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Packagech.fhir.ig.ch-idmp
Resource TypePackagedProductDefinition
IdPackagedProductDefinition-PMP-Comprehensive-Sample-Combipack.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: PackagedProductDefinition PMP-Comprehensive-Sample-Combipack

identifier: Clinical Product Identifier/CH-11111111-1234560010000-0002

packageFor: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic

containedItemQuantity: 1 Tube (Details: EDQM - Standard Terms code15058000 = 'Tube'), 6 Vaginal Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')

description:

Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen

LegalStatusOfSupplies

-Code
*D: Dispensed following expert advice

MarketingStatuses

-CountryStatusDateRange
*SwitzerlandMarketed2020-09-24 --> 2026-12-31

packaging

identifier: GTIN Global Trade Item Number/7680612345678

type: Box

quantity: 1

ShelfLifeStorages

-TypePeriod[x]SpecialPrecautionsForStorage
*Shelf life of the medicinal product as packaged for saleNo display for Duration (value: 24; unit: month; system: http://unitsofmeasure.org; code: mo)at room temperature (15 - 25°C)
* protect from light
* Store in the original container
*Shelf life after first opening the immediate packagingNo display for Duration (value: 6; unit: month; system: http://unitsofmeasure.org; code: mo)

packaging

type: Blister

quantity: 3

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Pessary; unitOfPresentation = Pessary

amount: 2 countable unit(s) (Details: UCUM code1 = '1')

packaging

type: Tube

quantity: 1

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube

amount: 10 mg (Details: UCUM codemg = 'mg')

packaging

type: Sachet

quantity: 1


Source1

{
  "resourceType": "PackagedProductDefinition",
  "id": "PMP-Comprehensive-Sample-Combipack",
  "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-11111111-1234560010000-0002"
    }
  ],
  "packageFor": [
    {
      "reference": "MedicinalProductDefinition/Comprehensive-Sample-Combipack"
    }
  ],
  "containedItemQuantity": [
    {
      "value": 1,
      "unit": "Tube",
      "system": "http://standardterms.edqm.eu",
      "code": "15058000"
    },
    {
      "value": 6,
      "unit": "Vaginal Tablet",
      "system": "http://standardterms.edqm.eu",
      "code": "15054000"
    }
  ],
  "description": "Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen",
  "legalStatusOfSupply": [
    {
      "code": {
        "coding": [
          {
            "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply",
            "code": "756005034000005",
            "display": "D: Dispensed following expert advice"
          }
        ]
      }
    }
  ],
  "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",
        "end": "2026-12-31"
      }
    }
  ],
  "packaging": {
    "identifier": [
      {
        "system": "https://www.gs1.org/gtin",
        "value": "7680612345678"
      }
    ],
    "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": 24,
          "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": "756005041000006",
                "display": "at room temperature (15 - 25°C)"
              }
            ]
          }
        ]
      },
      {
        "specialPrecautionsForStorage": [
          {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
                "code": "756005041000004",
                "display": "protect from light"
              }
            ]
          }
        ]
      },
      {
        "specialPrecautionsForStorage": [
          {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
                "code": "756005041000011",
                "display": "Store in the original container"
              }
            ]
          }
        ]
      },
      {
        "type": {
          "coding": [
            {
              "system": "http://spor.ema.europa.eu/v1/lists/100000073343",
              "code": "100000073404",
              "display": "Shelf life after first opening the immediate packaging"
            }
          ]
        },
        "periodDuration": {
          "value": 6,
          "unit": "month",
          "system": "http://unitsofmeasure.org",
          "code": "mo"
        }
      }
    ],
    "packaging": [
      {
        "type": {
          "coding": [
            {
              "system": "http://standardterms.edqm.eu",
              "code": "15007000",
              "display": "Blister"
            }
          ]
        },
        "quantity": 3,
        "containedItem": [
          {
            "item": {
              "reference": {
                "reference": "ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary"
              }
            },
            "amount": {
              "value": 2,
              "unit": "countable unit(s)",
              "system": "http://unitsofmeasure.org",
              "code": "1"
            }
          }
        ],
        "packaging": [
          {
            "type": {
              "coding": [
                {
                  "system": "http://standardterms.edqm.eu",
                  "code": "15058000",
                  "display": "Tube"
                }
              ]
            },
            "quantity": 1,
            "containedItem": [
              {
                "item": {
                  "reference": {
                    "reference": "ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream"
                  }
                },
                "amount": {
                  "value": 10,
                  "unit": "mg",
                  "system": "http://unitsofmeasure.org",
                  "code": "mg"
                }
              }
            ]
          }
        ]
      },
      {
        "type": {
          "coding": [
            {
              "system": "http://standardterms.edqm.eu",
              "code": "30054000",
              "display": "Sachet"
            }
          ]
        },
        "quantity": 1
      }
    ]
  }
}