{ "id": "lamictal", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "LAMICTAL", "generic": "拉莫三嗪", "aliases": [ "LAMICTAL", "LAMICTAL ODT", "lamotrigine", "拉莫三嗪" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前公开处方药标签（2025-10-10 更新；仅建立所引文件的阅读入口）。不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "拉莫三嗪口服普通片：25、100、150、200 mg；口服混悬用片：2、5、25 mg；口腔崩解片：25、50、100、200 mg（美国公开标签所列；本页只建立普通片 100 mg／100 片、150 mg／60 片、200 mg／60 片三个准确瓶装面板，不将其他剂型或包装合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "GlaxoSmithKline LLC / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "lamotrigine generic tablet", "lamotrigine extended-release tablet", "拉莫三嗪缓释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lamictal-lamotrigine-tablet-100mg-100-bottle-ndc-0173-0642-55", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0642-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 100 mg；100 片瓶装", "en": "Lamotrigine 100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-15.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 100", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lamictal-lamotrigine-tablet-150mg-60-bottle-ndc-0173-0643-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0643-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 150 mg；60 片瓶装", "en": "Lamotrigine 150 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-16.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白色", "en": "cream" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 150", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lamictal-lamotrigine-tablet-200mg-60-bottle-ndc-0173-0644-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0644-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 200 mg；60 片瓶装", "en": "Lamotrigine 200 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-17.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 200", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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-lamictal-lamotrigine-tablet-100mg-100-bottle-ndc-0173-0642-55", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-15.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "alt": "LAMICTAL 拉莫三嗪 100 mg、NDC 0173-0642-55、100 片瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "presentation": "LAMICTAL 拉莫三嗪：每片 100 mg，NDC 0173-0642-55，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LAMICTAL、拉莫三嗪 100 mg、NDC 0173-0642-55 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、普通口服片、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 25 mg、150 mg、200 mg、口服混悬用片、口腔崩解片、启动套装、其他包装、其他市场、原研身份、当前可得性、可替代性或任何个人的片数、加减量、重启、分片、联用、停用或换药方案。", "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "LAMICTAL 说明书放大阅读：普通片、口服混悬用片与口腔崩解片不能只按 mg 当成同一种产品", "en": "LAMICTAL label reading: standard tablets, tablets for oral suspension and ODTs are not one product just because the mg numbers look alike" }, "summary": { "zh": "本模块以 GSK 的 DailyMed 2025-10 美国公开标签为阅读入口，帮助核对 LAMICTAL、拉莫三嗪、准确剂型、每单位 mg 和目标市场。它不提供个人片数、加量、重启、停用、转换或联用方案。", "en": "This module uses GSK's October 2025 U.S. DailyMed public label to check LAMICTAL, lamotrigine, the exact dosage form, milligrams per unit and target market. It does not provide an individual's tablet count, escalation, restart, stopping, switching or combination plan." }, "checks": [ { "zh": "先分清普通片、口服混悬用片和口腔崩解片。25 mg、100 mg 等数字先是标签中某一准确制剂的单位标示量；它们不是网页能为任何人得出“今天吃几片”、把片剂改成另一剂型或按数字自行配量的答案。", "en": "First distinguish standard tablets, tablets for oral suspension and orally disintegrating tablets. Numbers such as 25 mg and 100 mg are labelled amounts for one exact formulation; they do not let a webpage determine a tablet count, change form or assemble an amount for anyone." }, { "zh": "标签提示严重皮疹风险，并将与丙戊酸相关产品共同使用、开始/加量过程及 HLA-B*1502 等列为需要专业处理的线索。这不等于每个人都应做某项检测，也不允许根据网页自行开始、重启、调量或停药。", "en": "The label flags serious-rash risk and identifies co-use with valproate-related products, the initiation/escalation process and HLA-B*1502 as matters for professional management. This neither means everyone needs a particular test nor permits self-starting, restarting, adjusting or stopping from a webpage." }, { "zh": "标签还列出与激素类避孕产品、其他抗癫痫药、抗感染药及蛋白酶抑制剂等相关的相互作用线索。家中有多种慢病药、避孕产品、抗感染药、草本或近期处方变化时，应把每一个实际药盒和完整药单交给药师或开方团队；不要按名称、用途或 mg 自行叠加、轮换或替代。", "en": "The label also lists interaction cues involving estrogen-containing contraceptive products, other antiseizure medicines, anti-infectives and protease inhibitors. With several chronic medicines, contraceptive products, anti-infectives, herbs or a recent prescription change, have a pharmacist or prescriber review every actual pack and the complete medicine list; do not self-combine, alternate or substitute from name, use or mg alone." }, { "zh": "新出现的皮疹、发热、口腔/眼部黏膜问题、面部或气道肿胀、晕厥、意识改变、持续或反复发作、自伤想法或其他急性严重不适，应及时使用当地紧急医疗或既有照护渠道；不要等待网页或自行改变药物。", "en": "With a new rash, fever, mouth/eye mucosal concern, face or airway swelling, fainting, altered consciousness, persistent/repeated seizures, self-harm thoughts or another acute serious concern, use local urgent or established care promptly; do not wait for a webpage or self-change the medicine." } ], "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "拉莫三嗪怎样起作用：标签明确保留“抗癫痫作用的精确机制尚未确定”", "en": "How lamotrigine works: the label explicitly retains that the precise anticonvulsant mechanism is not established" }, "summary": { "zh": "DailyMed 标签写明拉莫三嗪的精确抗癫痫作用机制尚未确定；它描述一种仍待在人类中证实的机制假说，即可能影响电压敏感性钠通道并调节兴奋性氨基酸递质释放。标签也写明其在双相障碍中的治疗作用机制尚未建立。这里保留不确定性，不把机制词变成诊断、个人疗效、基因解读、剂量、联用或换药结论。", "en": "The DailyMed label says lamotrigine's precise anticonvulsant mechanism is unknown. It describes a proposed mechanism whose relevance in humans remains to be established: possible effects on voltage-sensitive sodium channels and presynaptic release of excitatory amino-acid transmitters. The label also says its therapeutic mechanisms in bipolar disorder are not established. This preserves uncertainty rather than turning mechanism terms into diagnosis, individual response, genetic interpretation, dose, combination or switching conclusions." }, "checks": [ { "zh": "“钠通道”“谷氨酸”或“稳定神经膜”是标签中的实验/药理线索，不是判断某次发作、情绪变化、头晕、皮疹或其他不适原因的工具，也不能决定个人是否适合开始、加量、减少、停用或换药。", "en": "“Sodium channels,” “glutamate” or “membrane stabilisation” are experimental/pharmacologic cues in the label, not tools for deciding the cause of a seizure, mood change, dizziness, rash or another concern, and cannot decide whether someone should start, increase, reduce, stop or switch." }, { "zh": "即使另一种药也与癫痫、情绪、神经系统或相近机制有关，都不表示可以自行叠加、交替、以 mg 换算或用余药替代。准确剂型、完整药单、既往反应、检查资料和现行标签需要由专业人员一并核对。", "en": "Even if another medicine also relates to seizures, mood, the nervous system or a similar mechanism, this does not support self-combination, alternation, milligram conversion or use of leftovers as a substitute. Exact formulation, complete medicine list, prior reactions, relevant tests and current label need professional review together." }, { "zh": "机制页面不能处理严重皮疹警讯、意识改变、持续发作、心律相关症状或自伤风险。发生急性或严重问题时，应优先使用当地紧急医疗支持或联系负责团队，而不是根据网页试验不同规格、剂型或组合。", "en": "A mechanism page cannot manage serious-rash warning signs, altered consciousness, persistent seizures, rhythm-related symptoms or self-harm risk. With an acute or serious concern, prioritise local urgent care or the responsible team rather than experimenting with another strength, formulation or combination from a webpage." } ], "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪当前美国公开标签（GSK；2025-10-10 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "LAMICTAL", "generic": "拉莫三嗪", "dosageFormClass": "拉莫三嗪口服普通片：25、100、150、200 mg；口服混悬用片：2、5、25 mg；口腔崩解片：25、50、100、200 mg（美国公开标签所列；本页只建立普通片 100 mg／100 片、150 mg／60 片、200 mg／60 片三个准确瓶装面板，不将其他剂型或包装合并）" }, "labelSource": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "DailyMed 的 LAMICTAL（lamotrigine）当前美国公开标签把普通片、口服混悬用片和口腔崩解片分列。mg 是各准确产品单位的标示量；同名、相同通用名或相近数字并不能回答个人应吃几片、能否把一类换成另一类、能否与其他抗癫痫或精神类药同用，或是否该重新开始。", "history": "该美国公开标签列示 Initial U.S. Approval: 1994，并在 2025-10 更新。它还列出严重皮疹的加框警告及与其他药物相关的专业核对事项。标签版本和历史节点只定位所引美国资料，不能替代手中产品的现行说明书、处方判断或目标市场记录。", "sourceDocuments": [ { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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" } ], "applicationNumber": "DailyMed 当前美国公开标签所列 New Drug Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "1994", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1994。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1994. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed: LAMICTAL current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "2025-10-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-10-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-10-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed: LAMICTAL current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "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": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lamictal/", "en": "https://origindrug.com/en/drugs/lamictal/" }, "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." ] }