{ "id": "exelon-patch", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Exelon Patch", "generic": "利斯的明", "aliases": [ "EXELON PATCH", "rivastigmine transdermal system", "rivastigmine patch", "rivastigmine transdermal patch", "利斯的明透皮贴剂", "艾斯能" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "艾斯能®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_f8cd7f53465a714f", "label": "天津市医疗保障局：药品支付范围明细中的利斯的明透皮贴剂／艾斯能记录", "url": "https://ylbz.tj.gov.cn/xwzx/tzgg/202412/W020241217555076485828.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "reimbursement_lookup", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（正文 2024-05 修订；DailyMed SPL v30 于 2025-10-06 发布）", "dosageFormClass": "经皮缓释贴剂：4.6 mg/24h、9.5 mg/24h、13.3 mg/24h（美国标签所列）", "dosageFormClassCode": "transdermal_system", "route": "经皮", "routeCode": "transdermal", "historicalApprovalEntry": "2007-07-06（FDA 原始批准信所列 EXELON PATCH 首批批准日期）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-exelon-patch-4-6-ndc-0078-0501-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0501-15", "pouchCode": "NDC 0078-0501-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "4.6 mg/24h 标称释放；贴内总量 9 mg；面积 5 cm²", "en": "4.6 mg/24h nominal delivery; 9 mg total in the system; 5 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0B.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 4.6, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 9, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 5 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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-exelon-patch-9-5-ndc-0078-0502-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0502-15", "pouchCode": "NDC 0078-0502-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "9.5 mg/24h 标称释放；贴内总量 18 mg；面积 10 cm²", "en": "9.5 mg/24h nominal delivery; 18 mg total in the system; 10 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0C.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 9.5, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 18, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 10 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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-exelon-patch-13-3-ndc-0078-0503-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0503-15", "pouchCode": "NDC 0078-0503-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "13.3 mg/24h 标称释放；贴内总量 27 mg；面积 15 cm²", "en": "13.3 mg/24h nominal delivery; 27 mg total in the system; 15 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0F.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 13.3, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 27, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 15 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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-exelon-patch-9-5-ndc-0078-0502-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0C.jpg", "alt": "EXELON PATCH 利斯的明在美国 DailyMed Novartis 当前公开标签中的 9.5 mg/24h、NDC 0078-0502-15、30 贴装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "presentation": "EXELON PATCH 9.5 mg/24h，贴内总量 18 mg，面积 10 cm²，NDC 0078-0502-15，30 贴装包装面板", "notice": "此图只对应美国当前标签中的 9.5 mg/24h、NDC 0078-0502-15、30 贴包装。它不能代表 4.6 mg/24h、13.3 mg/24h、另一厂家贴剂、口服利斯的明、其他市场或当前可得性；不用于鉴定真伪，也不证明原研身份、可替代性或个人贴用方案。", "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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": "EXELON PATCH 说明书放大阅读：mg/24h、贴内总量与面积是三组不同身份字段", "en": "EXELON PATCH label reading: mg/24h, total patch content and area are different identity fields" }, "summary": { "zh": "本模块以美国 Novartis/DailyMed 当前公开标签为入口，帮助核对 EXELON PATCH、利斯的明经皮系统、24 小时标称释放量、贴内总量、面积、NDC 与包装。它不生成个人贴数、加减量、漏用、重复贴用、口服—贴剂转换或停用方案。", "en": "This module uses the current U.S. Novartis/DailyMed label to check EXELON PATCH, the rivastigmine transdermal system, nominal 24-hour delivery, total patch content, area, NDC and pack. It does not generate an individual patch count, titration, missed-use, duplicate-patch, oral-to-patch conversion or stopping plan." }, "checks": [ { "zh": "贴内总量不等于 24 小时标称释放量：例如 9.5 mg/24h 贴剂内含利斯的明碱总量 18 mg，面积 10 cm²。必须同时核对 mg/24h、总量、面积、NDC 与目标市场。", "en": "Total amount in the patch is not the nominal amount delivered over 24 hours: the 9.5 mg/24h system contains 18 mg total rivastigmine base and has an area of 10 cm². Check mg/24h, total content, area, NDC and market together." }, { "zh": "标签把旧贴未移除和同时使用多贴列为严重用药错误来源。照护记录应分别确认“旧贴已移除”和“新贴已贴上”；若发现重复贴用，不在网页上计算补救量，应使用当地医生、毒物咨询或紧急医疗渠道。", "en": "The label identifies failure to remove an old patch and use of multiple patches as sources of serious medication errors. A caregiver record should separately confirm ‘old patch removed’ and ‘new patch applied’. If duplicate patches are found, do not calculate a remedy online; use local clinician, poison-control or urgent-care routes." }, { "zh": "不能剪开、折叠、损坏或改动贴剂来获得“半量”；包装袋或贴剂不完整时，也不能把它视为正常完整产品。具体处理须回到准确产品的现行标签与药师。", "en": "Do not cut, fold, damage or alter a patch to obtain a ‘half amount’; a damaged pouch or patch is not the same as an intact product. Handling needs the current label for the exact product and pharmacist review." }, { "zh": "标签提示避免长时间外部热源。网页只提示核对加热垫、桑拿、强烈日晒等热暴露问题，不判断任何个人暴露是否安全，也不生成贴用位置或时长方案。", "en": "The label warns against prolonged exposure to external heat. This page only flags questions about heating pads, saunas, strong sun and other heat exposure; it does not decide whether an individual exposure is safe or generate an application-site or duration plan." }, { "zh": "EXELON 胶囊、口服液、品牌贴剂和其他厂家利斯的明贴剂是不同产品形态。不得按 mg 自行换算、叠加、轮换或替换；中断、漏用、换品牌、换强度或口服—贴剂转换须由医生或药师结合准确包装处理。", "en": "EXELON capsules, oral solution, brand patches and another manufacturer's rivastigmine patch are different product forms. Do not self-convert, combine, alternate or substitute them by milligrams; interruption, missed use, brand/strength change or oral-to-patch conversion needs a clinician or pharmacist with the exact package." } ], "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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": "利斯的明贴剂怎样起作用：标签描述可逆胆碱酯酶抑制，但不改变基础病程", "en": "How rivastigmine patch works: the label describes reversible cholinesterase inhibition, not disease modification" }, "summary": { "zh": "当前标签说明确切作用机制尚未完全确定；认为利斯的明通过可逆抑制胆碱酯酶对乙酰胆碱的水解，提高乙酰胆碱浓度并增强胆碱能功能。标签同时明确，没有证据证明它改变基础痴呆病程。", "en": "The current label states that the precise mechanism is not fully established. Rivastigmine is thought to increase acetylcholine by reversibly inhibiting its hydrolysis by cholinesterase, thereby enhancing cholinergic function. The label also states there is no evidence that it alters the course of the underlying dementing process." }, "checks": [ { "zh": "“提高乙酰胆碱”解释药理路径，不等于逆转痴呆、阻止进展或预测任何人的记忆、行为、跌倒或照护需要。", "en": "“Increasing acetylcholine” explains a pharmacologic pathway; it does not mean reversing dementia, stopping progression or predicting anyone's memory, behaviour, falls or care needs." }, { "zh": "随疾病进展及完整胆碱能神经元减少，标签说明作用可能减弱。该文字不能用来判断个人是否继续、加量、减量、暂停或转换产品。", "en": "The label explains that an effect may lessen as disease advances and fewer intact cholinergic neurons remain. This wording cannot decide whether an individual continues, increases, reduces, pauses or changes product." }, { "zh": "经皮给药只是递送方式，不表示与口服利斯的明、另一品牌贴剂或其他胆碱酯酶抑制剂可按 mg 自动替换、叠加或轮换。准确产品、完整药单和照护记录须由专业人员一起核对。", "en": "Transdermal delivery is a delivery route; it does not make oral rivastigmine, another patch brand or another cholinesterase inhibitor automatically substitutable, combinable or alternatable by milligrams. A professional needs the exact product, complete medicine list and care record together." } ], "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Clinical Pharmacology；Novartis）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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": "Exelon Patch", "generic": "利斯的明", "dosageFormClass": "经皮缓释贴剂：4.6 mg/24h、9.5 mg/24h、13.3 mg/24h（美国标签所列）" }, "labelSource": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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 EXELON PATCH（rivastigmine transdermal system）当前美国公开标签列出三种 24 小时标称释放量。页面把 mg/24h、每贴总载药量、贴剂面积、NDC 与 30 贴包装分开显示，避免把 9.5 mg/24h 误读为贴内只有 9.5 mg；它不生成个人贴数、开始、加减量、漏用、重复贴用、口服—贴剂转换或停用方案。", "history": "EXELON 口服制剂于 2000 年获批，EXELON PATCH NDA 022083 则于 2007-07-06 首批批准；13.3 mg/24h 规格在 2012 年 S-016 获批。当前标签页中的 Initial U.S. Approval: 2000 不能被误写为贴剂批准时间。中国大陆和其他市场的名称、规格、包装与现行状态须独立核验。", "sourceDocuments": [ { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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_2680c298152ad484", "label": "FDA：EXELON PATCH NDA 022083 原始批准信（2007-07-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bad6528c9cf11980", "label": "FDA：EXELON PATCH 13.3 mg/24h S-016 审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022083", "approvalTimeline": [ { "date": "2000-04-21", "title": { "zh": "EXELON 口服制剂历史批准节点", "en": "Historical EXELON oral-product approval node" }, "detail": { "zh": "FDA 贴剂批准资料说明 2000 年节点属于 EXELON 胶囊/口服液 NDA 020823，不是贴剂批准日期。", "en": "FDA patch approval material explains that the 2000 node belongs to EXELON capsules/oral solution under NDA 020823, not to patch approval." }, "source": { "id": "src_2680c298152ad484", "label": "FDA: EXELON PATCH NDA 022083 original approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2007-07-06", "title": { "zh": "EXELON PATCH 首批批准", "en": "Initial EXELON PATCH approval" }, "detail": { "zh": "FDA 原始批准信记录 4.6 mg/24h 与 9.5 mg/24h EXELON PATCH 于 2007-07-06 获批。", "en": "The FDA original letter records approval of the 4.6 mg/24h and 9.5 mg/24h EXELON PATCH presentations on 6 Jul 2007." }, "source": { "id": "src_2680c298152ad484", "label": "FDA: EXELON PATCH NDA 022083 original approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2012-08-31", "title": { "zh": "13.3 mg/24h 规格批准节点", "en": "13.3 mg/24h presentation approval node" }, "detail": { "zh": "FDA S-016 审评资料记录 13.3 mg/24h、15 cm²、贴内总量 27 mg 的补充规格节点。", "en": "FDA S-016 review material records the 13.3 mg/24h, 15 cm², 27 mg total-content supplemental presentation." }, "source": { "id": "src_bad6528c9cf11980", "label": "FDA: EXELON PATCH S-016 review material", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-05-08", "title": { "zh": "当前处方信息修订/更新", "en": "Current prescribing-information revision/update" }, "detail": { "zh": "DailyMed 页面列示正文 Revised 05/2024，并将 Drug Label Information Updated 标为 2024-05-08。", "en": "DailyMed lists the text as Revised 05/2024 and Drug Label Information Updated as 8 May 2024." }, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed: current EXELON PATCH public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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": "2025-10-06", "title": { "zh": "DailyMed SPL v30 公开", "en": "SPL v30 published on DailyMed" }, "detail": { "zh": "DailyMed 的 Published Date 为 2025-10-06；该日期不被解释成 2025 年发生新的临床修订。", "en": "DailyMed lists 6 Oct 2025 as the Published Date; it is not treated as a new 2025 clinical revision." }, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed: current EXELON PATCH public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "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 NDA 节点", "en": "Current label and NDA nodes linked" }, "detail": { "zh": "产品呈现对应 Novartis/DailyMed 当前美国标签和公开历史文件。", "en": "The product presentations correspond to the current Novartis/DailyMed U.S. label and public historical documents." } }, { "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": "地区名称、规格、包装、法定说明书与供应状态须独立核验。", "en": "Regional names, strengths, packs, legal labels and supply status require independent review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "9.5 mg/24h 是否表示贴内总共只有 9.5 mg？", "en": "Does 9.5 mg/24h mean the patch contains only 9.5 mg in total?" }, "answer": { "zh": "不是。美国标签列示该贴剂面积 10 cm²、贴内总量 18 mg、24 小时标称释放 9.5 mg。", "en": "No. The U.S. label lists a 10 cm² patch containing 18 mg total with nominal delivery of 9.5 mg over 24 hours." } } ], "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/exelon-patch/", "en": "https://origindrug.com/en/drugs/exelon-patch/" }, "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." ] }