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: Xospata 40 mg, Filmtabletten - JSON Representation

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{
  "resourceType" : "MedicinalProductDefinition",
  "id" : "Xospata-Filmcoatedtablet",
  "meta" : {
    "profile" : [
      🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
    ]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet</b></p><a name=\"Xospata-Filmcoatedtablet\"> </a><a name=\"hcXospata-Filmcoatedtablet\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-medicinalproductdefinition.html\">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10221000}\">Film-coated tablet</span></p><p><b>identifier</b>: <a href=\"NamingSystem-MPID.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Medical Product Identifier</a>/CH-01100869-0672110010000</p><p><b>indication</b>: </p><div><p>Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}\">A: Single dispensing requiring a medical or veterinary prescription</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}\">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}\">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc L01EX13}\">gilteritinib</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000001}\">Synthetic</span></p><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status 7560050074000003}\">No interruption of distribution reported</span></td><td>2020-09-24 --&gt; (ongoing)</td></tr></table><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Xospata.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-123; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Xospata.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-abc-123; status = current; type = Patient Information; date = 2021-11-09 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Xospata 40 mg, Filmtabletten</p><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 de-CH}\">German (Switzerland)</span></td></tr></table></blockquote></div>"
  },
  "extension" : [
    {
      "url" : "http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://standardterms.edqm.eu",
            "code" : "10221000",
            "display" : "Film-coated tablet"
          }
        ]
      }
    }
  ],
  "identifier" : [
    {
      "system" : "http://fhir.ch/ig/ch-idmp/sid/mpid",
      "value" : "CH-01100869-0672110010000"
    }
  ],
  "indication" : "Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.",
  "legalStatusOfSupply" : {
    "coding" : [
      {
        "system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply",
        "code" : "756005034000001",
        "display" : "A: Single dispensing requiring a medical or veterinary prescription"
      }
    ]
  },
  "additionalMonitoringIndicator" : {
    "coding" : [
      {
        "system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator",
        "code" : "756005001003",
        "display" : "No Warning"
      }
    ]
  },
  "pediatricUseIndicator" : {
    "coding" : [
      {
        "system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator",
        "code" : "756005003002",
        "display" : "Not authorised for the treatment in children"
      }
    ]
  },
  "classification" : [
    {
      "coding" : [
        {
          "system" : "http://www.whocc.no/atc",
          "code" : "L01EX13"
        }
      ]
    },
    {
      "coding" : [
        {
          "system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory",
          "code" : "756005039000001",
          "display" : "Synthetic"
        }
      ]
    }
  ],
  "marketingStatus" : [
    {
      "country" : {
        "coding" : [
          {
            "system" : "urn:iso:std:iso:3166",
            "code" : "CH",
            "display" : "Switzerland"
          }
        ]
      },
      "status" : {
        "coding" : [
          {
            "system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status",
            "code" : "7560050074000003",
            "display" : "No interruption of distribution reported"
          }
        ]
      },
      "dateRange" : {
        "start" : "2020-09-24"
      }
    }
  ],
  "attachedDocument" : [
    {
      🔗 "reference" : "DocumentReference/DocRef-FI-Xospata"
    },
    {
      🔗 "reference" : "DocumentReference/DocRef-PI-Xospata"
    }
  ],
  "name" : [
    {
      "productName" : "Xospata 40 mg, Filmtabletten",
      "usage" : [
        {
          "country" : {
            "coding" : [
              {
                "system" : "urn:iso:std:iso:3166",
                "code" : "CH",
                "display" : "Switzerland"
              }
            ]
          },
          "language" : {
            "coding" : [
              {
                "system" : "urn:ietf:bcp:47",
                "code" : "de-CH"
              }
            ]
          }
        }
      ]
    }
  ]
}