欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Intuniv
适用类别Human
治疗领域Attention Deficit Disorder with Hyperactivity
通用名/非专利名称guanfacine
活性成分guanfacine hydrochloride
产品号EMEA/H/C/003759
患者安全信息No
许可状态Authorised
ATC编码C02AC02
是否额外监管Yes
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2015/09/17
上市许可开发者/申请人/持有人Takeda Pharmaceuticals International AG Ireland
人用药物治疗学分组Antihypertensives;Antiadrenergic agents, centrally acting
兽用药物治疗学分组
欧盟委员会决定日期2024/05/16
修订号13
治疗适应症Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
适用物种
兽用药物ATC编码
首次发布日期2017/10/16
最后更新日期2024/06/10
产品说明书https://www.ema.europa.eu/en/documents/product-information/intuniv-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/intuniv
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