CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
<resource>
<MedicinalProductDefinition>
<id value="Entocort-Solvent-and-Tablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_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><a name="Entocort-Solvent-and-Tablet-en-US"> </a><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>domain</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human</span></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>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}">Abgabe auf ärztliche oder tierärztliche Verschreibung (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}">Zugelassen für die Anwendung bei Kindern</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 BWS Art 12. Abs. 5 VAZV</span>, <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode 756005004001}">Synthetika</span>, <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type 756001003002}">Originalpräparat</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>
</text>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm">
<valueCodeableConcept>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="50064000"/>
<display value="Tablet and solvent for rectal suspension"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText">
<valueString
value="Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin."/>
</extension>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID"/>
<value value="CH-7601001346451-5204201"/>
</identifier>
<domain>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human"/>
</coding>
</domain>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="50064000"/>
<display value="Tablet and solvent for rectal suspension"/>
</coding>
</combinedPharmaceuticalDoseForm>
<indication
value="Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum."/>
<legalStatusOfSupply>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005022003"/>
<display
value="Abgabe auf ärztliche oder tierärztliche Verschreibung (B)"/>
</coding>
</legalStatusOfSupply>
<additionalMonitoringIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator"/>
<code value="756005001003"/>
<display value="No Warning"/>
</coding>
</additionalMonitoringIndicator>
<pediatricUseIndicator>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator"/>
<code value="756005003001"/>
<display value="Zugelassen für die Anwendung bei Kindern"/>
</coding>
</pediatricUseIndicator>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="A07EA06"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category"/>
<code value="756005021001"/>
<display value="NA BWS Art 12. Abs. 5 VAZV"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode"/>
<code value="756005004001"/>
<display value="Synthetika"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type"/>
<code value="756001003002"/>
<display value="Originalpräparat"/>
</coding>
</classification>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-FI-Entocort"/>
</attachedDocument>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-PI-Entocort"/>
</attachedDocument>
<name>
<productName
value="ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type"/>
<code value="SMC"/>
<display value="Zugelassener Arzneimittelname"/>
</coding>
</type>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="de-CH"/>
<display value="German (Switzerland)"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/DocumentReference/DocRef-FI-Entocort"/>
<resource>
<DocumentReference>
<id value="DocRef-FI-Entocort"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<language value="de-CH"/>
<text>
<status value="generated"/>
<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><a name="DocRef-FI-Entocort-en-US"> </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>
</text>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber"/>
<value value="123456789-initial submission-Example-efg-123"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"/>
<code value="756005007001"/>
<display value="Fachinformation"/>
</coding>
</type>
<date value="2022-04-01T00:00:00Z"/>
<content>
<attachment>
<url
value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/DocumentReference/DocRef-PI-Entocort"/>
<resource>
<DocumentReference>
<id value="DocRef-PI-Entocort"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"/>
</meta>
<language value="de-CH"/>
<text>
<status value="generated"/>
<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><a name="DocRef-PI-Entocort-en-US"> </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>
</text>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber"/>
<value value="123456789-initial submission-Example-efg-321"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type"/>
<code value="756005007002"/>
<display value="Patienteninformation"/>
</coding>
</type>
<date value="2022-04-01T00:00:00Z"/>
<content>
<attachment>
<url
value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-5204201"/>
<resource>
<RegulatedAuthorization>
<id value="MA-5204201"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MA-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><a name="MA-5204201-en-US"> </a><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; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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}">zugelassen</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><a name="MA-5204201/holder-Tillotts-Pharma-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</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><a name="MA-5204201/regulator-SMC-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Tillotts-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100005174"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001346451"/>
</identifier>
<name value="Tillotts Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100010911"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001398511"/>
</identifier>
<name value="SMC"/>
</Organization>
</contained>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"/>
<value value="5204201"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002001"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</region>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005023007"/>
<display value="zugelassen"/>
</coding>
</status>
<statusDate value="1993-06-18"/>
<holder>
<reference value="#holder-Tillotts-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet"/>
<resource>
<PackagedProductDefinition>
<id value="PMP-Entocort-Solvent-and-Tablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_PMP-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><a name="PMP-Entocort-Solvent-and-Tablet-en-US"> </a><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; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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>
</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}">Abgabe auf ärztliche oder tierärztliche Verschreibung (B)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>urn:oid:2.51.1.1</code>/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}">Nicht über 30°C</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID"/>
<value value="CH-7601001346451-5204201-011"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
</packageFor>
<containedItemQuantity>
<value value="7"/>
<unit value="Tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</containedItemQuantity>
<containedItemQuantity>
<value value="7"/>
<unit value="Bottle"/>
<system value="http://standardterms.edqm.eu"/>
<code value="30008000"/>
</containedItemQuantity>
<description
value="ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005022003"/>
<display
value="Abgabe auf ärztliche oder tierärztliche Verschreibung (B)"/>
</coding>
</code>
</legalStatusOfSupply>
<packaging>
<identifier>
<system value="urn:oid:2.51.1.1"/>
<value value="7680520420118"/>
</identifier>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30009000"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<shelfLifeStorage>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073403"/>
<display
value="Shelf life of the medicinal product as packaged for sale"/>
</coding>
</type>
<periodDuration>
<value value="60"/>
<unit value="month"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005042009"/>
<display value="Nicht über 30°C"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-52042011"/>
<resource>
<RegulatedAuthorization>
<id value="MA-52042011"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><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><a name="MA-52042011-en-US"> </a><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; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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}">zugelassen</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><a name="MA-52042011/holder-Tillotts-Pharma-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</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><a name="MA-52042011/regulator-SMC-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Tillotts-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100005174"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001346451"/>
</identifier>
<name value="Tillotts Pharma AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100010911"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001398511"/>
</identifier>
<name value="SMC"/>
</Organization>
</contained>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber"/>
<value value="52042011"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002001"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</region>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005023007"/>
<display value="zugelassen"/>
</coding>
</status>
<statusDate value="1993-06-18"/>
<holder>
<reference value="#holder-Tillotts-Pharma-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/FOPH-17973"/>
<resource>
<RegulatedAuthorization>
<id value="FOPH-17973"/>
<text>
<status value="extensions"/>
<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><a name="FOPH-17973-en-US"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/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}">RektalVaginal</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><a name="FOPH-17973/holder-Tillotts-Pharma-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Tillotts-Pharma-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100005174"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001346451"/>
</identifier>
<name value="Tillotts Pharma AG"/>
</Organization>
</contained>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL">
<extension url="FOPHDossierNumber">
<valueIdentifier>
<system value="urn:oid:2.16.756.1"/>
<value value="17973"/>
</valueIdentifier>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status"/>
<code value="756001021001"/>
<display value="Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2004-02-01"/>
</extension>
<extension url="listingStatus">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status"/>
<code value="756001002001"/>
<display value="Listed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="listingPeriod">
<valuePeriod>
<start value="2004-02-01"/>
</valuePeriod>
</extension>
<extension url="firstListingDate">
<valueDate value="2004-02-01"/>
</extension>
<extension url="costShare">
<valueInteger value="10"/>
</extension>
<extension url="gamme">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme"/>
<code value="756002004005"/>
<display value="RektalVaginal"/>
</coding>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="40.89"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005002"/>
<display value="Ex-factory price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006007"/>
<display
value="Price mutation after triennal review of pharmaceuticals"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-12-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="63.4"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005001"/>
<display value="Retail price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006005"/>
<display value="VAT-change"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2024-01-01"/>
</extension>
</extension>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002003"/>
<display value="Reimbursement SL"/>
</coding>
</type>
<indication>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2007-01-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2007-01-01"/>
</valuePeriod>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2007-01-01"/>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="40.89"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005002"/>
<display value="Ex-factory price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006007"/>
<display
value="Price mutation after triennal review of pharmaceuticals"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-12-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="63.4"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005001"/>
<display value="Retail price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006005"/>
<display value="VAT-change"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2024-01-01"/>
</extension>
</extension>
</extension>
<reference>🔗
<reference value="ClinicalUseDefinition/IND-10009900"/>
</reference>
</indication>
<holder>
<reference value="#holder-Tillotts-Pharma-AG"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Budesonidum-2.3mg-Tablet"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-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><a name="MI-Budesonidum-2.3mg-Tablet-en-US"> </a><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>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="11012000"/>
<display value="Tablet for rectal suspension"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/MI-Solvent"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Solvent"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MI-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><a name="MI-Solvent-en-US"> </a><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>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="13035000"/>
<display value="Solvent for..."/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15009000"/>
<display value="Bottle"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension"/>
<resource>
<AdministrableProductDefinition>
<id value="PhP-Budesonidum-Suspension"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_PhP-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><a name="PhP-Budesonidum-Suspension-en-US"> </a><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; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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>
</text>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="11006000"/>
<display value="Rectal suspension"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15009000"/>
<display value="Bottle"/>
</coding>
</unitOfPresentation>
<routeOfAdministration>
<code>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20061000"/>
<display value="Rectal use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10009900"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10009900"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_IND-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><a name="IND-10009900-en-US"> </a><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; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Entocort-Solvent-and-Tablet"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10009900"/>
<display value="Colitis ulcerative"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="200000003194"/>
<display value="therapeutic"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/Budesonidum2.3"/>
<resource>
<Ingredient>
<id value="Budesonidum2.3"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_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><a name="Budesonidum2.3-en-US"> </a><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}">Wirkstoff</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance 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>
</text>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005051001"/>
<display value="Wirkstoff"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"/>
<code value="Q3OKS62Q6X"/>
<display value="Budesonide"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="2.3"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/Budesonidum2.0"/>
<resource>
<Ingredient>
<id value="Budesonidum2.0"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_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><a name="Budesonidum2.0-en-US"> </a><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}">Wirkstoff</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance 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>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Budesonidum-Suspension"/>
</for>
<role>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role"/>
<code value="756005051001"/>
<display value="Wirkstoff"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance"/>
<code value="Q3OKS62Q6X"/>
<display value="Budesonide"/>
</coding>
</concept>
</code>
<strength>
<concentrationRatio>
<numerator>
<value value="2"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="100"/>
<unit value="ml"/>
<system value="http://unitsofmeasure.org"/>
<code value="ml"/>
</denominator>
</concentrationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
</Bundle>