{
  "id": "exforge",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-21",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Exforge",
    "generic": "氨氯地平/缬沙坦",
    "aliases": [
      "EXFORGE",
      "amlodipine and valsartan",
      "amlodipine/valsartan",
      "氨氯地平/缬沙坦"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "美国当前 EXFORGE 氨氯地平/缬沙坦公开标签（DailyMed SPL v36：2026-02-17 生效/更新，2026-02-18 发布）",
    "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦 5/160、10/160、5/320、10/320 mg（当前美国标签所列）",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2007（当前美国标签所列 Initial U.S. Approval）",
    "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）当前公开标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "EXFORGE HCT",
      "hydrochlorothiazide",
      "氢氯噻嗪"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-exforge-amlodipine-5mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0488-15",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布",
        "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026"
      },
      "dosageForm": {
        "zh": "氨氯地平/缬沙坦口服薄膜衣片",
        "en": "amlodipine/valsartan oral film-coated tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0078-0488-15",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片：氨氯地平 5 mg + 缬沙坦 160 mg；30 片瓶装",
        "en": "Per tablet: amlodipine 5 mg + valsartan 160 mg; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-07.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        },
        {
          "ingredient": {
            "zh": "缬沙坦",
            "en": "valsartan"
          },
          "value": 160,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "儿童安全瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "深黄色",
          "en": "dark yellow"
        },
        "shape": {
          "zh": "椭圆形、有斜边薄膜衣片",
          "en": "ovaloid, bevel-edged film-coated tablet"
        },
        "imprint": "NVR / ECE",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5b99fe84908369a0",
        "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-exforge-amlodipine-10mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0489-15",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布",
        "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026"
      },
      "dosageForm": {
        "zh": "氨氯地平/缬沙坦口服薄膜衣片",
        "en": "amlodipine/valsartan oral film-coated tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0078-0489-15",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片：氨氯地平 10 mg + 缬沙坦 160 mg；30 片瓶装",
        "en": "Per tablet: amlodipine 10 mg + valsartan 160 mg; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-08.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        },
        {
          "ingredient": {
            "zh": "缬沙坦",
            "en": "valsartan"
          },
          "value": 160,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "儿童安全瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅黄色",
          "en": "light yellow"
        },
        "shape": {
          "zh": "椭圆形、有斜边薄膜衣片",
          "en": "ovaloid, bevel-edged film-coated tablet"
        },
        "imprint": "NVR / UIC",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5b99fe84908369a0",
        "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-exforge-amlodipine-5mg-valsartan-320mg-30-tablet-bottle-ndc-0078-0490-15",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布",
        "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026"
      },
      "dosageForm": {
        "zh": "氨氯地平/缬沙坦口服薄膜衣片",
        "en": "amlodipine/valsartan oral film-coated tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0078-0490-15",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片：氨氯地平 5 mg + 缬沙坦 320 mg；30 片瓶装",
        "en": "Per tablet: amlodipine 5 mg + valsartan 320 mg; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-09.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        },
        {
          "ingredient": {
            "zh": "缬沙坦",
            "en": "valsartan"
          },
          "value": 320,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "儿童安全瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "深黄色",
          "en": "very dark yellow"
        },
        "shape": {
          "zh": "椭圆形、有斜边薄膜衣片",
          "en": "ovaloid, bevel-edged film-coated tablet"
        },
        "imprint": "NVR / CSF",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5b99fe84908369a0",
        "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-exforge-amlodipine-10mg-valsartan-320mg-30-tablet-bottle-ndc-0078-0491-15",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布",
        "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026"
      },
      "dosageForm": {
        "zh": "氨氯地平/缬沙坦口服薄膜衣片",
        "en": "amlodipine/valsartan oral film-coated tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0078-0491-15",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片：氨氯地平 10 mg + 缬沙坦 320 mg；30 片瓶装",
        "en": "Per tablet: amlodipine 10 mg + valsartan 320 mg; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-10.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        },
        {
          "ingredient": {
            "zh": "缬沙坦",
            "en": "valsartan"
          },
          "value": 320,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签量；不是个人片数或调药规则",
            "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "儿童安全瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "深黄色",
          "en": "dark yellow"
        },
        "shape": {
          "zh": "椭圆形、有斜边薄膜衣片",
          "en": "ovaloid, bevel-edged film-coated tablet"
        },
        "imprint": "NVR / LUF",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5b99fe84908369a0",
        "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-exforge-amlodipine-5mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0488-15",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-07.jpg",
    "alt": "EXFORGE 氨氯地平/缬沙坦在美国 DailyMed 当前标签中的 5 mg/160 mg、NDC 0078-0488-15、30 片装包装面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v36（2026-02-17 生效/更新；2026-02-18 发布）",
    "presentation": "EXFORGE 氨氯地平/缬沙坦薄膜衣片：每片 5 mg/160 mg；NDC 0078-0488-15；30 片装包装面板。",
    "notice": "此图只对应美国当前标签中的 EXFORGE 5 mg/160 mg、NDC 0078-0488-15、30 片装。它不代表 10/160、5/320、10/320 mg，EXFORGE HCT 三成分片，单方氨氯地平/缬沙坦，其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、加减量、转换或联合方案。",
    "source": {
      "id": "src_5b99fe84908369a0",
      "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "EXFORGE 说明书放大阅读：5/160 先是两种成分的每片身份",
      "en": "EXFORGE label reading: 5/160 first identifies both ingredients in one tablet"
    },
    "summary": {
      "zh": "本模块以当前美国公开标签为阅读入口，帮助核对 EXFORGE、氨氯地平、缬沙坦、完整双数字、口服薄膜衣片与 NDC。它不决定个人是否需要两种降压成分、每天用几片、能否与其他降压药同用或如何调整。",
      "en": "This module uses the current U.S. public label to check EXFORGE, amlodipine, valsartan, the complete two-number marking, oral film-coated tablet and NDC. It does not decide whether someone needs both antihypertensive ingredients, a tablet count, co-use with another blood-pressure medicine or an adjustment."
    },
    "checks": [
      {
        "zh": "5/160、10/160、5/320、10/320 mg 都是每片中两种成分的完整标示。不能只看其中一个数字，也不能从数字推导个人每天几片、加减量或把两种单方药自行拼成同一复方。",
        "en": "5/160, 10/160, 5/320 and 10/320 mg are complete two-ingredient markings per tablet. Do not read only one number, derive a personal tablet count, adjust an amount or self-assemble the fixed combination from two single-ingredient products."
      },
      {
        "zh": "EXFORGE HCT 另含氢氯噻嗪，是三成分产品；它不是本页的 EXFORGE 双成分片。名称相近、都含氨氯地平或缬沙坦，均不能证明可自行叠加、轮换或替代。",
        "en": "EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product; it is not the two-ingredient EXFORGE tablet on this page. Similar names or a shared amlodipine/valsartan ingredient do not establish self-combination, alternation or substitution."
      },
      {
        "zh": "正在使用其他降压药、利尿剂、含缬沙坦/氯沙坦/厄贝沙坦等产品、止痛药、盐替代品、补充剂或多种药物时，应把实际药盒和完整药单交给药师或医生核对；网页不能把“同类”或“共同成分”变成可否合用的个人结论。",
        "en": "With another antihypertensive, diuretic, a product containing valsartan/losartan/irbesartan, pain medicine, salt substitute, supplement or multiple medicines, have the actual packs and complete list reviewed by a pharmacist or clinician. A webpage cannot turn a shared class or ingredient into an individual co-use conclusion."
      },
      {
        "zh": "怀孕/计划妊娠、晕厥、明显头晕、胸痛、呼吸困难、面部或咽喉肿胀等情况需要及时联系当地医生或紧急医疗支持；本页不决定是否自行停用、恢复或改用另一种药。",
        "en": "Pregnancy/planning pregnancy, fainting, marked dizziness, chest pain, breathing trouble, facial or throat swelling or another acute concern needs timely local clinical or urgent support; this page does not decide self-stopping, restarting or changing to another medicine."
      }
    ],
    "source": {
      "id": "src_5b99fe84908369a0",
      "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "氨氯地平/缬沙坦怎样起作用：标签描述两条不同的降压药理路径",
      "en": "How amlodipine/valsartan works: the label describes two different antihypertensive pathways"
    },
    "summary": {
      "zh": "当前标签将 EXFORGE 描述为二氢吡啶类钙通道阻滞剂氨氯地平与血管紧张素 II 受体阻滞剂缬沙坦的固定复方。机制帮助理解为何完整药单核对重要，不预测个人血压、肾功能、血钾、疗效、用量或是否适合换药。",
      "en": "The current label describes EXFORGE as a fixed combination of the dihydropyridine calcium-channel blocker amlodipine and the angiotensin-II receptor blocker valsartan. Mechanism helps explain why complete-list review matters; it does not predict an individual's blood pressure, kidney function, potassium, response, amount or whether a switch is suitable."
    },
    "checks": [
      {
        "zh": "两个作用路径不表示可把其他钙通道阻滞剂、ARB、ACE 抑制剂或复方降压药自行再加一层。任何新增、停用、轮换或替代都要由掌握完整药单和病史的专业人员核对。",
        "en": "Two pathways do not mean another calcium-channel blocker, ARB, ACE inhibitor or combination antihypertensive can be self-added. Any addition, stopping, alternation or substitution needs review by a professional with the complete list and history."
      },
      {
        "zh": "血管紧张素通路、血钾或肾功能等标签词是需要专业复核的线索，不是从家庭血压读数、症状或网络经验自行调整片数的依据。",
        "en": "Label terms involving the angiotensin pathway, potassium or kidney function are cues for professional review, not grounds to change tablet count from a home blood-pressure reading, symptoms or online experience."
      },
      {
        "zh": "机制说明不能处理脱水、严重低血压样不适、胸痛、过敏、妊娠相关风险或复杂多药联用。出现急性或严重担忧时应优先使用当地医疗支持。",
        "en": "A mechanism explanation cannot manage dehydration, severe low-blood-pressure-like symptoms, chest pain, allergy, pregnancy-related risk or complex polypharmacy. With an acute or serious concern, prioritise local medical support."
      }
    ],
    "source": {
      "id": "src_5b99fe84908369a0",
      "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Clinical Pharmacology；SPL v36）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "Exforge",
      "generic": "氨氯地平/缬沙坦",
      "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦 5/160、10/160、5/320、10/320 mg（当前美国标签所列）"
    },
    "labelSource": {
      "id": "src_5b99fe84908369a0",
      "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_5b99fe84908369a0",
          "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "美国国家医学图书馆 DailyMed",
          "en": "U.S. National Library of Medicine DailyMed"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "公开药品标签",
          "en": "Public medicine label"
        },
        "reviewedAt": "2026-08-20",
        "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": "美国国家医学图书馆 DailyMed",
        "en": "U.S. National Library of Medicine DailyMed"
      },
      "market": {
        "zh": "美国",
        "en": "United States"
      },
      "recordType": {
        "zh": "公开药品标签",
        "en": "Public medicine label"
      },
      "reviewedAt": "2026-08-20",
      "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": "DailyMed 当前 EXFORGE 标签将其列为氨氯地平和缬沙坦的固定剂量复方口服片，列有 5/160、10/160、5/320、10/320 mg 四种双成分标示。本页帮助核对品牌、两种成分、完整双数字、实际包装、标签版本和目标市场；不把任何一个数字变成个人片数、加减量、联合、换药或停药方案。",
    "history": "当前美国标签列示 Initial U.S. Approval: 2007，SPL v36 的 Effective/Updated 日期为 2026-02-17、DailyMed Published 日期为 2026-02-18。EXFORGE HCT 另含氢氯噻嗪，是另一种三成分产品；名称相近、同含氨氯地平或缬沙坦都不建立自行替代或叠加关系。",
    "sourceDocuments": [
      {
        "id": "src_5b99fe84908369a0",
        "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "NDA 021990",
    "approvalTimeline": [
      {
        "date": "2007-06-20",
        "title": {
          "zh": "NDA 021990 原始申请批准",
          "en": "NDA 021990 original application approval"
        },
        "detail": {
          "zh": "FDA Drugs@FDA 公开记录将 EXFORGE 的原始申请（ORIG 1）标为 2007-06-20 获批；该美国监管节点不建立其他市场的批准、供应或个人适用性。",
          "en": "The FDA Drugs@FDA public record lists EXFORGE original application (ORIG 1) as approved on 20 Jun 2007. This U.S. regulatory node does not establish approval, supply or individual suitability in another market."
        },
        "source": {
          "id": "src_37676edf6d98c53b",
          "label": "FDA: EXFORGE NDA 021990 original approval letter (2007-06-20)",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "approval_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2007",
        "title": {
          "zh": "当前标签所列美国初始批准年份",
          "en": "Initial U.S. approval year listed in the current label"
        },
        "detail": {
          "zh": "当前 EXFORGE 标签列示 Initial U.S. Approval: 2007；该年份不自动说明其他市场的产品状态。",
          "en": "The current EXFORGE label lists Initial U.S. Approval: 2007; it does not establish product status in another market."
        },
        "source": {
          "id": "src_5b99fe84908369a0",
          "label": "DailyMed: current EXFORGE public label, SPL v36",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2026-02-17",
        "title": {
          "zh": "当前 SPL v36 生效/更新日期",
          "en": "Current SPL v36 effective/updated date"
        },
        "detail": {
          "zh": "DailyMed 当前标签的 Effective/Updated 日期为 2026-02-17；该日期与公开日期分开记录。",
          "en": "The current DailyMed label's effective/updated date is 17 Feb 2026; it remains separate from publication."
        },
        "source": {
          "id": "src_5b99fe84908369a0",
          "label": "DailyMed: current EXFORGE public label, SPL v36",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2026-02-18",
        "title": {
          "zh": "DailyMed 公开当前 SPL v36",
          "en": "DailyMed published current SPL v36"
        },
        "detail": {
          "zh": "DailyMed 将当前 v36 的 Published Date 列为 2026-02-18；页面不把它解释成个人治疗建议。",
          "en": "DailyMed lists 18 Feb 2026 as the current v36 Published Date; this page does not interpret it as individual-treatment advice."
        },
        "source": {
          "id": "src_5b99fe84908369a0",
          "label": "DailyMed: current EXFORGE public label, SPL v36",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接当前双成分标签与一个精确包装展示",
          "en": "Current two-ingredient label and one exact package panel linked"
        },
        "detail": {
          "zh": "展示图只对应 5 mg/160 mg、NDC 0078-0488-15、30 片装；不据此建立实际在售、库存或其他规格状态。",
          "en": "The image corresponds only to the 5 mg/160 mg, NDC 0078-0488-15, 30-tablet panel; it does not establish actual marketing, stock or another-strength status."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本及其他市场",
          "en": "Mainland China, EU, Japan and other markets"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国标签推定当地商品名、批准、规格、供应、原研关系或可替代性。",
          "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. label."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "5/160 mg 是不是只看其中一个数字即可？",
          "en": "Can 5/160 mg be read as just one of its two numbers?"
        },
        "answer": {
          "zh": "不能。它表示这一准确复方片中氨氯地平和缬沙坦的两组标示量。页面不把它变成个人片数、调整或与单方药的换算。",
          "en": "No. It identifies the two labelled ingredient amounts in this exact fixed-combination tablet. The page does not turn it into an individual tablet count, adjustment or conversion to single-ingredient medicines."
        }
      },
      {
        "question": {
          "zh": "EXFORGE 与 EXFORGE HCT 能否自行互换？",
          "en": "Can EXFORGE and EXFORGE HCT be self-switched?"
        },
        "answer": {
          "zh": "不能。EXFORGE HCT 另含氢氯噻嗪，是三成分产品。相近品牌名不建立可自行互换关系；请带实际药盒和完整药单咨询药师或开方团队。",
          "en": "No. EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product. Similar brand names do not establish self-interchangeability; take the actual packs and complete medicine list to a pharmacist or prescribing team."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/exforge/",
    "en": "https://origindrug.com/en/drugs/exforge/"
  },
  "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."
  ]
}