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not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "elliptical tablet; no score" }, "imprint": "LILLY / 4420", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zyprexa-olanzapine-regular-tablet-10mg-30-bottle-ndc-6126963330", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-05.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "alt": "ZYPREXA 奥氮平在美国 DailyMed 公开标签中的 10 mg、NDC 61269-633-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v68（2026-02-16 发布）", "presentation": "ZYPREXA 奥氮平普通口服片：每片 10 mg；NDC 61269-633-30；30 片瓶装展示面。", "notice": "此图只对应美国公开标签中的 ZYPREXA 普通口服片 10 mg、NDC 61269-633-30、30 片瓶装。它不代表 2.5/5/7.5/15/20 mg、ZYPREXA ZYDIS 口崩片、ZYPREXA IntraMuscular 注射剂、ZYPREXA RELPREVV、其他包装、其他市场或其他奥氮平产品；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_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZYPREXA 说明书放大阅读：普通片、口崩片、注射剂和 mg 必须分开核对", "en": "ZYPREXA label reading: keep regular tablets, orally disintegrating tablets, injections 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 ZYPREXA、奥氮平、普通口服片、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、分片或停药建议。", "en": "This module uses the U.S. public label to check ZYPREXA, olanzapine, regular oral tablets, stated strength per tablet, the exact pack and target market; it provides no individual tablet count, schedule, missed-use remedy, co-use, switching, splitting or stopping advice." }, "checks": [ { "zh": "2.5、5、7.5、10、15、20 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。本页图片仅对应 10 mg、NDC 61269-633-30、30 片瓶装；名称、颜色或 mg 相同都不能证明另一盒是同一产品。", "en": "2.5, 5, 7.5, 10, 15 and 20 mg are stated amounts per regular tablet in the current label, not an answer to ‘how many tablets today.’ The image on this page is only for 10 mg, NDC 61269-633-30, a 30-tablet bottle; a matching name, colour or mg marking does not establish that another pack is the same product." }, { "zh": "ZYPREXA ZYDIS 是口崩片，ZYPREXA IntraMuscular 是肌内注射剂，ZYPREXA RELPREVV 是另一种长效注射剂。不要因共同含奥氮平或同属 ZYPREXA 品牌家族，就自行改剂型、叠加、轮换、以注射剂替代片剂，或从包装数字推断怎样掰开；应由开方团队或药师核对实际处方与现行标签。", "en": "ZYPREXA ZYDIS is an orally disintegrating tablet, ZYPREXA IntraMuscular is an intramuscular injection, and ZYPREXA RELPREVV is a separate long-acting injection. Do not self-change form, combine, alternate, replace tablets with an injection or infer splitting from package numbers merely because they share olanzapine or the ZYPREXA brand family; have the actual prescription and current label reviewed by the prescribing team or pharmacist." }, { "zh": "美国标签提示痴呆相关精神病老年患者的重要限制：ZYPREXA 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: ZYPREXA 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": "标签列出可能影响血压的药物、左旋多巴/多巴胺激动剂，以及特定肌内注射场景下的劳拉西泮等需要专业复核的联用线索。它们不等于网页可以判断某个人能否同用、应如何错开、怎样加减或替换；带上完整药单与实际包装请药师或医生逐项核对。", "en": "The label identifies co-medication review cues including medicines that can affect blood pressure, levodopa/dopamine agonists, and lorazepam in a specific intramuscular context. They do not let a website decide whether a person can use them together, how to separate them, or how to change or replace anything; take the complete medicine list and actual packs to a pharmacist or clinician for item-by-item review." } ], "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥氮平怎样起作用：标签描述多种受体作用，但不能据此指导个人调整", "en": "How olanzapine works: the label describes several receptor actions, not a guide for personal adjustment" }, "summary": { "zh": "美国 ZYPREXA 标签称，所列适应症中的奥氮平作用机制尚不完全清楚，并描述其可能与多巴胺和 5HT2 型血清素受体拮抗的组合有关。它解释的是标签中的药理路径，不预测任何个人的症状、反应、适用性、片数、注射方案或联用结果。", "en": "The U.S. ZYPREXA label says olanzapine's mechanism in the listed indications is unclear and describes a possible combination of dopamine and serotonin type 2 (5HT2) antagonism. This explains a labelled pharmacologic pathway; it does not predict anyone's symptoms, response, suitability, tablet count, injection plan or co-use outcome." }, "checks": [ { "zh": "“作用于多巴胺和血清素受体”是理解药物类别的一条线索，不是网页判断幻觉、情绪、睡眠、行为或认知变化原因的工具，也不能替代由专业人员结合准确诊断、病程与完整药单作出的判断。", "en": "“Acts on dopamine and serotonin receptors” is one clue for understanding a medicine class; it is not a website tool for deciding the cause of hallucinations, mood, sleep, behavioural or cognitive changes, and cannot replace professional judgement using the exact diagnosis, course and complete medicine list." }, { "zh": "同为抗精神病药、都涉及相近受体或都可能使人困倦，不表示 ZYPREXA、SEROQUEL 或其他产品可以自行叠加、替换、轮换或按 mg 换算。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": "Being antipsychotic medicines, involving related receptors or both potentially causing drowsiness does not permit self-combination, replacement, alternation or milligram conversion between ZYPREXA, SEROQUEL or another product. 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，而不是继续试验不同剂型或依据包装数字自行调整。", "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 rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（Clinical Pharmacology；H2-Pharma LLC；SPL v68）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "Zyprexa", "generic": "奥氮平", "dosageFormClass": "普通口服片：2.5 mg、5 mg、7.5 mg、10 mg、15 mg、20 mg（美国公开标签所列；本档案分别建立六种 30 片瓶装身份；不与 ZYDIS 口崩片或注射剂合并）" }, "labelSource": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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." } } ], "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 ZYPREXA（olanzapine）美国公开标签同时收录普通口服片、ZYDIS 口崩片与肌内注射剂。本页分别建立普通口服片 2.5、5、7.5、10、15、20 mg 的六种准确 30 片瓶装，帮助核对品牌、通用名、剂型、每片标示强度、NDC、外观线索、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、分片或停药方案。", "history": "当前公开标签列示 Initial U.S. Approval: 1996。本页的六张卡片只对应所引美国标签中 2.5 mg（NDC 61269-630-30）、5 mg（61269-631-30）、7.5 mg（61269-632-30）、10 mg（61269-633-30）、15 mg（61269-634-30）、20 mg（61269-635-30）的各一瓶 30 片普通片。共享奥氮平成分或 ZYPREXA 品牌家族，并不能使普通片、ZYDIS 口崩片、肌内注射剂或 RELPREVV 长效注射剂可自行替换、合并、轮换或按经验掰分。", "sourceDocuments": [ { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020592", "approvalTimeline": [ { "date": "1996", "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 ZYPREXA 标签列示 Initial U.S. Approval: 1996。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 ZYPREXA label lists Initial U.S. Approval: 1996. This year locates this U.S. archive only; it does not establish approval, supply or sale status in another market." }, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-16", "title": { "zh": "DailyMed 当前公开 SPL v68", "en": "Current public SPL v68 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 ZYPREXA/ZYDIS/肌内注射剂合并标签的 SPL v68 发布日期列为 2026-02-16。本页仅选取其中普通片的准确 10 mg 包装面板，不将其外推为口崩片、注射剂、其他包装、库存或个人使用结论。", "en": "DailyMed lists 16 Feb 2026 as the publication date for SPL v68, a combined ZYPREXA/ZYDIS/intramuscular-injection label. This page selects only the exact regular-tablet 10 mg package panel and does not extend it to orally disintegrating tablets, injections, another pack, stock or individual use." }, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接普通片公开标签与准确 10 mg 包装面板", "en": "Regular-tablet public label and exact 10 mg package panel linked" }, "detail": { "zh": "本页展示的面板仅对应普通口服片 10 mg、NDC 61269-633-30、30 片瓶装；不建立实际在售、库存、个人片数、分片、联用或其他规格状态。", "en": "The displayed panel only corresponds to regular oral 10 mg tablets, NDC 61269-633-30, in a 30-tablet bottle; it does not establish actual availability, stock, individual tablet count, splitting, co-use or another-strength status." } }, { "market": { "zh": "美国 ZYDIS、肌内注射剂、RELPREVV 与中国大陆、欧盟、日本及其他市场", "en": "U.S. ZYDIS, intramuscular injection, RELPREVV 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": "ZYDIS 口崩片、肌内注射剂与 RELPREVV 长效注射剂都是不同产品呈现；不从本页普通片标签推定这些产品或其他市场的商品名、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "ZYDIS orally disintegrating tablets, intramuscular injection and RELPREVV long-acting injection are different product presentations. This regular-tablet label does not establish a trade name, approval, strength, pack, supply, sale eligibility, originator/generic relationship or interchangeability for those products or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZYPREXA、ZYDIS 和注射剂都含奥氮平，能否只按 mg 自行换？", "en": "ZYPREXA, ZYDIS and injections all contain olanzapine. Can they be self-converted by mg?" }, "answer": { "zh": "不能。本页只建立美国普通口服片的公开标签阅读路径；ZYDIS、肌内注射剂和 RELPREVV 是不同产品呈现。共同成分、品牌家族或相近 mg 数字不能证明可自行互换、合并、轮换或按比例拆分。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": "No. This page establishes the U.S. public-label reading path for regular oral tablets only; ZYDIS, intramuscular injection and RELPREVV are different product presentations. 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/zyprexa/", "en": "https://origindrug.com/en/drugs/zyprexa/" }, "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." ] }