{ "id": "tegretol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Tegretol", "generic": "卡马西平", "aliases": [ "TEGRETOL", "Tegretol-XR", "carbamazepine", "卡马西平" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国 DailyMed 当前 TEGRETOL / TEGRETOL-XR（carbamazepine）公开标签，2026-07-15 生效。本档案只核对该标签列出的普通片、XR 缓释片、混悬液及所选 NDC 包装展示面；不推定中国大陆或其他市场的当前批准、商品名、供应、可售资格、原研/仿制关系或个人适用性。", "dosageFormClass": "TEGRETOL 200 mg 口服片；TEGRETOL-XR 缓释口服片：100 mg、200 mg、400 mg；另有 100 mg/5 mL 口服混悬液（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国公开标签版本：2026-07-15（不作为全球批准史结论）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "carbamazepine chewable tablet", "CARBATROL", "EQUETRO", "其他市场的卡马西平产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tegretol-carbamazepine-tablet-200mg-100bottle-ndc-0078-0509-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL 卡马西平口服片", "en": "TEGRETOL carbamazepine oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0509-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装", "en": "200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-04.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "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": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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-tegretol-carbamazepine-xr-tablet-100mg-100bottle-ndc-0078-0510-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0510-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装", "en": "100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-05.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "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": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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-tegretol-carbamazepine-xr-tablet-200mg-100bottle-ndc-0078-0511-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0511-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装", "en": "200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-01.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "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": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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-tegretol-carbamazepine-xr-tablet-400mg-100bottle-ndc-0078-0512-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0512-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg；100 片瓶装", "en": "400 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-03.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "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": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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-tegretol-carbamazepine-tablet-200mg-100bottle-ndc-0078-0509-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-04.jpg&id=967961", "alt": "TEGRETOL 卡马西平美国 DailyMed 公开标签中的 200 mg、NDC 0078-0509-05、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（Novartis，2026-07-15 生效）", "presentation": "TEGRETOL 卡马西平 200 mg 口服片；NDC 0078-0509-05；100 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 TEGRETOL 卡马西平 200 mg 口服片、NDC 0078-0509-05、100 片瓶装。它不代表 TEGRETOL-XR 100/200/400 mg 缓释片、100 mg/5 mL 口服混悬液、其他包装、其他市场或当前可得性；不用于鉴定真伪，也不提供个人片数、毫升数、掰开、研碎、替换或调整建议。", "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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": "TEGRETOL 说明书放大阅读：普通片、XR 缓释片与口服混悬液不能按名称或 mg 自行换算", "en": "TEGRETOL label reading: standard tablets, XR tablets and oral suspension cannot be self-converted by name or milligrams" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 TEGRETOL、TEGRETOL-XR、卡马西平、准确剂型、每单位标示量、NDC 和包装。它不提供任何人的片数、毫升数、间隔、漏用处理、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check TEGRETOL, TEGRETOL-XR, carbamazepine, the exact form, labelled amount per unit, NDC and package. It does not provide anyone's tablet count, millilitres, interval, missed-use action, combination, conversion or stopping plan." }, "checks": [ { "zh": "TEGRETOL 200 mg 普通口服片、TEGRETOL-XR 100/200/400 mg 缓释口服片和每 5 mL 含 100 mg 的口服混悬液，是标签分别列出的产品身份。相同品牌或通用名不能使它们自行按 mg、片数或 mL 换算、补用、叠加或替代。", "en": "The 200 mg TEGRETOL standard oral tablet, 100/200/400 mg TEGRETOL-XR extended-release oral tablets and oral suspension containing 100 mg per 5 mL are separately listed product identities. A shared brand or generic name does not make them self-convertible, make-up interchangeable, combinable or substitutable by milligrams, tablets or millilitres." }, { "zh": "这份标签为 TEGRETOL-XR 写明应整片吞服，不能压碎或咀嚼。该句只对应这款准确美国缓释片，不给本网页对任何其他卡马西平产品、普通片、液体或别的药品作出掰开、压碎、混合或替代许可；实际处理须以现行标签、处方和药师/开方团队为准。", "en": "This label states that TEGRETOL-XR should be swallowed whole and must not be crushed or chewed. That wording applies only to this exact U.S. extended-release tablet; it does not give this webpage permission to split, crush, mix or substitute any other carbamazepine product, standard tablet, liquid or medicine. Actual handling must follow the current label, prescription and pharmacist/prescribing-team advice." }, { "zh": "标签的黑框警告提示：具有遗传风险人群祖源的个人，在开始用药前应进行 HLA-B*1502 筛查。它不等于每个人都要做广泛基因检测，亦不能由网页推断个人祖源、检测项目、结果含义或是否能开始、继续、暂停或换药；应由开方团队、药师或遗传专业人员按实际情况解释。", "en": "The boxed warning states that people with ancestry in genetically at-risk populations should be screened for HLA-B*1502 before starting treatment. This does not mean everyone needs broad genetic testing, nor can a webpage infer an individual's ancestry, test choice, result meaning or whether to start, continue, pause or switch; the prescribing team, pharmacist or genetics professional must interpret the actual context." }, { "zh": "新的或进行性皮疹、水疱、口腔溃疡、发热、面部肿胀、黄疸样变化、明显嗜睡/意识改变、晕厥或其他急性问题，应及时联系当地医疗支持；不要仅因担心不良反应而依据网页自行补用、加量、骤停或换成另一种产品。", "en": "With a new or progressive rash, blistering, mouth sores, fever, facial swelling, jaundice-like changes, marked drowsiness/mental-status change, fainting or another acute concern, contact local medical support promptly. Do not self-make-up, increase, abruptly stop or change to another product from this webpage because of an adverse-effect concern." } ], "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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": "卡马西平怎样起作用：标签中的抗惊厥药理信息不等于个人调整依据", "en": "How carbamazepine works: anticonvulsant pharmacology in a label is not a basis for individual adjustment" }, "summary": { "zh": "DailyMed 标签将卡马西平列为抗惊厥药，并说明其发挥抗惊厥作用的确切机制尚不清楚。本页只帮助读者理解标签中的药理边界；它不判断任何人的症状原因、适应情形、产品选择、片数、毫升数、联用或调整方案。", "en": "The DailyMed label classifies carbamazepine as an anticonvulsant and states that the exact mechanism by which it exerts anticonvulsant activity is unknown. This page only explains the label's pharmacology boundary; it does not determine anyone's symptom cause, use context, product choice, tablet count, millilitres, combination or adjustment plan." }, "checks": [ { "zh": "“抗惊厥药”不是对任何抽搐、疼痛、头晕、情绪或神经系统症状的自我诊断，也不能替代由专业人员结合准确产品、病情和检查资料作出的判断。", "en": "“Anticonvulsant” is not a self-diagnosis for any seizure, pain, dizziness, mood or neurologic symptom and cannot replace professional judgement based on the exact product, condition and clinical information." }, { "zh": "共享通用名、作用类别或同为口服产品，不使普通片、缓释片、混悬液或另一种神经系统相关药物可以自行叠加、轮换、按 mg 换算或替代。完整药单和现行标签必须一起复核。", "en": "A shared generic name, pharmacologic class or oral route does not make standard tablets, extended-release tablets, suspension or another neurologic medicine self-combinable, alternatable, milligram-convertible or substitutable. The complete medicine list and current labels require joint review." }, { "zh": "机制页面不能处理突然或加重的抽搐、严重皮疹、意识改变、呼吸困难、晕厥或其他急性不适。出现这类问题时，应优先使用当地紧急医疗支持，而不是继续试验不同剂型或根据包装数字自行调整。", "en": "A mechanism page cannot manage sudden or worsening seizures, severe rash, mental-status change, breathing difficulty, fainting or another acute concern. With these problems, prioritise local urgent medical support rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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": "Tegretol", "generic": "卡马西平", "dosageFormClass": "TEGRETOL 200 mg 口服片；TEGRETOL-XR 缓释口服片：100 mg、200 mg、400 mg；另有 100 mg/5 mL 口服混悬液（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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 美国公开标签将 TEGRETOL 列为卡马西平 200 mg 口服片，将 TEGRETOL-XR 列为 100 mg、200 mg、400 mg 缓释口服片，并另列 100 mg/5 mL 口服混悬液。本页让读者逐项核对商品名、通用名、准确剂型、每单位标示量、NDC、包装展示面、说明书与药物警戒入口；mg 只用于药盒身份核对，不转换为个人片数、毫升数、开始、停用、联用、换药或购买结论。", "history": "该美国公开标签带有严重皮肤反应与 HLA-B*1502 相关黑框警告，并提示在具有遗传风险人群祖源的人群中应在开始前进行相应筛查。它并不等于所有人都需要进行广泛基因检测，也不能替代由开方团队、药师或遗传专业人员结合准确产品、祖源、病情和完整药单作出的判断。不同剂型、包装、市场或同通用名产品必须按实际药盒和目标市场现行资料分别核对。", "sourceDocuments": [ { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053（本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "2026-07-15", "title": { "zh": "当前美国公开标签的生效日期", "en": "Effective date of the current U.S. public label" }, "detail": { "zh": "DailyMed 当前 TEGRETOL / TEGRETOL-XR 美国公开标签列示 2026-07-15 生效。本页仅用此文件核对其列出的普通片、XR 缓释片、口服混悬液、NDC 与包装展示面；不据此判断实际在售、库存、购买或个人使用安排。", "en": "The current DailyMed U.S. public label for TEGRETOL / TEGRETOL-XR lists an effective date of 15 Jul 2026. This page uses that document only to check its listed standard tablets, XR tablets, oral suspension, NDCs and package panels; it does not establish actual marketing, stock, purchase or an individual use plan." }, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "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四个准确片剂瓶装展示面", "en": "Current public label and four exact tablet-bottle panels linked" }, "detail": { "zh": "本页展示 TEGRETOL 200 mg、NDC 0078-0509-05、100 片瓶装，以及 TEGRETOL-XR 100/200/400 mg、各 100 片瓶装的标签展示面。它们不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、毫升数、压碎/咀嚼、换药或可替代性。", "en": "This page displays label panels for TEGRETOL 200 mg, NDC 0078-0509-05, 100-tablet bottle and TEGRETOL-XR 100/200/400 mg, each in a 100-tablet bottle. They do not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, millilitres, crushing/chewing, switching or interchangeability." } }, { "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": "不从美国标签、SPL、NDC、英文商品名、包装图或标签持有人推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, SPL, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "TEGRETOL、TEGRETOL-XR 和口服混悬液都写卡马西平，能否按 mg 自行换用？", "en": "TEGRETOL, TEGRETOL-XR and oral suspension all say carbamazepine. Can they be self-switched by milligrams?" }, "answer": { "zh": "不能。准确剂型、每单位标示量、包装、标签版本、市场和处方都属于产品身份的一部分。共享通用名或相近 mg 数不建立换算或替代关系；请将实际产品和完整药单交给药师或开方团队核对。", "en": "No. The exact dosage form, labelled amount per unit, package, label version, market and prescription are all parts of product identity. A shared generic name or similar milligram amount does not create a conversion or substitution relationship; take the actual product and full medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "标签提到 HLA-B*1502，是否每个人都应做基因检测？", "en": "The label mentions HLA-B*1502. Does everyone need genetic testing?" }, "answer": { "zh": "不能从网页得出“所有人都需要”的结论。该标签针对具有遗传风险人群祖源的开始用药前筛查提示，实际是否筛查、筛什么、如何解释结果应由开方团队、药师或遗传专业人员结合个人背景和准确产品说明。", "en": "A webpage cannot conclude that everyone needs testing. The label's pre-treatment screening notice concerns people with ancestry in genetically at-risk populations; whether to test, what to test and how to interpret a result require the prescribing team, pharmacist or genetics professional to consider the individual's context and exact product." } } ], "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/tegretol/", "en": "https://origindrug.com/en/drugs/tegretol/" }, "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." ] }