{ "id": "trastuzumab-herceptin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "HERCEPTIN", "generic": "曲妥珠单抗", "aliases": [ "赫赛汀", "trastuzumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "赫赛汀®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "静脉输注用注射剂", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1998", "archiveSponsorText": "Genentech（FDA 1998 年历史批准信所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-herceptin-trastuzumab-150mg-single-dose-vial-1-vial-carton-5024213201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2026-05 更新）", "en": "DailyMed U.S. public label (Genentech; updated May 2026)" }, "dosageForm": { "zh": "HERCEPTIN 曲妥珠单抗静脉输注用冻干粉", "en": "HERCEPTIN trastuzumab 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 50242-132-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含曲妥珠单抗 150 mg 冻干粉；1 瓶装纸盒", "en": "Trastuzumab 150 mg lyophilised powder per single-dose vial; one-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=herceptin-08.jpg&setid=492dbdb2-077e-4064-bff3-372d6af0a7a2&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲妥珠单抗", "en": "trastuzumab" }, "value": 150, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签含量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled content 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": "无防腐剂、白色至淡黄色冻干粉单剂量瓶", "en": "preservative-free, white-to-pale-yellow 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 vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "150 mg 冻干粉单剂量玻璃瓶及纸盒", "en": "150 mg lyophilised-powder single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14c234c883680f84", "label": "DailyMed（NLM）：HERCEPTIN 150 mg 单剂量冻干粉瓶、1 瓶纸盒美国公开标签（Genentech；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "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" }, { "id": "us-herceptin-trastuzumab-150mg-single-dose-vial-10-vial-carton-5024213210", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2026-05 更新）", "en": "DailyMed U.S. public label (Genentech; updated May 2026)" }, "dosageForm": { "zh": "HERCEPTIN 曲妥珠单抗静脉输注用冻干粉", "en": "HERCEPTIN trastuzumab 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 50242-132-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含曲妥珠单抗 150 mg 冻干粉；10 瓶装纸盒", "en": "Trastuzumab 150 mg lyophilised powder per single-dose vial; ten-vial carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲妥珠单抗", "en": "trastuzumab" }, "value": 150, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签含量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled content 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": "无防腐剂、白色至淡黄色冻干粉单剂量瓶", "en": "preservative-free, white-to-pale-yellow 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": 10, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "150 mg 冻干粉单剂量玻璃瓶及纸盒", "en": "150 mg lyophilised-powder single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14c234c883680f84", "label": "DailyMed（NLM）：HERCEPTIN 150 mg 单剂量冻干粉瓶、10 瓶纸盒美国公开标签（Genentech；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "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=herceptin-08.jpg&setid=492dbdb2-077e-4064-bff3-372d6af0a7a2&type=img", "alt": "HERCEPTIN 曲妥珠单抗在美国 DailyMed Genentech 公开标签中的 150 mg 单剂量瓶纸盒正面图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2026-05 更新）", "presentation": "HERCEPTIN 注射用冻干粉：每瓶曲妥珠单抗 150 mg，单剂量瓶纸盒正面图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 HERCEPTIN、曲妥珠单抗 150 mg 单剂量瓶的纸盒图，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_d2b31628d6586924", "label": "DailyMed（NLM）：HERCEPTIN 公开标签（Genentech，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "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": "HERCEPTIN 说明书放大阅读：150 mg 单剂量粉针不等于同名皮下制剂或其他 HER2 药", "en": "HERCEPTIN label reading: a 150 mg single-dose powder vial is not a same-name subcutaneous product or another HER2 medicine" }, "summary": { "zh": "本模块以 Genentech 的美国 DailyMed 2026-05 HERCEPTIN 公开标签为阅读入口，帮助核对 HERCEPTIN、曲妥珠单抗、150 mg 单剂量冻干粉针、静脉输注和目标市场；它不把瓶身规格、复溶文字、漏用处理或 HER2 检测术语变成个人输注、居家操作或换药方案。", "en": "This module uses Genentech's May 2026 U.S. DailyMed public label for HERCEPTIN as a reading entry point. It helps check HERCEPTIN, trastuzumab, a 150 mg single-dose lyophilised-powder vial, intravenous infusion and target market; it does not turn vial strength, reconstitution text, missed-visit information or HER2 test terminology into an individual infusion, home procedure or switching plan." }, "checks": [ { "zh": "150 mg 描述这一准确单剂量冻干粉针的总含量，并不等于一次个人治疗量、可自行稀释的毫升数，或可保存/分装的余量。标签所列复溶、稀释、输注、贮存与废弃步骤属于治疗机构的无菌药品操作，不应从网页在家复现。", "en": "150 mg describes total content of this exact single-dose lyophilised-powder vial; it is not an individual treatment amount, a self-calculated diluent volume or product that may be saved/shared. The label's reconstitution, dilution, infusion, storage and disposal steps are sterile medication operations for the treating facility and should not be recreated at home from a webpage." }, { "zh": "这份标签是静脉输注用 HERCEPTIN 标签，与皮下曲妥珠单抗产品有不同给药说明；也明确不应与 ado-trastuzumab emtansine 或 fam-trastuzumab deruxtecan 互相替代。相同“曲妥珠单抗”字样、HER2 名称或相近包装不能支持自行换用、合用、漏用后补回或改变疗程。", "en": "This is an intravenous HERCEPTIN label and has different administration instructions from subcutaneous trastuzumab products; it also states that it must not be substituted for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Shared trastuzumab wording, HER2 terminology or similar packages do not support self-switching, combining, catch-up use or changing a course." }, { "zh": "标签警示心肌病、输注反应、肺毒性和胚胎-胎儿风险。呼吸困难、胸部不适、明显低血压样不适、发热寒战、持续咳嗽、异常乏力、浮肿或其他急性问题时，应及时联系肿瘤团队或使用当地紧急医疗支持；不要依据网页自行暂停或重启输注。", "en": "The label warns about cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal risk. With breathing difficulty, chest symptoms, marked low-blood-pressure-like illness, fever/chills, persistent cough, unusual fatigue, swelling or another acute concern, contact the oncology team promptly or use local urgent medical support; do not self-pause or restart infusions from a webpage." }, { "zh": "HER2 过表达、基因扩增或检测结果是特定疾病场景中由授权检测和专业团队综合解释的条件，不是看到一个检测名或数值即可自行判断是否应使用 HERCEPTIN。病理、检测方法、肿瘤类型、心功能、既往治疗与目标市场现行标签都须一并核对。", "en": "HER2 overexpression, gene amplification or a test result are conditions interpreted together by authorised testing and specialist teams in specific disease settings, not a basis for self-deciding on HERCEPTIN from one test name or value. Pathology, method, tumour type, cardiac function, prior treatment and the current target-market label must be reviewed together." } ], "source": { "id": "src_d2b31628d6586924", "label": "DailyMed（NLM）：HERCEPTIN 公开标签（Genentech，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "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": "曲妥珠单抗怎样起作用：标签描述其针对 HER2 过表达肿瘤细胞的作用", "en": "How trastuzumab works: the label describes activity against tumour cells that overexpress HER2" }, "summary": { "zh": "FDA 的 HERCEPTIN 标签描述曲妥珠单抗可抑制 HER2 过表达的人肿瘤细胞增殖，并可介导抗体依赖的细胞毒作用（ADCC）。这只解释标签中的机制路径；它不判断任何人的肿瘤是否符合相关检测条件、是否适用、应使用哪种曲妥珠单抗制剂、与何种治疗联用或何时开始/停止。", "en": "The FDA HERCEPTIN label describes trastuzumab as inhibiting proliferation of human tumour cells that overexpress HER2 and as mediating antibody-dependent cellular cytotoxicity (ADCC). This explains a label-described mechanism only; it does not determine whether a person's tumour meets relevant testing criteria, suitability, which trastuzumab product to use, combination treatment, or when to start/stop." }, "checks": [ { "zh": "“HER2”“靶向”或“抗体”不是凭一份旧检测报告、药名或网络信息自行判断能否使用的依据。病理检测的类型、样本、时间、目标市场标签、疾病阶段、心脏评估与完整治疗方案必须由肿瘤团队一起确认。", "en": "“HER2,” “targeted” or “antibody” is not a basis for deciding use from an old test report, medicine name or online information. Test type, specimen, timing, target-market label, disease setting, cardiac assessment and the complete treatment plan must be confirmed together by an oncology team." }, { "zh": "同一通用名或相似名称的静脉制剂、皮下复方制剂、生物类似药与不同市场产品不能从机制页面推断为可自行换算、互换或叠加。给药途径、制剂成分、剂量单位和专业给药安排都必须逐项核对。", "en": "Intravenous products, subcutaneous combination products, biosimilars and products from different markets with the same generic or a similar name cannot be assumed self-convertible, interchangeable or combinable from a mechanism page. Route, formulation ingredients, dose units and professional administration plan must each be checked." }, { "zh": "机制也不能解释或处理输注/注射反应、呼吸不适、胸部不适、心功能相关症状或其他急性问题。发生急性或严重不适时，应立即按当地肿瘤治疗团队和紧急医疗渠道处理，而不是根据网页调整方案。", "en": "Mechanism also cannot explain or manage an infusion/injection reaction, breathing trouble, chest discomfort, cardiac-function-related symptoms or another acute concern. For an acute or severe issue, use the local oncology team and emergency pathway immediately rather than adjusting from a webpage." } ], "source": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 2026 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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": "HERCEPTIN", "generic": "曲妥珠单抗", "dosageFormClass": "静脉输注用注射剂" }, "labelSource": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "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." } }, "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": "以 FDA 历史批准信与现行标签为入口的静脉输注档案；不得按通用名、照片或历史资料将其与皮下制剂或其他抗 HER2 产品直接等同。", "history": "FDA 的 HERCEPTIN 公开批准信与标签可用于阅读静脉输注这一给药途径。国家药监局 2020 年公开指导原则也以 Herceptin／赫赛汀作为曲妥珠单抗生物类似药的历史背景资料；该指导文件不能替代中国大陆当前产品记录。当前持有人、标签、输注条件和可得性必须按目标市场另行核验。", "sourceDocuments": [ { "id": "src_63b9839d33f24ec9", "label": "FDA：HERCEPTIN 生物制品批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "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": "FDA historical approval letter (1998)", "approvalTimeline": [ { "date": "1998", "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: 1998。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: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_8d371ccc40f91c78", "label": "FDA: HERCEPTIN intravenous-infusion label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026 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 2026 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_8d371ccc40f91c78", "label": "FDA: HERCEPTIN intravenous-infusion label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "NMPA 历史资料线索", "en": "NMPA historical reference" }, "detail": { "zh": "国家药监局 2020 年公开指导原则以 Herceptin／赫赛汀作为曲妥珠单抗生物类似药的历史背景资料。该文件仅提供历史检索线索，不构成中国大陆当前批准、持有人、标签、供应或可售资格结论。", "en": "A 2020 NMPA public guidance document uses Herceptin/赫赛汀 as historical background for trastuzumab biosimilar development. It is a historical search reference only, not a conclusion about current Mainland China approval, holder, labelling, supply or sale eligibility." }, "source": { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "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/trastuzumab-herceptin/", "en": "https://origindrug.com/en/drugs/trastuzumab-herceptin/" }, "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." ] }