FHIR © HL7.org  |  FHIRsmith 4.0.1  |  Server Home  |  XIG Home  |  XIG Stats  | 

FHIR IG analytics

Packagech.fhir.ig.ch-epl
Resource TypeRegulatedAuthorization
IdRegulatedAuthorization-MA-68793001.json
FHIR VersionR5

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 MA-68793001

identifier: Marketing Authorisation Number/68793001

subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01001107-0687930010000; indication = Paxlovid wird angewendet für die Behandlung der Coronavirus-Krankheit 2019 (COVID-19) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und bei denen ein erhöhtes Risiko für einen schweren Verlauf von COVID-19 besteht (siehe «Klinische Wirksamkeit»). Paxlovid ist nicht als Ersatz für eine Impfung gegen COVID-19 vorgesehen. Paxlovid sollte gemäss den offiziellen Empfehlungen und unter Berücksichtigung der lokalen epidemiologischen Daten zu zirkulierenden SARS-CoV-2-Varianten angewendet werden.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription single dispensation (A+); additionalMonitoringIndicator = Black Triangle Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = Protease inhibitors,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,08. INFEKTIONSKRANKHEITEN,08.03. Mittel gegen Viren

type: Marketing Authorisation

region: Switzerland

status: limited authorisation

statusDate: 2022-06-15

holder: Organization Pfizer AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-Pfizer-AG

Profile: Organization

identifier: Swissmedic Location Identifier/01001107, LOC Identifier/100015286, GLN Identifier/7601001010604

name: Pfizer 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-68793001",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-Pfizer-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01001107"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100015286"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001010604"
        }
      ],
      "name": "Pfizer 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": "68793001"
    }
  ],
  "subject": [
    {
      "reference": "MedicinalProductDefinition/Paxlovid-Filmcoatedtablet"
    }
  ],
  "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": "756005023002",
        "display": "limited authorisation"
      }
    ]
  },
  "statusDate": "2022-06-15",
  "holder": {
    "reference": "#holder-Pfizer-AG"
  },
  "regulator": {
    "reference": "#regulator-SMC"
  }
}