{ "id": "euthyrox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "EUTHYROX", "generic": "左甲状腺素钠", "aliases": [ "EUTHYROX", "优甲乐", "左甲状腺素钠", "levothyroxine", "levothyroxine sodium" ], "marketBrandNames": [ { "name": "优甲乐®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "historical_public_record", "note": { "zh": "Merck China 产品页将优甲乐®标为左甲状腺素钠片，并介绍 2020 年新配方上市及新旧配方过渡背景。它只是名称与配方历史线索；不证明当前批准、准确规格/包装、供应、销售资格或与美国 EUTHYROX、SYNTHROID 或其他左甲状腺素产品可替代。", "en": "The Merck China product page identifies EUTHYROX® as levothyroxine sodium tablets and describes a 2020 new-formulation launch and transition. It is only a name and formulation-history clue; it does not establish current approval, an exact strength/package, supply, sale eligibility or interchangeability with U.S. EUTHYROX, SYNTHROID or another levothyroxine product." }, "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "优甲乐®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：DailyMed 的 EUTHYROX 当前公开标签（SPL v10，2026-01-27 生效；处方信息 2025-12 修订）。中国大陆：Merck China 页面提供“优甲乐®／左甲状腺素钠片”名称及 2020 年新配方上市历史线索；不以该页建立当前批准、具体包装、供应、销售资格或跨市场可替代性结论。", "dosageFormClass": "美国当前公开标签：左甲状腺素钠口服片 25、50、75、88、100、112、125、137、150、175、200 mcg；本档案精确展示 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Provell Pharmaceuticals, LLC / DailyMed 当前美国公开标签；Merck China 优甲乐名称与配方历史页面" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SYNTHROID", "liothyronine", "甲状腺片", "左甲状腺素口服溶液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-euthyrox-levothyroxine-sodium-tablet-50mcg-30carton-ndc-72305-050-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v10，2026-01-27 生效；处方信息 2025-12 修订）", "en": "Current U.S. DailyMed public label (SPL v10, effective 27 Jan 2026; prescribing information revised Dec 2025)" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 72305-050-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mcg（0.05 mg）；30 片泡罩板纸盒（美国标签）", "en": "50 mcg (0.05 mg) per tablet; 30-tablet blister-pack carton (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=50mcgbox.jpg&setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 50, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、调量或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "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/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "EM / 50", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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": "us-euthyrox-levothyroxine-sodium-tablet-50mcg-30carton-ndc-72305-050-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=50mcgbox.jpg&setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275&type=img", "alt": "EUTHYROX 左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10（2026-01-27 生效；处方信息 2025-12 修订）", "presentation": "EUTHYROX 左甲状腺素钠：每片 50 mcg（0.05 mg），NDC 72305-050-30，30 片泡罩板纸盒（美国标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 EUTHYROX、左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30 和 30 片泡罩板纸盒。它只帮助核对品牌、通用名、每片标示量、包装和来源；不用于鉴定真伪，也不代表优甲乐中国包装、SYNTHROID、其他规格/包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、调量、停用、换药或购买方案。", "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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": "EUTHYROX／优甲乐说明书放大阅读：mcg、品牌与市场要一起看", "en": "EUTHYROX / EUTHYROX China label reading: mcg, brand and market must be checked together" }, "summary": { "zh": "本模块用 DailyMed 的美国 EUTHYROX 公开标签与 Merck China 的优甲乐名称/配方历史页面，帮助读者核对准确产品身份；它不提供任何人的片数、间隔、补用、调量、替代、联用或停药方案。", "en": "This module uses the U.S. DailyMed EUTHYROX public label and the Merck China EUTHYROX name/formulation-history page to check exact product identity; it does not provide anyone's tablet count, interval, make-up use, adjustment, substitution, combination or stopping plan." }, "checks": [ { "zh": "50 mcg 等于 0.05 mg；它是每片产品身份的单位换算，不是每天该吃几片、能否对半或如何调量的答案。应同时核对品牌、通用名、每片标示量、剂型、包装、目标市场和现行处方。", "en": "50 mcg equals 0.05 mg. This is a unit conversion for one tablet's identity, not an answer to daily tablet count, splitting or adjustment. Check the brand, generic name, labelled amount per tablet, form, package, target market and current prescription together." }, { "zh": "同为左甲状腺素、名称相近或数字相近，不使 EUTHYROX、优甲乐、SYNTHROID 或另一种甲状腺激素产品可以自行替换、交替、叠加或按片数换算。不同市场的标签和包装必须单独核对。", "en": "A shared levothyroxine ingredient, similar name or similar number does not make EUTHYROX, EUTHYROX China, SYNTHROID or another thyroid-hormone product self-substitutable, alternatable, combinable or convertible by tablet count. Labels and packages in different markets must be checked separately." }, { "zh": "美国标签有与食物、含钙/铁产品、抗酸药及其他药物相互作用相关的文字。实际服用时间或如何与其他药错开，必须依据准确产品的现行标签和开方团队/药师的个体化建议；网页不生成时间表。", "en": "The U.S. label includes language about food, calcium/iron-containing products, antacids and other medicine interactions. Actual timing or separation from another medicine must follow the current label for the exact product and individual advice from the prescribing team/pharmacist; this page does not generate a schedule." }, { "zh": "该美国标签含有“不得用于减重或肥胖治疗”的加框警告。任何心悸、胸痛、明显不适、用药清单变化或担心不良反应的问题，应联系当地医疗支持；不要据网页自行加量、补用、骤停或换成另一种产品。", "en": "The U.S. label carries a boxed warning that it is not for weight loss or obesity treatment. With palpitations, chest pain, marked symptoms, a changed medicine list or an adverse-effect concern, contact local medical support; do not self-increase, make up, abruptly stop or change product from this page." } ], "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左甲状腺素钠怎样起作用：标签药理不能替代个人甲状腺方案", "en": "How levothyroxine sodium works: label pharmacology cannot replace an individual thyroid plan" }, "summary": { "zh": "美国公开标签将左甲状腺素钠描述为合成 T4。它帮助理解通用名、产品身份与安全边界，不用来判断任何人的疾病原因、化验目标、片数、调量、换药或联用方案。", "en": "The U.S. public label describes levothyroxine sodium as synthetic T4. It helps explain the generic name, product identity and safety boundaries; it is not used to decide anyone's disease cause, laboratory target, tablet count, adjustment, switching or combination plan." }, "checks": [ { "zh": "“合成 T4”不是自我诊断、判断化验结果或自行增减药物的依据。症状和检查结果须由开方团队结合准确产品、既往病史和完整药单解释。", "en": "“Synthetic T4” is not a basis for self-diagnosis, interpreting laboratory results or changing a medicine independently. Symptoms and test results require interpretation by the prescribing team with the exact product, history and complete medicine list." }, { "zh": "共同通用名或共同机制不建立 EUTHYROX、优甲乐、SYNTHROID 或其他甲状腺相关产品之间的个人换算或可替代性；品牌、强度、剂型、市场和标签版本都是产品身份的一部分。", "en": "A shared generic name or mechanism does not establish personal conversion or interchangeability between EUTHYROX, EUTHYROX China, SYNTHROID or another thyroid-related product; brand, strength, form, market and label version are all part of product identity." }, { "zh": "不把机制页面用于处理急性胸痛、严重心悸、晕厥、显著呼吸困难或其他急性不适。遇到急性或严重问题，应优先使用当地紧急医疗支持，而不是试验不同品牌、强度或服用方式。", "en": "Do not use a mechanism page to manage acute chest pain, severe palpitations, fainting, marked breathing difficulty or another acute concern. With an acute or serious problem, prioritise local urgent medical support rather than experimenting with brand, strength or administration method." } ], "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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": "EUTHYROX", "generic": "左甲状腺素钠", "dosageFormClass": "美国当前公开标签：左甲状腺素钠口服片 25、50、75、88、100、112、125、137、150、175、200 mcg；本档案精确展示 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。" }, "labelSource": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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" }, "productRoutes": [ { "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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": "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." } }, "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": "EUTHYROX 与优甲乐是公开来源中可检索到的左甲状腺素钠品牌/名称线索。页面将“每片 50 mcg（0.05 mg）”、准确美国 NDC、30 片泡罩板纸盒和来源逐项对应；mcg 与 mg 是产品身份单位，不是个人片数、调整、补用、换药、与其他甲状腺产品互换或购买的答案。", "history": "Merck China 页面记载优甲乐在中国的 2020 年新配方上市及新旧配方过渡背景；该历史不能被外推为任何当前包装、当前批准、现行用药规则或替代结论。即使通用名相同，品牌、强度、剂型、包装、市场和标签版本不同也必须按实际产品与目标市场的现行资料逐项核对。", "sourceDocuments": [ { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid bc3c6830-ba68-4ba3-9896-a12d0ad0b275（美国公开标签；本档案不据此推定中国或其他市场状态）", "approvalTimeline": [ { "date": "2002", "title": { "zh": "美国公开标签所列初始批准年份", "en": "Initial U.S. approval year listed in the public label" }, "detail": { "zh": "DailyMed 的 EUTHYROX 美国公开标签列示 Initial U.S. Approval: 2002。该年份只定位此美国标签历史，不建立中国大陆或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The U.S. DailyMed public label for EUTHYROX lists Initial U.S. Approval: 2002. This year only locates this U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China or another market." }, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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" } }, { "date": "2020-03", "title": { "zh": "优甲乐中国新配方上市历史", "en": "EUTHYROX China new-formulation launch history" }, "detail": { "zh": "Merck China 页面将优甲乐®列为左甲状腺素钠片，并说明中国于 2020 年 3 月末进入新配方上市历史。它只用于核对名称和配方过渡背景，不代表现行批准、准确包装、供应、销售资格或与美国 EUTHYROX、SYNTHROID 或其他产品可替代。", "en": "The Merck China page identifies EUTHYROX® as levothyroxine sodium tablets and describes a late-March 2020 China new-formulation launch. It is used only to check the name and formulation-transition context, not current approval, exact packaging, supply, sale eligibility or interchangeability with U.S. EUTHYROX, SYNTHROID or another product." }, "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01-27", "title": { "zh": "DailyMed 当前美国公开标签生效", "en": "Current U.S. DailyMed public label effective" }, "detail": { "zh": "本档案以 DailyMed SPL v10（2026-01-27 生效；处方信息 2025-12 修订）核对美国 EUTHYROX 50 mcg、NDC 72305-050-30、30 片泡罩板纸盒。它不建立实际在售、库存、购买、个人片数、调量或换药方案。", "en": "This dossier uses DailyMed SPL v10 (effective 27 Jan 2026; prescribing information revised Dec 2025) to check U.S. EUTHYROX 50 mcg, NDC 72305-050-30 and the 30-tablet blister-pack carton. It does not establish actual marketing, stock, purchase, individual tablet count, adjustment or switching." }, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确纸盒面板", "en": "Current public label and one exact carton panel linked" }, "detail": { "zh": "本页只展示 EUTHYROX 左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、用药时间、调量、换药或可替代性。", "en": "This page displays only EUTHYROX levothyroxine sodium 50 mcg (0.05 mg), NDC 72305-050-30 and a 30-tablet blister-pack carton. It does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, timing, adjustment, switching or interchangeability." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "品牌名称与配方历史线索已链接；现行市场记录待逐项建立", "en": "Brand-name and formulation-history clue linked; current market record not established" }, "detail": { "zh": "Merck China 页面可核对优甲乐®／左甲状腺素钠片名称及 2020 年新配方过渡背景；不从该页面、美国标签、NDC、英文品牌或包装图推定中国现行批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "The Merck China page can be used to check the EUTHYROX® / levothyroxine sodium tablet name and its 2020 formulation-transition context. No current China approval, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from that page, the U.S. label, NDC, English brand or package image." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国或中国资料外推其他市场的商品名、批准、规格、供应、可售资格或可替代性；每个市场均需按当地现行监管资料单独核对。", "en": "No trade name, approval, strength, supply, sale eligibility or interchangeability in another market is inferred from the U.S. or China material; every market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mcg 与 0.05 mg 是不是两种规格？", "en": "Are 50 mcg and 0.05 mg two different strengths?" }, "answer": { "zh": "它们是同一每片标示量的单位换算。此事实只帮助核对药盒身份；不回答个人该吃几片、能否对半、如何调量或能否换成另一种产品。", "en": "They are unit expressions of the same labelled amount per tablet. This only helps check package identity; it does not answer tablet count, splitting, adjustment or whether another product can be substituted." } }, { "question": { "zh": "优甲乐与美国 EUTHYROX 能否按名称或 mcg 直接互换？", "en": "Can EUTHYROX China and U.S. EUTHYROX be directly exchanged by name or mcg?" }, "answer": { "zh": "不能。现有公开资料来自不同市场：美国页面是当前美国标签，中国页面是名称与配方历史线索。共同品牌、通用名或相近数字不建立个人换算或可替代性；请让药师或开方团队核对实际药盒、目标市场现行标签和完整药单。", "en": "No. The public materials are from different markets: the U.S. page is a current U.S. label, while the China page is a name/formulation-history clue. A shared brand, generic name or similar number does not create personal conversion or interchangeability; have a pharmacist or prescribing team check the actual pack, current target-market label and full medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/euthyrox/", "en": "https://origindrug.com/en/drugs/euthyrox/" }, "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." ] }