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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• JSON

: 5470402 - JSON Representation

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{
  "resourceType" : "RegulatedAuthorization",
  "id" : "MA-5470402",
  "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-5470402</b></p><a name=\"MA-5470402\"> </a><a name=\"hcMA-5470402\"> </a><a name=\"MA-5470402-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5470402</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: 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 = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,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>: 1999-08-17</p><p><b>holder</b>: <a href=\"#hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG\">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-5470402/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization  #holder-Sandoz-Pharmaceuticals-AG</b></p><a name=\"MA-5470402/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"MA-5470402/holder-Sandoz-Pharmaceuticals-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization  #regulator-SMC</b></p><a name=\"MA-5470402/regulator-SMC\"> </a><a name=\"hcMA-5470402/regulator-SMC\"> </a><a name=\"MA-5470402/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-Sandoz-Pharmaceuticals-AG",
      "meta" : {
        "profile" : [
          🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
        ]
      },
      "identifier" : [
        {
          "system" : "urn:oid:1.2.276.0.76",
          "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-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" : "5470402"
    }
  ],
  "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" : "zugelassen"
      }
    ]
  },
  "statusDate" : "1999-08-17",
  "holder" : {
    "reference" : "#holder-Sandoz-Pharmaceuticals-AG"
  },
  "regulator" : {
    "reference" : "#regulator-SMC"
  }
}