欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Bydureon
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称exenatide
活性成分exenatide
产品号EMEA/H/C/002020
患者安全信息No
许可状态Authorised
ATC编码A10BJ01
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2011/06/17
上市许可开发者/申请人/持有人AstraZeneca AB
人用药物治疗学分组Drugs used in diabetes
兽用药物治疗学分组
审评意见日期2011/04/14
欧盟委员会决定日期2024/11/20
修订号27
治疗适应症Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
适用物种
兽用药物ATC编码
首次发布日期2017/11/10
最后更新日期2024/11/21
产品说明书https://www.ema.europa.eu/en/documents/product-information/bydureon-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/bydureon
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