欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Votubia
适用类别Human
治疗领域Tuberous Sclerosis
通用名/非专利名称everolimus
活性成分everolimus
产品号EMEA/H/C/002311
患者安全信息No
许可状态Authorised
ATC编码L01XE10
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2011/09/02
上市许可开发者/申请人/持有人Novartis Europharm Limited
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2011/06/23
欧盟委员会决定日期2025/11/20
修订号34
治疗适应症Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.
适用物种
兽用药物ATC编码
首次发布日期2018/07/12
最后更新日期2025/11/20
产品说明书https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/votubia
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