{ "id": "ozempic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Ozempic", "generic": "司美格鲁肽", "aliases": [ "semaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开标签：DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "dosageFormClass": "司美格鲁肽皮下注射液：已逐项核对三个美国多剂量预充笔展示面（2 mg/3 mL、4 mg/3 mL、8 mg/3 mL）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下", "routeCode": "subcutaneous", "historicalApprovalEntry": "2017（FDA 标签所列美国初始批准）", "archiveSponsorText": "Novo Nordisk / FDA 与 DailyMed 公开监管资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ozempic-semaglutide-025-05mg-2mg-3ml-ndc-0169-4181-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4181-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "0.25 / 0.5 mg 标示给药档位；2 mg/3 mL（0.68 mg/mL）多剂量预充笔", "en": "0.25 / 0.5 mg labelled dose options; 2 mg/3 mL (0.68 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-69.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 2, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.25, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.5, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 0.68, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.68 mg/mL（标签浓度；不是个人注射量）", "en": "0.68 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（6 枚随附针头）", "en": "prefilled pen per carton (6 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "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-ozempic-semaglutide-1mg-4mg-3ml-ndc-0169-4130-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4130-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "1 mg 标示给药档位；4 mg/3 mL（1.34 mg/mL）多剂量预充笔", "en": "1 mg labelled dose option; 4 mg/3 mL (1.34 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-70.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 4, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 1, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 1.34, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "1.34 mg/mL（标签浓度；不是个人注射量）", "en": "1.34 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（4 枚随附针头）", "en": "prefilled pen per carton (4 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "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-ozempic-semaglutide-2mg-8mg-3ml-ndc-0169-4772-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4772-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "2 mg 标示给药档位；8 mg/3 mL（2.68 mg/mL）多剂量预充笔", "en": "2 mg labelled dose option; 8 mg/3 mL (2.68 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-72.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 8, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 2, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 2.68, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "2.68 mg/mL（标签浓度；不是个人注射量）", "en": "2.68 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（4 枚随附针头）", "en": "prefilled pen per carton (4 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "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": "us-ozempic-semaglutide-025-05mg-2mg-3ml-ndc-0169-4181-13", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-69.jpg", "alt": "OZEMPIC 0.25 mg/0.5 mg 多剂量预充式注射笔在美国 DailyMed 公开标签中的 2 mg/3 mL、NDC 0169-4181-13 纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "presentation": "OZEMPIC（司美格鲁肽）0.25 mg/0.5 mg 标示给药档位、2 mg/3 mL（0.68 mg/mL）多剂量预充笔，NDC 0169-4181-13；1 支预充笔与 6 枚随附针头/纸盒。", "notice": "此图只对应美国 DailyMed SPL v20 中 OZEMPIC、司美格鲁肽、NDC 0169-4181-13、2 mg/3 mL（0.68 mg/mL）的多剂量预充式注射笔展示面。它只帮助核对品牌、通用名、标示档位、总量、浓度、NDC、装置、包装与来源；不用于鉴定真伪，也不证明其他强度、其他 NDC、单剂量预充式注射器、其他市场、实际在售、库存、目标市场批准、原研身份、可替代性，或任何个人的注射量、频率、补用、加量、转换或联用方案。", "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "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": "OZEMPIC 说明书放大阅读：注射笔上的 mg 与 mg/mL 要一起看", "en": "OZEMPIC label reading: read mg and mg/mL on a pen together" }, "summary": { "zh": "本模块以 FDA 2026 美国标签为阅读入口，帮助分开核对 OZEMPIC 注射笔的商品名、每次给药标示、浓度、装置和目标市场；它不提供个人起始、加量、漏用补救或与另一种司美格鲁肽产品转换的方案。", "en": "This module uses the 2026 U.S. FDA label as a reading entry point. It separates the OZEMPIC pen’s brand, stated dose, concentration, device and target market; it does not provide an individual starting, escalation, missed-dose or conversion plan to another semaglutide product." }, "checks": [ { "zh": "先把 OZEMPIC、司美格鲁肽、皮下注射、具体注射笔/包装和目标市场一起核对。仅看到相同通用名、相似笔形或一个相近的 mg 数字，不能证明两件产品可互换。", "en": "Check OZEMPIC, semaglutide, subcutaneous injection, the exact pen/package and target market together. A shared generic name, similar pen shape or nearby mg number does not prove two products can be exchanged." }, { "zh": "包装上的 mg 是标示的药物量，mg/mL 还包含液体体积与浓度信息；它们都不是“今天该打多少格、打几次或能否把两支合并”的答案。应以实际产品的现行标签、处方和专业人员指导核对。", "en": "A package’s mg states an amount of medicine, while mg/mL also includes liquid volume and concentration. Neither answers how many dial settings, injections or combined devices a person should use today. Check the current label, prescription and professional guidance for the actual product." }, { "zh": "正在使用胰岛素、促胰岛素分泌药或其他降糖/减重产品时，不能因都与血糖或体重有关就自行叠加、轮换或替换。把全部药单、装置和实际使用时间带给开方团队或药师复核。", "en": "When insulin, an insulin secretagogue, or another glucose- or weight-related product is used, do not self-combine, alternate or substitute simply because they relate to glucose or weight. Bring the complete medicine list, devices and actual timing to the prescribing team or pharmacist." }, { "zh": "持续呕吐、明显脱水、无法进食饮水、严重腹痛或对怎样使用装置不确定时，应及时使用当地医疗渠道；网页不应被当作调整注射频率或剂量的工具。", "en": "With persistent vomiting, marked dehydration, inability to eat or drink, severe abdominal pain, or uncertainty about device use, use timely local medical pathways; a webpage must not be used to adjust injection frequency or dose." } ], "source": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 2026 美国处方信息（NDA 209637）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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": "司美格鲁肽怎样起作用：它激活 GLP-1 受体", "en": "How semaglutide works: it activates the GLP-1 receptor" }, "summary": { "zh": "FDA 标签将司美格鲁肽描述为 GLP-1 受体激动剂；这一通路与葡萄糖依赖性胰岛素分泌、胰高血糖素分泌和胃排空等标签所述作用有关。机制解释的是作用路径，不是任何个人的血糖变化、体重变化、剂量或适用性承诺。", "en": "The FDA label describes semaglutide as a GLP-1 receptor agonist. This pathway is linked in the label to glucose-dependent insulin secretion, glucagon secretion and gastric emptying. Mechanism explains an action pathway, not an individual's glucose change, weight change, dose or suitability." }, "checks": [ { "zh": "“GLP-1”不表示所有同类或同名产品可自行叠加、轮换或等量替代。注射装置、强度、给药途径、目标市场和全部药单仍需逐项核对。", "en": "“GLP-1” does not make all same-class or same-name products self-combinable, interchangeable or dose-equivalent. Injection device, strength, route, target market and the complete medicine list still need item-by-item review." }, { "zh": "标签对胃排空和血糖调节的描述，可提示口服合并用药和低血糖风险为何需要专业人员复核；它不能产生自行错开时间、补用或调整任何药物的规则。", "en": "The label’s discussion of gastric emptying and glucose regulation signals why oral co-medications and low-glucose risk need professional review; it cannot generate self-made spacing, make-up or adjustment rules." }, { "zh": "机制不是减重或控糖结果的保证。既往疾病、肾功能、饮食饮水、胃肠道症状和同时用药都需要回到现行标签、处方和专业评估。", "en": "Mechanism is not a guarantee of weight or glucose outcomes. Prior conditions, kidney function, food/fluid intake, gastrointestinal symptoms and co-medications all require the current label, prescription and professional assessment." } ], "source": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 2026 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Ozempic", "generic": "司美格鲁肽", "dosageFormClass": "司美格鲁肽皮下注射液：已逐项核对三个美国多剂量预充笔展示面（2 mg/3 mL、4 mg/3 mL、8 mg/3 mL）" }, "labelSource": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "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": [ { "id": "fda-2025-counterfeit-ozempic-us-supply-chain-alert", "issuedAt": "2025-12-05", "status": "fda_product_specific_counterfeit_alert", "title": { "zh": "FDA 药品警示：美国供应链中的特定假冒 Ozempic 1 mg 注射笔", "en": "FDA drug alert: specific counterfeit Ozempic 1 mg injection pens in the U.S. supply chain" }, "summary": { "zh": "FDA 于 2025-12-05 更新美国药品警示，说明其查获的假冒 Ozempic（semaglutide）1 mg 注射笔被非法分销至美国正规供应链中，公告列出标示批号 PAR1229 及笔身 EXP/LOT 字样位置这一特定核验线索，并要求美国患者不要使用符合该公告描述的产品。该记录只适用于美国、公告所述 1 mg 笔、批号/标签特征和公告日期；它不用于鉴定其他药盒真伪，不适用于其他规格、其他批次、其他市场或任何个人是否应使用 Ozempic 的结论。拍照文字识别、外观相似或网页搜索都不能替代药师、授权供应链和当地监管渠道对实际产品的核验。", "en": "In its U.S. alert updated on 2025-12-05, FDA said counterfeit Ozempic (semaglutide) 1 mg injection pens had been illegally distributed into the legitimate U.S. supply chain. The notice names lot PAR1229 and a specific EXP/LOT-text placement on the pen as checking cues, and tells U.S. patients not to use products that match its description. This record is limited to the U.S., the described 1 mg pen, lot/labelling features and notice date. It cannot authenticate another pack, apply to another strength, lot or market, or determine whether any individual should use Ozempic. Photo text recognition, visual similarity and an online search do not replace verification of the actual product through a pharmacist, authorised supply chain and local regulator routes." }, "source": { "id": "src_de13b9fd177e9431", "label": "FDA：美国供应链中特定假冒 Ozempic（semaglutide）1 mg 注射笔药品警示（2025-12-05 更新）", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 OZEMPIC（semaglutide）美国公开标签列示三个已逐项核对的多剂量预充式注射笔展示面：2 mg/3 mL、4 mg/3 mL、8 mg/3 mL。本页把商品名、通用名、标示给药档位、笔内总量、浓度、NDC、装置、包装与来源分开阅读；不将这些包装字段变成个人注射量、频率、补用、加量、转换、联用、购买或供应结论。", "history": "FDA 公开标签列示 OZEMPIC 的美国初始批准年份为 2017。此页三个包装展示面只对应 DailyMed SPL v20 中 NDC 0169-4181-13、0169-4130-13、0169-4772-12 的多剂量预充笔；同一标签内仍有 NDC 为 XXXX-XXXX-XX 的预充式注射器展示稿，不能被当作已确定的实际市售 NDC 或包装。标签会更新；任何实际使用、剂量、适应症、安全性或市场状态，均须以目标市场的现行文件和专业人员判断为准。", "sourceDocuments": [ { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 209637", "approvalTimeline": [ { "date": "2017", "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: 2017。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: 2017. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_33c06ed649c74a32", "label": "FDA: OZEMPIC prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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": "2026-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05 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 2026-05 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_33c06ed649c74a32", "label": "FDA: OZEMPIC prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.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": "rybelsus", "brand": "Rybelsus", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/rybelsus/", "en": "https://origindrug.com/en/drugs/rybelsus/" } }, "title": { "zh": "与 RYBELSUS／司美格鲁肽口服片 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When RYBELSUS / oral semaglutide tablets is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "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": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "wegovy", "brand": "Wegovy", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/wegovy/", "en": "https://origindrug.com/en/drugs/wegovy/" } }, "title": { "zh": "与 WEGOVY／司美格鲁肽产品 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When WEGOVY / semaglutide product is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "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": "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/ozempic/", "en": "https://origindrug.com/en/drugs/ozempic/" }, "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." ] }