FHIRsmith: PackagedProductDefinition/PackagedProductDefinition-PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.json

FHIR IG analytics

Package	ch.fhir.ig.ch-idmp
Resource Type	PackagedProductDefinition
Id	PackagedProductDefinition-PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.json
FHIR Version	R5

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: PackagedProductDefinition PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet

Profile: PackagedProductDefinition

identifier: Clinical Product Identifier/CH-01100869-0672110010000-0001

packageFor: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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

containedItemQuantity: 48 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')

description:

4 Blister zu 7 Tabletten in 1 Box

LegalStatusOfSupplies

Code

A: Single dispensing requiring a medical or veterinary prescription

MarketingStatuses

Country

Status

DateRange

Switzerland

Marketed

2020-09-24 --> (ongoing)

packaging
identifier: GTIN Global Trade Item Number/7680672110011
type: Box
quantity: 1
ShelfLifeStorages
- Type Period[x] SpecialPrecautionsForStorage
* Shelf life of the medicinal product as packaged for sale No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C
packaging
type: Blister
quantity: 4
containedItem
Items
- Reference
* ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
amount: 12 countable unit(s) (Details: UCUM code1 = '1')

Source1

{
  "resourceType": "PackagedProductDefinition",
  "id": "PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "system": "http://fhir.ch/ig/ch-idmp/sid/pcid",
      "value": "CH-01100869-0672110010000-0001"
    }
  ],
  "packageFor": [
    {
      "reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
    }
  ],
  "containedItemQuantity": [
    {
      "value": 48,
      "unit": "Tablet",
      "system": "http://standardterms.edqm.eu",
      "code": "15054000"
    }
  ],
  "description": "4 Blister zu 7 Tabletten in 1 Box",
  "legalStatusOfSupply": [
    {
      "code": {
        "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"
          }
        ]
      }
    }
  ],
  "marketingStatus": [
    {
      "country": {
        "coding": [
          {
            "system": "urn:iso:std:iso:3166",
            "code": "CH",
            "display": "Switzerland"
          }
        ]
      },
      "status": {
        "coding": [
          {
            "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status",
            "code": "756002026002",
            "display": "Marketed"
          }
        ]
      },
      "dateRange": {
        "start": "2020-09-24"
      }
    }
  ],
  "packaging": {
    "identifier": [
      {
        "system": "https://www.gs1.org/gtin",
        "value": "7680672110011"
      }
    ],
    "type": {
      "coding": [
        {
          "system": "http://standardterms.edqm.eu",
          "code": "30009000",
          "display": "Box"
        }
      ]
    },
    "quantity": 1,
    "shelfLifeStorage": [
      {
        "type": {
          "coding": [
            {
              "system": "http://spor.ema.europa.eu/v1/lists/100000073343",
              "code": "100000073403",
              "display": "Shelf life of the medicinal product as packaged for sale"
            }
          ]
        },
        "periodDuration": {
          "value": 36,
          "unit": "month",
          "system": "http://unitsofmeasure.org",
          "code": "mo"
        },
        "specialPrecautionsForStorage": [
          {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
                "code": "756005041000009",
                "display": "Do not store above 30°C"
              }
            ]
          }
        ]
      }
    ],
    "packaging": [
      {
        "type": {
          "coding": [
            {
              "system": "http://standardterms.edqm.eu",
              "code": "30007000",
              "display": "Blister"
            }
          ]
        },
        "quantity": 4,
        "containedItem": [
          {
            "item": {
              "reference": {
                "reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
              }
            },
            "amount": {
              "value": 12,
              "unit": "countable unit(s)",
              "system": "http://unitsofmeasure.org",
              "code": "1"
            }
          }
        ]
      }
    ]
  }
}