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unscored" }, "imprint": "25 / novo", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-0-25.jpg&setid=ee06186f-2aa3-4990-a760-757579d8f77b&type=img", "alt": "WEGOVY 0.25 mg/0.5 mL 单剂量预充注射器在美国 DailyMed 公开标签中的纸盒展开图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "WEGOVY 0.25 mg/0.5 mL、4 支单剂量预充注射器纸盒展开图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 WEGOVY 0.25 mg/0.5 mL 单剂量预充注射器的纸盒文字图，只帮助核对品牌、通用名、标示强度、给药途径、包装形式和来源；不用于鉴定真伪，也不证明其他强度、口服片、其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "WEGOVY 说明书放大阅读：同名不等于同一种给药产品", "en": "WEGOVY label reading: the same name does not mean the same administration product" }, "summary": { "zh": "本模块以当前 DailyMed 美国公开标签为阅读入口，帮助分开核对 WEGOVY 的商品名、给药途径、强度单位和包装形式；它不提供个人起始、加量、补用或替换方案。", "en": "This module uses the current U.S. DailyMed public label as a reading entry point. It helps separate WEGOVY’s name, route, strength unit and package form; it does not provide an individual starting, escalation, missed-dose or substitution plan." }, "checks": [ { "zh": "先把“皮下注射”或“口服”、具体产品强度、包装形式和目标市场一起核对。即使商品名与通用名相同，不同给药途径也不是可以只按名称、照片或总毫克数自动互换的同一产品。", "en": "Check “subcutaneous injection” or “oral”, the exact product strength, package form and target market together. Even with the same brand and generic name, different routes are not the same product to interchange by name, photo or total milligrams alone." }, { "zh": "注射产品中“mg/0.5 mL”或“mg/0.75 mL”同时包含每次给药装置中的药物量与液体体积；它不是“每天该打多少”的答案。口服片剂上的 mg 也必须按该准确产品的现行标签、处方和专业指导单独核对。", "en": "For injection products, “mg/0.5 mL” or “mg/0.75 mL” contains both the medicine amount and liquid volume in the stated device; it is not an answer to how much anyone should inject. Milligrams on an oral tablet also require separate checking against that exact product’s current label, prescription and professional guidance." }, { "zh": "注射笔、单剂量装置、口服片及不同强度的包装文字，都是产品身份线索，不是用于自行调整频率、补用、两次合并、拆分或改用另一种司美格鲁肽产品的指令。", "en": "Pen, single-dose device, oral-tablet and different-strength package wording are product-identity clues, not instructions to independently change frequency, make up, combine, split or change to another semaglutide product." }, { "zh": "若同时使用降糖药、存在脱水或胃肠道症状、计划操作，或对注射/口服转换有疑问，应带完整药单与实际包装请开方团队或药师核对；不要从网页推断个体适用性。", "en": "If other glucose-lowering medicines are used, dehydration or gastrointestinal symptoms occur, a procedure is planned, or an injection/oral change is being considered, bring the complete medicine list and actual package to the prescribing team or pharmacist; do not infer individual suitability from a webpage." } ], "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签", "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": "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 受体并参与食欲与能量摄入调节", "en": "How semaglutide works: it activates the GLP-1 receptor and participates in appetite and energy-intake regulation" }, "summary": { "zh": "DailyMed 的 WEGOVY 公开标签将司美格鲁肽描述为 GLP-1 类似物和 GLP-1 受体激动剂；GLP-1 是参与食欲与能量摄入调节的生理信号。标签还描述其可延缓胃排空，并以葡萄糖依赖方式促进胰岛素分泌、减少胰高血糖素分泌。这是机制概述，不是个人是否适用、用哪种给药途径、使用强度或调整频率的答案。", "en": "The public DailyMed WEGOVY label describes semaglutide as a GLP-1 analogue and GLP-1 receptor agonist; GLP-1 is a physiological signal involved in appetite and energy-intake regulation. The label also describes delayed gastric emptying and glucose-dependent stimulation of insulin secretion with reduced glucagon secretion. This is a mechanism overview, not an answer to individual suitability, route, strength or frequency adjustment." }, "checks": [ { "zh": "“影响食欲”不能被读成每个人都应使用、应少吃多少或能据此自行加量。体重、胃肠道反应、营养摄入、共病和全部用药都需要回到具体产品的现行标签、处方与专业评估。", "en": "“Affects appetite” cannot be read as everyone should use the product, should eat a certain amount less, or may self-increase it. Weight, gastrointestinal effects, nutrition intake, coexisting conditions and every medicine need the current label, prescription and professional assessment for the exact product." }, { "zh": "标签的“延缓胃排空”是理解为何口服药联用需要核对的一条线索；它不能给出自行错开时间、停用口服药、把注射产品与口服产品等量换算或把另一种 GLP-1 产品叠加的方案。", "en": "The label's “delays gastric emptying” is one clue for why oral co-medications need review; it cannot provide a self-made spacing schedule, stopping plan for oral medicines, equal conversion between injection and oral products, or a plan to add another GLP-1 product." }, { "zh": "同一通用名下，预充笔、预充注射器、FlexTouch 装置和口服片属于不同产品身份层面。即使药理机制相同，也必须逐项核对给药途径、装置、强度、目标市场与完整药单，不能按总毫克数自行替换。", "en": "Under the same generic name, prefilled pens, prefilled syringes, FlexTouch devices and oral tablets are different product-identity layers. Even with the same pharmacology, route, device, strength, target market and complete medicine list must be checked item by item; total milligrams do not permit self-substitution." } ], "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，临床药理）", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Wegovy", "generic": "司美格鲁肽", "dosageFormClass": "司美格鲁肽单剂量预充注射器：0.25、0.5、1 mg/0.5 mL，1.7、2.4、7.2 mg/0.75 mL；口服片：1.5、4、9、25 mg。皮下与口服是不同产品身份。" }, "labelSource": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "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" }, "productRoutes": [ { "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "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" }, "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." } }, { "source": { "id": "src_447c469410146fe0", "label": "FDA：WEGOVY 2025 美国标签（NDA 215256；当前标签以 DailyMed SPL v19 复核）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-wegovy-glp1-suicidal-ideation-label-safety-communication", "issuedAt": "2026-01-13", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Wegovy 等 GLP-1 受体激动剂的相关标签信息调整", "en": "FDA Drug Safety Communication: related labelling change for Wegovy and other GLP-1 receptor agonists" }, "summary": { "zh": "FDA 于 2026-01-13 发布安全通讯，要求对 Wegovy（司美格鲁肽）、Saxenda 和 Zepbound 的处方信息移除既有的自杀意念/行为风险信息；FDA 表示其综合审查未发现 GLP-1 受体激动剂使用与该风险增加相关。该通讯仅说明美国监管行动及其适用产品，不能替代手中产品、目标市场现行说明书或个人精神健康评估；如有新的或加重的情绪、行为或自伤想法，应立即联系当地紧急/医疗支持，而非自行改变药物。", "en": "On 2026-01-13, FDA issued a Drug Safety Communication requesting removal of existing suicidal-ideation/behavior language from prescribing information for Wegovy (semaglutide), Saxenda and Zepbound; FDA said its comprehensive review did not identify an increased risk with GLP-1 receptor agonists. The communication describes a U.S. regulatory action and named products only. It does not replace the exact product, current target-market label or an individual mental-health assessment; new or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support, not self-directed medicine changes." }, "source": { "id": "src_beb7f5a3f892688f", "label": "FDA：2026-01-13 Wegovy 等 GLP-1 受体激动剂药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp", "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": "美国 DailyMed 当前标签在同一 WEGOVY 品牌下列有皮下注射与口服片。本页将 6 个单剂量预充注射器和 4 个 30 片装口服片分别列出品牌、通用名、途径、标签量、NDC、容器与来源，帮助先确认手中产品。它不把 mg、mg/mL、包装数量或同一成分变成个人注射量、片数、转换、联用或换药结论。", "history": "同一商品名下的不同给药途径、容器、强度和包装不能只按通用名、名称、照片或数字自动等同。本文所列单剂量预充注射器与口服片是不同的标签产品身份；FlexTouch 等其他装置或包装也必须逐项按目标市场现行标签核验。", "sourceDocuments": [ { "id": "src_447c469410146fe0", "label": "FDA：WEGOVY 2025 美国标签（NDA 215256；当前标签以 DailyMed SPL v19 复核）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.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_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "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" }, { "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 215256", "approvalTimeline": [ { "date": "SPL v19, effective 2026-06-18", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 SPL v19, effective 2026-06-18 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated SPL v19, effective 2026-06-18 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed (NLM): current U.S. WEGOVY semaglutide injection and oral-tablet label", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "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": "不从美国公开标签推定当地批准、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. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "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": "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": "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" } ], "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/wegovy/", "en": "https://origindrug.com/en/drugs/wegovy/" }, "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." ] }