CH EPL (R5)
0.1.0 - ci-build

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

: 67431001 - XML Representation

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<RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="MA-67431001"/>
  <meta>
    <profile
             value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-67431001</b></p><a name="MA-67431001"> </a><a name="hcMA-67431001"> </a><a name="MA-67431001-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/67431001</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Triogen-250mg-Capsule.html">MedicinalProductDefinition: extension = Capsule, hard,TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = trientine,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>: 2020-05-28</p><p><b>holder</b>: <a href="#hcMA-67431001/holder-Ideogen-AG">Organization IDEOGEN AG</a></p><p><b>regulator</b>: <a href="#hcMA-67431001/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization  #holder-Ideogen-AG</b></p><a name="MA-67431001/holder-Ideogen-AG"> </a><a name="hcMA-67431001/holder-Ideogen-AG"> </a><a name="MA-67431001/holder-Ideogen-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100012910, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001403062</p><p><b>name</b>: IDEOGEN AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization  #regulator-SMC</b></p><a name="MA-67431001/regulator-SMC"> </a><a name="hcMA-67431001/regulator-SMC"> </a><a name="MA-67431001/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>
  </text>
  <contained>
    <Organization>
      <id value="holder-Ideogen-AG"/>
      <meta>
        <profile
                 value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
      </meta>
      <identifier>
        <system value="urn:oid:1.2.276.0.76"/>
        <value value="100012910"/>
      </identifier>
      <identifier>
        <system value="urn:oid:2.51.1.3"/>
        <value value="7601001403062"/>
      </identifier>
      <name value="IDEOGEN AG"/>
    </Organization>
  </contained>
  <contained>
    <Organization>
      <id value="regulator-SMC"/>
      <meta>
        <profile
                 value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
      </meta>
      <identifier>
        <system value="urn:oid:1.2.276.0.76"/>
        <value value="100010911"/>
      </identifier>
      <identifier>
        <system value="urn:oid:2.51.1.3"/>
        <value value="7601001398511"/>
      </identifier>
      <name value="SMC"/>
    </Organization>
  </contained>
  <identifier>
    <system
            value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"/>
    <value value="67431001"/>
  </identifier>
  <subject>🔗 
    <reference value="MedicinalProductDefinition/Triogen-250mg-Capsule"/>
  </subject>
  <type>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
      <code value="756000002001"/>
      <display value="Marketing Authorisation"/>
    </coding>
  </type>
  <region>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="CH"/>
      <display value="Switzerland"/>
    </coding>
  </region>
  <status>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"/>
      <code value="756005023007"/>
      <display value="zugelassen"/>
    </coding>
  </status>
  <statusDate value="2020-05-28"/>
  <holder>
    <reference value="#holder-Ideogen-AG"/>
  </holder>
  <regulator>
    <reference value="#regulator-SMC"/>
  </regulator>
</RegulatedAuthorization>