{
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    "timestamp_received": "2026-04-24T03:13:36.083028+00:00Z",
    "timestamp_returned": "2026-04-24T03:13:36.086770+00:00Z",
    "trace_id": "dd4f8f5f-aad3-4072-a0bc-e4c0aa2be415"
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
  },
  "data": [
    {
      "id": "ind:ema.mabthera:1",
      "indication": "MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged >= 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).",
      "initial_approval_date": "2020-03-16",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/mabthera-h-c-165-ii-0168-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized rituximab in combination with chemotherapy for the treatment of pediatric patients (aged >= 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL) / Burkitt leukemia (mature B-cell acute leukemia) (BAL) or Burkitt-like lymphoma (BLL). This indication is based on a multicenter, open-label, randomized study of Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide and triple drug [methotrexate/cytarabine/ corticosteroid] intrathecal therapy) alone or in combination with rituximab.",
      "raw_biomarkers": "CD20 positive",
      "raw_cancer_type": "diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL)",
      "raw_therapeutics": "MabThera (rituximab) in combination with chemotherapy",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:ema.mabthera",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "MabThera (rituximab) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Roche Registration GmbH. MabThera (rituximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf. Revised November 2023. Accessed March 19, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera",
          "https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Roche Registration GmbH.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "MabThera",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "rituximab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2009-10-30",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2023-11-29",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}