CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions
@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 "6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle> ] ) ] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/DocumentReference/DocRef-FI-Entocort"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/DocumentReference/DocRef-FI-Entocort> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/DocumentReference/DocRef-PI-Entocort"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/DocumentReference/DocRef-PI-Entocort> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/RegulatedAuthorisation/MA-5204201"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/RegulatedAuthorisation/MA-5204201> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/RegulatedAuthorisation/MA-52042011"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/RegulatedAuthorisation/MA-52042011> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/RegulatedAuthorisation/FOPH-17973"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/RegulatedAuthorisation/FOPH-17973> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/ManufacturedItemDefinition/MI-Solvent"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/ManufacturedItemDefinition/MI-Solvent> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/ClinicalUseDefinition/IND-10009900"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/ClinicalUseDefinition/IND-10009900> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/Ingredient/Budesonidum2.3"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/Ingredient/Budesonidum2.3> ) ] [ fhir:fullUrl [ fhir:v "http://example.org/Ingredient/Budesonidum2.0"^^xsd:anyURI ] ; ( fhir:resource <http://example.org/Ingredient/Budesonidum2.0> ) ] ) . # <http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "Entocort-Solvent-and-Tablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_Entocort-Solvent-and-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Entocort-Solvent-and-Tablet</b></p><a name=\"Entocort-Solvent-and-Tablet\"> </a><a name=\"hcEntocort-Solvent-and-Tablet\"> </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\">IDMP MedicinalProductDefinition</a></p></div><p><b>CH - SMC Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 50064000}\">Tablet and solvent for rectal suspension</span></p><p><b>CH - EPL Full Limitation Text</b>: Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.</p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001346451-5204201</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 50064000}\">Tablet and solvent for rectal suspension</span></p><p><b>indication</b>: </p><div><p>Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}\">Medicinal product subject to medical or veterinary prescription (B)</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}\">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator 756005003001}\">Authorised for the treatment in children</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc A07EA06}\">budesonide</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category 756005021001}\">NA KAS art. 12 para. 5 TPLO</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode 756005004001}\">Synthetic</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type 756001003002}\">Originator product</span></p><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Entocort.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-efg-123; status = current; type = Fachinformation; date = 2022-04-01 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Entocort.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-efg-321; status = current; type = Patienteninformation; date = 2022-04-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type SMC}\">Zugelassener Arzneimittelname</span></p><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 de-CH}\">German (Switzerland)</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "50064000" ] ; fhir:display [ fhir:v "Tablet and solvent for rectal suspension" ] ] ) ] ] [ fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin." ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID"^^xsd:anyURI ] ; fhir:value [ fhir:v "CH-7601001346451-5204201" ] ] ) ; # fhir:combinedPharmaceuticalDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "50064000" ] ; fhir:display [ fhir:v "Tablet and solvent for rectal suspension" ] ] ) ] ; # fhir:indication [ fhir:v "Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum."] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005022003" ] ; fhir:display [ fhir:v "Medicinal product subject to medical or veterinary prescription (B)" ] ] ) ] ; # fhir:additionalMonitoringIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005001003" ] ; fhir:display [ fhir:v "No Warning" ] ] ) ] ; # fhir:pediatricUseIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005003001" ] ; fhir:display [ fhir:v "Authorised for the treatment in children" ] ] ) ] ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://www.whocc.no/atc"^^xsd:anyURI ] ; fhir:code [ fhir:v "A07EA06" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005021001" ] ; fhir:display [ fhir:v "NA KAS art. 12 para. 5 TPLO" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005004001" ] ; fhir:display [ fhir:v "Synthetic" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756001003002" ] ; fhir:display [ fhir:v "Originator product" ] ] ) ] ) ; # fhir:attachedDocument ( [ fhir:reference [ fhir:v "DocumentReference/DocRef-FI-Entocort" ] ] [ fhir:reference [ fhir:v "DocumentReference/DocRef-PI-Entocort" ] ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "SMC" ] ; fhir:display [ fhir:v "Zugelassener Arzneimittelname" ] ] ) ] ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; 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:code [ fhir:v "de-CH" ] ; fhir:display [ fhir:v "German (Switzerland)" ] ] ) ] ] ) ] ) . # <http://example.org/DocumentReference/DocRef-FI-Entocort> a fhir:DocumentReference ; fhir:id [ fhir:v "DocRef-FI-Entocort"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference> ] ) ] ; # fhir:language [ fhir:v "de-CH"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"de-CH\" lang=\"de-CH\"><a name=\"DocumentReference_DocRef-FI-Entocort\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Entocort</b></p><a name=\"DocRef-FI-Entocort\"> </a><a name=\"hcDocRef-FI-Entocort\"> </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\">Language: de-CH</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-documentreference.html\">CH IDMP DocumentReference</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber</code>/123456789-initial submission-Example-efg-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type 756005007001}\">Fachinformation</span></p><p><b>date</b>: 2022-04-01 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/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1</a></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "123456789-initial submission-Example-efg-123" ] ] ) ; # fhir:status [ fhir:v "current"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005007001" ] ; fhir:display [ fhir:v "Fachinformation" ] ] ) ] ; # fhir:date [ fhir:v "2022-04-01T00:00:00Z"^^xsd:dateTime] ; # fhir:content ( [ fhir:attachment [ fhir:url [ fhir:v "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1"^^xsd:anyURI ] ] ] ) . # <http://example.org/DocumentReference/DocRef-PI-Entocort> a fhir:DocumentReference ; fhir:id [ fhir:v "DocRef-PI-Entocort"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference> ] ) ] ; # fhir:language [ fhir:v "de-CH"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"de-CH\" lang=\"de-CH\"><a name=\"DocumentReference_DocRef-PI-Entocort\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-PI-Entocort</b></p><a name=\"DocRef-PI-Entocort\"> </a><a name=\"hcDocRef-PI-Entocort\"> </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\">Language: de-CH</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-documentreference.html\">CH IDMP DocumentReference</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber</code>/123456789-initial submission-Example-efg-321</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type 756005007002}\">Patienteninformation</span></p><p><b>date</b>: 2022-04-01 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/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1</a></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "123456789-initial submission-Example-efg-321" ] ] ) ; # fhir:status [ fhir:v "current"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005007002" ] ; fhir:display [ fhir:v "Patienteninformation" ] ] ) ] ; # fhir:date [ fhir:v "2022-04-01T00:00:00Z"^^xsd:dateTime] ; # fhir:content ( [ fhir:attachment [ fhir:url [ fhir:v "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1"^^xsd:anyURI ] ] ] ) . # <http://example.org/RegulatedAuthorisation/MA-5204201> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "MA-5204201"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-5204201\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-5204201</b></p><a name=\"MA-5204201\"> </a><a name=\"hcMA-5204201\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-regulatedauthorization.html\">IDMP RegulatedAuthorization</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5204201</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status 756005023007}\">valid</span></p><p><b>statusDate</b>: 1993-06-18</p><p><b>holder</b>: <a href=\"#hcMA-5204201/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-5204201/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"MA-5204201/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcMA-5204201/holder-Tillotts-Pharma-AG\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100005174, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-5204201/regulator-SMC\"> </a><a name=\"hcMA-5204201/regulator-SMC\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:contained ( [ a fhir:Organization ; fhir:id [ fhir:v "holder-Tillotts-Pharma-AG" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:1.2.276.0.76"^^xsd:anyURI ] ; fhir:value [ fhir:v "100005174" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ] ; fhir:value [ fhir:v "7601001346451" ] ] ) ; fhir:name [ fhir:v "Tillotts Pharma AG" ] ] [ a fhir:Organization ; fhir:id [ fhir:v "regulator-SMC" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:1.2.276.0.76"^^xsd:anyURI ] ; fhir:value [ fhir:v "100010911" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ] ; fhir:value [ fhir:v "7601001398511" ] ] ) ; fhir:name [ fhir:v "SMC" ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "5204201" ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"^^xsd:anyURI ] ; 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:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005023007" ] ; fhir:display [ fhir:v "valid" ] ] ) ] ; # fhir:statusDate [ fhir:v "1993-06-18"^^xsd:date] ; # fhir:holder [ fhir:reference [ fhir:v "#holder-Tillotts-Pharma-AG" ] ] ; # fhir:regulator [ fhir:reference [ fhir:v "#regulator-SMC" ] ] . # <http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "PMP-Entocort-Solvent-and-Tablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_PMP-Entocort-Solvent-and-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Entocort-Solvent-and-Tablet</b></p><a name=\"PMP-Entocort-Solvent-and-Tablet\"> </a><a name=\"hcPMP-Entocort-Solvent-and-Tablet\"> </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\">IDMP PackagedProductDefinition</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001346451-5204201-011</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</a></p><p><b>containedItemQuantity</b>: 7 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span>, 7 Bottle<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code30008000 = 'Bottle')</span></p><p><b>description</b>: </p><div><p>ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk</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-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}\">Medicinal product subject to medical or veterinary prescription (B)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href=\"NamingSystem-GTIN.html\" title=\"GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.\">Global Trade Item Number</a>/7680520420118</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: 60; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage 756005042009}\">Do not store above 30°C</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID"^^xsd:anyURI ] ; fhir:value [ fhir:v "CH-7601001346451-5204201-011" ] ] ) ; # fhir:packageFor ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "7"^^xsd:decimal ] ; fhir:unit [ fhir:v "Tablet" ] ; fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "15054000" ] ] [ fhir:value [ fhir:v "7"^^xsd:decimal ] ; fhir:unit [ fhir:v "Bottle" ] ; fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "30008000" ] ] ) ; # fhir:description [ fhir:v "ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk"] ; # fhir:legalStatusOfSupply ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005022003" ] ; fhir:display [ fhir:v "Medicinal product subject to medical or veterinary prescription (B)" ] ] ) ] ] ) ; # fhir:packaging [ ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:2.51.1.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "7680520420118" ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; 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: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 "60"^^xsd:decimal ] ; fhir:unit [ fhir:v "month" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mo" ] ] ; ( fhir:specialPrecautionsForStorage [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005042009" ] ; fhir:display [ fhir:v "Do not store above 30°C" ] ] ) ] ) ] ) ] . # <http://example.org/RegulatedAuthorisation/MA-52042011> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "MA-52042011"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-52042011\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-52042011</b></p><a name=\"MA-52042011\"> </a><a name=\"hcMA-52042011\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-regulatedauthorization.html\">IDMP RegulatedAuthorization</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/52042011</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status 756005023007}\">valid</span></p><p><b>statusDate</b>: 1993-06-18</p><p><b>holder</b>: <a href=\"#hcMA-52042011/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-52042011/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"MA-52042011/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcMA-52042011/holder-Tillotts-Pharma-AG\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100005174, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-52042011/regulator-SMC\"> </a><a name=\"hcMA-52042011/regulator-SMC\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:contained ( [ a fhir:Organization ; fhir:id [ fhir:v "holder-Tillotts-Pharma-AG" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:1.2.276.0.76"^^xsd:anyURI ] ; fhir:value [ fhir:v "100005174" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ] ; fhir:value [ fhir:v "7601001346451" ] ] ) ; fhir:name [ fhir:v "Tillotts Pharma AG" ] ] [ a fhir:Organization ; fhir:id [ fhir:v "regulator-SMC" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:1.2.276.0.76"^^xsd:anyURI ] ; fhir:value [ fhir:v "100010911" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ] ; fhir:value [ fhir:v "7601001398511" ] ] ) ; fhir:name [ fhir:v "SMC" ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "52042011" ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"^^xsd:anyURI ] ; 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:code [ fhir:v "CH" ] ; fhir:display [ fhir:v "Switzerland" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005023007" ] ; fhir:display [ fhir:v "valid" ] ] ) ] ; # fhir:statusDate [ fhir:v "1993-06-18"^^xsd:date] ; # fhir:holder [ fhir:reference [ fhir:v "#holder-Tillotts-Pharma-AG" ] ] ; # fhir:regulator [ fhir:reference [ fhir:v "#regulator-SMC" ] ] . # <http://example.org/RegulatedAuthorisation/FOPH-17973> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "FOPH-17973"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_FOPH-17973\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-17973</b></p><a name=\"FOPH-17973\"> </a><a name=\"hcFOPH-17973\"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <a href=\"NamingSystem-Dossier.html\" title=\"Identifier holding the Dossier number of FOPH\">FOPH Dossier Number</a>/17973</li><li>status: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></li><li>statusDate: 2004-02-01</li><li>listingStatus: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></li><li>listingPeriod: 2004-02-01 --> (ongoing)</li><li>firstListingDate: 2004-02-01</li><li>costShare: 10</li><li>gamme: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004005}\">Rectal Vaginal</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF40.89</span> (CHF)</li><li>type: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}\">Ex-factory price</span></li><li>changeType: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006007}\">Price mutation after triennal review of pharmaceuticals</span></li><li>changeDate: 2023-12-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF63.40</span> (CHF)</li><li>type: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}\">Retail price</span></li><li>changeType: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}\">VAT-change</span></li><li>changeDate: 2024-01-01</li></ul></blockquote><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Entocort-Solvent-and-Tablet.html\">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001346451-5204201-011; containedItemQuantity = 7 Tablet,7 Bottle; description = ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002003}\">Reimbursement SL</span></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td/><td><a href=\"ClinicalUseDefinition-IND-10009900.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-17973/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"FOPH-17973/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcFOPH-17973/holder-Tillotts-Pharma-AG\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100005174, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:contained ( [ a fhir:Organization ; fhir:id [ fhir:v "holder-Tillotts-Pharma-AG" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization> ] ) ] ; ( fhir:identifier [ fhir:system [ fhir:v "urn:oid:1.2.276.0.76"^^xsd:anyURI ] ; fhir:value [ fhir:v "100005174" ] ] [ fhir:system [ fhir:v "urn:oid:2.51.1.3"^^xsd:anyURI ] ; fhir:value [ fhir:v "7601001346451" ] ] ) ; fhir:name [ fhir:v "Tillotts Pharma AG" ] ] ) ; # fhir:extension ( [ ( fhir:extension [ fhir:url [ fhir:v "FOPHDossierNumber"^^xsd:anyURI ] ; fhir:value [ a fhir:Identifier ; fhir:system [ fhir:v "urn:oid:2.16.756.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "17973" ] ] ] [ fhir:url [ fhir:v "status"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "756001021001" ] ; fhir:display [ fhir:v "Reimbursed" ] ] ) ] ] [ fhir:url [ fhir:v "statusDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2004-02-01"^^xsd:date ] ] [ fhir:url [ fhir:v "listingStatus"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "756001002001" ] ; fhir:display [ fhir:v "Listed" ] ] ) ] ] [ fhir:url [ fhir:v "listingPeriod"^^xsd:anyURI ] ; fhir:value [ a fhir:Period ; fhir:start [ fhir:v "2004-02-01"^^xsd:date ] ] ] [ fhir:url [ fhir:v "firstListingDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2004-02-01"^^xsd:date ] ] [ fhir:url [ fhir:v "costShare"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 10 ] ] [ fhir:url [ fhir:v "gamme"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002004005" ] ; fhir:display [ fhir:v "Rectal Vaginal" ] ] ) ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"^^xsd:anyURI ] ] [ ( fhir:extension [ fhir:url [ fhir:v "value"^^xsd:anyURI ] ; fhir:value [ a fhir:Money ; fhir:value [ fhir:v 40.89 ] ; fhir:currency [ fhir:v "CHF" ] ] ] [ fhir:url [ fhir:v "type"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002005002" ] ; fhir:display [ fhir:v "Ex-factory price" ] ] ) ] ] [ fhir:url [ fhir:v "changeType"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002006007" ] ; fhir:display [ fhir:v "Price mutation after triennal review of pharmaceuticals" ] ] ) ] ] [ fhir:url [ fhir:v "changeDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2023-12-01"^^xsd:date ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"^^xsd:anyURI ] ] [ ( fhir:extension [ fhir:url [ fhir:v "value"^^xsd:anyURI ] ; fhir:value [ a fhir:Money ; fhir:value [ fhir:v 63.4 ] ; fhir:currency [ fhir:v "CHF" ] ] ] [ fhir:url [ fhir:v "type"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002005001" ] ; fhir:display [ fhir:v "Retail price" ] ] ) ] ] [ fhir:url [ fhir:v "changeType"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002006005" ] ; fhir:display [ fhir:v "VAT-change" ] ] ) ] ] [ fhir:url [ fhir:v "changeDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2024-01-01"^^xsd:date ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"^^xsd:anyURI ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756000002003" ] ; fhir:display [ fhir:v "Reimbursement SL" ] ] ) ] ; # fhir:indication ( [ ( fhir:extension [ ( fhir:extension [ fhir:url [ fhir:v "status"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002071001" ] ; fhir:display [ fhir:v "Limitation Reimbursed" ] ] ) ] ] [ fhir:url [ fhir:v "statusDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2007-01-01"^^xsd:date ] ] [ fhir:url [ fhir:v "period"^^xsd:anyURI ] ; fhir:value [ a fhir:Period ; fhir:start [ fhir:v "2007-01-01"^^xsd:date ] ] ] [ fhir:url [ fhir:v "firstLimitationDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2007-01-01"^^xsd:date ] ] [ ( fhir:extension [ fhir:url [ fhir:v "value"^^xsd:anyURI ] ; fhir:value [ a fhir:Money ; fhir:value [ fhir:v 40.89 ] ; fhir:currency [ fhir:v "CHF" ] ] ] [ fhir:url [ fhir:v "type"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002005002" ] ; fhir:display [ fhir:v "Ex-factory price" ] ] ) ] ] [ fhir:url [ fhir:v "changeType"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002006007" ] ; fhir:display [ fhir:v "Price mutation after triennal review of pharmaceuticals" ] ] ) ] ] [ fhir:url [ fhir:v "changeDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2023-12-01"^^xsd:date ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"^^xsd:anyURI ] ] [ ( fhir:extension [ fhir:url [ fhir:v "value"^^xsd:anyURI ] ; fhir:value [ a fhir:Money ; fhir:value [ fhir:v 63.4 ] ; fhir:currency [ fhir:v "CHF" ] ] ] [ fhir:url [ fhir:v "type"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002005001" ] ; fhir:display [ fhir:v "Retail price" ] ] ) ] ] [ fhir:url [ fhir:v "changeType"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"^^xsd:anyURI ] ; fhir:code [ fhir:v "756002006005" ] ; fhir:display [ fhir:v "VAT-change" ] ] ) ] ] [ fhir:url [ fhir:v "changeDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2024-01-01"^^xsd:date ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"^^xsd:anyURI ] ] ) ; fhir:url [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"^^xsd:anyURI ] ] ) ; fhir:reference [ fhir:reference [ fhir:v "ClinicalUseDefinition/IND-10009900" ] ] ] ) ; # fhir:holder [ fhir:reference [ fhir:v "#holder-Tillotts-Pharma-AG" ] ] . # <http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet> a fhir:ManufacturedItemDefinition ; fhir:id [ fhir:v "MI-Budesonidum-2.3mg-Tablet"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MI-Budesonidum-2.3mg-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Budesonidum-2.3mg-Tablet</b></p><a name=\"MI-Budesonidum-2.3mg-Tablet\"> </a><a name=\"hcMI-Budesonidum-2.3mg-Tablet\"> </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\">CH IDMP ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11012000}\">Tablet for rectal suspension</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:code [ fhir:v "11012000" ] ; fhir:display [ fhir:v "Tablet for rectal suspension" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "15054000" ] ; fhir:display [ fhir:v "Tablet" ] ] ) ] . # <http://example.org/ManufacturedItemDefinition/MI-Solvent> a fhir:ManufacturedItemDefinition ; fhir:id [ fhir:v "MI-Solvent"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MI-Solvent\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Solvent</b></p><a name=\"MI-Solvent\"> </a><a name=\"hcMI-Solvent\"> </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\">CH IDMP ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 13035000}\">Solvent for...</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15009000}\">Bottle</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:code [ fhir:v "13035000" ] ; fhir:display [ fhir:v "Solvent for..." ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "15009000" ] ; fhir:display [ fhir:v "Bottle" ] ] ) ] . # <http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension> a fhir:AdministrableProductDefinition ; fhir:id [ fhir:v "PhP-Budesonidum-Suspension"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_PhP-Budesonidum-Suspension\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Budesonidum-Suspension</b></p><a name=\"PhP-Budesonidum-Suspension\"> </a><a name=\"hcPhP-Budesonidum-Suspension\"> </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\">CH IDMP AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11006000}\">Rectal suspension</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15009000}\">Bottle</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 20061000}\">Rectal use</span></td></tr></table></div>"^^rdf:XMLLiteral ] ; # fhir:status [ fhir:v "active"] ; # fhir:formOf ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:administrableDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "11006000" ] ; fhir:display [ fhir:v "Rectal suspension" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "15009000" ] ; fhir:display [ fhir:v "Bottle" ] ] ) ] ; # fhir:routeOfAdministration ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "20061000" ] ; fhir:display [ fhir:v "Rectal use" ] ] ) ] ] ) . # <http://example.org/ClinicalUseDefinition/IND-10009900> a fhir:ClinicalUseDefinition ; fhir:id [ fhir:v "IND-10009900"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10009900\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10009900</b></p><a name=\"IND-10009900\"> </a><a name=\"hcIND-10009900\"> </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\">CH IDMP ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product</a></p><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 10009900}\">Colitis ulcerative</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:type [ fhir:v "indication"] ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" ] ] ) ; # fhir:indication [ fhir:diseaseSymptomProcedure [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "10009900" ] ; fhir:display [ fhir:v "Colitis ulcerative" ] ] ) ] ] ; fhir:intendedEffect [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000003186"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003194" ] ; fhir:display [ fhir:v "therapeutic" ] ] ) ] ] ] . # <http://example.org/Ingredient/Budesonidum2.3> a fhir:Ingredient ; fhir:id [ fhir:v "Budesonidum2.3"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Budesonidum2.3\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Budesonidum2.3</b></p><a name=\"Budesonidum2.3\"> </a><a name=\"hcBudesonidum2.3\"> </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\">IDMP Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-MI-Budesonidum-2.3mg-Tablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet for rectal suspension; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role 756005051001}\">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-epl/CodeSystem/ch-SMC-substance Q3OKS62Q6X}\">Budesonide</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2.3 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005051001" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"^^xsd:anyURI ] ; fhir:code [ fhir:v "Q3OKS62Q6X" ] ; fhir:display [ fhir:v "Budesonide" ] ] ) ] ] ; ( fhir:strength [ fhir:presentation [ a fhir:Ratio ; fhir:numerator [ fhir:value [ fhir:v 2.3 ] ; fhir:unit [ fhir:v "mg" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; 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:code [ fhir:v "15054000" ] ] ] ] ) ] . # <http://example.org/Ingredient/Budesonidum2.0> a fhir:Ingredient ; fhir:id [ fhir:v "Budesonidum2.0"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"^^xsd:anyURI ; fhir:link <http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Budesonidum2.0\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Budesonidum2.0</b></p><a name=\"Budesonidum2.0\"> </a><a name=\"hcBudesonidum2.0\"> </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\">IDMP Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"AdministrableProductDefinition-PhP-Budesonidum-Suspension.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Rectal suspension; unitOfPresentation = Bottle</a></p><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role 756005051001}\">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-epl/CodeSystem/ch-SMC-substance Q3OKS62Q6X}\">Budesonide</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concentration[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/100 ml<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeml = 'ml')</span></td></tr></table></blockquote></div>"^^rdf:XMLLiteral ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "AdministrableProductDefinition/PhP-Budesonidum-Suspension" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "756005051001" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"^^xsd:anyURI ] ; fhir:code [ fhir:v "Q3OKS62Q6X" ] ; fhir:display [ fhir:v "Budesonide" ] ] ) ] ] ; ( fhir:strength [ fhir:concentration [ a fhir:Ratio ; fhir:numerator [ fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:unit [ fhir:v "mg" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mg" ] ] ; fhir:denominator [ fhir:value [ fhir:v "100"^^xsd:decimal ] ; fhir:unit [ fhir:v "ml" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "ml" ] ] ] ] ) ] . #
IG © 2023+ Federal Office of Public Health FOPH. Package ch.fhir.ig.ch-epl#1.0.0-ci-build based on FHIR 5.0.0. Generated 2025-09-01
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