{ "id": "sinemet", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "Sinemet", "generic": "卡比多巴/左旋多巴（复方）", "aliases": [ "SINEMET", "carbidopa and levodopa", "carbidopa/levodopa", "卡比多巴 左旋多巴" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（2026-07 修订；DailyMed v6 于 2026-08-24 发布）及同页保留的有结束日期 NDC 记录", "dosageFormClass": "当前供应段列出即释口服复方片 10 mg/100 mg 与 25 mg/100 mg；25 mg/250 mg 已不再营销", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1975（FDA 公开审评资料支持的批准年份；精确日期在后续文件中存在单处冲突）", "archiveSponsorText": "Organon LLC / DailyMed（NLM）当前公开标签与结构化 NDC 档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-sinemet-10-100-ndc-78206-166-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-166-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 10 mg + 左旋多巴 100 mg；当前结构化记录无营销结束日期", "en": "Per tablet: carbidopa 10 mg + levodopa 100 mg; no marketing end date in the current structured record" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深斑蓝色", "en": "dark dapple blue" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "647", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-100-ndc-78206-190-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-190-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 100 mg；当前结构化记录无营销结束日期", "en": "Per tablet: carbidopa 25 mg + levodopa 100 mg; no marketing end date in the current structured record" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": "2025-02-28", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "650", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-100-ndc-78206-168-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-168-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 100 mg；营销记录结束于 2026-02-21", "en": "Per tablet: carbidopa 25 mg + levodopa 100 mg; marketing record ended 2026-02-21" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_ndc_record_marketing_ended_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": "2026-02-21", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "650", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-250-ndc-78206-167-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-167-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 250 mg；营销记录结束于 2021-06-02", "en": "Per tablet: carbidopa 25 mg + levodopa 250 mg; marketing record ended 2021-06-02" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_ndc_record_marketing_ended_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": "2021-06-02", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅斑蓝色", "en": "light dapple blue" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "654", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-sinemet-25-100-ndc-78206-190-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-06.jpg", "alt": "SINEMET 卡比多巴/左旋多巴在美国 DailyMed Organon 当前公开标签中的 25 mg/100 mg、NDC 78206-190-01、无刻痕、100 片装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（Organon；2026-07 修订；2026-08-24 发布）", "presentation": "SINEMET 每片卡比多巴 25 mg / 左旋多巴 100 mg，NDC 78206-190-01，无刻痕，100 片瓶装标签图", "notice": "此图只对应当前 HOW SUPPLIED 所列的 NDC 78206-190-01（25 mg/100 mg、无刻痕、100 片）。同页保留的 NDC 78206-168-01 有刻痕旧面板，但其结构化营销记录已于 2026-02-21 结束；本图不代表该历史包装、其他强度、其他市场或实时库存，不用于鉴定真伪，也不证明原研身份、可替代性或任何个人能否分片。", "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SINEMET 说明书放大阅读：25/100 是两种成分的每片含量，不是片数", "en": "SINEMET label reading: 25/100 is a per-tablet two-ingredient identity, not a tablet count" }, "summary": { "zh": "本模块以 2026-07 修订、2026-08-24 发布的美国当前公开标签为阅读入口，帮助核对 SINEMET、卡比多巴/左旋多巴、即释片、每片两种成分、NDC、刻痕、当前供应段与带结束日期的历史记录。它不提供个人片数、时间表、漏用补救、餐食/铁剂间隔、联用、转换或停药方案。", "en": "This module uses the current U.S. label revised Jul 2026 and published 24 Aug 2026 to check SINEMET, carbidopa/levodopa, immediate-release tablets, both ingredients per tablet, NDC, score state, the current How Supplied section and dated historical records. It does not provide an individual tablet count, schedule, missed-use remedy, food/iron interval, combination, switch or stopping plan." }, "checks": [ { "zh": "“10/100”“25/100”“25/250”分别表示每片卡比多巴与左旋多巴的标示量；不能把两个数相加当成总强度，更不能从包装数字推导今天应服几片。", "en": "“10/100”, “25/100” and “25/250” state carbidopa and levodopa amounts in each tablet. Do not add the two numbers into one total strength or derive today's tablet count from package numbers." }, { "zh": "同为 25 mg/100 mg，也要继续核对 NDC、刻痕和日期：当前 HOW SUPPLIED 列 NDC 78206-190-01（无刻痕）；NDC 78206-168-01（有刻痕）的结构化营销记录已于 2026-02-21 结束。相同品牌和强度不能掩盖当前/历史差别，更不能替网页回答能否分片。", "en": "The same 25 mg / 100 mg strength still requires the NDC, score state and date: the current How Supplied section lists NDC 78206-190-01 (unscored), while the structured marketing record for NDC 78206-168-01 (scored) ended 21 Feb 2026. Matching brand and strength cannot erase the current-versus-historical distinction or let a webpage decide splitting." }, { "zh": "本档案是即释片。Sinemet CR、Rytary、Crexont、Dhivy、Duopa、Vyalev 或其他卡比多巴/左旋多巴制剂并非本页同一产品呈现；不能按成分名或毫克比自行替换、叠加或轮换。", "en": "This archive concerns immediate-release tablets. Sinemet CR, Rytary, Crexont, Dhivy, Duopa, Vyalev and other carbidopa/levodopa products are not this same presentation; do not self-substitute, combine or alternate them by ingredient name or milligram ratio." }, { "zh": "标签提示高蛋白饮食变化、铁盐或含铁复合维生素等可能影响左旋多巴的可利用度。页面只提示把饮食变化、补充剂和完整药单交给药师或处方医生核对，不生成个人餐时或间隔。", "en": "The label notes that dietary changes high in protein and iron salts or iron-containing multivitamins may affect levodopa availability. This page only prompts review of diet changes, supplements and the complete medicine list with a pharmacist or prescriber; it does not generate personal meal timing or spacing." }, { "zh": "老年人并不是自动减半。当前标签报告老年人左旋多巴暴露可能增加，并指出不能排除部分老人对幻觉等不良反应更敏感；跌倒、嗜睡、体位性低血压、认知或行为变化都应结合准确处方、完整药单和照护观察由专业团队复核。", "en": "Older age does not mean automatically taking half. The current label reports that levodopa exposure may be higher in older adults and that greater sensitivity to adverse reactions such as hallucinations cannot be ruled out. Falls, somnolence, orthostatic effects, and cognitive or behavioural changes need professional review using the exact prescription, complete medicine list and caregiver observations." }, { "zh": "不要自行补服、加倍、骤减、骤停或增加其他抗帕金森药。突然入睡、昏厥、严重意识/行为变化、发热伴明显僵硬或惊厥等急性担忧，应及时使用当地紧急医疗支持。", "en": "Do not self-make-up, double, abruptly reduce or stop, or add another antiparkinson medicine. Sudden sleep, fainting, severe mental/behavioural change, fever with marked rigidity or a seizure warrants prompt local urgent medical support." } ], "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡比多巴/左旋多巴怎样起作用：一个进入脑内，一个主要在外周减少分解", "en": "How carbidopa/levodopa works: one reaches the brain while the other mainly reduces peripheral breakdown" }, "summary": { "zh": "DailyMed 标签说明，多巴胺本身不易通过血脑屏障，左旋多巴可进入脑内并转化为多巴胺；卡比多巴主要抑制外周左旋多巴脱羧，使更多左旋多巴可供转运至脑部。它解释固定复方的药理路径，不预测个人效果、持续时间、适用性或用量。", "en": "The DailyMed label explains that dopamine itself does not readily cross the blood-brain barrier, while levodopa can reach the brain and be converted to dopamine. Carbidopa mainly inhibits peripheral levodopa decarboxylation, making more levodopa available for transport to the brain. This explains the fixed combination's pharmacologic pathway; it does not predict individual effect, duration, suitability or use." }, "checks": [ { "zh": "左旋多巴进入脑内并转化为多巴胺，是机制描述，不是对任何人的症状原因、改善幅度、持续时间或应服片数的答案。", "en": "Levodopa reaching the brain and becoming dopamine is a mechanism description, not an answer about anyone's symptom cause, degree or duration of benefit, or tablet count." }, { "zh": "卡比多巴主要作用于外周，并不把固定复方变成可任意拆开的两个单药。相同成分名、不同释放方式、不同途径或不同品牌都需要按准确产品单独复核。", "en": "Carbidopa acts mainly in the periphery; it does not turn the fixed combination into two freely separable medicines. A shared ingredient name across release forms, routes or brands still needs exact-product review." }, { "zh": "食物中的某些氨基酸、铁剂与合并药物可能影响这一过程，但机制页面不能换算个人餐时、补服或间隔。多药老人应携带实际药瓶、补充剂和完整清单由药师或处方团队核对。", "en": "Some dietary amino acids, iron and co-medications may affect this process, but a mechanism page cannot calculate personal meal timing, make-up use or spacing. Older people with multiple medicines should bring actual bottles, supplements and the full list for pharmacist or prescribing-team review." } ], "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Clinical Pharmacology；Organon；2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Sinemet", "generic": "卡比多巴/左旋多巴（复方）", "dosageFormClass": "当前供应段列出即释口服复方片 10 mg/100 mg 与 25 mg/100 mg；25 mg/250 mg 已不再营销" }, "labelSource": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "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": "2026-09-05", "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": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品在处方信息中加入维生素 B6 缺乏及相关癫痫发作警告；公告明确列出 Sinemet 和 Sinemet CR。该通讯覆盖多种剂型和途径，不能据此推断任何个人是否存在风险、是否需要检测或补充，亦不能据此自行停药、改变剂型或调整用药。请在手中准确产品与现行说明书的语境下由开方团队或药师核对。", "en": "On 2026-03-20, FDA issued a Drug Safety Communication requiring all carbidopa/levodopa products to add a warning about vitamin B6 deficiency and associated seizures; the communication explicitly lists Sinemet and Sinemet CR. It covers multiple forms and routes, but cannot determine an individual’s risk, need for testing or supplementation, or support self-stopping, form changes or dose changes. Review the exact product and current label with the prescribing team or pharmacist." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SINEMET（carbidopa and levodopa）当前美国公开标签列出即释口服固定复方片。当前 HOW SUPPLIED 只列 NDC 78206-166-01（10/100、有刻痕）与 NDC 78206-190-01（25/100、无刻痕）；同页结构化数据仍保留已结束的 NDC 78206-168-01（25/100、有刻痕，结束于 2026-02-21）和 NDC 78206-167-01（25/250，结束于 2021-06-02）。档案把当前与历史包装明确分层，不把无结束日期解释成实时库存，也不生成个人片数、时间表、漏用、餐食、联用、转换或停药方案。", "history": "FDA 后续公开审评资料支持 SINEMET 于 1975 年获批，但其中一份文件对精确日期存在单处不一致；因此本页只公开年份。当前阅读入口是 2026-07 修订、2026-08-24 发布的 Organon/DailyMed v6 标签；2026-03-19 的 S-076 批准函作为标签更新节点保留。中国大陆商品名、现行 NMPA 状态与可获得性尚未建立，不从美国档案外推。", "sourceDocuments": [ { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_3bc195e8a700b754", "label": "DailyMed（NLM）：SINEMET 当前美国电子说明书 PDF（Organon；2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "electronic_label_pdf", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_69e8c207a6f25f6b", "label": "FDA：SINEMET NDA 017555 S-076 批准函（2026-03-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017555Orig1s076ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d8b51a230a323587", "label": "FDA：2022 临床药理审评中的 SINEMET 1975 年批准历史线索", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214869Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 017555", "approvalTimeline": [ { "date": "1975", "title": { "zh": "FDA 后续审评资料支持的美国批准年份", "en": "U.S. approval year supported by later FDA reviews" }, "detail": { "zh": "FDA 2022 临床药理审评资料记录 SINEMET 于 1975 年获批；其他 FDA 后续资料对 5 月精确日期存在单处不一致，因此本页只公开年份。", "en": "A 2022 FDA clinical-pharmacology review records SINEMET approval in 1975. Another later FDA source has one conflicting May day, so this page publishes only the year." }, "source": { "id": "src_d8b51a230a323587", "label": "FDA: 2022 clinical-pharmacology review with SINEMET approval-history context", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214869Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03-19", "title": { "zh": "NDA 017555 S-076 批准与标签修订", "en": "NDA 017555 S-076 approval and label revision" }, "detail": { "zh": "FDA 公开批准函记录 S-076 于 2026-03-19 获批；DailyMed 当前标签的修订日亦为该日。", "en": "The FDA public letter records S-076 approval on 19 Mar 2026; the current DailyMed label carries the same revision date." }, "source": { "id": "src_69e8c207a6f25f6b", "label": "FDA: SINEMET NDA 017555 S-076 approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017555Orig1s076ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-08-24", "title": { "zh": "DailyMed 当前 SPL v6 公开", "en": "Current SPL v6 published on DailyMed" }, "detail": { "zh": "DailyMed 当前档案显示正文 Revised 7/2026，v6 于 2026-08-24 发布；当前 HOW SUPPLIED 只列 10/100 NDC 78206-166-01 与 25/100 NDC 78206-190-01，同时结构化数据保留两条有营销结束日期的历史 NDC。", "en": "The current DailyMed record shows text revised Jul 2026 and v6 published 24 Aug 2026. The current How Supplied section lists only 10/100 NDC 78206-166-01 and 25/100 NDC 78206-190-01, while structured data retain two historical NDCs with marketing-end dates." }, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed: current SINEMET public label and structured NDC data", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两个当前供应段 NDC；两个有结束日期的历史 NDC", "en": "Two NDCs in current How Supplied; two dated historical NDCs" }, "detail": { "zh": "当前供应段列 78206-166-01 与 78206-190-01；结构化记录显示 78206-168-01 于 2026-02-21 结束、78206-167-01 于 2021-06-02 结束。监管记录不证明实时库存。", "en": "The current How Supplied section lists 78206-166-01 and 78206-190-01. Structured records show 78206-168-01 ended 21 Feb 2026 and 78206-167-01 ended 2 Jun 2021. Regulatory records do not prove live stock." } }, { "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": "不从美国档案推定当地商品名、批准、规格、供应或原研关系。", "en": "No local trade name, approval, strength, supply or originator relationship is inferred from the U.S. archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为 25/100，能否把历史有刻痕包装当成当前包装来分片？", "en": "Can the historical scored 25/100 pack be treated as the current pack for splitting?" }, "answer": { "zh": "不能。当前 HOW SUPPLIED 列的是无刻痕 NDC 78206-190-01；有刻痕 NDC 78206-168-01 的营销记录已结束。包装图片、相同强度和旧刻痕不能替代手上准确药瓶、现行标签与药师判断。", "en": "No. The current How Supplied section lists unscored NDC 78206-190-01; the marketing record for scored NDC 78206-168-01 has ended. A package image, shared strength or historical score line cannot replace the exact bottle, current label and pharmacist review." } } ], "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/sinemet/", "en": "https://origindrug.com/en/drugs/sinemet/" }, "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." ] }