{
  "id": "exelon-oral",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-28",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Exelon Oral",
    "generic": "利斯的明口服胶囊/口服液",
    "aliases": [
      "EXELON",
      "rivastigmine",
      "rivastigmine hard capsules",
      "rivastigmine oral solution",
      "利斯的明胶囊",
      "利斯的明口服液",
      "rivastigmine capsules",
      "EXELON capsules",
      "EXELON capsules 1.5 mg",
      "EXELON capsules 3 mg",
      "EXELON capsules 4.5 mg",
      "EXELON capsules 6 mg",
      "EXELON oral solution",
      "EXELON oral solution 2 mg/ml",
      "1.5 mg",
      "3 mg",
      "4.5 mg",
      "6 mg",
      "2 mg/ml"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "神经与认知",
    "sourceArchiveMarket": "欧盟当前 EXELON 利斯的明胶囊与口服液产品资料（EMA 页面 2026-02-24 更新；产品资料 PDF 2026-02）",
    "dosageFormClass": "口服硬胶囊：1.5、3、4.5、6 mg；口服液：2 mg/mL（欧盟当前产品资料所列）",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1998-05-12（EMA 所列欧盟上市许可日期；当前口服产品资料于 2026-02 更新）",
    "archiveSponsorText": "Novartis Europharm Limited / European Medicines Agency 当前欧盟产品资料"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "EXELON oral solution 2 mg/ml",
      "EXELON capsules 1.5 mg",
      "EXELON capsules 3 mg",
      "EXELON capsules 4.5 mg",
      "EXELON capsules 6 mg",
      "利斯的明口服液",
      "利斯的明胶囊"
    ],
    "excludedProductCues": [
      "EXELON PATCH",
      "rivastigmine transdermal system",
      "rivastigmine patch",
      "透皮贴剂",
      "mg/24h"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
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      "id": "eu-exelon-hard-capsule-1-5mg",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明硬胶囊",
        "en": "EXELON rivastigmine hard capsule"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/98/066/001-003",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒利斯的明 1.5 mg；欧盟产品资料列示 28、56、112 粒包装",
        "en": "Rivastigmine 1.5 mg per capsule; EU product information lists 28, 56, 112-capsule packs"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
            "en": "rivastigmine"
          },
          "value": 1.5,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令",
            "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": null,
      "physicalClues": {
        "color": {
          "zh": "黄色帽/黄色体；红色压印",
          "en": "yellow cap/yellow body; red imprint"
        },
        "shape": {
          "zh": "硬胶囊；内装类白色至微黄色粉末",
          "en": "hard capsule containing off-white to slightly yellow powder"
        },
        "imprint": "EXELON 1,5 mg",
        "scoreStatus": "not_applicable",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-exelon-hard-capsule-3mg",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明硬胶囊",
        "en": "EXELON rivastigmine hard capsule"
      },
      "route": {
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        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/98/066/004-006",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒利斯的明 3 mg；欧盟产品资料列示 28、56、112 粒包装",
        "en": "Rivastigmine 3 mg per capsule; EU product information lists 28, 56, 112-capsule packs"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
            "en": "rivastigmine"
          },
          "value": 3,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令",
            "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": null,
      "physicalClues": {
        "color": {
          "zh": "橙色帽/橙色体；红色压印",
          "en": "orange cap/orange body; red imprint"
        },
        "shape": {
          "zh": "硬胶囊；内装类白色至微黄色粉末",
          "en": "hard capsule containing off-white to slightly yellow powder"
        },
        "imprint": "EXELON 3 mg",
        "scoreStatus": "not_applicable",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_11f6dce81d63da04",
        "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-exelon-hard-capsule-4-5mg",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明硬胶囊",
        "en": "EXELON rivastigmine hard capsule"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/98/066/007-009",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒利斯的明 4.5 mg；欧盟产品资料列示 28、56、112 粒包装",
        "en": "Rivastigmine 4.5 mg per capsule; EU product information lists 28, 56, 112-capsule packs"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
            "en": "rivastigmine"
          },
          "value": 4.5,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令",
            "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": null,
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": null,
      "physicalClues": {
        "color": {
          "zh": "红色帽/红色体；白色压印",
          "en": "red cap/red body; white imprint"
        },
        "shape": {
          "zh": "硬胶囊；内装类白色至微黄色粉末",
          "en": "hard capsule containing off-white to slightly yellow powder"
        },
        "imprint": "EXELON 4,5 mg",
        "scoreStatus": "not_applicable",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
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        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-exelon-hard-capsule-6mg",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明硬胶囊",
        "en": "EXELON rivastigmine hard capsule"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
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      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/98/066/010-012",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒利斯的明 6 mg；欧盟产品资料列示 28、56、112 粒包装",
        "en": "Rivastigmine 6 mg per capsule; EU product information lists 28, 56, 112-capsule packs"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
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          },
          "value": 6,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令",
            "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction"
          }
        }
      ],
      "concentration": null,
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      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": null,
      "physicalClues": {
        "color": {
          "zh": "红色帽/橙色体；红色压印",
          "en": "red cap/orange body; red imprint"
        },
        "shape": {
          "zh": "硬胶囊；内装类白色至微黄色粉末",
          "en": "hard capsule containing off-white to slightly yellow powder"
        },
        "imprint": "EXELON 6 mg",
        "scoreStatus": "not_applicable",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "audience": "public",
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        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
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        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-exelon-oral-solution-2mgml-50ml",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明口服液",
        "en": "EXELON rivastigmine oral solution"
      },
      "route": {
        "zh": "口服（标签产品身份字段）",
        "en": "oral (label product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "EU/1/98/066/018",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_mL",
      "primaryDisplay": {
        "zh": "利斯的明 2 mg/mL；50 mL 棕色玻璃瓶；配口服给药器",
        "en": "Rivastigmine 2 mg/mL; 50 mL amber-glass bottle with oral dosing syringe"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
            "en": "rivastigmine"
          },
          "value": 2,
          "unit": "mg/mL",
          "basisCode": "per_mL",
          "basisLabel": {
            "zh": "每毫升浓度；不是个人毫升数或自行换算指令",
            "en": "concentration per mL; not an individual's millilitres or a self-conversion instruction"
          }
        }
      ],
      "concentration": null,
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      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 50,
        "unit": {
          "zh": "mL/瓶；随附口服给药器",
          "en": "mL per bottle; oral dosing syringe supplied"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "澄清黄色溶液",
          "en": "clear yellow solution"
        },
        "shape": null,
        "imprint": null,
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        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "eu-exelon-oral-solution-2mgml-120ml",
      "marketCode": "EU",
      "labelVersion": {
        "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）",
        "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)"
      },
      "dosageForm": {
        "zh": "EXELON 利斯的明口服液",
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      },
      "route": {
        "zh": "口服（标签产品身份字段）",
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      },
      "routeCodes": [
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      ],
      "productCode": "EU/1/98/066/013",
      "pouchCode": null,
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      "primaryStrengthBasisCode": "per_mL",
      "primaryDisplay": {
        "zh": "利斯的明 2 mg/mL；120 mL 棕色玻璃瓶；配口服给药器",
        "en": "Rivastigmine 2 mg/mL; 120 mL amber-glass bottle with oral dosing syringe"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "利斯的明",
            "en": "rivastigmine"
          },
          "value": 2,
          "unit": "mg/mL",
          "basisCode": "per_mL",
          "basisLabel": {
            "zh": "每毫升浓度；不是个人毫升数或自行换算指令",
            "en": "concentration per mL; not an individual's millilitres or a self-conversion instruction"
          }
        }
      ],
      "concentration": null,
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      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": false,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 120,
        "unit": {
          "zh": "mL/瓶；随附口服给药器",
          "en": "mL per bottle; oral dosing syringe supplied"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "澄清黄色溶液",
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        },
        "shape": null,
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      },
      "comparisonNotice": null,
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        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
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      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
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  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "已核验 EMA 当前口服产品资料与胶囊外观文字，但未保留与单一强度、单一包装一一对应的官方原品牌包装图，故不展示包装图片",
      "en": "Current EMA oral-product information and capsule appearance text were reviewed, but no official original-brand package image matching one exact strength and pack was retained, so no package visual is shown"
    },
    "summary": {
      "zh": "本档案保留 EXELON、利斯的明、四种胶囊强度、2 mg/mL 口服液、胶囊颜色与压印、口服液容器和欧盟许可号。EMA 当前产品资料提供准确文字身份，但此次未保留可安全公开展示且与单一剂型、单一规格和单一包装准确对应的官方原品牌包装图；为避免把零售图、版本不明图、其他市场图片、贴剂或另一种利斯的明产品误作准确口服 EXELON 外观，页面不展示包装图片，只保留一手产品资料供放大阅读。",
      "en": "This dossier retains EXELON, rivastigmine, four capsule strengths, the 2 mg/mL oral solution, capsule colours and imprints, oral-solution container and EU authorisation numbers. Current EMA product information provides exact textual identity, but no official original-brand image was retained that can safely be displayed and matched to one dosage form, one strength and one pack. To avoid presenting a retail image, version-uncertain image, another-market image, a patch or another rivastigmine product as the exact oral EXELON appearance, the page withholds package imagery and retains the primary product information for enlarged reading."
    },
    "source": {
      "id": "src_11f6dce81d63da04",
      "label": "EMA：EXELON 利斯的明当前欧盟产品资料（2026-02）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "EXELON 口服说明书放大阅读：每粒 mg、每毫升 mg/mL 与贴剂 mg/24h 不是同一种数字",
      "en": "EXELON oral label reading: mg per capsule, mg/mL and patch mg/24h are different quantities"
    },
    "summary": {
      "zh": "本模块以 EMA 当前欧盟产品资料为入口，帮助核对 EXELON、利斯的明、四种胶囊、2 mg/mL 口服液、准确许可号、外观文字和给药器。它不生成个人胶囊数、毫升数、频次、递增、漏用补救、开始、停用、口服制剂转换或口服—贴剂转换方案。",
      "en": "This module uses current EMA EU product information to check EXELON, rivastigmine, four capsule strengths, the 2 mg/mL oral solution, exact authorisation numbers, appearance text and the dosing syringe. It does not generate an individual's capsule count, millilitres, frequency, titration, missed-use remedy, initiation, stopping, oral-form conversion or oral-to-patch conversion."
    },
    "checks": [
      {
        "zh": "先看剂型，再看数字：胶囊的 1.5、3、4.5、6 mg 是每粒标示量；口服液的 2 mg/mL 是浓度；贴剂的 mg/24h 是 24 小时标称释放量。三类数字不能直接相除、相加或互换。",
        "en": "Check the dosage form before the number: 1.5, 3, 4.5 and 6 mg are amounts per capsule; 2 mg/mL is the oral-solution concentration; mg/24h is nominal patch delivery over 24 hours. These quantities cannot be directly divided, added or exchanged."
      },
      {
        "zh": "EMA 产品资料列明胶囊应整粒吞服，外盒文字还写明不要压碎或打开。不要为获得“半量”自行打开、倒粉、分装或混合胶囊；包装、处方和药师意见必须一起核对。",
        "en": "EMA product information states that capsules are swallowed whole, and the package text says not to crush or open them. Do not open, pour out, divide or mix capsule contents to obtain a ‘half amount’; check the pack, prescription and pharmacist advice together."
      },
      {
        "zh": "口服液是 2 mg/mL，随附口服给药器；瓶身 50 mL 或 120 mL 是容器总量，不是一次用量。网页不依据浓度、瓶量或说明书处方段落替个人计算毫升数。",
        "en": "The oral solution is 2 mg/mL and comes with an oral dosing syringe; 50 mL or 120 mL is the bottle content, not one use. The site does not calculate an individual's millilitres from concentration, bottle size or prescribing text."
      },
      {
        "zh": "EMA 说明书描述胶囊与口服液在专业处方框架下的等剂量转换，但这不是让公众自行换算的授权。任何转换都应让医生或药师按准确处方、实际包装、给药器和中断情况处理。",
        "en": "The EMA label describes equal-dose interchange between capsules and oral solution within professional prescribing. This is not permission for public self-conversion. Any change needs a clinician or pharmacist using the exact prescription, actual pack, dosing syringe and interruption history."
      },
      {
        "zh": "EXELON 口服制剂与 EXELON PATCH 是不同产品形态。不要按相同品牌或利斯的明成分自行叠加、轮换或换成贴剂；中断、漏用、呕吐、腹泻、体重下降或用药后明显不适，应联系负责治疗团队按当前说明书处理。",
        "en": "EXELON oral products and EXELON PATCH are different product forms. Do not self-combine, alternate or switch to a patch because they share a brand or rivastigmine. Interruption, missed use, vomiting, diarrhoea, weight loss or marked symptoms after use need the treating team and current product information."
      }
    ],
    "source": {
      "id": "src_11f6dce81d63da04",
      "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "利斯的明怎样起作用：可逆抑制胆碱酯酶，不等于逆转基础病程",
      "en": "How rivastigmine works: reversible cholinesterase inhibition does not mean reversing the underlying disease"
    },
    "summary": {
      "zh": "EMA 产品资料说明，利斯的明通过促进胆碱能神经传递来发挥作用，具体路径包括可逆抑制乙酰胆碱酯酶和丁酰胆碱酯酶；它用于帮助理解药理，不预测个人记忆变化、适用性、起效、胶囊数、毫升数或能否换剂型。",
      "en": "EMA product information describes rivastigmine as enhancing cholinergic neurotransmission through reversible inhibition of acetylcholinesterase and butyrylcholinesterase. This explains pharmacology; it does not predict an individual's memory change, suitability, onset, capsule count, millilitres or whether dosage forms can be switched."
    },
    "checks": [
      {
        "zh": "作用机制不是“越多越好”的依据，也不能根据症状自行加量、叠加其他胆碱酯酶抑制剂或突然停用。",
        "en": "Mechanism is not a ‘more is better’ rule and cannot justify self-increasing, adding another cholinesterase inhibitor or abrupt stopping."
      },
      {
        "zh": "同一成分经胶囊、口服液或贴剂进入身体，产品身份、数字口径和说明书处理仍不同；机制相同不等于剂型可自行互换。",
        "en": "The same ingredient delivered by capsule, oral solution or patch still has different product identities, quantity conventions and label handling; shared mechanism does not make the forms self-interchangeable."
      },
      {
        "zh": "老人常有多种处方药、非处方药和补充剂。请把实际药盒、给药器、完整药单和症状变化交给药师或处方团队逐项核对，网页不代替个体化评估。",
        "en": "Older people often use several prescriptions, OTC products and supplements. Bring the actual packs, dosing syringe, full medicine list and symptom changes for item-by-item review by a pharmacist or prescriber; the site does not replace individual assessment."
      }
    ],
    "source": {
      "id": "src_11f6dce81d63da04",
      "label": "EMA：EXELON 当前欧盟产品资料（药效学；2026-02）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-28",
      "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": "Exelon Oral",
      "generic": "利斯的明口服胶囊/口服液",
      "dosageFormClass": "口服硬胶囊：1.5、3、4.5、6 mg；口服液：2 mg/mL（欧盟当前产品资料所列）"
    },
    "labelSource": {
      "id": "src_11f6dce81d63da04",
      "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）",
      "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "EU",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_11f6dce81d63da04",
          "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）",
          "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-28",
        "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."
        }
      },
      {
        "source": {
          "id": "src_7b8da8b5b6d44be9",
          "label": "EMA：EXELON 欧洲公共评估报告页面（2026-02-24 更新）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "landing_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-28",
        "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": "EMA",
        "en": "EMA"
      },
      "market": {
        "zh": "欧盟/欧洲经济区",
        "en": "European Union / European Economic Area"
      },
      "recordType": {
        "zh": "监管产品记录或欧盟产品资料",
        "en": "Regulatory product record or EU product information"
      },
      "reviewedAt": "2026-08-28",
      "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": "EMA 当前欧盟 EXELON 产品资料分别列出 1.5、3、4.5、6 mg 硬胶囊和 2 mg/mL 口服液。本页帮助老人和照护者先核对剂型、每粒标示量或每毫升浓度、胶囊颜色与压印、口服液瓶量、给药器和许可号；不把说明书中的处方文字变成个人胶囊数、毫升数、频次、递增、漏用补救、停用或换成贴剂的方案。",
    "history": "EMA 记录 EXELON 的欧盟上市许可自 1998-05-12 有效。当前产品资料同时覆盖胶囊、口服液和贴剂；本档案只建立口服产品路径，现有 EXELON PATCH 档案继续单独记录贴剂。共享品牌和成分不表示可按 mg 自行换算、叠加、轮换或替换。",
    "sourceDocuments": [
      {
        "id": "src_7b8da8b5b6d44be9",
        "label": "EMA：EXELON 欧洲公共评估报告页面（2026-02-24 更新）",
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "landing_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_11f6dce81d63da04",
        "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      }
    ],
    "applicationNumber": "EU/1/98/066（EMA 集中上市许可；本档案限当前欧盟口服产品资料）",
    "approvalTimeline": [
      {
        "date": "1998-05-12",
        "title": {
          "zh": "EXELON 欧盟上市许可节点",
          "en": "EXELON EU marketing-authorisation node"
        },
        "detail": {
          "zh": "EMA 产品页列示 EXELON 的欧盟上市许可自 1998-05-12 有效。本页以该节点定位欧盟品牌档案，不把它解释成其他市场的批准、供应或原研/仿制结论。",
          "en": "EMA lists EXELON's EU marketing authorisation as valid from 12 May 1998. This node locates the EU brand record; it is not treated as approval, supply or an originator/generic conclusion for another market."
        },
        "source": {
          "id": "src_7b8da8b5b6d44be9",
          "label": "EMA：EXELON 欧洲公共评估报告页面",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "landing_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "date": "2026-02-09",
        "title": {
          "zh": "当前欧盟产品资料版本",
          "en": "Current EU product-information version"
        },
        "detail": {
          "zh": "EMA 当前产品资料 PDF 的修改日期为 2026-02-09，并分别列出 1.5、3、4.5、6 mg 胶囊和 2 mg/mL 口服液。该日期定位文件版本，不表示各规格在任何地点都有库存或可购买。",
          "en": "The current EMA product-information PDF has a modification date of 9 Feb 2026 and separately lists 1.5, 3, 4.5 and 6 mg capsules plus the 2 mg/mL oral solution. The date identifies a document version and does not establish local stock or purchase availability for every presentation."
        },
        "source": {
          "id": "src_11f6dce81d63da04",
          "label": "EMA：EXELON 利斯的明当前欧盟产品资料",
          "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "date": "2026-02-24",
        "title": {
          "zh": "EMA 产品页最近更新",
          "en": "EMA product page last updated"
        },
        "detail": {
          "zh": "EMA 页面显示 Last updated 24 February 2026。本页将页面更新时间与产品资料日期分开记录，避免把网页维护日期误读成临床用法变化。",
          "en": "EMA displays ‘Last updated 24 February 2026’. This dossier keeps the page-update date separate from the product-information date so that a web-maintenance date is not misread as a change in clinical use."
        },
        "source": {
          "id": "src_7b8da8b5b6d44be9",
          "label": "EMA：EXELON 欧洲公共评估报告页面",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "landing_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "欧盟",
          "en": "European Union"
        },
        "status": {
          "zh": "已链接当前产品资料与六个准确口服产品身份",
          "en": "Current product information and six exact oral-product identities linked"
        },
        "detail": {
          "zh": "本页分别记录四种硬胶囊强度和两个口服液瓶量，均以 EMA 当前欧盟产品资料为边界；不建立库存、购买、真伪鉴定、个人用量或自行转换结论。",
          "en": "The dossier separately records four capsule strengths and two oral-solution bottle sizes, bounded by current EMA EU product information. It does not establish stock, purchase, authentication, individual use or self-directed conversion."
        }
      },
      {
        "market": {
          "zh": "中国大陆、美国、日本及其他市场",
          "en": "Mainland China, United States, Japan and other markets"
        },
        "status": {
          "zh": "待逐项建立现行市场记录",
          "en": "Current market record not established"
        },
        "detail": {
          "zh": "不从欧盟许可、EMA 商品名、规格、包装文字或共同成分推定当地批准、持有人、供应、可售资格、原研/仿制关系或可替代性。",
          "en": "No local approval, holder, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the EU authorisation, EMA trade name, strengths, pack text or shared ingredient."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "2 mg/mL 是否表示一次就要使用 2 mg 或 1 mL？",
          "en": "Does 2 mg/mL mean one use must be 2 mg or 1 mL?"
        },
        "answer": {
          "zh": "不是。2 mg/mL 是每毫升浓度，只是口服液产品身份字段。个人毫升数必须按准确处方、随附给药器和专业人员核对，网页不计算。",
          "en": "No. 2 mg/mL is the concentration per millilitre and identifies the oral-solution product. Individual millilitres require the exact prescription, supplied dosing syringe and professional review; the site does not calculate them."
        }
      },
      {
        "question": {
          "zh": "EXELON 胶囊、口服液和贴剂能否只按 mg 自行换？",
          "en": "Can EXELON capsules, oral solution and patches be self-switched from mg numbers alone?"
        },
        "answer": {
          "zh": "不能。每粒 mg、mg/mL 和 mg/24h 是不同口径。EMA 说明书中的转换文字属于专业处方框架，任何转换都要让医生或药师根据准确产品与中断情况处理。",
          "en": "No. Milligrams per capsule, mg/mL and mg/24h use different quantity bases. Conversion text in EMA product information belongs to professional prescribing; any change needs a clinician or pharmacist using the exact product and interruption history."
        }
      }
    ],
    "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/exelon-oral/",
    "en": "https://origindrug.com/en/drugs/exelon-oral/"
  },
  "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."
  ]
}