{ "id": "dupixent", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "DUPIXENT", "generic": "度普利尤单抗", "aliases": [ "DUPIXENT", "dupilumab", "度普利尤单抗" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DUPIXENT 当前公开标签（DailyMed 页面 2026-04-22 更新；本档案仅核对所列 300 mg/2 mL 双支预充式注射器纸盒）", "dosageFormClass": "皮下注射液：单剂量预充式注射器（带针头保护装置）；本档案只对应所列 300 mg/2 mL、2 支纸盒", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下", "routeCode": "subcutaneous", "historicalApprovalEntry": "2017（FDA 标签所列 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-aventis U.S. LLC / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DUPIXENT 预充式注射笔", "DUPIXENT 200 mg/1.14 mL", "dupilumab 200 mg/1.14 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dupixent-dupilumab-300mg-2ml-two-prefilled-syringes-ndc-0024-5914-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-04-22 更新）", "en": "U.S. DailyMed public label (updated 22 Apr 2026)" }, "dosageForm": { "zh": "皮下注射液：单剂量预充式注射器（带针头保护装置）", "en": "subcutaneous injection: single-dose pre-filled syringe with needle shield" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0024-5914-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_prefilled_syringe", "primaryDisplay": { "zh": "每支预充式注射器：度普利尤单抗 300 mg/2 mL（150 mg/mL）；2 支单剂量预充式注射器纸盒", "en": "Dupilumab 300 mg/2 mL (150 mg/mL) per pre-filled syringe; carton of 2 single-dose pre-filled syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780&name=dupixent-126.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度普利尤单抗", "en": "dupilumab" }, "value": 300, "unit": "mg", "basisCode": "per_prefilled_syringe", "basisLabel": { "zh": "每支预充式注射器的标签标示量；不是个人注射量或换算", "en": "labelled amount per pre-filled syringe; not an individual injection amount or conversion" } } ], "concentration": null, "container": { "typeCode": "prefilled_syringe_with_needle_shield", "typeLabel": { "zh": "带针头保护装置的单剂量预充式注射器", "en": "single-dose pre-filled syringe with needle shield" }, "fill": null, "countPerPackage": 2, "countUnit": { "zh": "支/盒", "en": "syringes per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose pre-filled syringes per carton" } }, "physicalClues": { "color": { "zh": "蓝绿色调纸盒", "en": "blue-green carton" }, "shape": { "zh": "2 支单剂量预充式注射器纸盒", "en": "carton of 2 single-dose pre-filled syringes" }, "imprint": "DUPIXENT / dupilumab / 300 mg/2 mL / NDC 0024-5914-01", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dupixent-dupilumab-300mg-2ml-two-prefilled-syringes-ndc-0024-5914-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780&name=dupixent-126.jpg&type=img", "alt": "DUPIXENT 度普利尤单抗在美国 DailyMed 当前标签中的 300 mg/2 mL、NDC 0024-5914-01、2 支单剂量预充式注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（2026-04-22 更新）", "presentation": "DUPIXENT：度普利尤单抗 300 mg/2 mL（150 mg/mL），NDC 0024-5914-01，2 支单剂量预充式注射器纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 DUPIXENT、度普利尤单抗、300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01 与 2 支单剂量预充式注射器纸盒。它只帮助核对产品身份和来源；不用于鉴定真伪，也不证明预充式注射笔、200 mg/1.14 mL、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的使用方案。", "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DUPIXENT 说明书放大阅读：先分清 300 mg/2 mL、150 mg/mL 与准确注射装置", "en": "DUPIXENT label reading: first distinguish 300 mg/2 mL, 150 mg/mL and the exact delivery device" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 DUPIXENT 300 mg/2 mL 双支单剂量预充式注射器纸盒、NDC 与标签入口。它不提供个人注射量、时间表、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only the DUPIXENT 300 mg/2 mL carton of two single-dose pre-filled syringes, NDC and label route in the current U.S. DailyMed public label. It provides no individual injection amount, schedule, missed-use handling, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "核对时要把 DUPIXENT、度普利尤单抗、300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01、2 支单剂量预充式注射器、给药途径和目标市场放在一起看。只看到“dupilumab”“300 mg”或相近外盒颜色，不足以证明另一种笔式装置、强度、包装或国家/地区产品相同。", "en": "For checking, keep DUPIXENT, dupilumab, 300 mg/2 mL (150 mg/mL), NDC 0024-5914-01, two single-dose pre-filled syringes, route and target market together. Seeing only “dupilumab,” “300 mg,” or a similar carton colour does not establish that a pen device, strength, package or product in another country is the same." }, { "zh": "300 mg/2 mL 是这支准确产品的总标示量和体积，150 mg/mL 是浓度；二者都不是个人应使用多少或多久使用一次的指令。不要按包装数字自行推算、合并或替代其他强度或装置。", "en": "300 mg/2 mL is the labelled total amount and volume for this exact product, while 150 mg/mL is the concentration; neither is an instruction for how much or how often an individual should use it. Do not calculate, combine or substitute another strength or device from package numbers." }, { "zh": "本标签面板对应带针头保护装置的单剂量预充式注射器，不等同于预充式注射笔。装置操作、准备、遗漏、损坏、外观异常、储存或处置问题，应以手中准确产品的现行说明书和医生/药师指导为准；不要用网页替代实际产品说明。", "en": "This label panel is for a single-dose pre-filled syringe with needle shield, not a pre-filled pen. Device operation, preparation, missed use, damage, an unusual appearance, storage or disposal questions require the current instructions for the actual product and clinician/pharmacist guidance; do not use this webpage in place of the product instructions." }, { "zh": "如果担心过敏样反应、呼吸困难、面部或喉部肿胀、明显不适或其他急性问题，应立即使用当地紧急或医疗支持；不要因为网页上的通用信息自行继续、暂停或更换注射产品。", "en": "If concerned about an allergy-like reaction, breathing difficulty, swelling of the face or throat, marked illness or another acute problem, use local emergency or medical support immediately; do not independently continue, pause or change an injectable product from general web information." } ], "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度普利尤单抗的机制阅读：标签列为白细胞介素-4 受体 α 拮抗剂", "en": "Mechanism reading for dupilumab: the label classifies it as an interleukin-4 receptor alpha antagonist" }, "summary": { "zh": "美国 DUPIXENT 标签将度普利尤单抗列为白细胞介素-4 受体 α 拮抗剂。这个术语帮助读取产品的药理类别；它不预测某个人的症状、适用性、反应速度、联用选择或是否应改变治疗。", "en": "The U.S. DUPIXENT label classifies dupilumab as an interleukin-4 receptor alpha antagonist. This term helps read the product’s pharmacologic category; it does not predict an individual’s symptoms, suitability, response speed, co-use choice or whether treatment should change." }, "checks": [ { "zh": "药理类别不能替代对实际诊断、症状严重程度、既往反应、同时用药或手中准确装置的专业核对。不要因为机制名称相同或不同而自行加用、停用、轮换或替换注射产品。", "en": "A pharmacologic class cannot replace professional review of the actual diagnosis, symptom severity, prior reactions, co-medication or exact device in hand. Do not self-add, stop, alternate or replace an injectable product because a mechanism name is the same or different." }, { "zh": "同一通用名出现于不同强度、包装、装置或市场时，机制不会证明这些产品可互换。需要比较时，应先让专业人员核对准确产品、目标市场现行标签和完整用药清单。", "en": "When the same generic name appears in different strengths, packages, devices or markets, mechanism does not prove those products are interchangeable. For a comparison, first have a professional check the exact product, current label for the target market and complete medicine list." }, { "zh": "机制术语也不能解释注射部位问题、急性不适或是否应继续治疗。出现急性或明显不适时，应按当地紧急或医疗渠道处理，并让负责团队结合实际产品判断。", "en": "A mechanism term also cannot explain an injection-site concern, an acute illness or whether treatment should continue. With an acute or marked concern, use local emergency or clinical pathways and have the responsible team assess the actual product." } ], "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DUPIXENT", "generic": "度普利尤单抗", "dosageFormClass": "皮下注射液：单剂量预充式注射器（带针头保护装置）；本档案只对应所列 300 mg/2 mL、2 支纸盒" }, "labelSource": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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." } }, { "source": { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": "2026-08-20", "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": "美国 DailyMed 当前公开标签将 DUPIXENT 列为度普利尤单抗皮下注射液。此档案只帮助把商品名、通用名、准确注射装置、每支标示量、纸盒数量、NDC 与美国公开标签逐项对应；它不把标签强度、设备名称或网页文字变成个人注射量、间隔、开始、停用、换药或购买建议。", "history": "FDA 当前标签列出该产品的美国初始批准年份为 2017。本档案保留的是 2026-04-22 更新的美国公开标签入口和其中一个准确纸盒面板；不同强度、预充式注射笔、其他市场标签和后续版本均须另行核对，不能因商品名或通用名相同而自行互换。", "sourceDocuments": [ { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 761055（FDA 当前标签链接）/ DailyMed SPL setid 595f437d-2729-40bb-9c62-c8ece1f82780", "approvalTimeline": [ { "date": "2017", "title": { "zh": "当前美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "FDA 2026 年 DUPIXENT 标签列示 Initial U.S. Approval: 2017。该年份仅定位美国产品标签历史，不推定其他市场的批准、供应、可售资格、原研/仿制关系或任何个人适用性。", "en": "The FDA 2026 DUPIXENT label lists Initial U.S. Approval: 2017. This year only locates the U.S. product-label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-04-22", "title": { "zh": "DailyMed 当前公开标签更新", "en": "Current DailyMed public label updated" }, "detail": { "zh": "DailyMed 将该美国公开标签的 Updated 日期列为 2026-04-22。本页只用此版本核对 300 mg/2 mL、NDC 0024-5914-01 与 2 支单剂量预充式注射器纸盒；不据此判断实际在售、库存、购买或个人使用安排。", "en": "DailyMed lists 22 Apr 2026 as the Updated date for this U.S. public label. This page uses that version only to check 300 mg/2 mL, NDC 0024-5914-01 and the two-syringe carton; it does not establish actual marketing, stock, purchase or an individual use plan." }, "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确预充式注射器纸盒面板", "en": "Current public label and one exact pre-filled-syringe carton panel linked" }, "detail": { "zh": "本页只展示 DUPIXENT 度普利尤单抗 300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01、2 支单剂量预充式注射器（带针头保护装置）纸盒。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人注射量、时间表、装置操作、换药或可替代性。", "en": "This page displays only the DUPIXENT dupilumab 300 mg/2 mL (150 mg/mL), NDC 0024-5914-01 carton of two single-dose pre-filled syringes with needle shield. It does not authenticate a product or establish actual marketing, stock, purchase, individual injection amount, schedule, device operation, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、BLA、NDC、英文品牌、装置名称或包装图推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, BLA, NDC, English brand, device name or package image; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为度普利尤单抗，预充式注射器、预充式注射笔或不同强度能否按毫克数自行换用？", "en": "With the same generic name dupilumab, can a pre-filled syringe, a pre-filled pen or another strength be self-switched by milligram amount?" }, "answer": { "zh": "不能。装置、强度、包装、标签版本、市场和处方都属于产品身份的一部分。相同通用名或相近毫克数不建立换算或替代关系；请把实际产品和完整用药清单交给药师或开方团队核对。", "en": "No. Device, strength, package, label version, market and prescription are all parts of product identity. A shared generic name or similar milligram amount does not create a conversion or substitution relationship; take the actual product and full medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dupixent/", "en": "https://origindrug.com/en/drugs/dupixent/" }, "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." ] }