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    "timestamp_received": "2026-11-09T16:11:55.016721Z",
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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:rydapt:0",
      "type": "Indication",
      "description": "Rydapt is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive.",
      "contributions": [
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          "type": "Contribution",
          "description": "Adding EMA approvals for use to database",
          "date": "2024-10-20",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
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            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
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        {
          "id": "ctrb:ema:2017-09-18:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2017-09-18",
          "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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          "id": "doc:ema:rydapt",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Rydapt (midostaurin) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "Novartis Europharm Ltd. Rydapt (midostaurin) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf. Revised July 2023. Accessed March 22, 2024.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt"
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          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "agent",
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                "id": "agent:org:ema",
                "type": "Agent",
                "agentType": "organization",
                "name": "European Medicines Agency",
                "description": "Regulatory agency that approves medicines for use in the European Union."
              },
              "description": "The organization that published this document."
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              "name": "company",
              "value": "Novartis Europharm Ltd.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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            {
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              "value": "Rydapt",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "midostaurin",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2017-10-25",
              "description": "The publication date for the initial version of this document."
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              "value": "2023-07-26",
              "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)."
            },
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              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
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      "extensions": [
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          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
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          "name": "statement description",
          "value": "The European Medicines Agency (EMA) has authorized midostaurin in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintence therapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. Midostaurin's product information further states that AML patients must have confirmation of the FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}