{ "id": "paxil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Paxil", "generic": "帕罗西汀", "aliases": [ "paroxetine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂（10、20、30、40 mg）及口服混悬剂（10 mg/5 mL；标签注明当时未上市）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-paxil-paroxetine-tablet-20mg-30-count-bottle-ndc-54868-2976-2-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2976-2", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 20 mg；30 片瓶装（美国历史标签）", "en": "Paroxetine 20 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=2976.jpg&setid=40226242-da82-4dd7-bca2-eebb14501264&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色；历史标签所列", "en": "pink; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 20；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 20; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 20 mg、30 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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-paxil-paroxetine-tablet-20mg-60-count-bottle-ndc-54868-2976-3-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2976-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 20 mg；60 片瓶装（美国历史标签）", "en": "Paroxetine 20 mg per tablet; 60-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色；历史标签所列", "en": "pink; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 20；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 20; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 20 mg、60 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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-paxil-paroxetine-tablet-30mg-30-count-bottle-ndc-54868-3526-0-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3526-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 30 mg；30 片瓶装（美国历史标签）", "en": "Paroxetine 30 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色；历史标签所列", "en": "blue; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 30；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 30; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 30 mg、30 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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-paxil-paroxetine-tablet-30mg-60-count-bottle-ndc-54868-3526-1-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3526-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 30 mg；60 片瓶装（美国历史标签）", "en": "Paroxetine 30 mg per tablet; 60-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色；历史标签所列", "en": "blue; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 30；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 30; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 30 mg、60 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=2976.jpg&setid=40226242-da82-4dd7-bca2-eebb14501264&type=img", "alt": "PAXIL 20 mg 帕罗西汀片在美国 DailyMed 历史公开标签中的 GlaxoSmithKline 包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 历史公开标签（GlaxoSmithKline，2012-01-05）", "presentation": "PAXIL 20 mg 口服片剂历史包装标签图（DailyMed 公开档案所列；GlaxoSmithKline 2012-01-05 文件）。", "notice": "此为美国 DailyMed 历史公开标签中与 PAXIL 20 mg 口服片剂对应的包装文字图，只帮助核对品牌、通用名、标示强度、剂型、历史标签版本和来源；不用于鉴定真伪，也不证明 10/30/40 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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": "PAXIL / 帕罗西汀说明书放大阅读：mg、mg/5 mL 与“不要自行骤停”", "en": "PAXIL label reading: mg, mg/5 mL and why not to stop abruptly" }, "summary": { "zh": "本模块以 FDA 2024 与 DailyMed 的 PAXIL 公开标签为阅读入口，帮助核对片剂、口服混悬剂、标示强度与包装文字；它不把这些文字转换为个人开始、联用、换药、加减或停药方案。", "en": "This module uses the 2024 FDA and DailyMed PAXIL public labels as reading entry points. It helps check tablets, oral suspension, labelled strength and package wording; it does not turn them into an individual start, combination, switch, adjustment or stopping plan." }, "checks": [ { "zh": "FDA 2024 标签列出 10、20、30、40 mg 片剂；口服混悬剂为 10 mg/5 mL，且该标签注明当时未上市。mg 与 mg/5 mL 分别是片剂强度和液体浓度的标示方式；它们不能按片数或毫升数凭经验自行换算、替代或加减。", "en": "The 2024 FDA label lists 10, 20, 30 and 40 mg tablets, and an oral suspension of 10 mg/5 mL that the label states was not then marketed. Mg and mg/5 mL label tablet strength and liquid concentration respectively; they cannot be self-converted, substituted or adjusted by tablet count or millilitres from experience." }, { "zh": "这张 DailyMed 图只对应历史 PAXIL 20 mg 片剂标签。包装图、片剂颜色或刻字是核对线索，不是鉴定真伪的工具，也不能证明另一个市场、另一种强度、混悬剂或其他帕罗西汀产品相同。", "en": "This DailyMed image corresponds only to a historical PAXIL 20 mg tablet label. Package artwork, tablet colour or imprint are checking clues, not tools to authenticate a medicine, and cannot prove that another market, strength, suspension or paroxetine product is the same." }, { "zh": "标签将与其他影响血清素、凝血或代谢的药物，以及 MAOI 相关转换，列为需要专业核对的事项。请把全部处方药、非处方药、补充剂和近期变动交给药师或开方团队；不要因同属抗抑郁药或名称相近而自行叠加、轮换或替换。", "en": "The label identifies other medicines that affect serotonin, clotting or metabolism, and MAOI-related transitions, as issues requiring professional review. Give the pharmacist or prescribing team all prescription medicines, non-prescription products, supplements and recent changes; do not self-combine, alternate or substitute because products share an antidepressant class or similar name." }, { "zh": "FDA 标签提示停用可能出现不良反应，并要求由专业人员处理逐步减量。若有想停药、换药、漏服、情绪或行为突然变化，或出现紧急安全风险，应联系开方团队并使用当地紧急支持；不要根据剩余药量、包装图或网页自行骤停。", "en": "The FDA label notes that discontinuation may cause adverse reactions and that a professional should manage gradual reduction. With a wish to stop, a switch, missed use, sudden mood or behaviour change, or an urgent safety risk, contact the prescribing team and use local emergency support; do not abruptly stop from remaining medication, a package image or a webpage." } ], "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（剂型、强度、相互作用与停用警示）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帕罗西汀怎样起作用：与中枢神经系统的血清素再摄取有关", "en": "How paroxetine works: it is linked to serotonin reuptake in the central nervous system" }, "summary": { "zh": "FDA 2024 标签将 PAXIL 描述为选择性血清素再摄取抑制剂，并说明其用于多种情况的机制尚不清楚，但推测与抑制中枢神经系统神经元对血清素的再摄取、从而增强血清素活动有关。这用于解释机制文字，不预测个人症状、适用性、片数、起效时间或转换方案。", "en": "The 2024 FDA label describes PAXIL as a selective serotonin reuptake inhibitor and states that its mechanism across its uses is unknown but presumed linked to inhibition of CNS neuronal serotonin reuptake, increasing serotonergic activity. This explains mechanism wording; it does not predict an individual's symptoms, suitability, tablet count, onset or switching plan." }, "checks": [ { "zh": "“影响血清素再摄取”是药理路径，不是某个人该选择哪一种抗抑郁药、是否需要基因检测、何时见效或是否能自行加减的答案。需要结合完整病史、实际产品、全部药单和现行标签由专业人员判断。", "en": "‘Affects serotonin reuptake’ is a pharmacologic pathway, not an answer to which antidepressant someone should choose, whether genetic testing is needed, when an effect will occur or whether self-adjustment is possible. These questions require professional judgement using the full history, actual product, complete medicine list and current label." }, { "zh": "同属 SSRI、都涉及血清素，或包装名称不同，都不表示可以自行叠加、隔天轮换或从一种药直接换到另一种。FDA 标签把与其他影响血清素药物及 MAOI 的关系列为需要明确核对的安全问题。", "en": "Sharing the SSRI class, serotonin involvement or different package names does not permit self-combination, alternate-day rotation or a direct change from one medicine to another. The FDA label identifies relationships with other serotonin-affecting medicines and MAOIs as safety questions needing explicit review." }, { "zh": "机制阅读不能替代对停用、漏服、妊娠相关顾虑、异常出血、情绪或行为变化的个体处理。出现担忧时应带上实际包装和完整药单联系开方团队；紧急安全风险应使用当地紧急医疗或危机支持。", "en": "Mechanism reading cannot replace individual handling of discontinuation, missed use, pregnancy-related concerns, unusual bleeding, or mood and behaviour changes. With concerns, contact the prescribing team with the actual package and complete medicine list; use local emergency medical or crisis support for urgent safety risk." } ], "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（12.1 Mechanism of Action）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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": "Paxil", "generic": "帕罗西汀", "dosageFormClass": "口服片剂（10、20、30、40 mg）及口服混悬剂（10 mg/5 mL；标签注明当时未上市）" }, "labelSource": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "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." } }, { "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "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": "FDA 的 PAXIL（paroxetine）2024 美国标签列示 10、20、30、40 mg 口服片剂及 10 mg/5 mL 口服混悬剂，并列出美国初始批准年份为 1992。DailyMed 还保留 2012 年历史标签中可逐项核对的 20 mg、30 mg 口服片瓶装身份卡。本页将它们作为来源可追溯的放大阅读入口；不据此推定中国大陆或其他市场的当前批准、包装、持有人、原研关系、供应或可售资格。", "history": "PAXIL、帕罗西汀、片剂或口服混悬剂、每单位标示强度/浓度、标签版本和目标市场必须一起核对。四张美国历史文字身份卡只对应 20 mg 或 30 mg、30 片或 60 片的具体瓶装；相同通用名、相近颜色、相同数字或片剂刻痕都不能确认其他包装的身份、真实性、可掰开性或可替代性。", "sourceDocuments": [ { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "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 020031 / 020710", "approvalTimeline": [ { "date": "1992", "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: 1992。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: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA: PAXIL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024 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 2024 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_e8ad8b16b3a54002", "label": "FDA: PAXIL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/paxil/", "en": "https://origindrug.com/en/drugs/paxil/" }, "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." ] }