| 商品名称 | Actos |
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| 适用类别 | Human |
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| 治疗领域 | Diabetes Mellitus, Type 2 |
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| 通用名/非专利名称 | pioglitazone |
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| 活性成分 | pioglitazone hydrochloride |
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| 产品号 | EMEA/H/C/000285 |
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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 | A10BG03 |
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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 | 2000/10/13 |
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| 上市许可开发者/申请人/持有人 | CHEPLAPHARM Arzneimittel GmbH |
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| 人用药物治疗学分组 | Drugs used in diabetes |
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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 | 2023/08/11 |
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| 修订号 | 30 |
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| 治疗适应症 | Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. |
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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 | 2016/05/26 |
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| 最后更新日期 | 2023/08/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/actos-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/actos |
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