{ "id": "aricept", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Aricept", "generic": "多奈哌齐", "aliases": [ "donepezil", "donepezil hydrochloride", "ARICEPT", "Aricept", "多奈哌齐", "盐酸多奈哌齐", "盐酸多奈哌齐片", "多奈哌齐片", "安理申" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "安理申®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_b714bd77500b54db", "label": "诸暨市人民政府：2025 年医院药品目录中的安理申／多奈哌齐片 5 mg×7 片记录", "url": "https://www.zhuji.gov.cn/art/2025/1/2/art_1453401_59147560.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v33，2026-06-30 发布）", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、23 mg；口腔崩解片：5 mg、10 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Eisai Inc. / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aricept-tablet-5mg-ndc-62856-245-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT 多奈哌齐盐酸盐薄膜衣口服片", "en": "ARICEPT donepezil hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-245-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg；30 片瓶装", "en": "5 mg; 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30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-11.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 23, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "reddish" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 23", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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-aricept-odt-5mg-ndc-62856-831-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT ODT 多奈哌齐盐酸盐口腔崩解片", "en": "ARICEPT ODT donepezil hydrochloride orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-831-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg；30 片单位剂量泡罩盒（10×3）", "en": "5 mg; 30-tablet unit-dose blister carton (10 × 3)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-12.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩盒", "en": "unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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-aricept-odt-10mg-ndc-62856-832-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT ODT 多奈哌齐盐酸盐口腔崩解片", "en": "ARICEPT ODT donepezil hydrochloride orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-832-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "10 mg；30 片单位剂量泡罩盒（10×3）", "en": "10 mg; 30-tablet unit-dose blister carton (10 × 3)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-13.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩盒", "en": "unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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-aricept-tablet-5mg-ndc-62856-245-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-0f.jpg", "alt": "ARICEPT 多奈哌齐盐酸盐 5 mg、NDC 62856-245-30、30 片瓶装的美国 DailyMed 当前标签包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（2026-06-30 发布）", "presentation": "ARICEPT 多奈哌齐盐酸盐 5 mg 薄膜衣口服片、NDC 62856-245-30、30 片瓶装包装面板（当前美国标签所列）。", "notice": "此图只对应 ARICEPT、薄膜衣口服片、5 mg、NDC 62856-245-30 与 30 片瓶装；不用于鉴定真伪，也不代表 10 mg、23 mg、ARICEPT ODT、其他包装、其他市场、当前可得性或任何个人用药方案。", "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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": "ARICEPT 说明书放大阅读：普通片、口腔崩解片与 23 mg 必须一起核对", "en": "ARICEPT label reading: tablets, ODT and 23 mg must be checked together" }, "summary": { "zh": "本模块以 Eisai 的当前美国 DailyMed 标签为阅读入口，帮助核对 ARICEPT 的普通片、口腔崩解片、每片标示量、NDC 与包装；它不提供个人开始、加量、停用、转换或拆分方案。", "en": "This module uses Eisai's current U.S. DailyMed label as a reading entry point. It helps check ARICEPT tablets, orally disintegrating tablets, labelled amount per tablet, NDC and package; it does not provide an individual start, increase, stop, switch or splitting plan." }, "checks": [ { "zh": "先核对 ARICEPT、通用名多奈哌齐、普通片或口腔崩解片、每片标示强度和目标市场。一个“5”“10”或“23”数字不能单独说明应如何服用，也不能证明与另一种包装可互换。", "en": "First check ARICEPT, donepezil, tablet or orally disintegrating tablet, labelled strength per unit and target market. A “5”, “10” or “23” alone does not say how a person should use it or prove interchangeability with another pack." }, { "zh": "当前美国标签区分 5、10、23 mg 普通片和 5、10 mg 口腔崩解片；其中 23 mg 普通片的标签写明不应掰开、压碎或咀嚼。不同市场或产品版本须回到该准确产品的现行标签复核。", "en": "The current U.S. label distinguishes 5, 10 and 23 mg tablets and 5 and 10 mg orally disintegrating tablets; it states that the 23 mg tablet should not be split, crushed or chewed. Another market or product version needs checking against the current label for that exact product." }, { "zh": "标签列出可能需要关注的心率、胃肠道、体重、麻醉及与抗胆碱能或其他胆碱能药物的联用问题。家中同时有多种记忆、睡眠、感冒、止痛或膀胱相关药物时，应带完整药单请药师复核，不要自行叠加、替代或停用。", "en": "The label identifies issues that may require attention involving heart rate, gastrointestinal effects, weight, anaesthesia and combinations with anticholinergic or other cholinergic medicines. When multiple memory, sleep, cold, pain or bladder products are at home, bring the complete list to a pharmacist rather than self-combining, substituting or stopping." }, { "zh": "出现昏厥、明显心率异常、持续呕吐/脱水、黑便或其他急性不适，应寻求及时医疗评估；网页和历史标签不能替代紧急判断。", "en": "For fainting, a marked heart-rate concern, persistent vomiting/dehydration, black stools or another acute symptom, seek timely medical assessment; a webpage and historical label cannot replace urgent judgement." } ], "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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": "多奈哌齐怎样起作用：它可逆性抑制乙酰胆碱酯酶", "en": "How donepezil works: it reversibly inhibits acetylcholinesterase" }, "summary": { "zh": "FDA 标签将多奈哌齐描述为可逆性乙酰胆碱酯酶抑制剂，并说明其主要药理作用是抑制乙酰胆碱水解。该机制帮助理解它为何与其他影响胆碱能系统的产品需要一起核对；它不预测个人记忆变化，也不决定个人强度、加减量、停用或与其他认知相关药物的转换。", "en": "The FDA label describes donepezil as a reversible acetylcholinesterase inhibitor and states that its main pharmacologic action is inhibition of acetylcholine hydrolysis. This helps explain why products affecting the cholinergic system need review together; it does not predict an individual's memory change or decide individual strength, adjustment, discontinuation or conversion with another cognition-related medicine." }, "checks": [ { "zh": "共同影响胆碱能系统，不表示多奈哌齐与其他记忆药、膀胱药、抗过敏/感冒药或保健品可自行叠加、抵消、替代或轮换。所有处方药、非处方药和补充剂都应带给药师或开方团队逐项核对。", "en": "A shared effect on the cholinergic system does not make donepezil self-combinable, cancellable, substitutable or alternatable with another memory medicine, bladder medicine, allergy/cold product or supplement. Every prescription, OTC product and supplement should be reviewed item by item with a pharmacist or prescribing team." }, { "zh": "机制不能把 5、10、23 mg 或普通片/口腔崩解片转换为个人的服用规则，也不能说明某个数字“更适合”某人。具体剂型、强度、既往情况、其他用药与现行标签必须一并核对。", "en": "Mechanism cannot convert 5, 10 or 23 mg, or tablet/ODT form, into an individual's use rule, nor show that one number “suits” someone better. Exact form, strength, prior circumstances, other medicines and the current label must be checked together." }, { "zh": "心率变化、昏厥、胃肠道不适、体重变化或新的行为/意识问题都不能从机制页面自行处理。出现急性症状或考虑改变任何认知相关药物时，应及时使用当地专业支持。", "en": "Heart-rate changes, fainting, gastrointestinal symptoms, weight change or a new behaviour/awareness concern cannot be self-managed from a mechanism page. With an acute symptom or a plan to change any cognition-related medicine, use timely local professional support." } ], "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Clinical Pharmacology；Eisai；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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": "Aricept", "generic": "多奈哌齐", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、23 mg；口腔崩解片：5 mg、10 mg（当前美国标签所列）" }, "labelSource": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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." } } ], "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 的当前 ARICEPT / ARICEPT ODT 美国公开标签列示多奈哌齐盐酸盐的普通口服片与口腔崩解片。页面帮助把完整品牌名、准确剂型、每片标示量、NDC、包装与目标市场一起核对；不据此生成个人开始、加量、停用、转换或购买方案。", "history": "相同通用名或相近数字，不能把普通片、口腔崩解片、不同强度或其他认知相关药物变成可自行互换的产品。认知相关药物及家中其他处方药、非处方药和补充剂，应连同完整用药清单一起由药师或开方团队核对。", "sourceDocuments": [ { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020690 / 022568（当前美国标签所列品牌标签体系）", "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 ARICEPT / ARICEPT ODT 标签列示 Initial U.S. Approval: 1996；该年份不自动说明其他市场状态。", "en": "The current ARICEPT / ARICEPT ODT label lists Initial U.S. Approval: 1996; it does not establish status in another market." }, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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": "2026-06-30", "title": { "zh": "DailyMed 当前 SPL v33 公开", "en": "Current SPL v33 published on DailyMed" }, "detail": { "zh": "DailyMed 的媒体目录列示 ARICEPT / ARICEPT ODT 当前 SPL v33 于 2026-06-30 发布，并含本页列示的 5 个精确包装面板。该日期和图片不证明实际在售、库存或其他包装/市场状态。", "en": "DailyMed's media listing shows current ARICEPT / ARICEPT ODT SPL v33 published on 30 Jun 2026 and includes the five exact package panels shown here. The date and images do not establish actual marketing, stock or another package/market status." }, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "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": "已链接当前标签与 5 个精确包装面板", "en": "Current label and five exact package panels linked" }, "detail": { "zh": "展示面板分别对应 5 mg、10 mg、23 mg 普通片以及 5 mg、10 mg ARICEPT ODT 的特定 NDC；不据此建立实际在售、库存、个人服用或其他包装状态。", "en": "The display panels correspond separately to the specified NDCs for 5 mg, 10 mg and 23 mg tablets and 5 mg and 10 mg ARICEPT ODT; they do not establish actual marketing, stock, individual use or another-package status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, package, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ARICEPT 与 ARICEPT ODT 能否只看同样的毫克数就自行互换？", "en": "Can ARICEPT and ARICEPT ODT be self-switched just because the milligrams match?" }, "answer": { "zh": "不能。普通片与口腔崩解片是不同的准确产品形态；相同通用名或相同数字不足以建立自行互换、掰开、压碎、咀嚼或调整方案。请把实际包装、NDC 与完整药单交给药师或开方团队核对。", "en": "No. Tablets and orally disintegrating tablets are different exact product forms. A shared generic name or number does not establish self-switching, splitting, crushing, chewing or adjustment. Have a pharmacist or prescribing team check the actual package, NDC and complete medicine list." } }, { "question": { "zh": "23 mg 是不是可以由较低强度的片剂自行拼出来？", "en": "Can 23 mg be self-assembled from lower-strength tablets?" }, "answer": { "zh": "不能。本页仅展示标签身份；当前美国标签将 23 mg 普通片单列，并写明不应掰开、压碎或咀嚼。网页不把包装数字转换为个人片数或转换方案。", "en": "No. This page shows label identity only. The current U.S. label lists the 23 mg tablet separately and says it should not be split, crushed or chewed. This page does not convert package numbers into a personal tablet count or switching plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aricept/", "en": "https://origindrug.com/en/drugs/aricept/" }, "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." ] }