欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Instanyl
适用类别Human
治疗领域Pain;Cancer
通用名/非专利名称fentanyl
活性成分Fentanyl citrate
产品号EMEA/H/C/000959
患者安全信息No
许可状态Authorised
ATC编码N02AB03
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2009/07/20
上市许可开发者/申请人/持有人Istituto Gentili S.r.l.
人用药物治疗学分组Analgesics
兽用药物治疗学分组
欧盟委员会决定日期2025/08/12
修订号40
治疗适应症Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.  Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
适用物种
兽用药物ATC编码
首次发布日期2018/05/08
最后更新日期2025/08/13
产品说明书https://www.ema.europa.eu/en/documents/product-information/instanyl-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/instanyl
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