{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 80
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
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      "primarysourcecountry": "RO",
      "occurcountry": "RO",
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      "reporttype": "1",
      "serious": "1",
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      "receivedateformat": "102",
      "receivedate": "20140625",
      "receiptdateformat": "102",
      "receiptdate": "20140702",
      "fulfillexpeditecriteria": "1",
      "companynumb": "RO-ASTRAZENECA-2014SE45337",
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      "reportduplicate": {
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        "duplicatenumb": "RO-ASTRAZENECA-2014SE45337"
      },
      "primarysource": {
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        "qualification": "3"
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        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
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        "receiverorganization": "FDA"
      },
      "patient": {
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        "patientonsetageunit": "801",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Hypertension",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Cerebral haemorrhage",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Bladder disorder",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Cerebrovascular accident",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.1",
            "reactionmeddrapt": "Abdominal pain upper",
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        ],
        "drug": [
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CEREBROLYSIN",
            "activesubstance": {
              "activesubstancename": "CEREBROLYSIN"
            }
          },
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            },
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                "70720-951"
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              ],
              "route": [
                "SUBCUTANEOUS"
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              "substance_name": [
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                "211544",
                "314008"
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            "actiondrug": "5",
            "activesubstance": {
              "activesubstancename": "GOSERELIN ACETATE"
            },
            "openfda": {
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                "NDA019726",
                "NDA020578"
              ],
              "brand_name": [
                "ZOLADEX"
              ],
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                "GOSERELIN"
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              "manufacturer_name": [
                "TerSera Therapeutics LLC"
              ],
              "product_ndc": [
                "70720-950",
                "70720-951"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "SUBCUTANEOUS"
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              "substance_name": [
                "GOSERELIN ACETATE"
              ],
              "rxcui": [
                "105641",
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                "314008"
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                "c48edbf8-425f-4e11-8892-467e868d9fba",
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              ],
              "spl_set_id": [
                "294b168b-6e5f-4db9-bf70-d599271458b3",
                "e4cb3c20-2738-400a-b522-3f36f71fe6c5"
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                "70720-950-36",
                "70720-951-30"
              ],
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                "6YUU2PV0U8"
              ]
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          {
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            "medicinalproduct": "CASODEX",
            "activesubstance": {
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                "NDA020498"
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                "CASODEX"
              ],
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                "BICALUTAMIDE"
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              "manufacturer_name": [
                "ANI Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "62559-680"
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              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
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              "substance_name": [
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              "nui": [
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}