMEA/H/C/000977 |
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| 患者安全信息 | No |
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| 许可状态 | Lapsed |
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| ATC编码 | G03 |
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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 | 2009/02/24 |
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| 上市许可开发者/申请人/持有人 | Dr. Friedrich Eberth Arzneimittel GmbH |
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| 人用药物治疗学分组 | Sex hormones and modulators of the genital system |
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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 | 2012/02/27 |
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| 修订号 | 2 |
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| 治疗适应症 | Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (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 | 2012/02/27 |
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| 最后更新日期 | 2012/06/21 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/fablyn-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/fablyn |
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