{
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    "name": "Molecular Oncology Almanac",
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    "url": "https://moalmanac.org",
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  "data": [
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      "id": "ind:ema:glivec:7",
      "type": "Indication",
      "description": "Glivec is indicated for the treatment of the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-20:0",
          "type": "Contribution",
          "description": "Adding EMA approvals for use to database",
          "date": "2024-10-20",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
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        {
          "id": "ctrb:ema:2009-04-29:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2009-04-29",
          "contributor": {
            "id": "agent:org:ema",
            "type": "Agent",
            "agentType": "organization",
            "name": "European Medicines Agency",
            "description": "Regulatory agency that approves medicines for use in the European Union."
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      "reportedIn": [
        {
          "id": "doc:ema:glivec",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Glivec (imatinib) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "Novartis Europharm Limited. Glivec (imatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf. Revised November 2023. Accessed March 7, 2024.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/glivec"
          ],
          "doi": null,
          "pmid": null,
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              "name": "agent",
              "value": {
                "id": "agent:org:ema",
                "type": "Agent",
                "agentType": "organization",
                "name": "European Medicines Agency",
                "description": "Regulatory agency that approves medicines for use in the European Union."
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              "description": "The organization that published this document."
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            {
              "name": "company",
              "value": "Novartis Europharm Limited.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Glivec",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "imatinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2009-08-18",
              "description": "The publication date for the initial version of this document."
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            {
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              "value": "2023-11-20",
              "description": "The publication date for the document."
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              "value": null,
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The European Medicines Agency (EMA) has authorized imatinib for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD 117) positive gastrointestinal stromal tumors (GIST). Patients who have a low or very low risk of recurrence should not received adjuvant treatment.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}