{ "id": "vibramycin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "VIBRAMYCIN", "generic": "多西环素", "aliases": [ "Vibramycin Hyclate", "Vibramycin Monohydrate", "Vibramycin Calcium", "多西环素", "盐酸多西环素", "doxycycline", "doxycycline hyclate", "doxycycline monohydrate", "doxycycline calcium", "0069-0950-50", "0069-0970-65", "0069-0971-74", "VIBRA", "PFIZER 095" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 当前 VIBRAMYCIN 公开标签（2026-05-13 生效，SPL v47）；标签明确说明全部所列剂型和强度目前均未上市销售", "dosageFormClass": "口服胶囊、复溶后口服混悬液用粉末及口服混悬液；三个产品的盐型、浓度基准和包装不同", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1967", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（DailyMed 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "doxycycline injection", "intravenous doxycycline", "外用多西环素" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vibramycin-hyclate-doxycycline-100mg-50-capsule-bottle-ndc-0069-0950-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Hyclate 盐酸多西环素胶囊", "en": "VIBRAMYCIN Hyclate doxycycline hyclate capsule" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0950-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于多西环素 100 mg；50 粒瓶装", "en": "Equivalent to doxycycline 100 mg per capsule; 50-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-07.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或疗程", "en": "labelled amount per capsule; not an individual's capsule count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2024-11-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅蓝色", "en": "aqua blue" }, "shape": { "zh": "胶囊", "en": "capsule" }, "imprint": "VIBRA / PFIZER 095", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 每粒相当于多西环素 100 mg；50 粒瓶装、NDC 0069-0950-50 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vibramycin-monohydrate-doxycycline-25mg-per-5ml-60ml-suspension-ndc-0069-0970-65", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Monohydrate 复溶后口服混悬液用粉末", "en": "VIBRAMYCIN Monohydrate powder for oral suspension" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0970-65", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "复溶后每 5 mL 含多西环素 25 mg；总量 60 mL", "en": "Doxycycline 25 mg per 5 mL after reconstitution; total volume 60 mL" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-03.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 25, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle_after_reconstitution", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2017-06-24", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "黄色粉末，复溶后为覆盆子味口服混悬液", "en": "yellow powder; raspberry-flavoured oral suspension after reconstitution" }, "shape": { "zh": "复溶用瓶装粉末", "en": "powder for reconstitution in bottle" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 复溶后每 5 mL 含多西环素 25 mg；总量 60 mL、NDC 0069-0970-65 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vibramycin-calcium-doxycycline-50mg-per-5ml-473ml-suspension-ndc-0069-0971-74", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Calcium 多西环素钙口服混悬液（标签亦称 syrup）", "en": "VIBRAMYCIN Calcium doxycycline calcium oral suspension (also described as syrup in the label)" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0971-74", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含多西环素 50 mg；总量 473 mL", "en": "Doxycycline 50 mg per 5 mL; total volume 473 mL" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-06a.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 50, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle_after_reconstitution", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-08-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "覆盆子/苹果味口服混悬液", "en": "raspberry/apple-flavoured oral suspension" }, "shape": { "zh": "473 mL 瓶装液体", "en": "473 mL bottled liquid" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 每 5 mL 含多西环素 50 mg；总量 473 mL、NDC 0069-0971-74 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vibramycin-hyclate-doxycycline-100mg-50-capsule-bottle-ndc-0069-0950-50", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-07.jpg&archiveid=964117", "alt": "VIBRAMYCIN Hyclate 100 mg、NDC 0069-0950-50、50 粒瓶装在 DailyMed 当前公开标签中的包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v47（2026-05-13 生效）", "presentation": "VIBRAMYCIN Hyclate 100 mg 胶囊、NDC 0069-0950-50、50 粒瓶装历史产品面板", "notice": "此图只对应标签中的准确 100 mg 胶囊历史产品。标签明确标注 PRODUCT DISCONTINUED；图片不用于鉴定真伪，也不证明当前库存、可购买性、另一规格或另一市场状态。", "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIBRAMYCIN 说明书放大阅读：先分清胶囊、液体浓度与停止销售状态", "en": "VIBRAMYCIN label reading: separate the capsule, liquid concentration and discontinued status" }, "summary": { "zh": "当前美国标签列有三个不同口服产品，但同时明确说明它们均已停止销售。页面帮助读者识别每粒与每 5 mL 的不同基准、需要尽快求助的严重症状及完整药单核对入口，不提供个人粒数、毫升数、间隔或疗程。", "en": "The current U.S. label lists three different oral products while explicitly stating that all are discontinued. This page helps distinguish per-capsule from per-5-mL quantities, identify serious symptoms requiring prompt help and prepare a complete medicine list for review; it gives no personal capsule count, millilitres, interval or course." }, "checks": [ { "zh": "100 mg 是每粒胶囊的标签标示量；25 mg/5 mL 和 50 mg/5 mL 是两种不同液体产品的浓度。三者不能只按数字自行换算、混用、替换或拼接疗程。", "en": "100 mg is the labelled amount per capsule; 25 mg/5 mL and 50 mg/5 mL are concentrations of two different liquid products. Do not self-convert, combine, substitute or assemble a course from these numbers." }, { "zh": "标签提示多西环素可能引起光敏反应、食管刺激或溃疡、严重皮肤反应、颅内高压及艰难梭菌相关腹泻。严重或迅速加重的症状、呼吸困难、面唇舌喉肿胀、广泛皮疹/水疱、视力变化、剧烈头痛、持续或带血腹泻等需要尽快使用当地急救或医疗支持。", "en": "The label warns about photosensitivity, oesophageal irritation or ulceration, severe skin reactions, intracranial hypertension and C. difficile-associated diarrhoea. Severe or rapidly worsening symptoms, breathing difficulty, swelling of the face/lips/tongue/throat, widespread rash or blisters, vision change, severe headache, or persistent/bloody diarrhoea require prompt local emergency or medical support." }, { "zh": "胶囊/片剂标签要求配足量液体吞服，以降低食管刺激和溃疡风险。若吞咽困难、实际产品不同或使用方式不清楚，应先让药师或开方团队核对准确说明书，不要自行打开胶囊或改用历史液体产品。", "en": "The capsule/tablet label calls for adequate fluid to reduce oesophageal irritation and ulceration. If swallowing is difficult, the actual product differs or instructions are unclear, ask a pharmacist or prescriber to check the exact label first; do not open a capsule or switch to a historical liquid product yourself." }, { "zh": "抗酸药、含铁/钙/镁/铝制品、其他处方药和补充剂都应列入完整药单交给药师核对。网页不根据药名列表生成同服间隔，也不替代处方。", "en": "Antacids, iron/calcium/magnesium/aluminium products, other prescriptions and supplements belong on the complete medicine list for pharmacist review. The site does not generate co-use spacing from a name list and does not replace the prescription." } ], "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "多西环素怎样起作用：结合细菌 30S 核糖体亚基，抑制蛋白质合成", "en": "How doxycycline works: binding the bacterial 30S ribosomal subunit and inhibiting protein synthesis" }, "summary": { "zh": "当前标签的微生物学部分说明，多西环素通过结合细菌 30S 核糖体亚基抑制蛋白质合成，并具有抑菌活性。机制不能仅凭发热、咳嗽、咽痛或皮疹判断病因、敏感性、是否需要抗菌药或疗程。", "en": "The microbiology section of the current label states that doxycycline inhibits bacterial protein synthesis by binding the 30S ribosomal subunit and has bacteriostatic activity. The mechanism cannot determine the cause, susceptibility, need for an antibacterial or course from fever, cough, sore throat or rash alone." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要使用剩药、与家人共用、因症状相似自行启动或提前停止。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share with family, start because symptoms look similar or stop early on your own." }, { "zh": "同属四环素类、同为多西环素或毫克数相同，也不证明不同盐型、剂型、包装和市场产品可以自行替换。", "en": "A shared tetracycline class, doxycycline ingredient or milligram number does not prove that different salts, forms, packs and markets are self-interchangeable." }, { "zh": "机制段落不能替代培养、药敏、感染部位、年龄、妊娠哺乳状态、器官功能和完整药单的专业判断，也不能从网页自动生成个人疗程。", "en": "A mechanism paragraph cannot replace professional review of cultures, susceptibility, infection site, age, pregnancy or breastfeeding, organ function and the complete medicine list, and it cannot generate an individual course from this page." } ], "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VIBRAMYCIN", "generic": "多西环素", "dosageFormClass": "口服胶囊、复溶后口服混悬液用粉末及口服混悬液；三个产品的盐型、浓度基准和包装不同" }, "labelSource": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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_fe3a40ffffd88fab", "label": "DailyMed（NLM）：VIBRAMYCIN 当前美国公开标签 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "2026-08-28", "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": "VIBRAMYCIN 当前美国公开标签包含 100 mg 胶囊、25 mg/5 mL 复溶后混悬液和 50 mg/5 mL 口服混悬液三个准确产品记录，并明确标注全部产品已经停止销售。本页保留品牌、盐型、浓度基准、NDC、包装图和安全阅读点；不把历史标签误写成当前库存，也不把 mg 或 mg/5 mL 变成个人服用量。", "history": "DailyMed 当前标签把 VIBRAMYCIN 三个口服产品分别连接到 1967 或 1974 年开始的美国 NDA 营销记录，并给出各自的营销结束日期。标签在 2026 年仍作为监管公开记录更新，不表示这些停止销售的品牌产品重新上市。其他多西环素产品必须按申请号、盐型、剂型、强度和市场另行核验。", "sourceDocuments": [ { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_fe3a40ffffd88fab", "label": "DailyMed（NLM）：VIBRAMYCIN 当前美国公开标签 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 050007 / 050006 / 050480（VIBRAMYCIN 三个停止销售的美国口服产品记录）", "approvalTimeline": [ { "date": "1967-12-05", "title": { "zh": "VIBRAMYCIN Hyclate 胶囊美国营销起始记录", "en": "U.S. marketing-start record for VIBRAMYCIN Hyclate capsules" }, "detail": { "zh": "当前标签产品表把 100 mg 胶囊与 NDA 050007 及该日期相连；营销结束日期列为 2024-11-30。", "en": "The current label product table links the 100 mg capsule to NDA 050007 and this date; it lists a marketing end date of 30 Nov 2024." }, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-05-13", "title": { "zh": "DailyMed 当前 SPL v47 生效", "en": "Current DailyMed SPL v47 effective" }, "detail": { "zh": "该日期定位当前公开文件版本。标签同时明确所有剂型与强度目前均未上市销售，因此文件更新不能被解释为产品重新供应。", "en": "This date identifies the current public document version. The label also explicitly states that all forms and strengths are not currently marketed, so the document update must not be read as renewed supply." }, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签存在；标签所列三个产品均已停止销售", "en": "Current public label exists; all three listed products are discontinued" }, "detail": { "zh": "标签保留三个 NDA、NDC、产品图和营销结束日期。它是可追溯的监管记录，不是库存、购买资格或重新上市结论。", "en": "The label retains three NDAs, NDCs, product images and marketing end dates. It is a traceable regulatory record, not a stock, purchase-eligibility or relaunch finding." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌记录推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator/generic relationship or interchangeability is inferred from the U.S. historical brand record." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签还在更新，是否表示 VIBRAMYCIN 现在还能买到？", "en": "If the label is still updated, does that mean VIBRAMYCIN is currently available?" }, "answer": { "zh": "不是。当前标签明确写明所有所列剂型和强度目前均未上市销售，并在产品表中列出营销结束日期。标签存在是监管档案事实，不是库存或购买结论。", "en": "No. The current label explicitly says that all listed forms and strengths are not currently marketed and gives marketing end dates in the product tables. The label's existence is a regulatory-record fact, not a stock or purchasing conclusion." } }, { "question": { "zh": "25 mg/5 mL 是否等于一次应该喝 5 mL？", "en": "Does 25 mg/5 mL mean a person should take 5 mL at one time?" }, "answer": { "zh": "不是。25 mg/5 mL 只表示复溶后液体的标签浓度；个人毫升数、频率和疗程必须来自准确处方并由专业人员核对。", "en": "No. 25 mg/5 mL only states the labelled concentration after reconstitution. Individual millilitres, frequency and course must come from the exact prescription and professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vibramycin/", "en": "https://origindrug.com/en/drugs/vibramycin/" }, "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." ] }