{ "id": "ranexa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "RANEXA", "generic": "雷诺嗪缓释片", "aliases": [ "Ranexa", "ranolazine", "ranolazine prolonged-release tablets", "ranolazine extended-release tablets", "雷诺嗪", "雷诺嗪缓释片", "Latixa", "RANEXA", "NDA 021526", "EMEA/H/C/000805", "61958-1001-1", "61958-1002-1", "RANEXA 375 mg", "RANEXA 500 mg", "RANEXA 750 mg", "RANEXA 1000 mg" ], "marketBrandNames": [ { "name": "RANEXA", "market": { "zh": "欧盟", "en": "European Union" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "EMEA/H/C/000805 当前集中许可；375、500、750 mg 缓释片。", "en": "Current central authorisation EMEA/H/C/000805; 375, 500 and 750 mg prolonged-release tablets." }, "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "name": "RANEXA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 021526 的 500 与 1000 mg 历史 RLD 当前均列为 Discontinued；旧包装图只用于识别历史标签。", "en": "Historical RLD products under NDA 021526 at 500 and 1000 mg are currently listed as Discontinued; 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currently listed as Discontinued in the Orange Book)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪薄膜衣缓释片", "en": "RANEXA ranolazine film-coated extended-release tablet" }, "route": { "zh": "口服；整片吞服（美国历史产品身份字段）", "en": "oral; swallowed whole (historical U.S. product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61958-1002-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 1000 mg；60 片瓶装（美国历史品牌标签）", "en": "Ranolazine 1000 mg per tablet; 60-tablet bottle (historical U.S. brand label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ranexa-03.jpg&setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签强度；不是个人片数、频率、增量或与欧盟规格的换算", "en": "historical labelled strength per tablet; not an individual's tablet count, frequency, titration or conversion to an EU strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_brand_record_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pale yellow" }, "shape": { "zh": "长椭圆形、无刻痕缓释片", "en": "oblong, unscored extended-release tablet" }, "imprint": "CVT1000", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ranexa-ranolazine-extended-release-500mg-60-tablet-bottle-ndc-6195810011-historical", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ranexa-02.jpg&setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc&type=img", "alt": "RANEXA 雷诺嗪缓释片 500 mg、60 片、NDC 61958-1001-1 的美国 2010 DailyMed 历史标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed Gilead 历史品牌标签；2010-04-26 更新；当前产品行已停止销售", "presentation": "RANEXA 雷诺嗪缓释片，每片 500 mg，60 片瓶装，NDC 61958-1001-1（美国历史包装）。", "notice": "此图仅对应美国 2010 历史标签中的 500 mg、60 片瓶装；不代表美国当前供应，也不代表欧盟 375/500/750 mg 包装、1000 mg 历史瓶或其他市场产品。包装图只用于辅助核对，不用于鉴定真伪。", "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RANEXA 说明书放大阅读：缓释片要整片吞服，也不是胸痛急救药", "en": "RANEXA label reading: swallow the prolonged-release tablet whole, and do not treat it as an acute-rescue medicine" }, "summary": { "zh": "欧盟当前资料与美国历史品牌标签均要求整片吞服，不得压碎、掰开或咀嚼。欧盟当前强度是 375、500、750 mg，美国历史强度是 500、1000 mg；这些数字不能跨市场换算。RANEXA 不会终止一次急性心绞痛发作，新发、异常、剧烈或持续胸痛应立即按既定急救计划和当地急救系统处理。", "en": "Current EU information and the historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Current EU strengths are 375, 500 and 750 mg, while historical U.S. strengths are 500 and 1000 mg; these figures are not a cross-market conversion table. RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan and local emergency services." }, "checks": [ { "zh": "先看‘缓释’：不得压碎、掰开或咀嚼。片上没有刻痕不等于可以凭感觉掰半；即使某个市场出现相同 mg 数，也不能把多个小规格自行拼成另一个市场的大规格。", "en": "Start with ‘prolonged/extended release’: do not crush, break or chew. An unscored tablet is not permission to split by feel, and a shared mg figure across markets does not permit assembling one market's larger strength from another's smaller tablets." }, { "zh": "RANEXA 是长期稳定型心绞痛用药档案，不是 NITROSTAT 等舌下硝酸甘油的急救替代品。胸痛新发、与平时不同、剧烈、持续，或伴呼吸困难、出汗、晕厥等表现时，应立即使用当地急救服务，不要等待网页或自行追加。", "en": "RANEXA is a chronic stable-angina dossier, not a rescue substitute for sublingual nitroglycerin such as NITROSTAT. New, different, severe or persistent chest pain, or pain with breathing difficulty, sweating or fainting, requires immediate local emergency care; do not wait for a website or self-add a tablet." }, { "zh": "强 CYP3A 抑制剂（如克拉霉素、酮康唑、伊曲康唑、伏立康唑及部分 HIV 蛋白酶抑制剂）和诱导剂（如利福平、卡马西平、苯妥英、苯巴比妥、圣约翰草）是优先核对项；不要靠错开几小时自行解决。", "en": "Strong CYP3A inhibitors such as clarithromycin, ketoconazole, itraconazole, voriconazole and some HIV protease inhibitors, and inducers such as rifampin, carbamazepine, phenytoin, phenobarbital and St John's wort, are priority review items. Do not try to solve them by self-separating doses by a few hours." }, { "zh": "地尔硫䓬、维拉帕米、氟康唑、红霉素、环孢素和葡萄柚等可影响雷诺嗪暴露；地高辛、辛伐他汀、二甲双胍及其他药物也可能需要一起核对。网页不根据两个药名给出能否同服或怎样减量。", "en": "Diltiazem, verapamil, fluconazole, erythromycin, ciclosporin and grapefruit can affect ranolazine exposure; digoxin, simvastatin, metformin and other medicines may also need joint review. This site does not decide co-use or dose reduction from two names." }, { "zh": "雷诺嗪可延长 QT。本人或家族有长 QT、正在服用胺碘酮、索他洛尔、某些抗精神病药或其他延长 QT 药物，或出现晕厥、心悸、严重头晕时，应尽快让医疗团队核对；严重或持续症状需立即求助。", "en": "Ranolazine can prolong QT. A personal or family long-QT history, amiodarone, sotalol, certain antipsychotics or other QT-prolonging medicines, or fainting, palpitations or severe dizziness needs prompt clinical review; severe or persistent symptoms require immediate help." }, { "zh": "老人、体重不超过 60 kg、肾功能下降、肝功能问题或中重度心衰会增加暴露或不良反应核对的重要性。头晕、乏力、便秘、恶心和跌倒风险要结合完整药单与监测计划处理，不能自行停药或换药。", "en": "Older age, weight at or below 60 kg, reduced kidney function, liver problems or moderate-to-severe heart failure increases the importance of exposure and adverse-event review. Dizziness, weakness, constipation, nausea and fall risk must be handled with the full medicine list and monitoring plan, not self-stopping or switching." } ], "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "雷诺嗪怎样起作用：可能减少心肌细胞内钠、钙负荷，但机制不能变成个人选药规则", "en": "How ranolazine works: it may reduce myocardial sodium/calcium loading, but the mechanism is not a personal selection rule" }, "summary": { "zh": "美国标签说明雷诺嗪的抗心绞痛确切机制尚未完全确定，并记录其在治疗浓度可抑制心肌晚期钠电流；EMA 公众概要以减少进入心肌细胞的钙离子流来解释可能的舒张作用。这个机制只帮助理解稳定型心绞痛、QT、相互作用和监测，不能推算个人片数、急救方案或与硝酸甘油、β 受体阻滞剂、钙通道阻滞剂的替换。", "en": "The U.S. label says the precise antianginal mechanism is not fully determined and records inhibition of the cardiac late sodium current at therapeutic concentrations; the EMA public overview explains a possible relaxation effect through reduced calcium-ion entry into heart-muscle cells. This only supports understanding stable angina, QT, interactions and monitoring. It cannot calculate a tablet count, emergency plan or substitution with nitroglycerin, a beta blocker or a calcium-channel blocker." }, "checks": [ { "zh": "雷诺嗪对晚期钠电流和 QT 的作用不是‘越多越好’的证据；暴露受肝肾功能、体重和相互作用药物影响，不能从胸痛频率或心电图数字自行加量。", "en": "Effects on late sodium current and QT are not evidence that more is better. Exposure varies with liver/kidney function, body weight and interacting medicines, so chest-pain frequency or one ECG number cannot direct self-increase." }, { "zh": "EMA 资料提到已知 CYP2D6 代谢状态可在多重风险因素下帮助专业评估，但这不等于所有人都应做全基因筛查。网页不从基因结果替个人选择、加减或停用 RANEXA。", "en": "EMA information notes that known CYP2D6 metaboliser status may inform professional caution when several risk factors coexist, but this is not a recommendation for whole-genome screening in everyone. The site does not use a genetic result to select, increase, reduce or stop RANEXA for an individual." }, { "zh": "稳定型心绞痛的长期作用与急性胸痛处置是两件事；不要因为机理听起来‘改善供血’就把缓释片当急救药，或停掉既定的急救与长期方案。", "en": "Long-term stable-angina action and acute chest-pain response are different. A mechanism that sounds like ‘improving blood flow’ does not turn an extended-release tablet into a rescue medicine or justify stopping an established emergency or long-term plan." } ], "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RANEXA", "generic": "雷诺嗪缓释片", "dosageFormClass": "雷诺嗪缓释片：欧盟当前 375/500/750 mg；美国历史 500/1000 mg。片剂应整片吞服，不得压碎、掰开或咀嚼；不同市场毫克数不是自行换算或多片拼规格依据" }, "labelSource": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "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": "RANEXA 是雷诺嗪缓释片，用于稳定型心绞痛长期治疗场景，不是胸痛发作时替代硝酸甘油的急救药。‘缓释’表示药物随时间释放，因此必须整片吞服，不得压碎、掰开或咀嚼。老人、肾功能或肝功能问题、低体重、头晕跌倒风险，以及与克拉霉素、唑类抗真菌药、地尔硫䓬、维拉帕米、卡马西平、利福平、圣约翰草、葡萄柚、地高辛、辛伐他汀和其他延长 QT 药物同用时，都应带完整药单让医生或药师逐项核对。", "history": "FDA 于 2006-01-27 批准 NDA 021526 的 RANEXA 500 mg 缓释片，2007-02-12 批准 1000 mg；FDA 原始批准信保留了用于证明缓释特性的多时间点溶出要求。欧盟于 2008-07-09 授予 RANEXA 集中许可，当前产品资料列 375、500、750 mg 缓释片。美国两个历史 RLD 现均列为 Discontinued，因此美国旧包装图不能写成当前供应。", "sourceDocuments": [ { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_bb114a794784e085", "label": "FDA：RANEXA NDA 021526 原始批准信（2006-01-27；缓释产品溶出要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "EMA EMEA/H/C/000805；FDA NDA 021526", "approvalTimeline": [ { "date": "2006-01-27", "title": { "zh": "FDA 批准 RANEXA 500 mg 缓释片", "en": "FDA approved RANEXA 500 mg extended-release tablets" }, "detail": { "zh": "NDA 021526 原始批准信同时保留多个时间点的溶出规格，用于确认缓释产品性能；这不是个人分片或服药时间表。", "en": "The NDA 021526 original approval letter retained multiple dissolution time points to establish extended-release product performance; this is not an individual splitting or dosing schedule." }, "source": { "id": "src_bb114a794784e085", "label": "FDA：RANEXA NDA 021526 原始批准信（2006-01-27；缓释产品溶出要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2007-02-12", "title": { "zh": "FDA 批准 1000 mg 历史规格", "en": "FDA approved the historical 1000 mg strength" }, "detail": { "zh": "当前 Orange Book 将 500 与 1000 mg 产品行均列为 Discontinued，且不是 RS。", "en": "Current Orange Book data list both 500 and 1000 mg product rows as Discontinued and not RS." }, "source": { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2008-07-09", "title": { "zh": "欧盟集中上市许可", "en": "EU central marketing authorisation" }, "detail": { "zh": "EMA 当前 EPAR 列示 RANEXA（原名 Latixa）、雷诺嗪和 EMEA/H/C/000805，当前持有人为 Menarini International Operations Luxembourg S.A.。", "en": "The current EMA EPAR lists RANEXA (previously Latixa), ranolazine and EMEA/H/C/000805, with Menarini International Operations Luxembourg S.A. as the current holder." }, "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "当前集中许可；375、500、750 mg 缓释片", "en": "Current central authorisation; 375, 500 and 750 mg prolonged-release tablets" }, "detail": { "zh": "EMA 的许可与产品资料不证明具体国家药房库存、购买资格、个人适用性或与美国历史强度可换算。", "en": "EMA authorisation and product information do not establish national pharmacy stock, purchasing eligibility, individual suitability or conversion to historical U.S. strengths." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "500 与 1000 mg 历史 RLD 当前列为 Discontinued", "en": "Historical 500 and 1000 mg RLD products currently listed as Discontinued" }, "detail": { "zh": "2010 DailyMed 两个 60 片瓶装面板只作历史身份与外观核对，不代表当前营销或供应。", "en": "Two 60-tablet bottle panels in the 2010 DailyMed label are retained only for historical identity and appearance review, not ongoing marketing or supply." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从欧盟或美国资料推定当地商品名、批准、规格、包装、供应、原研/仿制关系或可替代性。", "en": "No local brand, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from EU or U.S. material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RANEXA 缓释片能不能掰半或压碎？", "en": "Can a RANEXA prolonged-release tablet be split or crushed?" }, "answer": { "zh": "所引欧盟当前资料和美国历史品牌标签都要求整片吞服，不得压碎、掰开或咀嚼。不要用半片或多片自行拼规格；如吞咽困难，应拿实际药盒让医生或药师重新评估，而不是改变片剂结构。", "en": "The cited current EU information and historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Do not assemble strengths from tablet portions or multiple tablets. For swallowing difficulty, have the actual pack reviewed rather than changing the tablet structure." } }, { "question": { "zh": "胸痛时能不能临时多吃一片 RANEXA？", "en": "Can an extra RANEXA tablet be taken during chest pain?" }, "answer": { "zh": "不能由网页这样决定。美国标签明确提示 RANEXA 不会终止一次急性心绞痛发作；新发、异常、剧烈或持续胸痛应立即按既定急救计划和当地急救系统处理，并说明完整药单。", "en": "A website cannot make that decision. The U.S. label explicitly says RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan, local emergency services and disclosure of the full medicine list." } }, { "question": { "zh": "服用 RANEXA 前是不是人人都要做全基因筛查？", "en": "Does everyone need whole-genome screening before RANEXA?" }, "answer": { "zh": "所引 EMA 资料没有提出人人进行全基因筛查。它只说明：当 CYP2D6 状态已经通过基因分型获知时，可在存在多项暴露风险因素的患者中帮助专业判断。是否需要任何检测应由医疗团队结合药单、肝肾功能、体重、心电图和病史决定。", "en": "The cited EMA information does not recommend whole-genome screening for everyone. It only notes that already-known CYP2D6 status may help professional caution when several exposure risk factors coexist. Any testing decision belongs with the clinical team after reviewing medicines, liver/kidney function, weight, ECG and history." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ranexa/", "en": "https://origindrug.com/en/drugs/ranexa/" }, "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." ] }