{ "id": "lantus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Lantus", "generic": "甘精胰岛素", "aliases": [ "来得时", "insulin glargine", "LANTUS SoloStar" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "来得时®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_62724608c8ba22b4", "label": "Sanofi China：来得时®（甘精胰岛素）产品公开页", "url": "https://www.sanofi.cn/zh/your-health/products/insulin-glargine-injection", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开标签；其他市场状态未在本页建立", "dosageFormClass": "皮下注射液；U-100 10 mL 多剂量小瓶与 3 mL SoloStar 单人使用预填充笔为不同包装/装置形式（当前美国公开标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下使用（具体使用由专业人员核对）", "routeCode": "subcutaneous", "historicalApprovalEntry": "2000（当前美国公开标签所列美国初始批准）", "archiveSponsorText": "DailyMed（NLM）当前美国公开标签；sanofi-aventis U.S. LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "TOUJEO", "U-300", "300 units/mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lantus-insulin-glargine-u100-10ml-vial-ndc-0088-2220-33", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v35 于 2025-07-02 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025" }, "dosageForm": { "zh": "LANTUS 甘精胰岛素注射液", "en": "LANTUS insulin glargine injection" }, "route": { "zh": "皮下使用（标签范围；网页不决定个人注射单位或时间）", "en": "subcutaneous use (label scope; this page does not determine an individual's injection units or timing)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0088-2220-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 units/mL（U-100）；10 mL 多剂量小瓶；1 瓶/盒", "en": "100 units/mL (U-100); 10 mL multiple-dose vial; 1 vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-35.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甘精胰岛素", "en": "insulin glargine" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位、剂量或换药规则", "en": "labelled concentration; not an individual's injection units, dose or switching rule" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 units/mL（U-100；标签浓度，不是个人注射量）", "en": "100 units/mL (U-100; labelled concentration, not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_vial", "typeLabel": { "zh": "10 mL 多剂量小瓶；1 瓶/盒", "en": "10 mL multiple-dose vial; 1 vial per carton" }, "fill": { "value": 10, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "vial per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "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_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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-lantus-solostar-insulin-glargine-u100-3ml-pen-ndc-0088-2219-05", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v35 于 2025-07-02 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025" }, "dosageForm": { "zh": "LANTUS 甘精胰岛素注射液", "en": "LANTUS insulin glargine injection" }, "route": { "zh": "皮下使用（标签范围；网页不决定个人注射单位或时间）", "en": "subcutaneous use (label scope; this page does not determine an individual's injection units or timing)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0088-2219-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 units/mL（U-100）；3 mL SoloStar 单人使用预填充笔；5 支/盒", "en": "100 units/mL (U-100); 3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-36.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甘精胰岛素", "en": "insulin glargine" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位、剂量或换药规则", "en": "labelled concentration; not an individual's injection units, dose or switching rule" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 units/mL（U-100；标签浓度，不是个人注射量）", "en": "100 units/mL (U-100; labelled concentration, not an individual injection amount)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL SoloStar 单人使用预填充笔；5 支/盒", "en": "3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "支/盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "solostar_prefilled_pen", "name": { "zh": "SoloStar", "en": "SoloStar" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "支/盒", "en": "pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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-lantus-solostar-insulin-glargine-u100-3ml-pen-ndc-0088-2219-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-36.jpg", "alt": "LANTUS SoloStar 甘精胰岛素在美国 DailyMed 当前标签中的 U-100、3 mL 单人使用预填充笔、NDC 0088-2219-05、5 支/盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v35（2025-07-02 发布）", "presentation": "LANTUS SoloStar 甘精胰岛素：100 units/mL（U-100），3 mL 单人使用预填充笔，NDC 0088-2219-05，5 支/盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 LANTUS SoloStar、甘精胰岛素、100 units/mL（U-100）、3 mL 单人使用预填充笔、NDC 0088-2219-05 与 5 支/盒。它只帮助核对品牌、通用名、标签浓度、剂型、装置、包装数量与来源；不用于鉴定真伪，也不证明 10 mL 小瓶、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的注射单位、注射时间、混用、换药或血糖处理方案。", "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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": "LANTUS / 来得时说明书放大阅读：单位、浓度、注射装置不能只看一个数字", "en": "LANTUS label reading: units, concentration and delivery device cannot be reduced to one number" }, "summary": { "zh": "本模块以 FDA 与 DailyMed 的美国公开标签为阅读入口，帮助识别 LANTUS、甘精胰岛素、100 units/mL（U-100）、皮下注射途径及小瓶/预填充笔。它不生成个人注射单位、换用方案、混用方案或血糖处理方案。", "en": "This module uses U.S. FDA and DailyMed public labels as reading entry points for LANTUS, insulin glargine, 100 units/mL (U-100), the subcutaneous route and vial/prefilled-pen presentations. It does not generate individual injection units, switching, mixing or glucose-management plans." }, "checks": [ { "zh": "“100 units/mL（U-100）”描述的是该标签所列产品的浓度；“U（单位）”与 mg 不是可凭网页相互换算的同一单位。剂量窗显示、每次实际使用单位和产品浓度必须在医生或药师确认的准确装置、处方与现行标签中一起核对。", "en": "“100 units/mL (U-100)” describes the concentration of the labelled product. Units and mg are not one unit that can be converted from a webpage. A dose-window display, the actual units used and product concentration must be checked together against the exact device, prescription and current label with a clinician or pharmacist." }, { "zh": "同一公开档案中可见小瓶、预填充笔等不同包装/装置文字。它们是产品身份的一部分；不要把一支笔、一瓶或另一种胰岛素的经验套用到本产品，更不要根据外观或“都是甘精胰岛素”自行换算、替换或混用。", "en": "The public archive includes wording for different presentations such as vials and prefilled pens. They are part of product identity. Do not apply experience with another pen, vial or insulin to this product, or self-convert, substitute or mix products from appearance or a shared insulin-glargine name." }, { "zh": "标签提示每次注射前核对胰岛素标签，以降低用药错误风险；更改胰岛素方案可使高血糖或低血糖风险发生变化，需要密切的专业监督。出现困惑、产品改变、血糖异常或不适时，应使用实际包装和完整药单联系医疗团队，不要等待网页给出调整答案。", "en": "The label tells patients to check the insulin label before each injection to reduce medication errors, and notes that regimen changes can alter hyperglycaemia or hypoglycaemia risk and need close professional supervision. With confusion, a product change, abnormal glucose results or symptoms, contact the care team with the actual pack and complete medicine list rather than waiting for a website adjustment answer." }, { "zh": "包装图、品牌名或“长效”描述都不能鉴定真伪、证明可替代性或决定个人的注射时间与单位。此页不替代面对实际装置的教学；阅读、视力、记忆或操作困难时，请药师、护士或医生进行现场核对和示范。", "en": "A pack image, brand name or “long-acting” description cannot authenticate a product, prove interchangeability or decide an individual's injection timing or units. This page does not replace teaching with the actual device; seek an in-person check and demonstration from a pharmacist, nurse or clinician if reading, vision, memory or handling is difficult." } ], "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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": "甘精胰岛素怎样起作用：它影响葡萄糖的利用与肝脏葡萄糖生成", "en": "How insulin glargine works: it affects glucose use and hepatic glucose production" }, "summary": { "zh": "FDA 公开标签将甘精胰岛素的主要作用归入调节葡萄糖代谢：促进外周组织，尤其骨骼肌和脂肪组织摄取葡萄糖，并抑制肝脏葡萄糖生成。这解释的是作用路径，不给出个人单位、注射时间、换用或低血糖处理方案。", "en": "The FDA public label describes insulin glargine's primary activity as regulating glucose metabolism: it stimulates peripheral glucose uptake, especially in skeletal muscle and fat, and inhibits hepatic glucose production. This explains a pathway; it does not give individual units, injection timing, switching or hypoglycaemia-management plans." }, "checks": [ { "zh": "机制不是“单位公式”。包装上的 100 units/mL 是浓度，U（单位）也不是可从网页换算成 mg 的同一单位；实际使用的单位、产品浓度和装置必须按准确处方与现行标签一起核对。", "en": "Mechanism is not a “unit formula.” The 100 units/mL on a pack is concentration, and U (units) is not the same unit as mg for webpage conversion; the actual units used, product concentration and device must be checked together against the exact prescription and current label." }, { "zh": "同属胰岛素或都标为“长效”并不使产品、装置或监测要求相同。不要仅凭共同机理、外观或名称片段自行替换、混用或调整。", "en": "Being insulins or both described as “long-acting” does not make products, devices or monitoring requirements the same. Do not self-substitute, mix or adjust from a shared mechanism, appearance or fragment of a name." }, { "zh": "血糖异常、身体不适、拿到不同包装或读不清装置时，网页的机制说明不能决定下一步。请带上实际产品和完整药单联系医疗团队或药师核对。", "en": "With abnormal glucose readings, feeling unwell, a different pack or uncertainty reading a device, a webpage mechanism explanation cannot decide the next step. Take the actual product and full medicine list to the care team or pharmacist for review." } ], "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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": "Lantus", "generic": "甘精胰岛素", "dosageFormClass": "皮下注射液；U-100 10 mL 多剂量小瓶与 3 mL SoloStar 单人使用预填充笔为不同包装/装置形式（当前美国公开标签所列）" }, "labelSource": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "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." } } ], "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 与 DailyMed 的 LANTUS（insulin glargine）公开标签将其列为皮下注射用甘精胰岛素，标签列示美国初始批准年份为 2000。此页用于放大阅读品牌、通用名、U-100 浓度、皮下注射途径以及小瓶/预填充笔等产品身份线索；不据此推定中国大陆或其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "胰岛素的“单位（U）”、每毫升浓度、注射装置和不同产品名称必须一起核对。即使通用名相近或都写“长效”，也不能从包装图、一个数字或经验自行换算、替换、混用或调整。", "sourceDocuments": [ { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 021081", "approvalTimeline": [ { "date": "2000", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 LANTUS 标签列示 Initial U.S. Approval: 2000。该年份仅定位这一美国标签档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current LANTUS label lists Initial U.S. Approval: 2000. This year locates this U.S. label record only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-07-02", "title": { "zh": "DailyMed 当前公开 SPL v35", "en": "Current public SPL v35 published on DailyMed" }, "detail": { "zh": "DailyMed 将 LANTUS 当前 SPL v35 的发布日期列为 2025-07-02。本页分别展示一个 U-100 10 mL 多剂量小瓶和一个 U-100 3 mL SoloStar 单人使用预填充笔的准确标签面板；不据此建立实际在售、库存、个人注射单位、注射时间、混用、换药或其他包装状态。", "en": "DailyMed lists 2 Jul 2025 as the publication date for current LANTUS SPL v35. This page separately displays one exact U-100 10 mL multiple-dose vial panel and one U-100 3 mL SoloStar single-patient-use prefilled-pen panel; it does not establish actual availability, stock, individual injection units, injection timing, mixing, switching or another-package status." }, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签、10 mL 小瓶与 3 mL SoloStar 准确包装面板", "en": "Current label, 10 mL vial and 3 mL SoloStar exact package panels linked" }, "detail": { "zh": "包装面板分别对应 NDC 0088-2220-33 小瓶和 NDC 0088-2219-05 SoloStar 预填充笔。它们不用于鉴定真伪，也不建立实际在售、库存、个人单位、注射时间、混用或可替代性。", "en": "The package panels correspond respectively to NDC 0088-2220-33 vial and NDC 0088-2219-05 SoloStar prefilled pen. They do not authenticate a product or establish actual availability, stock, individual units, injection timing, mixing or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "U-100、10 mL 小瓶和 3 mL SoloStar 预填充笔能否仅凭数字或“都是甘精胰岛素”互换？", "en": "Can U-100, a 10 mL vial and a 3 mL SoloStar prefilled pen be exchanged from a number or a shared insulin-glargine name alone?" }, "answer": { "zh": "不能。U-100 是该标签中浓度的写法，10 mL 小瓶与 3 mL SoloStar 预填充笔是不同包装/装置身份。共同通用名、相同浓度或包装图片不能证明可自行换用、混用、调整单位或改变时间；请让药师或开方团队核对实际产品、处方和完整药单。", "en": "No. U-100 is the label's concentration notation, while the 10 mL vial and 3 mL SoloStar prefilled pen are different package/device identities. A shared generic name, matching concentration or package image does not establish self-switching, mixing, unit adjustment or a timing change; have a pharmacist or prescribing team review the actual product, prescription and complete medicine list." } }, { "question": { "zh": "为什么页面强调查看标签，却不提供个人单位或换用步骤？", "en": "Why does the page emphasise checking the label but not provide individual units or switching steps?" }, "answer": { "zh": "当前标签提示胰岛素方案改变可能影响高血糖或低血糖风险，且需要密切专业监督。网页的作用是帮助识别准确包装、浓度和来源，并把个人问题带回医疗团队；它不是剂量、换药、混用或血糖处理工具。", "en": "The current label notes that changes in an insulin regimen may affect hyperglycaemia or hypoglycaemia risk and need close professional supervision. This page helps identify the exact package, concentration and source, then routes individual questions back to the care team; it is not a tool for dosing, switching, mixing or glucose management." } } ], "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/lantus/", "en": "https://origindrug.com/en/drugs/lantus/" }, "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." ] }