{ "id": "methycobal-mecobalamin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Methycobal", "generic": "甲钴胺", "aliases": [ "弥可保", "弥可保®", "甲钴胺片", "mecobalamin", "methylcobalamin", "Methycobal", "メチコバール", "メコバラミン", "甲钴胺" ], "marketBrandNames": [ { "name": "メチコバール / Methycobal", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "dated_public_record", "note": { "zh": "日本原件按 250 μg、500 μg 片及细粒分栏。", "en": "The Japanese original separates 250/500 microgram tablets from fine granules." }, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "METHYCOBAL", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "政府记录为 500 MCG 糖衣片，注册号 SIN06291P；持有人为 EISAI (SINGAPORE)。", "en": "The government record identifies a 500 MCG sugar-coated tablet, SIN06291P, held by EISAI (SINGAPORE)." }, "source": { "id": "src_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "弥可保®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "historical_public_record", "note": { "zh": "2018 年企业公告中的品牌线索，不能替代中国现行说明书。", "en": "A brand clue from a 2018 company announcement, not a current Chinese leaflet." }, "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "弥可保®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "本页阅读日本口服片说明书，另列新加坡 500 μg 产品记录。中国弥可保仅有企业历史品牌资料，不代表已核实中国现行说明书、规格或批准状态。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（日本 500 μg 片销售开始）", "archiveSponsorText": "Eisai" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "甲钴胺", "弥可保", "Methycobal", "mecobalamin", "methylcobalamin", "メチコバール" ], "excludedProductCues": [ "cyanocobalamin", "氰钴胺", "hydroxocobalamin", "羟钴胺", "cobamamide", "腺苷钴胺", "Rozebalamin", "ロゼバラミン" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-methycobal-250mcg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 电子添文，2023 年 4 月第 1 版", "en": "PMDA electronic label, April 2023, first revision" }, "dosageForm": { "zh": "甲钴胺糖衣片", "en": "Mecobalamin sugar-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product identity)" }, "routeCodes": [ "oral" ], "productCode": "15400AMZ01326000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲钴胺 250 μg；100 片包装", "en": "250 micrograms mecobalamin per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲钴胺", "en": "mecobalamin" }, "value": 250, "unit": "μg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-methycobal-500mcg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 电子添文，2023 年 4 月第 1 版", "en": "PMDA electronic label, April 2023, first revision" }, "dosageForm": { "zh": "甲钴胺糖衣片", "en": "Mecobalamin sugar-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product identity)" }, "routeCodes": [ "oral" ], "productCode": "15400AMZ01327000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲钴胺 500 μg；100 片包装", "en": "500 micrograms mecobalamin per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲钴胺", "en": "mecobalamin" }, "value": 500, "unit": "μg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "原件有日本片剂图；本页不冒用外盒照片", "en": "Japanese tablet images are in the original; no substitute carton photo" }, "summary": { "zh": "可从日本患者指南核对片剂外观。这里未取得与具体包装对应的外盒照片，不用电商图、注射剂或别国包装代替；外观不能单独证明真伪。", "en": "Use the Japanese patient guide to inspect tablet appearance. No exact carton photograph has been verified here. Retail, injection or other-market images are not substituted; appearance alone cannot authenticate medicine." }, "source": { "id": "src_839ae851935d166d", "label": "PMDA: Methycobal patient guide, May 2026", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_3136004C1038_1_00GW/170033_3136004C1038_1_00GW.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先认单位，再核对用法", "en": "Large-print leaflet reading: units before tablet counts" }, "summary": { "zh": "日本电子说明书是 2023 年 4 月版，患者指南是 2026 年 5 月版；两者用途不同。中国药盒请另核中国原件，本页不把访问日期写成说明书修订日期。", "en": "The Japanese label is dated April 2023 and its patient guide May 2026. They serve different purposes. Check the Chinese original for a Chinese pack; access dates are not revision dates." }, "checks": [ { "zh": "μg（也写 mcg）是微克；mg 是毫克。500 μg = 0.5 mg，250 μg = 0.25 mg。单位换算只解释含量，不自动生成片数。", "en": "μg (also mcg) means micrograms; mg means milligrams. 500 μg = 0.5 mg and 250 μg = 0.25 mg. Unit conversion explains strength, not your tablet count." }, { "zh": "先把处方上的“每次用量、每天次数”和实际规格一起交给药师核对。不要只见“半毫克”就掰片，也不要把注射液或细粒按片数替换。", "en": "Have the prescribed amount, frequency and actual strength checked together. “Half a milligram” is not an instruction to halve a tablet or substitute injections or granules." }, { "zh": "日本说明书提醒：看不到效果时不应漫无目的地用上一个多月。请安排复评，而不是自行加量或把所有麻木都当作缺维生素。", "en": "The Japanese label cautions against continuing for over a month without benefit. Arrange reassessment rather than increasing the dose or assuming all numbness is vitamin deficiency." }, { "zh": "日本患者指南列出食欲下降、恶心、呕吐、腹泻等可能反应；不舒服或出现和平时不同的症状时，联系医生或药师。", "en": "The Japanese patient guide lists appetite loss, nausea, vomiting and diarrhoea among possible effects. Contact a clinician or pharmacist about new or unusual symptoms." }, { "zh": "药片要从泡罩中取出再服用，不能连同剪下的小格包装吞下。日本指南要求避光、防潮保存；实际药盒的保管说明仍要核对。", "en": "Remove the tablet from its blister before swallowing; never swallow a cut-out blister cell. The Japanese guide advises protection from light and moisture; check your actual pack’s storage directions." } ], "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "参与神经细胞代谢，不是“多吃就能补好神经”", "en": "Supports cellular metabolism; more does not mean better nerves" }, "summary": { "zh": "甲钴胺是维生素 B12 的一种形式，用于周围神经病。它像细胞代谢的“助手”，帮助身体完成神经细胞需要的化学反应；不等于一吃就能立即止痛。", "en": "Mecobalamin is a form of vitamin B12 used for peripheral neuropathies. It helps chemical processes needed by nerve cells; it is not a promise of immediate pain relief." }, "checks": [ { "zh": "进一步看机制：它作为酶的“助手”，参与把同型半胱氨酸转为蛋氨酸的反应。这不是根据某一项化验自行选药的依据。", "en": "In more detail, it acts as an enzyme helper in converting homocysteine to methionine. This is not a basis for selecting treatment from a single laboratory result." }, { "zh": "药理机制不能证明你的麻木原因，也不能据此决定疗程；是否适用需要结合诊断。", "en": "A mechanism does not identify the cause of your numbness or determine treatment duration; suitability depends on diagnosis." }, { "zh": "“都叫 B12”不等于产品相同。把复合维生素、其他 B12 制剂及全部药盒一起核对，避免漏报或重复使用。", "en": "A B12 label does not make products identical. Review multivitamins, other B12 preparations and all medicine packs together to avoid omissions or duplication." }, { "zh": "患者指南要求到其他医院就诊或另买药时告知正在使用本药。网页不根据“维生素”三个字判断联合用药安全。", "en": "The patient guide asks users to disclose this medicine at other clinics or when buying other medicines. This site does not infer combination safety from the word vitamin." } ], "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Methycobal", "generic": "甲钴胺", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-09-09", "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_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "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": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-09-09", "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": "甲钴胺是维生素 B12 的一种形式，口服产品用于周围神经病。先认清单位：500 μg 等于 0.5 mg，不是 500 mg。药盒上的每片含量，不等于医生为你安排的一次用量。", "history": "日本标签记载 500 μg 片于 1981 年 9 月开始销售。卫材 2018 年的苏州工厂公告将弥可保列为中国口服固体制剂产品，并另行介绍注射剂生产。这是剂型与生产历史线索，不是今日库存或全球首次上市证明。", "sourceDocuments": [ { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_839ae851935d166d", "label": "PMDA: Methycobal patient guide, May 2026", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_3136004C1038_1_00GW/170033_3136004C1038_1_00GW.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "JP 15400AMZ01326000 / 15400AMZ01327000; SG SIN06291P", "approvalTimeline": [ { "date": "1981-09", "title": { "zh": "日本 500 μg 片开始销售", "en": "Japanese 500 microgram tablet sales began" }, "detail": { "zh": "日本标签记录的本规格销售日期，不是全球首发结论。", "en": "A product-specific Japanese sales date, not a global-first claim." }, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2018-01-11", "title": { "zh": "中国口服固体制剂生产历史", "en": "Oral solid-dose manufacturing history in China" }, "detail": { "zh": "卫材公告介绍苏州新厂规划，并将弥可保口服产品与注射剂生产分开介绍；历史计划不改写为今天的实际产量。", "en": "Eisai’s announcement described Suzhou factory plans and separated oral products from injection manufacturing. Historical plans are not presented as today’s output." }, "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "历史品牌线索；现行说明书未核实", "en": "Historical brand clue; current leaflet not verified" }, "detail": { "zh": "尚未取得中国现行官方说明书和独立 NMPA 记录，不填入未经核实的批准编号、包装、价格或库存。", "en": "A current Chinese official leaflet and independent NMPA record have not been verified. Approval IDs, packs, prices and inventory are not invented." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 公开原件已核对", "en": "Public PMDA originals checked" }, "detail": { "zh": "本页两项 100 片包装仅作日本产品身份示例，不表示列齐所有包装或实时供应。", "en": "The two 100-tablet presentations are Japanese identity examples, not all pack sizes or live supply." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府产品记录已核对", "en": "Government product record checked" }, "detail": { "zh": "SIN06291P 对应 500 MCG 糖衣片；登记分类不移植到其他国家，也不等于本站提供销售。", "en": "SIN06291P identifies a 500 MCG sugar-coated tablet. Its local classification does not transfer to other countries or mean this site sells it." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 μg 比 0.5 mg 多吗？", "en": "Is 500 μg more than 0.5 mg?" }, "answer": { "zh": "不多，两者是同一个含量的不同写法。500 mg 则是 0.5 mg 的一千倍；核对时把数字和单位一起读给药师听。", "en": "No: these express the same amount. 500 mg is a thousand times 0.5 mg; read the number and unit together when checking with your pharmacist." } }, { "question": { "zh": "维生素类药就能随便加吗？", "en": "Can I freely add a vitamin medicine?" }, "answer": { "zh": "不要仅凭这个名称自行加量或叠加。先核对所有药品及营养补充剂的成分，并说清楚症状和已使用多久。", "en": "Do not add or increase treatment merely because it is a vitamin. Review all medicine and supplement ingredients, symptoms and duration of use." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/methycobal-mecobalamin/", "en": "https://origindrug.com/en/drugs/methycobal-mecobalamin/" }, "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." ] }