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no score" }, "imprint": "SEROQUEL / 300", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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-seroquel-quetiapine-immediate-tablet-400mg-100-bottle-ndc-0310027910", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0279-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 400 mg；100 片瓶装", "en": "Quetiapine 400 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0279-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形双凸薄膜衣片；无刻痕", "en": "capsule-shaped biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 400", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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-seroquel-quetiapine-immediate-tablet-100mg-100-bottle-ndc-0310027110", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0271-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "alt": "SEROQUEL 喹硫平在美国 DailyMed 公开标签中的 100 mg、NDC 0310-0271-10、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025-01-22 更新）", "presentation": "SEROQUEL 喹硫平普通薄膜衣片：每片 100 mg；NDC 0310-0271-10；100 片瓶装展示面。另有五种独立准确瓶装卡片，不能相互替代。", "notice": "此图只对应美国公开标签中的 SEROQUEL 普通薄膜衣片 100 mg、NDC 0310-0271-10、100 片瓶装。页面另分开列出 25/50/200/400 mg 的 100 片瓶装及 300 mg 的 60 片瓶装；每一张卡都只对应其自身 NDC、强度与包装。它不代表 SEROQUEL XR 缓释片、其他包装、其他市场或其他喹硫平产品；不用于鉴定真伪，也不生成个人片数、时间表、分片、联用、转换或停药方案。", "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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": "SEROQUEL 说明书放大阅读：普通片、XR 缓释片与 mg 必须分开核对", "en": "SEROQUEL label reading: keep immediate tablets, XR tablets and mg markings separate" }, "summary": { "zh": "本模块以美国公开标签为阅读入口，帮助核对 SEROQUEL、喹硫平、普通薄膜衣片、每片标示强度、准确包装与目标市场；不提供个人片数、时间表、漏用补救、联用、换药或停药建议。", "en": "This module uses the U.S. public label to check SEROQUEL, quetiapine, immediate tablets, stated strength per tablet, the exact pack and target market; it provides no individual tablet count, schedule, missed-use remedy, co-use, switching or stopping advice." }, "checks": [ { "zh": "25、50、100、200、300、400 mg 是当前标签所列普通片的每片标示强度，不是“今天应服几片”的答案。页面把 25/50/100/200/400 mg 的 100 片瓶装和 300 mg 的 60 片瓶装分开列出；名称或 mg 相同都不能证明另一盒是同一产品或可自行转换。", "en": "25, 50, 100, 200, 300 and 400 mg are stated amounts per immediate tablet in the current label, not an answer to 'how many tablets today.' This page lists 100-tablet bottles for 25/50/100/200/400 mg separately from the 60-tablet bottle for 300 mg; a matching name or mg marking does not establish that another pack is the same product or can be self-converted." }, { "zh": "SEROQUEL XR 是缓释片，属于不同产品呈现。不要因同为喹硫平、同属 SEROQUEL 品牌或看到相近 mg 数字，就自行把普通片改成 XR、把 XR 改回普通片、叠加、隔天轮换或按经验掰开；应由开方团队或药师核对实际处方与现行标签。", "en": "SEROQUEL XR is an extended-release tablet and a different product presentation. Do not self-change immediate tablets to XR, change XR back to immediate tablets, combine, alternate days or split from experience merely because both contain quetiapine, share the SEROQUEL name or have similar mg markings; have the actual prescription and current label reviewed by the prescribing team or pharmacist." }, { "zh": "美国标签对痴呆相关精神病老年患者列有重要限制：SEROQUEL 不获批用于这一人群。此处是标签阅读提示，不是网页对任何人的诊断或治疗结论；高龄、认知变化、跌倒、晕厥、嗜睡或多药并用时，应尽快让当地医疗团队核对全部药物和实际药盒。", "en": "The U.S. label carries an important limitation for elderly people with dementia-related psychosis: SEROQUEL is not approved for that population. This is a label-reading prompt, not a web diagnosis or treatment conclusion for any person; with older age, cognitive change, falls, fainting, drowsiness or multiple medicines, ask the local care team to review every medicine and actual pack promptly." }, { "zh": "标签包含嗜睡、头晕/体位性低血压、代谢变化以及与其他中枢作用产品、酒精或其他药物共同使用时的核对事项。不要从网页自行开始、停用、加减、与镇静产品叠加或把不适归因于某一盒药；携带完整药单请医生或药师判断。", "en": "The label includes drowsiness, dizziness/orthostatic hypotension, metabolic changes and review considerations with other centrally acting products, alcohol or other medicines. Do not self-start, stop, adjust, add a sedating product or assign a symptom to one pack from this page; take the complete medicine list to a clinician or pharmacist for assessment." }, { "zh": "出现昏厥、跌倒伴受伤、明显意识或行为改变、严重过敏样反应、持续高热伴肌强直、心悸/胸部不适或其他急性严重问题时，应及时使用当地紧急医疗支持，而不是依据网页自行暂停、恢复或换用另一种精神科药物。", "en": "With fainting, a fall with injury, marked mental or behavioural change, a severe allergy-like reaction, persistent fever with muscle rigidity, palpitations/chest discomfort or another acute serious concern, use local urgent medical support promptly rather than self-pausing, restarting or changing to another psychiatric medicine from a webpage." } ], "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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": "喹硫平怎样起作用：受体作用说明不能代替个人治疗判断", "en": "How quetiapine works: a receptor explanation does not replace individual treatment judgement" }, "summary": { "zh": "美国标签将喹硫平的作用与多种神经递质受体的拮抗作用联系起来，其中对血清素 5HT2 受体的拮抗强于对多巴胺 D2 受体的拮抗。该说明帮助理解标签中的药理描述，不预测个人症状、适用性、疗效、片数、睡眠安排或能否与其他药物联用。", "en": "The U.S. label relates quetiapine's activity to antagonism at multiple neurotransmitter receptors, with greater antagonism at serotonin 5HT2 than dopamine D2 receptors. This helps read the pharmacology description; it does not predict individual symptoms, suitability, benefit, tablet count, sleep timing or co-use with another medicine." }, "checks": [ { "zh": "“作用于 5HT2、D2 等受体”描述的是药理路径，不是从失眠、情绪、幻觉、焦虑、行为变化或一次体验自行判断是否需要、适合或应改变治疗的工具。", "en": "'Acts at 5HT2, D2 and other receptors' describes a pharmacologic pathway, not a tool for deciding a need, suitability or treatment change from insomnia, mood, hallucinations, anxiety, behavioural change or one experience." }, { "zh": "同样影响神经递质、都被称为抗精神病药，或都可能使人困倦，都不表示可以自行叠加、替换、轮换或由一种产品换算到另一种。品牌、准确剂型、释放方式、既往反应、身体状况和完整药单都必须由专业人员逐项核对。", "en": "A related neurotransmitter effect, antipsychotic class or shared potential for drowsiness does not permit self-combination, replacement, alternation or conversion from one product to another. Brand, exact form, release characteristics, prior reactions, health context and the complete medicine list all need item-by-item professional review." }, { "zh": "机制文字不能处理突发的严重嗜睡、昏厥、跌倒、发热伴肌强直、胸部不适或明显行为改变。出现急性或严重担忧时，应优先使用当地医疗和紧急支持。", "en": "A mechanism explanation cannot manage sudden severe drowsiness, fainting, a fall, fever with muscle rigidity, chest discomfort or marked behavioural change. With an acute or serious concern, prioritise local medical and emergency support." } ], "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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": "Seroquel", "generic": "喹硫平", "dosageFormClass": "普通口服薄膜衣片：25 mg、50 mg、100 mg、200 mg、300 mg、400 mg（美国公开标签所列；六种准确瓶装分别建立）；不与 SEROQUEL XR 缓释片混同" }, "labelSource": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SEROQUEL（quetiapine）美国公开标签列出普通口服薄膜衣片。页面帮助核对品牌、通用名、普通片或缓释片、每片标示强度、实际包装、标签版本与目标市场；不把任何 mg 数字转成个人片数、服用时间、漏用处理、联用、转换或停药方案。", "history": "当前公开标签列示 Initial U.S. Approval: 1997，并由 AstraZeneca Pharmaceuticals LP 作为包装方。SEROQUEL XR 是另一份缓释片标签；共享喹硫平成分、品牌家族或相近 mg 数字，不能证明两种制剂可自行替换、合并、轮换或按经验掰分。", "sourceDocuments": [ { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 020639", "approvalTimeline": [ { "date": "1997", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 SEROQUEL 标签列示 Initial U.S. Approval: 1997。该年份仅定位这一美国档案，不建立其他市场的批准、供应或可售状态。", "en": "The current SEROQUEL label lists Initial U.S. Approval: 1997. This year locates this U.S. archive only; it does not establish approval, supply or sale status in another market." }, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-01-22", "title": { "zh": "DailyMed 当前公开标签更新", "en": "Current DailyMed public-label update" }, "detail": { "zh": "DailyMed 页面将 SEROQUEL 普通口服片标为 2025-01-22 更新，包装方为 AstraZeneca Pharmaceuticals LP。该公开记录只支持本页的标签阅读与包装身份核对，不说明个人用药、实际库存或其他市场状态。", "en": "DailyMed marks the SEROQUEL immediate-tablet page updated on 22 Jan 2025 and identifies AstraZeneca Pharmaceuticals LP as packager. This public record supports label reading and package identity on this page only, not individual use, actual stock or another-market status." }, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "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": "已链接普通片公开标签与六种准确瓶装面板", "en": "Immediate-tablet public label and six exact bottle panels linked" }, "detail": { "zh": "页面分别记录 NDC 0310-0275-10（25 mg，100 片）、0310-0278-10（50 mg，100 片）、0310-0271-10（100 mg，100 片）、0310-0272-10（200 mg，100 片）、0310-0274-60（300 mg，60 片）和 0310-0279-10（400 mg，100 片）。这些身份卡不建立实际在售、库存、个人片数、分片、联用或相互替代关系。", "en": "The page separately records NDC 0310-0275-10 (25 mg, 100 tablets), 0310-0278-10 (50 mg, 100 tablets), 0310-0271-10 (100 mg, 100 tablets), 0310-0272-10 (200 mg, 100 tablets), 0310-0274-60 (300 mg, 60 tablets), and 0310-0279-10 (400 mg, 100 tablets). These identity cards do not establish actual availability, stock, individual tablet count, splitting, co-use or interchangeability." } }, { "market": { "zh": "美国 SEROQUEL XR 与中国大陆、欧盟、日本及其他市场", "en": "U.S. SEROQUEL XR and Mainland China, EU, Japan and other markets" }, "status": { "zh": "明确分开或待逐项建立市场记录", "en": "Explicitly separate or market record not established" }, "detail": { "zh": "SEROQUEL XR 缓释片是不同产品呈现；不从本页普通片标签推定 XR 或任何其他市场的商品名、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "SEROQUEL XR extended-release tablets are a different product presentation. This immediate-tablet label does not establish a trade name, approval, strength, pack, supply, sale eligibility, originator/generic relationship or interchangeability for XR or any other market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "SEROQUEL 与 SEROQUEL XR 只有释放方式不同吗？", "en": "Do SEROQUEL and SEROQUEL XR differ only by release?" }, "answer": { "zh": "本页只建立普通薄膜衣片的美国公开标签阅读路径；XR 是另一个缓释片产品呈现。不能由共同成分、品牌家族或相近 mg 数字自行推导两者可换、可合并、可轮换或可按比例拆分。应由药师或开方团队核对实际处方、完整药单与目标市场的现行标签。", "en": "This page establishes the U.S. public-label reading path for immediate film-coated tablets only; XR is a separate extended-release presentation. A shared ingredient, brand family or similar mg marking cannot establish self-substitution, co-use, alternation or proportional splitting. A pharmacist or prescribing team must review the actual prescription, complete medicine list and current target-market label." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/seroquel/", "en": "https://origindrug.com/en/drugs/seroquel/" }, "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." ] }