{ "id": "paxlovid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "PAXLOVID", "generic": "奈玛特韦/利托那韦", "aliases": [ "PAXLOVID", "nirmatrelvir and ritonavir", "nirmatrelvir/ritonavir", "奈玛特韦/利托那韦", "奈玛特韦利托那韦" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 PAXLOVID 奈玛特韦/利托那韦联装口服片公开标签（DailyMed SPL v12，2026-02-23 发布）", "dosageFormClass": "奈玛特韦片与利托那韦片联装口服片（美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2023（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-paxlovid-co-pack-300mg-100mg-3-tablet-blister-ndc-0069-5045-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v12，2026-02-23 发布", "en": "DailyMed SPL v12, published 23 Feb 2026" }, "dosageForm": { "zh": "PAXLOVID 奈玛特韦片与利托那韦片联装口服片", "en": "PAXLOVID nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-5045-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_component_tablet", "primaryDisplay": { "zh": "奈玛特韦 150 mg × 2 + 利托那韦 100 mg × 1；3 片泡罩卡", "en": "Nirmatrelvir 150 mg × 2 + ritonavir 100 mg × 1; 3-tablet blister card" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a&name=paxlovid-14.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈玛特韦", "en": "nirmatrelvir" }, "value": 150, "unit": "mg", "basisCode": "per_component_tablet", "basisLabel": { "zh": "每一奈玛特韦片的标签量；不是个人片数或使用方案", "en": "labelled amount in each nirmatrelvir tablet; not an individual's tablet count or use plan" } }, { "ingredient": { "zh": "利托那韦", "en": "ritonavir" }, "value": 100, "unit": "mg", "basisCode": "per_component_tablet", "basisLabel": { "zh": "每一利托那韦片的标签量；不是个人片数或使用方案", "en": "labelled amount in each ritonavir tablet; not an individual's tablet count or use plan" } } ], "concentration": null, "container": { "typeCode": "blister_card", "typeLabel": { "zh": "泡罩卡", "en": "blister card" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "泡罩卡/包", "en": "blister card per pack" }, "unitsPerContainer": { "count": 3, "unit": { "zh": "片/泡罩卡", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "泡罩卡/包", "en": "blister card per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-paxlovid-co-pack-300mg-100mg-3-tablet-blister-ndc-0069-5045-06", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a&name=paxlovid-14.jpg", "alt": "PAXLOVID 奈玛特韦/利托那韦在美国 DailyMed 当前公开标签中的 300 mg；100 mg 联装口服片 NDC 0069-5045-06 包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v12（2026-02-23 发布）", "presentation": "PAXLOVID 奈玛特韦片/利托那韦片联装口服片：300 mg；100 mg，NDC 0069-5045-06 包装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 PAXLOVID 奈玛特韦片/利托那韦片联装口服片、300 mg；100 mg、NDC 0069-5045-06 包装展示面。包装面板保留原始标签文字，但本页不把它转成个人服用次数、片数、肾功能方案、联用、停用、补用、转换或其他市场结论；它不代表其他包装、其他肾功能包装、其他市场、实际可得性、原研身份或可替代性，也不用于鉴定真伪。", "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PAXLOVID 说明书放大阅读：先把两种成分、联装包装和完整药单一起核对", "en": "PAXLOVID label reading: check both ingredients, the co-packaged product and the complete medicine list together" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 PAXLOVID、奈玛特韦/利托那韦、联装口服片、准确包装面板和目标市场。它不提供个人片数、开始时间、肾功能方案、漏用补救、联用、停用或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check PAXLOVID, nirmatrelvir/ritonavir, the co-packaged oral tablets, the exact package panel and target market. It provides no individual tablet count, start time, renal plan, missed-use remedy, co-use, stopping or switching plan." }, "checks": [ { "zh": "PAXLOVID 是两种成分的联装产品。包装上的奈玛特韦和利托那韦名称、毫克数字或药片外观，都不是把其中一部分与家中另一盒药自行拆分、补齐、替代或调整的依据；应由药师或开方团队核对准确处方、实际包装和现行标签。", "en": "PAXLOVID is a co-packaged two-ingredient product. Component names, milligram markings or tablet appearance on the pack do not justify self-separating, making up, substituting or adjusting one part with another medicine at home; have the exact prescription, actual pack and current label reviewed by a pharmacist or prescribing team." }, { "zh": "本页图片只对应美国 NDC 0069-5045-06 的一个联装包装面板。标签还涉及不同肾功能情况下的产品信息；品牌相同、颜色相近或都写有奈玛特韦/利托那韦，不能证明两盒包装或其内容可自行互换。", "en": "The page image corresponds only to one U.S. co-packaged panel, NDC 0069-5045-06. The label also contains product information for different renal circumstances; the same brand, similar colour or nirmatrelvir/ritonavir wording does not establish that two packs or their contents can be self-interchanged." }, { "zh": "美国标签对显著药物相互作用设有醒目警示：PAXLOVID 中的利托那韦可强烈影响某些合并药物的暴露，可能造成严重、危及生命或致命事件。开始前及使用期间应让医生或药师逐项复核全部处方药、非处方药和草本/补充剂；不要因为网页、药盒或他人经验自行停掉、减量、加量或错开任何长期用药。", "en": "The U.S. label has a prominent warning about significant drug interactions: ritonavir in PAXLOVID can strongly alter exposure to certain co-medications and may lead to serious, life-threatening or fatal events. Before and during use, have a clinician or pharmacist review every prescription medicine, OTC product and herbal/supplement product item by item; do not self-stop, reduce, increase or separate any long-term medicine because of a webpage, package or another person's experience." }, { "zh": "出现呼吸困难、面部/口唇/舌部肿胀、吞咽困难、严重皮疹，或其他急性严重不适时，应立即使用当地紧急医疗支持。对 COVID-19 症状、适用性、开始时间、肾功能、肝功能或相互作用的判断，仍需由当地医疗团队根据准确诊断、检验与完整药单处理。", "en": "With breathing difficulty, swelling of the face/lips/tongue, difficulty swallowing, severe rash or another acute serious concern, use local emergency medical support immediately. Questions about COVID-19 symptoms, suitability, timing, kidney function, liver function or interactions still require the local care team to use the exact diagnosis, tests and complete medicine list." } ], "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Boxed Warning、Patient Counseling；Pfizer；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "PAXLOVID 怎样起作用：两种成分在联装产品中承担不同标签角色", "en": "How PAXLOVID works: the two ingredients have different labelled roles in one co-packaged product" }, "summary": { "zh": "美国 PAXLOVID 标签将奈玛特韦描述为针对 SARS-CoV-2 主蛋白酶的抑制剂，将利托那韦描述为 HIV-1 蛋白酶抑制剂和 CYP3A 抑制剂。它解释的是公开标签中的药理路径，不判断任何人的感染、风险、适用性、服用安排或与其他药物同用的结果。", "en": "The U.S. PAXLOVID label describes nirmatrelvir as an inhibitor of the SARS-CoV-2 main protease and ritonavir as an HIV-1 protease inhibitor and CYP3A inhibitor. This explains labelled pharmacologic pathways; it does not decide anyone's infection, risk, suitability, use arrangement or outcome with another medicine." }, "checks": [ { "zh": "“作用于病毒蛋白酶”不能用来从网页判断某个人是否需要抗病毒治疗、是否为 COVID-19、症状是否会自行好转，或何时开始任何产品。诊断、检测和时效判断应由当地医疗渠道完成。", "en": "“Acts on a viral protease” cannot be used by a webpage to decide whether a person needs antiviral treatment, has COVID-19, will improve on their own or should start any product at a particular time. Diagnosis, testing and time-sensitive assessment belong with local medical care." }, { "zh": "利托那韦的 CYP3A 抑制作用也是为什么完整药单很重要：机制词不能告诉网页某一种降压药、降脂药、抗凝药、镇静药、草本或补充剂是否应停、减、换或错开。任何这类决定都必须由熟悉准确处方和全部产品的人作出。", "en": "Ritonavir's CYP3A inhibition is also why the complete medicine list matters: a mechanism term cannot tell a webpage whether a blood-pressure medicine, lipid medicine, anticoagulant, sedative, herb or supplement should be stopped, reduced, changed or separated. Such decisions must be made by someone reviewing the exact prescription and every product." }, { "zh": "共同出现在 PAXLOVID 标签中不使奈玛特韦、利托那韦或其他含利托那韦产品可自行混用；共同成分、相近包装数字或过去的处方经历都不能替代这一准确联装产品和现行标签的专业核对。", "en": "Appearing together on the PAXLOVID label does not make nirmatrelvir, ritonavir or another ritonavir-containing product self-combinable. A shared ingredient, similar package number or past prescription experience cannot replace professional review of this exact co-packaged product and current label." } ], "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Clinical Pharmacology；Pfizer；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "PAXLOVID", "generic": "奈玛特韦/利托那韦", "dosageFormClass": "奈玛特韦片与利托那韦片联装口服片（美国公开标签所列）" }, "labelSource": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2024-paxlovid-eua-labelled-product-transition-alert", "issuedAt": "2024-03-13", "status": "fda_drug_alert_product_status_transition", "title": { "zh": "FDA 药品警示：美国 EUA 标签 PAXLOVID 的授权状态变化", "en": "FDA drug alert: U.S. authorisation-status change for EUA-labelled PAXLOVID" }, "summary": { "zh": "FDA 于 2024-03-13 更新公告，说明在美国市场，带 EUA 标签的 PAXLOVID（包括标签或延长有效期信息仍在的产品）不再获紧急使用授权；公告要求美国流通中的该类 EUA 标签产品按适用规定退回或处置，同时区分 NDA 批准标签产品。这是美国、特定标签状态和特定日期的监管信息；它不判断其他市场、任何药盒真伪、个人是否应使用 PAXLOVID，或能否自行改变联用药物。请以实际药盒、所在市场的现行文件和开方/药师核对为准。", "en": "In an update dated 2024-03-13, FDA said that in the U.S. PAXLOVID labelled for EUA use, including product whose labelled or extended expiration information remained, was no longer authorised for emergency use; the notice directs handling of EUA-labelled product in U.S. distribution and distinguishes NDA-approved labelling. This is U.S.-market information for a specific labelling status and date. It does not determine another market, authenticity of any pack, whether an individual should use PAXLOVID, or whether co-medication can be changed independently. Check the actual pack, the current document for its market and the prescribing team or pharmacist." }, "source": { "id": "src_e56ae8bf3217e8db", "label": "FDA：2024-03-13 EUA 标签 PAXLOVID 授权状态更新", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-revises-letter-authorization-emergency-use-authorization-paxlovid", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 PAXLOVID 公开标签将其列为奈玛特韦片与利托那韦片联装口服产品。本页只帮助核对品牌、两种成分、联装口服片、准确包装面板、目标市场和标签版本；不把包装图中的数字或原始说明转成任何人的服用次数、片数、肾功能方案、联用、停用、转换或购买建议。", "history": "当前公开标签列示 Initial U.S. Approval: 2023。PAXLOVID 是包含两种成分的联装产品；不能因看到其中任一成分名称、相近毫克数字或另一盒利托那韦产品，就自行拆分、补齐、合并、替换或调整。", "sourceDocuments": [ { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 217188", "approvalTimeline": [ { "date": "2023", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 PAXLOVID 标签列示 Initial U.S. Approval: 2023。该年份仅定位这一美国档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格或个人适用性。", "en": "The current PAXLOVID label lists Initial U.S. Approval: 2023. This year locates this U.S. archive only; it does not establish approval, supply, sale eligibility or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-23", "title": { "zh": "DailyMed 当前公开 SPL v12", "en": "Current public SPL v12 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 PAXLOVID 联装口服片 SPL v12 的发布日期列为 2026-02-23。本页只选取一个准确 300 mg；100 mg、NDC 0069-5045-06 包装面板，不能据此推定其他包装、肾功能包装、库存、开始时间、联用或个人用法。", "en": "DailyMed lists 23 Feb 2026 as the publication date for PAXLOVID co-packaged oral-tablet SPL v12. This page selects only one exact 300 mg; 100 mg package panel, NDC 0069-5045-06, and does not establish another pack, a renal-related pack, stock, start time, co-use or individual use." }, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接联装口服片公开标签与一个准确包装面板", "en": "Co-packaged oral-tablet public label and one exact package panel linked" }, "detail": { "zh": "本页展示的面板只对应 PAXLOVID 奈玛特韦片/利托那韦片联装口服片、300 mg；100 mg、NDC 0069-5045-06。它不建立实际在售、库存、个人用法、肾功能方案、联用、停用、补用或其他包装状态。", "en": "The displayed panel only corresponds to PAXLOVID nirmatrelvir/ritonavir co-packaged oral tablets, 300 mg; 100 mg, NDC 0069-5045-06. It does not establish actual availability, stock, individual use, a renal plan, co-use, stopping, make-up use or another-pack status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装上写着奈玛特韦和利托那韦，能否拿另一盒含其中一项成分的药来补、换或搭配？", "en": "The package names nirmatrelvir and ritonavir. Can another medicine containing one component be used to make up, replace or pair with it?" }, "answer": { "zh": "不能。本页只建立这一联装产品的美国公开标签阅读路径。共同成分、相近毫克数字或另一盒产品不能证明可自行补齐、拆分、合并、替换、错开或调整；应立即让药师或开方团队核对完整药单、实际包装和现行标签。", "en": "No. This page establishes only the U.S. public-label reading path for this co-packaged product. A shared component, similar milligram marking or another pack cannot establish self-make-up, separation, combination, replacement, spacing or adjustment; have a pharmacist or prescribing team promptly review the complete medicine list, actual pack and current label." } }, { "question": { "zh": "为什么在 PAXLOVID 页面反复要求核对全部药物、非处方药和草本/补充剂？", "en": "Why does the PAXLOVID page repeatedly ask for review of all medicines, OTC products and herbs/supplements?" }, "answer": { "zh": "因为当前美国标签对显著药物相互作用设有醒目警示，且利托那韦可强烈影响某些合并药物的暴露。这个提示不列出或决定任何个人该停、该改或该继续的产品；它的目的只是引导尽快进行逐项专业复核。", "en": "Because the current U.S. label has a prominent warning about significant drug interactions and ritonavir can strongly alter exposure to some co-medications. This prompt does not list or decide which product an individual should stop, change or continue; its purpose is to direct prompt item-by-item professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/paxlovid/", "en": "https://origindrug.com/en/drugs/paxlovid/" }, "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." ] }