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Packagech.fhir.ig.ch-idmp
Resource TypeRegulatedAuthorization
IdRegulatedAuthorization-MA-68291001.json
FHIR VersionR5

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Narrative

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

Generated Narrative: RegulatedAuthorization MA-68291001

identifier: Marketing Authorisation Number/68291001

subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0682910030000-0001; containedItemQuantity = 20 mg; description = Durchstechflasche 1 Stk

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-68291001",
  "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": "68291001"
    }
  ],
  "subject": [
    {
      "reference": "PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-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"
  }
}