FHIRsmith: RegulatedAuthorization/RegulatedAuthorization-MA-6829104.json

FHIR IG analytics

Package	ch.fhir.ig.ch-idmp
Resource Type	RegulatedAuthorization
Id	RegulatedAuthorization-MA-6829104.json
FHIR Version	R5

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Narrative

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

Generated Narrative: RegulatedAuthorization MA-6829104

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/6829104

subject: 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

type: Marketing Authorisation

region: Switzerland

status: approved

statusDate: 2021-11-09

validityPeriod: 2021-11-09 --> 2026-11-08

holder: Organization Astellas Pharma AG

regulator: Organization SMC

Generated Narrative: Organization #holder-Astellas-Pharma-AG

Profile: Organization
identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964
name: Astellas Pharma AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC

Source1

{
  "resourceType": "RegulatedAuthorization",
  "id": "MA-6829104",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-Astellas-Pharma-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01100869"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100010745"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001000964"
        }
      ],
      "name": "Astellas Pharma AG"
    },
    {
      "resourceType": "Organization",
      "id": "regulator-SMC",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100010911"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001398511"
        }
      ],
      "name": "SMC"
    }
  ],
  "identifier": [
    {
      "system": "http://fhir.ch/ig/ch-idmp/sid/authno",
      "value": "6829104"
    }
  ],
  "subject": [
    {
      "reference": "MedicinalProductDefinition/Padcev-30mg-Powder"
    }
  ],
  "type": {
    "coding": [
      {
        "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
        "code": "756000002001",
        "display": "Marketing Authorisation"
      }
    ]
  },
  "region": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "CH",
          "display": "Switzerland"
        }
      ]
    }
  ],
  "status": {
    "coding": [
      {
        "system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status",
        "code": "756005010000001",
        "display": "approved"
      }
    ]
  },
  "statusDate": "2021-11-09",
  "validityPeriod": {
    "start": "2021-11-09",
    "end": "2026-11-08"
  },
  "holder": {
    "reference": "#holder-Astellas-Pharma-AG"
  },
  "regulator": {
    "reference": "#regulator-SMC"
  }
}