{ "id": "victoza", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Victoza", "generic": "利拉鲁肽", "aliases": [ "liraglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "皮下注射液（FDA 2010 标签档案及 DailyMed 2025-11 公开标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2010（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-victoza-liraglutide-18mg-3ml-2-prefilled-pens-0169406012", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2025-11-17 发布）", "en": "DailyMed SPL v31 (published 17 Nov 2025)" }, "dosageForm": { "zh": "VICTOZA 利拉鲁肽单人使用预充注射笔", "en": "VICTOZA liraglutide single-patient-use prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0169-4060-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "每支笔总含量 18 mg/3 mL（6 mg/mL）；可选择的标签档位为 0.6、1.2 或 1.8 mg；每盒 2 支笔", "en": "18 mg/3 mL total per pen (6 mg/mL); labelled selectable settings are 0.6, 1.2 or 1.8 mg; 2 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carton-2pen.jpg&setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利拉鲁肽（每支笔总含量）", "en": "liraglutide (total per pen)" }, "value": 18, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内总量；不是一次个人注射量", "en": "total in each prefilled pen; not an individual's one-time injection amount" } }, { "ingredient": { "zh": "利拉鲁肽（浓度）", "en": "liraglutide (concentration)" }, "value": 6, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射毫升数", "en": "labelled concentration; not an individual's injection volume" } } ], "concentration": null, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "单人使用多剂量预充注射笔；针头不随盒提供", "en": "single-patient-use multidose prefilled pen; needles not included" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": null, "countUnit": null, "unitsPerContainer": { "count": 18, "unit": { "zh": "mg 总量/笔", "en": "mg total per pen" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支预充笔/盒；针头不随盒提供", "en": "prefilled pens per carton; needles not included" } }, "physicalClues": { "color": null, "shape": { "zh": "带剂量选择器的单人使用预充注射笔与纸盒", "en": "single-patient-use prefilled pen with dose selector and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 当前美国公开标签（Novo Nordisk；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "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-victoza-liraglutide-18mg-3ml-3-prefilled-pens-0169406013", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2025-11-17 发布）", "en": "DailyMed SPL v31 (published 17 Nov 2025)" }, "dosageForm": { "zh": "VICTOZA 利拉鲁肽单人使用预充注射笔", "en": "VICTOZA liraglutide single-patient-use prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0169-4060-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "每支笔总含量 18 mg/3 mL（6 mg/mL）；可选择的标签档位为 0.6、1.2 或 1.8 mg；每盒 3 支笔", "en": "18 mg/3 mL total per pen (6 mg/mL); labelled selectable settings are 0.6, 1.2 or 1.8 mg; 3 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carton-3pen.jpg&setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利拉鲁肽（每支笔总含量）", "en": "liraglutide (total per pen)" }, "value": 18, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内总量；不是一次个人注射量", "en": "total in each prefilled pen; not an individual's one-time injection amount" } }, { "ingredient": { "zh": "利拉鲁肽（浓度）", "en": "liraglutide (concentration)" }, "value": 6, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射毫升数", "en": "labelled concentration; not an individual's injection volume" } } ], "concentration": null, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "单人使用多剂量预充注射笔；针头不随盒提供", "en": "single-patient-use multidose prefilled pen; needles not included" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": null, "countUnit": null, "unitsPerContainer": { "count": 18, "unit": { "zh": "mg 总量/笔", "en": "mg total per pen" } } }, "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": 3, "unit": { "zh": "支预充笔/盒；针头不随盒提供", "en": "prefilled pens per carton; needles not included" } }, "physicalClues": { "color": null, "shape": { "zh": "带剂量选择器的单人使用预充注射笔与纸盒", "en": "single-patient-use prefilled pen with dose selector and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 当前美国公开标签（Novo Nordisk；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "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=carton-3pen.jpg&id=905929", "alt": "VICTOZA 18 mg/3 mL（6 mg/mL）、3 支预充笔、NDC 0169-4060-13 的美国 DailyMed 公开标签纸盒主展示面", "archiveMarket": "美国", "labelVersion": "2025-11", "presentation": "VICTOZA 18 mg/3 mL（6 mg/mL）、3 支预充笔、NDC 0169-4060-13 纸盒主展示面（DailyMed 2025-11 公开标签所列）。", "notice": "此图只对应美国 DailyMed 标签中的 VICTOZA、18 mg/3 mL（6 mg/mL）、3 支预充笔和 NDC 0169-4060-13；它只帮助核对品牌、通用名、浓度、给药途径、包装/装置线索和来源，不用于鉴定真伪，也不证明其他包装、原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "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": "VICTOZA 说明书放大阅读：6 mg/mL 是浓度，不是一次的个人用量", "en": "VICTOZA label reading: 6 mg/mL is a concentration, not an individual one-time amount" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，帮助区分 VICTOZA 预充笔上 18 mg/3 mL、6 mg/mL 与给药设置文字的含义；它不指导个人注射、调量、漏用补用或与其他注射产品转换。", "en": "This module uses the public DailyMed label as a reading entry point. It helps distinguish the meanings of 18 mg/3 mL, 6 mg/mL and dose-setting wording on a VICTOZA prefilled pen; it does not guide individual injection, dose change, missed-dose management or a switch with another injectable product." }, "checks": [ { "zh": "“18 mg/3 mL”描述整支预充笔中的标示药物总量和液体体积；“6 mg/mL”描述浓度。二者都不是“今天该打多少”或“是否可以把另一种注射笔当成一样”的答案。", "en": "“18 mg/3 mL” describes the stated total medicine amount and liquid volume in the prefilled pen; “6 mg/mL” describes concentration. Neither answers how much someone should inject today or whether another injection pen can be treated as the same." }, { "zh": "标签所列 0.6 mg、1.2 mg、1.8 mg 是该准确装置可标示的剂量设置，不是读者可依据网页自行开始、加量、减量或与其他 GLP-1 类产品互换的规则。", "en": "The label’s 0.6 mg, 1.2 mg and 1.8 mg are dose settings stated for that exact device, not rules a reader may use to independently start, increase, reduce or interchange with another GLP-1 product from a webpage." }, { "zh": "预充笔为单一患者使用装置；外观、针头、注射部位、保存和是否可与其他注射剂同用均要回到准确产品的现行使用说明、处方和专业人员指导。", "en": "A prefilled pen is a single-patient-use device. Appearance, needles, injection site, storage and whether it can be used with another injectable product all require the current instructions, prescription and professional guidance for the exact product." }, { "zh": "如果同时使用胰岛素或其他降糖药、出现持续胃肠道不适或正在考虑更换注射产品，请带上全部药物和实际包装请药师/开方团队核对；不要根据照片或总毫克数自行转换。", "en": "If insulin or other glucose-lowering medicines are also used, persistent gastrointestinal symptoms occur, or an injectable-product change is being considered, bring every medicine and the actual package to a pharmacist or prescribing team; do not self-convert from a photo or total milligrams." } ], "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "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": "利拉鲁肽怎样起作用：它激活 GLP-1 受体", "en": "How liraglutide works: it activates the GLP-1 receptor" }, "summary": { "zh": "DailyMed 的 VICTOZA 公开标签将利拉鲁肽描述为 GLP-1 受体激动剂。标签将该机制与葡萄糖升高时的胰岛素释放、葡萄糖依赖性的胰高血糖素降低及胃排空延迟联系起来。它解释的是一条作用路径，不预测个人血糖、胃肠道反应、体重变化、适用性、注射设置或与其他降糖药的组合。", "en": "The DailyMed public label for VICTOZA describes liraglutide as a GLP-1 receptor agonist. It links this mechanism with insulin release when glucose is elevated, glucose-dependent lowering of glucagon and delayed gastric emptying. This explains an action pathway, not an individual's glucose, gastrointestinal response, weight change, suitability, injection setting or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“GLP-1”不表示 VICTOZA 能与 OZEMPIC、WEGOVY、TRULICITY、MOUNJARO、其他利拉鲁肽产品或任何降糖药自行叠加、轮换或按总毫克数换算。每种产品的品牌、成分、装置、用途、强度和完整药单都要由专业人员逐项核对。", "en": "“GLP-1” does not make VICTOZA self-combinable, alternatable or convertible by total milligrams with OZEMPIC, WEGOVY, TRULICITY, MOUNJARO, another liraglutide product or any glucose-lowering medicine. Every product's brand, ingredient, device, use, strength and complete medicine list need item-by-item professional review." }, { "zh": "胃排空与血糖调节的机制不能生成自行错开口服药、补打、加量或换笔的规则。正在使用胰岛素、其他降糖药、口服药或出现持续胃肠道不适时，应带完整药单和实际包装请药师或开方团队复核。", "en": "Gastric-emptying and glucose-regulation mechanisms cannot create rules for self-spacing oral medicines, making up an injection, increasing use or switching pens. When insulin, another glucose medicine or oral medicine is used, or persistent gastrointestinal symptoms occur, bring the complete medicine list and actual packs to a pharmacist or prescribing team for review." }, { "zh": "“6 mg/mL”“18 mg/3 mL”及装置上的设置都是产品身份信息，不会从机制中导出个人注射量或证明另一支笔可替代。出现严重或持续不适、明显低血糖相关症状、拿到不同装置或对产品有疑问时，应使用当地医疗支持，而不是依据网页自行调整。", "en": "“6 mg/mL,” “18 mg/3 mL” and settings on a device are product-identity information; the mechanism does not derive an individual injection amount or prove another pen can substitute. With severe or persistent discomfort, marked symptoms related to low glucose, a different device or uncertainty about a product, use local medical support rather than self-adjust from a webpage." } ], "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Victoza", "generic": "利拉鲁肽", "dosageFormClass": "皮下注射液（FDA 2010 标签档案及 DailyMed 2025-11 公开标签所列）" }, "labelSource": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1c0d98095d46de65", "label": "FDA：VICTOZA 2010 美国标签档案（NDA 022341）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 VICTOZA（liraglutide）美国标签档案将其列为皮下注射用制剂，并列出美国初始批准年份为 2010。该页只提供可复核的美国监管档案；不据此推定现行标签、其他市场的批准、规格、持有人、供应或可售资格。", "history": "注射制剂不能仅按通用名与口服或其他给药途径产品互相等同。任何市场的产品身份、现行标签与专业使用信息都须单独核验。", "sourceDocuments": [ { "id": "src_1c0d98095d46de65", "label": "FDA：VICTOZA 2010 美国标签档案（NDA 022341）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_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": "NDA 022341", "approvalTimeline": [ { "date": "2010", "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: 2010。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: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1c0d98095d46de65", "label": "FDA: VICTOZA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2010 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 2010 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_1c0d98095d46de65", "label": "FDA: VICTOZA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/victoza/", "en": "https://origindrug.com/en/drugs/victoza/" }, "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." ] }