{ "id": "diamicron-mr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "DIAMICRON MR", "generic": "格列齐特", "aliases": [ "Diamicron", "Diamicron MR", "gliclazide", "格列齐特", "格列齐特缓释片", "格列齐特缓释", "MR gliclazide", "达美康缓释片", "达美康", "DIAMICRON MR", "Diamicron 60 mg MR", "ARTG 154042" ], "marketBrandNames": [ { "name": "达美康", "market": { "zh": "中国大陆（2025 年医院公开记录）", "en": "Mainland China (2025 public hospital record)" }, "evidenceStatus": "dated_public_record", "note": { "zh": "青岛市第三人民医院 2025 年 5 月 26 日公开记录列有“格列齐特缓释片（达美康）”、15×60 mg、缓释片和施维雅（天津）制药有限公司。这里帮助按中文药盒名称查找；它不是现行批准、当前价格或在售证明。下方澳大利亚 DIAMICRON 60 mg MR 说明书属于另一个市场，不能据此确认中国药盒的用法或互换关系。", "en": "Qingdao Third People's Hospital's public record dated 26 May 2025 lists gliclazide modified-release tablets (达美康), 15 × 60 mg and Servier (Tianjin) Pharmaceutical Co., Ltd. This is a Chinese pack-name search clue, not evidence of current authorization, price or availability. The Australian DIAMICRON 60 mg MR leaflet below belongs to a separate market and does not establish instructions or interchangeability for a Chinese pack." }, "source": { "id": "src_bfcd3ef4b4a99670", "label": "青岛政务网：青岛市第三人民医院药品公开记录（2025-05-26；达美康名称核对）", "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdsyy/zzbs/jg/202506/t20250604_9610087.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "public_hospital_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } ], "mainlandChinaTradeNameCue": { "value": "达美康®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年基层医疗机构药品信息中的达美康／格列齐特缓释片 60 mg 记录", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "澳大利亚：TGA ARTG 154042 当前公开记录列示 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack，并提供 Product Information（PI）及 Consumer Medicine Information（CMI）入口。本页不从该记录推定中国大陆、美国、欧盟或其他市场的批准、名称、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "格列齐特 60 mg MR（modified release，缓释）口服片；TGA ARTG 154042 所列泡罩包装", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009-11-11（澳大利亚 TGA ARTG 154042 登记日期）", "archiveSponsorText": "Servier Laboratories (Aust) Pty Ltd（TGA ARTG 154042 所列 sponsor）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "gliclazide immediate-release tablet", "格列齐特普通片", "GLICLAZIDE SANDOZ MR", "other gliclazide product", "其他格列齐特产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-diamicron-mr-gliclazide-60mg-tablet-blister-artg-154042", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 154042（2026-08-26 核验）", "en": "TGA ARTG 154042 (verified 26 Aug 2026)" }, "dosageForm": { "zh": "DIAMICRON 60 mg MR 格列齐特缓释口服片", "en": "DIAMICRON 60 mg MR gliclazide modified-release oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 154042", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 60 mg；MR 缓释片；泡罩包装（澳大利亚 TGA ARTG）", "en": "60 mg labelled per tablet; MR modified-release tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列齐特", "en": "gliclazide" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, schedule or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "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": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 TGA 产品级记录与官方电子说明书，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "The TGA product-level record and official electronic leaflets were reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 TGA ARTG 154042 中 DIAMICRON 60 mg MR、格列齐特 60 mg 片、MR 缓释剂型、泡罩包装及 PI/CMI 入口。此次没有保留可与这一准确 ARTG 展示面逐一对应的官方包装图；为避免把零售图、版本不明图、其他市场图或普通片图片误作准确 DIAMICRON MR 包装，页面不展示包装图片，只保留官方电子说明书供放大阅读。", "en": "This dossier retains DIAMICRON 60 mg MR, gliclazide 60 mg tablets, the MR modified-release form, blister packaging and PI/CMI routes in TGA ARTG 154042. No official package image that can be matched one-to-one to this exact ARTG presentation was retained; to avoid treating a retail image, version-uncertain image, another-market image or immediate-release-tablet image as an exact DIAMICRON MR package, the page withholds package imagery and retains the official electronic leaflets for enlarged reading." }, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "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": "DIAMICRON MR 说明书放大阅读：60 mg 与 MR 先是准确片剂身份", "en": "DIAMICRON MR label reading: 60 mg and MR identify an exact tablet first" }, "summary": { "zh": "本模块只阅读 TGA ARTG 154042 及其官方 PI/CMI 入口中的 DIAMICRON 60 mg MR、格列齐特、每片 60 mg、缓释片和泡罩包装。它不提供个人片数、开始、漏用处理、进餐、分片、研碎、同服、停用、换药或购买方案。", "en": "This module reads only DIAMICRON 60 mg MR, gliclazide, 60 mg per tablet, modified-release form and blister packaging in TGA ARTG 154042 and its official PI/CMI routes. It provides no individual tablet count, start, missed-use handling, meals, splitting, crushing, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先同时核对 DIAMICRON MR、格列齐特、每片 60 mg、MR（缓释）、泡罩包装、ARTG 154042 与目标市场。60 mg 是这一准确澳大利亚缓释片的标签标示量，不是网页可换算成个人片数、把两种强度相加或由普通片替代的规则。", "en": "Check DIAMICRON MR, gliclazide, 60 mg per tablet, MR (modified release), blister pack, ARTG 154042 and target market together. 60 mg is the labelled amount for this exact Australian modified-release tablet, not a web rule for personal tablet counts, adding strengths or replacing it with an immediate-release tablet." }, { "zh": "MR 是剂型身份，不只是药名后的字母。格列齐特普通片、另一持有人产品、其他缓释产品或其他市场包装，即使通用名或毫克数相同，也不能仅凭名称当作同一产品、自动互换或自行并用。", "en": "MR is part of dosage-form identity, not just letters after a name. A gliclazide immediate-release tablet, another sponsor's product, another modified-release product or another-market pack is not the same product merely because a generic name or milligram number matches; none becomes automatically interchangeable or suitable for self-directed co-use." }, { "zh": "PI/CMI 是准确产品的官方电子说明书入口。任何与低血糖、既往反应、肾肝问题、其他降糖药、饮酒、非处方药或补充剂有关的问题，都应把实际药盒、现行处方和完整药单交由药师或开方团队按当前文件逐项核对；本页不据此决定继续、暂停、补用或改变治疗。", "en": "The PI/CMI are official electronic-leaflet routes for the exact product. Questions about low blood glucose, prior reactions, kidney/liver problems, another glucose-lowering medicine, alcohol, OTC products or supplements require the actual pack, current prescription and complete medicine list to be checked item by item by a pharmacist or prescriber against current documents; this page does not decide continuation, pausing, make-up use or a treatment change." }, { "zh": "出现意识改变、抽搐、昏厥、呼吸困难、严重过敏表现或其他急性严重不适时，应使用当地紧急与医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药或用另一盒药抵消。", "en": "For altered consciousness, seizure, fainting, breathing difficulty, serious allergic features or another acute severe concern, use local urgent and medical pathways; do not wait for a web search or self-add, stop or counteract with another pack based on this page." } ], "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR 官方 Product Information / Consumer Medicine Information 入口", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "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": "格列齐特怎样起作用：它促使胰岛 β 细胞分泌胰岛素（机制说明，不是血糖方案）", "en": "How gliclazide works: it stimulates insulin secretion from pancreatic beta cells (a mechanism, not a glucose plan)" }, "summary": { "zh": "TGA 公开的 DIAMICRON MR 产品信息将格列齐特描述为口服磺脲类降糖药，并说明其可通过促使胰岛 β 细胞分泌胰岛素来降低血糖。本段只解释活性成分的作用路径；本档案的准确产品身份仍仅以 ARTG 154042 所列 DIAMICRON 60 mg MR 缓释片为准，机制不决定任何人的血糖、是否适用、每次片数、进餐、联用、暂停或替代。", "en": "TGA-released DIAMICRON MR product information describes gliclazide as an oral sulfonylurea that can lower blood glucose by stimulating insulin secretion from pancreatic beta cells. This explains an active-ingredient pathway only. The exact product identity in this dossier remains the DIAMICRON 60 mg MR modified-release tablet in ARTG 154042; mechanism does not determine anyone's glucose, suitability, tablet count, meals, co-use, pausing or substitution." }, "checks": [ { "zh": "“促使胰岛素分泌”不能解释某一次血糖变化、出汗、头晕、乏力或其他不适的原因，也不能让网页判断任何人应怎样处理。出现实际症状或读数问题时，请带实际药盒、处方和完整药单联系当地药师、开方团队或适当医疗支持。", "en": "“Stimulates insulin secretion” cannot explain the cause of one glucose change, sweating, dizziness, weakness or another symptom, and it cannot tell a webpage how any person should respond. With an actual symptom or reading concern, take the real pack, prescription and complete medicine list to a local pharmacist, prescriber or appropriate medical support." }, { "zh": "同为“降糖药”或都影响胰岛素，不表示 DIAMICRON MR 可与其他格列齐特、胰岛素、其他降糖药、非处方药、补充剂或饮酒自行叠加、错开、轮换或替代。产品的剂型、强度、目标市场标签和完整药单需要一起核对。", "en": "Being glucose-lowering products, or both affecting insulin, does not make DIAMICRON MR self-combinable, time-separable, alternatable or substitutable with another gliclazide product, insulin, another glucose-lowering medicine, OTC product, supplement or alcohol. Dosage form, strength, target-market label and the complete medicine list need review together." }, { "zh": "MR（缓释）属于准确片剂身份；作用机制并不授权掰开、研碎、把普通片与缓释片相互换算，或从毫克数字推导个人片数。对外观、吞咽、漏用、其他药物或生活方式有疑问时，应以当前官方说明书和专业人员核对为下一步。", "en": "MR (modified release) is part of exact tablet identity. A mechanism explanation does not authorise splitting, crushing, converting an immediate-release tablet and a modified-release tablet, or deriving a personal tablet count from a milligram number. For questions about appearance, swallowing, missed use, other medicines or lifestyle, the next step is the current official leaflet and professional review." } ], "source": { "id": "src_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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": "DIAMICRON MR", "generic": "格列齐特", "dosageFormClass": "格列齐特 60 mg MR（modified release，缓释）口服片；TGA ARTG 154042 所列泡罩包装" }, "labelSource": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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_3fd2581eec98dada", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-03389-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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_d4f5f1aa968cc2fe", "label": "澳大利亚 DIAMICRON 60 mg MR 患者说明书：2022 年版，未确认现行（MIMS 发布，ACSQHC 托管）", "url": "https://www.safetyandquality.gov.au/documents/de0382dc-d3d4-4c12-b131-a53300ff4a49?cmiFormat=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-09-12", "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_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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": "TGA 的产品级登记记录可核对 DIAMICRON 60 mg MR、格列齐特、每片 60 mg、modified release（MR）与泡罩包装，并直达该准确澳大利亚产品的 PI 和 CMI。页面帮助读者先辨认名称、剂型、每片标示量、市场和官方电子说明书；不把 mg、MR、包装数字或“降糖药”类别转换为个人片数、进餐、漏用、联用、停用、换药、替代或购买结论。", "history": "本档案以澳大利亚 TGA ARTG 154042 为产品身份锚点：ARTG 名称为 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack，登记日期为 2009-11-11，所列 sponsor 为 Servier Laboratories (Aust) Pty Ltd。MR 是该准确片剂身份的一部分；相同通用名、类似品牌名或同写 60 mg，均不能证明普通片、其他缓释片、其他包装或其他市场产品可自行掰开、互换、叠加、轮换或替代。", "sourceDocuments": [ { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_3fd2581eec98dada", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-03389-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_a27efd02f220275e", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Consumer Medicine Information（CMI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-03390-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_d4f5f1aa968cc2fe", "label": "澳大利亚 DIAMICRON 60 mg MR 患者说明书：2022 年版，未确认现行（MIMS 发布，ACSQHC 托管）", "url": "https://www.safetyandquality.gov.au/documents/de0382dc-d3d4-4c12-b131-a53300ff4a49?cmiFormat=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" }, { "id": "src_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "澳大利亚 TGA ARTG 154042（DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack）", "approvalTimeline": [ { "date": "2009-11-11", "title": { "zh": "TGA ARTG 登记日期", "en": "TGA ARTG registration date" }, "detail": { "zh": "TGA ARTG 154042 将 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack 的 ARTG Date 列为 2009-11-11。该日期只定位这一个澳大利亚监管产品记录，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "TGA ARTG 154042 lists 11 Nov 2009 as the ARTG date for DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack. This date locates only this Australian regulatory product record; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-08-26", "title": { "zh": "产品级记录与 PI/CMI 入口复核", "en": "Product-level record and PI/CMI entry routes verified" }, "detail": { "zh": "本轮核验可从 TGA ARTG 154042 直达该产品的 Product Information（PI）与 Consumer Medicine Information（CMI）入口。PI/CMI 由相关 sponsor 提供给 TGA 发布；页面仅把它们作为原始阅读入口，不将其转换为个人片数、停用、换药或购买结论。", "en": "This review confirmed that TGA ARTG 154042 links to this product's Product Information (PI) and Consumer Medicine Information (CMI) routes. The PI/CMI are supplied to TGA by the relevant sponsor for publication; this page presents them only as primary reading routes and does not turn them into individual tablet-count, stopping, switching or purchase conclusions." }, "source": { "id": "src_a27efd02f220275e", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR PI/CMI 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-03390-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "已链接 TGA ARTG 产品级记录与 PI/CMI 官方入口", "en": "TGA ARTG product-level record and official PI/CMI routes linked" }, "detail": { "zh": "本页只记录 ARTG 154042 中的 DIAMICRON 60 mg MR、格列齐特 60 mg 片、MR 缓释剂型与泡罩包装；不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、联用、停用、换药或可替代性。", "en": "This page records only DIAMICRON 60 mg MR, gliclazide 60 mg tablets, the MR modified-release form and blister packaging in ARTG 154042; it does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, the United States, the 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": "不从澳大利亚 ARTG 名称、登记日期、sponsor、PI/CMI 或泡罩包装推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the Australian ARTG name, date, sponsor, PI/CMI or blister pack; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "DIAMICRON MR 的 60 mg、MR 与泡罩包装能告诉我该吃几片，或能否换成普通格列齐特片吗？", "en": "Can DIAMICRON MR's 60 mg, MR and blister pack tell me how many to take or whether I can change to an immediate-release gliclazide tablet?" }, "answer": { "zh": "不能。这些字段只识别 TGA ARTG 154042 所列的准确澳大利亚缓释片。共同通用名、相近 mg、相似品牌或包装文字都不建立自行开始、增加、补用、掰开、研碎、停用、联用、轮换或替代关系；请带实际药盒、现行处方和完整药单请药师或开方团队核对。", "en": "No. These fields identify only the exact Australian modified-release tablet in TGA ARTG 154042. A shared generic name, nearby mg number, similar brand or package wording does not establish self-initiation, increase, make-up use, splitting, crushing, stopping, co-use, alternation or substitution; have a pharmacist or prescriber review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面给出 PI/CMI 链接，却不直接给我调整用法？", "en": "Why does the page link the PI/CMI without directly telling me to change use?" }, "answer": { "zh": "PI/CMI 是这个准确产品的官方原始阅读入口，但具体治疗决定需要把处方、实际包装、其他药物、既往反应和健康状况放在一起核对。不要仅因网页、标题或单一说明书段落自行停药、换药、加量、减量或错开时间。", "en": "The PI/CMI are official primary reading routes for this exact product, but treatment decisions require the prescription, actual pack, other medicines, prior reactions and health status to be reviewed together. Do not self-stop, switch, increase, reduce or separate timing from a webpage, headline or one leaflet section alone." } } ], "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/diamicron-mr/", "en": "https://origindrug.com/en/drugs/diamicron-mr/" }, "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." ] }