{ "id": "remicade", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Remicade", "generic": "英夫利昔单抗", "aliases": [ "infliximab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-06 更新；100 mg 单剂量冻干粉瓶）", "dosageFormClass": "静脉输注用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1998（美国公开标签所列初始批准）", "archiveSponsorText": "Janssen Biotech / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-remicade-infliximab-100mg-single-dose-vial-ndc-57894-030-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2025-06 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jun 2025)" }, "dosageForm": { "zh": "REMICADE 英夫利昔单抗静脉输注用冻干粉", "en": "REMICADE infliximab lyophilised powder for intravenous infusion" }, "route": { "zh": "复溶并稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after reconstitution and dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 57894-030-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含英夫利昔单抗 100 mg 白色冻干粉；每盒 1 瓶", "en": "Infliximab 100 mg white lyophilised powder per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Remicade_Carton_10378704.jpg&setid=a0a046c1-056d-45a9-bfd9-13b47c24f257&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "英夫利昔单抗", "en": "infliximab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, reconstitution or dilution plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial_lyophilised_powder", "typeLabel": { "zh": "无菌、无防腐剂白色冻干粉单剂量瓶", "en": "sterile, preservative-free white lyophilised-powder single-dose vial" }, "fill": null, "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": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "白色冻干粉（标签描述）", "en": "white lyophilised powder (label description)" }, "shape": { "zh": "100 mg 单剂量玻璃瓶及纸盒", "en": "100 mg single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 100 mg 单剂量冻干粉瓶美国公开标签面板（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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": "us-remicade-infliximab-100mg-single-dose-vial-ndc-57894-030-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Remicade_Carton_10378704.jpg&setid=a0a046c1-056d-45a9-bfd9-13b47c24f257&type=img", "alt": "REMICADE 英夫利昔单抗在美国 DailyMed Janssen Biotech 公开标签中的 100 mg 单剂量瓶纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Janssen Biotech，2025-06 更新）", "presentation": "REMICADE 注射用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶纸盒展开图（DailyMed Janssen Biotech 公开标签所列）。", "notice": "此为美国 DailyMed Janssen Biotech 公开标签中明确对应 REMICADE、英夫利昔单抗 100 mg 单剂量瓶的纸盒展开图，只帮助核对品牌、通用名、剂型、标示强度、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_a04dececdf95e1a0", "label": "DailyMed（NLM）：REMICADE 公开标签（Janssen Biotech，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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": "REMICADE 说明书放大阅读：100 mg 单剂量瓶是输注产品身份，不是居家用量", "en": "REMICADE label reading: a 100 mg single-dose vial identifies an infusion product, not an at-home amount" }, "summary": { "zh": "以 DailyMed 当前 REMICADE 美国公开标签为阅读入口，核对英夫利昔单抗、100 mg 单剂量冻干粉瓶、静脉输注制剂和目标市场；不把瓶身数字、配制文字或疾病名称变成个人剂量、家庭操作、停药或联合方案。", "en": "Using the current U.S. DailyMed public label for REMICADE as an entry point, this checks infliximab, a 100 mg single-dose lyophilised vial, intravenous infusion and target market; it does not turn vial markings, preparation text or a disease name into an individual dose, home handling, stopping or combination plan." }, "checks": [ { "zh": "100 mg 是这一个单剂量瓶的产品身份线索，不是自己该用几瓶、能否留存余量、分装或在家配制的答案。复溶、稀释、输注、监测和剩余处置应由治疗机构按现行标签和处方完成。", "en": "100 mg is a product-identity clue for this single-dose vial, not an answer to vial count, saving leftovers, sharing or preparing it at home. Reconstitution, dilution, infusion, monitoring and remaining-product handling belong to the treatment facility under the current label and prescription." }, { "zh": "同为 TNF 相关治疗、免疫调节药或静脉用药，不表示可与其他生物制剂、免疫抑制剂、激素、疫苗或感染治疗自行叠加、轮换或替代。", "en": "Being a TNF-related treatment, immune-modifying medicine or intravenous product does not permit self-combination, alternation or substitution with another biologic, immunosuppressant, steroid, vaccine or infection treatment." }, { "zh": "发热、持续咳嗽、呼吸不适、严重腹痛、异常出血、明显无力、神经变化或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "With fever, persistent cough, breathing trouble, severe abdominal pain, unusual bleeding, marked weakness, neurologic change or another acute concern, contact the treatment team promptly or use local urgent medical support." } ], "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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": "英夫利昔单抗怎样起作用：标签描述其结合并中和 TNFα 的功能", "en": "How infliximab works: the label describes binding and neutralising TNF-alpha activity" }, "summary": { "zh": "FDA 的 REMICADE 标签描述英夫利昔单抗可结合 TNFα 的可溶性和跨膜形式，并抑制其功能活性。TNFα 参与炎症和免疫反应；这解释一条免疫信号路径，不诊断炎症性疾病，也不决定个人是否适用、输注频率、合用药物或是否应转换治疗。", "en": "The FDA REMICADE label describes infliximab as binding soluble and transmembrane TNF-alpha and inhibiting its functional activity. TNF-alpha participates in inflammatory and immune responses; this explains one immune-signalling pathway, not diagnosis of inflammatory disease or individual suitability, infusion frequency, co-medication or whether to switch treatment." }, "checks": [ { "zh": "“抗 TNF”不等于所有炎症、关节痛、腹痛、皮疹或肠道症状都适合英夫利昔单抗，更不能从机制页面决定开始、延迟、停用、补用或改变输注间隔。", "en": "“Anti-TNF” does not mean every inflammatory concern, joint pain, abdominal symptom, rash or bowel symptom is suitable for infliximab, and a mechanism page cannot decide starting, delaying, stopping, redosing or changing an infusion interval." }, { "zh": "同属抗 TNF 类、都有生物制剂字样或曾对另一种产品有效/无效，都不表示可以自行叠加、轮换或替代。产品、疾病评估、感染筛查、输注设置、完整药单和现行标签必须由专科团队核对。", "en": "Being in an anti-TNF class, carrying a biologic label or having response/non-response to another product does not permit self-combination, alternation or substitution. Product, disease assessment, infection screening, infusion setting, complete medicine list and current label require specialist review." }, { "zh": "标签包含严重感染、输注反应及其他警示。发热、持续咳嗽、呼吸困难、严重皮疹、晕厥或其他急性不适时，应及时使用当地医疗支持，而不是从机制推导下一次输注或联用安排。", "en": "The label includes warnings about serious infection, infusion reactions and other risks. With fever, persistent cough, breathing trouble, severe rash, fainting or another acute concern, use timely local medical support rather than deriving the next infusion or combination plan from mechanism." } ], "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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": "Remicade", "generic": "英夫利昔单抗", "dosageFormClass": "静脉输注用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶" }, "labelSource": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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_b100135e17c1fbea", "label": "FDA：REMICADE 2017 美国历史标签（BLA 103772）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.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 REMICADE（infliximab）当前美国公开标签列示每瓶 100 mg 的静脉输注用冻干粉单剂量瓶。本页把商品名、通用名、每瓶标示量、NDC、包装图和来源对应；不把 100 mg 变成个人输注量、瓶数、配制、间隔、换药或购买结论。", "history": "静脉输注生物制品必须按准确制剂、单剂量瓶、标示强度、配制要求、市场与现行标签核对；包装图不构成真实性、互换性或个人适用性结论。", "sourceDocuments": [ { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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_b100135e17c1fbea", "label": "FDA：REMICADE 2017 美国历史标签（BLA 103772）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.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 103772", "approvalTimeline": [ { "date": "DailyMed 当前公开标签，2025-06 更新", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed 当前公开标签，2025-06 更新 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed 当前公开标签，2025-06 更新 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed: current REMICADE U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "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": "不从美国公开标签推定当地批准、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. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "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/remicade/", "en": "https://origindrug.com/en/drugs/remicade/" }, "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." ] }