FHIRsmith: RegulatedAuthorization/RegulatedAuthorization-FOPH-20416.json

FHIR IG analytics

Package	ch.fhir.ig.ch-epl
Resource Type	RegulatedAuthorization
Id	RegulatedAuthorization-FOPH-20416.json
FHIR Version	R5

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

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

Generated Narrative: RegulatedAuthorization FOPH-20416

CH EPL - Reimbursement SL
url
FOPHDossierNumber
value: FOPH Dossier Number/20416
url
status
value: Reimbursed
url
statusDate
value: 2023-01-01
url
expiryDate
value: 2025-03-31
url
listingStatus
value: Listed
url
listingPeriod
value: 2023-01-01 --> 2024-12-31
url
firstListingDate
value: 2017-09-01
url
costShare
value: 10
url
gamme
value: Parenteral Depot
url
priceModel
value: true
value: CHF4,407.68 (CHF)
type: Ex-factory price
changeType: Normal price mutation
changeDate: 2023-01-01
url
CH EPL - Product Price
value: CHF4,768.50 (CHF)
type: Retail price
changeType: VAT-change
changeDate: 2024-01-01
url
CH EPL - Product Price

subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01003060-0662310010000-0001; containedItemQuantity = 1 Vial; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf

type: Reimbursement SL

Indications

Extension

Reference

ClinicalUseDefinition: type = indication

holder: Organization MSD Merck Sharp & Dohme AG

Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG

Profile: Organization
identifier: Swissmedic Location Identifier/01003060, LOC Identifier/100080484, GLN Identifier/7601001001138
name: MSD Merck Sharp & Dohme AG

Source1

{
  "resourceType": "RegulatedAuthorization",
  "id": "FOPH-20416",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-MSD-Merck-Sharp-Dohme-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01003060"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100080484"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001001138"
        }
      ],
      "name": "MSD Merck Sharp & Dohme AG"
    }
  ],
  "extension": [
    {
      "extension": [
        {
          "url": "FOPHDossierNumber",
          "valueIdentifier": {
            "system": "urn:oid:2.16.756.1",
            "value": "20416"
          }
        },
        {
          "url": "status",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
                "code": "756001021001",
                "display": "Reimbursed"
              }
            ]
          }
        },
        {
          "url": "statusDate",
          "valueDate": "2023-01-01"
        },
        {
          "url": "expiryDate",
          "valueDate": "2025-03-31"
        },
        {
          "url": "listingStatus",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status",
                "code": "756001002001",
                "display": "Listed"
              }
            ]
          }
        },
        {
          "url": "listingPeriod",
          "valuePeriod": {
            "start": "2023-01-01",
            "end": "2024-12-31"
          }
        },
        {
          "url": "firstListingDate",
          "valueDate": "2017-09-01"
        },
        {
          "url": "costShare",
          "valueInteger": 10
        },
        {
          "url": "gamme",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
                "code": "756002004005",
                "display": "Parenteral Depot"
              }
            ]
          }
        },
        {
          "url": "priceModel",
          "valueBoolean": true
        },
        {
          "extension": [
            {
              "url": "value",
              "valueMoney": {
                "value": 4407.68,
                "currency": "CHF"
              }
            },
            {
              "url": "type",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
                    "code": "756002005002",
                    "display": "Ex-factory price"
                  }
                ]
              }
            },
            {
              "url": "changeType",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
                    "code": "756002006009",
                    "display": "Normal price mutation"
                  }
                ]
              }
            },
            {
              "url": "changeDate",
              "valueDate": "2023-01-01"
            }
          ],
          "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
        },
        {
          "extension": [
            {
              "url": "value",
              "valueMoney": {
                "value": 4768.5,
                "currency": "CHF"
              }
            },
            {
              "url": "type",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
                    "code": "756002005001",
                    "display": "Retail price"
                  }
                ]
              }
            },
            {
              "url": "changeType",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
                    "code": "756002006008",
                    "display": "VAT-change"
                  }
                ]
              }
            },
            {
              "url": "changeDate",
              "valueDate": "2024-01-01"
            }
          ],
          "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
        }
      ],
      "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
    }
  ],
  "subject": [
    {
      "reference": "PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"
    }
  ],
  "type": {
    "coding": [
      {
        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
        "code": "756000002003",
        "display": "Reimbursement SL"
      }
    ]
  },
  "indication": [
    {
      "extension": [
        {
          "extension": [
            {
              "url": "status",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus",
                    "code": "756002071001",
                    "display": "Limitation Reimbursed"
                  }
                ]
              }
            },
            {
              "url": "statusDate",
              "valueDate": "2025-11-01"
            },
            {
              "url": "period",
              "valuePeriod": {
                "start": "2025-11-01"
              }
            },
            {
              "url": "firstLimitationDate",
              "valueDate": "2023-01-01"
            },
            {
              "url": "indicationCode",
              "valueString": "20416.17"
            },
            {
              "url": "limitationIndication",
              "valueReference": {
                "reference": "ClinicalUseDefinition/LIM-254837009"
              }
            }
          ],
          "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"
        }
      ],
      "reference": {
        "reference": "ClinicalUseDefinition/IND-10075566"
      }
    },
    {
      "extension": [
        {
          "extension": [
            {
              "url": "status",
              "valueCodeableConcept": {
                "coding": [
                  {
                    "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus",
                    "code": "756002071001",
                    "display": "Limitation Reimbursed"
                  }
                ]
              }
            },
            {
              "url": "statusDate",
              "valueDate": "2023-01-01"
            },
            {
              "url": "period",
              "valuePeriod": {
                "start": "2023-01-01",
                "end": "2024-12-31"
              }
            },
            {
              "url": "reimbursementEndDate",
              "valueDate": "2025-03-31"
            },
            {
              "url": "firstLimitationDate",
              "valueDate": "2023-01-01"
            },
            {
              "url": "indicationCode",
              "valueString": "20416.XX"
            },
            {
              "url": "limitationIndication",
              "valueReference": {
                "reference": "ClinicalUseDefinition/LIM-20416.XX"
              }
            },
            {
              "extension": [
                {
                  "url": "value",
                  "valueMoney": {
                    "value": 4407.68,
                    "currency": "CHF"
                  }
                },
                {
                  "url": "type",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
                        "code": "756002005002",
                        "display": "Ex-factory price"
                      }
                    ]
                  }
                },
                {
                  "url": "changeType",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
                        "code": "756002006009",
                        "display": "Normal price mutation"
                      }
                    ]
                  }
                },
                {
                  "url": "changeDate",
                  "valueDate": "2023-01-01"
                }
              ],
              "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
            },
            {
              "extension": [
                {
                  "url": "value",
                  "valueMoney": {
                    "value": 4768.5,
                    "currency": "CHF"
                  }
                },
                {
                  "url": "type",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
                        "code": "756002005001",
                        "display": "Retail price"
                      }
                    ]
                  }
                },
                {
                  "url": "changeType",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
                        "code": "756002006008",
                        "display": "VAT-change"
                      }
                    ]
                  }
                },
                {
                  "url": "changeDate",
                  "valueDate": "2024-01-01"
                }
              ],
              "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
            }
          ],
          "url": "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"
        }
      ]
    }
  ],
  "holder": {
    "reference": "#holder-MSD-Merck-Sharp-Dohme-AG"
  }
}