CH EPL (R5)
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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 1.0.0-ci-build 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

: 52042011 - XML Representation

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<RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="MA-52042011"/>
  <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-52042011</b></p><a name="MA-52042011"> </a><a name="hcMA-52042011"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-regulatedauthorization.html">IDMP RegulatedAuthorization</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/52042011</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; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</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}">valid</span></p><p><b>statusDate</b>: 1993-06-18</p><p><b>holder</b>: <a href="#hcMA-52042011/holder-Tillotts-Pharma-AG">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href="#hcMA-52042011/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-52042011/holder-Tillotts-Pharma-AG"> </a><a name="hcMA-52042011/holder-Tillotts-Pharma-AG"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-epl-organization.html">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100005174, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</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-52042011/regulator-SMC"> </a><a name="hcMA-52042011/regulator-SMC"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-epl-organization.html">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010911, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
  </text>
  <contained>
    <Organization>
      <id value="holder-Tillotts-Pharma-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="100005174"/>
      </identifier>
      <identifier>
        <system value="urn:oid:2.51.1.3"/>
        <value value="7601001346451"/>
      </identifier>
      <name value="Tillotts Pharma 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="52042011"/>
  </identifier>
  <subject>🔗 
    <reference
               value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
  </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="valid"/>
    </coding>
  </status>
  <statusDate value="1993-06-18"/>
  <holder>
    <reference value="#holder-Tillotts-Pharma-AG"/>
  </holder>
  <regulator>
    <reference value="#regulator-SMC"/>
  </regulator>
</RegulatedAuthorization>