{
  "id": "duphalac-lactulose",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-09",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Duphalac",
    "generic": "乳果糖",
    "aliases": [
      "杜密克",
      "杜密克®",
      "乳果糖口服溶液",
      "lactulose",
      "Duphalac",
      "乳果糖"
    ],
    "marketBrandNames": [
      {
        "name": "杜密克® / Duphalac®",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "evidenceStatus": "dated_public_record",
        "note": {
          "zh": "袋装 OTC 原件；不是所有乳果糖产品的通用说明书。",
          "en": "Sachet OTC original, not a universal lactulose leaflet."
        },
        "source": {
          "id": "src_ef32e8bef5ca9032",
          "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
          "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "first_party_leaflet",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        }
      },
      {
        "name": "Duphalac",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "evidenceStatus": "dated_public_record",
        "note": {
          "zh": "NDF 记录为 67 g/100 mL；保留当地标示口径。",
          "en": "NDF records 67 g/100 mL; local notation is preserved."
        },
        "source": {
          "id": "src_c61a51c19f35ff25",
          "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28",
          "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "regulatory_product_record",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        }
      }
    ],
    "mainlandChinaTradeNameCue": {
      "value": "杜密克®",
      "status": "discovery_cue_requires_target_market_verification",
      "source": {
        "id": "src_ef32e8bef5ca9032",
        "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      }
    }
  },
  "identity": {
    "therapeuticArea": "消化系统",
    "sourceArchiveMarket": "中国杜密克袋装处方与非处方原件；英国、新加坡记录分列，不互套用法。",
    "dosageFormClass": "口服液体制剂",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1988（英国批准记录）",
    "archiveSponsorText": "Abbott B.V. / Mylan Products Ltd. (market-specific)"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "杜密克",
      "乳果糖",
      "lactulose",
      "Duphalac"
    ],
    "excludedProductCues": [
      "diosmectite",
      "蒙脱石",
      "polyethylene glycol",
      "聚乙二醇"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "cn-duphalac-otc-15ml-6-sachets",
      "marketCode": "CN",
      "labelVersion": {
        "zh": "袋装 OTC 原件，2025-05-21 修订",
        "en": "Sachet OTC original, revised 21 May 2025"
      },
      "dosageForm": {
        "zh": "乳果糖口服溶液",
        "en": "Lactulose oral solution"
      },
      "route": {
        "zh": "口服",
        "en": "Oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "HJ20171057",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_mL",
      "primaryDisplay": {
        "zh": "667 mg/mL；15 mL/袋；6 袋/盒",
        "en": "667 mg/mL; 15 mL/sachet; 6 sachets/carton"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "乳果糖",
            "en": "lactulose"
          },
          "value": 667,
          "unit": "mg",
          "basisCode": "per_mL",
          "basisLabel": {
            "zh": "每毫升含量，不是一次用量",
            "en": "Per mL, not a personal dose"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-09",
        "currentLabelDisplayed": false,
        "ndcDirectoryListed": false,
        "marketAvailability": "label_listed_not_live_supply",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 6,
        "unit": {
          "zh": "袋/盒",
          "en": "sachets/carton"
        }
      },
      "physicalClues": null,
      "comparisonNotice": null,
      "source": {
        "id": "src_ef32e8bef5ca9032",
        "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "cn-duphalac-otc-15ml-10-sachets",
      "marketCode": "CN",
      "labelVersion": {
        "zh": "袋装 OTC 原件，2025-05-21 修订",
        "en": "Sachet OTC original, revised 21 May 2025"
      },
      "dosageForm": {
        "zh": "乳果糖口服溶液",
        "en": "Lactulose oral solution"
      },
      "route": {
        "zh": "口服",
        "en": "Oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "HJ20171057",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_mL",
      "primaryDisplay": {
        "zh": "667 mg/mL；15 mL/袋；10 袋/盒",
        "en": "667 mg/mL; 15 mL/sachet; 10 sachets/carton"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "乳果糖",
            "en": "lactulose"
          },
          "value": 667,
          "unit": "mg",
          "basisCode": "per_mL",
          "basisLabel": {
            "zh": "每毫升含量，不是一次用量",
            "en": "Per mL, not a personal dose"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-09",
        "currentLabelDisplayed": false,
        "ndcDirectoryListed": false,
        "marketAvailability": "label_listed_not_live_supply",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 10,
        "unit": {
          "zh": "袋/盒",
          "en": "sachets/carton"
        }
      },
      "physicalClues": null,
      "comparisonNotice": null,
      "source": {
        "id": "src_ef32e8bef5ca9032",
        "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "cn-duphalac-otc-15ml-20-sachets",
      "marketCode": "CN",
      "labelVersion": {
        "zh": "袋装 OTC 原件，2025-05-21 修订",
        "en": "Sachet OTC original, revised 21 May 2025"
      },
      "dosageForm": {
        "zh": "乳果糖口服溶液",
        "en": "Lactulose oral solution"
      },
      "route": {
        "zh": "口服",
        "en": "Oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "HJ20171057",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_mL",
      "primaryDisplay": {
        "zh": "667 mg/mL；15 mL/袋；20 袋/盒",
        "en": "667 mg/mL; 15 mL/sachet; 20 sachets/carton"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "乳果糖",
            "en": "lactulose"
          },
          "value": 667,
          "unit": "mg",
          "basisCode": "per_mL",
          "basisLabel": {
            "zh": "每毫升含量，不是一次用量",
            "en": "Per mL, not a personal dose"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-09",
        "currentLabelDisplayed": false,
        "ndcDirectoryListed": false,
        "marketAvailability": "label_listed_not_live_supply",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 20,
        "unit": {
          "zh": "袋/盒",
          "en": "sachets/carton"
        }
      },
      "physicalClues": null,
      "comparisonNotice": null,
      "source": {
        "id": "src_ef32e8bef5ca9032",
        "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "先核文字身份，暂不展示外盒照片",
      "en": "Check text identity; exact carton photo not shown"
    },
    "summary": {
      "zh": "尚未取得与这三个中国 OTC 包装逐一对应的官方外盒图。包装卡不证明真伪或现货。",
      "en": "No official carton images matched individually to these three Chinese OTC packs were obtained. Cards establish neither authenticity nor stock."
    },
    "source": {
      "id": "src_ef32e8bef5ca9032",
      "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
      "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "first_party_leaflet",
      "market": "CN",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-09-09",
      "reviewedAt": "2026-09-09"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "大字读说明书：先分清 OTC 与处方版",
      "en": "Large-print reading: distinguish OTC and prescription versions"
    },
    "summary": {
      "zh": "本段阅读中国袋装 OTC 原件：用于慢性功能性便秘。袋数不是用量；老人及有其他疾病者应由医生指导使用。",
      "en": "This reads the Chinese sachet OTC original for chronic functional constipation. Pack count is not a dose; older adults and people with other conditions need medical guidance."
    },
    "checks": [
      {
        "zh": "667 mg/mL 是浓度；15 mL 是一袋体积。原件另写“15 mL：10 g”，保留标签的取整口径，不拿袋数决定一次喝多少。",
        "en": "667 mg/mL is concentration; 15 mL is sachet volume. The leaflet also states 15 mL:10 g using its rounded notation."
      },
      {
        "zh": "不明原因腹痛、肠梗阻或急性炎症性肠病等属于原件禁忌；先就医查原因。",
        "en": "Unexplained abdominal pain, obstruction and acute inflammatory bowel disease are among the contraindications; seek assessment first."
      },
      {
        "zh": "腹泻会造成水分和电解质丢失。老人长期使用需核对监测；同时有利尿药、强心苷等，应带完整药单问药师。",
        "en": "Diarrhoea can disturb fluid and electrolytes. Older long-term users need monitoring review; bring a complete list, including diuretics or cardiac glycosides."
      },
      {
        "zh": "若治疗二三天后便秘没有改善或反复出现，咨询医生；儿童、妊娠及哺乳期须另核原件限制。",
        "en": "Consult a clinician if constipation persists or recurs after two or three days; separately check paediatric, pregnancy and breastfeeding restrictions."
      }
    ],
    "source": {
      "id": "src_ef32e8bef5ca9032",
      "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
      "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "first_party_leaflet",
      "market": "CN",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-09-09",
      "reviewedAt": "2026-09-09"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "帮助肠道保留水分，让大便变软",
      "en": "Helps retain water in the bowel and soften stool"
    },
    "summary": {
      "zh": "肠道细菌把乳果糖分解成有机酸，改变肠内环境，并通过渗透作用增加水分、促进排便。",
      "en": "Bowel bacteria break lactulose into organic acids; the resulting osmotic effect increases water in the bowel and supports bowel movement."
    },
    "checks": [
      {
        "zh": "它不是即刻见效的“清肠水”；英国说明书提示可能需二三天起效，各市场原件应分开读。",
        "en": "It is not an instant bowel cleanse. The UK label notes that an effect may take two or three days; keep local instructions separate."
      },
      {
        "zh": "肝性脑病也是处方原件中的用途，但与便秘的治疗目标不同，不能抄用另一用途的剂量。",
        "en": "Hepatic encephalopathy is a prescription indication with different treatment goals; do not copy its dose for constipation."
      },
      {
        "zh": "吸收很少不等于没有副作用；腹胀、腹痛、腹泻及电解质问题仍需留意。",
        "en": "Low absorption does not mean no adverse effects: bloating, pain, diarrhoea and electrolyte problems still matter."
      }
    ],
    "source": {
      "id": "src_7598b6ea3f635a2e",
      "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022",
      "url": "https://www.medicines.org.uk/emc/product/5525/smpc",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "UK",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-09",
      "reviewedAt": "2026-09-09"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "Duphalac",
      "generic": "乳果糖",
      "dosageFormClass": "口服液体制剂"
    },
    "labelSource": {
      "id": "src_ef32e8bef5ca9032",
      "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
      "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "first_party_leaflet",
      "market": "CN",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-09-09",
      "reviewedAt": "2026-09-09"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_ef32e8bef5ca9032",
          "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
          "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "first_party_leaflet",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        },
        "status": "manufacturer_public_label_verified",
        "authority": {
          "zh": "雅培中国",
          "en": "Abbott China"
        },
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "recordType": {
          "zh": "企业公开说明书",
          "en": "Manufacturer public leaflet"
        },
        "reviewedAt": "2026-09-09",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_d09b4df491f3fd70",
          "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21",
          "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "first_party_leaflet",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        },
        "status": "manufacturer_public_label_verified",
        "authority": {
          "zh": "雅培中国",
          "en": "Abbott China"
        },
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "recordType": {
          "zh": "企业公开说明书",
          "en": "Manufacturer public leaflet"
        },
        "reviewedAt": "2026-09-09",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_7598b6ea3f635a2e",
          "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022",
          "url": "https://www.medicines.org.uk/emc/product/5525/smpc",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "英国电子药品目录 eMC",
          "en": "UK electronic medicines compendium (emc)"
        },
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "recordType": {
          "zh": "公开药品说明书或患者说明书",
          "en": "Public product information or patient leaflet"
        },
        "reviewedAt": "2026-09-09",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_c61a51c19f35ff25",
          "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28",
          "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "regulatory_product_record",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "新加坡国家药物目录 NDF",
          "en": "Singapore National Drug Formulary (NDF)"
        },
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "recordType": {
          "zh": "政府药物目录产品资料与说明书节选",
          "en": "Government drug formulary product information and leaflet excerpts"
        },
        "reviewedAt": "2026-09-09",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      }
    ],
    "recordRoute": {
      "status": "manufacturer_public_label_verified",
      "authority": {
        "zh": "雅培中国",
        "en": "Abbott China"
      },
      "market": {
        "zh": "中国大陆",
        "en": "Mainland China"
      },
      "recordType": {
        "zh": "企业公开说明书",
        "en": "Manufacturer public leaflet"
      },
      "reviewedAt": "2026-09-09",
      "scope": {
        "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
        "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
      }
    },
    "channels": [
      {
        "id": "china-nmpa-drug-evaluation-centre",
        "authority": "NMPA 药品评价中心",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "title": {
          "zh": "药物警戒快讯与安全警示",
          "en": "Drug-vigilance bulletins and safety notices"
        },
        "purpose": {
          "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。",
          "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item."
        },
        "source": {
          "id": "src_05ff2860226564d4",
          "label": "国家药监局药品评价中心：药物警戒与安全警示入口",
          "url": "https://www.cdr-adr.org.cn/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-drug-safety-communications",
        "authority": "FDA",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "药物安全通讯",
          "en": "Drug Safety Communications"
        },
        "purpose": {
          "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。",
          "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications."
        },
        "source": {
          "id": "src_9177df9e1825aa72",
          "label": "FDA：Drug Safety Communications",
          "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-medwatch",
        "authority": "FDA MedWatch",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "安全信息与严重问题报告",
          "en": "Safety information and serious-problem reporting"
        },
        "purpose": {
          "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。",
          "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality."
        },
        "source": {
          "id": "src_e4739cd55d27ab51",
          "label": "FDA：MedWatch 药品安全信息与不良事件报告计划",
          "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "ema-pharmacovigilance",
        "authority": "EMA",
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "title": {
          "zh": "药物警戒概览与 EudraVigilance",
          "en": "Pharmacovigilance overview and EudraVigilance"
        },
        "purpose": {
          "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。",
          "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment."
        },
        "source": {
          "id": "src_2ad42a3deae747d1",
          "label": "EMA：Pharmacovigilance overview",
          "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mhra-drug-safety-update",
        "authority": "MHRA",
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "title": {
          "zh": "Drug Safety Update",
          "en": "Drug Safety Update"
        },
        "purpose": {
          "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。",
          "en": "Primary UK MHRA medicine-safety updates for professionals and the public."
        },
        "source": {
          "id": "src_23fdbe67abeafc63",
          "label": "MHRA：Drug Safety Update",
          "url": "https://www.gov.uk/drug-safety-update",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "pmda-drug-safety",
        "authority": "PMDA",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "title": {
          "zh": "药品安全信息",
          "en": "Medicine safety information"
        },
        "purpose": {
          "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。",
          "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents."
        },
        "source": {
          "id": "src_06d6be2880f12024",
          "label": "PMDA：Safety Information Regarding Drugs",
          "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mfds-drug-safety-letters",
        "authority": "MFDS",
        "market": {
          "zh": "韩国",
          "en": "Republic of Korea"
        },
        "title": {
          "zh": "药品安全性书信",
          "en": "Medicine safety letters"
        },
        "purpose": {
          "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。",
          "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case."
        },
        "source": {
          "id": "src_2d7f5018cd05eff4",
          "label": "MFDS：药品安全性书信（韩文原始资料）",
          "url": "https://www.mfds.go.kr/brd/m_545/list.do",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "KR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "hsa-adverse-events",
        "authority": "HSA",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "title": {
          "zh": "不良反应报告与药物安全信息",
          "en": "Adverse-event reporting and medicine-safety information"
        },
        "purpose": {
          "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。",
          "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information."
        },
        "source": {
          "id": "src_9240397d5a8574c1",
          "label": "HSA：Report adverse events",
          "url": "https://www.hsa.gov.sg/adverse-events/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "health-canada-medeffect-advisories",
        "authority": "Health Canada",
        "market": {
          "zh": "加拿大",
          "en": "Canada"
        },
        "title": {
          "zh": "MedEffect 加拿大：建议、警告与召回",
          "en": "MedEffect Canada: advisories, warnings and recalls"
        },
        "purpose": {
          "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。",
          "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item."
        },
        "source": {
          "id": "src_212ec921fa6634ad",
          "label": "Health Canada：MedEffect Canada 建议、警告与召回",
          "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "tga-safety-alerts",
        "authority": "TGA",
        "market": {
          "zh": "澳大利亚",
          "en": "Australia"
        },
        "title": {
          "zh": "药品安全警示",
          "en": "Medicine safety alerts"
        },
        "purpose": {
          "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。",
          "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products."
        },
        "source": {
          "id": "src_ffe6142814f88fac",
          "label": "TGA：Safety alerts",
          "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "AU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "swissmedic-pharmacovigilance",
        "authority": "Swissmedic",
        "market": {
          "zh": "瑞士",
          "en": "Switzerland"
        },
        "title": {
          "zh": "药物警戒与不良反应报告",
          "en": "Pharmacovigilance and suspected adverse-reaction reporting"
        },
        "purpose": {
          "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。",
          "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality."
        },
        "source": {
          "id": "src_c854f813ce2671df",
          "label": "Swissmedic：Pharmacovigilance",
          "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "CH",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "medsafe-safety-communications",
        "authority": "Medsafe",
        "market": {
          "zh": "新西兰",
          "en": "New Zealand"
        },
        "title": {
          "zh": "药品安全通讯",
          "en": "Medicine safety communications"
        },
        "purpose": {
          "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。",
          "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information."
        },
        "source": {
          "id": "src_3510c1a523ec9769",
          "label": "Medsafe：Safety Communications",
          "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "NZ",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "sahpra-safety-information",
        "authority": "SAHPRA",
        "market": {
          "zh": "南非",
          "en": "South Africa"
        },
        "title": {
          "zh": "药物安全信息、警示与药物警戒",
          "en": "Medicine safety information, alerts and pharmacovigilance"
        },
        "purpose": {
          "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。",
          "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information."
        },
        "source": {
          "id": "src_25b0aaefee742163",
          "label": "SAHPRA：Safety Information Updates / Pharmacovigilance",
          "url": "https://www.sahpra.org.za/safety-information-and-updates/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "ZA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "who-medicine-safety-alerts",
        "authority": "WHO",
        "market": {
          "zh": "全球",
          "en": "Global"
        },
        "title": {
          "zh": "药品与疫苗安全警示档案",
          "en": "Medicine and vaccine safety-alert archive"
        },
        "purpose": {
          "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。",
          "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market."
        },
        "source": {
          "id": "src_9a7dc56ec34c7e1a",
          "label": "WHO：Safety alerts for medicines and vaccines",
          "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "GLOBAL",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "anvisa-pharmacovigilance",
        "authority": "Anvisa",
        "market": {
          "zh": "巴西",
          "en": "Brazil"
        },
        "title": {
          "zh": "药物警戒、警示与 VigiMed",
          "en": "Pharmacovigilance, alerts and VigiMed"
        },
        "purpose": {
          "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。",
          "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item."
        },
        "source": {
          "id": "src_5de362c12580111d",
          "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）",
          "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "BR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "notices": [],
    "boundary": {
      "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。",
      "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline."
    },
    "scope": "official_routes_only_no_live_alert_inference"
  },
  "archive": {
    "summary": "杜密克的成分是乳果糖，用于帮助缓解便秘。667 mg/mL 表示每毫升的成分含量，15 mL 是一袋液体的体积。先确认手里是哪个市场、处方版还是非处方版，再核对医生或药师给你的用法。",
    "history": "英国所列首次批准日期为 1988-03-14，不是全球首发结论。中国雅培袋装处方与非处方文件均标注 2025-05-21 修订；新加坡另以 SIN02818P 登记。",
    "sourceDocuments": [
      {
        "id": "src_ef32e8bef5ca9032",
        "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      {
        "id": "src_d09b4df491f3fd70",
        "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21",
        "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "first_party_leaflet",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      {
        "id": "src_7598b6ea3f635a2e",
        "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022",
        "url": "https://www.medicines.org.uk/emc/product/5525/smpc",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "UK",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      },
      {
        "id": "src_c61a51c19f35ff25",
        "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28",
        "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "regulatory_product_record",
        "market": "SG",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-09",
        "reviewedAt": "2026-09-09"
      }
    ],
    "applicationNumber": "CN HJ20171057; UK PL 46302/0032; SG SIN02818P",
    "approvalTimeline": [
      {
        "date": "1988-03-14",
        "title": {
          "zh": "英国所列首次批准",
          "en": "First authorisation listed in the UK"
        },
        "detail": {
          "zh": "仅对应英国原件的本市场日期。",
          "en": "Market-specific date in the UK original."
        },
        "source": {
          "id": "src_7598b6ea3f635a2e",
          "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022",
          "url": "https://www.medicines.org.uk/emc/product/5525/smpc",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        }
      },
      {
        "date": "2025-05-21",
        "title": {
          "zh": "中国说明书修订",
          "en": "Chinese leaflets revised"
        },
        "detail": {
          "zh": "袋装 OTC 与处方文件分别保留。",
          "en": "Sachet OTC and prescription documents remain separate."
        },
        "source": {
          "id": "src_d09b4df491f3fd70",
          "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21",
          "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "first_party_leaflet",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-09",
          "reviewedAt": "2026-09-09"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "status": {
          "zh": "企业公开原件已核对",
          "en": "First-party originals checked"
        },
        "detail": {
          "zh": "处方文件列便秘及肝性脑病用途，袋装包装列 6 袋；OTC 另列 6/10/20 袋。本页包装卡只引用 OTC；未独立核验 NMPA 当前记录。",
          "en": "The prescription document covers constipation and hepatic encephalopathy and lists a six-sachet carton. OTC lists 6/10/20. Pack cards cite OTC only; a separate current NMPA check is not completed."
        }
      },
      {
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "status": {
          "zh": "政府 NDF 产品记录已核对",
          "en": "Government NDF product record checked"
        },
        "detail": {
          "zh": "SIN02818P，持有人 Abbott Laboratories (Singapore) Private Limited，制造商 Abbott Biologicals B.V.；不等于中国包装或实时库存。",
          "en": "SIN02818P: holder Abbott Laboratories (Singapore) Private Limited; manufacturer Abbott Biologicals B.V. This is not Chinese packaging or live stock."
        }
      },
      {
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "status": {
          "zh": "eMC 原件已核对",
          "en": "emc original checked"
        },
        "detail": {
          "zh": "原件正文修订日期是 2022 年 4 月；本次访问日期不是新修订日期。",
          "en": "The text revision is April 2022; this access check is not a new label revision."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "不含辅料，就是无糖吗？",
          "en": "Does no excipients mean sugar-free?"
        },
        "answer": {
          "zh": "不是。处方原件同时写有生产过程带入的半乳糖、乳糖及亚硫酸盐相关提示；糖不耐受、糖尿病或过敏应按具体原件咨询。",
          "en": "No. The prescription original also discusses galactose, lactose and sulphite associated with manufacturing. Review sugar intolerance, diabetes or allergy against the exact original."
        }
      },
      {
        "question": {
          "zh": "两种说明书能挑方便的那份用吗？",
          "en": "Can I choose whichever leaflet is more convenient?"
        },
        "answer": {
          "zh": "不能。用准确药盒和处方核对用途、版本、计量工具及个人用法；不要混合处方版、OTC 或国外方案。",
          "en": "No. Match your pack and prescription to the indication, version, measuring device and individual instructions rather than mixing versions or countries."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "dose-unit-literacy",
      "medicine-label-for-everyday-questions",
      "interactions-are-not-a-home-scheduling-problem"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/duphalac-lactulose/",
    "en": "https://origindrug.com/en/drugs/duphalac-lactulose/"
  },
  "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."
  ]
}