FHIRsmith: RegulatedAuthorization/RegulatedAuthorization-MA-54704089.json

FHIR IG analytics

Package	ch.fhir.ig.ch-epl
Resource Type	RegulatedAuthorization
Id	RegulatedAuthorization-MA-54704089.json
FHIR Version	R5

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Narrative

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

Generated Narrative: RegulatedAuthorization MA-54704089

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/54704089

subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen. Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = norethisterone and estrogen,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 1999-08-17

holder: Organization Sandoz Pharmaceuticals AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG

Profile: Organization
identifier: Swissmedic Location Identifier/01006431, LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals 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-54704089",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-Sandoz-Pharmaceuticals-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01006431"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100054743"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001029439"
        }
      ],
      "name": "Sandoz Pharmaceuticals 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": "54704089"
    }
  ],
  "subject": [
    {
      "reference": "MedicinalProductDefinition/Estalis-Transdermalpatch"
    }
  ],
  "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": "1999-08-17",
  "holder": {
    "reference": "#holder-Sandoz-Pharmaceuticals-AG"
  },
  "regulator": {
    "reference": "#regulator-SMC"
  }
}