{ "id": "onglyza-saxagliptin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "ONGLYZA", "generic": "沙格列汀", "aliases": [ "Onglyza", "saxagliptin", "saxagliptin hydrochloride", "沙格列汀", "安立泽", "NDA 022350", "DIN 02375842", "DIN 02333554" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 FDA Orange Book：ONGLYZA 2.5 mg 与 5 mg 片均为 NDA 022350 历史 RLD、当前 DISCN，且并非因安全性或有效性撤回；加拿大 Health Canada DPD：5 mg（DIN 02333554）与 2.5 mg（DIN 02375842）均为 Marketed。公开美国标签用于说明书阅读，不等于美国当前库存。", "dosageFormClass": "薄膜衣口服片：每片相当于沙格列汀 2.5 mg 或 5 mg。标签明确不得掰开或切开；两个规格不是网页替个人选择或换算的方案。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（美国初始批准）", "archiveSponsorText": "AstraZeneca（美国历史 NDA／加拿大当前 DPD 品牌记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ONGLYZA", "Onglyza saxagliptin", "沙格列汀", "安立泽" ], "excludedProductCues": [ "KOMBIGLYZE XR", "saxagliptin metformin", "QTERN", "dapagliflozin saxagliptin", "QTERNMET XR", "JANUVIA", "TRADJENTA" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-onglyza-saxagliptin-2-5mg-ndc-0310-6100-30-nda-022350", "marketCode": "US", "labelVersion": { "zh": "美国公开标签档案；Orange Book 当前 DISCN", "en": "U.S. public-label archive; currently DISCN in Orange Book" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 2.5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 2.5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6100-30 / NDA 022350", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 2.5 mg；不是个人片数", "en": "Equivalent to saxagliptin 2.5 mg per tablet; not an individual's tablet count" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=933594", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-onglyza-saxagliptin-5mg-ndc-0310-6105-30-nda-022350", "marketCode": "US", "labelVersion": { "zh": "美国公开标签档案；Orange Book 当前 DISCN", "en": "U.S. public-label archive; currently DISCN in Orange Book" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6105-30 / NDA 022350", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 5 mg；不是个人片数", "en": "Equivalent to saxagliptin 5 mg per tablet; not an individual's tablet count" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&archiveid=933594", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-onglyza-saxagliptin-2-5mg-din-02375842", "marketCode": "CA", "labelVersion": { "zh": "Health Canada DPD 当前 Marketed 记录（2026-07-29 数据更新）", "en": "Current Health Canada DPD Marketed record (data updated 29 Jul 2026)" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 2.5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 2.5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "DIN 02375842", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 2.5 mg；不是个人片数", "en": "Equivalent to saxagliptin 2.5 mg per tablet; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_marketed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-onglyza-saxagliptin-5mg-din-02333554", "marketCode": "CA", "labelVersion": { "zh": "Health Canada DPD 当前 Marketed 记录（2026-07-29 数据更新）", "en": "Current Health Canada DPD Marketed record (data updated 29 Jul 2026)" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "DIN 02333554", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 5 mg；不是个人片数", "en": "Equivalent to saxagliptin 5 mg per tablet; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_marketed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未取得与四个市场产品身份逐一对应的当前官方包装主图", "en": "No current official principal pack image was obtained one-to-one for all four market identities" }, "summary": { "zh": "页面下方单列两张美国有日期历史包装面板：5 mg 对应 NDC 0310-6105-30，标签列示营销终止日为 2026-03-31；2.5 mg 对应 NDC 0310-6100-30，标签列示营销终止日为 2025-08-31。加拿大当前包装可能不同，因此这些美国历史面板不替代加拿大现行药盒，也不证明库存、可购买性或个人适用。", "en": "Two dated U.S. historical package panels are separately displayed below: 5 mg corresponds to NDC 0310-6105-30, whose label lists a marketing end date of 31 Mar 2026; 2.5 mg corresponds to NDC 0310-6100-30, whose label lists 31 Aug 2025. Current Canadian packs may differ, so these U.S. historical panels do not substitute for current Canadian packaging or establish stock, purchasing availability or individual suitability." }, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ONGLYZA 说明书放大阅读：胰腺、心衰、肾功能和重复降糖成分", "en": "ONGLYZA enlarged label: pancreas, heart failure, kidney function and duplicate glucose-lowering ingredients" }, "summary": { "zh": "严重且持续的腹痛、气短或平卧呼吸困难、脚踝水肿、体重快速增加、严重过敏或起水疱脱皮都需要及时联系医疗团队。网页不根据血糖、肾功能或症状替个人改变规格。", "en": "Severe persistent abdominal pain, shortness of breath or orthopnoea, ankle swelling, rapid weight gain, serious allergy, blistering or skin erosion requires timely clinical contact. The site does not change an individual's strength from glucose, kidney function or symptoms." }, "checks": [ { "zh": "2.5 mg 和 5 mg 是每片含量，不是每次片数。肾功能和强 CYP3A4/5 抑制剂可能影响专业用药决策，但网页不把检查值或药名自动换成规格。", "en": "2.5 mg and 5 mg are amounts per tablet, not tablet counts. Kidney function and strong CYP3A4/5 inhibitors may affect professional decisions, but the site does not convert test results or medicine names into a strength." }, { "zh": "严重、持续、可能向背部放射的腹痛，伴或不伴呕吐，可能提示胰腺炎，应按标签及时联系医疗团队。", "en": "Severe persistent abdominal pain that may radiate to the back, with or without vomiting, may signal pancreatitis and needs timely clinical contact as directed by the label." }, { "zh": "气短、平卧呼吸困难、脚踝或小腿水肿、体重异常快速增加或异常乏力可能提示心力衰竭，尤其既往心衰或肾脏问题者应优先核对。", "en": "Shortness of breath, orthopnoea, ankle or leg swelling, unusually rapid weight gain or unusual fatigue may signal heart failure, especially with prior heart failure or kidney problems." }, { "zh": "ONGLYZA、KOMBIGLYZE XR、QTERN 与 QTERNMET XR 可能共享沙格列汀；不要只按商品名叠加。与胰岛素或磺脲类同用时低血糖风险可能增加。", "en": "ONGLYZA, KOMBIGLYZE XR, QTERN and QTERNMET XR may share saxagliptin; do not combine from brand names. Hypoglycaemia risk may rise with insulin or a sulfonylurea." }, { "zh": "标签明确不得掰开或切开 ONGLYZA 片。刻印用于核对外观，不是自行减半许可。", "en": "The label says not to split or cut ONGLYZA tablets. Markings identify appearance and are not permission to halve a tablet." } ], "source": { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沙格列汀怎样起作用：抑制 DPP-4，延长餐后肠促胰素信号", "en": "How saxagliptin works: DPP-4 inhibition prolongs post-meal incretin signalling" }, "summary": { "zh": "标签说明 DPP-4 会快速灭活 GLP-1 与 GIP；抑制 DPP-4 可提高活性肠促胰素水平，在血糖依赖条件下促进胰岛素并降低胰高血糖素。这个机制不能替个人解释血糖波动或决定联合方案。", "en": "The label explains that DPP-4 rapidly inactivates GLP-1 and GIP. DPP-4 inhibition increases active incretin levels, supporting glucose-dependent insulin release and lower glucagon. This does not interpret an individual's glucose variation or choose a combination." }, "checks": [ { "zh": "“血糖依赖”不等于绝不会低血糖；与胰岛素或磺脲类同时使用时仍需按标签核对风险。", "en": "Glucose-dependent does not mean hypoglycaemia is impossible; co-use with insulin or a sulfonylurea still requires labelled risk review." }, { "zh": "沙格列汀不是西格列汀或利格列汀，DPP-4 同类关系不能建立按毫克换算、轮换或叠加。", "en": "Saxagliptin is not sitagliptin or linagliptin; a shared DPP-4 class does not permit milligram conversion, rotation or combination." }, { "zh": "ONGLYZA 不是胰岛素，也不治疗 1 型糖尿病或糖尿病酮症酸中毒；网页不会依据一次血糖读数推荐药物。", "en": "ONGLYZA is not insulin and does not treat type 1 diabetes or diabetic ketoacidosis; the site does not recommend a medicine from one glucose reading." } ], "source": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ONGLYZA", "generic": "沙格列汀", "dosageFormClass": "薄膜衣口服片：每片相当于沙格列汀 2.5 mg 或 5 mg。标签明确不得掰开或切开；两个规格不是网页替个人选择或换算的方案。" }, "labelSource": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "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": "2026-08-31", "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_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "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": "2026-08-31", "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_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "2026-08-31", "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": "ONGLYZA 是沙格列汀品牌档案。普通人优先看三件事：持续剧烈上腹痛可能涉及胰腺炎；气短、平卧呼吸困难、脚踝水肿或体重快速增加可能涉及心力衰竭；与胰岛素或磺脲类同用时低血糖风险可能增加。", "history": "美国 NDA 022350 于 2009-07-31 批准 2.5 mg 与 5 mg 片，当前 Orange Book 品牌行均为 DISCN。加拿大 DPD 当前将 DIN 02333554（5 mg）与 DIN 02375842（2.5 mg）列为 Marketed。", "sourceDocuments": [ { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国历史 NDA 022350；加拿大 DIN 02375842 / 02333554", "approvalTimeline": [ { "date": "2009-07-31", "title": { "zh": "美国 ONGLYZA 2.5 mg 与 5 mg 初始批准", "en": "Initial U.S. approval of ONGLYZA 2.5 mg and 5 mg" }, "detail": { "zh": "Orange Book 记录 NDA 022350 两个历史 RLD 产品，当前均为 DISCN。", "en": "Orange Book records two historical RLD products under NDA 022350, both currently DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2024-10-08", "title": { "zh": "美国患者用药指南修订", "en": "U.S. Medication Guide revised" }, "detail": { "zh": "指南强化胰腺炎、心力衰竭、低血糖、严重关节痛和大疱性类天疱疮等普通人可识别信号。", "en": "The guide highlights patient-recognisable signals involving pancreatitis, heart failure, hypoglycaemia, severe joint pain and bullous pemphigoid." }, "source": { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-07-29", "title": { "zh": "加拿大当前 Marketed 数据更新", "en": "Current Canadian Marketed data updated" }, "detail": { "zh": "DPD 保留 ONGLYZA 2.5 mg 与 5 mg 两个 Marketed DIN。", "en": "DPD retains Marketed DIN records for ONGLYZA 2.5 mg and 5 mg." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "公开标签可阅读，但不证明当前品牌库存。", "en": "The public label remains readable but does not establish current brand stock." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "2.5 mg 与 5 mg 均为 Marketed", "en": "2.5 mg and 5 mg both Marketed" }, "detail": { "zh": "分别对应 DIN 02375842 与 02333554；实际供应仍需当地核对。", "en": "DIN 02375842 and 02333554 respectively; actual supply still requires local checking." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 可以掰半当 2.5 mg 吗？", "en": "Can a 5 mg tablet be halved to make 2.5 mg?" }, "answer": { "zh": "不能自行这样做。患者指南明确写明不得掰开或切开；2.5 mg 是独立规格，个人选择必须由开方团队按准确产品与肾功能等信息决定。", "en": "Do not decide this yourself. The Medication Guide says not to split or cut the tablet. The 2.5 mg product is a separate strength, and individual selection requires the prescriber to review the exact product and factors such as kidney function." } }, { "question": { "zh": "复方药里已经有沙格列汀，还能加 ONGLYZA 吗？", "en": "Can ONGLYZA be added if a combination product already contains saxagliptin?" }, "answer": { "zh": "不要自行叠加。先核对 KOMBIGLYZE XR、QTERN 或 QTERNMET XR 的全部有效成分，并让药师检查是否重复。", "en": "Do not self-add it. Check every active ingredient in KOMBIGLYZE XR, QTERN or QTERNMET XR and have a pharmacist assess duplication." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/onglyza-saxagliptin/", "en": "https://origindrug.com/en/drugs/onglyza-saxagliptin/" }, "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." ] }