CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions

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• XML
• JSON

: 5204201 - JSON Representation

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{
  "resourceType" : "RegulatedAuthorization",
  "id" : "MA-5204201",
  "meta" : {
    "profile" : [
      🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-5204201</b></p><a name=\"MA-5204201\"> </a><a name=\"hcMA-5204201\"> </a><a name=\"MA-5204201-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5204201</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status 756005023007}\">zugelassen</span></p><p><b>statusDate</b>: 1993-06-18</p><p><b>holder</b>: <a href=\"#hcMA-5204201/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-5204201/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization  #holder-Tillotts-Pharma-AG</b></p><a name=\"MA-5204201/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcMA-5204201/holder-Tillotts-Pharma-AG\"> </a><a name=\"MA-5204201/holder-Tillotts-Pharma-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization  #regulator-SMC</b></p><a name=\"MA-5204201/regulator-SMC\"> </a><a name=\"hcMA-5204201/regulator-SMC\"> </a><a name=\"MA-5204201/regulator-SMC-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
  },
  "contained" : [
    {
      "resourceType" : "Organization",
      "id" : "holder-Tillotts-Pharma-AG",
      "meta" : {
        "profile" : [
          🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
        ]
      },
      "identifier" : [
        {
          "system" : "urn:oid:1.2.276.0.76",
          "value" : "100005174"
        },
        {
          "system" : "urn:oid:2.51.1.3",
          "value" : "7601001346451"
        }
      ],
      "name" : "Tillotts Pharma AG"
    },
    {
      "resourceType" : "Organization",
      "id" : "regulator-SMC",
      "meta" : {
        "profile" : [
          🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
        ]
      },
      "identifier" : [
        {
          "system" : "urn:oid:1.2.276.0.76",
          "value" : "100010911"
        },
        {
          "system" : "urn:oid:2.51.1.3",
          "value" : "7601001398511"
        }
      ],
      "name" : "SMC"
    }
  ],
  "identifier" : [
    {
      "system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber",
      "value" : "5204201"
    }
  ],
  "subject" : [
    {
      🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
    }
  ],
  "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" : "zugelassen"
      }
    ]
  },
  "statusDate" : "1993-06-18",
  "holder" : {
    "reference" : "#holder-Tillotts-Pharma-AG"
  },
  "regulator" : {
    "reference" : "#regulator-SMC"
  }
}