| 商品名称 | Actelsar HCT |
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| 适用类别 | Human |
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| 治疗领域 | Essential Hypertension |
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| 通用名/非专利名称 | telmisartan;hydrochlorothiazide |
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| 活性成分 | telmisartan;hydrochlorothiazide |
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| 产品号 | EMEA/H/C/002676 |
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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 | C09DA07 |
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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 | 2013/03/13 |
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| 上市许可开发者/申请人/持有人 | Actavis Group PTC ehf |
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| 人用药物治疗学分组 | Agents acting on the renin-angiotensin system;Angiotensin II antagonists and diuretics |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2013/01/17 |
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| 欧盟委员会决定日期 | 2025/05/08 |
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| 修订号 | 19 |
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| 治疗适应症 | Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately. |
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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 | 2018/06/19 |
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| 最后更新日期 | 2025/05/13 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/actelsar-hct-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/actelsar-hct |
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