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60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-11.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "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": "白色", "en": "white" }, "shape": { "zh": "长圆形、薄膜衣、有刻痕片", "en": "oblong, film-coated, scored tablet" }, "imprint": "ucb 1000", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keppra-levetiracetam-oral-solution-100mg-per-ml-473ml-bottle-ndc-50474-001-48", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦口服溶液", "en": "KEPPRA levetiracetam oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-001-48", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 mg/mL；473 mL（16 fl oz）瓶装", "en": "100 mg/mL; 473 mL (16 fl oz) bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-12.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 100, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 标签浓度；不是个人 mL 数、换算或调药规则", "en": "labelled concentration per mL; not an individual's millilitre amount, conversion or adjustment rule" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 100, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mg/mL", "en": "100 mg/mL" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" } }, "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": 1, "unit": { "zh": "473 mL 瓶装（16 fl oz）", "en": "473 mL bottle (16 fl oz)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-keppra-levetiracetam-tablet-500mg-ndc-50474-595-40", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-09.jpg", "alt": "KEPPRA 左乙拉西坦在美国 DailyMed UCB 公开标签中的 500 mg、120 片装容器标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（UCB, Inc.，2026-01 更新）", "presentation": "KEPPRA 左乙拉西坦薄膜衣片：每片 500 mg、120 片装容器标签图（DailyMed UCB, Inc. 公开标签所列）。", "notice": "此为美国 DailyMed UCB, Inc. 公开标签中明确对应 KEPPRA、左乙拉西坦 500 mg、120 片装的容器标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明其他规格、口服溶液、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KEPPRA 说明书放大阅读：片剂的 mg 与口服溶液的 mg/mL 不是“几片／几毫升”的答案", "en": "KEPPRA label reading: tablet mg and oral-solution mg/mL are not answers to a tablet or millilitre count" }, "summary": { "zh": "本模块以 DailyMed 的 KEPPRA 美国公开标签为阅读入口，核对左乙拉西坦、片剂或口服溶液、标示强度／浓度和目标市场。它不提供个人剂量、液体换算、加量、转换、骤停或联用方案。", "en": "This module uses the DailyMed KEPPRA U.S. public label to check levetiracetam, tablet or oral solution, stated strength/concentration and target market. It does not provide an individual's dose, liquid conversion, escalation, conversion, abrupt stopping or combination plan." }, "checks": [ { "zh": "先核对 KEPPRA、左乙拉西坦、片剂或口服溶液、准确的 mg 或 mg/mL、包装和目标市场。mg 是一个单位中的标示量，mg/mL 是液体浓度；两者都不是网页能替任何人得出“今天该用多少”的答案。", "en": "First check KEPPRA, levetiracetam, tablet or oral solution, the exact mg or mg/mL wording, presentation and target market. mg is a stated amount in a unit and mg/mL is liquid concentration; neither lets a webpage determine what anyone should use today." }, { "zh": "标签说明片剂应整片吞服，不应咀嚼或研碎。刻痕、颜色、大小或与其他片剂相似，都不授权自行掰开、研碎、换成液体、按经验换算或用别的规格替代。", "en": "The label states that tablets should be swallowed whole and not chewed or crushed. A score line, colour, size or resemblance to another tablet does not authorise self-splitting, crushing, conversion to liquid, experience-based conversion or substitution with another strength." }, { "zh": "标签提示避免突然撤药，因为可能增加发作频率或出现癫痫持续状态风险；这不是让读者自行决定何时停用的说明。对漏用、药物转换、行为或情绪变化以及任何停药计划，应联系负责团队或药师核对准确产品与现行处方。", "en": "The label advises avoiding abrupt withdrawal because seizure frequency may increase or status epilepticus may occur; this is not an instruction for readers to decide when to stop. For a missed use, medicine transition, behavioural or mood change, or any stopping plan, contact the responsible team or pharmacist to review the exact product and current prescription." }, { "zh": "标签指出肾功能会影响左乙拉西坦的清除，老年人尤其需要谨慎核对肾功能相关资料。这个信息解释为何完整药单、实验室资料和处方需要专业复核，不构成任何个人调整、间隔改变或自行补用规则。", "en": "The label notes that renal function affects levetiracetam clearance and that older adults require particular care around renal-function information. This explains why the complete medicine list, laboratory information and prescription need professional review; it does not create an individual adjustment, interval-change or self-make-up rule." } ], "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左乙拉西坦怎样起作用：标签明确写明其抗癫痫作用机制尚未完全确定", "en": "How levetiracetam works: the label explicitly says its exact antiepileptic mechanism is not fully known" }, "summary": { "zh": "KEPPRA 标签写明其精确抗癫痫作用机制尚未明确，并描述动物实验中观察到与突触囊泡蛋白 2A（SV2A）的结合可能有助于其作用。这里保留“可能”和证据边界：机制词用于理解资料，不用于预测个人疗效、决定诊断、剂量、联用或转换。", "en": "The KEPPRA label says its precise antiepileptic mechanism is unknown and describes experimental evidence that binding to synaptic vesicle protein 2A (SV2A) may contribute. This keeps the word 'may' and the evidence boundary: mechanism terms help read the source and do not predict individual response or decide diagnosis, dose, combination or switching." }, "checks": [ { "zh": "“SV2A”是一个标签中的实验与药理线索，不是任何一次发作、意识改变、跌倒或不适原因的诊断工具，也不能决定某个人是否应使用、增加或转换任何抗癫痫药。", "en": "“SV2A” is an experimental and pharmacologic clue in a label, not a diagnostic tool for a seizure, altered consciousness, fall or another concern, and it cannot decide whether someone should use, increase or switch any antiseizure medicine." }, { "zh": "即使另一种药也作用于神经系统，或名称、用途看似相关，也不能据此自行叠加、轮换、替代或把不同剂型按 mg 等量换算。完整药单、既往发作情况、肾功能相关资料和现行标签需要由专业人员一起评估。", "en": "Even if another medicine also affects the nervous system or seems related by name or use, this does not support self-combination, alternation, substitution or milligram-for-milligram conversion across dosage forms. The complete medicine list, seizure history, renal-function information and current label need professional review together." }, { "zh": "出现持续或反复发作、意识未恢复、严重皮疹或面部／气道肿胀、明显行为异常或其他急性问题，应优先使用当地紧急医疗或既有照护渠道；机制页面不能替代现场评估。", "en": "With persistent or repeated seizures, failure to regain consciousness, severe rash or face/airway swelling, marked behavioural change or another acute concern, prioritise local emergency care or established care pathways; a mechanism page cannot replace in-person assessment." } ], "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Keppra", "generic": "左乙拉西坦", "dosageFormClass": "薄膜衣片：250 / 500 / 750 / 1000 mg；口服溶液：100 mg/mL（本档案所列）" }, "labelSource": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3b6463247d31e848", "label": "FDA：KEPPRA 历史处方信息（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102%2C021505s042lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": "2026-08-20", "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 KEPPRA（levetiracetam）美国公开标签列出 250、500、750、1000 mg 薄膜衣片及 100 mg/mL 口服溶液。页面帮助读者先区分准确产品、单位和目标市场；不据此生成个人剂量、液体与片剂换算、加减量、联用、停药或购买结论。", "history": "“500 mg”与“100 mg/mL”描述的是不同剂型中的标示强度或浓度，不能只看相似数字就换算片数或毫升数。该页面仅建立美国公开标签的阅读路径；任何实际使用、肾功能相关调整、转换或停用均必须由开方团队依据现行标签和个人情况完成。", "sourceDocuments": [ { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_3b6463247d31e848", "label": "FDA：KEPPRA 历史处方信息（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102%2C021505s042lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021035 / 021505（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "1999", "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: 1999。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: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed: KEPPRA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-01 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 2026-01 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_6df3cfaae703b5de", "label": "DailyMed: KEPPRA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/keppra/", "en": "https://origindrug.com/en/drugs/keppra/" }, "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." ] }