欧盟集中审批药品

概述

本数据库收载了欧盟EMA（European Medicines Agency）经过集中程序批准在欧盟上市的2200余条药品详细信息，公众摘要、说明书等相关文件。

同时提取了授权产品信息PDF文件中药品授权编号、规格、剂型、给药途径、包装等信息，帮助用户便捷获取药品基本信息。

数据结构及样例

{
  "产品编号":"EMEA/H/C/006105",
  "药品名称":"Rytelo"
  "通用名":"imetelstat",
  "公司":"Geron Netherlands B.V.",
  "活性成分":"imetelstat",
  "活性成分（中）":"艾泰司他",
  "规格":"47 mg;188 mg",
  "剂型":"Powder for concentrate for solution for infusion",
  "剂型（中）":"注射剂",
  "给药途径":"Intravenous use",
  "给药途径（中文）":"注射",
  "批准日期":"2025-03-07",
  "拒绝申请日期":"",
  "市场状态":"Authorised",
  "撤回申请日期":"",
  "撤回批准日期":"",
  "上市许可撤销/到期/失效日期":"",
  "意见状态":"",
  "意见日期":"",
  "ATC":"L01XX80",
  "药物治疗分类":"Antineoplastic agents",
  "治疗领域":"Anemia;Myelodysplastic Syndromes",
  "适应症":"Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). "
  "孤儿药":"yes",
  "补充监测":"yes",
  "仿制药":"no",
  "生物类似药":"no",
  "加速审评":"no",
  "条件批准":"no",
  "特殊情况批准":"no",
  "先进疗法":"no",
  "优先药物":"no",
  "更新日期":"2025-03-11",
  "药物概述下载":"文件链接",
  "药品说明书":"文件链接", 
  "授权产品信息":"文件链接",
  "官网":"https://mri.cts-mrp.eu/portal/details?productnumber=HU/H/0403/003",
}