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effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-242-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 300 mg；90 粒瓶装", "en": "Pregabalin 300 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-22.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 300, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules 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": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "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-lyrica-pregabalin-20mg-per-ml-473ml-bottle-ndc-58151-244-35", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林口服溶液", "en": "LYRICA pregabalin oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-244-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "普瑞巴林 20 mg/mL；473 mL（16 fl oz）瓶装", "en": "Pregabalin 20 mg/mL; 473 mL (16 fl oz) bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-23.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 20, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 标签浓度；不是个人 mL 数、换算或调药规则", "en": "labelled concentration per mL; not an individual's millilitre amount, conversion or adjustment rule" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 20, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "20 mg/mL", "en": "20 mg/mL" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "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": 1, "unit": { "zh": "473 mL 瓶装（16 fl oz）", "en": "473 mL bottle (16 fl oz)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "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-lyrica-pregabalin-75mg-90-capsule-bottle-ndc-58151-238-77", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-17.jpg", "alt": "LYRICA 普瑞巴林在美国 DailyMed 当前公开标签中的 75 mg、90 粒、NDC 58151-238-77 瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v18，2025-09-29 发布", "presentation": "LYRICA 普瑞巴林 75 mg 胶囊，90 粒瓶装，NDC 58151-238-77。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LYRICA、普瑞巴林 75 mg 胶囊、NDC 58151-238-77 和 90 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、剂型、包装数量和来源；不用于鉴定真伪，也不证明 25/50/100/150/200/225/300 mg 胶囊、20 mg/mL 口服溶液、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的粒数、换算、开始、停用或换药方案。", "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "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": "LYRICA 说明书放大阅读：胶囊、口服液与毫克不能只看一个数字", "en": "LYRICA label reading: capsules, oral solution and milligrams are not one number" }, "summary": { "zh": "本模块只帮助阅读 FDA 2025 美国标签中的产品身份与风险线索；不提供普瑞巴林的个人剂量、漏服处理、减量或换药方案。", "en": "This module only helps read product-identity and risk clues in the 2025 U.S. FDA label; it does not provide an individual pregabalin dose, missed-dose, taper or switching plan." }, "checks": [ { "zh": "先核对 LYRICA、普瑞巴林、口服胶囊或口服溶液、标示强度及目标市场。胶囊的 mg 与口服液的浓度不是“几粒/几毫升”可自行换算的答案；应按实际处方和该产品标签确认。", "en": "Check LYRICA, pregabalin, capsule or oral solution, stated strength and target market together. Capsule mg and oral-solution concentration are not an answer that can be self-converted into a number of capsules or millilitres; confirm from the actual prescription and product label." }, { "zh": "该 FDA 标签将头晕和嗜睡等列为需要留意的不良反应，也提示与其他中枢神经系统抑制性药物联用需额外核对。高龄、跌倒、饮酒，或同时使用助眠、镇静、止痛等产品时，应带完整药单向药师或医生确认。", "en": "This FDA label lists effects such as dizziness and somnolence for attention and flags combinations with other central-nervous-system depressants for extra review. With older age, falls, alcohol, or sleep, sedative or pain medicines, bring the full medicine list to a pharmacist or clinician." }, { "zh": "标签还提示不应自行突然停用。任何想减量、停用或在胶囊与口服液之间转换的情况，都应由开方团队按具体产品和病情给出安排，而不是按网页或包装照片操作。", "en": "The label also warns against self-directed abrupt discontinuation. Any taper, stop, or conversion between capsule and oral solution needs a plan from the prescribing team for the exact product and condition, not a webpage or package photo." } ], "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普瑞巴林怎样起作用：它与中枢神经系统电压门控钙通道的 α2-δ 位点高亲和结合", "en": "How pregabalin works: it binds with high affinity at the alpha2-delta site of voltage-gated calcium channels in the central nervous system" }, "summary": { "zh": "FDA 标签说明普瑞巴林与中枢神经系统电压门控钙通道辅助亚基 α2-δ 位点高亲和结合；其完整作用机制尚未完全阐明。标签也说明它虽在结构上与 GABA 有关，却不直接结合 GABAA、GABAB 或苯二氮䓬受体。机制解释的是药理线索，不判断个人疼痛、癫痫、焦虑、剂量或是否适合与其他镇静性药物同用。", "en": "The FDA label says pregabalin binds with high affinity at the alpha2-delta site, an auxiliary subunit of voltage-gated calcium channels in central-nervous-system tissues; its full mechanism is not completely understood. The label also says that although it is structurally related to GABA, it does not directly bind GABAA, GABAB or benzodiazepine receptors. Mechanism explains pharmacologic clues, not an individual's pain, seizure, anxiety, dose or suitability with another sedating medicine." }, "checks": [ { "zh": "名字或结构与 GABA 有关，不表示 LYRICA 就等同于苯二氮䓬类、助眠药、阿片类或其他镇静药，也不表示可自行叠加、替换或按毫克数换算。尤其在高龄、跌倒、饮酒或多药并用时，完整药单必须由专业人员核对。", "en": "A name or structural relationship to GABA does not make LYRICA equivalent to a benzodiazepine, sleep medicine, opioid or other sedative, or self-combinable, substitutable or convertible by milligrams. Especially with older age, falls, alcohol or multiple medicines, the complete medicine list needs professional review." }, { "zh": "钙通道 α2-δ 位点的机制不把胶囊、口服溶液、缓释产品或不同强度变成可以自行互换的同一产品。剂型、浓度、肾功能、实际包装和处方都必须作为完整信息核对。", "en": "An alpha2-delta calcium-channel mechanism does not turn capsules, oral solution, extended-release products or different strengths into one self-interchangeable product. Dosage form, concentration, kidney function, actual pack and prescription must be checked as complete information." }, { "zh": "嗜睡、头晕、意识改变、呼吸相关不适、跌倒或其他新症状，不能从机制页面判断应自行增减或停用。请带实际包装和完整药单联系当地医生、药师或需要时的紧急支持。", "en": "Drowsiness, dizziness, altered alertness, breathing-related discomfort, falls or another new symptom cannot be used with a mechanism page to decide self-increase, reduction or stopping. Contact a local clinician, pharmacist or, when needed, urgent support with the actual pack and complete medicine list." } ], "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "Lyrica", "generic": "普瑞巴林", "dosageFormClass": "口服胶囊 25/50/75/100/150/200/225/300 mg；口服溶液 20 mg/mL（本档案所列）" }, "labelSource": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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." } }, { "source": { "id": "src_1a44b9231093d507", "label": "DailyMed（NLM）：LYRICA 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c5d6728-be43-4e1b-9f14-a7ce920e12a3", "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2019-gabapentinoid-serious-breathing-pregabalin", "issuedAt": "2019-12-19", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Lyrica（pregabalin）在内的加巴喷丁类药物严重呼吸问题风险沟通", "en": "FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Lyrica (pregabalin)" }, "summary": { "zh": "FDA 于 2019-12-19 发布药物安全通讯，明确列出 Lyrica（pregabalin），并说明在存在呼吸风险因素时使用加巴喷丁类药物可能出现严重呼吸困难；公告所列背景包括与阿片类镇痛药或其他中枢神经系统抑制药同用、降低肺功能的疾病及高龄。FDA 要求在美国加巴喷丁类药物处方信息中增加呼吸抑制风险警语。该记录是美国、特定日期的类别监管沟通，不表示手中任何 Lyrica 包装、其他剂型或市场、任何联用，或任何个人已发生问题，也不支持自行停药、减量、加量、换药或把 Lyrica 与其他镇静性药物自行叠加／拆分。出现呼吸困难、反应异常、难以唤醒或其他紧急症状时应立即使用当地急救服务；非紧急的联用或风险问题应连同实际包装和完整药单由开方团队或药师核对。", "en": "On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Lyrica (pregabalin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Lyrica pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Lyrica with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team." }, "source": { "id": "src_d155de4d5f6093e9", "label": "FDA：2019-12-19 加巴喷丁／普瑞巴林（含 Neurontin、Lyrica）严重呼吸问题药物安全通讯", "url": "https://www.fda.gov/safety/medical-product-safety-information/neurontin-gralise-horizant-gabapentin-and-lyrica-lyrica-cr-pregabalin-drug-safety-communication", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LYRICA（pregabalin）当前美国公开标签列示 25–300 mg 口服胶囊与 20 mg/mL 口服溶液，并列出美国初始批准年份为 2004。不同剂型、强度、浓度、肾功能和实际处方不能只按商品名、每粒数或他人经验推定。", "history": "神经痛、带状疱疹后神经痛、纤维肌痛和癫痫相关的标签词不是自我诊断或自行换药依据。产品身份、适应症和实际使用方案需与目标市场现行标签及负责团队核对。", "sourceDocuments": [ { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_1a44b9231093d507", "label": "DailyMed（NLM）：LYRICA 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c5d6728-be43-4e1b-9f14-a7ce920e12a3", "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" } ], "applicationNumber": "NDA 021446 / 022488", "approvalTimeline": [ { "date": "2004", "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: 2004。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: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_21858543296b9ccf", "label": "FDA: LYRICA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025 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 2025 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_21858543296b9ccf", "label": "FDA: LYRICA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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/lyrica/", "en": "https://origindrug.com/en/drugs/lyrica/" }, "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." ] }