{ "id": "trintellix-vortioxetine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "TRINTELLIX", "generic": "沃替西汀", "aliases": [ "Trintellix", "BRINTELLIX", "Brintellix", "vortioxetine", "vortioxetine hydrobromide", "沃替西汀", "氢溴酸沃替西汀", "沃替西汀片", "心达悦", "TRINTELLIX", "NDA 204447", "64764-720-30", "64764-730-30", "64764-750-30" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 TRINTELLIX 当前品牌片剂标签（5/10/20 mg；三个 30 片瓶装面板；NDA 204447）及欧盟 BRINTELLIX 现行产品资料（5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂）", "dosageFormClass": "美国口服薄膜衣片：5 mg、10 mg、20 mg；欧盟 BRINTELLIX 另列 15 mg 薄膜衣片和 20 mg/mL 口服滴剂。市场、品牌、剂型、每片/每 mL 单位必须分开，不据共同成分换算", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2013（FDA NDA 204447；欧盟 EMEA/H/C/002717）", "archiveSponsorText": "Takeda（美国 NDA 204447 申请与当前标签销售方）；H. Lundbeck A/S（商标及欧盟持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BRILINTA", "Brilinta", "ticagrelor", "替格瑞洛", "generic vortioxetine", "vortioxetine oral drops", "沃替西汀口服滴剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trintellix-vortioxetine-5mg-30-bottle-ndc-6476472030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-720-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 5 mg；30 片瓶装", "en": "Vortioxetine 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-11.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "5 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 5 mg、NDC 64764-720-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trintellix-vortioxetine-10mg-30-bottle-ndc-6476473030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-730-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 10 mg；30 片瓶装", "en": "Vortioxetine 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-12.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "10 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trintellix-vortioxetine-20mg-30-bottle-ndc-6476475030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-750-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 20 mg；30 片瓶装", "en": "Vortioxetine 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-13.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "20 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 20 mg、NDC 64764-750-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trintellix-vortioxetine-10mg-30-bottle-ndc-6476473030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-12.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "alt": "TRINTELLIX 沃替西汀 10 mg、NDC 64764-730-30、30 片瓶装在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v18（2025-03-05 更新；2025-03-11 发布）", "presentation": "TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装标签展示面", "notice": "此图只对应当前美国标签中的 TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装。另两个强度各有独立包装卡；它不代表欧盟 BRINTELLIX 15 mg、口服滴剂、BRILINTA、通用药、其他市场、库存或可购买资格，不用于鉴定真伪，也不生成个人片数或停换药方案。", "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRINTELLIX 说明书放大阅读：先分清沃替西汀、BRINTELLIX 与 BRILINTA", "en": "TRINTELLIX label reading: separate vortioxetine, BRINTELLIX and BRILINTA first" }, "summary": { "zh": "美国 TRINTELLIX 与欧盟 BRINTELLIX 都可指向沃替西汀产品，但目标市场、规格和剂型不同；BRILINTA 则是替格瑞洛抗血小板药。名称、每片 mg、剂型、市场与实际药盒必须一起核对，不能只看前几个字母。", "en": "U.S. TRINTELLIX and EU BRINTELLIX can identify vortioxetine products, but their markets, strengths and dosage forms differ. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, mg per tablet, dosage form, market and actual pack together rather than the first few letters." }, "checks": [ { "zh": "美国 5、10、20 mg 是每片以沃替西汀计的标签标示量，不是一次几片或一天几次。欧盟还列 15 mg 片和 20 mg/mL 口服滴剂；“每片 mg”与“每 mL mg”不是同一单位，不能自行换算或按颜色替代。", "en": "U.S. 5, 10 and 20 mg are labelled vortioxetine amounts per tablet, not tablets per dose or doses per day. The EU also lists a 15 mg tablet and 20 mg/mL oral drops. Mg per tablet and mg per mL are different units and must not be self-converted or substituted by colour." }, { "zh": "不要把 TRINTELLIX／BRINTELLIX 与 BRILINTA 混同。BRILINTA 含替格瑞洛，是抗血小板药；若药单、处方或药盒名称不清，先暂停凭名字自行判断，带实际包装让药师或开方团队核对。", "en": "Do not confuse TRINTELLIX/BRINTELLIX with BRILINTA. BRILINTA contains ticagrelor and is an antiplatelet medicine. If a list, prescription or pack name is unclear, stop guessing from the name and have a pharmacist or prescriber check the actual packaging." }, { "zh": "MAOI、利奈唑胺、静脉亚甲蓝，以及其他影响血清素的抗抑郁药、曲马多、锂剂、丁螺环酮、安非他明、色氨酸或圣约翰草都属于血清素综合征优先核对项。发热伴激越、震颤、肌强直、腹泻、意识变化或抽搐需要立即使用当地急救支持。", "en": "MAOIs, linezolid, intravenous methylene blue and other serotonergic antidepressants, tramadol, lithium, buspirone, amphetamines, tryptophan or St John's wort are priority serotonin-syndrome checks. Fever with agitation, tremor, muscle rigidity, diarrhoea, altered awareness or seizures requires immediate local emergency support." }, { "zh": "阿司匹林、NSAID 止痛药、华法林、抗血小板药或其他抗凝药可能增加出血风险；老年人、使用利尿药或容量不足者还要优先留意低钠。新出现严重出血、明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估。", "en": "Aspirin, NSAID pain medicines, warfarin, antiplatelets or other anticoagulants may add bleeding risk. Older adults, people taking diuretics or those who are volume depleted also need priority review for hyponatraemia. New severe bleeding, marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment." }, { "zh": "强 CYP2D6 抑制剂（如安非他酮、氟西汀、帕罗西汀、奎尼丁）和强酶诱导剂（如利福平、卡马西平、苯妥英）可能影响专业用药安排。标签提到 CYP2D6 不等于每个人都要做全基因筛查；网页不会根据基因、年龄或药名生成个人加减量或停换药表。", "en": "Strong CYP2D6 inhibitors such as bupropion, fluoxetine, paroxetine or quinidine and strong enzyme inducers such as rifampin, carbamazepine or phenytoin may affect professional management. A CYP2D6 label statement does not mean everyone needs whole-genome screening, and the site does not generate an individual dose-change or stopping/switching plan from genes, age or a medicine name." }, { "zh": "症状好转、不舒服、恶心、漏服、担心副作用或出现性功能问题，都不是自行骤停、隔天轮换、叠加另一种抗抑郁药或用剩药替换的依据。自伤/自杀想法、明显行为改变、严重过敏样反应或其他急性严重问题需要立即使用当地急救或危机支持。", "en": "Feeling better, unwell, nauseated, missing a dose, fearing an adverse effect or noticing sexual problems is not a reason to abruptly self-stop, alternate days, add another antidepressant or substitute leftovers. Thoughts of self-harm/suicide, marked behavioural change, a severe allergy-like reaction or another acute serious concern requires immediate local emergency or crisis support." } ], "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沃替西汀怎样起作用：影响血清素转运体和多种受体，但完整治疗机制仍未确定", "en": "How vortioxetine works: serotonin-transporter and receptor activity without a fully established therapeutic mechanism" }, "summary": { "zh": "当前标签说明，沃替西汀抗抑郁作用的完整机制尚未完全理解；其作用被认为与抑制血清素转运体（5-HT reuptake）并调节多种 5-HT 受体有关。这个“多模式”药理描述不能预测某个人是否适合、是否优于另一种抗抑郁药、该选多少 mg，或能否与其他血清素药叠加。", "en": "The current label says the complete antidepressant mechanism of vortioxetine is not fully understood. Its activity is thought to involve inhibition of the serotonin transporter (5-HT reuptake) and modulation of several 5-HT receptors. This multimodal pharmacology does not predict individual suitability, superiority to another antidepressant, strength choice or safe combination with another serotonergic medicine." }, "checks": [ { "zh": "作用机制是理解药理和相互作用的线索，不是凭症状自行诊断抑郁、选药、加量或停药的工具。既往反应、其他疾病、完整药单、年龄、肝肾情况和专业评估都可能影响个人决策。", "en": "Mechanism is a clue for pharmacology and interaction review, not a tool to self-diagnose depression, choose a medicine, increase a dose or stop treatment from symptoms. Prior response, other conditions, the full medicine list, age, liver/kidney status and professional assessment may all affect an individual decision." }, { "zh": "同属抗抑郁药、都影响血清素或商品名相近，不表示 TRINTELLIX 可以和 CELEXA、LEXAPRO、ZOLOFT、PROZAC、PAXIL、CYMBALTA、EFFEXOR 等按 mg 换算、轮换或叠加。", "en": "Shared antidepressant use, serotonergic activity or similar names do not permit milligram conversion, rotation or combination of TRINTELLIX with CELEXA, LEXAPRO, ZOLOFT, PROZAC, PAXIL, CYMBALTA, EFFEXOR or another product." }, { "zh": "原研与仿制产品可以共享活性成分和监管等效性依据，但辅料、外观与具体包装未必相同。是否可替代必须查目标市场现行批准与处方；不能从颜色、刻字、共同成分或机制自行判断哪一盒更好。", "en": "Originator and generic products can share an active ingredient and regulatory equivalence basis while excipients, appearance and exact packaging may differ. Any substitution must use the current target-market approval and prescription, not colour, imprint, a shared ingredient or mechanism to decide which pack is better." } ], "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TRINTELLIX", "generic": "沃替西汀", "dosageFormClass": "美国口服薄膜衣片：5 mg、10 mg、20 mg；欧盟 BRINTELLIX 另列 15 mg 薄膜衣片和 20 mg/mL 口服滴剂。市场、品牌、剂型、每片/每 mL 单位必须分开，不据共同成分换算" }, "labelSource": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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_3a8053007dd9b12c", "label": "EMA：BRINTELLIX 5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂现行产品资料（2026-01-19 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/brintellix-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "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": "2026-08-30", "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": "TRINTELLIX 是沃替西汀口服片的美国品牌档案，欧盟同一活性成分品牌名为 BRINTELLIX；它不是名称相近的抗血小板药 BRILINTA。当前美国标签展示 5、10、20 mg 三个 30 片瓶装。本页优先解释每片 mg、跨市场名字、血清素综合征、低钠、出血、停药和 CYP2D6／多药联用边界；不提供个人片数、加减量、停药、换药或基因检测方案。", "history": "FDA 于 2013-09-30 批准 NDA 204447，当时美国品牌名为 BRINTELLIX。FDA 的药物警戒记录指出该名称曾与抗血小板药 BRILINTA 混淆，并于 2016 年批准把美国沃替西汀品牌改名为 TRINTELLIX；欧盟仍使用 BRINTELLIX。名称历史本身不是停换药、叠加或跨市场购买建议。", "sourceDocuments": [ { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3823311748fdf53b", "label": "FDA Drugs@FDA：TRINTELLIX / BRINTELLIX（vortioxetine）NDA 204447 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204447", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_1c3af9dee460528a", "label": "FDA：BRINTELLIX（vortioxetine）NDA 204447 初始批准函（2013-09-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_591e92aac633ab2e", "label": "FDA：沃替西汀 NDA 204447 临床审评资料（Takeda；5/10/15/20 mg 研发与初始申请记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447orig1s000medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_2ebecd1e029b04ba", "label": "FDA AEMS：BRINTELLIX 与 BRILINTA 名称混淆信号及 2016 年改名 TRINTELLIX 的安全记录", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/april-june-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9cbef3a94c720a1d", "label": "EMA：BRINTELLIX（vortioxetine）EPAR 与欧盟现行产品资料入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3a8053007dd9b12c", "label": "EMA：BRINTELLIX 5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂现行产品资料（2026-01-19 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/brintellix-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 204447（TRINTELLIX / former U.S. name BRINTELLIX / vortioxetine tablets）；EMA EMEA/H/C/002717（BRINTELLIX）", "approvalTimeline": [ { "date": "2013-09-30", "title": { "zh": "美国 NDA 204447 初始批准", "en": "Initial U.S. NDA 204447 approval" }, "detail": { "zh": "FDA 批准函记录 BRINTELLIX（vortioxetine）5、10、15、20 mg 片用于成人重性抑郁障碍；这里记录初始申请史，不把历史 15 mg 自动写成当前美国展示包装。", "en": "The FDA approval letter records BRINTELLIX (vortioxetine) 5, 10, 15 and 20 mg tablets for adult major depressive disorder. This is initial application history and does not turn historical 15 mg into a current displayed U.S. pack." }, "source": { "id": "src_1c3af9dee460528a", "label": "FDA：BRINTELLIX（vortioxetine）NDA 204447 初始批准函（2013-09-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2013-12-18", "title": { "zh": "欧盟 BRINTELLIX 获得上市许可", "en": "EU BRINTELLIX marketing authorisation" }, "detail": { "zh": "EMA EPAR 记录欧盟许可及 H. Lundbeck A/S 持有人；现行产品资料列 5、10、15、20 mg 片和 20 mg/mL 口服滴剂。", "en": "The EMA EPAR records the EU authorisation and H. Lundbeck A/S as holder. Current product information lists 5, 10, 15 and 20 mg tablets and 20 mg/mL oral drops." }, "source": { "id": "src_9cbef3a94c720a1d", "label": "EMA：BRINTELLIX（vortioxetine）EPAR 与欧盟现行产品资料入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2016-05-01", "title": { "zh": "美国品牌由 BRINTELLIX 改名为 TRINTELLIX", "en": "U.S. brand changed from BRINTELLIX to TRINTELLIX" }, "detail": { "zh": "FDA 药物警戒记录说明改名用于降低与替格瑞洛抗血小板药 BRILINTA 的处方和调配混淆。日期仅定位监管安全行动，不表示个人应换药或更换市场包装。", "en": "The FDA safety record says the change was intended to reduce prescribing and dispensing confusion with the antiplatelet medicine BRILINTA (ticagrelor). The date identifies a regulatory safety action and does not mean an individual should change medicine or market pack." }, "source": { "id": "src_2ebecd1e029b04ba", "label": "FDA AEMS：BRINTELLIX 与 BRILINTA 名称混淆信号及 2016 年改名 TRINTELLIX 的安全记录", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/april-june-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-03-05", "title": { "zh": "当前美国 DailyMed SPL v18 更新", "en": "Current U.S. DailyMed SPL v18 updated" }, "detail": { "zh": "当前品牌标签展示 5、10、20 mg 三个 30 片瓶装面板和 Medication Guide。标签存在不能证明本地库存、可购买性或个人适用性。", "en": "The current brand label displays 5, 10 and 20 mg 30-tablet bottle panels and a Medication Guide. A label does not establish local stock, purchase availability or individual suitability." }, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 TRINTELLIX 当前品牌标签、Medication Guide、NDA 记录和三个准确 30 片瓶装", "en": "Current TRINTELLIX brand label, Medication Guide, NDA record and three exact 30-tablet bottles linked" }, "detail": { "zh": "本档案只把官方展示面写入产品呈现；其余 7、90、500 片标签 NDC 仍可在原始标签核对，但不在没有独立展示面时虚构包装图。", "en": "Only official display panels are entered as product presentations. Other 7-, 90- and 500-tablet label NDCs remain available in the source label, but no package image is invented without a separate display panel." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "已链接 BRINTELLIX EPAR 和现行 5/10/15/20 mg 片剂、20 mg/mL 口服滴剂资料", "en": "BRINTELLIX EPAR and current 5/10/15/20 mg tablets plus 20 mg/mL oral-drops information linked" }, "detail": { "zh": "欧盟产品资料提供多个包装数量；本页先建立市场与剂型边界，不把任何欧盟包装推定为中国大陆或美国包装，也不把滴剂单位换成片数。", "en": "EU product information lists several pack quantities. This page first establishes market and dosage-form boundaries and does not infer that an EU pack is a Mainland-China or U.S. pack or convert drops into tablet counts." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not yet established" }, "detail": { "zh": "别名“心达悦”只保留为检索线索，不在缺少本轮现行一手记录时推定当地批准、包装、持有人、供应、原研/仿制关系或可替代性。", "en": "The alias “心达悦” is retained only as a search clue. Without a current first-party record in this review, no local approval, pack, holder, supply, originator/generic relationship or interchangeability is inferred." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BRINTELLIX、TRINTELLIX 和 BRILINTA 是一回事吗？", "en": "Are BRINTELLIX, TRINTELLIX and BRILINTA the same medicine?" }, "answer": { "zh": "不是。TRINTELLIX 是美国现用沃替西汀品牌名，欧盟仍使用 BRINTELLIX；BRILINTA 是替格瑞洛抗血小板药。必须核对完整名称、通用名、市场和实际药盒，不能只看相似拼写。", "en": "No. TRINTELLIX is the current U.S. vortioxetine brand name, while the EU still uses BRINTELLIX. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, generic, market and actual pack rather than similar spelling." } }, { "question": { "zh": "美国没有展示 15 mg，能用 5 mg 和 10 mg 自己拼成吗？", "en": "The current U.S. panels do not show 15 mg. Can I assemble it from 5 mg and 10 mg myself?" }, "answer": { "zh": "不能从算术或欧盟 15 mg 产品自行安排。当前美国展示面、欧盟产品资料和个人处方是不同层次；任何片数组合、换规格或跨市场替代都必须由负责治疗的专业人员核对。", "en": "Do not arrange that from arithmetic or the EU 15 mg product. Current U.S. display panels, EU product information and an individual prescription are different layers. The treating professional must review any tablet combination, strength change or cross-market substitution." } }, { "question": { "zh": "标签提到 CYP2D6，是不是要先做全基因筛查？", "en": "The label mentions CYP2D6. Does everyone need whole-genome screening first?" }, "answer": { "zh": "标签并没有把全基因筛查设为所有人的统一前提。更常见的第一步是把准确药盒、处方药、非处方药、补充剂、既往反应和相关病史交给开方团队核对；是否需要特定基因检测由专业人员解释。", "en": "The label does not make whole-genome screening a universal prerequisite. A usual first step is to give the prescriber the exact pack, prescription and non-prescription medicines, supplements, prior response and relevant history. A professional should explain whether a specific genetic test is relevant." } }, { "question": { "zh": "能把 TRINTELLIX 与另一种抗抑郁药隔天换着吃吗？", "en": "Can TRINTELLIX be alternated by day with another antidepressant?" }, "answer": { "zh": "不要自行轮换、叠加或骤停。共同影响血清素不表示可交替，且停药反应、血清素综合征和相互作用都需要结合完整药单由开方团队安排。", "en": "Do not self-alternate, combine or abruptly stop. Shared serotonergic activity does not permit rotation, and discontinuation effects, serotonin syndrome and interactions require prescriber management using the full medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "generic-drugs-and-bioequivalence", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trintellix-vortioxetine/", "en": "https://origindrug.com/en/drugs/trintellix-vortioxetine/" }, "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." ] }