{ "id": "vascepa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "VASCEPA", "generic": "二十碳五烯酸乙酯", "aliases": [ "VASCEPA", "icosapent ethyl", "二十碳五烯酸乙酯", "EPA ethyl ester" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 VASCEPA 公开标签（SPL v21，2026-03-23 更新）列示二十碳五烯酸乙酯 0.5 g／1 g 口服胶囊及所展示的准确 NDC 瓶装面板。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系、鱼油/补充剂等同关系或可替代性。", "dosageFormClass": "二十碳五烯酸乙酯口服胶囊：每粒 500 mg 或 1000 mg（美国当前公开标签所列；展示三个准确 NDC 瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Amarin Pharma Inc.（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "fish oil dietary supplement", "鱼油补充剂", "other omega-3 product", "其他 omega-3 产品", "non-VASCEPA icosapent ethyl package", "非 VASCEPA 的二十碳五烯酸乙酯包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vascepa-icosapent-ethyl-capsule-500mg-240-bottle-ndc-5293700340", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-003-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 500 mg；240 粒瓶装", "en": "Icosapent ethyl 500 mg per capsule; 240-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-03.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "椭圆形胶囊，约 15 mm；无刻痕，不是自行打开或分用指示", "en": "oval capsule, about 15 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "V500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700120", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-001-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 1000 mg；120 粒瓶装", "en": "Icosapent ethyl 1000 mg per capsule; 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-04.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 1000, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "长椭圆形胶囊，约 25 mm；无刻痕，不是自行打开或分用指示", "en": "oblong capsule, about 25 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "VASCEPA", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700520", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-005-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 1000 mg；120 粒瓶装", "en": "Icosapent ethyl 1000 mg per capsule; 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-06.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 1000, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "椭圆形胶囊，约 25 mm；无刻痕，不是自行打开或分用指示", "en": "oval capsule, about 25 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "IPE", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700120", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-04.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "alt": "VASCEPA 二十碳五烯酸乙酯 1 g、NDC 52937-001-20、120 粒瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v21（2026-03-23 更新）", "presentation": "VASCEPA 二十碳五烯酸乙酯：每粒 1000 mg，NDC 52937-001-20，120 粒瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 VASCEPA、二十碳五烯酸乙酯 1 g、NDC 52937-001-20 与 120 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、包装、外观和来源；不用于鉴定真伪，也不代表 0.5 g、NDC 52937-005-20、其他包装、普通鱼油、其他 omega-3 产品、其他二十碳五烯酸乙酯、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的胶囊数、联用、换药或停药方案。", "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯 1 g、120 粒瓶装当前美国公开标签面板（Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VASCEPA／二十碳五烯酸乙酯说明书放大阅读：先认清 0.5／1 g、NDC 与瓶装", "en": "VASCEPA label reading: identify 0.5/1 g, NDC and the bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 VASCEPA、二十碳五烯酸乙酯、每粒 0.5 g／1 g、准确 NDC、瓶装、外形与警示。它不提供个人胶囊数、用药时间、同服、停用、换药、打开胶囊、分用或购买方案。", "en": "This module reads only VASCEPA, icosapent ethyl, 0.5/1 g per capsule, exact NDCs, bottles, appearance and warnings in the current U.S. DailyMed label. It provides no individual capsule count, timing, co-use, stopping, switching, opening, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 VASCEPA、二十碳五烯酸乙酯、0.5 g 或 1 g、实际 NDC、瓶装数量、琥珀黄色胶囊、压印与目标市场。g/mg 是这个准确胶囊每粒的标示量，不是网页可计算的个人胶囊数，也不是与鱼油、其他 omega-3 产品或其他降脂产品的换算、叠加规则。", "en": "Check VASCEPA, icosapent ethyl, 0.5 g or 1 g, the actual NDC, bottle count, amber capsule, imprint and target market together. g/mg is the labelled amount in that exact capsule, not a web calculation for capsule count or a conversion/combining rule for fish oil, another omega-3 product or another lipid-related product." }, { "zh": "当前标签所示胶囊无刻痕；颜色、大小、椭圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行打开、分用、减量或由一种包装替换另一种的指令。", "en": "The displayed label capsules are unscored. Colour, size, oval shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-open, split, reduce use or replace one package with another." }, { "zh": "当前标签包含心房颤动/扑动、出血、鱼类过敏以及与抗凝药或抗血小板药同用等阅读条目。请把全部处方药、非处方药、补充剂和实际药盒交给药师或开方团队逐项核对；网页不能把这些条目变成个人的“能否同服”或“能否替代鱼油”结论。", "en": "The current label includes reading items for atrial fibrillation/flutter, bleeding, fish allergy, and use with anticoagulant or antiplatelet medicines. Give every prescription medicine, OTC product, supplement and actual pack to a pharmacist or prescribing team for item-by-item review; this page cannot turn these items into an individual co-use or fish-oil-substitution conclusion." }, { "zh": "出现急性严重不适、呼吸困难、明显过敏样反应、异常出血或其他令人担心的症状时，应优先使用当地医疗支持；不要通过同时停换多种药或补充剂来试探原因。", "en": "With an acute serious concern, breathing difficulty, a marked allergy-like reaction, unusual bleeding or another worrying symptom, prioritise local medical support; do not test the cause by stopping or changing several medicines or supplements at once." } ], "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Warnings, Drug Interactions and Patient Counseling；Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签称作用机制尚未完全明确，不是自行选择或替代规则", "en": "Mechanism reading: the label says the mechanism is not completely understood, not a self-selection or substitution rule" }, "summary": { "zh": "当前美国标签写明二十碳五烯酸乙酯的作用机制尚未完全明确，并说明若干观察结果的直接临床意义不明确。这帮助读者避免把“EPA”“鱼油”或单一机制词当成自行选择、替代、叠加或停用产品的依据。", "en": "The current U.S. label states that the mechanism of action of icosapent ethyl is not completely understood and that the direct clinical significance of certain observations is unclear. This helps avoid treating “EPA”, “fish oil”, or a single mechanism phrase as a basis to self-select, substitute, combine or stop a product." }, "checks": [ { "zh": "标签中的 EPA 与脂质相关术语只帮助阅读当前文件，不能证明普通鱼油、其他 omega-3 产品或其他二十碳五烯酸乙酯包装与 VASCEPA 相等、可替代或可一起使用。", "en": "EPA and lipid-related terms in the label only help read the current document; they do not prove that ordinary fish oil, another omega-3 product or another icosapent-ethyl package equals VASCEPA, can replace it or can be used together." }, { "zh": "机制页不把任何人的化验结果、既往反应、过敏史、心律问题、出血风险、年龄、合并疾病或完整药单简化为“该不该选这款产品”的答案；已有检查或基因报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's test results, prior reactions, allergy history, rhythm concerns, bleeding risk, age, coexisting conditions or complete medicine list to an answer about whether to choose this product; existing test or genetic reports also need professional interpretation with those materials." }, { "zh": "不要把机制、包装图或一个 g/mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和药师或医生。", "en": "Do not use mechanism, a package image or one g/mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and a pharmacist or clinician." } ], "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Clinical Pharmacology；Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VASCEPA", "generic": "二十碳五烯酸乙酯", "dosageFormClass": "二十碳五烯酸乙酯口服胶囊：每粒 500 mg 或 1000 mg（美国当前公开标签所列；展示三个准确 NDC 瓶装）" }, "labelSource": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "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": "2026-08-25", "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": "2026-08-25", "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": "DailyMed 的当前 VASCEPA（icosapent ethyl）美国公开标签列示 0.5 g／1 g 口服胶囊、准确 NDC、瓶装数量、琥珀黄色胶囊外观及压印。本页帮助读者先把商品名、通用名、每粒标示量、准确包装、公开电子说明书和药物警戒阅读路径放在一起；它不把 mg、包装数量、EPA、鱼油或“同为降脂相关”转换为个人胶囊数、同服、轮换、停用、换药、替代或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 2012，SPL v21 更新日期为 2026-03-23。0.5 g／1 g 是所示准确胶囊每粒的标签标示量，240 粒或 120 粒是准确瓶装的数量；它们不等于任何人的处方胶囊数，也不能与普通鱼油、其他 omega-3 产品、其他二十碳五烯酸乙酯包装、其他降脂产品或其他市场产品按数字自行换算、替换或叠加。", "sourceDocuments": [ { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（VASCEPA；NDA 202057）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202057", "approvalTimeline": [ { "date": "2012", "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 VASCEPA 美国公开标签列示 Initial U.S. Approval: 2012。该年份只定位所引美国标签历史，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、原研/仿制关系、鱼油/补充剂等同关系或个人适用性。", "en": "The current U.S. VASCEPA public label lists Initial U.S. Approval: 2012. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, fish-oil/supplement equivalence or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-23", "title": { "zh": "当前 SPL v21 更新日期", "en": "Current SPL v21 updated" }, "detail": { "zh": "DailyMed 当前 VASCEPA 公开标签的 Updated 日期为 2026-03-23，版本为 SPL v21。本页分别展示 0.5 g、NDC 52937-003-40、240 粒瓶装，以及 1 g、NDC 52937-001-20 与 NDC 52937-005-20 的 120 粒瓶装面板；不据此建立实际在售、库存、购买、个人胶囊数、联用、停用、换药、替代或其他市场状态。", "en": "The current DailyMed VASCEPA public label lists 23 Mar 2026 as Updated, version SPL v21. This page separately displays the 0.5 g/NDC 52937-003-40/240-capsule bottle and the 1 g/NDC 52937-001-20 and NDC 52937-005-20/120-capsule bottle panels; it does not establish actual availability, stock, purchase, individual capsule count, co-use, stopping, switching, substitution or another-market status." }, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三组准确瓶装面板", "en": "Current public label and three exact bottle panels linked" }, "detail": { "zh": "本页分别展示 VASCEPA 二十碳五烯酸乙酯 0.5 g、NDC 52937-003-40、240 粒瓶装；1 g、NDC 52937-001-20、120 粒瓶装；1 g、NDC 52937-005-20、120 粒瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人胶囊数、开始、停用、联用、换药、与鱼油或其他产品替代或可替代性。", "en": "This page separately displays VASCEPA icosapent ethyl 0.5 g/NDC 52937-003-40/240-capsule bottle; 1 g/NDC 52937-001-20/120-capsule bottle; and 1 g/NDC 52937-005-20/120-capsule bottle. It does not authenticate a product or establish actual availability, stock, purchase, individual capsule count, initiation, stopping, co-use, switching, substitution with fish oil or another product, or interchangeability." } }, { "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、NDA、NDC、英文品牌、包装图、EPA、鱼油或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系、补充剂等同关系或可替代性；每个市场均须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, supplement equivalence or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image, EPA, fish oil or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.5 g、1 g 与瓶装数量能不能用来自己决定胶囊数，或用普通鱼油替代、与其他降脂产品同服？", "en": "Can 0.5 g, 1 g and bottle count be used to decide my own capsule count, replace it with ordinary fish oil, or use it with another lipid-related product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 VASCEPA 胶囊和包装。名称相似、同含 EPA、相近 g/mg 数字、包装照片或同为降脂相关产品，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact VASCEPA capsules and packages in the cited U.S. label. A similar name, EPA content, nearby g/mg number, package photo or lipid-related context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面提到出血、心律、过敏和联用药，却不告诉我自己是否应改药或停用？", "en": "Why does the page mention bleeding, rhythm, allergy and co-medications without telling me whether to change or stop medicine?" }, "answer": { "zh": "这些是当前美国标签中警示、相互作用和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；药师或医生需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "These are reading entry points for the current U.S. label's warnings, interactions and patient-counselling sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; a pharmacist or clinician needs the exact product, history, tests and complete medicine list for item-by-item 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/vascepa/", "en": "https://origindrug.com/en/drugs/vascepa/" }, "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." ] }