欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Wegovy
适用类别Human
治疗领域Obesity;Overweight
通用名/非专利名称semaglutide
活性成分semaglutide
产品号EMEA/H/C/005422
患者安全信息No
许可状态Authorised
ATC编码A10BJ06
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2022/01/06
上市许可开发者/申请人/持有人Novo Nordisk A/S
人用药物治疗学分组Antiobesity preparations, excl. diet products
兽用药物治疗学分组
审评意见日期2021/11/11
欧盟委员会决定日期2025/09/25
修订号12
治疗适应症Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of• ≥30 kg/m2 (obesity), or• ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with• obesity* and• body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)
适用物种
兽用药物ATC编码
首次发布日期2021/11/11
最后更新日期2025/09/30
产品说明书https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy
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