{ "id": "trulicity", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Trulicity", "generic": "度拉糖肽", "aliases": [ "dulaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射液（单剂量预充笔；FDA 2025 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2014（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trulicity-dulaglutide-0-75mg-0-5ml-single-dose-pen-0002143380", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose 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 0002-1433-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 0.75 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 0.75 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-point75mg-004-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 0.75, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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-trulicity-dulaglutide-1-5mg-0-5ml-single-dose-pen-0002143480", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose 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 0002-1434-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 1.5 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 1.5 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-1point5mg-005-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 1.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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-trulicity-dulaglutide-3mg-0-5ml-single-dose-pen-0002223680", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose 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 0002-2236-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 3 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 3 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-3mg-055-02.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 3, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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-trulicity-dulaglutide-4-5mg-0-5ml-single-dose-pen-0002318280", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose 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 0002-3182-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 4.5 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 4.5 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-4point5mg-056-02.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 4.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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=us-trulicity-sup-1point5mg-005-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "alt": "TRULICITY 1.5 mg/0.5 mL 单剂量预充笔在美国 DailyMed 公开标签中的四支装纸盒展开图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "TRULICITY 1.5 mg/0.5 mL、4 支单剂量预充笔纸盒展开图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 TRULICITY 1.5 mg/0.5 mL 四支单剂量预充笔的纸盒文字图，只帮助核对品牌、通用名、标示强度、给药途径、装置和来源；不用于鉴定真伪，也不证明其他强度、其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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": "TRULICITY 说明书放大阅读：mg/0.5 mL 是装置强度，不是个人注射指令", "en": "TRULICITY label reading: mg/0.5 mL identifies device strength, not an individual injection instruction" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，帮助区分 TRULICITY 单剂量预充笔的名称、强度和注射途径；它不提供个人起始、加量、漏用补用或与其他注射药转换的方案。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point. It helps distinguish a TRULICITY single-dose pen's name, strength and injection route; it does not provide an individual starting, escalation, missed-dose or switching plan." }, "checks": [ { "zh": "该标签列出 0.75、1.5、3、4.5 mg/0.5 mL 单剂量预充笔。每个数字首先描述该准确装置中标示的药物量与液体体积；不能据此自行把两支、不同强度或另一种注射产品相加、拆分或互换。", "en": "The label lists 0.75, 1.5, 3 and 4.5 mg/0.5 mL single-dose pens. Each number first describes the stated medicine amount and liquid volume in that exact device; it does not permit self-combining, splitting or exchanging pens, strengths or another injectable product." }, { "zh": "该标签把与胰岛素或促胰岛素分泌药联用时的低血糖风险列为需要专业人员核对的情形。手中同时有多支“降糖针”或口服降糖药时，应带完整药单和实际包装请药师/开方团队核对，不要只按名称或频次自行叠加。", "en": "The label identifies hypoglycaemia risk with insulin or insulin secretagogues as a situation for professional review. When several glucose-lowering injections or oral medicines are present, bring the complete list and actual packages for pharmacist or prescriber review rather than self-combining from names or frequency alone." }, { "zh": "标签说明 TRULICITY 与胰岛素应为分开注射，不能混在同一注射中。它不等于所有人都应联用，也不说明任何人该怎样调整胰岛素；实际安排须以处方和专业指导为准。", "en": "The label states that TRULICITY and insulin are separate injections and must not be mixed in the same injection. That does not mean everyone should combine them or determine an insulin adjustment; the actual plan requires the prescription and professional guidance." }, { "zh": "图片、颜色、笔型和包装数字只能用于定位来源。不同市场、标签版本和产品包装可能不同；它们不能鉴定真伪、确认当前市场批准或替代出现不适、急性疾病或操作前后的医疗指示。", "en": "Images, colours, pen design and package numbers only help locate a source. Markets, label versions and packages can differ; they cannot authenticate a product, establish current market approval or replace medical instructions during symptoms, acute illness or procedures." } ], "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 处方信息（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度拉糖肽怎样起作用：它激活 GLP-1 受体，作用受血糖状态影响", "en": "How dulaglutide works: it activates the GLP-1 receptor, with actions related to glucose state" }, "summary": { "zh": "DailyMed 的 TRULICITY 公开标签描述：度拉糖肽激活胰腺 β 细胞上的 GLP-1 受体，增加细胞内 cAMP，继而促进葡萄糖依赖的胰岛素释放；同时减少胰高血糖素分泌并延缓胃排空。这解释药物作用路径，不等于能从一次血糖、体重、食欲或注射笔数字推导个人该怎样使用。", "en": "The public DailyMed TRULICITY label describes dulaglutide as activating the GLP-1 receptor on pancreatic beta cells, increasing intracellular cAMP and leading to glucose-dependent insulin release; it also decreases glucagon secretion and delays gastric emptying. This explains a drug-action pathway, not how an individual should use it based on one glucose result, body weight, appetite or a pen number." }, "checks": [ { "zh": "“葡萄糖依赖”是标签对药理作用的描述，并不把低血糖、联用或个人风险自动排除。与胰岛素、促胰岛素分泌药或其他降糖药一起使用时，完整药单和具体处方仍须由药师或开方团队核对。", "en": "“Glucose-dependent” describes pharmacology in the label; it does not automatically rule out hypoglycaemia, combination issues or individual risk. When insulin, an insulin secretagogue or other glucose-lowering medicines are also used, the complete list and exact prescription still need pharmacist or prescriber review." }, { "zh": "“延缓胃排空”能帮助理解为什么不能仅按包装或网络摘要自行安排同服的口服药。它不提供服药间隔、漏用后的补救、手术前后安排或胃肠道症状的个人处理方案。", "en": "“Delays gastric emptying” helps explain why oral co-medications cannot be scheduled from a package or web summary alone. It does not supply an individual spacing schedule, missed-use remedy, peri-procedural plan or response to gastrointestinal symptoms." }, { "zh": "0.75、1.5、3、4.5 mg/0.5 mL 描述的是不同标示强度的单剂量装置；药理机制相同不代表两支、两种强度或另一种 GLP-1 注射药可以自行相加、拆分、轮换或替代。", "en": "0.75, 1.5, 3 and 4.5 mg/0.5 mL describe single-dose devices with different stated strengths; shared pharmacology does not make two pens, two strengths or another GLP-1 injection self-combinable, splittable, alternable or substitutable." } ], "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06，临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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": "Trulicity", "generic": "度拉糖肽", "dosageFormClass": "皮下注射液（单剂量预充笔；FDA 2025 标签所列）" }, "labelSource": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.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." } }, { "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 TRULICITY（dulaglutide）2025 美国标签列示其为皮下注射用制剂，并列出美国初始批准年份为 2014。页面提供可复核的美国监管资料入口；不据此推定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": "注射笔上的商品名、通用名、标示强度、液体体积和目标市场必须同时核对。标签中的规格或给药频次描述不能转换为个人开始、加量、漏用补用、与其他降糖药联用或换药方案。", "sourceDocuments": [ { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "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": "BLA 125469", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA: TRULICITY prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 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 2025-05 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_198d9ae73f3553a3", "label": "FDA: TRULICITY prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：治疗窗较窄的口服药先做完整核对", "en": "When COUMADIN / warfarin is on the same list: review a narrow-therapeutic-index oral medicine first" }, "summary": { "zh": "FDA 的 2025 TRULICITY 标签说明其可延缓胃排空，可能降低同用口服药的吸收速率；并明确将华法林列为治疗窗较窄、需要由专业人员监测药物水平的口服药示例。这张卡只提示把华法林、TRULICITY、所有实际药盒、非处方药和补充剂交给药师或开方团队核对；它不提供个人监测目标、给药间隔或调整方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2025 TRULICITY label says it delays gastric emptying and may reduce the rate of absorption of concomitant oral medicines; it names warfarin as an example of an oral medicine with a narrow therapeutic index for which professionals monitor drug levels. This card only signals that warfarin, TRULICITY, every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it provides no individual monitoring target, timing interval or adjustment plan and does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025 美国处方信息（7.1 Oral Medications：华法林为治疗窗较窄口服药示例）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "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/trulicity/", "en": "https://origindrug.com/en/drugs/trulicity/" }, "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." ] }