{
  "id": "namzaric",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-28",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "NAMZARIC",
    "generic": "盐酸美金刚/盐酸多奈哌齐（复方）",
    "aliases": [
      "NAMZARIC",
      "memantine and donepezil hydrochlorides",
      "memantine hydrochloride and donepezil hydrochloride",
      "盐酸美金刚/盐酸多奈哌齐",
      "美金刚多奈哌齐复方缓释胶囊",
      "memantine and donepezil",
      "美金刚多奈哌齐",
      "盐酸美金刚盐酸多奈哌齐",
      "NDA 206439"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "神经与认知",
    "sourceArchiveMarket": "美国 NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊当前公开标签（DailyMed：2026-03-06 修订，SPL v23；NDA 206439）",
    "dosageFormClass": "缓释口服胶囊：每粒 7 mg/10 mg、14 mg/10 mg、21 mg/10 mg 或 28 mg/10 mg（前者为盐酸美金刚，后者为盐酸多奈哌齐；当前美国标签所列）",
    "dosageFormClassCode": "oral_modified_release",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2014（当前美国标签所列 Initial U.S. Approval）",
    "archiveSponsorText": "AbbVie Inc.（当前美国公开标签所列分销方；标签另列 Merz Pharma 与 Adamas Pharmaceuticals 授权关系）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "NAMENDA",
      "NAMENDA XR",
      "ARICEPT",
      "memantine tablet",
      "donepezil tablet",
      "美金刚片",
      "多奈哌齐片",
      "separate memantine and donepezil products",
      "分开的美金刚与多奈哌齐产品"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-namzaric-memantine-donepezil-er-capsule-7mg-10mg-30-bottle-ndc-0456-1207-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）",
        "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)"
      },
      "dosageForm": {
        "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊",
        "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0456-1207-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒：盐酸美金刚 7 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装",
        "en": "Per capsule: memantine hydrochloride 7 mg + donepezil hydrochloride 10 mg; 30-capsule bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0b.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸美金刚",
            "en": "memantine hydrochloride"
          },
          "value": 7,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令",
            "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸多奈哌齐",
            "en": "donepezil hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第二种成分的标签标示量；不是与 7 mg 相除或相加的计算式",
            "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 7 mg"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "30 粒瓶装",
          "en": "30-capsule bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅绿色不透明胶囊体、橙色不透明胶囊帽",
          "en": "light-green opaque body and orange opaque cap"
        },
        "shape": {
          "zh": "缓释胶囊",
          "en": "extended-release capsule"
        },
        "imprint": "FL 7/10",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_aef2a99c82265450",
        "label": "DailyMed（NLM）：NAMZARIC 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-namzaric-memantine-donepezil-er-capsule-14mg-10mg-30-bottle-ndc-0456-1214-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）",
        "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)"
      },
      "dosageForm": {
        "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊",
        "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0456-1214-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒：盐酸美金刚 14 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装",
        "en": "Per capsule: memantine hydrochloride 14 mg + donepezil hydrochloride 10 mg; 30-capsule bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0c.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸美金刚",
            "en": "memantine hydrochloride"
          },
          "value": 14,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令",
            "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸多奈哌齐",
            "en": "donepezil hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第二种成分的标签标示量；不是与 14 mg 相除或相加的计算式",
            "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 14 mg"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "30 粒瓶装",
          "en": "30-capsule bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅绿色不透明胶囊",
          "en": "light-green opaque capsule"
        },
        "shape": {
          "zh": "缓释胶囊",
          "en": "extended-release capsule"
        },
        "imprint": "FL 14/10",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_aef2a99c82265450",
        "label": "DailyMed（NLM）：NAMZARIC 14 mg/10 mg、NDC 0456-1214-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-namzaric-memantine-donepezil-er-capsule-21mg-10mg-30-bottle-ndc-0456-1221-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）",
        "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)"
      },
      "dosageForm": {
        "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊",
        "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0456-1221-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒：盐酸美金刚 21 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装",
        "en": "Per capsule: memantine hydrochloride 21 mg + donepezil hydrochloride 10 mg; 30-capsule bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0d.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸美金刚",
            "en": "memantine hydrochloride"
          },
          "value": 21,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令",
            "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸多奈哌齐",
            "en": "donepezil hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第二种成分的标签标示量；不是与 21 mg 相除或相加的计算式",
            "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 21 mg"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "30 粒瓶装",
          "en": "30-capsule bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色不透明胶囊体、橙色不透明胶囊帽",
          "en": "white opaque body and orange opaque cap"
        },
        "shape": {
          "zh": "缓释胶囊",
          "en": "extended-release capsule"
        },
        "imprint": "FL 21/10",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_aef2a99c82265450",
        "label": "DailyMed（NLM）：NAMZARIC 21 mg/10 mg、NDC 0456-1221-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-namzaric-memantine-donepezil-er-capsule-28mg-10mg-30-bottle-ndc-0456-1228-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）",
        "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)"
      },
      "dosageForm": {
        "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊",
        "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0456-1228-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒：盐酸美金刚 28 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装",
        "en": "Per capsule: memantine hydrochloride 28 mg + donepezil hydrochloride 10 mg; 30-capsule bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0e.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
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          "ingredient": {
            "zh": "盐酸美金刚",
            "en": "memantine hydrochloride"
          },
          "value": 28,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令",
            "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸多奈哌齐",
            "en": "donepezil hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒第二种成分的标签标示量；不是与 28 mg 相除或相加的计算式",
            "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 28 mg"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "30 粒瓶装",
          "en": "30-capsule bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
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        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "蓝色不透明胶囊",
          "en": "blue opaque capsule"
        },
        "shape": {
          "zh": "缓释胶囊",
          "en": "extended-release capsule"
        },
        "imprint": "FL 28/10",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
        "audience": "public",
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        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
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        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-namzaric-memantine-donepezil-er-capsule-7mg-10mg-30-bottle-ndc-0456-1207-30",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0b.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img",
    "alt": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐在美国 DailyMed 当前标签中的 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前标签（2026-03-06 修订；SPL v23）",
    "presentation": "NAMZARIC：每粒盐酸美金刚 7 mg + 盐酸多奈哌齐 10 mg，NDC 0456-1207-30，30 粒瓶装。",
    "notice": "此图只对应美国 DailyMed 当前标签中的 NAMZARIC 7 mg/10 mg、NDC 0456-1207-30 与 30 粒瓶装。它只帮助核对品牌、双成分、每粒两组标签量、缓释胶囊、包装数量和来源；不用于鉴定真伪，也不证明其他强度、滴定包装、分开的美金刚或多奈哌齐产品、其他市场、实际可得性、原研身份、可替代性或任何个人的胶囊数、打开方式、联用、停用、换药方案。",
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      "id": "src_aef2a99c82265450",
      "label": "DailyMed（NLM）：NAMZARIC 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）",
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      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "NAMZARIC 说明书放大阅读：斜线两侧是同一粒胶囊中的两种成分，不是除法或两颗药",
      "en": "NAMZARIC label reading: the two numbers identify two ingredients in one capsule, not division or two medicines"
    },
    "summary": {
      "zh": "本模块只阅读当前美国标签中的 NAMZARIC、盐酸美金刚、盐酸多奈哌齐、四种缓释胶囊强度、准确 NDC、包装面板和胶囊处理文字。它不提供个人胶囊数、递增、漏用补救、开始、停用、联用、换药或购买方案。",
      "en": "This module reads only NAMZARIC, memantine hydrochloride, donepezil hydrochloride, four extended-release capsule strengths, exact NDCs, package panels and capsule-handling text in the current U.S. label. It provides no individual capsule count, titration, missed-use remedy, initiation, stopping, co-use, switching or purchase plan."
    },
    "checks": [
      {
        "zh": "先把 NAMZARIC、两种成分、7/10、14/10、21/10 或 28/10 mg、准确 NDC、缓释胶囊和目标市场一起核对。斜线前是盐酸美金刚，斜线后是盐酸多奈哌齐；它不是数学除法，也不是两颗可分开的药。",
        "en": "Check NAMZARIC, both ingredients, 7/10, 14/10, 21/10 or 28/10 mg, the exact NDC, extended-release capsule and target market together. The number before the slash is memantine hydrochloride and the number after it is donepezil hydrochloride; this is not mathematical division or two separable medicines."
      },
      {
        "zh": "当前标签写明胶囊可完整吞服；在该准确产品的标签条件下，也可打开后把全部内容撒在苹果酱上立即吞下且不要咀嚼，但不能只取一部分，不能分次。这个产品级例外不代表其他缓释胶囊也能打开，更不是网页要求任何人这样做。",
        "en": "The current label says the capsule may be swallowed intact. Under this exact product's labelled conditions it may also be opened, with all contents sprinkled on applesauce and swallowed immediately without chewing; only part must not be used and the dose must not be divided. This product-specific exception does not mean another extended-release capsule may be opened and is not an instruction from this site for anyone to do so."
      },
      {
        "zh": "NAMZARIC 已同时含美金刚与多奈哌齐。药单中若另有 NAMENDA、NAMENDA XR、ARICEPT、其他美金刚/多奈哌齐或认知相关药，必须先按完整成分表请药师或开方团队核对重复成分、剂型和处方转换；不要自行叠加、轮换或停掉其中任何一盒。",
        "en": "NAMZARIC already contains memantine and donepezil. If the medicine list also includes NAMENDA, NAMENDA XR, ARICEPT, another memantine/donepezil product or a cognition-related medicine, have a pharmacist or prescriber review duplicate ingredients, dosage forms and the prescribed transition from the complete ingredient list before any change; do not self-add, alternate or stop any pack."
      },
      {
        "zh": "标签中的肾功能、心率/传导、晕厥、胃肠道、泌尿、癫痫、肺部情况和相互作用段落用于提示需要专业核对，不让网页判断某个头晕、跌倒、意识改变、恶心、食欲变化或其他不适是否由这款药造成。急性或严重变化应及时使用当地医疗支持。",
        "en": "The label's kidney, heart-rate/conduction, fainting, gastrointestinal, urinary, seizure, pulmonary and interaction sections identify matters for professional review; they do not let a webpage determine whether dizziness, a fall, altered consciousness, nausea, appetite change or another concern was caused by this medicine. Use timely local medical support for an acute or serious change."
      }
    ],
    "source": {
      "id": "src_aef2a99c82265450",
      "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03 修订，SPL v23）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "NAMZARIC 的两条作用路径：美金刚关联 NMDA 受体，多奈哌齐抑制乙酰胆碱酯酶",
      "en": "NAMZARIC's two pathways: memantine relates to NMDA receptors and donepezil inhibits acetylcholinesterase"
    },
    "summary": {
      "zh": "当前美国标签说明 NAMZARIC 含两种已批准成分：美金刚被描述为低至中等亲和力、非竞争性 NMDA 受体拮抗剂；多奈哌齐被描述为可逆性乙酰胆碱酯酶抑制剂。两条机制帮助理解复方身份，不预测个人认知变化、适用性、起效时间、胶囊数或联用方案。",
      "en": "The current U.S. label states that NAMZARIC contains two approved ingredients: memantine is described as a low-to-moderate-affinity uncompetitive NMDA-receptor antagonist, and donepezil as a reversible acetylcholinesterase inhibitor. The two pathways help explain the combination identity; they do not predict an individual's cognitive change, suitability, onset, capsule count or co-use plan."
    },
    "checks": [
      {
        "zh": "两条机制不等于“两种药越多越强”，也不表示可以把 NAMZARIC 与分开的美金刚或多奈哌齐自行叠加。固定复方、单方、普通释放和缓释产品必须按准确药盒与处方分别核对。",
        "en": "Two pathways do not mean that more ingredients are stronger, or that NAMZARIC may be self-added to separate memantine or donepezil. Fixed combinations, single-ingredient products, immediate-release and extended-release forms must be checked separately against the exact pack and prescription."
      },
      {
        "zh": "机制不能把 7、14、21、28 mg 或固定的 10 mg 变成个人递增、减量、拆分、停药或换药规则，也不能解释每一次记忆、行为、睡眠、胃口或跌倒变化。",
        "en": "Mechanism cannot turn 7, 14, 21 or 28 mg, or the fixed 10 mg component, into an individual titration, reduction, division, stopping or switching rule, and it cannot explain every change in memory, behaviour, sleep, appetite or falls."
      },
      {
        "zh": "照护者若不确定药单是否重复、患者是否吞咽了完整胶囊，或出现明显急性变化，应把实际药盒、全部处方/非处方药和发生时间带给药师、开方团队或当地急救支持；不要从药理名词自行补用或重给。",
        "en": "If a caregiver is unsure whether the medicine list duplicates ingredients, whether a whole capsule was swallowed, or notices a marked acute change, take the actual packs, all prescription/OTC products and the timing to a pharmacist, prescriber or local urgent support; do not self-repeat or redose from pharmacology terms."
      }
    ],
    "source": {
      "id": "src_aef2a99c82265450",
      "label": "DailyMed（NLM）：NAMZARIC 当前美国公开标签（Clinical Pharmacology；AbbVie；2026-03 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "NAMZARIC",
      "generic": "盐酸美金刚/盐酸多奈哌齐（复方）",
      "dosageFormClass": "缓释口服胶囊：每粒 7 mg/10 mg、14 mg/10 mg、21 mg/10 mg 或 28 mg/10 mg（前者为盐酸美金刚，后者为盐酸多奈哌齐；当前美国标签所列）"
    },
    "labelSource": {
      "id": "src_aef2a99c82265450",
      "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_aef2a99c82265450",
          "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "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": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      }
    ],
    "recordRoute": {
      "status": "product_level_public_record_verified",
      "authority": {
        "zh": "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": "2026-08-28",
      "scope": {
        "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
        "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
      }
    },
    "channels": [
      {
        "id": "china-nmpa-drug-evaluation-centre",
        "authority": "NMPA 药品评价中心",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "title": {
          "zh": "药物警戒快讯与安全警示",
          "en": "Drug-vigilance bulletins and safety notices"
        },
        "purpose": {
          "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。",
          "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item."
        },
        "source": {
          "id": "src_05ff2860226564d4",
          "label": "国家药监局药品评价中心：药物警戒与安全警示入口",
          "url": "https://www.cdr-adr.org.cn/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-drug-safety-communications",
        "authority": "FDA",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "药物安全通讯",
          "en": "Drug Safety Communications"
        },
        "purpose": {
          "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。",
          "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications."
        },
        "source": {
          "id": "src_9177df9e1825aa72",
          "label": "FDA：Drug Safety Communications",
          "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-medwatch",
        "authority": "FDA MedWatch",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "安全信息与严重问题报告",
          "en": "Safety information and serious-problem reporting"
        },
        "purpose": {
          "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。",
          "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality."
        },
        "source": {
          "id": "src_e4739cd55d27ab51",
          "label": "FDA：MedWatch 药品安全信息与不良事件报告计划",
          "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "ema-pharmacovigilance",
        "authority": "EMA",
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "title": {
          "zh": "药物警戒概览与 EudraVigilance",
          "en": "Pharmacovigilance overview and EudraVigilance"
        },
        "purpose": {
          "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。",
          "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment."
        },
        "source": {
          "id": "src_2ad42a3deae747d1",
          "label": "EMA：Pharmacovigilance overview",
          "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mhra-drug-safety-update",
        "authority": "MHRA",
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "title": {
          "zh": "Drug Safety Update",
          "en": "Drug Safety Update"
        },
        "purpose": {
          "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。",
          "en": "Primary UK MHRA medicine-safety updates for professionals and the public."
        },
        "source": {
          "id": "src_23fdbe67abeafc63",
          "label": "MHRA：Drug Safety Update",
          "url": "https://www.gov.uk/drug-safety-update",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "pmda-drug-safety",
        "authority": "PMDA",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "title": {
          "zh": "药品安全信息",
          "en": "Medicine safety information"
        },
        "purpose": {
          "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。",
          "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents."
        },
        "source": {
          "id": "src_06d6be2880f12024",
          "label": "PMDA：Safety Information Regarding Drugs",
          "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mfds-drug-safety-letters",
        "authority": "MFDS",
        "market": {
          "zh": "韩国",
          "en": "Republic of Korea"
        },
        "title": {
          "zh": "药品安全性书信",
          "en": "Medicine safety letters"
        },
        "purpose": {
          "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。",
          "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case."
        },
        "source": {
          "id": "src_2d7f5018cd05eff4",
          "label": "MFDS：药品安全性书信（韩文原始资料）",
          "url": "https://www.mfds.go.kr/brd/m_545/list.do",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "KR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "hsa-adverse-events",
        "authority": "HSA",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "title": {
          "zh": "不良反应报告与药物安全信息",
          "en": "Adverse-event reporting and medicine-safety information"
        },
        "purpose": {
          "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。",
          "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information."
        },
        "source": {
          "id": "src_9240397d5a8574c1",
          "label": "HSA：Report adverse events",
          "url": "https://www.hsa.gov.sg/adverse-events/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "health-canada-medeffect-advisories",
        "authority": "Health Canada",
        "market": {
          "zh": "加拿大",
          "en": "Canada"
        },
        "title": {
          "zh": "MedEffect 加拿大：建议、警告与召回",
          "en": "MedEffect Canada: advisories, warnings and recalls"
        },
        "purpose": {
          "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。",
          "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item."
        },
        "source": {
          "id": "src_212ec921fa6634ad",
          "label": "Health Canada：MedEffect Canada 建议、警告与召回",
          "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "tga-safety-alerts",
        "authority": "TGA",
        "market": {
          "zh": "澳大利亚",
          "en": "Australia"
        },
        "title": {
          "zh": "药品安全警示",
          "en": "Medicine safety alerts"
        },
        "purpose": {
          "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。",
          "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products."
        },
        "source": {
          "id": "src_ffe6142814f88fac",
          "label": "TGA：Safety alerts",
          "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "AU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "swissmedic-pharmacovigilance",
        "authority": "Swissmedic",
        "market": {
          "zh": "瑞士",
          "en": "Switzerland"
        },
        "title": {
          "zh": "药物警戒与不良反应报告",
          "en": "Pharmacovigilance and suspected adverse-reaction reporting"
        },
        "purpose": {
          "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。",
          "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality."
        },
        "source": {
          "id": "src_c854f813ce2671df",
          "label": "Swissmedic：Pharmacovigilance",
          "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "CH",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "medsafe-safety-communications",
        "authority": "Medsafe",
        "market": {
          "zh": "新西兰",
          "en": "New Zealand"
        },
        "title": {
          "zh": "药品安全通讯",
          "en": "Medicine safety communications"
        },
        "purpose": {
          "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。",
          "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information."
        },
        "source": {
          "id": "src_3510c1a523ec9769",
          "label": "Medsafe：Safety Communications",
          "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "NZ",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "sahpra-safety-information",
        "authority": "SAHPRA",
        "market": {
          "zh": "南非",
          "en": "South Africa"
        },
        "title": {
          "zh": "药物安全信息、警示与药物警戒",
          "en": "Medicine safety information, alerts and pharmacovigilance"
        },
        "purpose": {
          "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。",
          "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information."
        },
        "source": {
          "id": "src_25b0aaefee742163",
          "label": "SAHPRA：Safety Information Updates / Pharmacovigilance",
          "url": "https://www.sahpra.org.za/safety-information-and-updates/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "ZA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "who-medicine-safety-alerts",
        "authority": "WHO",
        "market": {
          "zh": "全球",
          "en": "Global"
        },
        "title": {
          "zh": "药品与疫苗安全警示档案",
          "en": "Medicine and vaccine safety-alert archive"
        },
        "purpose": {
          "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。",
          "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market."
        },
        "source": {
          "id": "src_9a7dc56ec34c7e1a",
          "label": "WHO：Safety alerts for medicines and vaccines",
          "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "GLOBAL",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "anvisa-pharmacovigilance",
        "authority": "Anvisa",
        "market": {
          "zh": "巴西",
          "en": "Brazil"
        },
        "title": {
          "zh": "药物警戒、警示与 VigiMed",
          "en": "Pharmacovigilance, alerts and VigiMed"
        },
        "purpose": {
          "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。",
          "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item."
        },
        "source": {
          "id": "src_5de362c12580111d",
          "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）",
          "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "BR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "notices": [],
    "boundary": {
      "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。",
      "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline."
    },
    "scope": "official_routes_only_no_live_alert_inference"
  },
  "archive": {
    "summary": "美国 DailyMed 当前 NAMZARIC 标签将其列为盐酸美金刚与盐酸多奈哌齐的缓释口服复方胶囊，并列出 7/10、14/10、21/10 和 28/10 mg 四种每粒成分量。本页帮助照护者先识别两种成分、斜线两侧数字、缓释胶囊、准确 NDC、瓶装面板和标签来源；不把这些数字或说明书文字变成个人胶囊数、递增、漏用补救、打开胶囊、停用、联用、换药或购买方案。",
    "history": "当前美国公开标签列示 Initial U.S. Approval: 2014，并标示 2026-03 修订。标签说明 NAMZARIC 是美金刚与多奈哌齐的固定复方缓释胶囊；这不表示它与分开的 NAMENDA、NAMENDA XR、ARICEPT、其他美金刚/多奈哌齐产品或其他市场包装可以自行叠加、拆分、轮换或按毫克换算。",
    "sourceDocuments": [
      {
        "id": "src_aef2a99c82265450",
        "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      }
    ],
    "applicationNumber": "NDA 206439",
    "approvalTimeline": [
      {
        "date": "2014",
        "title": {
          "zh": "FDA 标签所列美国初始批准年份",
          "en": "Initial U.S. approval year listed in the FDA label"
        },
        "detail": {
          "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。",
          "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market."
        },
        "source": {
          "id": "src_aef2a99c82265450",
          "label": "DailyMed: NAMZARIC memantine and donepezil hydrochlorides current U.S. public label",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "date": "2026-03-06 revised; DailyMed SPL v23",
        "title": {
          "zh": "FDA 标签档案版本",
          "en": "FDA label archive version"
        },
        "detail": {
          "zh": "本页链接 2026-03-06 revised; DailyMed SPL v23 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。",
          "en": "This page links the 2026-03-06 revised; DailyMed SPL v23 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document."
        },
        "source": {
          "id": "src_aef2a99c82265450",
          "label": "DailyMed: NAMZARIC memantine and donepezil hydrochlorides current U.S. public label",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接公开标签档案",
          "en": "Public label archive linked"
        },
        "detail": {
          "zh": "仅对应本页所列 FDA 文件。",
          "en": "Only the FDA document listed on this page is linked."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本",
          "en": "Mainland China, EU, Japan"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。",
          "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "标签档案能代表现在的产品信息吗？",
          "en": "Does a label archive represent current product information?"
        },
        "answer": {
          "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。",
          "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label."
        }
      },
      {
        "question": {
          "zh": "为什么这里不展示价格或原研/仿制结论？",
          "en": "Why are price and originator/generic conclusions not shown?"
        },
        "answer": {
          "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。",
          "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "how-to-read-a-drug-label",
      "regulatory-sources-first"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/namzaric/",
    "en": "https://origindrug.com/en/drugs/namzaric/"
  },
  "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."
  ]
}