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90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰橙色", "en": "grey-orange" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DX", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 160 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-320mg-0078036034", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0360-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 320 mg；90 片瓶装", "en": "320 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深灰紫色", "en": "dark grey-violet" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DXL", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 320 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-320mg-0078125934", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1259-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 320 mg；90 片瓶装", "en": "320 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深灰紫色", "en": "dark grey-violet" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DXL", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 320 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diovan-valsartan-tablet-40mg-0078042315", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-tablets-03.jpg&setid=5ddba454-f3e6-43c2-a7a6-58365d297213&type=img", "alt": "DIOVAN 40 mg 缬沙坦片在美国 DailyMed 公开标签中的 30 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "2026-08", "presentation": "DIOVAN 40 mg 缬沙坦、NDC 0078-0423-15、30 片瓶装主展示面（DailyMed 页面 2026-08-11 更新标签）", "notice": "此为美国 DailyMed 公开标签中的包装文字图，只帮助核对 DIOVAN、通用名、标示强度、NDC 和口服片剂线索；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DIOVAN 说明书放大阅读：不同 mg 与同类降压药不能靠名称自行拼用", "en": "DIOVAN label reading: different mg strengths and related blood-pressure medicines are not for self-combining" }, "summary": { "zh": "本模块以 DailyMed 2026-08 美国公开标签为阅读入口，帮助核对 DIOVAN、缬沙坦、口服片剂、不同 mg 和片剂外观；它不把标签数字转换为个人剂量、联用、停药或换药方案。", "en": "This module uses the Aug 2026 U.S. DailyMed public label as a reading entry point. It helps check DIOVAN, valsartan, oral tablets, different mg markings and tablet appearance; it does not turn label numbers into an individual dose, combination, stop or switch plan." }, "checks": [ { "zh": "公开标签列有 40、80、160、320 mg 片剂。每个数字首先是该片的标示强度；不同 mg、不同市场或不同包装不能自行拼成“今天该吃几片”的答案，应以实际处方和现行标签为准。", "en": "The public label lists 40, 80, 160 and 320 mg tablets. Each number first identifies that tablet's stated strength; different mg markings, markets or packs cannot be self-combined into an answer for how many tablets to take today. Use the actual prescription and current label." }, { "zh": "片剂的颜色、形状或刻字是辅助核对线索，不是验证真伪、判断可替代性或决定能否掰开、研碎的依据。涉及实际药盒时，应让药师核对该市场、该版本和该规格的现行资料。", "en": "Tablet colour, shape or debossing are supporting checks, not a way to authenticate a medicine, establish interchangeability, or decide whether it may be split or crushed. For an actual pack, ask a pharmacist to check current information for that market, version and strength." }, { "zh": "标签提示肾功能变化、血钾、锂盐、非甾体抗炎药及其他作用于肾素-血管紧张素系统的药物需要核对。止痛药、补充剂、其他降压药和完整药单都应一并交给药师或医生；网页不能给出个人“能不能同服”的结论。", "en": "The label identifies kidney-function changes, potassium, lithium, non-steroidal anti-inflammatory medicines and other medicines acting on the renin-angiotensin system as items needing review. Pain medicines, supplements, other blood-pressure medicines and the complete medicine list should be shown together to a pharmacist or clinician; a webpage cannot give an individual answer about taking them together." }, { "zh": "怀孕、近期脱水、肾功能或其他健康状况变化，都可能改变需要由专业人员复核的内容。不要因血压读数、剩余药片或包装变化自行停用、加量、交替或改用另一种同类药。", "en": "Pregnancy, recent dehydration, kidney-function changes or other health changes can alter what needs professional review. Do not self-stop, increase, alternate or substitute another related medicine because of a blood-pressure reading, remaining tablets or a package change." } ], "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "缬沙坦怎样起作用：它阻断血管紧张素 II 的 AT₁ 受体", "en": "How valsartan works: it blocks the AT1 receptor for angiotensin II" }, "summary": { "zh": "FDA 标签将 DIOVAN 描述为选择性血管紧张素 II AT₁ 受体阻滞剂。它阻断血管紧张素 II 在相关组织与 AT₁ 受体的结合，从而影响血管收缩和醛固酮分泌相关通路。这个机制不决定个人血压、肾功能、血钾、剂量或是否应换药。", "en": "The FDA label describes DIOVAN as a selective angiotensin II AT1-receptor blocker. It blocks angiotensin II binding at AT1 receptors in relevant tissues, affecting pathways related to vasoconstriction and aldosterone secretion. This mechanism does not decide an individual's blood pressure, kidney function, potassium, dose or whether to switch medicines." }, "checks": [ { "zh": "与氯沙坦或其他 ARB 共享 AT₁ 受体机制，不表示两者可自行同服、隔日轮换、按 mg 换算或以“哪个更强”决定替换。任何转换或联合问题都需把实际产品、完整药单和病史交由专业人员核对。", "en": "Sharing an AT1-receptor mechanism with losartan or another ARB does not make products self-combinable, alternatable on different days, convertible by mg or replaceable by deciding which is “stronger.” Any switching or combination question needs the actual products, complete medicine list and history reviewed by professionals." }, { "zh": "机制不能把 40、80、160、320 mg 或药片外观变成个人加量、减量、掰开或停药的依据。药品数字先是产品身份线索；具体用法必须回到现行标签和个人处方。", "en": "Mechanism cannot turn 40, 80, 160 or 320 mg, or tablet appearance, into a basis for personal increase, reduction, splitting or stopping. Product numbers are first identity clues; specific use must return to the current label and individual prescription." }, { "zh": "脱水、肾功能或血钾变化、怀孕，以及同时使用止痛药、补充剂、锂盐或其他影响肾素-血管紧张素系统的药物时，不能从本页给出个人处理结论。出现晕厥、明显不适或其他新问题，应使用当地医疗支持。", "en": "With dehydration, kidney-function or potassium changes, pregnancy, or concurrent pain medicines, supplements, lithium or another medicine affecting the renin-angiotensin system, this page cannot give an individual management conclusion. With fainting, marked discomfort or another new concern, use local medical support." } ], "source": { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Diovan", "generic": "缬沙坦", "dosageFormClass": "美国：缬沙坦口服薄膜衣片 40 mg、80 mg、160 mg、320 mg；中国大陆有日期政府记录：代文缬沙坦胶囊 80 mg（仅名称/剂型线索，不并入美国片剂包装）" }, "labelSource": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（NDA 021283）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "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": [], "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 DIOVAN（valsartan）有日期公开标签列有 40、80、160、320 mg 口服薄膜衣片；本页分别建立七个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "FDA 历史标签记录其美国初始批准年份为 1996。本页的七个包装面板只对应 DailyMed 页面 2026-08-11 更新时所列的 DIOVAN 单方缬沙坦 40 mg、80 mg、160 mg、320 mg 瓶装。济宁市政府 2026 年公开药品价格页面列有‘代文胶囊-缬沙坦胶囊 80 mg×7 粒/盒、北京诺华’，这里只用作中文名称和胶囊剂型检索线索，不把它冒充美国片剂包装、NMPA 当前记录、库存或购买结论；DIOVAN HCT、EXFORGE、EXFORGE HCT、ENTRESTO 等复方也不能并入本单方档案。", "sourceDocuments": [ { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（NDA 021283）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6886ccd150c2c1fd", "label": "济宁市政府：2026 年药品价格页面列示代文胶囊／缬沙坦胶囊 80 mg×7 粒（有日期名称与剂型线索）", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } ], "applicationNumber": "NDA 021283", "approvalTimeline": [ { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_809fb1049996c290", "label": "FDA: DIOVAN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_809fb1049996c290", "label": "FDA: DIOVAN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/diovan/", "en": "https://origindrug.com/en/drugs/diovan/" }, "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." ] }