{ "id": "wellbutrin-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "WELLBUTRIN XL", "generic": "安非他酮", "aliases": [ "WELLBUTRIN XL", "bupropion", "bupropion hydrochloride", "安非他酮", "盐酸安非他酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 WELLBUTRIN XL 盐酸安非他酮现行公开标签（DailyMed SPL v27，2026-02-06 发布；本档案仅建立缓释口服片阅读入口）", "dosageFormClass": "WELLBUTRIN XL 盐酸安非他酮缓释口服片：当前产品身份与供应信息列 150 mg、300 mg；450 mg 仅见于标签的用法和研究文字，不是当前产品包装规格", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985（美国当前公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Bausch Health US LLC（DailyMed 当前美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "WELLBUTRIN SR", "WELLBUTRIN immediate release", "ZYBAN", "bupropion sustained-release tablet", "bupropion immediate-release tablet", "安非他酮缓释片", "安非他酮普通片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-150mg-30-bottle-ndc-0187-0730-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "en": "Current DailyMed public label (published 6 Feb 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "WELLBUTRIN XL 盐酸安非他酮缓释口服片", "en": "WELLBUTRIN XL bupropion hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0730-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸安非他酮 150 mg；30 片瓶装（NDC 0187-0730-30）", "en": "Bupropion hydrochloride 150 mg per tablet; 30-tablet bottle (NDC 0187-0730-30)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=150carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸安非他酮（每片 XL 缓释片）", "en": "bupropion hydrochloride (per XL extended-release tablet)" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片 XL 缓释片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per XL extended-release tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白至淡黄色", "en": "creamy white to pale yellow" }, "shape": { "zh": "圆形，约 7 mm", "en": "round, approximately 7 mm" }, "imprint": "WELLBUTRIN XL 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 150 mg、NDC 0187-0730-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-300mg-30-bottle-ndc-0187-0731-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "en": "Current DailyMed public label (published 6 Feb 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "WELLBUTRIN XL 盐酸安非他酮缓释口服片", "en": "WELLBUTRIN XL bupropion hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0731-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸安非他酮 300 mg；30 片瓶装（NDC 0187-0731-30）", "en": "Bupropion hydrochloride 300 mg per tablet; 30-tablet bottle (NDC 0187-0731-30)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=300carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸安非他酮（每片 XL 缓释片）", "en": "bupropion hydrochloride (per XL extended-release tablet)" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片 XL 缓释片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per XL extended-release tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白至淡黄色", "en": "creamy white to pale yellow" }, "shape": { "zh": "圆形，约 9 mm", "en": "round, approximately 9 mm" }, "imprint": "WELLBUTRIN XL 300", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 300 mg、NDC 0187-0731-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-150mg-30-bottle-ndc-0187-0730-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=150carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "alt": "WELLBUTRIN XL 盐酸安非他酮在美国 DailyMed 当前标签中的 150 mg、NDC 0187-0730-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "presentation": "WELLBUTRIN XL 盐酸安非他酮：每片 150 mg，NDC 0187-0730-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 WELLBUTRIN XL、盐酸安非他酮 150 mg、NDC 0187-0730-30 与 30 片瓶装。它只帮助核对商品名、通用名、每片标示量、XL 缓释片、包装数量、片剂外观、刻印和来源；不用于鉴定真伪，也不证明 300 mg、标签其他章节出现的 450 mg、其他安非他酮剂型或品牌、其他包装、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、掰片、研碎、停药、联用或换药方案。", "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 150 mg、NDC 0187-0730-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "WELLBUTRIN XL 说明书放大阅读：先核对“XL 缓释片”，再看标签警示", "en": "WELLBUTRIN XL label reading: identify the XL extended-release tablet before reading label warnings" }, "summary": { "zh": "本模块使用美国 DailyMed 当前公开标签，帮助阅读 WELLBUTRIN XL、盐酸安非他酮、缓释口服片和目标市场之间的区别。它不提供个人片数、给药时间、漏用补救、转换、合用、停用或诊断建议。", "en": "This module uses the current U.S. DailyMed public label to distinguish WELLBUTRIN XL, bupropion hydrochloride, extended-release oral tablets and the target market. It provides no individual tablet count, timing, missed-use remedy, conversion, co-use, stopping or diagnostic advice." }, "checks": [ { "zh": "先把 WELLBUTRIN XL、盐酸安非他酮、XL 缓释口服片、实际每单位标示量、NDC、药盒和目标市场一起核对。当前产品身份与供应信息只列 150 mg、300 mg；标签其他章节出现的 450 mg 是用法或研究文字，不是第三种产品包装，更不是网页给任何人的片数、间隔或一日总量。", "en": "Check WELLBUTRIN XL, bupropion hydrochloride, the XL extended-release oral tablet, the actual labelled amount per unit, NDC, pack and target market together. Current product-identity and supply information lists only 150 mg and 300 mg. A 450 mg figure elsewhere in the label belongs to dosing or study text, not a third product package and not a webpage instruction for anyone's tablet count, interval or daily total." }, { "zh": "美国标签含有关于儿童、青少年和年轻成人抗抑郁药相关自杀想法和行为风险的加框警示，并提示密切观察变化。它是阅读、沟通和及时获取当地专业支持的提示，不是网页对任何人的诊断、处方、停药或照护结论。出现自伤/伤人想法、严重行为或情绪突变，或任何紧急担忧时，应优先使用当地紧急医疗与危机支持。", "en": "The U.S. label has a boxed warning about suicidal thoughts and behaviours associated with antidepressants in children, adolescents and young adults, and calls for close observation of changes. This is a cue for reading, communication and prompt local professional support, not a webpage diagnosis, prescription, stopping or care decision for anyone. With thoughts of self-harm or harm to others, a severe behavioural or mood change, or any urgent concern, prioritise local emergency medical and crisis support." }, { "zh": "标签提示癫痫发作风险。不要因为另一盒药也写安非他酮、也用于情绪/戒烟相关目的，或包装上有相近毫克数字，就自行叠加、隔天轮换、补用、掰开、研碎或替换。请将处方药、非处方药、补充剂和实际药盒一起交给药师或开方团队逐项复核。", "en": "The label warns about seizure risk. Do not self-combine, alternate on different days, make up a dose, split, crush or substitute because another pack also says bupropion, relates to mood or smoking cessation, or has a nearby milligram number. Take prescription medicines, OTC products, supplements and actual packs to a pharmacist or prescribing team for item-by-item review." }, { "zh": "出现呼吸困难、面部或舌部肿胀、昏厥、癫痫发作、无法唤醒、胸部不适、严重跌倒或其他急性严重担忧时，应优先使用当地紧急医疗支持；不要等待网页检索或以另一种药物自行抵消。", "en": "With breathing difficulty, swelling of the face or tongue, fainting, a seizure, inability to wake, chest discomfort, a serious fall or another acute serious concern, prioritise local emergency medical support; do not wait for a website search or self-counteract with another medicine." } ], "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "安非他酮怎样起作用：标签机制描述不能替代个体化评估", "en": "How bupropion works: label mechanism descriptions do not replace individual assessment" }, "summary": { "zh": "美国 WELLBUTRIN XL 标签将其归为氨基酮类抗抑郁药，并描述去甲肾上腺素和多巴胺再摄取抑制的药理特性。该信息帮助理解类别词，不预测任何人的症状、反应、适用性、剂量、联用、转换或停药方案。", "en": "The U.S. WELLBUTRIN XL label classifies it as an aminoketone antidepressant and describes pharmacological inhibition of norepinephrine and dopamine reuptake. This helps read class terms; it does not predict anyone's symptoms, response, suitability, dose, co-use, conversion or stopping plan." }, "checks": [ { "zh": "“影响去甲肾上腺素和多巴胺再摄取”是药理线索，不是网页判断情绪、睡眠、戒烟过程、认知变化、激越或行为变化原因的工具，也不能替代专业人员结合病史、检查、病程与完整药单作出的判断。", "en": "“Affects norepinephrine and dopamine reuptake” is a pharmacology clue, not a website tool for deciding the cause of mood, sleep, smoking-cessation, cognitive, agitation or behavioural changes, and cannot replace professional judgement using history, tests, course and the complete medicine list." }, { "zh": "同为抗抑郁药、都可能影响去甲肾上腺素/多巴胺，或都与情绪有关，不表示 WELLBUTRIN XL 与另一种抗抑郁药、安非他酮产品、镇静药或其他产品可自行叠加、轮换、替代或按 mg 换算。", "en": "Being antidepressants, affecting norepinephrine/dopamine, or relating to mood does not make WELLBUTRIN XL and another antidepressant, bupropion product, sedating medicine or other product self-combinable, alternatable, substitutable or milligram-convertible." }, { "zh": "机制说明不能处理癫痫发作、昏厥、严重焦虑或激越、明显情绪/行为改变、胸部不适、吞咽/呼吸问题或其他急性担忧。遇到急性或严重担忧，应优先使用当地医疗和紧急支持，而不是自行改变任何药物。", "en": "A mechanism explanation cannot manage a seizure, fainting, severe anxiety or agitation, a marked mood or behavioural change, chest discomfort, swallowing/breathing problems or another acute concern. With an acute or serious concern, prioritise local medical and emergency support rather than self-changing any medicine." } ], "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "WELLBUTRIN XL", "generic": "安非他酮", "dosageFormClass": "WELLBUTRIN XL 盐酸安非他酮缓释口服片：当前产品身份与供应信息列 150 mg、300 mg；450 mg 仅见于标签的用法和研究文字，不是当前产品包装规格" }, "labelSource": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "2026-08-28", "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": "美国 DailyMed 当前 WELLBUTRIN XL 公开标签将其列为盐酸安非他酮缓释口服片，产品身份与供应信息只列 150 mg 和 300 mg。本页帮助核对品牌、成分、缓释剂型、准确包装、文件日期和标签警示；标签其他章节出现的 450 mg 是用法或研究文字，不是第三种当前产品包装，也不能转化为任何人的片数、开始、停止、联用、换药或照护决定。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1985，并标示 SPL v27 于 2026-02-06 发布。上述信息仅定位所引美国文件；不建立中国大陆、欧盟、日本或其他市场的现行品牌、供应、可购、可替代或个人治疗结论。WELLBUTRIN XL、其他安非他酮普通片、缓释片及其他品牌/用途的产品必须按准确剂型和现行标签分别核对。", "sourceDocuments": [ { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 021515（WELLBUTRIN XL 美国现行公开标签所列）", "approvalTimeline": [ { "date": "1985", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1985。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1985. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed: WELLBUTRIN XL bupropion hydrochloride current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "DailyMed SPL v27, published 2026-02-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v27, published 2026-02-06 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v27, published 2026-02-06 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed: WELLBUTRIN XL bupropion hydrochloride current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/wellbutrin-xl/", "en": "https://origindrug.com/en/drugs/wellbutrin-xl/" }, "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." ] }