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数据权威！全球上市药品批准数据
数据库权威整合美国、欧盟、日本等60余国/地区上市药品批准数据。涵盖药物名称、活性成分、生产企业、剂型与给药途径、说明书及审评文档等关键信息，并对多国数据完成标准化汉化。用户一键搜索即可获取目标药品全球上市数据，高效驱动药物研发与信息决策。
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数据权威！全球上市药品批准数据
数据库权威整合美国、欧盟、日本等60余国/地区上市药品批准数据。涵盖药物名称、活性成分、生产企业、剂型与给药途径、说明书及审评文档等关键信息，并对多国数据完成标准化汉化。用户一键搜索即可获取目标药品全球上市数据，高效驱动药物研发与信息决策。
1. 美国FDA批准药品
1.1概述
本数据库权威收录1939年至今美国FDA批准上市（含暂定批准）的全部药品信息，涵盖5万+项审批记录。核心数据维度包括：商品名、申请机构、申请号、活性成分、剂型与给药途径、是否参比制剂、生物等效性试验对照药标识、治疗等效性代码、药品提交类型（如NDA/BLA/ANDA）、审评类别及完整审批历史。用户可精准查询药品注册审批详情、说明书及批准文件等关键文档。
1.2 数据结构及样例
JSON格式
{
"药品名称": "ZOMIG",
"申请号": "021450",
"申请类型": "NDA（新药申请）",
"申请途径": "505(b)",
"规格": "2.5MG/SPRAY",
"剂型/给药途径": "SPRAY;NASAL",
"剂型（摩熵）": "",
"给药途径（药融云）": "",
"申报企业": "AMNEAL",
"活性成分": ["ZOLMITRIPTAN"],
"活性成分（中）": "佐米曲普坦",
"提交类型": "Type 3新剂型",
"批准日期": "",
"市场状态": ["处方药"],
"参比制剂(RLD)": "是",
"对照制剂(RS)": "是",
"治疗等效代码": "AB",
"说明书": ["Label (PDF) （2018-12-21·发布、链接：内部链接）"],
"审评文件": [
"(PDF) Pharmacology Review(s)（2003-09-30·发布、链接：内部链接1）",
"(PDF) Statistical Review(s)（2003-09-30·发布、链接：内部链接2）"
],
"官网": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=021450",
"孤儿药": "",
"橙皮书/紫皮书": "橙皮书",
"首仿药": "",
"无仿药的已过专利期及独占期药品": "",
"ATC分类": "神经系统药物>镇痛药>抗偏头痛药>选择性5-羟色胺（5HT1）促效药",
"药理分类": [""],
"辅料": "LANOLIN;PETROLATUM;WATER（示例数据）",
"黑框警告": "WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.（示例数据）",
"审评通道": ["加速审评", "竞争性仿制药疗法"],
"加速审评": [{
"FDA接收时间": "2008-11-03",
"加速审评批准时间": "2008-11-03",
"审评耗时（月）": "6",
"适应症": "FORTHETREATMENTOFGLIOBLASTOMAWITHPROGRESSIVEDISEASEFOLLOWINGPRIORTHERAPY",
"适应症加速审评的撤销状态": "Converted",
"撤销日期": "2017-05-12",
"批准依据": "Based on a Surrogate Endpoint"
}],
"突破疗法": [{
"提交序号": "SUPPLEMENT-85",
"批准时间": "2022-09-05",
"适应症": "Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency"
}],
"快速通道": [{
"批准时间": "2022-09-05",
"适应症": "Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency"
}],
"竞争性仿制疗法（CGT）": [{
"RLD名称": "ZOMIG",
"RLD申请号": "ZOMIG",
"ANDA批准日期": "2025-04-15",
"是否资格获得CGT市场排他权": "No",
"CGT市场排他权收回": "N/A",
"以CGT市场排他权上市日期": "N/A",
"官网": "https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals"
}],
"Para IV声明详情": [{
"规格": "5 mg/spray",
"ANDA申请数量": "1",
"ANDA申请日期": "2013-11-14",
"180天独占期决定状态": "Extinguished",
"180天独占期决定发布日期": "2021-01-12",
"首个申请批准时间": ""
}, {
"规格": "2.5 mg/spray",
"ANDA申请数量": "1",
"ANDA申请日期": "2016-06-09",
"180天独占期决定状态": "Extinguished",
"180天独占期决定发布日期": "2020-07-27"
}]
}
2. 欧盟集中审批药品
2.1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。
同时提供授权产品信息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。
2.2 数据结构及样例
JSON格式
{
"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"
}
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