{ "id": "entecavir-baraclude", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Baraclude", "generic": "恩替卡韦", "aliases": [ "博路定", "entecavir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "博路定®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_3823f8c9f3b5ecb5", "label": "BMS China：博路定（恩替卡韦片）历史公开资料（2017）", "url": "https://www.bms.com/cn/media/press-release-listing/-17082017.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签资料（SPL v42：2019-11-06 生效，2025-12-22 发布）", "dosageFormClass": "口服薄膜衣片（0.5 mg、1 mg）及即用型口服溶液（0.05 mg/mL；有日期美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2005（DailyMed 美国标签所列初始批准）", "archiveSponsorText": "E.R. Squibb & Sons / DailyMed 美国公开标签资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-baraclude-tablet-0-5mg-30-tablet-bottle-ndc-0003-1611-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦口服薄膜衣片", "en": "BARACLUDE entecavir oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1611-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 0.5 mg；30 片儿童安全瓶装", "en": "0.5 mg per tablet; 30-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-halfmg-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或与口服溶液自行换算", "en": "labelled amount per tablet; not an individual's tablet count, course or self-conversion to oral solution" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "三角形薄膜衣片", "en": "triangular film-coated tablet" }, "imprint": "BMS / 1611", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-baraclude-tablet-1mg-30-tablet-bottle-ndc-0003-1612-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦口服薄膜衣片", "en": "BARACLUDE entecavir oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1612-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1 mg；30 片儿童安全瓶装", "en": "1 mg per tablet; 30-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-1mg-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或与 0.5 mg 片/口服溶液自行换算", "en": "labelled amount per tablet; not an individual's tablet count, course or self-conversion to 0.5 mg tablets/oral solution" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "三角形薄膜衣片", "en": "triangular film-coated tablet" }, "imprint": "BMS / 1612", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-baraclude-oral-solution-0-05mg-per-ml-210ml-bottle-ndc-0003-1614-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦即用型口服溶液", "en": "BARACLUDE entecavir ready-to-use oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1614-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05 mg/mL；210 mL 儿童安全瓶装", "en": "0.05 mg/mL; 210 mL child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-os-halfmgml-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 0.05, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人毫升数、量具用法或与片剂自行换算", "en": "labelled concentration; not an individual's millilitres, measuring-device instruction or self-conversion to tablets" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.05 mg/mL", "numerator": { "value": 0.05, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.05 mg/mL（标签浓度；不是个人毫升数）", "en": "0.05 mg/mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": { "value": 210, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-baraclude-tablet-0-5mg-30-tablet-bottle-ndc-0003-1611-12", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-halfmg-car.jpg", "alt": "BARACLUDE 0.5 mg 恩替卡韦片在美国 DailyMed SPL v42 公开标签中的 30 片包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）", "presentation": "BARACLUDE 0.5 mg、30 片儿童安全瓶装展示面（有日期美国公开标签所列）。", "notice": "此为美国 DailyMed SPL v42 中明确对应 BARACLUDE 0.5 mg、30 片瓶装的包装展示面，只帮助核对品牌、通用名、标示强度、片剂、NDC、包装数量和来源；不用于鉴定真伪，也不证明 1 mg、口服溶液、其他包装、其他市场标签、当前供应、原研身份、目标市场批准或可售资格。", "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BARACLUDE / 恩替卡韦说明书放大阅读：片剂、口服溶液与“不能自行停用”", "en": "BARACLUDE label reading: tablets, oral solution and why not to self-stop" }, "summary": { "zh": "本模块以 DailyMed 的 BARACLUDE 美国公开标签为阅读入口，帮助核对品牌、恩替卡韦、片剂/口服溶液、0.5 mg、1 mg、0.05 mg/mL 和包装文字；它不把这些信息转换为任何人的治疗、换药、加减量或停药方案。", "en": "This module uses the U.S. DailyMed BARACLUDE public label as a reading entry point. It helps check the brand, entecavir, tablet/oral solution, 0.5 mg, 1 mg, 0.05 mg/mL and package text; it does not convert these into anyone's treatment, switch, dose change or stopping plan." }, "checks": [ { "zh": "0.5 mg、1 mg 是标签列示的片剂标示强度；0.05 mg/mL 是口服溶液浓度。mg、mg/mL、片数和毫升数不是同一个单位，不能因包装数字相近而自行换算、替代或加减。", "en": "0.5 mg and 1 mg are labelled tablet strengths; 0.05 mg/mL is the oral-solution concentration. mg, mg/mL, tablet count and millilitre amount are not the same unit and cannot be self-converted, substituted or adjusted because package numbers look similar." }, { "zh": "DailyMed 标签的 0.5 mg 片剂包装图只能对应这一个美国代表性包装。它不能确认来自其他市场、其他规格、口服溶液或仿制产品的外观、批准状态或真实性。", "en": "The DailyMed 0.5 mg tablet image only corresponds to that one representative U.S. package. It cannot confirm the appearance, approval status or authenticity of another market, strength, oral solution or generic product." }, { "zh": "该标签提示停止抗乙型肝炎治疗后可能出现严重急性加重。任何漏服、想停用、换产品或担心不适的情况，都应带实际包装和完整药单联系开方团队或药师；不要以网页或包装图自行决定下一步。", "en": "The label warns that severe acute exacerbations can occur after anti-hepatitis B therapy is stopped. With a missed dose, a wish to stop, a product change or symptoms, take the actual package and complete medicine list to the prescribing team or pharmacist; do not decide the next step from a webpage or package image." }, { "zh": "标签列有肾功能相关的产品信息，也提到部分移植后或免疫抑制治疗情境需要专业评估。年龄、其他疾病或同时服用的药物都不能靠网页自动换成个人用法；应由专业人员结合准确产品和现行标签核对。", "en": "The label includes kidney-function-related product information and notes circumstances involving some post-transplant or immunosuppressive treatment that require professional assessment. Age, conditions or concomitant medicines cannot be converted by a webpage into an individual regimen; a professional must check the exact product and current label." } ], "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（剂型、强度与警告；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "恩替卡韦怎样起作用：它在细胞内影响乙肝病毒逆转录酶的多个步骤", "en": "How entecavir works: it affects multiple steps of hepatitis B virus reverse transcriptase inside cells" }, "summary": { "zh": "DailyMed 标签说明，恩替卡韦是对乙型肝炎病毒逆转录酶有活性的脱氧鸟苷核苷类似物；被磷酸化为活性三磷酸形式后，可竞争性影响病毒逆转录酶的多个活动。这解释药理路径，不预测个人病毒学指标、适用性、疗程、片数或停药时机。", "en": "The DailyMed label explains that entecavir is a deoxyguanosine nucleoside analogue active against hepatitis B virus reverse transcriptase. After phosphorylation to its active triphosphate form, it competitively affects multiple reverse-transcriptase activities. This explains a pharmacologic pathway; it does not predict an individual's virologic markers, suitability, course, tablet count or stopping time." }, "checks": [ { "zh": "“影响乙肝病毒逆转录酶”只说明一条病毒复制相关路径，不能由此判断任何人的感染阶段、化验结果或是否需要开始、继续或停用治疗。", "en": "‘Affects hepatitis B virus reverse transcriptase’ describes one replication-related pathway only; it cannot determine anyone's infection stage, laboratory result or whether treatment should start, continue or stop." }, { "zh": "片剂与口服溶液可以含同一活性成分，却有不同剂型、标示单位和现行标签信息。共同机制不使它们成为可自行按片数或毫升数换算、交替或替代的产品。", "en": "Tablets and oral solution can contain the same active ingredient while having different forms, labelled units and current-label information. A shared mechanism does not make them products that can be self-converted by tablet count or millilitres, alternated or substituted." }, { "zh": "机制页面也不能用来处理漏服、停止、联合用药或移植后用药的决定。任何此类问题应使用目标市场的现行标签，并由熟悉完整药单和临床情况的专业人员复核。", "en": "A mechanism page also cannot resolve decisions about missed doses, stopping, combinations or post-transplant use. Such questions require the current target-market label and professional review by someone familiar with the complete medicine list and clinical context." } ], "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（微生物学；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "Baraclude", "generic": "恩替卡韦", "dosageFormClass": "口服薄膜衣片（0.5 mg、1 mg）及即用型口服溶液（0.05 mg/mL；有日期美国公开标签所列）" }, "labelSource": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_bb8e05e50e2f7f61", "label": "FDA：BARACLUDE 2018 美国标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 BARACLUDE（entecavir）有日期美国公开标签列出 0.5 mg 片、1 mg 片和 0.05 mg/mL 即用型口服溶液，并提供三张分别对应的包装展示面。本页把三者分开核对；不把 mg、mg/mL、片数、瓶装毫升数或相同通用名转换为任何人的服用量、剂型替换、停药或购买决定。该资料正文版本为 2019 年，不代表当前供应。", "history": "中文检索线索“博路定”、英文品牌 BARACLUDE、通用名恩替卡韦、NDC、片剂或口服溶液、每单位标示强度和目标市场需要同时核对。相同通用名、相近包装或相同数字不能替代准确产品、目标市场现行标签和专业复核。", "sourceDocuments": [ { "id": "src_bb8e05e50e2f7f61", "label": "FDA：BARACLUDE 2018 美国标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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 021797 / 021798（以具体 FDA 文件核对）", "approvalTimeline": [ { "date": "2005", "title": { "zh": "美国公开历史资料入口", "en": "U.S. public historical-material entry point" }, "detail": { "zh": "本档案以 Baraclude® 的 FDA 公开资料为历史阅读入口；批准编号和具体产品文件须回到对应数据库页面逐项核验。", "en": "This archive uses FDA public material for Baraclude® as a historical reading entry point; approval number and specific product document must be checked record by record in the database." }, "source": { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA search", "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" } }, { "date": "2018-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2018-06 FDA 标签档案；任何现行信息均应由目标市场当前文件复核。", "en": "This page links the Jun 2018 FDA label archive; all current information needs review against the target market’s current record." }, "source": { "id": "src_bb8e05e50e2f7f61", "label": "FDA: Baraclude prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019-11", "title": { "zh": "DailyMed SPL v42 有日期标签版本", "en": "DailyMed SPL v42 dated label version" }, "detail": { "zh": "DailyMed 的 BARACLUDE SPL v42 标示 2019-11-06 生效，并在媒体目录中列为 2025-12-22 发布。它支持本页三个精确包装展示面；不代表当前供应或其他市场状态。", "en": "BARACLUDE DailyMed SPL v42 is marked effective 6 Nov 2019 and listed in the media directory as published 22 Dec 2025. It supports this page's three exact package panels; it does not establish current supply or another-market status." }, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "本页仅建立文件阅读路径。", "en": "This page establishes only a document-reading path." } }, { "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产品状态。", "en": "No local product status is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "历史标签能用于决定实际用药吗？", "en": "Can a historical label decide actual use?" }, "answer": { "zh": "不能。历史文件用于理解资料来源；个体用药和现行风险信息必须依据目标市场的最新标签并咨询专业人员。", "en": "No. Historical material is for understanding sources; individual use and current safety information require the latest target-market label and professional advice." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/entecavir-baraclude/", "en": "https://origindrug.com/en/drugs/entecavir-baraclude/" }, "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." ] }