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

: TRIOGEN Kaps 250 mg Ds 100 Stk (Bundle) - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="c97d5d89-4467-4c1e-9954-9d1e1d1d46e2"/>
  <meta>
    <profile
             value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"/>
  </meta>
  <type value="collection"/>
  <entry>
    <fullUrl
             value="http://example.org/MedicinalProductDefinition/Triogen-250mg-Capsule"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="Triogen-250mg-Capsule"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Triogen-250mg-Capsule"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Triogen-250mg-Capsule</b></p><a name="Triogen-250mg-Capsule"> </a><a name="hcTriogen-250mg-Capsule"> </a><a name="Triogen-250mg-Capsule-en-US"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title="Codes:{http://standardterms.edqm.eu 10210000}">Capsule, hard</span></p><p><b>CH - EPL Full Limitation Text</b>: 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.</p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001403062-6743101</p><p><b>domain</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human</span></p><p><b>indication</b>: </p><div><p>Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}">Dispensation on medical or veterinary prescription (B)</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc A16AX12}">trientine</span>, <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode S}">Synthetika</span></p><p><b>attachedDocument</b>: </p><ul><li><a href="DocumentReference-DocRef-FI-Triogen.html">DocumentReference: status = current; type = Fachinformation</a></li><li><a href="DocumentReference-DocRef-PI-Triogen.html">DocumentReference: status = current; type = Patienteninformation</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Triogen 250 mg, Kapseln</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type SMC}">Zugelassener Arzneimittelname</span></p><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{urn:ietf:bcp:47 de-CH}">German (Switzerland)</span></td></tr></table></blockquote></div>
        </text>
        <extension
                   url="http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm">
          <valueCodeableConcept>
            <coding>
              <system value="http://standardterms.edqm.eu"/>
              <code value="10210000"/>
              <display value="Capsule, hard"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension
                   url="http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText">
          <valueString
                       value="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."/>
        </extension>
        <identifier>
          <system
                  value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID"/>
          <value value="CH-7601001403062-6743101"/>
        </identifier>
        <domain>
          <coding>
            <system value="http://spor.ema.europa.eu/v1/lists/100000000004"/>
            <code value="100000000012"/>
            <display value="Human"/>
          </coding>
        </domain>
        <indication
                    value="Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen."/>
        <legalStatusOfSupply>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
            <code value="756005022003"/>
            <display
                     value="Dispensation on medical or veterinary prescription (B)"/>
          </coding>
        </legalStatusOfSupply>
        <classification>
          <coding>
            <system value="http://www.whocc.no/atc"/>
            <code value="A16AX12"/>
          </coding>
        </classification>
        <classification>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode"/>
            <code value="S"/>
            <display value="Synthetika"/>
          </coding>
        </classification>
        <attachedDocument>🔗 
          <reference value="DocumentReference/DocRef-FI-Triogen"/>
        </attachedDocument>
        <attachedDocument>🔗 
          <reference value="DocumentReference/DocRef-PI-Triogen"/>
        </attachedDocument>
        <name>
          <productName value="Triogen 250 mg, Kapseln"/>
          <type>
            <coding>
              <system
                      value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type"/>
              <code value="SMC"/>
              <display value="Zugelassener Arzneimittelname"/>
            </coding>
          </type>
          <usage>
            <country>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="CH"/>
                <display value="Switzerland"/>
              </coding>
            </country>
            <language>
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="de-CH"/>
                <display value="German (Switzerland)"/>
              </coding>
            </language>
          </usage>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/DocumentReference/DocRef-FI-Triogen"/>
    <resource>
      <DocumentReference>
        <id value="DocRef-FI-Triogen"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-FI-Triogen"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-FI-Triogen</b></p><a name="DocRef-FI-Triogen"> </a><a name="hcDocRef-FI-Triogen"> </a><a name="DocRef-FI-Triogen-en-US"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type FI}">Fachinformation</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1</a></td></tr></table></blockquote></div>
        </text>
        <status value="current"/>
        <type>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"/>
            <code value="FI"/>
            <display value="Fachinformation"/>
          </coding>
        </type>
        <content>
          <attachment>
            <url
                 value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1"/>
          </attachment>
        </content>
      </DocumentReference>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/DocumentReference/DocRef-PI-Triogen"/>
    <resource>
      <DocumentReference>
        <id value="DocRef-PI-Triogen"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-PI-Triogen"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-PI-Triogen</b></p><a name="DocRef-PI-Triogen"> </a><a name="hcDocRef-PI-Triogen"> </a><a name="DocRef-PI-Triogen-en-US"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type PI}">Patienteninformation</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1</a></td></tr></table></blockquote></div>
        </text>
        <status value="current"/>
        <type>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"/>
            <code value="PI"/>
            <display value="Patienteninformation"/>
          </coding>
        </type>
        <content>
          <attachment>
            <url
                 value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&amp;lang=DE&amp;authNr=67431&amp;supportMultipleResults=1"/>
          </attachment>
        </content>
      </DocumentReference>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/RegulatedAuthorisation/MA-6743101"/>
    <resource>
      <RegulatedAuthorization>
        <id value="MA-6743101"/>
        <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"><a name="RegulatedAuthorization_MA-6743101"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-6743101</b></p><a name="MA-6743101"> </a><a name="hcMA-6743101"> </a><a name="MA-6743101-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/6743101</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 = Dispensation on medical or veterinary prescription (B); classification = trientine,Synthetika</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 Z}">zugelassen</span></p><p><b>statusDate</b>: 2020-05-28</p><p><b>holder</b>: <a href="#hcMA-6743101/holder-Ideogen-AG">Organization IDEOGEN AG</a></p><p><b>regulator</b>: <a href="#hcMA-6743101/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-6743101/holder-Ideogen-AG"> </a><a name="hcMA-6743101/holder-Ideogen-AG"> </a><a name="MA-6743101/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-6743101/regulator-SMC"> </a><a name="hcMA-6743101/regulator-SMC"> </a><a name="MA-6743101/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="6743101"/>
        </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="Z"/>
            <display value="zugelassen"/>
          </coding>
        </status>
        <statusDate value="2020-05-28"/>
        <holder>
          <reference value="#holder-Ideogen-AG"/>
        </holder>
        <regulator>
          <reference value="#regulator-SMC"/>
        </regulator>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://example.org/PackagedProductDefinition/PMP-Triogen-250mg-Capsule"/>
    <resource>
      <PackagedProductDefinition>
        <id value="PMP-Triogen-250mg-Capsule"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_PMP-Triogen-250mg-Capsule"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Triogen-250mg-Capsule</b></p><a name="PMP-Triogen-250mg-Capsule"> </a><a name="hcPMP-Triogen-250mg-Capsule"> </a><a name="PMP-Triogen-250mg-Capsule-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001403062-6743101-001</p><p><b>packageFor</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 = Dispensation on medical or veterinary prescription (B); classification = trientine,Synthetika</a></p><p><b>containedItemQuantity</b>: 100 Capsule<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms  code15012000 = 'Capsule')</span></p><p><b>description</b>: </p><div><p>TRIOGEN Kaps 250 mg Ds 100 Stk</p>
</div><h3>LegalStatusOfSupplies</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}">Dispensation on medical or veterinary prescription (B)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>urn:oid:2.51.1.1</code>/7680674310013</p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30009000}">Box</span></p><p><b>quantity</b>: 1</p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073403}">Shelf life of the medicinal product as packaged for sale</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage NO30}">Nicht über 30°C</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system
                  value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID"/>
          <value value="CH-7601001403062-6743101-001"/>
        </identifier>
        <packageFor>🔗 
          <reference
                     value="MedicinalProductDefinition/Triogen-250mg-Capsule"/>
        </packageFor>
        <containedItemQuantity>
          <value value="100"/>
          <unit value="Capsule"/>
          <system value="http://standardterms.edqm.eu"/>
          <code value="15012000"/>
        </containedItemQuantity>
        <description value="TRIOGEN Kaps 250 mg Ds 100 Stk"/>
        <legalStatusOfSupply>
          <code>
            <coding>
              <system
                      value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
              <code value="756005022003"/>
              <display
                       value="Dispensation on medical or veterinary prescription (B)"/>
            </coding>
          </code>
        </legalStatusOfSupply>
        <packaging>
          <identifier>
            <system value="urn:oid:2.51.1.1"/>
            <value value="7680674310013"/>
          </identifier>
          <type>
            <coding>
              <system value="http://standardterms.edqm.eu"/>
              <code value="30009000"/>
              <display value="Box"/>
            </coding>
          </type>
          <quantity value="1"/>
          <shelfLifeStorage>
            <type>
              <coding>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
                <code value="100000073403"/>
                <display
                         value="Shelf life of the medicinal product as packaged for sale"/>
              </coding>
            </type>
            <specialPrecautionsForStorage>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
                <code value="NO30"/>
                <display value="Nicht über 30°C"/>
              </coding>
            </specialPrecautionsForStorage>
          </shelfLifeStorage>
        </packaging>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/RegulatedAuthorisation/MA-67431001"/>
    <resource>
      <RegulatedAuthorization>
        <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"><a name="RegulatedAuthorization_MA-67431001"> </a><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 = Dispensation on medical or veterinary prescription (B); classification = trientine,Synthetika</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 Z}">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="Z"/>
            <display value="zugelassen"/>
          </coding>
        </status>
        <statusDate value="2020-05-28"/>
        <holder>
          <reference value="#holder-Ideogen-AG"/>
        </holder>
        <regulator>
          <reference value="#regulator-SMC"/>
        </regulator>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/RegulatedAuthorisation/FOPH-21070"/>
    <resource>
      <RegulatedAuthorization>
        <id value="FOPH-21070"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_FOPH-21070"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization FOPH-21070</b></p><a name="FOPH-21070"> </a><a name="hcFOPH-21070"> </a><a name="FOPH-21070-en-US"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/21070</li><li>status: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}">Reimbursed</span></li><li>statusDate: 2020-09-01</li><li>listingStatus: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}">Listed</span></li><li>listingPeriod: 2020-09-01 --&gt; (ongoing)</li><li>firstListingDate: 2020-09-01</li><li>costShare: 10</li><li>gamme: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004001}">Oral</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF4,117.12</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}">Ex-factory price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006010}">Price mutation at first listing</span></li><li>changeDate: 2020-09-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF4,470.40</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}">Retail price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}">VAT-change</span></li><li>changeDate: 2024-01-01</li></ul></blockquote><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Triogen-250mg-Capsule.html">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001403062-6743101-001; containedItemQuantity = 100 Capsule; description = TRIOGEN Kaps 250 mg Ds 100 Stk</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002003}">Reimbursement SL</span></p><h3>Indications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td/><td><a href="ClinicalUseDefinition-IND-10061091.html">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href="#hcFOPH-21070/holder-Ideogen-AG">Organization IDEOGEN AG</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization  #holder-Ideogen-AG</b></p><a name="FOPH-21070/holder-Ideogen-AG"> </a><a name="hcFOPH-21070/holder-Ideogen-AG"> </a><a name="FOPH-21070/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></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>
        <extension
                   url="http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL">
          <extension url="FOPHDossierNumber">
            <valueIdentifier>
              <system value="urn:oid:2.16.756.1"/>
              <value value="21070"/>
            </valueIdentifier>
          </extension>
          <extension url="status">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status"/>
                <code value="756001021001"/>
                <display value="Reimbursed"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="statusDate">
            <valueDate value="2020-09-01"/>
          </extension>
          <extension url="listingStatus">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status"/>
                <code value="756001002001"/>
                <display value="Listed"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="listingPeriod">
            <valuePeriod>
              <start value="2020-09-01"/>
            </valuePeriod>
          </extension>
          <extension url="firstListingDate">
            <valueDate value="2020-09-01"/>
          </extension>
          <extension url="costShare">
            <valueInteger value="10"/>
          </extension>
          <extension url="gamme">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme"/>
                <code value="756002004001"/>
                <display value="Oral"/>
              </coding>
            </valueCodeableConcept>
          </extension>
        </extension>
        <extension
                   url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
          <extension url="value">
            <valueMoney>
              <value value="4117.12"/>
              <currency value="CHF"/>
            </valueMoney>
          </extension>
          <extension url="type">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
                <code value="756002005002"/>
                <display value="Ex-factory price"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="changeType">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
                <code value="756002006010"/>
                <display value="Price mutation at first listing"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="changeDate">
            <valueDate value="2020-09-01"/>
          </extension>
        </extension>
        <extension
                   url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
          <extension url="value">
            <valueMoney>
              <value value="4470.4"/>
              <currency value="CHF"/>
            </valueMoney>
          </extension>
          <extension url="type">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
                <code value="756002005001"/>
                <display value="Retail price"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="changeType">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
                <code value="756002006005"/>
                <display value="VAT-change"/>
              </coding>
            </valueCodeableConcept>
          </extension>
          <extension url="changeDate">
            <valueDate value="2024-01-01"/>
          </extension>
        </extension>
        <subject>🔗 
          <reference
                     value="PackagedProductDefinition/PMP-Triogen-250mg-Capsule"/>
        </subject>
        <type>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
            <code value="756000002003"/>
            <display value="Reimbursement SL"/>
          </coding>
        </type>
        <indication>
          <extension
                     url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
            <extension url="status">
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
                  <code value="756002071001"/>
                  <display value="Limitation Reimbursed"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension url="statusDate">
              <valueDate value="2020-09-01"/>
            </extension>
            <extension url="period">
              <valuePeriod>
                <start value="2020-09-01"/>
              </valuePeriod>
            </extension>
            <extension url="firstLimitationDate">
              <valueDate value="2020-09-01"/>
            </extension>
            <extension url="limitationIndication">
              <valueReference>🔗 
                <reference value="ClinicalUseDefinition/LIM-79886009"/>
              </valueReference>
            </extension>
            <extension
                       url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
              <extension url="value">
                <valueMoney>
                  <value value="4117.12"/>
                  <currency value="CHF"/>
                </valueMoney>
              </extension>
              <extension url="type">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
                    <code value="756002005002"/>
                    <display value="Ex-factory price"/>
                  </coding>
                </valueCodeableConcept>
              </extension>
              <extension url="changeType">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
                    <code value="756002006007"/>
                    <display
                             value="Price mutation after triennal review of pharmaceuticals"/>
                  </coding>
                </valueCodeableConcept>
              </extension>
              <extension url="changeDate">
                <valueDate value="2020-09-01"/>
              </extension>
            </extension>
            <extension
                       url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
              <extension url="value">
                <valueMoney>
                  <value value="4470.4"/>
                  <currency value="CHF"/>
                </valueMoney>
              </extension>
              <extension url="type">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
                    <code value="756002005001"/>
                    <display value="Retail price"/>
                  </coding>
                </valueCodeableConcept>
              </extension>
              <extension url="changeType">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
                    <code value="756002006005"/>
                    <display value="VAT-change"/>
                  </coding>
                </valueCodeableConcept>
              </extension>
              <extension url="changeDate">
                <valueDate value="2024-01-01"/>
              </extension>
            </extension>
          </extension>
          <reference>🔗 
            <reference value="ClinicalUseDefinition/IND-10061091"/>
          </reference>
        </indication>
        <holder>
          <reference value="#holder-Ideogen-AG"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://example.org/ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="MI-Trientinum-250mg-Capsule"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-Trientinum-250mg-Capsule"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MI-Trientinum-250mg-Capsule</b></p><a name="MI-Trientinum-250mg-Capsule"> </a><a name="hcMI-Trientinum-250mg-Capsule"> </a><a name="MI-Trientinum-250mg-Capsule-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10210000}">Capsule, hard</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15012000}">Capsule</span></p></div>
        </text>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="10210000"/>
            <display value="Capsule, hard"/>
          </coding>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="15012000"/>
            <display value="Capsule"/>
          </coding>
        </unitOfPresentation>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://example.org/AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="PhP-Trientinum-250mg-Capsule"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_PhP-Trientinum-250mg-Capsule"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition PhP-Trientinum-250mg-Capsule</b></p><a name="PhP-Trientinum-250mg-Capsule"> </a><a name="hcPhP-Trientinum-250mg-Capsule"> </a><a name="PhP-Trientinum-250mg-Capsule-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</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 = Dispensation on medical or veterinary prescription (B); classification = trientine,Synthetika</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10210000}">Capsule, hard</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15012000}">Capsule</span></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://standardterms.edqm.eu 20053000}">Oral use</span></td></tr></table></div>
        </text>
        <status value="active"/>
        <formOf>🔗 
          <reference
                     value="MedicinalProductDefinition/Triogen-250mg-Capsule"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="10210000"/>
            <display value="Capsule, hard"/>
          </coding>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="15012000"/>
            <display value="Capsule"/>
          </coding>
        </unitOfPresentation>
        <routeOfAdministration>
          <code>
            <coding>
              <system value="http://standardterms.edqm.eu"/>
              <code value="20053000"/>
              <display value="Oral use"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/Ingredient/Trientinum250"/>
    <resource>
      <Ingredient>
        <id value="Trientinum250"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Trientinum250"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Trientinum250</b></p><a name="Trientinum250"> </a><a name="hcTrientinum250"> </a><a name="Trientinum250-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Trientinum-250mg-Capsule.html">AdministrableProductDefinition: status = active; administrableDoseForm = Capsule, hard; unitOfPresentation = Capsule</a></li><li><a href="ManufacturedItemDefinition-MI-Trientinum-250mg-Capsule.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Capsule, hard; unitOfPresentation = Capsule</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role WIRKS}">Wirkstoff</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance SJ76Y07H5F}">Trientine</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>250 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemg = 'mg')</span>/1 Capsule<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms  code15012000 = 'Capsule')</span></td></tr></table></blockquote></div>
        </text>
        <status value="active"/>
        <for>🔗 
          <reference
                     value="AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule"/>
        </for>
        <for>🔗 
          <reference
                     value="ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule"/>
        </for>
        <role>
          <coding>
            <system
                    value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"/>
            <code value="WIRKS"/>
            <display value="Wirkstoff"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system
                        value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"/>
                <code value="SJ76Y07H5F"/>
                <display value="Trientine"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationRatio>
              <numerator>
                <value value="250"/>
                <unit value="mg"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="mg"/>
              </numerator>
              <denominator>
                <value value="1"/>
                <unit value="Capsule"/>
                <system value="http://standardterms.edqm.eu"/>
                <code value="15012000"/>
              </denominator>
            </presentationRatio>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/ClinicalUseDefinition/IND-10061091"/>
    <resource>
      <ClinicalUseDefinition>
        <id value="IND-10061091"/>
        <meta>
          <profile
                   value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10061091"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10061091</b></p><a name="IND-10061091"> </a><a name="hcIND-10061091"> </a><a name="IND-10061091-en-US"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Cuprior-150mg-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet,CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, 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-7640109110007-6771901; domain = Human; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); classification = gilteritinib,Synthetika</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://www.meddra.org 10061091}">Wilson's disease</span></td></tr></table><h3>IntendedEffects</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
        </text>
        <type value="indication"/>
        <subject>🔗 
          <reference
                     value="MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet"/>
        </subject>
        <indication>
          <diseaseSymptomProcedure>
            <concept>
              <coding>
                <system value="https://www.meddra.org"/>
                <code value="10061091"/>
                <display value="Wilson's disease"/>
              </coding>
            </concept>
          </diseaseSymptomProcedure>
          <intendedEffect>
            <concept>
              <coding>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
                <code value="200000003194"/>
                <display value="therapeutic"/>
              </coding>
            </concept>
          </intendedEffect>
        </indication>
      </ClinicalUseDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="http://example.org/ClinicalUseDefinition/LIM-79886009"/>
    <resource>
      <ClinicalUseDefinition>
        <id value="LIM-79886009"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_LIM-79886009"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition LIM-79886009</b></p><a name="LIM-79886009"> </a><a name="hcLIM-79886009"> </a><a name="LIM-79886009-en-US"> </a><p><b>type</b>: Indication</p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 79886009}">Disorder of copper metabolism</span></td></tr></table><h3>IntendedEffects</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 200000003194}">therapeutic</span></td></tr></table></blockquote></div>
        </text>
        <type value="indication"/>
        <indication>
          <diseaseSymptomProcedure>
            <concept>
              <coding>
                <system value="http://snomed.info/sct"/>
                <code value="79886009"/>
                <display value="Disorder of copper metabolism"/>
              </coding>
            </concept>
          </diseaseSymptomProcedure>
          <intendedEffect>
            <concept>
              <coding>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
                <code value="200000003194"/>
                <display value="therapeutic"/>
              </coding>
            </concept>
          </intendedEffect>
        </indication>
      </ClinicalUseDefinition>
    </resource>
  </entry>
</Bundle>