{ "id": "keytruda", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "Keytruda", "generic": "帕博利珠单抗", "aliases": [ "pembrolizumab", "可瑞达", "K药", "K 药" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "可瑞达®（常见俗称：K 药）", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a7c6f20b63b39c7f", "label": "默沙东中国：帕博利珠单抗（商品名可瑞达®）在华获批公开资料", "url": "https://www.msdchina.com.cn/2024/09/14/company_news_2024-09-14/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-07-10 生效）及 FDA 监管档案", "dosageFormClass": "静脉输注用注射液：100 mg/4 mL（25 mg/mL）单剂量瓶；同一 SPL 另保留 50 mg 冻干粉展示面板，须与主规格分开阅读", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）", "archiveSponsorText": "Merck Sharp & Dohme / DailyMed 当前美国公开标签；FDA 监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-keytruda-injection-100mg-4ml-ndc-0006-3026-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-07-10 生效）", "en": "Current U.S. DailyMed public label (effective 10 Jul 2026)" }, "dosageForm": { "zh": "KEYTRUDA 帕博利珠单抗注射液", "en": "KEYTRUDA pembrolizumab injection" }, "route": { "zh": "静脉输注用", "en": "for intravenous infusion" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0006-3026-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "100 mg/4 mL（25 mg/mL）；单剂量瓶；1 瓶/盒", "en": "100 mg/4 mL (25 mg/mL); single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=keytruda-08.jpg&setid=9333c79b-d487-4538-a9f0-71b91a02b287&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕博利珠单抗", "en": "pembrolizumab" }, "value": 100, "unit": "mg", "basisCode": "per_vial", "basisLabel": { "zh": "每个 4 mL 单剂量瓶的标签标示量", "en": "labelled amount per 4 mL single-dose vial" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "4 mL 单剂量瓶", "en": "4 mL single-dose vial" }, "fill": { "value": 4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "vial per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_da1d50934ec1a937", "label": "DailyMed（NLM）：KEYTRUDA 100 mg/4 mL、NDC 0006-3026-02 当前美国标签面板（2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "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-keytruda-injection-100mg-4ml-ndc-0006-3026-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=keytruda-08.jpg&setid=9333c79b-d487-4538-a9f0-71b91a02b287&type=img", "alt": "KEYTRUDA 帕博利珠单抗在美国 DailyMed Merck 公开标签中的 100 mg/4 mL 单剂量瓶纸盒展开图（NDC 0006-3026-02）", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Merck Sharp & Dohme，2026-07 更新；包装图稿 2025）", "presentation": "KEYTRUDA 注射液：100 mg/4 mL（25 mg/mL），静脉输注用单剂量瓶纸盒展开图，NDC 0006-3026-02（DailyMed Merck 公开标签所列）。", "notice": "此图对应当前公开标签剂型章节所列 KEYTRUDA 100 mg/4 mL（25 mg/mL）单剂量瓶；同一份 SPL 仍包含 50 mg 冻干粉的另一张包装图，二者不得混作同一规格。图片只帮助核对品牌、通用名、剂型、浓度、包装代码和来源；不用于鉴定真伪，也不证明其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_badb7cf312d9bb57", "label": "DailyMed（NLM）：KEYTRUDA 公开标签（Merck Sharp & Dohme，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "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": "KEYTRUDA 说明书放大阅读：瓶身的 mg/mL 是输注制剂身份，不是家庭用量", "en": "KEYTRUDA label reading: mg/mL on a vial identifies an infusion product, not an at-home amount" }, "summary": { "zh": "本模块以 Merck Sharp & Dohme LLC 的美国 DailyMed 2026-07 KEYTRUDA 公开标签为阅读入口，帮助核对 KEYTRUDA、帕博利珠单抗、静脉用注射剂、100 mg/4 mL（25 mg/mL）单剂量瓶、包装和目标市场；它不把瓶身浓度、输注安排、检测术语或标签风险文字变成个人治疗方案。", "en": "This module uses Merck Sharp & Dohme LLC's July 2026 U.S. DailyMed public label for KEYTRUDA as a reading entry point. It helps check KEYTRUDA, pembrolizumab, injection for intravenous use, a 100 mg/4 mL (25 mg/mL) single-dose vial, package and target market; it does not turn vial concentration, infusion scheduling, test terminology or label risk wording into an individual treatment plan." }, "checks": [ { "zh": "100 mg/4 mL 与 25 mg/mL 是这支准确单剂量瓶的总含量和浓度线索，不是“该输多少”“能否分给两个人”或“能否在家处理”的答案。静脉输注制剂的配制、稀释、输注、剩余处置和每次安排必须由治疗机构按现行标签与处方负责。", "en": "100 mg/4 mL and 25 mg/mL are total-content and concentration clues for this exact single-dose vial, not answers to “how much to infuse,” “can it be shared,” or “can it be handled at home.” Preparation, dilution, infusion, remaining-product handling and each visit plan for an intravenous product belong to the treating facility under the current label and prescription." }, { "zh": "同为“免疫治疗”、PD-1/PD-L1 抗体或静脉用药，不表示 KEYTRUDA 可与 OPDIVO、化疗、靶向药、激素或其他生物制剂自行叠加、轮换、漏用后补回或替代。肿瘤类型、病理/分子检测、既往方案、器官功能和全套药物清单必须由肿瘤团队统一核对。", "en": "Being called immunotherapy, a PD-1/PD-L1 antibody or an intravenous medicine does not make KEYTRUDA self-combinable, alternatable, catch-up replaceable or substitutable with OPDIVO, chemotherapy, targeted therapy, steroids or another biologic. Tumour type, pathology/molecular testing, prior regimen, organ function and the full medicine list require integrated oncology-team review." }, { "zh": "标签提示免疫介导反应可涉及肺、肠道、肝脏、内分泌器官、肾脏、皮肤等，也提示输注相关反应。新的或加重的呼吸困难、持续腹泻、黄疸样变化、异常乏力/意识变化、尿量变化、严重皮疹、发热寒战或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持，而不是等下一次输注时再自行判断。", "en": "The label notes immune-mediated reactions that may involve lungs, bowel, liver, endocrine organs, kidneys and skin, as well as infusion-related reactions. New or worsening breathing difficulty, persistent diarrhoea, jaundice-like changes, unusual fatigue/mental-status change, changed urine output, severe rash, fever/chills or another acute concern needs prompt contact with the treatment team or local urgent medical support rather than waiting to self-assess at the next infusion." }, { "zh": "PD-L1、MSI-H、dMMR、TMB-H 等检测名称出现在部分适应症的标签条件中，但看到一个检测名、数值或网络解读并不能确认某个人适合 KEYTRUDA。样本、方法、疾病场景、合并方案及目标市场现行标签都需要由肿瘤团队解释。", "en": "Test names such as PD-L1, MSI-H, dMMR and TMB-H appear in label conditions for some indications, but seeing a test name, value or online interpretation cannot confirm that an individual fits KEYTRUDA. Specimen, method, disease setting, combination plan and the current target-market label require oncology-team interpretation." } ], "source": { "id": "src_badb7cf312d9bb57", "label": "DailyMed（NLM）：KEYTRUDA 公开标签（Merck Sharp & Dohme，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "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": "帕博利珠单抗怎样起作用：标签描述其阻断 PD-1 与 PD-L1/PD-L2 的结合", "en": "How pembrolizumab works: the label describes blocking PD-1 binding to PD-L1/PD-L2" }, "summary": { "zh": "FDA 的 KEYTRUDA 标签描述帕博利珠单抗与 PD-1 受体结合，阻断其与 PD-L1 和 PD-L2 的相互作用，从而解除 PD-1 通路介导的 T 细胞反应抑制。它解释免疫检查点路径，不预测个人获益，也不决定检测条件、分期、联合方案或输注频率。", "en": "The FDA KEYTRUDA label describes pembrolizumab as binding PD-1 and blocking interaction with PD-L1/PD-L2, releasing PD-1-pathway-mediated inhibition of T-cell responses. It explains an immune-checkpoint pathway, not individual benefit, testing criteria, stage, combination plan or infusion frequency." }, "checks": [ { "zh": "“PD-1/PD-L1”不是自行解读检测结果或选择免疫治疗的工具。检测方法、样本、评分、疾病类型、既往治疗和所在市场现行标签必须由肿瘤团队结合完整病理资料确认。", "en": "“PD-1/PD-L1” is not a tool for self-interpreting a test or selecting immunotherapy. Test method, specimen, score, disease type, prior therapy and current target-market label must be confirmed by an oncology team with the full pathology record." }, { "zh": "同属免疫检查点药物，或都写“免疫治疗”，不表示 KEYTRUDA 能与另一种免疫药、靶向药、化疗、激素或补充剂自行叠加、轮换或替代。", "en": "Being an immune-checkpoint medicine, or both being called immunotherapy, does not make KEYTRUDA self-combinable, alternatable or substitutable with another immune medicine, targeted therapy, chemotherapy, steroid or supplement." }, { "zh": "出现新发或加重的呼吸困难、持续腹泻、黄疸、明显乏力、严重皮疹、视力/神经变化或其他急性问题时，应及时联系治疗团队或紧急医疗支持。", "en": "With new or worsening breathing trouble, persistent diarrhoea, jaundice, marked weakness, severe rash, visual/neurologic change or another acute concern, contact the treatment team or urgent medical support promptly." } ], "source": { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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": "Keytruda", "generic": "帕博利珠单抗", "dosageFormClass": "静脉输注用注射液：100 mg/4 mL（25 mg/mL）单剂量瓶；同一 SPL 另保留 50 mg 冻干粉展示面板，须与主规格分开阅读" }, "labelSource": { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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": "DailyMed 的 KEYTRUDA（pembrolizumab）2026 当前美国标签在“剂型与规格”中列出 100 mg/4 mL（25 mg/mL）单剂量瓶。本页以这一现行规格的精确面板为主展示，并把同一 SPL 仍保留的 50 mg 冻干粉展示面板视作另一产品呈现，不混作同一规格。", "history": "静脉输注产品的完整身份还取决于规格、配制与给药要求、市场和标签版本；本页面不提供诊疗、处方、替代或购买结论。", "sourceDocuments": [ { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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_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 125514", "approvalTimeline": [ { "date": "2014", "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: 2014。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: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_299287440a5b0890", "label": "FDA: KEYTRUDA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 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 2026-07 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_299287440a5b0890", "label": "FDA: KEYTRUDA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.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" } } ], "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/keytruda/", "en": "https://origindrug.com/en/drugs/keytruda/" }, "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." ] }