CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
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<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle"/>
</meta>
<language value="de-CH"/>
<type value="collection"/>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
<resource>
<MedicinalProductDefinition>
<id value="Xospata-Filmcoatedtablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Xospata-Filmcoatedtablet"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet</b></p><a name="Xospata-Filmcoatedtablet"> </a><a name="hcXospata-Filmcoatedtablet"> </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-medicinalproductdefinition.html">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title="Codes:{http://standardterms.edqm.eu 10221000}">Film-coated tablet</span></p><p><b>identifier</b>: <a href="NamingSystem-MPID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Medical Product Identifier</a>/CH-01100869-0672110010000</p><p><b>indication</b>: </p><div><p>Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></p><p><b>additionalMonitoringIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc L01EX13}">gilteritinib</span>, <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000001}">Synthetic</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status 7560050074000003}">No interruption of distribution reported</span></td><td>2020-09-24 --> (ongoing)</td></tr></table><p><b>attachedDocument</b>: </p><ul><li><a href="DocumentReference-DocRef-FI-Xospata.html">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-123; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></li><li><a href="DocumentReference-DocRef-PI-Xospata.html">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-abc-123; status = current; type = Patient Information; date = 2021-11-09 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Xospata 40 mg, Filmtabletten</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-idmp/StructureDefinition/authorizedDoseForm">
<valueCodeableConcept>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10221000"/>
<display value="Film-coated tablet"/>
</coding>
</valueCodeableConcept>
</extension>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/mpid"/>
<value value="CH-01100869-0672110010000"/>
</identifier>
<indication
value="Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden."/>
<legalStatusOfSupply>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000001"/>
<display
value="A: Single dispensing requiring a medical or veterinary prescription"/>
</coding>
</legalStatusOfSupply>
<additionalMonitoringIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator"/>
<code value="756005001003"/>
<display value="No Warning"/>
</coding>
</additionalMonitoringIndicator>
<pediatricUseIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator"/>
<code value="756005003002"/>
<display value="Not authorised for the treatment in children"/>
</coding>
</pediatricUseIndicator>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="L01EX13"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory"/>
<code value="756005039000001"/>
<display value="Synthetic"/>
</coding>
</classification>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status"/>
<code value="7560050074000003"/>
<display value="No interruption of distribution reported"/>
</coding>
</status>
<dateRange>
<start value="2020-09-24"/>
</dateRange>
</marketingStatus>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-FI-Xospata"/>
</attachedDocument>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-PI-Xospata"/>
</attachedDocument>
<name>
<productName value="Xospata 40 mg, Filmtabletten"/>
<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"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata"/>
<resource>
<DocumentReference>
<id value="DocRef-FI-Xospata"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-FI-Xospata"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-FI-Xospata</b></p><a name="DocRef-FI-Xospata"> </a><a name="hcDocRef-FI-Xospata"> </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-documentreference.html">DocumentReference</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AttNo.html" title="Temporary Namingsystem in this implementation guide until officially released by Swissmedic">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-xyz-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000001}">Information for healthcare professionals</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</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/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1">https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1</a></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/attno"/>
<value value="123456989-initial submission-Example-xyz-123"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"/>
<code value="756005040000001"/>
<display value="Information for healthcare professionals"/>
</coding>
</type>
<date value="2021-11-09T00:00:00Z"/>
<content>
<attachment>
<url
value="https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata"/>
<resource>
<DocumentReference>
<id value="DocRef-PI-Xospata"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_DocRef-PI-Xospata"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-PI-Xospata</b></p><a name="DocRef-PI-Xospata"> </a><a name="hcDocRef-PI-Xospata"> </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-documentreference.html">DocumentReference</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AttNo.html" title="Temporary Namingsystem in this implementation guide until officially released by Swissmedic">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-abc-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000002}">Patient Information</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Language</b></td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td>German (Switzerland)</td><td><a href="https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1">https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1</a></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/attno"/>
<value value="123456989-initial submission-Example-abc-123"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"/>
<code value="756005040000002"/>
<display value="Patient Information"/>
</coding>
</type>
<date value="2021-11-09T00:00:00Z"/>
<content>
<attachment>
<language value="de-CH"/>
<url
value="https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101"/>
<resource>
<RegulatedAuthorization>
<id value="MA-6721101"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-6721101"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-6721101</b></p><a name="MA-6721101"> </a><a name="hcMA-6721101"> </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">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AuthNo.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Marketing Authorisation Number</a>/6721101</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> (ongoing)</p><p><b>holder</b>: <a href="#hcMA-6721101/holder-Astellas-Pharma-AG">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href="#hcMA-6721101/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name="MA-6721101/holder-Astellas-Pharma-AG"> </a><a name="hcMA-6721101/holder-Astellas-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-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-SMCLocID.html" title="Temporary NamingSystem in this implementation guide until officially released by Swissmedic">Swissmedic Location Identifier</a>/01100869, <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>/100010745, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-6721101/regulator-SMC"> </a><a name="hcMA-6721101/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-idmp-organization.html">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-Astellas-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system
value="https://www.swissmedic.ch/fhir/identifier/locations"/>
<value value="01100869"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="100010745"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001000964"/>
</identifier>
<name value="Astellas Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<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://fhir.ch/ig/ch-idmp/sid/authno"/>
<value value="6721101"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"/>
<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-idmp/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005010000001"/>
<display value="approved"/>
</coding>
</status>
<statusDate value="2021-11-09"/>
<validityPeriod>
<start value="2021-11-09"/>
</validityPeriod>
<holder>
<reference value="#holder-Astellas-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<resource>
<PackagedProductDefinition>
<id value="PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name="PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><a name="hcPMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </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-packagedproductdefinition.html">PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href="NamingSystem-PCID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Clinical Product Identifier</a>/CH-01100869-0672110010000-0001</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</a></p><p><b>containedItemQuantity</b>: 48 Tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>4 Blister zu 7 Tabletten in 1 Box</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-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></td></tr></table><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status 756002026002}">Marketed</span></td><td>2020-09-24 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number</a>/7680672110011</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>Period[x]</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>No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000009}">Do not store above 30°C</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30007000}">Blister</span></p><p><b>quantity</b>: 4</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 12 countable unit(s)<span style="background: LightGoldenRodYellow"> (Details: UCUM code1 = '1')</span></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/pcid"/>
<value value="CH-01100869-0672110010000-0001"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</packageFor>
<containedItemQuantity>
<value value="48"/>
<unit value="Tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</containedItemQuantity>
<description value="4 Blister zu 7 Tabletten in 1 Box"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000001"/>
<display
value="A: Single dispensing requiring a medical or veterinary prescription"/>
</coding>
</code>
</legalStatusOfSupply>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"/>
<code value="756002026002"/>
<display value="Marketed"/>
</coding>
</status>
<dateRange>
<start value="2020-09-24"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="https://www.gs1.org/gtin"/>
<value value="7680672110011"/>
</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>
<periodDuration>
<value value="36"/>
<unit value="month"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000009"/>
<display value="Do not store above 30°C"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30007000"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="4"/>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</reference>
</item>
<amount>
<value value="12"/>
<unit value="countable unit(s)"/>
<system value="http://unitsofmeasure.org"/>
<code value="1"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001"/>
<resource>
<RegulatedAuthorization>
<id value="MA-67211001"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-67211001"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-67211001</b></p><a name="MA-67211001"> </a><a name="hcMA-67211001"> </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">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AuthNo.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Marketing Authorisation Number</a>/67211001</p><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0672110010000-0001; containedItemQuantity = 48 Tablet; description = 4 Blister zu 7 Tabletten in 1 Box</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> (ongoing)</p><p><b>holder</b>: <a href="#hcMA-67211001/holder-Astellas-Pharma-AG">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href="#hcMA-67211001/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name="MA-67211001/holder-Astellas-Pharma-AG"> </a><a name="hcMA-67211001/holder-Astellas-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-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-SMCLocID.html" title="Temporary NamingSystem in this implementation guide until officially released by Swissmedic">Swissmedic Location Identifier</a>/01100869, <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>/100010745, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-67211001/regulator-SMC"> </a><a name="hcMA-67211001/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-idmp-organization.html">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-Astellas-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system
value="https://www.swissmedic.ch/fhir/identifier/locations"/>
<value value="01100869"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="100010745"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001000964"/>
</identifier>
<name value="Astellas Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<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://fhir.ch/ig/ch-idmp/sid/authno"/>
<value value="67211001"/>
</identifier>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"/>
<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-idmp/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005010000001"/>
<display value="approved"/>
</coding>
</status>
<statusDate value="2021-11-09"/>
<validityPeriod>
<start value="2021-11-09"/>
</validityPeriod>
<holder>
<reference value="#holder-Astellas-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name="MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><a name="hcMI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </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-manufactureditemdefinition.html">ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10221000}">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15054000}">Tablet</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10221000"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<resource>
<AdministrableProductDefinition>
<id value="PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name="PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </a><a name="hcPhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"> </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-administrableproductdefinition.html">AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10221000}">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15054000}">Tablet</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/Xospata-Filmcoatedtablet"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10221000"/>
<display value="Film-coated tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
<display value="Tablet"/>
</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://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40"/>
<resource>
<Ingredient>
<id value="GilteritinibiHemifumaras40"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_GilteritinibiHemifumaras40"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient GilteritinibiHemifumaras40</b></p><a name="GilteritinibiHemifumaras40"> </a><a name="hcGilteritinibiHemifumaras40"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000001}">Active</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-idmp/CodeSystem/ch-SMC-substance 5RZZ0Z1GJT}">Gilteritinib fumarate</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 44.2 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</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-idmp/CodeSystem/ch-SMC-substance 66D92MGC8M}">Gilteritinib</span></td></tr></table><p><b>strength</b>: 40 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000001"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="5RZZ0Z1GJT"/>
<display value="Gilteritinib fumarate"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="44.2"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="66D92MGC8M"/>
<display value="Gilteritinib"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="40"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum"/>
<resource>
<Ingredient>
<id value="Mannitolum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Mannitolum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Mannitolum</b></p><a name="Mannitolum"> </a><a name="hcMannitolum"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 3OWL53L36A}">Mannitol</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="3OWL53L36A"/>
<display value="Mannitol"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum"/>
<resource>
<Ingredient>
<id value="Hydroxypropylcellulosum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Hydroxypropylcellulosum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Hydroxypropylcellulosum</b></p><a name="Hydroxypropylcellulosum"> </a><a name="hcHydroxypropylcellulosum"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 9XZ8H6N6OH}">Hyprolose</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="9XZ8H6N6OH"/>
<display value="Hyprolose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile"/>
<resource>
<Ingredient>
<id value="HydroxypropylcellulosumSubstitutumHumile"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_HydroxypropylcellulosumSubstitutumHumile"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient HydroxypropylcellulosumSubstitutumHumile</b></p><a name="HydroxypropylcellulosumSubstitutumHumile"> </a><a name="hcHydroxypropylcellulosumSubstitutumHumile"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 2165RE0K14}">Hydroxypropylcellulose, low-substituted</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="2165RE0K14"/>
<display value="Hydroxypropylcellulose, low-substituted"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum"/>
<resource>
<Ingredient>
<id value="Talcum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Talcum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Talcum</b></p><a name="Talcum"> </a><a name="hcTalcum"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 7SEV7J4R1U}">Talc</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="7SEV7J4R1U"/>
<display value="Talc"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000"/>
<resource>
<Ingredient>
<id value="Macrogolum8000"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Macrogolum8000"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Macrogolum8000</b></p><a name="Macrogolum8000"> </a><a name="hcMacrogolum8000"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance Q662QK8M3B}">Macrogol 8000</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="Q662QK8M3B"/>
<display value="Macrogol 8000"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171"/>
<resource>
<Ingredient>
<id value="E171"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_E171"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient E171</b></p><a name="E171"> </a><a name="hcE171"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 15FIX9V2JP}">Titanium dioxide</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="15FIX9V2JP"/>
<display value="Titanium dioxide"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum"/>
<resource>
<Ingredient>
<id value="E172Flavum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_E172Flavum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient E172Flavum</b></p><a name="E172Flavum"> </a><a name="hcE172Flavum"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 15FIX9V2JP}">Titanium dioxide</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="15FIX9V2JP"/>
<display value="Titanium dioxide"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate"/>
<resource>
<Ingredient>
<id value="MagnesiumStearate"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_MagnesiumStearate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient MagnesiumStearate</b></p><a name="MagnesiumStearate"> </a><a name="hcMagnesiumStearate"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 70097M6I30}">Magnesium stearate</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="70097M6I30"/>
<display value="Magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum"/>
<resource>
<Ingredient>
<id value="Hypromellosum"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Hypromellosum"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Hypromellosum</b></p><a name="Hypromellosum"> </a><a name="hcHypromellosum"> </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-ingredient.html">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}">Excipient</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-idmp/CodeSystem/ch-SMC-substance 3NXW29V3WO}">Hypromellose</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005035000002"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"/>
<code value="3NXW29V3WO"/>
<display value="Hypromellose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10081514"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10081514"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10081514</b></p><a name="IND-10081514"> </a><a name="hcIND-10081514"> </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-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</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 10081514}">Acute myeloid leukemia refractory</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 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10081514"/>
<display value="Acute myeloid leukemia refractory"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10081513"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10081513"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10081513</b></p><a name="IND-10081513"> </a><a name="hcIND-10081513"> </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-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</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 10081513}">Acute myeloid leukaemia refractory</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 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10081513"/>
<display value="Acute myeloid leukaemia refractory"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10059034"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10059034"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10059034</b></p><a name="IND-10059034"> </a><a name="hcIND-10059034"> </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-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</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 10059034}">Acute myeloid leukaemia recurrent</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 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10059034"/>
<display value="Acute myeloid leukaemia recurrent"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10060558"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10060558"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10060558</b></p><a name="IND-10060558"> </a><a name="hcIND-10060558"> </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-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</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 10060558}">Acute myeloid leukemia recurrent</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 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10060558"/>
<display value="Acute myeloid leukemia recurrent"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10084619"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-10084619"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10084619</b></p><a name="IND-10084619"> </a><a name="hcIND-10084619"> </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-clinicalusedefinition-indication.html">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Xospata-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</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 10084619}">FLT3-Gen-Mutation</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 756005042000002}">therapeutic</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Xospata-Filmcoatedtablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10084619"/>
<display value="FLT3-Gen-Mutation"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="756005042000002"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
</Bundle>