{
  "id": "duoplavin-clopidogrel-aspirin",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-06",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "DuoPlavin",
    "generic": "氯吡格雷／乙酰水杨酸（阿司匹林）",
    "aliases": [
      "DUOPLAVIN",
      "Duo Plavin",
      "clopidogrel acetylsalicylic acid",
      "clopidogrel aspirin",
      "clopidogrel/aspirin",
      "氯吡格雷阿司匹林",
      "氯吡格雷/阿司匹林",
      "氯吡格雷乙酰水杨酸",
      "氯吡格雷阿司匹林片"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "抗凝与血液",
    "sourceArchiveMarket": "欧盟：DuoPlavin EMEA/H/C/001143 当前集中授权档案、2026-06-11 更新的产品资料、两种强度及 15 个授权包装号。EMA 明确并非所有包装规格都一定上市，因此这些记录不代表实时库存、价格、购买资格或任一成员国当前供应。中国大陆、美国、日本及其他市场须另查当地现行记录。",
    "dosageFormClass": "DuoPlavin 薄膜衣片把氯吡格雷 75 mg 与阿司匹林 75 mg 或 100 mg 放在同一片内。两个数字分属两种有效成分，不是 150 mg 或 175 mg 的单一药；本页不从椭圆外形推导可掰片。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服（固定两成分产品身份字段）",
    "routeCode": "oral",
    "historicalApprovalEntry": "2010（欧盟集中授权）",
    "archiveSponsorText": "Sanofi Winthrop Industrie（EMA 当前上市许可持有人）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "DuoPlavin 75 mg/75 mg",
      "DuoPlavin 75 mg/100 mg",
      "clopidogrel/acetylsalicylic acid film-coated tablets",
      "氯吡格雷阿司匹林片"
    ],
    "excludedProductCues": [
      "PLAVIX",
      "clopidogrel alone",
      "单方氯吡格雷",
      "aspirin alone",
      "单方阿司匹林",
      "Bayer Aspirin",
      "AGGRENOX",
      "dipyridamole",
      "DuoCover",
      "EMEA/H/C/000874"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-14-tablet-eu-1-10-619-001",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/001",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；14 片泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 14-tablet blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 14,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 14,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-28-tablet-eu-1-10-619-002",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/002",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；28 片泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 28-tablet blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 28,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 28,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-30x1-tablet-eu-1-10-619-003",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/003",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；30 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 30 × 1-tablet unit-dose blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-50x1-tablet-eu-1-10-619-004",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/004",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；50 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 50 × 1-tablet unit-dose blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 50,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 50,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-84-tablet-eu-1-10-619-005",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/005",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；84 片泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 84-tablet blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 84,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 84,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-90x1-tablet-eu-1-10-619-006",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/006",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；90 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 90 × 1-tablet unit-dose blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 90,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 90,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-100x1-tablet-eu-1-10-619-007",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/007",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；100 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 100 × 1-tablet unit-dose blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-30-tablet-eu-1-10-619-015",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/015",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；30 片泡罩纸盒；不是一种 150 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 30-tablet blister carton; not one 150 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A75",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-14-tablet-eu-1-10-619-008",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/008",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；14 片泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 14-tablet blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 14,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 14,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-28-tablet-eu-1-10-619-009",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/009",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；28 片泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 28-tablet blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 28,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 28,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-30x1-tablet-eu-1-10-619-010",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/010",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；30 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 30 × 1-tablet unit-dose blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-50x1-tablet-eu-1-10-619-011",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/011",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；50 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 50 × 1-tablet unit-dose blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 50,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 50,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-84-tablet-eu-1-10-619-012",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/012",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；84 片泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 84-tablet blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "全铝泡罩纸盒",
          "en": "all-aluminium blister carton"
        },
        "fill": null,
        "countPerPackage": 84,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 84,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-90x1-tablet-eu-1-10-619-013",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/013",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；90 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 90 × 1-tablet unit-dose blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 90,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 90,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-100x1-tablet-eu-1-10-619-014",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）",
        "en": "Current EMA EU product information (updated 11 Jun 2026)"
      },
      "dosageForm": {
        "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片",
        "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet"
      },
      "route": {
        "zh": "口服（固定两成分产品身份字段）",
        "en": "oral (fixed two-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/10/619/014",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；100 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物",
        "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 100 × 1-tablet unit-dose blister carton; not one 175 mg medicine"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氯吡格雷（以硫酸氢盐计）",
            "en": "clopidogrel (as hydrogen sulphate)"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率",
            "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "乙酰水杨酸（阿司匹林，ASA）",
            "en": "acetylsalicylic acid (aspirin, ASA)"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法",
            "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "unit_dose_blister_carton",
        "typeLabel": {
          "zh": "全铝单位剂量泡罩纸盒",
          "en": "all-aluminium unit-dose blister carton"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅粉色",
          "en": "light pink"
        },
        "shape": {
          "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定",
          "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication"
        },
        "imprint": "C75 / A100",
        "scoreStatus": "no_source_backed_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "官方文字可核对片色与刻印；没有准确包装图就明确留白",
      "en": "Official text supports colour and imprint checks; no exact pack image means an explicit blank"
    },
    "summary": {
      "zh": "75/75 mg 为黄色、刻 C75／A75；75/100 mg 为浅粉色、刻 C75／A100。颜色、形状、刻印、泡罩或网页截图只能作为线索，不能单独证明真伪；本页没有准确官方包装图，不用相似药盒代替。",
      "en": "The 75/75 mg tablet is yellow and marked C75/A75; the 75/100 mg tablet is light pink and marked C75/A100. Colour, shape, imprint, blister or a web screenshot is only a clue and cannot establish authenticity; no similar pack substitutes for an unavailable exact official pack image."
    },
    "source": {
      "id": "src_e2d29127841a1da3",
      "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
      "reviewedAt": "2026-09-06"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "DuoPlavin 说明书放大阅读：一片两种成分，先查重复与出血",
      "en": "DuoPlavin enlarged label: two ingredients in one tablet—check duplication and bleeding first"
    },
    "summary": {
      "zh": "75/75 与 75/100 的第一个 75 mg 都是氯吡格雷，第二个数字才是同一片中的阿司匹林。网页解释有效成分、包装、警戒信号和就医边界，不生成个人片数、停换药、漏服或手术停药方案。",
      "en": "In 75/75 and 75/100, the first 75 mg is clopidogrel and the second figure is aspirin in that same tablet. The page explains ingredients, packs, warning signals and care boundaries; it does not generate individual tablet counts, stopping/switching, missed-use or perioperative plans."
    },
    "checks": [
      {
        "zh": "这片药已经含阿司匹林与氯吡格雷。请把处方药、非处方止痛/感冒药、保健品及实际药盒一起核对；另一份阿司匹林、PLAVIX/氯吡格雷、其他抗血小板药、口服抗凝药、肝素、溶栓药或 NSAID 可能增加出血风险，不能靠错开时间自行消除。",
        "en": "This tablet already contains aspirin and clopidogrel. Review prescriptions, OTC pain/cold products, supplements and actual packs together. Another aspirin, PLAVIX/clopidogrel, antiplatelet, oral anticoagulant, heparin, thrombolytic or NSAID may increase bleeding risk; self-separating times does not remove that risk."
      },
      {
        "zh": "呕血或咖啡渣样呕吐、黑便或血便、持续或无法控制的出血、突然严重头痛伴意识/言语/肢体变化、昏厥、呼吸困难或严重过敏表现，应及时使用当地医疗服务；严重急性表现使用急救。",
        "en": "Vomiting blood or coffee-ground material, black or bloody stool, persistent or uncontrolled bleeding, sudden severe headache with awareness/speech/limb change, fainting, breathing difficulty or severe allergy requires prompt local medical care; severe acute features require emergency help."
      },
      {
        "zh": "手术、拔牙或任何侵入性操作前，应主动告知医生和牙医正在使用 DuoPlavin。不要根据网页自行停药：停用和操作时间必须由负责团队结合血栓与出血风险决定。",
        "en": "Tell physicians and dentists about DuoPlavin before surgery, dental work or another invasive procedure. Do not stop it from a web page; the responsible team must decide timing from both thrombotic and bleeding risks."
      },
      {
        "zh": "严重肾功能或肝功能问题、活动性出血或消化性溃疡、对阿司匹林/NSAID 过敏或相关哮喘、孕期、既往跌倒出血，以及 SSRI、奥美拉唑/埃索美拉唑、利福平等同处药单时，应优先请专业人员核对当前说明书。",
        "en": "Severe kidney or liver problems, active bleeding or peptic ulcer, aspirin/NSAID allergy or related asthma, pregnancy, prior falls/bleeding, or co-listing of an SSRI, omeprazole/esomeprazole, rifampicin or similar medicines requires priority professional review of the current label."
      },
      {
        "zh": "每片含乳糖 7 mg（75/75）或 8 mg（75/100），并含氢化蓖麻油 3.3 mg；后者可能引起胃部不适或腹泻。辅料差异适合用于准确产品过敏/耐受核对，不是“原研一定更好”的证据。",
        "en": "Each tablet contains lactose 7 mg (75/75) or 8 mg (75/100) and hydrogenated castor oil 3.3 mg; the latter may cause stomach upset or diarrhoea. Excipient differences support exact-product allergy/tolerance review and do not prove that an originator is always better."
      },
      {
        "zh": "官方产品资料没有给本页可用于公众自行掰片的许可。即使片剂呈椭圆形，也不要把外观当成刻痕或等分依据；吞咽困难应让药师核对准确产品与可行方案。",
        "en": "The official product information provides no public self-splitting permission used by this page. An oval shape is not a score or equal-division instruction; swallowing difficulty needs pharmacist review of the exact product and an appropriate option."
      }
    ],
    "source": {
      "id": "src_e2d29127841a1da3",
      "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "为什么一片里有两条抗血小板路径：作用相加，也会让出血核对更重要",
      "en": "Why one tablet uses two antiplatelet pathways: additive action also raises the priority of bleeding review"
    },
    "summary": {
      "zh": "氯吡格雷的活性代谢物不可逆抑制血小板 ADP 的 P2Y12 通路；阿司匹林不可逆抑制血小板环氧化酶并降低血栓烷 A2。两条路径解释固定复方设计，也解释为什么不能把另一种“防血栓药”随意叠加。",
      "en": "Clopidogrel's active metabolite irreversibly inhibits the platelet ADP P2Y12 pathway; aspirin irreversibly inhibits platelet cyclooxygenase and lowers thromboxane A2. The two pathways explain the fixed combination and why another antithrombotic medicine must not be added casually."
    },
    "checks": [
      {
        "zh": "CYP2C19 参与氯吡格雷活化，说明书说明低代谢者活性代谢物和血小板作用较低，也列出可识别基因型的检测；这不等于每个人都必须先做全基因筛查，更不允许网页据基因自行调片数。",
        "en": "CYP2C19 contributes to clopidogrel activation. The label notes lower active-metabolite exposure and platelet effect in poor metabolisers and the availability of genotype tests. This does not mean everyone needs whole-genome screening or permit a website to adjust tablet counts from genes."
      },
      {
        "zh": "奥美拉唑、埃索美拉唑等 CYP2C19 抑制剂可能降低氯吡格雷活性代谢物；强诱导剂又可能增加活性代谢物与出血风险。相互作用必须按准确药名、剂量、适应证和完整药单由专业人员评估，不能生成通用错开时间表。",
        "en": "CYP2C19 inhibitors such as omeprazole and esomeprazole may reduce clopidogrel active metabolite, while strong inducers may increase active metabolite and bleeding risk. Review must use the exact medicine, amount, indication and complete list; the site does not generate a universal separation schedule."
      },
      {
        "zh": "DuoPlavin、单方 PLAVIX、单方阿司匹林、AGGRENOX、BRILINTA、EFFIENT、PLETAL 与各种抗凝药不是按共同“防血栓”用途或总 mg 互换的同一种药。",
        "en": "DuoPlavin, single-ingredient PLAVIX, aspirin alone, AGGRENOX, BRILINTA, EFFIENT, PLETAL and anticoagulants are not one medicine that can be interchanged by a shared antithrombotic purpose or total milligrams."
      }
    ],
    "source": {
      "id": "src_e2d29127841a1da3",
      "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "DuoPlavin",
      "generic": "氯吡格雷／乙酰水杨酸（阿司匹林）",
      "dosageFormClass": "DuoPlavin 薄膜衣片把氯吡格雷 75 mg 与阿司匹林 75 mg 或 100 mg 放在同一片内。两个数字分属两种有效成分，不是 150 mg 或 175 mg 的单一药；本页不从椭圆外形推导可掰片。"
    },
    "labelSource": {
      "id": "src_e2d29127841a1da3",
      "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_e2d29127841a1da3",
          "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
          "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
          "reviewedAt": "2026-09-06"
        },
        "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": "2026-09-06",
        "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_c244551409ab29d8",
          "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin",
          "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": "2026-09-06",
          "reviewedAt": "2026-09-06"
        },
        "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": "2026-09-06",
        "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": "2026-09-06",
      "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": "DuoPlavin 一片已经同时含氯吡格雷和阿司匹林。老人整理药盒时应先按成分核对是否又出现 PLAVIX/氯吡格雷、阿司匹林或含阿司匹林的止痛/感冒药，以及抗凝药、其他抗血小板药、肝素、溶栓药或 NSAID；疑似重复可能有临床意图，也可能是误服风险，不要自行叠加、错开、停用或替换。",
    "history": "EMA 记录 DuoPlavin 于 2010-03-14 获欧盟集中授权，当前产品资料于 2026-06-11 更新。两种规格都是固定复方，用于已分别使用氯吡格雷与阿司匹林的成人继续治疗；这一监管定位不能转换成个人是否该换为复方、每天几片或用多久的网页建议。",
    "sourceDocuments": [
      {
        "id": "src_c244551409ab29d8",
        "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin",
        "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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_e2d29127841a1da3",
        "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_b9f3a330c9c24b24",
        "label": "EMA：DuoPlavin 面向公众的药品概览",
        "url": "https://www.ema.europa.eu/en/documents/overview/duoplavin-epar-medicine-overview_en.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "medicine_overview",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      }
    ],
    "applicationNumber": "EMA EMEA/H/C/001143（DuoPlavin clopidogrel/acetylsalicylic acid）",
    "approvalTimeline": [
      {
        "date": "2010-03-14",
        "title": {
          "zh": "欧盟集中授权",
          "en": "EU central authorisation"
        },
        "detail": {
          "zh": "EMA 当前 EPAR 将 DuoPlavin EMEA/H/C/001143 的授权日列为 2010-03-14。",
          "en": "The current EMA EPAR lists 14 Mar 2010 as the authorisation date for DuoPlavin EMEA/H/C/001143."
        },
        "source": {
          "id": "src_c244551409ab29d8",
          "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin",
          "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": "2026-09-06",
          "reviewedAt": "2026-09-06"
        }
      },
      {
        "date": "2026-06-11",
        "title": {
          "zh": "EMA 产品资料更新",
          "en": "EMA product information updated"
        },
        "detail": {
          "zh": "当前产品资料把两种强度、警告、相互作用、辅料、外观和包装号集中在同一官方文件中。",
          "en": "The current product information consolidates both strengths, warnings, interactions, excipients, appearance and pack authorisation numbers in one official document."
        },
        "source": {
          "id": "src_e2d29127841a1da3",
          "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）",
          "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-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": "2026-09-06",
          "reviewedAt": "2026-09-06"
        }
      },
      {
        "date": "2026-09-06",
        "title": {
          "zh": "公开资料复核",
          "en": "Public-source review"
        },
        "detail": {
          "zh": "逐项核对 EPAR、产品资料与公众概览；未把另一撤回申请 EMEA/H/C/000874 当成当前产品。",
          "en": "EPAR, product information and public overview were checked item by item; the separate withdrawn application EMEA/H/C/000874 was not treated as the current product."
        },
        "source": {
          "id": "src_c244551409ab29d8",
          "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin",
          "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": "2026-09-06",
          "reviewedAt": "2026-09-06"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "欧盟",
          "en": "European Union"
        },
        "status": {
          "zh": "当前集中授权记录",
          "en": "Current centrally authorised record"
        },
        "detail": {
          "zh": "15 个包装授权号来自当前产品资料；并非所有包装一定上市，网页不把授权号写成库存。",
          "en": "Fifteen pack authorisation numbers come from current product information; not all pack sizes may be marketed, so authorisation numbers are not live inventory."
        }
      },
      {
        "market": {
          "zh": "中国大陆、美国、日本及其他市场",
          "en": "Mainland China, United States, Japan and other markets"
        },
        "status": {
          "zh": "待逐项建立当地现行记录",
          "en": "Current local record not established"
        },
        "detail": {
          "zh": "不从欧盟名称、包装或共同成分推定当地批准、品牌、参比身份、供应、医保、价格或可替代性。",
          "en": "EU names, packs or shared ingredients do not establish local approval, brand, reference status, supply, reimbursement, price or interchangeability."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "75/100 mg 是不是一片 175 mg 的药？",
          "en": "Is 75/100 mg one 175 mg medicine?"
        },
        "answer": {
          "zh": "不是。75 mg 是同一片中的氯吡格雷，100 mg 是阿司匹林；两个有效成分必须分开理解，不能相加后与任何 175 mg 产品比较。",
          "en": "No. Seventy-five mg is clopidogrel and 100 mg is aspirin in that same tablet. The two active ingredients must remain separate and must not be summed for comparison with any 175 mg product."
        }
      },
      {
        "question": {
          "zh": "已经吃 DuoPlavin，还能再吃阿司匹林或 PLAVIX 吗？",
          "en": "Can aspirin or PLAVIX be added when taking DuoPlavin?"
        },
        "answer": {
          "zh": "不要自行添加。DuoPlavin 已含两种成分；把所有处方药、非处方药和药盒交给药师或临床医生核对。发现疑似重复也不要自行停药。",
          "en": "Do not add one yourself. DuoPlavin already contains both ingredients. Have a pharmacist or clinician review every prescription, OTC product and pack, and do not self-stop when possible duplication is found."
        }
      },
      {
        "question": {
          "zh": "为了手术或拔牙，我可以先停几天吗？",
          "en": "Can I stop it for a few days before surgery or dental work?"
        },
        "answer": {
          "zh": "网页不能给停药天数。提前告诉负责医生和牙医，由他们结合操作类型、出血风险和血栓风险制定方案。",
          "en": "A website cannot set the number of stopping days. Tell the responsible clinician and dentist in advance so they can balance the procedure, bleeding risk and thrombotic risk."
        }
      },
      {
        "question": {
          "zh": "我需要做 CYP2C19 或全基因筛查吗？",
          "en": "Do I need CYP2C19 or whole-genome testing?"
        },
        "answer": {
          "zh": "说明书确认 CYP2C19 与氯吡格雷活化有关并有基因检测，但没有支持网页要求所有人做全基因筛查。是否检测应由负责团队结合适应证、既往事件、相互作用和当地指南决定。",
          "en": "The label confirms a CYP2C19 role in clopidogrel activation and available genotype tests, but it does not support a website requiring whole-genome screening for everyone. The treating team should decide from the indication, prior events, interactions and local guidance."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label",
      "how-to-review-a-family-medicine-list",
      "medicine-safety-and-pharmacovigilance"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/duoplavin-clopidogrel-aspirin/",
    "en": "https://origindrug.com/en/drugs/duoplavin-clopidogrel-aspirin/"
  },
  "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."
  ]
}