{ "id": "imuran-azathioprine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "IMURAN", "generic": "硫唑嘌呤片", "aliases": [ "IMURAN", "Imuran", "azathioprine", "azathioprine tablets", "硫唑嘌呤", "硫唑嘌呤片", "依木兰", "NDA 016324", "54766-590-10", "IMURAN 50" ], "marketBrandNames": [ { "name": "IMURAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时供应或个人适用。", "en": "Current brand label; a regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前 IMURAN 品牌标签列出硫唑嘌呤 50 mg 刻痕口服片、NDC 54766-590-10 与 100 片瓶装面板。美国 NDA、NDC 与品牌标签不等于其他市场批准、参比身份、实时供应、购买资格或个人适用性。", "dosageFormClass": "IMURAN 硫唑嘌呤刻痕口服片：每片 50 mg，100 片瓶装。50 mg 是每片含量，100 Tablets 是整瓶片数；刻痕只作准确产品外观线索，不自动生成掰片或减量许可。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1968（FDA 审评资料）", "archiveSponsorText": "Sebela Pharmaceuticals Inc.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "IMURAN azathioprine", "IMURAN 50 mg", "硫唑嘌呤片", "依木兰" ], "excludedProductCues": [ "generic azathioprine", "AZASAN", "mercaptopurine", "6-mercaptopurine", "allopurinol", "febuxostat", "CELLCEPT", "TREXALL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-imuran-azathioprine-tablet-50mg-100-bottle-ndc-5476659010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2025-11 修订；SPL v6）", "en": "Current U.S. DailyMed brand label (revised November 2025; SPL v6)" }, "dosageForm": { "zh": "IMURAN 硫唑嘌呤刻痕口服片", "en": "IMURAN azathioprine scored oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54766-590-10", "pouchCode": null, "applicationNumber": "NDA 016324", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硫唑嘌呤 50 mg；100 片瓶装", "en": "Azathioprine 50 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=CA59010001%20Imuran.jpg&setid=606101a0-6244-7eff-e053-2a91aa0acadd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫唑嘌呤", "en": "azathioprine" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "双圆形刻痕片，约 11 mm", "en": "double-circle scored tablet, about 11 mm" }, "imprint": "IMURAN / 50", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-imuran-azathioprine-tablet-50mg-100-bottle-ndc-5476659010", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=CA59010001%20Imuran.jpg&setid=606101a0-6244-7eff-e053-2a91aa0acadd&type=img", "alt": "IMURAN 硫唑嘌呤 50 mg、NDC 54766-590-10、100 片瓶装的 DailyMed 官方纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2025-11 修订；SPL v6）", "presentation": "IMURAN 硫唑嘌呤：每片 50 mg，NDC 54766-590-10，100 片瓶装；黄色双圆形刻痕片，IMURAN / 50。", "notice": "此图只对应所引美国 50 mg、100 片瓶装标签面板，不代表通用药、其他硫唑嘌呤强度、注射剂、其他市场或实时库存，不用于鉴定真伪，也不授权分片、加减量、换药或停药。", "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IMURAN 说明书放大阅读：每片 50 mg、骨髓抑制、感染、基因与关键相互作用", "en": "IMURAN enlarged label: 50 mg per tablet, marrow suppression, infection, genetics and key interactions" }, "summary": { "zh": "50 mg 是每片硫唑嘌呤含量，100 Tablets 是整瓶片数，都不是个人用量。刻痕是本产品外观与身份线索；是否分片、如何使用或调整，必须回到准确处方、血细胞计数、肝肾功能、完整药单与治疗团队。", "en": "The 50 mg figure is the azathioprine amount per tablet and 100 Tablets is the bottle count; neither is an individual amount. The score is an appearance and identity clue. Splitting, use or adjustment requires the exact prescription, blood counts, liver and kidney function, complete medicine list and treating team." }, "checks": [ { "zh": "说明书有恶性肿瘤黑框警告，长期免疫抑制与淋巴瘤等风险相关。它不是适合自行开始、增加、轮换或与另一种免疫抑制剂叠加的普通药。", "en": "The label carries a boxed malignancy warning, and chronic immunosuppression is associated with lymphoma and other risks. This is not an ordinary medicine to self-start, increase, rotate or combine with another immunosuppressant." }, { "zh": "骨髓抑制可能造成白细胞、血小板或其他血细胞异常。说明书要求规律全血细胞计数（CBC）与血小板监测；异常出血或瘀青、发热或感染信号应尽快联系医疗团队，网页不能解读化验后替代处置。", "en": "Bone-marrow suppression can alter white cells, platelets and other blood cells. The label requires regular CBC and platelet monitoring. Unusual bleeding or bruising, fever or infection signs require prompt contact with the care team; the site cannot interpret tests and replace care." }, { "zh": "TPMT 或 NUDT15 活性降低可增加严重、危及生命的骨髓毒性风险；说明书同时明确基因型/表型检测不能替代血细胞计数。是否检测、如何解释及是否调整只由专业团队决定。", "en": "Reduced TPMT or NUDT15 activity can raise the risk of severe, life-threatening myelotoxicity. The label also states that genotype or phenotype testing cannot replace blood-count monitoring. Testing, interpretation and changes belong to the clinical team." }, { "zh": "严重细菌、病毒、真菌、原虫或机会性感染可能发生；新发神经症状还要考虑罕见但严重的 PML。不要只靠网页判断，也不要自行停用移植或免疫治疗药，须迅速联系负责团队。", "en": "Serious bacterial, viral, fungal, protozoal or opportunistic infection can occur. New neurological symptoms also require consideration of rare but serious PML. Do not rely on a website or self-stop transplant or immune therapy; promptly contact the responsible team." }, { "zh": "别嘌醇会抑制硫唑嘌呤灭活途径，非布司他与 IMURAN 同用在标签中不推荐；复方新诺明、氨基水杨酸类、利巴韦林及其他影响骨髓的药也需优先核对。网页不生成减量比例或错开时间表。", "en": "Allopurinol inhibits an azathioprine-inactivation pathway, and the label does not recommend concomitant febuxostat. Co-trimoxazole, aminosalicylates, ribavirin and other marrow-affecting medicines also require priority review. The site does not generate a reduction ratio or separation schedule." }, { "zh": "妊娠、备孕或哺乳需要尽早由相关专业团队权衡风险；2024 年 FDA 更新还涉及妊娠期肝内胆汁淤积症。不要自行停药或等待网页给出结论。", "en": "Pregnancy, pregnancy planning or breastfeeding requires early specialist risk-benefit review. A 2024 FDA update also addressed intrahepatic cholestasis of pregnancy. Do not self-stop or wait for a website conclusion." } ], "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：嘌呤代谢线索不能生成个人剂量或联用方案", "en": "Mechanism reading: purine-metabolism clues cannot generate an individual dose or combination plan" }, "summary": { "zh": "硫唑嘌呤是 6-巯基嘌呤的咪唑衍生物，许多生物学效应与后者相似；标签同时说明其生化作用精确方式尚不清楚。它及代谢物影响嘌呤代谢和核酸相关过程，从而产生免疫抑制效应。机制不能单独证明个人适合、替代监测或决定和另一种免疫抑制剂联用。", "en": "Azathioprine is an imidazolyl derivative of 6-mercaptopurine and shares many biological effects with it; the label also says the precise mode of biochemical action is not known. It and its metabolites affect purine metabolism and nucleic-acid-related processes, contributing to immunosuppression. Mechanism alone cannot prove individual suitability, replace monitoring or decide combination with another immunosuppressant." }, "checks": [ { "zh": "TPMT、NUDT15 与黄嘌呤氧化酶是理解毒性和相互作用的重要通路，但不是公众自行套用的剂量计算器。", "en": "TPMT, NUDT15 and xanthine oxidase are important pathways for understanding toxicity and interactions, not public dose calculators." }, { "zh": "即使与其他药共同用于移植或免疫疾病，也不能按共同用途、mg 或机制词自行互换、叠加或轮换。", "en": "Even when medicines share transplant or immune-disease uses, shared purpose, milligrams or mechanism terms do not permit self-interchange, combination or rotation." }, { "zh": "老人、肝肾功能变化或多药使用者的风险判断必须结合诊断、实际处方、CBC 与完整药单；机制图不能替代监测和专业复核。", "en": "Risk assessment for older adults, changed liver or kidney function, or polypharmacy requires the diagnosis, actual prescription, CBC and complete medicine list. A mechanism diagram cannot replace monitoring and professional review." } ], "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "IMURAN", "generic": "硫唑嘌呤片", "dosageFormClass": "IMURAN 硫唑嘌呤刻痕口服片：每片 50 mg，100 片瓶装。50 mg 是每片含量，100 Tablets 是整瓶片数；刻痕只作准确产品外观线索，不自动生成掰片或减量许可。" }, "labelSource": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "IMURAN 是硫唑嘌呤的美国品牌档案。50 mg 是每片含量，100 Tablets 是整瓶数量，不是应该吃几片。它是需要专业管理的免疫抑制剂：恶性肿瘤黑框警告、骨髓抑制与血细胞计数、严重感染、肝脏/胰腺反应、妊娠风险，以及别嘌醇、非布司他、复方新诺明等相互作用都应优先核对；网页不生成个人剂量、分片、停换药或基因检测决定。", "history": "FDA 审评资料记载 IMURAN NDA 016324 于 1968 年批准。2024 年 FDA 批准函记录妊娠期肝内胆汁淤积症安全标签更新；当前 DailyMed SPL v6 于 2025-11 修订，保留恶性肿瘤黑框警告并详列骨髓抑制、感染、TPMT/NUDT15 与相互作用信息。", "sourceDocuments": [ { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_9c8b683d5f0ba209", "label": "FDA：IMURAN 硫唑嘌呤 NDA 016324/S-040 补充批准函（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016324Orig1s040ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_142cd58a6efb5266", "label": "FDA：类风湿关节炎审评资料表列 IMURAN NDA 016324 于 1968 年批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 016324", "approvalTimeline": [ { "date": "1968", "title": { "zh": "IMURAN 美国批准年份", "en": "U.S. approval year for IMURAN" }, "detail": { "zh": "FDA 后续审评资料表把 IMURAN、NDA 016324 与 1968 年批准相连。", "en": "A later FDA review table links IMURAN, NDA 016324 and approval in 1968." }, "source": { "id": "src_142cd58a6efb5266", "label": "FDA：类风湿关节炎审评资料表列 IMURAN NDA 016324 于 1968 年批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2024-06-13", "title": { "zh": "FDA 妊娠安全标签补充批准", "en": "FDA pregnancy-safety labelling supplement approval" }, "detail": { "zh": "FDA 批准函记录妊娠期肝内胆汁淤积症相关标签更新。", "en": "The FDA letter records a label update concerning intrahepatic cholestasis of pregnancy." }, "source": { "id": "src_9c8b683d5f0ba209", "label": "FDA：IMURAN 硫唑嘌呤 NDA 016324/S-040 补充批准函（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016324Orig1s040ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-11-08", "title": { "zh": "当前 DailyMed 品牌标签生效", "en": "Current DailyMed brand label effective" }, "detail": { "zh": "SPL v6 列出 50 mg、100 片瓶装产品与现行安全内容。", "en": "SPL v6 lists the 50 mg, 100-tablet bottle and current safety content." }, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "本页展示一个准确 50 mg、100 片瓶装标签面板；不证明实时供应。", "en": "This page displays one exact 50 mg, 100-tablet label panel; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、参比、商品名、包装和供应尚未逐市场确认", "en": "Local approval, reference, brand, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "做了 TPMT/NUDT15 基因检测就不用查血了吗？", "en": "Does TPMT/NUDT15 testing remove the need for blood counts?" }, "answer": { "zh": "不能。当前说明书明确检测不能替代 CBC 监测；检测和化验都需要治疗团队结合实际情况解释。", "en": "No. The current label explicitly says testing cannot replace CBC monitoring; both require interpretation by the treating team." } }, { "question": { "zh": "有刻痕就能自己掰半片吗？", "en": "Does the score mean I can halve the tablet myself?" }, "answer": { "zh": "不能这样推断。刻痕用于核对准确产品外观；个人是否分片、如何调整只看准确处方和专业确认。", "en": "That cannot be inferred. The score helps identify the exact product; individual splitting and adjustment require the exact prescription and professional confirmation." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/imuran-azathioprine/", "en": "https://origindrug.com/en/drugs/imuran-azathioprine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }