| 商品名称 | Pioglitazone Teva Pharma |
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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/002410 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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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 | 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 | 2012/03/26 |
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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 used in diabetes |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2012/01/19 |
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| 欧盟委员会决定日期 | 2021/06/21 |
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| 修订号 | 13 |
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| 治疗适应症 | Pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained. |
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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 | 2018/01/31 |
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| 最后更新日期 | 2022/08/30 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pioglitazone-teva-pharma-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pioglitazone-teva-pharma |
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