欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Incresync
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称alogliptin;pioglitazone
活性成分alogliptin;pioglitazone
产品号EMEA/H/C/002178
患者安全信息No
许可状态Authorised
ATC编码A10BD09
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2013/09/19
上市许可开发者/申请人/持有人Takeda Pharma A/S
人用药物治疗学分组Drugs used in diabetes;Combinations of oral blood glucose lowering drugs
兽用药物治疗学分组
审评意见日期2013/07/25
欧盟委员会决定日期2022/09/07
修订号13
治疗适应症Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).
适用物种
兽用药物ATC编码
首次发布日期2018/05/25
最后更新日期2022/09/09
产品说明书https://www.ema.europa.eu/en/documents/product-information/incresync-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/incresync
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