{ "id": "zovirax-acyclovir", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "ZOVIRAX", "generic": "阿昔洛韦（acyclovir）口服制剂", "aliases": [ "Zovirax", "acyclovir", "阿昔洛韦", "阿昔洛韦片", "阿昔洛韦胶囊", "阿昔洛韦口服混悬液", "ZOVIRAX", "NDA 018828", "NDA 019909", "NDA 020089", "acyclovir 200 mg capsule", "acyclovir 200 mg/5 mL", "acyclovir 400 mg tablet", "acyclovir 800 mg tablet" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "本页定位美国历史 ZOVIRAX 口服档案：200 mg 胶囊（NDA 018828）、200 mg/5 mL 口服混悬液（NDA 019909）、400 mg 与 800 mg 口服片（NDA 020089）。FDA 的 2008 品牌标签明确提示其未必是最新批准标签；当前公开阅读入口为两份不同的仿制药 DailyMed 标签。它们不证明历史品牌当前供应、其他国家批准、原研关系、包装或个人可替代性。", "dosageFormClass": "阿昔洛韦的口服胶囊、普通口服片与口服混悬液是不同产品身份。200 mg/5 mL 的液体浓度、200 mg 胶囊和 400/800 mg 片剂不能仅按共同通用名或数字自行换算、混用、替代或拼接。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985—1991（FDA 历史口服品牌申请记录）", "archiveSponsorText": "历史 ZOVIRAX 美国口服标签与 FDA 监管档案；当前公开阅读的仿制药标签主体见各 DailyMed 原始页面" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ZOVIRAX", "Zovirax", "acyclovir", "阿昔洛韦" ], "excludedProductCues": [ "ZOVIRAX ointment", "ZOVIRAX cream", "ZOVIRAX injection", "acyclovir topical", "acyclovir injection", "valacyclovir", "VALTREX" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未展示 ZOVIRAX 外观图：历史品牌文件与当前仿制药标签不能混作同一包装", "en": "ZOVIRAX image withheld: a historical brand file and current generic labels are not one package" }, "summary": { "zh": "本页保留的是历史 ZOVIRAX 口服产品身份和当前阿昔洛韦仿制药公开标签；没有公开一手图像能与当前 ZOVIRAX、一个准确剂型、一个准确规格和一个准确包装逐一对应。为避免把仿制药、外用药、注射剂、其他市场或历史包装当作用户手中产品，本页不展示药盒或药片外观。", "en": "This page retains historical ZOVIRAX oral-product identity and current public generic acyclovir labels, but no public primary image is retained that matches current ZOVIRAX, one exact form, one exact strength and one exact pack one-to-one. To avoid presenting generic, topical, injectable, other-market or historical imagery as the visitor's product, no pack or tablet visual is displayed." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOVIRAX／阿昔洛韦说明书放大阅读：先分清每片、每粒和每 5 mL", "en": "ZOVIRAX / acyclovir label reading: first separate per tablet, per capsule and per 5 mL" }, "summary": { "zh": "历史 ZOVIRAX 标签把口服胶囊、片剂和混悬液分别列出；当前公开阅读资料也分别来自胶囊/片剂和混悬液标签。本模块帮助核对准确剂型、标签单位和需要尽快求助的风险线索，不提供个人片数、毫升数、频率或疗程。", "en": "The historical ZOVIRAX label lists capsules, tablets and suspension separately, and current public reading sources are also separate capsule/tablet and suspension labels. This module helps check the exact form, label unit and urgent-risk cues; it provides no individual tablet, capsule, millilitre, frequency or course instruction." }, "checks": [ { "zh": "200 mg 胶囊是每粒标示量；400 mg、800 mg 是每片标示量；200 mg/5 mL 表示每 5 mL 液体中的标示量。它们不是可以相加、按经验换算或直接推出“该吃几颗/几毫升”的个人答案。", "en": "A 200 mg capsule is an amount per capsule; 400 mg and 800 mg are amounts per tablet; 200 mg/5 mL is an amount in each 5 mL of liquid. They are not numbers to add, convert by experience or turn into an individual's capsule, tablet or millilitre answer." }, { "zh": "胶囊、片剂和混悬液即使都写阿昔洛韦，也不能仅凭共同通用名或总 mg 自行替代；液体还必须同时核对浓度、量具、标签与实际处方。吞咽困难、量具不清或实际药盒不同，应先让药师核对。", "en": "Capsules, tablets and suspension cannot be self-substituted from a shared acyclovir name or total milligrams. A liquid also requires checking its concentration, measuring device, label and actual prescription together. Swallowing difficulty, an unclear device or a different pack needs pharmacist review first." }, { "zh": "当前仿制药标签提示肾功能相关风险，且已报告罕见但严重的皮肤不良反应线索。明显尿量变化、异常嗜睡/意识改变、广泛皮疹、口眼黏膜受累、呼吸困难或其他急性严重不适，应及时使用当地医疗支持；不要自行加量、停药或把剩药给家人。", "en": "Current generic labels include kidney-related risk and rare serious skin-reaction cues. Marked urine change, unusual drowsiness or altered awareness, extensive rash, mouth/eye mucosal involvement, breathing difficulty or another acute serious concern needs timely local medical support. Do not self-increase, stop or share leftover medicine." }, { "zh": "ZOVIRAX 口服档案不包含外用软膏、乳膏或注射剂；VALTREX／伐昔洛韦也是不同药物。相近抗病毒用途不表示可以自行轮换、叠加或按毫克换算。", "en": "This oral ZOVIRAX archive excludes topical ointment, cream and injection; VALTREX / valacyclovir is also a different medicine. A related antiviral use does not permit self-rotation, co-use or milligram conversion." } ], "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿昔洛韦怎样起作用：病毒 DNA 聚合酶相关机制不等于任何皮疹都该用药", "en": "How acyclovir works: a viral-DNA-polymerase mechanism does not mean every rash needs medicine" }, "summary": { "zh": "FDA 历史标签将阿昔洛韦描述为针对疱疹病毒的合成核苷类似物。机制帮助理解为什么剂型、准确诊断、肾功能和完整药单重要；它不能从皮疹、疼痛、水疱或他人经验判断个人是否需要、如何使用或用多久。", "en": "The historical FDA label describes acyclovir as a synthetic nucleoside analogue active against herpesviruses. The mechanism explains why form, exact diagnosis, kidney function and the complete medicine list matter; it cannot decide from a rash, pain, blisters or another person's experience whether someone needs it, how to use it or for how long." }, "checks": [ { "zh": "“抗病毒”不是对所有感染、口腔溃疡、皮疹或感冒的通用结论。不要依据症状相似、旅行经历或家中剩药自行开始、延长、叠加或分享阿昔洛韦。", "en": "“Antiviral” is not a universal conclusion for every infection, mouth sore, rash or cold. Do not start, extend, combine or share acyclovir from similar symptoms, travel history or leftover household medicine." }, { "zh": "与伐昔洛韦、其他抗病毒药、免疫抑制剂、止痛药或可能影响肾脏的药物同在药单时，需要用准确产品、肾功能资料和完整用药清单逐项核对；网页不自动安排错开时间或调整剂量。", "en": "If valacyclovir, another antiviral, immunosuppression, pain medicines or medicines that may affect kidneys appear on the list, review the exact products, kidney information and complete list item by item. The site does not set separation times or adjust a dose." }, { "zh": "即使症状名称、病毒名称或他人的处方相似，也不能据此省略诊断、实验室检查或随访。负责团队会根据准确适应症、年龄、免疫状态、肾功能、妊娠相关信息和当地标签决定下一步；网页不替代这项判断。", "en": "Even a similar symptom name, virus name or another person's prescription cannot replace diagnosis, testing or follow-up. The responsible team uses the exact indication, age, immune status, kidney function, pregnancy-related information and local label to decide next steps; the site does not replace that judgment." } ], "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZOVIRAX", "generic": "阿昔洛韦（acyclovir）口服制剂", "dosageFormClass": "阿昔洛韦的口服胶囊、普通口服片与口服混悬液是不同产品身份。200 mg/5 mL 的液体浓度、200 mg 胶囊和 400/800 mg 片剂不能仅按共同通用名或数字自行换算、混用、替代或拼接。" }, "labelSource": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_7365a4fba3b6bb37", "label": "DailyMed（NLM）：阿昔洛韦 200 mg 胶囊与片剂当前美国公开仿制药标签（EMC Pharma；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ff18ddde-a07d-47b6-86bc-92d0e80ccde1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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_fda09da96d5e0fed", "label": "DailyMed（NLM）：阿昔洛韦口服混悬液当前美国公开仿制药标签（2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a9ea291-4ad5-48a8-8c08-5a17c8757549", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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": "2026-09-13", "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": "ZOVIRAX 是阿昔洛韦的历史美国口服品牌档案。200 mg 胶囊、200 mg/5 mL 口服混悬液、400 mg 和 800 mg 片剂分别属于不同剂型和产品记录。网页先帮助读者辨认“每粒、每片或每 5 mL”这些标签单位，再阅读官方说明书；不把它们变成任何人的片数、毫升数、频率、疗程、补服或换药方案。", "history": "FDA 历史标签覆盖 ZOVIRAX 口服胶囊、片剂与混悬液；外用软膏、乳膏和注射剂属于不同途径，不并入本口服档案。当前 DailyMed 的阿昔洛韦仿制药标签可用于阅读当前产品级警示，但不应被说成仍在售的历史 ZOVIRAX 原品牌包装。", "sourceDocuments": [ { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_7365a4fba3b6bb37", "label": "DailyMed（NLM）：阿昔洛韦 200 mg 胶囊与片剂当前美国公开仿制药标签（EMC Pharma；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ff18ddde-a07d-47b6-86bc-92d0e80ccde1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_fda09da96d5e0fed", "label": "DailyMed（NLM）：阿昔洛韦口服混悬液当前美国公开仿制药标签（2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a9ea291-4ad5-48a8-8c08-5a17c8757549", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "历史 ZOVIRAX 美国口服申请：NDA 018828（200 mg 胶囊）、NDA 019909（200 mg/5 mL 混悬液）、NDA 020089（400 mg/800 mg 片剂）", "approvalTimeline": [ { "date": "1985-01-25", "title": { "zh": "ZOVIRAX 200 mg 口服胶囊 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 200 mg oral capsules" }, "detail": { "zh": "FDA 监管资料将 NDA 018828 与 ZOVIRAX 200 mg 口服胶囊相连。日期用于定位历史美国产品记录，不是当前供应、个人开始用药日或处方频率。", "en": "FDA regulatory material links NDA 018828 with ZOVIRAX 200 mg oral capsules. The date locates a historical U.S. record, not current supply, anyone's start date or prescription frequency." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1989-12-22", "title": { "zh": "ZOVIRAX 200 mg/5 mL 口服混悬液 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 200 mg/5 mL oral suspension" }, "detail": { "zh": "FDA 监管资料将 NDA 019909 与口服混悬液相连；液体浓度不能与胶囊或片剂的数字直接互换。", "en": "FDA regulatory material links NDA 019909 with oral suspension; its liquid concentration cannot be directly exchanged with capsule or tablet numbers." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1991-04-30", "title": { "zh": "ZOVIRAX 400 mg/800 mg 口服片 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 400 mg/800 mg oral tablets" }, "detail": { "zh": "FDA 监管资料将 NDA 020089 与 400 mg、800 mg 口服片分别相连。两种强度都是产品身份字段，不是个人用量或换算指令。", "en": "FDA regulatory material links NDA 020089 separately with 400 mg and 800 mg oral tablets. Both strengths are product-identity fields, not an individual-use or conversion instruction." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 ZOVIRAX 口服文件与当前仿制药阅读入口已分开链接", "en": "Historical ZOVIRAX oral file and current generic reading entries linked separately" }, "detail": { "zh": "历史品牌文件与当前仿制药标签分别保留，避免将历史品牌资料说成实时标签或库存。", "en": "The historical brand file and current generic labels are retained separately, avoiding any statement that a historical brand document is a current label or stock record." } }, { "market": { "zh": "中国大陆、日本、欧盟及其他市场", "en": "Mainland China, Japan, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌、仿制药标签或共同通用名推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from the U.S. historical brand, generic labels or a shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "200 mg/5 mL 与 200 mg 胶囊是一回事吗？", "en": "Are 200 mg/5 mL and a 200 mg capsule the same thing?" }, "answer": { "zh": "不是同一个产品身份字段。前者说明每 5 mL 液体中的标示量，后者说明每粒胶囊中的标示量；是否能使用、如何量取或能否替换必须按准确处方和当前标签由药师或开方人员核对。", "en": "They are not the same product-identity field. The first states an amount in each 5 mL of liquid, while the second states an amount in each capsule. Whether either can be used, measured or substituted requires the exact prescription and current label to be reviewed by a pharmacist or prescriber." } }, { "question": { "zh": "ZOVIRAX 与 VALTREX 能按毫克互换吗？", "en": "Can ZOVIRAX and VALTREX be exchanged by milligrams?" }, "answer": { "zh": "不能。它们是不同药物，剂型、标签、代谢和个人情况都可能不同。不要按相近抗病毒用途、共同家庭成员或数字自行换药、叠加或轮换。", "en": "No. They are different medicines and can differ in form, label, metabolism and individual context. Do not self-switch, combine or alternate from a related antiviral use, shared household member or numbers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zovirax-acyclovir/", "en": "https://origindrug.com/en/drugs/zovirax-acyclovir/" }, "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." ] }