{ "id": "rybelsus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Rybelsus", "generic": "司美格鲁肽", "aliases": [ "oral semaglutide", "semaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（页面更新 2026-01-30；标签修订 2026-01）。本档案只建立标签明确列出的 RYBELSUS 3 mg、7 mg、14 mg 口服片及各自 30 片瓶装身份；不从该资料推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可得性或可替代性。", "dosageFormClass": "口服司美格鲁肽片剂；不同配方、强度与包装必须分别核对（美国 2026 当前标签）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2019（FDA 原始批准资料：RYBELSUS NDA 213051）", "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-rybelsus-oral-semaglutide-tablet-3mg-30-bottle-ndc-0169430330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4303-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 3 mg；30 片瓶装", "en": "Semaglutide 3 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_3mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "3 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rybelsus-oral-semaglutide-tablet-7mg-30-bottle-ndc-0169430730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4307-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 7 mg；30 片瓶装", "en": "Semaglutide 7 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_7mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 7, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "7 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rybelsus-oral-semaglutide-tablet-14mg-30-bottle-ndc-0169431430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4314-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 14 mg；30 片瓶装", "en": "Semaglutide 14 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_14mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 14, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "14 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_3mg_carton.jpg", "alt": "RYBELSUS 司美格鲁肽 3 mg、30 片、NDC 0169-4303-30 的美国 DailyMed 当前口服片纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v13（2026-05-20 发布；标签修订 2026-01）", "presentation": "RYBELSUS 3 mg 口服片、NDC 0169-4303-30、30 片纸盒面板（当前美国 DailyMed 标签所列）。", "notice": "此图只对应 RYBELSUS、口服片、3 mg、NDC 0169-4303-30 与 30 片包装；不用于鉴定真伪，也不代表其他强度、R2 配方、OZEMPIC 口服片、OZEMPIC 注射剂、WEGOVY、其他市场或任何个人用药方案。", "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RYBELSUS 说明书放大阅读：口服片、配方与毫克数必须一起核对", "en": "RYBELSUS label reading: oral tablets, formulation and milligrams must be checked together" }, "summary": { "zh": "本模块以 FDA 2026 美国标签与 DailyMed 当前公开标签为阅读入口，帮助核对 RYBELSUS 的口服途径、完整品牌名、配方提示、每片标示强度和包装；它不提供个人起始、加量、补用、注射/口服转换或替换方案。", "en": "This module uses the FDA 2026 label and the current DailyMed public label as reading entries. It helps check RYBELSUS's oral route, full brand name, formulation cue, labelled strength per tablet and pack; it does not provide an individual starting, escalation, missed-use, injection-to-oral conversion or switching plan." }, "checks": [ { "zh": "先同时核对 RYBELSUS、司美格鲁肽、口服片、每片强度、包装和目标市场。通用名相同并不使它与 OZEMPIC 注射剂、WEGOVY 或另一种口服片成为可按名称或照片自行互换的同一产品。", "en": "Check RYBELSUS, semaglutide, oral tablet, labelled strength per tablet, pack and target market together. A shared generic name does not make it the same product as OZEMPIC injection, WEGOVY or another oral tablet for self-switching by name or photo." }, { "zh": "当前美国标签同时列出不同配方与不同片剂强度，并明确不能按毫克对毫克自行替换。包装上的数字是身份线索，不是自行换算、合并、掰开、补用或改用另一种产品的指令。", "en": "The current U.S. label lists different formulations and tablet strengths and states that they are not self-substitutable milligram for milligram. A number on the pack is an identity clue, not an instruction to convert, combine, split, make up or change products." }, { "zh": "“口服”也不表示可把它与其他口服药、饮料、进食时间或注射产品自行安排成固定方案。实际产品的现行标签、处方、全部药单和药师/开方团队指导必须一起核对。", "en": "“Oral” also does not provide a self-made schedule with other oral medicines, drinks, meals or an injection product. The current label for the actual product, prescription, complete medicine list and pharmacist/prescribing-team guidance must be reviewed together." }, { "zh": "持续呕吐、明显脱水、严重腹痛、低血糖样症状或对手上产品是否准确不确定时，应使用当地医疗渠道或咨询药师/开方团队；网页不替代紧急判断。", "en": "For persistent vomiting, marked dehydration, severe abdominal pain, low-glucose-like symptoms or uncertainty about the product in hand, use local medical channels or contact a pharmacist/prescribing team; a webpage does not replace urgent judgement." } ], "source": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.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": "口服司美格鲁肽怎样起作用：GLP-1 受体通路不等于可以自行换算产品", "en": "How oral semaglutide works: a GLP-1 pathway does not make products self-convertible" }, "summary": { "zh": "当前标签将口服司美格鲁肽描述为 GLP-1 类似物和 GLP-1 受体激动剂，并涉及葡萄糖依赖性胰岛素分泌、胰高血糖素分泌和胃排空等作用。这是机制概述，不是个人控糖结果、适用性、剂量、餐食安排或换药方案。", "en": "The current label describes oral semaglutide as a GLP-1 analogue and GLP-1 receptor agonist, involving glucose-dependent insulin secretion, glucagon secretion and gastric emptying. This is a mechanism overview, not an individual's glucose outcome, suitability, dose, meal plan or switching plan." }, "checks": [ { "zh": "GLP-1 是作用通路线索，不表示所有同类、同名或同通用名产品可自行叠加、隔天轮换或按总毫克数等量替换。", "en": "GLP-1 is an action-pathway clue; it does not make every same-class, same-name or same-generic product self-combinable, alternatable or milligram-equivalent." }, { "zh": "标签所述胃排空变化说明为什么同时使用的口服药和实际进食安排需要专业人员复核；它不能生成自行错开、停用、补用或调整其他药物的规则。", "en": "The label's discussion of gastric emptying explains why co-administered oral medicines and actual meal timing need professional review; it cannot generate self-made spacing, stopping, make-up or adjustment rules for other medicines." }, { "zh": "机制不是疗效或不良反应的个人预测。胃肠道症状、脱水、肾功能、其他降糖药和完整药单都需要回到准确产品的现行标签与专业评估。", "en": "Mechanism is not an individual prediction of benefit or adverse effects. Gastrointestinal symptoms, dehydration, kidney function, other glucose-lowering medicines and the complete medicine list require the current label for the exact product and professional assessment." } ], "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Rybelsus", "generic": "司美格鲁肽", "dosageFormClass": "口服司美格鲁肽片剂；不同配方、强度与包装必须分别核对（美国 2026 当前标签）" }, "labelSource": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.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_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.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_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "DailyMed 的当前美国公开标签列有 RYBELSUS（semaglutide）3 mg、7 mg、14 mg 口服片。本页分别建立三种 30 片瓶装面板的品牌、通用名、每片标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人片数、疗程、转换、联用或购买结论。", "history": "本页只建立当前 DailyMed 标签所列的 RYBELSUS 3 mg（NDC 0169-4303-30）、7 mg（NDC 0169-4307-30）和 14 mg（NDC 0169-4314-30）各 30 片瓶装身份。完整商品名、口服片、每片 mg、NDC、瓶装和目标市场须同时核对；共享通用名、相近数字或照片不能自行回答能否换用、联用、掰开、补用或改用另一种司美格鲁肽产品。", "sourceDocuments": [ { "id": "src_1e19329b60038cbf", "label": "FDA：RYBELSUS NDA 213051 原始批准资料（2019-09-20）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.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_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "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 213051", "approvalTimeline": [ { "date": "2019-09-20", "title": { "zh": "RYBELSUS 原始美国批准", "en": "Original U.S. RYBELSUS approval" }, "detail": { "zh": "FDA 原始批准资料记录 RYBELSUS（司美格鲁肽口服片）NDA 213051 于 2019-09-20 获批。该历史节点不自动说明当前标签、供应、持有人或其他市场状态。", "en": "FDA original-approval material records approval of RYBELSUS (oral semaglutide tablets), NDA 213051, on 20 Sep 2019. This historical entry does not establish current labeling, availability, holder or another-market status." }, "source": { "id": "src_1e19329b60038cbf", "label": "FDA：RYBELSUS NDA 213051 原始批准资料（2019-09-20）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "FDA 当前口服片处方信息修订", "en": "FDA current oral-tablet prescribing information revised" }, "detail": { "zh": "本页链接的 FDA 处方信息标示修订于 2026-01，并将 RYBELSUS 与 OZEMPIC 口服片置于同一文件；必须核对完整品牌、口服片配方、强度、包装与目标市场，不能从共享通用名推定互换。", "en": "The linked FDA prescribing information is revised January 2026 and covers RYBELSUS and OZEMPIC tablets in one document. Check the complete brand, oral-tablet formulation, strength, pack and target market; a shared generic name does not establish interchangeability." }, "source": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.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": "2026-05-20", "title": { "zh": "DailyMed 当前 SPL v13 公开", "en": "Current DailyMed SPL v13 published" }, "detail": { "zh": "DailyMed 媒体目录列示当前 SPL v13 于 2026-05-20 发布，并包含 RYBELSUS 准确 3 mg 纸盒面板。该日期与图片不表示其他包装、其他市场或实际可得性。", "en": "The DailyMed media listing shows current SPL v13 published on 20 May 2026 and includes the exact RYBELSUS 3 mg carton panel. That date and image do not establish another pack, another market or actual availability." }, "source": { "id": "src_bd3a04f8202e1084", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（SPL v13，2026-05-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 原始批准、当前口服片标签与一个精确 3 mg 纸盒面板", "en": "FDA original approval, current oral-tablet label and one exact 3 mg carton panel linked" }, "detail": { "zh": "展示图只对应 RYBELSUS 3 mg、NDC 0169-4303-30、30 片纸盒；不据此建立其他强度、R2 配方、OZEMPIC 口服片/注射剂、WEGOVY 或实际在售状态。", "en": "The image corresponds only to RYBELSUS 3 mg, NDC 0169-4303-30 and a 30-tablet carton; it does not establish other strengths, R2 formulation, OZEMPIC tablets/injection, WEGOVY or actual availability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国文件推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from U.S. documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "能否把 RYBELSUS 与任何 Ozempic 或 Wegovy 产品按毫克数互换？", "en": "Can RYBELSUS be exchanged milligram for milligram with any Ozempic or Wegovy product?" }, "answer": { "zh": "不能。本页只帮助区分产品身份；共享通用名、相近数字或包装照片不足以建立剂型、配方、给药途径或转换关系。请带准确包装和完整药单请药师/开方团队核对。", "en": "No. This page only distinguishes product identity; a shared generic name, similar numbers or package photo is insufficient to establish dosage form, formulation, route or conversion. Have a pharmacist or prescribing team review the exact pack and complete medicine list." } }, { "question": { "zh": "3 mg、7 mg、14 mg 或 R2 配方的数字是什么意思？", "en": "What do 3 mg, 7 mg, 14 mg or R2 formulation numbers mean?" }, "answer": { "zh": "它们是准确产品包装上的身份信息。当前标签同时提示不同配方和强度不能按毫克对毫克自行替换；网页不把这些数字变成任何人的片数、调整或转换方案。", "en": "They are identity information on the exact product pack. The current label also notes that formulations and strengths are not self-substitutable milligram for milligram; this page does not turn these numbers into anyone's tablet-count, adjustment or conversion plan." } } ], "relatedMedicineChecks": [ { "target": { "id": "ozempic", "brand": "Ozempic", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/ozempic/", "en": "https://origindrug.com/en/drugs/ozempic/" } }, "title": { "zh": "与 OZEMPIC／司美格鲁肽注射剂 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When OZEMPIC / semaglutide injection 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/rybelsus/", "en": "https://origindrug.com/en/drugs/rybelsus/" }, "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." ] }