This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ab55cf13-a819-4875-adaa-5545e2cbdddf"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle> ] ) ] ; # fhir:language [ fhir:v "de-CH"] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558> ) ] [ fhir:fullUrl [ fhir:v "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619"^^xsd:anyURI ; fhir:l <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619> ] ; ( fhir:resource <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619> ) ] ) . # <http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "Xospata-Filmcoatedtablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "<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>\n</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>"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm> ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "10221000" ] ; fhir:display [ fhir:v "Film-coated tablet" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/mpid"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/mpid> ] ; fhir:value [ fhir:v "CH-01100869-0672110010000" ] ] ) ; # fhir:indication [ fhir:v "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."] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply> ] ; fhir:code [ fhir:v "756005034000001" ] ; fhir:display [ fhir:v "A: Single dispensing requiring a medical or veterinary prescription" ] ] ) ] ; # fhir:additionalMonitoringIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator> ] ; fhir:code [ fhir:v "756005001003" ] ; fhir:display [ fhir:v "No Warning" ] ] ) ] ; # fhir:pediatricUseIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator> ] ; fhir:code [ fhir:v "756005003002" ] ; fhir:display [ fhir:v "Not authorised for the treatment in children" ] ] ) ] ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://www.whocc.no/atc"^^xsd:anyURI ; fhir:l <http://www.whocc.no/atc> ] ; fhir:code [ fhir:v "L01EX13" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory> ] ; fhir:code [ fhir:v "756005039000001" ] ; fhir:display [ fhir:v "Synthetic" ] ] ) ] ) ; # fhir:marketingStatus ( [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ; fhir:l <urn:iso:std:iso:3166> ] ; fhir:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ; fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status> ] ; fhir:code [ fhir:v "7560050074000003" ] ; fhir:display [ fhir:v "No interruption of distribution reported" ] ] ) ] ; fhir:dateRange [ fhir:start [ fhir:v "2020-09-24"^^xsd:date ] ] ] ) ; # fhir:attachedDocument ( [ fhir:l fhir:DocumentReference/DocRef-FI-Xospata ; fhir:reference [ fhir:v "DocumentReference/DocRef-FI-Xospata" ] ] [ fhir:l fhir:DocumentReference/DocRef-PI-Xospata ; fhir:reference [ fhir:v "DocumentReference/DocRef-PI-Xospata" ] ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "Xospata 40 mg, Filmtabletten" ] ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ; fhir:l <urn:iso:std:iso:3166> ] ; fhir:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ; fhir:l <urn:ietf:bcp:47> ] ; fhir:code [ fhir:v "de-CH" ] ] ) ] ] ) ] ) . # <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata> a fhir:DocumentReference ; fhir:id [ fhir:v "DocRef-FI-Xospata"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/attno"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/attno> ] ; fhir:value [ fhir:v "123456989-initial submission-Example-xyz-123" ] ] ) ; # fhir:status [ fhir:v "current"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type> ] ; fhir:code [ fhir:v "756005040000001" ] ; fhir:display [ fhir:v "Information for healthcare professionals" ] ] ) ] ; # fhir:date [ fhir:v "2021-11-09T00:00:00Z"^^xsd:dateTime] ; # fhir:content ( [ fhir:attachment [ fhir:url [ fhir:v "https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1"^^xsd:anyURI ; fhir:l <https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1> ] ] ] ) . # <http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata> a fhir:DocumentReference ; fhir:id [ fhir:v "DocRef-PI-Xospata"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/attno"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/attno> ] ; fhir:value [ fhir:v "123456989-initial submission-Example-abc-123" ] ] ) ; # fhir:status [ fhir:v "current"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type> ] ; fhir:code [ fhir:v "756005040000002" ] ; fhir:display [ fhir:v "Patient Information" ] ] ) ] ; # fhir:date [ fhir:v "2021-11-09T00:00:00Z"^^xsd:dateTime] ; # fhir:content ( [ fhir:attachment [ fhir:language [ fhir:v "de-CH" ] ; fhir:url [ fhir:v "https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1"^^xsd:anyURI ; fhir:l <https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1> ] ] ] ) . # <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "MA-6721101"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:contained ( [ a fhir:Organization ; fhir:id [ fhir:v "holder-Astellas-Pharma-AG" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "https://www.swissmedic.ch/fhir/identifier/locations"^^xsd:anyURI ; fhir:l <https://www.swissmedic.ch/fhir/identifier/locations> ] ; fhir:value [ fhir:v "01100869" ] ] [ fhir:system [ fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/v1/locations> ] ; fhir:value [ fhir:v "100010745" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ; fhir:l <urn:oid:2.51.1.3> ] ; fhir:value [ fhir:v "7601001000964" ] ] ) ; fhir:name [ fhir:v "Astellas Pharma AG" ] ] [ a fhir:Organization ; fhir:id [ fhir:v "regulator-SMC" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/v1/locations> ] ; fhir:value [ fhir:v "100010911" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ; fhir:l <urn:oid:2.51.1.3> ] ; fhir:value [ fhir:v "7601001398511" ] ] ) ; fhir:name [ fhir:v "SMC" ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/authno"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/authno> ] ; fhir:value [ fhir:v "6721101" ] ] ) ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs> ] ; fhir:code [ fhir:v "756000002001" ] ; fhir:display [ fhir:v "Marketing Authorisation" ] ] ) ] ; # fhir:region ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ; fhir:l <urn:iso:std:iso:3166> ] ; fhir:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status> ] ; fhir:code [ fhir:v "756005010000001" ] ; fhir:display [ fhir:v "approved" ] ] ) ] ; # fhir:statusDate [ fhir:v "2021-11-09"^^xsd:date] ; # fhir:validityPeriod [ fhir:start [ fhir:v "2021-11-09"^^xsd:date ] ] ; # fhir:holder [ fhir:l <#holder-Astellas-Pharma-AG> ; fhir:reference [ fhir:v "#holder-Astellas-Pharma-AG" ] ] ; # fhir:regulator [ fhir:l <#regulator-SMC> ; fhir:reference [ fhir:v "#regulator-SMC" ] ] . # <http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>\n</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>"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/pcid"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/pcid> ] ; fhir:value [ fhir:v "CH-01100869-0672110010000-0001" ] ] ) ; # fhir:packageFor ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "48"^^xsd:decimal ] ; fhir:unit [ fhir:v "Tablet" ] ; fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "15054000" ] ] ) ; # fhir:description [ fhir:v "4 Blister zu 7 Tabletten in 1 Box"] ; # fhir:legalStatusOfSupply ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply> ] ; fhir:code [ fhir:v "756005034000001" ] ; fhir:display [ fhir:v "A: Single dispensing requiring a medical or veterinary prescription" ] ] ) ] ] ) ; # fhir:marketingStatus ( [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ; fhir:l <urn:iso:std:iso:3166> ] ; fhir:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ; fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status> ] ; fhir:code [ fhir:v "756002026002" ] ; fhir:display [ fhir:v "Marketed" ] ] ) ] ; fhir:dateRange [ fhir:start [ fhir:v "2020-09-24"^^xsd:date ] ] ] ) ; # fhir:packaging [ ( fhir:identifier [ fhir:system [ fhir:v "https://www.gs1.org/gtin"^^xsd:anyURI ; fhir:l <https://www.gs1.org/gtin> ] ; fhir:value [ fhir:v "7680672110011" ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "30009000" ] ; fhir:display [ fhir:v "Box" ] ] ) ] ; fhir:quantity [ fhir:v 1 ] ; ( fhir:shelfLifeStorage [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000073343"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/100000073343> ] ; fhir:code [ fhir:v "100000073403" ] ; fhir:display [ fhir:v "Shelf life of the medicinal product as packaged for sale" ] ] ) ] ; fhir:period [ a fhir:Duration ; fhir:value [ fhir:v "36"^^xsd:decimal ] ; fhir:unit [ fhir:v "month" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "mo" ] ] ; ( fhir:specialPrecautionsForStorage [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage> ] ; fhir:code [ fhir:v "756005041000009" ] ; fhir:display [ fhir:v "Do not store above 30°C" ] ] ) ] ) ] ) ; ( fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "30007000" ] ; fhir:display [ fhir:v "Blister" ] ] ) ] ; fhir:quantity [ fhir:v 4 ] ; ( fhir:containedItem [ fhir:item [ fhir:reference [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ] ; fhir:amount [ fhir:value [ fhir:v "12"^^xsd:decimal ] ; fhir:unit [ fhir:v "countable unit(s)" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "1" ] ] ] ) ] ) ] . # <http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "MA-67211001"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:contained ( [ a fhir:Organization ; fhir:id [ fhir:v "holder-Astellas-Pharma-AG" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "https://www.swissmedic.ch/fhir/identifier/locations"^^xsd:anyURI ; fhir:l <https://www.swissmedic.ch/fhir/identifier/locations> ] ; fhir:value [ fhir:v "01100869" ] ] [ fhir:system [ fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/v1/locations> ] ; fhir:value [ fhir:v "100010745" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ; fhir:l <urn:oid:2.51.1.3> ] ; fhir:value [ fhir:v "7601001000964" ] ] ) ; fhir:name [ fhir:v "Astellas Pharma AG" ] ] [ a fhir:Organization ; fhir:id [ fhir:v "regulator-SMC" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "https://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/v1/locations> ] ; fhir:value [ fhir:v "100010911" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ; fhir:l <urn:oid:2.51.1.3> ] ; fhir:value [ fhir:v "7601001398511" ] ] ) ; fhir:name [ fhir:v "SMC" ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/sid/authno"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/sid/authno> ] ; fhir:value [ fhir:v "67211001" ] ] ) ; # fhir:subject ( [ fhir:l fhir:PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs> ] ; fhir:code [ fhir:v "756000002001" ] ; fhir:display [ fhir:v "Marketing Authorisation" ] ] ) ] ; # fhir:region ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ; fhir:l <urn:iso:std:iso:3166> ] ; fhir:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status> ] ; fhir:code [ fhir:v "756005010000001" ] ; fhir:display [ fhir:v "approved" ] ] ) ] ; # fhir:statusDate [ fhir:v "2021-11-09"^^xsd:date] ; # fhir:validityPeriod [ fhir:start [ fhir:v "2021-11-09"^^xsd:date ] ] ; # fhir:holder [ fhir:l <#holder-Astellas-Pharma-AG> ; fhir:reference [ fhir:v "#holder-Astellas-Pharma-AG" ] ] ; # fhir:regulator [ fhir:l <#regulator-SMC> ; fhir:reference [ fhir:v "#regulator-SMC" ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> a fhir:ManufacturedItemDefinition ; fhir:id [ fhir:v "MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:manufacturedDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "10221000" ] ; fhir:display [ fhir:v "Film-coated tablet" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "15054000" ] ; fhir:display [ fhir:v "Tablet" ] ] ) ] . # <http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet> a fhir:AdministrableProductDefinition ; fhir:id [ fhir:v "PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:formOf ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:administrableDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "10221000" ] ; fhir:display [ fhir:v "Film-coated tablet" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "15054000" ] ; fhir:display [ fhir:v "Tablet" ] ] ) ] ; # fhir:routeOfAdministration ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "20053000" ] ; fhir:display [ fhir:v "Oral use" ] ] ) ] ] ) . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40> a fhir:Ingredient ; fhir:id [ fhir:v "GilteritinibiHemifumaras40"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000001" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "5RZZ0Z1GJT" ] ; fhir:display [ fhir:v "Gilteritinib fumarate" ] ] ) ] ] ; ( fhir:strength [ fhir:presentation [ a fhir:Ratio ; fhir:numerator [ fhir:value [ fhir:v 44.2 ] ; fhir:unit [ fhir:v "mg" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "mg" ] ] ; fhir:denominator [ fhir:value [ fhir:v "1"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablet" ] ; fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "15054000" ] ] ] ; ( fhir:referenceStrength [ fhir:substance [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "66D92MGC8M" ] ; fhir:display [ fhir:v "Gilteritinib" ] ] ) ] ] ; fhir:strength [ a fhir:Ratio ; fhir:numerator [ fhir:value [ fhir:v "40"^^xsd:decimal ] ; fhir:unit [ fhir:v "mg" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "mg" ] ] ; fhir:denominator [ fhir:value [ fhir:v "1"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablet" ] ; fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "15054000" ] ] ] ] ) ] ) ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum> a fhir:Ingredient ; fhir:id [ fhir:v "Mannitolum"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "3OWL53L36A" ] ; fhir:display [ fhir:v "Mannitol" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum> a fhir:Ingredient ; fhir:id [ fhir:v "Hydroxypropylcellulosum"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "9XZ8H6N6OH" ] ; fhir:display [ fhir:v "Hyprolose" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile> a fhir:Ingredient ; fhir:id [ fhir:v "HydroxypropylcellulosumSubstitutumHumile"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "2165RE0K14" ] ; fhir:display [ fhir:v "Hydroxypropylcellulose, low-substituted" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum> a fhir:Ingredient ; fhir:id [ fhir:v "Talcum"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "7SEV7J4R1U" ] ; fhir:display [ fhir:v "Talc" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000> a fhir:Ingredient ; fhir:id [ fhir:v "Macrogolum8000"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "Q662QK8M3B" ] ; fhir:display [ fhir:v "Macrogol 8000" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171> a fhir:Ingredient ; fhir:id [ fhir:v "E171"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "15FIX9V2JP" ] ; fhir:display [ fhir:v "Titanium dioxide" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum> a fhir:Ingredient ; fhir:id [ fhir:v "E172Flavum"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "15FIX9V2JP" ] ; fhir:display [ fhir:v "Titanium dioxide" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate> a fhir:Ingredient ; fhir:id [ fhir:v "MagnesiumStearate"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "70097M6I30" ] ; fhir:display [ fhir:v "Magnesium stearate" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum> a fhir:Ingredient ; fhir:id [ fhir:v "Hypromellosum"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:l fhir:AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] [ fhir:l fhir:ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet ; fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role> ] ; fhir:code [ fhir:v "756005035000002" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance> ] ; fhir:code [ fhir:v "3NXW29V3WO" ] ; fhir:display [ fhir:v "Hypromellose" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10081514"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ; fhir:l <https://www.meddra.org> ] ; fhir:code [ fhir:v "10081514" ] ; fhir:display [ fhir:v "Acute myeloid leukemia refractory" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186> ] ; fhir:code [ fhir:v "756005042000002" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10081513"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ; fhir:l <https://www.meddra.org> ] ; fhir:code [ fhir:v "10081513" ] ; fhir:display [ fhir:v "Acute myeloid leukaemia refractory" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186> ] ; fhir:code [ fhir:v "756005042000002" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10059034"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ; fhir:l <https://www.meddra.org> ] ; fhir:code [ fhir:v "10059034" ] ; fhir:display [ fhir:v "Acute myeloid leukaemia recurrent" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186> ] ; fhir:code [ fhir:v "756005042000002" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10060558"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ; fhir:l <https://www.meddra.org> ] ; fhir:code [ fhir:v "10060558" ] ; fhir:display [ fhir:v "Acute myeloid leukemia recurrent" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186> ] ; fhir:code [ fhir:v "756005042000002" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . # <http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10084619"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:l fhir:MedicinalProductDefinition/Xospata-Filmcoatedtablet ; fhir:reference [ fhir:v "MedicinalProductDefinition/Xospata-Filmcoatedtablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ; fhir:l <https://www.meddra.org> ] ; fhir:code [ fhir:v "10084619" ] ; fhir:display [ fhir:v "FLT3-Gen-Mutation" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ; fhir:l <http://spor.ema.europa.eu/v1/lists/200000003186> ] ; fhir:code [ fhir:v "756005042000002" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . #
IG © 2026+ Refdata Foundation. Package ch.fhir.ig.ch-idmp#1.0.0-ballot based on FHIR 5.0.0. Generated 2026-06-12
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