FHIRsmith: PackagedProductDefinition/PackagedProductDefinition-PMP-Enfortumabum-vedotinum-30-Powder.json

FHIR IG analytics

Package	ch.fhir.ig.ch-idmp
Resource Type	PackagedProductDefinition
Id	PackagedProductDefinition-PMP-Enfortumabum-vedotinum-30-Powder.json
FHIR Version	R5

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Narrative

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

Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-30-Powder

Profile: PackagedProductDefinition

identifier: Clinical Product Identifier/CH-01100869-0682910040000-0002

packageFor: MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910040000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics

containedItemQuantity: 30 mg (Details: UCUM codemg = 'mg')

description:

Durchstechflasche 1 Stk

LegalStatusOfSupplies

Code

A: Single dispensing requiring a medical or veterinary prescription

MarketingStatuses

Country

Status

DateRange

Switzerland

Marketed

2011-09-11 --> (ongoing)

packaging
identifier: GTIN Global Trade Item Number/7680682910014
type: Box
quantity: 1
ShelfLifeStorages
- Type Period[x] SpecialPrecautionsForStorage
* Shelf life after dilution or reconstitution according to directions No display for Duration (value: 16; unit: hour; system: http://unitsofmeasure.org; code: h) Store in the original container
packaging
type: Vial
quantity: 1
containedItem
Items
- Reference
* ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial
amount: 30 mg (Details: UCUM codemg = 'mg')

Source1

{
  "resourceType": "PackagedProductDefinition",
  "id": "PMP-Enfortumabum-vedotinum-30-Powder",
  "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-01100869-0682910040000-0002"
    }
  ],
  "packageFor": [
    {
      "reference": "MedicinalProductDefinition/Padcev-30mg-Powder"
    }
  ],
  "containedItemQuantity": [
    {
      "value": 30,
      "unit": "mg",
      "system": "http://unitsofmeasure.org",
      "code": "mg"
    }
  ],
  "description": "Durchstechflasche 1 Stk",
  "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": "2011-09-11"
      }
    }
  ],
  "packaging": {
    "identifier": [
      {
        "system": "https://www.gs1.org/gtin",
        "value": "7680682910014"
      }
    ],
    "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": "100000073405",
              "display": "Shelf life after dilution or reconstitution according to directions"
            }
          ]
        },
        "periodDuration": {
          "value": 16,
          "unit": "hour",
          "system": "http://unitsofmeasure.org",
          "code": "h"
        },
        "specialPrecautionsForStorage": [
          {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
                "code": "756005041000011",
                "display": "Store in the original container"
              }
            ]
          }
        ]
      }
    ],
    "packaging": [
      {
        "type": {
          "coding": [
            {
              "system": "http://standardterms.edqm.eu",
              "code": "30069000",
              "display": "Vial"
            }
          ]
        },
        "quantity": 1,
        "containedItem": [
          {
            "item": {
              "reference": {
                "reference": "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
              }
            },
            "amount": {
              "value": 30,
              "unit": "mg",
              "system": "http://unitsofmeasure.org",
              "code": "mg"
            }
          }
        ]
      }
    ]
  }
}