{
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    "name": "Molecular Oncology Almanac",
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    "url": "https://moalmanac.org",
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  "data": [
    {
      "id": "ind:ema:lynparza:3",
      "type": "Indication",
      "description": "Lynparza is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.",
      "contributions": [
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          "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",
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            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
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        {
          "id": "ctrb:ema:2022-08-02:0",
          "type": "Contribution",
          "description": "Indication received approval from the European Commission.",
          "date": "2022-08-02",
          "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:lynparza",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Lynparza (olaparib) [product information]. EMA.",
          "title": null,
          "aliases": [],
          "description": "AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.",
          "urls": [
            "https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf",
            "https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza"
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          "doi": null,
          "pmid": null,
          "extensions": [
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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": "AstraZeneca AB.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Lynparza",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "olaparib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2015-01-09",
              "description": "The publication date for the initial version of this document."
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              "value": "2024-08-20",
              "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."
            }
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      "extensions": [
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          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
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          "value": "The European Medicines Agency (EMA) has authorized olaparib as both a monotherapy and in combination with endocrine for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Lynparza's product information cites the OlympiA trial, where olaparib was compared against placebo for the treatment of patients with germline BRCA1/2 mutated and HER2-negative high risk early breast cancer.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}