{ "id": "repatha", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "REPATHA", "generic": "依洛尤单抗", "aliases": [ "REPATHA", "evolocumab", "依洛尤单抗", "瑞百安" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 REPATHA（evolocumab）皮下注射液公开标签；页面 2026-08-19 更新、标签 2026-07 修订。本记录只对应美国标签所列产品，不推定中国大陆或其他市场的当前批准、供应、报销或可得性。", "dosageFormClass": "皮下注射液：140 mg/mL 预充式单剂量笔、SureClick® 自动注射器或预充式单剂量注射器（DailyMed 当前美国公开标签所列；本页精确展示 2 支自动注射器纸盒）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下给药（准确装置和使用方法仅以实际包装中的现行说明书及专业培训为准）", "routeCode": "subcutaneous", "historicalApprovalEntry": "2015（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "Amgen USA Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "alirocumab", "阿利西尤单抗", "inclisiran", "英克司兰", "evolocumab tablet", "依洛尤单抗片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-repatha-evolocumab-140mg-ml-two-autoinjector-carton-ndc-72511-760-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（页面 2026-08-19 更新；标签 2026-07 修订）", "en": "Current U.S. DailyMed public label (page updated 19 Aug 2026; label revised Jul 2026)" }, "dosageForm": { "zh": "皮下注射液：单剂量自动注射器", "en": "subcutaneous injection: single-dose autoinjector" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 72511-760-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "REPATHA 依洛尤单抗 140 mg/mL；2 支自动注射器纸盒（NDC 72511-760-02）", "en": "REPATHA evolocumab 140 mg/mL; carton of 2 autoinjectors (NDC 72511-760-02)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=repatha_amgenusa-115.jpg&setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依洛尤单抗", "en": "evolocumab" }, "value": 140, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 的标签浓度；不是个人注射量或换算", "en": "labelled concentration per mL; not an individual injection amount or conversion" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "140 mg/mL", "numerator": { "value": 140, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "140 mg/mL（标签浓度；不是个人注射量）", "en": "140 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_autoinjector", "typeLabel": { "zh": "单剂量自动注射器", "en": "single-dose autoinjector" }, "fill": null, "countPerPackage": 2, "countUnit": { "zh": "支/纸盒", "en": "autoinjectors per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量自动注射器/纸盒", "en": "single-dose autoinjectors per carton" } }, "physicalClues": { "color": { "zh": "以实际美国公开标签纸盒为准", "en": "refer to the exact U.S. public-label carton" }, "shape": { "zh": "2 支自动注射器纸盒", "en": "carton of 2 autoinjectors" }, "imprint": "REPATHA / evolocumab / 140 mg/mL / NDC 72511-760-02", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed（NLM）：REPATHA 依洛尤单抗当前美国公开标签（Amgen USA；页面 2026-08-19 更新，标签 2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-repatha-evolocumab-140mg-ml-two-autoinjector-carton-ndc-72511-760-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=repatha_amgenusa-115.jpg&setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e&type=img", "alt": "REPATHA 依洛尤单抗在美国 DailyMed 当前标签中的 140 mg/mL、NDC 72511-760-02、2 支自动注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（页面 2026-08-19 更新；标签 2026-07 修订）", "presentation": "REPATHA 依洛尤单抗：140 mg/mL，NDC 72511-760-02，2 支单剂量自动注射器纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 REPATHA、依洛尤单抗、140 mg/mL、NDC 72511-760-02 与 2 支单剂量自动注射器纸盒。它只帮助核对品牌、通用名、标签浓度、装置、包装数量和来源；不用于鉴定真伪，也不证明其他自动注射器、预充式笔、预充式注射器、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的注射量、时间、开始、停用、联用或换药方案。", "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed（NLM）：REPATHA 依洛尤单抗当前美国公开标签（Amgen USA；页面 2026-08-19 更新，标签 2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REPATHA 说明书放大阅读：140 mg/mL 是准确注射产品身份，不是个人注射方案", "en": "REPATHA label reading: 140 mg/mL identifies an exact injection product; it is not an individual injection plan" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 REPATHA、依洛尤单抗、皮下注射液、140 mg/mL 和所列单剂量装置类型。它将产品身份与安全核对线索放在一起，但不提供个人注射、给药时间、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only REPATHA, evolocumab, subcutaneous injection, 140 mg/mL and the listed single-dose device types in the current U.S. DailyMed label. It places product identity and safety-review cues together, but provides no individual injection, timing, missed-use, initiation, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "把 REPATHA、依洛尤单抗、皮下注射液、准确装置、140 mg/mL、实际包装和目标市场一起核对。这个数字是标签上的产品浓度/身份线索，不是网页可以换算成个人每次注射量、频率或时间表的规则，也不能据此与片剂、另一种注射产品或另一市场包装自行互换。", "en": "Check REPATHA, evolocumab, subcutaneous injection, the exact device, 140 mg/mL, the actual pack and target market together. This figure is a labelled concentration/identity cue, not a web rule that can calculate anyone's injection amount, frequency or schedule, and it cannot self-convert tablets, another injection product or another-market pack." }, { "zh": "当前美国标签列有预充式单剂量笔、SureClick® 自动注射器和预充式单剂量注射器；部分针头保护套含天然橡胶衍生物，标签提示乳胶敏感者需要专业人员核对准确展示型。包装名称相似、共享通用名或照片相似，都不足以确认装置、材料或使用方式。", "en": "The current U.S. label lists a prefilled single-dose pen, SureClick® autoinjector and prefilled single-dose syringe; some needle covers contain a natural-rubber derivative, so the label flags exact-presentation review for people sensitive to latex. Similar pack names, a shared generic name or similar photos do not establish device, materials or use." }, { "zh": "标签列出严重超敏反应（包括血管性水肿）和注射部位反应等安全信息。出现呼吸困难、面部/口唇/咽喉肿胀、晕厥或其他急性严重不适时，应优先使用当地紧急医疗渠道；网页不能替代对此类症状的现场评估，也不建议自行以停用、补用或换药处理。", "en": "The label includes safety information on serious hypersensitivity, including angioedema, and injection-site reactions. With breathing difficulty, swelling of the face, lips or throat, fainting or another acute serious concern, prioritise local emergency care; a webpage cannot replace assessment of such symptoms and does not direct self-stopping, make-up use or switching." }, { "zh": "若药单中同时有阿托伐他汀、瑞舒伐他汀、依折麦布、其他降脂注射剂、抗凝药、非处方药、草本或补充剂，应将所有实际包装与完整药单交给药师或开方团队复核。共同的“降脂”目标不表示可以自行叠加、轮换、按 mg 换算或替代。", "en": "If atorvastatin, rosuvastatin, ezetimibe, another lipid-lowering injection, anticoagulants, OTC products, herbs or supplements are also on the list, have a pharmacist or prescribing team review every actual pack and the full medicine list. A shared “lipid-lowering” goal does not make products self-combinable, alternatable, milligram-convertible or substitutable." } ], "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07; product identity, device and safety information)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依洛尤单抗怎样起作用：标签将其归为 PCSK9 抑制剂", "en": "How evolocumab works: the label classifies it as a PCSK9 inhibitor" }, "summary": { "zh": "DailyMed 当前标签将 REPATHA 描述为 PCSK9 抑制剂。这个机制词帮助理解标签的药理分类，却不预测个人的 LDL-C 数值、心血管风险、耐受性、注射方案、是否适合联用或是否需要换药。", "en": "The current DailyMed label describes REPATHA as a PCSK9 inhibitor. This mechanism term helps explain the label's pharmacologic classification; it does not predict an individual's LDL-C value, cardiovascular risk, tolerance, injection plan, suitability for co-use or whether to switch." }, "checks": [ { "zh": "“PCSK9 抑制剂”是药理路径用语，不表示任意胆固醇异常都适用，也不表示与他汀、依折麦布、阿利西尤单抗或英克司兰可以自行并用、轮换或互换。产品、装置、目标市场标签、化验与完整药单必须由专业人员逐项复核。", "en": "“PCSK9 inhibitor” is pharmacologic-pathway wording; it does not mean every cholesterol concern is suitable, nor does it permit self-combination, alternation or exchange with a statin, ezetimibe, alirocumab or inclisiran. The product, device, target-market label, testing and full medicine list need item-by-item professional review." }, { "zh": "同样涉及 LDL-C、动脉粥样硬化或家族性高胆固醇血症的文字，不足以判断任何人的诊断、遗传情况、风险分层或是否需要基因检测。标签列出适用人群不等于网页可以替代临床判断；涉及家族史、化验或基因报告时，应由熟悉实际资料的团队解读。", "en": "Shared wording about LDL-C, atherosclerosis or familial hypercholesterolemia is insufficient to determine anyone's diagnosis, genetic context, risk classification or need for genetic testing. A labelled population does not replace clinical judgement; family history, laboratory results or genetic reports should be interpreted by a team familiar with the actual information." }, { "zh": "机制解释不能替代药物警戒、准确装置说明书或多药核对。开始任何新产品、发生疑似不良反应、装置/包装不一致或希望改变治疗时，应先让药师或开方团队核对实际包装、目标市场文件与完整药单。", "en": "A mechanism explanation does not replace pharmacovigilance, the exact device instructions or multi-medicine review. Before starting any new product, with a suspected adverse reaction, a device/pack mismatch or a contemplated treatment change, first have a pharmacist or prescribing team review the actual pack, target-market documents and complete medicine list." } ], "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "REPATHA", "generic": "依洛尤单抗", "dosageFormClass": "皮下注射液：140 mg/mL 预充式单剂量笔、SureClick® 自动注射器或预充式单剂量注射器（DailyMed 当前美国公开标签所列；本页精确展示 2 支自动注射器纸盒）" }, "labelSource": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "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": "2026-08-22", "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_81862f01661fd28d", "label": "FDA: REPATHA evolocumab U.S. prescribing information (revised 2025-08; historical label version)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.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": "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": "2026-08-22", "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 当前美国公开标签将 REPATHA 列为依洛尤单抗皮下注射液，并将其归为 PCSK9 抑制剂。本页帮助读者把商品名、通用名、准确注射装置、标签浓度、美国标签和药物警戒入口逐项对应；它不把包装数字、给药途径或降脂目标变成个人注射、开始、停用、联用、换药或购买建议。", "history": "DailyMed 当前标签列示 REPATHA 的美国初始批准为 2015，并标示为生物制品许可申请产品。该档案仅定位该美国公开标签；同类降脂注射剂、同通路产品、其他市场产品及不同装置，均必须按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "id": "src_81862f01661fd28d", "label": "FDA: REPATHA evolocumab U.S. prescribing information (revised 2025-08; historical label version)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.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" } ], "applicationNumber": "BLA 125522", "approvalTimeline": [ { "date": "2015", "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: 2015。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: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed: current REPATHA evolocumab U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "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_1d21e07b9c9d0ea7", "label": "DailyMed: current REPATHA evolocumab U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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/repatha/", "en": "https://origindrug.com/en/drugs/repatha/" }, "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." ] }