| 商品名称 | Ibandronic Acid Teva |
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| 适用类别 | Human |
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| 治疗领域 | Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone;Osteoporosis, Postmenopausal |
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| 通用名/非专利名称 | ibandronic acid |
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| 活性成分 | ibandronic acid |
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| 产品号 | EMEA/H/C/001195 |
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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 | M05BA06 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | 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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| 上市许可日期 | 2010/09/17 |
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| 上市许可开发者/申请人/持有人 | Teva Pharma 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 | 2010/06/24 |
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| 欧盟委员会决定日期 | 2024/08/16 |
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| 修订号 | 13 |
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| 治疗适应症 | Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mg Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established. |
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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 | 2016/11/10 |
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| 最后更新日期 | 2024/08/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ibandronic-acid-teva-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ibandronic-acid-teva |
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