{
  "id": "prandin-novonorm-repaglinide",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-31",
    "status": "published_traceable_archive"
  },
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    "brand": "NovoNorm / PRANDIN",
    "generic": "瑞格列奈",
    "aliases": [
      "NovoNorm",
      "PRANDIN",
      "Prandin",
      "repaglinide",
      "瑞格列奈",
      "瑞格列奈片",
      "诺和龙",
      "repaglinide tablets",
      "NDA 020741",
      "EMEA/H/C/000187",
      "EMEA/H/C/000362"
    ],
    "marketBrandNames": [
      {
        "name": "NovoNorm",
        "market": {
          "zh": "EU",
          "en": "EU"
        },
        "note": null,
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          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
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          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      },
      {
        "name": "Prandin",
        "market": {
          "zh": "EU",
          "en": "EU"
        },
        "note": null,
        "source": {
          "id": "src_ee2a949c77b2dc48",
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          "documentStatus": "current_regulatory_record",
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          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      },
      {
        "name": "PRANDIN",
        "market": {
          "zh": "US",
          "en": "US"
        },
        "note": null,
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录",
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          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
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          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "name": "NovoNorm",
        "market": {
          "zh": "CN",
          "en": "CN"
        },
        "note": null,
        "source": {
          "id": "src_6886ccd150c2c1fd",
          "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索",
          "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_price_record",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      }
    ],
    "mainlandChinaTradeNameCue": {
      "value": "诺和龙®",
      "status": "discovery_cue_requires_target_market_verification",
      "source": {
        "id": "src_281bcdb5add33c39",
        "label": "泾县人民政府：医保高值药品参考清单中的诺和龙／瑞格列奈片记录",
        "url": "https://www.ahxx.gov.cn/group1/M00/47/45/Cpc8VmZo5wiAK4pvAAM6bEblTyM892.pdf",
        "audience": "public",
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        "documentStatus": "historical_public_record",
        "documentKind": "government_medicine_listing",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-12",
        "reviewedAt": "2026-09-12"
      }
    }
  },
  "identity": {
    "therapeuticArea": "代谢",
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    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1997（美国初始批准）／1998（欧盟 NovoNorm 首次授权）",
    "archiveSponsorText": "Novo Nordisk（欧盟授权记录与美国历史原研参比记录）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
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      "NovoNorm repaglinide",
      "PRANDIN repaglinide",
      "瑞格列奈",
      "瑞格列奈片",
      "诺和龙"
    ],
    "excludedProductCues": [
      "PRANDIMET",
      "repaglinide and metformin",
      "瑞格列奈二甲双胍",
      "STARLIX",
      "nateglinide",
      "那格列奈"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
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      },
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      },
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      "primaryDisplay": {
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            "zh": "每片标签标示量；不是个人频次或餐时方案",
            "en": "labelled amount per tablet; not an individual's frequency or meal schedule"
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        "en": "1 mg repaglinide per tablet; yellow round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count"
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        "en": "NovoNorm repaglinide 2 mg oral tablet"
      },
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        "zh": "口服",
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      "primaryDisplay": {
        "zh": "每片含瑞格列奈 2 mg；桃色圆形凸面片，刻 Novo Nordisk 标志；不是个人每次片数",
        "en": "2 mg repaglinide per tablet; peach-coloured round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count"
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            "zh": "每片标签标示量；不是个人频次或餐时方案",
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      "source": {
        "id": "src_10e511bf83430e3b",
        "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录",
        "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "有官方片剂外观文字，但未取得六个身份逐一对应的当前官方包装主图",
      "en": "Official tablet appearance text is available, but no current official principal pack image was obtained one-to-one for all six identities"
    },
    "summary": {
      "zh": "EMA 说明书描述 0.5 mg 为白色、1 mg 为黄色、2 mg 为桃色的圆形凸面片，并刻 Novo Nordisk 标志。颜色和标志只能作为欧盟准确产品的辅助线索；美国历史 PRANDIN、中国诺和龙以及不同批次包装可能不同，不能据此单独判断真伪。",
      "en": "The EMA label describes round convex tablets engraved with the Novo Nordisk logo: white for 0.5 mg, yellow for 1 mg and peach-coloured for 2 mg. Colour and logo are supporting clues only for the exact EU product. Historical U.S. PRANDIN, China-market NovoNorm and packs from other periods may differ, so appearance alone cannot establish authenticity."
    },
    "source": {
      "id": "src_26f15f0758888053",
      "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
      "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-31",
      "reviewedAt": "2026-08-31"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "NovoNorm 说明书放大阅读：每片含量、餐时语言、低血糖与相互作用",
      "en": "NovoNorm enlarged label: per-tablet strength, meal-related wording, hypoglycaemia and interactions"
    },
    "summary": {
      "zh": "说明书把瑞格列奈与正餐相联系，但本站不生成个人几点服、漏餐怎么办或补不补服的时间表。请按自己药盒、处方和当前说明书向开方者或药师核对；若出现意识混乱、抽搐、昏迷或严重低血糖疑虑，应立即寻求当地急救。",
      "en": "The label links repaglinide to main meals, but this site does not generate an individual clock time, missed-meal rule or make-up instruction. Check the exact pack, prescription and current label with the prescriber or pharmacist. Confusion, seizure, unconsciousness or concern about severe hypoglycaemia requires immediate local emergency help."
    },
    "checks": [
      {
        "zh": "0.5 mg、1 mg、2 mg 是每片含量，不是每餐片数；不同规格、不同市场和不同包装不能只按数字自行拼片或互换。",
        "en": "0.5 mg, 1 mg and 2 mg are amounts per tablet, not tablets per meal. Different strengths, markets and packs must not be assembled or interchanged from numbers alone."
      },
      {
        "zh": "说明书有餐前和漏餐相关文字，但个人餐次、血糖、处方和合并药不同。网页只提示核对，不自动生成餐时或漏服方案。",
        "en": "The label contains pre-meal and missed-meal wording, but meal patterns, glucose, prescriptions and co-medications differ. The site prompts verification and does not generate a meal-time or missed-dose plan."
      },
      {
        "zh": "瑞格列奈可导致低血糖；出汗、发抖、头晕、头痛或行为意识改变应及时按个人既有专业应急计划处理并联系医疗团队。抽搐、意识丧失或昏迷立即求助当地急救。",
        "en": "Repaglinide can cause hypoglycaemia. Sweating, tremor, dizziness, headache or behavioural or awareness change requires prompt action under the individual's established professional emergency plan and clinical contact. Seizure, loss of consciousness or coma requires immediate local emergency help."
      },
      {
        "zh": "吉非贝齐与瑞格列奈合用属于说明书禁忌。氯吡格雷可能显著增加瑞格列奈暴露；二甲双胍或其他降糖药可增加低血糖风险；β 受体阻滞剂可能掩盖低血糖信号。请带完整药单核对，不要自行停换或错开。",
        "en": "Gemfibrozil co-use is contraindicated by the label. Clopidogrel may substantially increase repaglinide exposure; metformin or another glucose-lowering medicine can increase hypoglycaemia risk; beta blockers may mask hypoglycaemia signals. Review the full medicine list and do not self-stop, switch or separate medicines."
      },
      {
        "zh": "严重肝功能障碍属于禁忌；体弱、营养不足、肝肾问题以及 75 岁以上人群需要专业核对。说明书指出 75 岁以上未开展临床研究，网页不会把年龄自动换成规格。",
        "en": "Severe hepatic dysfunction is contraindicated. Frailty, malnutrition, liver or kidney problems and age over 75 require professional review. The label says no clinical studies were conducted above age 75; the site does not convert age into a strength."
      },
      {
        "zh": "PRANDIMET 同时含瑞格列奈和二甲双胍，是不同复方产品；不能把它与单方 NovoNorm／PRANDIN 按商品名叠加。",
        "en": "PRANDIMET contains both repaglinide and metformin and is a different combination product. It must not be combined with single-ingredient NovoNorm or PRANDIN by brand name."
      }
    ],
    "source": {
      "id": "src_26f15f0758888053",
      "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
      "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-31",
      "reviewedAt": "2026-08-31"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "瑞格列奈怎样起作用：短效促胰岛素分泌，不等于胰岛素本身",
      "en": "How repaglinide works: a short-acting insulin secretagogue, not insulin itself"
    },
    "summary": {
      "zh": "EMA 说明书称瑞格列奈通过关闭胰岛 β 细胞膜上的 ATP 依赖性钾通道，使细胞去极化、钙通道开放并促进胰岛素释放；这一作用依赖仍有功能的 β 细胞。机制不能替个人解释一次血糖或决定联用、换药和规格。",
      "en": "The EMA label says repaglinide closes ATP-dependent potassium channels in pancreatic beta-cell membranes, depolarising the cells, opening calcium channels and stimulating insulin release. This depends on functioning beta cells. The mechanism cannot interpret one glucose result or choose a combination, switch or strength for an individual."
    },
    "checks": [
      {
        "zh": "瑞格列奈不是胰岛素，也不用于 1 型糖尿病或糖尿病酮症酸中毒。",
        "en": "Repaglinide is not insulin and is not for type 1 diabetes or diabetic ketoacidosis."
      },
      {
        "zh": "瑞格列奈、磺脲类和那格列奈都可能促进胰岛素分泌，但作用位点、产品和证据不同；同类或相近机制不允许按 mg 自行换算、叠加或轮换。",
        "en": "Repaglinide, sulfonylureas and nateglinide may all promote insulin release, but their targets, products and evidence differ. A related class or mechanism does not permit self-conversion, combination or rotation by milligrams."
      },
      {
        "zh": "说明书描述 CYP2C8、CYP3A4 与 OATP1B1 相关相互作用，不表示普通人需要全基因组检测，也不能由网页从基因或药名自动计算方案。",
        "en": "The label describes interactions involving CYP2C8, CYP3A4 and OATP1B1. This does not mean everyone needs whole-genome testing, and the site does not calculate a plan from genes or medicine names."
      }
    ],
    "source": {
      "id": "src_26f15f0758888053",
      "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
      "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-31",
      "reviewedAt": "2026-08-31"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "NovoNorm / PRANDIN",
      "generic": "瑞格列奈",
      "dosageFormClass": "口服片：0.5 mg、1 mg、2 mg 均为每片瑞格列奈含量；这些数字不是每次片数。EMA 说明书列出 30、90、120 或 270 片铝/铝泡罩包装，并注明并非所有包装规格都会上市；网页不把包装数量变成个人用法。"
    },
    "labelSource": {
      "id": "src_26f15f0758888053",
      "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
      "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-31",
      "reviewedAt": "2026-08-31"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_26f15f0758888053",
          "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
          "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-31",
        "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_05bf258a552c35fe",
          "label": "EMA：NovoNorm 瑞格列奈 EPAR 授权记录",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-31",
        "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_ee2a949c77b2dc48",
          "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-31",
        "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_10e511bf83430e3b",
          "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-08-29",
        "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": "EMA",
        "en": "EMA"
      },
      "market": {
        "zh": "欧盟/欧洲经济区",
        "en": "European Union / European Economic Area"
      },
      "recordType": {
        "zh": "监管产品记录或欧盟产品资料",
        "en": "Regulatory product record or EU product information"
      },
      "reviewedAt": "2026-08-31",
      "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": "NovoNorm／PRANDIN 是瑞格列奈品牌档案。0.5、1、2 mg 是每片含量，不是个人餐次或片数；说明书把使用与进餐相联系，但网页不会据此生成个人餐时表。低血糖、吉非贝齐禁忌，以及氯吡格雷、其他降糖药和可能掩盖低血糖信号的 β 受体阻滞剂，是优先核对事项。",
    "history": "FDA 于 1997-12-22 批准 PRANDIN NDA 020741；EMA 产品说明书记录 NovoNorm 于 1998-08-17 首次授权，EMA 数据另记录 Prandin 于 2001-01-29 获得授权。三个美国品牌规格当前均为 DISCN；欧盟两项授权记录与美国历史记录必须分开阅读。",
    "sourceDocuments": [
      {
        "id": "src_26f15f0758888053",
        "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
        "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-31",
        "reviewedAt": "2026-08-31"
      },
      {
        "id": "src_05bf258a552c35fe",
        "label": "EMA：NovoNorm 瑞格列奈 EPAR 授权记录",
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-31",
        "reviewedAt": "2026-08-31"
      },
      {
        "id": "src_ee2a949c77b2dc48",
        "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录",
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-31",
        "reviewedAt": "2026-08-31"
      },
      {
        "id": "src_10e511bf83430e3b",
        "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录",
        "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_6886ccd150c2c1fd",
        "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索",
        "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_price_record",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-31",
        "reviewedAt": "2026-08-31"
      }
    ],
    "applicationNumber": "欧盟 EMEA/H/C/000187（NovoNorm）、EMEA/H/C/000362（Prandin）；美国 NDA 020741（历史 PRANDIN）",
    "approvalTimeline": [
      {
        "date": "1997-12-22",
        "title": {
          "zh": "美国 PRANDIN 初始批准",
          "en": "Initial U.S. approval of PRANDIN"
        },
        "detail": {
          "zh": "FDA Orange Book 收录 NDA 020741 的 0.5、1、2 mg 历史 RLD 产品；当前均为 DISCN。",
          "en": "The FDA Orange Book records historical 0.5, 1 and 2 mg RLD products under NDA 020741; all are currently DISCN."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "1998-08-17",
        "title": {
          "zh": "欧盟 NovoNorm 首次授权",
          "en": "Initial EU authorisation of NovoNorm"
        },
        "detail": {
          "zh": "EMA 产品说明书记录首次授权日期为 1998-08-17。",
          "en": "EMA product information records the initial authorisation date as 17 August 1998."
        },
        "source": {
          "id": "src_26f15f0758888053",
          "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书",
          "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      },
      {
        "date": "2001-01-29",
        "title": {
          "zh": "欧盟 Prandin 获得授权",
          "en": "EU authorisation of Prandin"
        },
        "detail": {
          "zh": "EMA 保留独立 Prandin EPAR 授权记录。",
          "en": "EMA retains a separate authorised Prandin EPAR record."
        },
        "source": {
          "id": "src_ee2a949c77b2dc48",
          "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      },
      {
        "date": "2026-04-28",
        "title": {
          "zh": "中国政府公开页出现诺和龙名称与规格线索",
          "en": "China government page shows a dated NovoNorm name and strength cue"
        },
        "detail": {
          "zh": "该页面列有诺和龙／瑞格列奈片 1 mg×30 与 2 mg×30；仅作为有日期名称线索，不证明 NMPA 当前状态或库存。",
          "en": "The page lists NovoNorm/repaglinide tablets at 1 mg × 30 and 2 mg × 30. It is only a dated name cue and does not establish current NMPA status or stock."
        },
        "source": {
          "id": "src_6886ccd150c2c1fd",
          "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索",
          "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_price_record",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-31",
          "reviewedAt": "2026-08-31"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "欧盟",
          "en": "European Union"
        },
        "status": {
          "zh": "NovoNorm 与 Prandin 当前授权记录",
          "en": "Current authorised NovoNorm and Prandin records"
        },
        "detail": {
          "zh": "EMA 当前公开两个非仿制 EPAR 产品记录；实际供应仍须按国家核对。",
          "en": "EMA publicly retains two non-generic EPAR product records; actual supply still requires country-specific checking."
        }
      },
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "历史 RLD，当前 DISCN",
          "en": "Historical RLD; currently DISCN"
        },
        "detail": {
          "zh": "0.5、1、2 mg 品牌行均已停止销售，公开记录称并非因安全性或有效性撤回；不证明当前品牌有货。",
          "en": "The 0.5, 1 and 2 mg brand rows are discontinued, with public records indicating no safety-or-effectiveness withdrawal; this does not establish current brand stock."
        }
      },
      {
        "market": {
          "zh": "中国",
          "en": "China"
        },
        "status": {
          "zh": "有日期政府公开名称线索",
          "en": "Dated government public-name cue"
        },
        "detail": {
          "zh": "“诺和龙”名称可用于搜索和药盒核对起点；NMPA 批准文号、当前说明书、库存和真伪仍需官方渠道逐项核验。",
          "en": "The NovoNorm name can start search and pack checking. NMPA approval number, current label, stock and authenticity still require item-by-item official verification."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "两片 0.5 mg 能自行换成一片 1 mg 吗？",
          "en": "Can two 0.5 mg tablets be self-replaced by one 1 mg tablet?"
        },
        "answer": {
          "zh": "不能只做算术替换。虽然总标示量相同，准确产品、处方、包装、市场和个人计划仍需由药师或开方者核对。",
          "en": "Do not make an arithmetic substitution. Even when the labelled total matches, the exact product, prescription, pack, market and individual plan still require pharmacist or prescriber review."
        }
      },
      {
        "question": {
          "zh": "没吃饭时网页能告诉我怎么处理吗？",
          "en": "Can the website tell me what to do if I do not eat?"
        },
        "answer": {
          "zh": "不能生成个人指令。说明书把瑞格列奈与正餐相联系，但请按自己处方和当前药盒说明书联系药师或开方者；若已经服用后出现低血糖疑虑，及时按既有专业应急计划处理，严重症状立即求助当地急救。",
          "en": "The site cannot generate an individual instruction. The label links repaglinide to main meals, but use the exact prescription and current pack label and contact a pharmacist or prescriber. If it was already taken and hypoglycaemia is a concern, follow the established professional emergency plan promptly; severe symptoms require immediate local emergency help."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dose-unit-literacy",
      "same-class-is-not-same-medicine",
      "how-to-read-a-drug-label"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/prandin-novonorm-repaglinide/",
    "en": "https://origindrug.com/en/drugs/prandin-novonorm-repaglinide/"
  },
  "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."
  ]
}