欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tasmar
适用类别Human
治疗领域Parkinson Disease
通用名/非专利名称tolcapone
活性成分tolcapone
产品号EMEA/H/C/000132
患者安全信息No
许可状态Authorised
ATC编码N04BX01
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1997/08/27
上市许可开发者/申请人/持有人Viatris Healthcare Limited
人用药物治疗学分组Anti-Parkinson drugs;Other dopaminergic agents
兽用药物治疗学分组
欧盟委员会决定日期2025/09/08
修订号26
治疗适应症Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
适用物种
兽用药物ATC编码
首次发布日期2018/08/08
最后更新日期2025/09/10
产品说明书https://www.ema.europa.eu/en/documents/product-information/tasmar-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tasmar
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