FHIRsmith: RegulatedAuthorization/RegulatedAuthorization-MA-6743101.json

FHIR IG analytics

Package	ch.fhir.ig.ch-epl
Resource Type	RegulatedAuthorization
Id	RegulatedAuthorization-MA-6743101.json
FHIR Version	R5

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Narrative

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

Generated Narrative: RegulatedAuthorization MA-6743101

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/6743101

subject: MedicinalProductDefinition: extension = Capsule, hard; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100828-0674310010000; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 2020-05-28

holder: Organization IDEOGEN AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-Ideogen-AG

Profile: Organization
identifier: Swissmedic Location Identifier/01100828, LOC Identifier/100012910, GLN Identifier/7601001403062
name: IDEOGEN AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products

Source1

{
  "resourceType": "RegulatedAuthorization",
  "id": "MA-6743101",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-Ideogen-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01100828"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100012910"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001403062"
        }
      ],
      "name": "IDEOGEN AG"
    },
    {
      "resourceType": "Organization",
      "id": "regulator-SMC",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/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": "Swissmedic Swiss Agency for Therapeutic Products"
    }
  ],
  "identifier": [
    {
      "system": "http://fhir.ch/ig/ch-epl/sid/authno",
      "value": "6743101"
    }
  ],
  "subject": [
    {
      "reference": "MedicinalProductDefinition/Triogen-250mg-Capsule"
    }
  ],
  "type": {
    "coding": [
      {
        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
        "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-epl/CodeSystem/ch-SMC-authorisation-status",
        "code": "756005023007",
        "display": "valid"
      }
    ]
  },
  "statusDate": "2020-05-28",
  "holder": {
    "reference": "#holder-Ideogen-AG"
  },
  "regulator": {
    "reference": "#regulator-SMC"
  }
}