{ "id": "adalimumab-humira", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Humira", "generic": "阿达木单抗", "aliases": [ "修美乐", "adalimumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "修美乐®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射：预充式笔或预充式玻璃注射器（DailyMed 2025-12 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2002", "archiveSponsorText": "AbbVie Inc. / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-humira-adalimumab-40mg-0-4ml-two-single-dose-prefilled-pens-ndc-0074-0554-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（AbbVie；2025-12 更新）", "en": "DailyMed U.S. public label (AbbVie; updated Dec 2025)" }, "dosageForm": { "zh": "HUMIRA 阿达木单抗单剂量预充式注射笔", "en": "HUMIRA adalimumab single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0074-0554-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含阿达木单抗 40 mg/0.4 mL；29G 固定针；每盒 2 支", "en": "Adalimumab 40 mg/0.4 mL per single-dose prefilled pen; fixed 29-gauge needle; 2 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humira-41.jpg&setid=608d4f0d-b19f-46d3-749a-7159aa5f933d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿达木单抗", "en": "adalimumab" }, "value": 40, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人注射量、次数、起始套装或换药规则", "en": "labelled content per single-dose prefilled pen; not an individual's injection amount, count, starter pack or switching rule" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "带 29G、1/2 英寸固定针的单剂量预充式笔", "en": "single-dose prefilled pen with fixed 29-gauge, 1/2-inch needle" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "HUMIRA PEN 两支装纸盒；每支笔置于独立剂量托盘", "en": "two-pen HUMIRA PEN carton; each pen is held in a separate dose tray" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d45ff3899a43b5a5", "label": "DailyMed（NLM）：HUMIRA 40 mg/0.4 mL 两支预充式笔美国公开标签面板（AbbVie；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humira-41.jpg&setid=608d4f0d-b19f-46d3-749a-7159aa5f933d&type=img", "alt": "HUMIRA PEN 40 mg/0.4 mL 阿达木单抗在美国 DailyMed 公开标签中的 AbbVie 2 支预充式笔包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（AbbVie Inc.，2025-12 更新）", "presentation": "HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔包装面板（NDC 0074-0554-02；DailyMed 公开标签所列；AbbVie 包装面板）。", "notice": "此为美国 DailyMed 公开标签中明确对应 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔（NDC 0074-0554-02）的 AbbVie 包装面板，只帮助核对品牌、通用名、标示强度、注射体积、皮下注射、装置、包装数量和来源；不用于鉴定真伪，也不证明 80 mg/0.8 mL、40 mg/0.8 mL、20 mg/0.2 mL、10 mg/0.1 mL、预充式玻璃注射器、起始套装、其他包装、其他市场标签、当前包装、原研/生物类似药关系、目标市场批准或可售资格。", "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "HUMIRA 说明书放大阅读：mg、mL、装置和盒数必须一起核对", "en": "HUMIRA label reading: check mg, mL, device and carton count together" }, "summary": { "zh": "本模块以 DailyMed 2025-12 美国标签为阅读入口，帮助核对 HUMIRA、adalimumab、皮下注射、预充式笔/玻璃注射器、mg/mL 与包装数量；不把包装信息变成个人注射、加量、换药或联合方案。", "en": "This module uses the DailyMed U.S. label updated in December 2025 as a reading entry point. It helps check HUMIRA, adalimumab, subcutaneous use, prefilled pen/syringe, mg/mL and carton count; it does not turn packaging information into an individual injection, adjustment, switch or combination plan." }, "checks": [ { "zh": "本页展示的图只对应 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔。40 mg 和 0.4 mL 必须作为同一产品身份一起读；“2 支”是该盒包装数量，不自动等于个人应使用的次数或周期。", "en": "The image on this page is only for HUMIRA PEN 40 mg/0.4 mL, two single-dose prefilled pens. Read 40 mg and 0.4 mL together as one product identity; “two pens” is the carton quantity, not an automatic statement of an individual schedule or number of uses." }, { "zh": "同一标签列有 80 mg/0.8 mL、40 mg/0.8 mL、40 mg/0.4 mL、20 mg/0.2 mL、10 mg/0.1 mL 等不同呈现。mg 数字相同不代表装置、体积、包装或方案相同；不能据此自行换算、拆分、合并或改用另一盒。", "en": "The same label lists 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL and 10 mg/0.1 mL presentations. The same mg number does not prove that the device, volume, package or regimen is the same; do not self-convert, split, combine or switch cartons from that fact." }, { "zh": "预充式笔和预充式玻璃注射器都是标签中单独列示的产品呈现。照片相似、名称相同或都是皮下注射，都不足以说明装置可互换、可以拆开、补用或由他人操作；以实际处方、具体产品说明和培训要求为准。", "en": "Prefilled pens and prefilled glass syringes are separately listed product presentations in the label. A similar photograph, matching name or the same subcutaneous route does not show that devices are interchangeable, may be opened, made up or administered by another person; use the actual prescription, product instructions and required training." }, { "zh": "标签含有严重感染、恶性肿瘤等重要警示，并对其他生物制品和活疫苗列出相互作用/使用边界。发热、感染症状、暴露史、疫苗安排或正在用的全部药物都应交给负责团队核对；网页不能判断个人何时注射、暂停、联用或改用。", "en": "The label includes major warnings such as serious infections and malignancy, and lists boundaries involving other biologic products and live vaccines. Fever, infection symptoms, exposure history, vaccination plans and every current medicine need review by the responsible team; a webpage cannot decide when an individual injects, pauses, combines or changes treatment." } ], "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "阿达木单抗怎样起作用：它针对 TNF-α 信号，但机制不是自行用药规则", "en": "How adalimumab works: it targets TNF-alpha signalling, but mechanism is not a self-treatment rule" }, "summary": { "zh": "DailyMed 标签将阿达木单抗描述为 TNF 阻断剂：它特异性结合 TNF-α 并阻断其与细胞表面 TNF 受体的相互作用。该说明帮助读懂“TNF 抑制/阻断”，不能决定谁适合使用、如何切换、是否叠加或何时注射。", "en": "The DailyMed label describes adalimumab as a TNF blocker: it specifically binds TNF-alpha and blocks interaction with cell-surface TNF receptors. This helps read “TNF blockade”; it does not decide who is suitable, how to switch, whether to combine products or when to inject." }, "checks": [ { "zh": "TNF 是参与炎症和免疫反应的细胞因子；“阻断 TNF-α”描述的是药物靶点，并不等于可以从症状或某个化验值自行判断感染、疾病活动或下一针安排。", "en": "TNF is a cytokine involved in inflammatory and immune responses. “Blocking TNF-alpha” describes a drug target; it does not allow infection, disease activity or the next injection to be self-decided from symptoms or one laboratory value." }, { "zh": "机制相同、同为 TNF 抑制剂或同为生物制品，均不表示可自行叠加、交替或替代。标签对其他生物制品与活疫苗另列边界；变更前应由专业人员核对完整药单、感染风险、疫苗与具体产品。", "en": "A shared mechanism, TNF-blocker class or biologic status does not make products suitable for self-combination, alternation or substitution. The label separately sets boundaries for other biologics and live vaccines; a professional should review the complete medicine list, infection risk, vaccines and exact products before a change." }, { "zh": "包装与机制都不能替代注射装置培训、保存条件、实际处方或当地现行标签。对不确定的盒面、装置、剩余剂量或多药并用，应先让药师或负责团队核对实物与完整药单。", "en": "Neither packaging nor mechanism replaces device training, storage conditions, the actual prescription or current local labelling. For an uncertain carton, device, remaining dose or multiple medicines, have a pharmacist or the responsible team check the physical product and complete medicine list first." } ], "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新；12.1 机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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": "Humira", "generic": "阿达木单抗", "dosageFormClass": "皮下注射：预充式笔或预充式玻璃注射器（DailyMed 2025-12 标签所列）" }, "labelSource": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "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_21f4718c4b517a98", "label": "FDA：HUMIRA 2020 美国标签档案（BLA 125057）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "DailyMed 的 HUMIRA（adalimumab）2025-12 美国公开标签列示其为皮下注射用制剂、美国初始批准年份为 2002，并明确区分预充式笔与预充式玻璃注射器。此页的包装图仅对应 40 mg/0.4 mL、2 支预充式笔；不能从这一个盒面推定其他浓度、针筒、起始套装、任何个人方案、其他市场或可售状态。", "history": "本页包装图仅对应美国 DailyMed 公开标签中 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔（NDC 0074-0554-02）。同一美国标签另列 80 mg/0.8 mL、40 mg/0.8 mL、20 mg/0.2 mL、10 mg/0.1 mL，以及预充式笔和玻璃注射器等不同呈现；商品名或“阿达木单抗”名称本身不能决定装置、规格、用法或可替代性。", "sourceDocuments": [ { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_21f4718c4b517a98", "label": "FDA：HUMIRA 2020 美国标签档案（BLA 125057）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125057", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_21f4718c4b517a98", "label": "FDA: HUMIRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2020 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_21f4718c4b517a98", "label": "FDA: HUMIRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/adalimumab-humira/", "en": "https://origindrug.com/en/drugs/adalimumab-humira/" }, "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." ] }