欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Panretin
适用类别Human
治疗领域Sarcoma, Kaposi
通用名/非专利名称alitretinoin
活性成分alitretinoin
产品号EMEA/H/C/000279
患者安全信息No
许可状态Withdrawn
ATC编码L01XX22
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2000/10/11
上市许可开发者/申请人/持有人Eisai GmbH
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
欧盟委员会决定日期2019/01/24
修订号17
治疗适应症Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when: lesions are not ulcerated or lymphoedematous, and; treatment of visceral KS is not required, and; lesions are not responding to systemic antiretroviral therapy, and; radiotherapy or chemotherapy are not appropriate.
适用物种
兽用药物ATC编码
首次发布日期2018/06/21
最后更新日期2021/01/11
产品说明书https://www.ema.europa.eu/en/documents/product-information/panretin-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/panretin
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