{ "id": "tapazole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "TAPAZOLE", "generic": "甲巯咪唑（甲硫咪唑）", "aliases": [ "Tapazole", "methimazole", "thiamazole", "甲巯咪唑", "甲硫咪唑", "他巴唑", "甲巯咪唑片", "NDA 007517", "DIN 00015741", "DIN 02296039" ], "marketBrandNames": [ { "name": "TAPAZOLE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_public_record", "note": { "zh": "NDA 007517 的 5 mg 与 10 mg 历史 RLD 当前列为 DISCN；不是当前品牌供应记录。", "en": "Historical 5 mg and 10 mg RLD products under NDA 007517 are currently listed as discontinued; this is not a current brand-supply record." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "TAPAZOLE", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "historical_public_record", "note": { "zh": "5 mg 与 10 mg 产品均于 2026-07-16 列为 Cancelled Post Market；2025-12-19 产品专论仍作为有日期说明书档案阅读。", "en": "The 5 mg and 10 mg products were both listed Cancelled Post Market on 16 Jul 2026; the 19 Dec 2025 product monograph remains a dated label archive." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 FDA Orange Book：TAPAZOLE 5 mg 与 10 mg 口服片 NDA 007517 为历史 RLD、当前 DISCN，且 FDA 判定并非因安全性或有效性撤回；加拿大 DPD：TAPAZOLE 5 mg（DIN 00015741）与 10 mg（DIN 02296039）均于 2026-07-16 列为 Cancelled Post Market。加拿大同成分通用药另有 Marketed 记录，但不等于品牌供应或自动可替代。", "dosageFormClass": "历史品牌口服片：每片甲巯咪唑 5 mg 或 10 mg；5 mg 与 10 mg 是每片含量，不是网页给出的个人片数；美国、加拿大及当前通用药记录必须分开核对。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1951（加拿大最早市场日期）；美国 NDA 007517 批准早于 1982", "archiveSponsorText": "美国历史 NDA：King Pharmaceuticals Inc.；加拿大历史品牌：Knight Therapeutics Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TAPAZOLE", "Tapazole methimazole", "甲巯咪唑", "甲硫咪唑", "他巴唑" ], "excludedProductCues": [ "propylthiouracil", "PTU", "丙硫氧嘧啶", "carbimazole", "卡比马唑", "radioactive iodine", "左甲状腺素" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tapazole-methimazole-5mg-tablet-nda-007517-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 5 mg 口服片（美国历史 RLD）", "en": "TAPAZOLE methimazole 5 mg oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 007517 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 5 mg；美国历史 RLD，当前列为停止销售", "en": "Methimazole 5 mg per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或调药指令", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tapazole-methimazole-10mg-tablet-nda-007517-product-004-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 10 mg 口服片（美国历史 RLD）", "en": "TAPAZOLE methimazole 10 mg oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 007517 / Product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 10 mg；美国历史 RLD，当前列为停止销售", "en": "Methimazole 10 mg per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或调药指令", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-tapazole-methimazole-5mg-tablet-din-00015741-historical", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 产品专论 2025-12-19；DPD 状态 2026-07-16", "en": "Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 5 mg 口服片（加拿大历史品牌记录）", "en": "TAPAZOLE methimazole 5 mg oral tablet (historical Canadian brand record)" }, "route": { "zh": "口服（加拿大历史监管产品身份字段）", "en": "oral (historical Canadian regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "DIN 00015741", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 5 mg；DPD 于 2026-07-16 列为 Cancelled Post Market", "en": "Methimazole 5 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片产品专论标示量；不是个人片数、频率或调药指令", "en": "product-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "cancelled_post_market", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-tapazole-methimazole-10mg-tablet-din-02296039-historical", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 产品专论 2025-12-19；DPD 状态 2026-07-16", "en": "Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 10 mg 口服片（加拿大历史品牌记录）", "en": "TAPAZOLE methimazole 10 mg oral tablet (historical Canadian brand record)" }, "route": { "zh": "口服（加拿大历史监管产品身份字段）", "en": "oral (historical Canadian regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "DIN 02296039", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 10 mg；DPD 于 2026-07-16 列为 Cancelled Post Market", "en": "Methimazole 10 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片产品专论标示量；不是个人片数、频率或调药指令", "en": "product-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "cancelled_post_market", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "没有取得与四个历史产品身份一一对应的官方包装主图", "en": "No official principal pack image was obtained one-to-one for the four historical product identities" }, "summary": { "zh": "本页只按 FDA Orange Book、Health Canada DPD 与产品专论列出美国和加拿大的 5 mg／10 mg 历史产品身份。没有用当前通用药、零售图片、旧广告或相似白色圆片替代品牌包装；药片颜色、刻印、包装数量和真伪必须以手中实际产品及对应现行说明书核对。", "en": "The page lists the historical U.S. and Canadian 5 mg / 10 mg product identities only from the FDA Orange Book, Health Canada DPD and product monograph. Current generics, retail images, old advertising and look-alike white round tablets are not substituted for brand packaging. Colour, imprint, pack count and authenticity require the actual product and its matching current label." }, "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAPAZOLE 说明书放大阅读：发热、寒战或咽痛不能只当普通感冒", "en": "TAPAZOLE label reading: fever, chills or sore throat must not be dismissed as an ordinary cold" }, "summary": { "zh": "产品专论把粒细胞缺乏和肝毒性列入严重警示。出现发热、寒战、咽痛、反复感染，或黄疸、深色尿、右上腹痛、异常乏力时，应按当地急诊与医疗体系及时评估；不要只靠网页自行停药、换药、补服或等待。", "en": "The product monograph places agranulocytosis and liver toxicity in the serious warnings. Fever, chills, sore throat, repeated infection, jaundice, dark urine, right-upper abdominal pain or unusual fatigue requires timely assessment through local urgent and clinical services. Do not use the website alone to stop, switch, make up or wait." }, "checks": [ { "zh": "5 mg 与 10 mg 是每片所含甲巯咪唑的量，不是一次该吃几片。个人方案与甲状腺功能、病因、年龄、孕期、其他药物及监测结果有关；网页不把化验值换算为片数。", "en": "5 mg and 10 mg are amounts of methimazole per tablet, not the number of tablets to take. An individual plan depends on thyroid function, cause, age, pregnancy, other medicines and monitoring results; the site does not convert laboratory values into tablet counts." }, { "zh": "发热、寒战、咽痛、口腔溃疡或频繁感染可能与严重白细胞减少有关。不要因症状像感冒就自行继续、停药或吃抗菌药掩盖；按说明书尽快联系开方团队或当地急诊服务。", "en": "Fever, chills, sore throat, mouth ulcers or frequent infection may relate to severe white-cell reduction. Do not self-continue, stop or mask it with an antibacterial because it resembles a cold; contact the prescriber or local urgent service promptly as directed by the label." }, { "zh": "皮肤或眼白发黄、深色尿、右上腹痛、持续恶心呕吐、食欲明显下降或异常乏力可能提示肝脏问题，需要及时专业评估。", "en": "Yellow skin or eyes, dark urine, right-upper abdominal pain, persistent nausea or vomiting, marked appetite loss or unusual fatigue may signal liver injury and needs prompt professional assessment." }, { "zh": "怀孕、准备怀孕或可能怀孕时应尽快告诉开方团队；说明书特别提示妊娠早期风险。网页不会替个人选择甲巯咪唑、丙硫氧嘧啶或其他方案。", "en": "Tell the prescribing team promptly about pregnancy, plans for pregnancy or possible pregnancy; the label highlights first-trimester risk. The site does not choose methimazole, propylthiouracil or another option for an individual." }, { "zh": "华法林或其他抗凝药、茶碱，以及可能影响白细胞、肝脏或甲状腺状态的药物都应放在同一张完整药单里核对。甲状腺状态变化本身也可能改变联用药的监测需求。", "en": "Warfarin or another anticoagulant, theophylline and medicines that may affect white cells, liver or thyroid status belong on one complete list for review. Changes in thyroid status itself may alter monitoring needs for co-medications." }, { "zh": "历史 TAPAZOLE 品牌记录与当前同成分通用药不是同一个可视包装。不能只凭“白色圆片”“有刻痕”或相同 mg 判断真伪、厂牌或可替代性。", "en": "The historical TAPAZOLE brand records and current same-ingredient generics are not one visual package. A white round tablet, a score or the same mg figure cannot establish authenticity, manufacturer or interchangeability." } ], "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲巯咪唑怎样起作用：减少新甲状腺激素的合成，不会立刻清除已经存在的激素", "en": "How methimazole works: it reduces new thyroid-hormone synthesis but does not immediately remove hormone already present" }, "summary": { "zh": "产品专论说明甲巯咪唑抑制甲状腺激素合成，但不会使甲状腺或血液中已经储存、循环的甲状腺激素失活。因此症状改善可能需要时间；作用机理不能用来自行加量、停药或判断已经恢复正常。", "en": "The product monograph explains that methimazole inhibits thyroid-hormone synthesis but does not inactivate hormone already stored in the thyroid or circulating in blood. Improvement may therefore take time; the mechanism cannot be used to self-increase, stop or decide that thyroid status has normalised." }, "checks": [ { "zh": "心悸、手抖、怕热、体重或睡眠变化可能来自甲亢、甲减、其他疾病或药物；症状相似不等于应该把抗甲状腺药与左甲状腺素自行叠加、轮换或抵消。", "en": "Palpitations, tremor, heat intolerance, weight or sleep change may arise from hyperthyroidism, hypothyroidism, another illness or medicines. Similar symptoms do not justify self-combining, alternating or offsetting an antithyroid medicine with levothyroxine." }, { "zh": "甲巯咪唑、丙硫氧嘧啶和卡比马唑不是按毫克一比一互换的同一种产品；品牌、活性成分、强度、市场和说明书必须一起核对。", "en": "Methimazole, propylthiouracil and carbimazole are not one product interchangeable milligram for milligram. Brand, active ingredient, strength, market and label must be checked together." }, { "zh": "网页解释“为什么要监测”，但不解释个人化验单，也不提供停药、减量、补服、交替或疗程结论。", "en": "The page explains why monitoring matters but does not interpret an individual's laboratory results or provide stopping, reduction, make-up, alternating or course decisions." } ], "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TAPAZOLE", "generic": "甲巯咪唑（甲硫咪唑）", "dosageFormClass": "历史品牌口服片：每片甲巯咪唑 5 mg 或 10 mg；5 mg 与 10 mg 是每片含量，不是网页给出的个人片数；美国、加拿大及当前通用药记录必须分开核对。" }, "labelSource": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TAPAZOLE 是甲巯咪唑历史品牌档案，用于帮助读懂抗甲状腺药说明书。最重要的不是从 5 mg 或 10 mg 自行算片数，而是知道发热、寒战、咽痛或反复感染可能提示严重白细胞问题；黄疸、深色尿、右上腹痛或异常乏力可能提示肝脏问题，需要按现行标签尽快联系医疗团队。", "history": "Health Canada 记录 TAPAZOLE 5 mg 最早市场日期为 1951-12-31，10 mg 为 2008-01-07；两项 DIN 均在 2026-07-16 转为 Cancelled Post Market。美国 NDA 007517 的 5 mg 与 10 mg 产品批准早于 1982，当前 Orange Book 列为 DISCN，并注明 FDA 判定并非因安全性或有效性撤回。历史品牌状态不等于当前库存；当前通用药须按实际厂牌、DIN/NDC、说明书和药片外观另行核对。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内按甲巯咪唑 5 mg 核对", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内按甲巯咪唑 10 mg 核对", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "美国历史 NDA 007517；加拿大 DIN 00015741 / 02296039", "approvalTimeline": [ { "date": "1951-12-31", "title": { "zh": "加拿大 TAPAZOLE 5 mg 最早市场日期", "en": "Earliest Canadian market date for TAPAZOLE 5 mg" }, "detail": { "zh": "Health Canada DPD 记录 DIN 00015741 的最早市场日期为 1951-12-31；这是历史品牌时间线，不证明当前供应。", "en": "Health Canada DPD records 31 Dec 1951 as the earliest market date for DIN 00015741. This is historical brand chronology, not current supply." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "Approved prior to 1982", "title": { "zh": "美国 TAPAZOLE NDA 007517 历史批准", "en": "Historical U.S. approval of TAPAZOLE NDA 007517" }, "detail": { "zh": "Orange Book 将 5 mg 与 10 mg 历史产品列为 RLD、DISCN，并注明并非因安全性或有效性撤回。", "en": "Orange Book lists the historical 5 mg and 10 mg products as RLD and discontinued, with a determination that they were not withdrawn for safety or effectiveness reasons." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-12-19", "title": { "zh": "加拿大产品专论修订", "en": "Canadian product monograph revised" }, "detail": { "zh": "有日期产品专论覆盖 5 mg 与 10 mg 片、严重警示、患者用药信息和药物机理；可读文件不等于当前品牌供应。", "en": "The dated monograph covers 5 mg and 10 mg tablets, serious warnings, patient information and mechanism. An accessible document does not establish current brand supply." }, "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-07-16", "title": { "zh": "加拿大 5 mg 与 10 mg 品牌 DIN 转为上市后取消", "en": "Canadian 5 mg and 10 mg brand DINs moved to Cancelled Post Market" }, "detail": { "zh": "DPD 对 DIN 00015741 与 02296039 均显示 Cancelled Post Market。本页以实时 DPD 覆盖 2026-08-26 导入索引中的旧 Marketed 状态。", "en": "DPD displays Cancelled Post Market for DIN 00015741 and 02296039. This live status supersedes the stale Marketed value in the imported 26 Aug 2026 index." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，当前停止销售", "en": "Historical RLD; currently discontinued" }, "detail": { "zh": "5 mg 与 10 mg 产品均为 NDA 007517 历史 RLD、DISCN；不是当前品牌库存或购买入口。", "en": "The 5 mg and 10 mg products are historical RLDs under NDA 007517 and are listed discontinued; this is not current brand stock or a purchase route." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "品牌 5 mg 与 10 mg 均为 Cancelled Post Market", "en": "Brand 5 mg and 10 mg both Cancelled Post Market" }, "detail": { "zh": "DPD 状态日期均为 2026-07-16。相同成分的当前 Marketed 通用药需按各自 DIN 和说明书核对，不能继承 TAPAZOLE 包装身份。", "en": "Both DPD status dates are 16 Jul 2026. Current marketed same-ingredient generics require their own DIN and label review and do not inherit TAPAZOLE package identity." } }, { "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": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从 methimazole、thiamazole、甲巯咪唑或甲硫咪唑名称推定当地品牌、批准、供应、包装、真伪或可替代性。", "en": "No local brand, approval, supply, packaging, authenticity or interchangeability is inferred from the names methimazole, thiamazole, 甲巯咪唑 or 甲硫咪唑." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "发热和咽痛只是感冒吗？", "en": "Are fever and sore throat just a cold?" }, "answer": { "zh": "服用甲巯咪唑时不能只按普通感冒处理，因为说明书将发热、寒战、咽痛和频繁感染列为粒细胞缺乏的警示表现。请按标签尽快联系开方团队或当地急诊服务；网页不能替代血液检查。", "en": "While taking methimazole, these cannot be treated as an ordinary cold alone because the label lists fever, chills, sore throat and frequent infection as warning features of agranulocytosis. Contact the prescriber or local urgent service promptly as directed by the label; the site cannot replace a blood test." } }, { "question": { "zh": "5 mg 片掰成两半就等于 2.5 mg，可以自己这样做吗？", "en": "Does halving a 5 mg tablet equal 2.5 mg, and can I do that myself?" }, "answer": { "zh": "不能从网页自行决定。旧品牌、当前通用药、刻痕、含量均可能不同；能否分片以及个人处方必须由药师根据手中准确产品说明书和开方指示核对。", "en": "Do not decide this from the website. Historical brand and current generic products, scores and labelled amounts may differ. A pharmacist must check the exact product label and prescription before any splitting decision." } }, { "question": { "zh": "甲状腺指标正常后可以马上停药吗？", "en": "Can the medicine be stopped immediately once thyroid tests are normal?" }, "answer": { "zh": "不要自行停药。甲巯咪唑影响新激素合成，已有激素、病因、复发风险和监测计划仍需专业判断；网页不解释个人化验结果或制定停药方案。", "en": "Do not self-stop. Methimazole affects new hormone synthesis, while existing hormone, disease cause, relapse risk and the monitoring plan still require professional judgement. The site does not interpret personal results or create a stopping plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tapazole/", "en": "https://origindrug.com/en/drugs/tapazole/" }, "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." ] }