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Packagech.fhir.ig.ch-idmp
Resource TypeMedicinalProductDefinition
IdMedicinalProductDefinition-Xospata-Filmcoatedtablet.json
FHIR VersionR5

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet

CH SMC - Authorized Dose Form: Film-coated tablet

identifier: Medical Product Identifier/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: A: Single dispensing requiring a medical or veterinary prescription

additionalMonitoringIndicator: No Warning

pediatricUseIndicator: Not authorised for the treatment in children

classification: gilteritinib, Synthetic

MarketingStatuses

-CountryStatusDateRange
*SwitzerlandNo interruption of distribution reported2020-09-24 --> (ongoing)

attachedDocument:

name

productName: Xospata 40 mg, Filmtabletten

Usages

-CountryLanguage
*SwitzerlandGerman (Switzerland)

Source1

{
  "resourceType": "MedicinalProductDefinition",
  "id": "Xospata-Filmcoatedtablet",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "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"
              }
            ]
          }
        }
      ]
    }
  ]
}