CH EPL (R5)
1.0.0-ballot - ballot
CH EPL (R5)
1.0.0-ballot - ballot
This page is part of the CH EPL (R5) (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
<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"><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><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>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}">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>
</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="Medicinal product subject to medical or veterinary prescription (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="Authorised for the treatment in children"/>
</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 KAS art. 12 para. 5 TPLO"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode"/>
<code value="756005004001"/>
<display value="Synthetic"/>
</coding>
</classification>
<classification>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type"/>
<code value="756001003002"/>
<display value="Originator product"/>
</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>