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="5bb930aa-f30d-4f10-aeef-e85f6b5f8d59"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/Estalis-Transdermalpatch"/>
<resource>
<MedicinalProductDefinition>
<id value="Estalis-Transdermalpatch"/>
<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_Estalis-Transdermalpatch"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Estalis-Transdermalpatch</b></p><a name="Estalis-Transdermalpatch"> </a><a name="hcEstalis-Transdermalpatch"> </a><a name="Estalis-Transdermalpatch-en-US"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title="Codes:{http://standardterms.edqm.eu 10519000}">Transdermal patch</span></p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001029439-5470402</p><p><b>domain</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human</span></p><p><b>indication</b>: </p><div><p>Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.</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 756005003002}">Nicht zugelassen für die Anwendung bei Kindern</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc G03FA01}">norethisterone and estrogen</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-Estalis.html">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-123; status = current; type = Fachinformation; date = 2021-10-01 00:00:00+0000</a></li><li><a href="DocumentReference-DocRef-PI-Estalis.html">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-321; status = current; type = Patienteninformation; date = 2021-10-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: ESTALIS Matrixpfl 50/250 24 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="10519000"/>
<display value="Transdermal patch"/>
</coding>
</valueCodeableConcept>
</extension>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID"/>
<value value="CH-7601001029439-5470402"/>
</identifier>
<domain>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human"/>
</coding>
</domain>
<indication
value="Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden."/>
<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="756005003002"/>
<display value="Nicht zugelassen für die Anwendung bei Kindern"/>
</coding>
</pediatricUseIndicator>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="G03FA01"/>
</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-Estalis"/>
</attachedDocument>
<attachedDocument>🔗
<reference value="DocumentReference/DocRef-PI-Estalis"/>
</attachedDocument>
<name>
<productName value="ESTALIS Matrixpfl 50/250 24 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-Estalis"/>
<resource>
<DocumentReference>
<id value="DocRef-FI-Estalis"/>
<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-Estalis"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-FI-Estalis</b></p><a name="DocRef-FI-Estalis"> </a><a name="hcDocRef-FI-Estalis"> </a><a name="DocRef-FI-Estalis-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-hij-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>: 2021-10-01 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=54704&supportMultipleResults=1">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&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-hij-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="2021-10-01T00:00:00Z"/>
<content>
<attachment>
<url
value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/DocumentReference/DocRef-PI-Estalis"/>
<resource>
<DocumentReference>
<id value="DocRef-PI-Estalis"/>
<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-Estalis"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference DocRef-PI-Estalis</b></p><a name="DocRef-PI-Estalis"> </a><a name="hcDocRef-PI-Estalis"> </a><a name="DocRef-PI-Estalis-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-hij-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>: 2021-10-01 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=54704&supportMultipleResults=1">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&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-hij-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="2021-10-01T00:00:00Z"/>
<content>
<attachment>
<url
value="https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&supportMultipleResults=1"/>
</attachment>
</content>
</DocumentReference>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-5470402"/>
<resource>
<RegulatedAuthorization>
<id value="MA-5470402"/>
<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-5470402"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-5470402</b></p><a name="MA-5470402"> </a><a name="hcMA-5470402"> </a><a name="MA-5470402-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5470402</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,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>: 1999-08-17</p><p><b>holder</b>: <a href="#hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href="#hcMA-5470402/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name="MA-5470402/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="MA-5470402/holder-Sandoz-Pharmaceuticals-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-5470402/regulator-SMC"> </a><a name="hcMA-5470402/regulator-SMC"> </a><a name="MA-5470402/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-Sandoz-Pharmaceuticals-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="100054743"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001029439"/>
</identifier>
<name value="Sandoz Pharmaceuticals 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="5470402"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</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="1999-08-17"/>
<holder>
<reference value="#holder-Sandoz-Pharmaceuticals-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/PMP-Estalis-Transdermalpatch"/>
<resource>
<PackagedProductDefinition>
<id value="PMP-Estalis-Transdermalpatch"/>
<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-Estalis-Transdermalpatch"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch</b></p><a name="PMP-Estalis-Transdermalpatch"> </a><a name="hcPMP-Estalis-Transdermalpatch"> </a><a name="PMP-Estalis-Transdermalpatch-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001029439-5470402-097</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>containedItemQuantity</b>: 24 Patch<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></p><p><b>description</b>: </p><div><p>ESTALIS Matrixpfl 50/250 24 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>/7680547040979</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: 6; 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 756005042004}">vor Licht Schützen</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system
value="http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID"/>
<value value="CH-7601001029439-5470402-097"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</packageFor>
<containedItemQuantity>
<value value="24"/>
<unit value="Patch"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15036000"/>
</containedItemQuantity>
<description value="ESTALIS Matrixpfl 50/250 24 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="7680547040979"/>
</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="6"/>
<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="756005042004"/>
<display value="vor Licht Schützen"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/MA-54704089"/>
<resource>
<RegulatedAuthorization>
<id value="MA-54704089"/>
<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-54704089"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-54704089</b></p><a name="MA-54704089"> </a><a name="hcMA-54704089"> </a><a name="MA-54704089-en-US"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/54704089</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,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>: 1999-08-17</p><p><b>holder</b>: <a href="#hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href="#hcMA-54704089/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name="MA-54704089/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="MA-54704089/holder-Sandoz-Pharmaceuticals-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-54704089/regulator-SMC"> </a><a name="hcMA-54704089/regulator-SMC"> </a><a name="MA-54704089/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-Sandoz-Pharmaceuticals-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="100054743"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001029439"/>
</identifier>
<name value="Sandoz Pharmaceuticals 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="54704089"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</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="1999-08-17"/>
<holder>
<reference value="#holder-Sandoz-Pharmaceuticals-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/RegulatedAuthorisation/FOPH-17418"/>
<resource>
<RegulatedAuthorization>
<id value="FOPH-17418"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_FOPH-17418"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization FOPH-17418</b></p><a name="FOPH-17418"> </a><a name="hcFOPH-17418"> </a><a name="FOPH-17418-en-US"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/17418</li><li>status: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}">Reimbursed</span></li><li>statusDate: 2000-04-15</li><li>listingStatus: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}">Listed</span></li><li>listingPeriod: 2000-04-15 --> (ongoing)</li><li>firstListingDate: 2000-04-15</li><li>costShare: 10</li><li>gamme: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004011}">Transdermal</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF32.44</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: 2014-11-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF53.65</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-Estalis-Transdermalpatch.html">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001029439-5470402-097; containedItemQuantity = 24 Patch; description = ESTALIS Matrixpfl 50/250 24 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-10031285.html">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href="#hcFOPH-17418/holder-Sandoz-Pharmaceuticals-AG">Organization Sandoz Pharmaceuticals AG</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name="FOPH-17418/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="hcFOPH-17418/holder-Sandoz-Pharmaceuticals-AG"> </a><a name="FOPH-17418/holder-Sandoz-Pharmaceuticals-AG-en-US"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href="https://www.gs1.org/standards/id-keys/gln" title="Global Location Number">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Sandoz-Pharmaceuticals-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="100054743"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001029439"/>
</identifier>
<name value="Sandoz Pharmaceuticals 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="17418"/>
</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="2000-04-15"/>
</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="2000-04-15"/>
</valuePeriod>
</extension>
<extension url="firstListingDate">
<valueDate value="2000-04-15"/>
</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="756002004011"/>
<display value="Transdermal"/>
</coding>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="32.44"/>
<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="2014-11-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="53.65"/>
<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-Estalis-Transdermalpatch"/>
</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="2000-04-15"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2000-04-15"/>
</valuePeriod>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2000-04-15"/>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="32.44"/>
<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="2014-11-01"/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="53.65"/>
<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-10031285"/>
</reference>
</indication>
<holder>
<reference value="#holder-Sandoz-Pharmaceuticals-AG"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch"/>
<resource>
<ManufacturedItemDefinition>
<id value="MI-Estradiolum-Norethisteroni-Transdermalpatch"/>
<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-Estradiolum-Norethisteroni-Transdermalpatch"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch</b></p><a name="MI-Estradiolum-Norethisteroni-Transdermalpatch"> </a><a name="hcMI-Estradiolum-Norethisteroni-Transdermalpatch"> </a><a name="MI-Estradiolum-Norethisteroni-Transdermalpatch-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10519000}">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15036000}">Patch</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10519000"/>
<display value="Transdermal patch"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15036000"/>
<display value="Patch"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch"/>
<resource>
<AdministrableProductDefinition>
<id value="PhP-Estradiolum-Norethisteroni-Transdermalpatch"/>
<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-Estradiolum-Norethisteroni-Transdermalpatch"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch</b></p><a name="PhP-Estradiolum-Norethisteroni-Transdermalpatch"> </a><a name="hcPhP-Estradiolum-Norethisteroni-Transdermalpatch"> </a><a name="PhP-Estradiolum-Norethisteroni-Transdermalpatch-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10519000}">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://standardterms.edqm.eu 15036000}">Patch</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 20070000}">Transdermal use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10519000"/>
<display value="Transdermal patch"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15036000"/>
<display value="Patch"/>
</coding>
</unitOfPresentation>
<routeOfAdministration>
<code>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20070000"/>
<display value="Transdermal use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10030247"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10030247"/>
<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-10030247"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10030247</b></p><a name="IND-10030247"> </a><a name="hcIND-10030247"> </a><a name="IND-10030247-en-US"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,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 10030247}">Oestrogenmangel</span></td></tr></table><h3>Comorbidities</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 10027308}">Menopause</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 200000003192}">preventive</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10030247"/>
<display value="Oestrogenmangel"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<comorbidity>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10027308"/>
<display value="Menopause"/>
</coding>
</concept>
</comorbidity>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="200000003192"/>
<display value="preventive"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ClinicalUseDefinition/IND-10031285"/>
<resource>
<ClinicalUseDefinition>
<id value="IND-10031285"/>
<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-10031285"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition IND-10031285</b></p><a name="IND-10031285"> </a><a name="hcIND-10031285"> </a><a name="IND-10031285-en-US"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Estalis-Transdermalpatch.html">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.
Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,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 10031285}">Osteoporose postmenopausal</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 200000003192}">preventive</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/Estalis-Transdermalpatch"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="https://www.meddra.org"/>
<code value="10031285"/>
<display value="Osteoporose postmenopausal"/>
</coding>
</concept>
</diseaseSymptomProcedure>
<intendedEffect>
<concept>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000003186"/>
<code value="200000003192"/>
<display value="preventive"/>
</coding>
</concept>
</intendedEffect>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/Ingredient/Estradiol-hemihydrate-0.512mg"/>
<resource>
<Ingredient>
<id value="Estradiol-hemihydrate-0.512mg"/>
<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_Estradiol-hemihydrate-0.512mg"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Estradiol-hemihydrate-0.512mg</b></p><a name="Estradiol-hemihydrate-0.512mg"> </a><a name="hcEstradiol-hemihydrate-0.512mg"> </a><a name="Estradiol-hemihydrate-0.512mg-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Estradiolum-Norethisteroni-Transdermalpatch.html">AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li><li><a href="ManufacturedItemDefinition-MI-Estradiolum-Norethisteroni-Transdermalpatch.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li></ul><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 CXY7B3Q98Z}">Estradiol-hemihydrate</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>0.512 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 Patch<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch"/>
</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="CXY7B3Q98Z"/>
<display value="Estradiol-hemihydrate"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="0.512"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Patch"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15036000"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/Ingredient/Norethisteroni-acetas-0.496mg"/>
<resource>
<Ingredient>
<id value="Norethisteroni-acetas-0.496mg"/>
<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_Norethisteroni-acetas-0.496mg"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg</b></p><a name="Norethisteroni-acetas-0.496mg"> </a><a name="hcNorethisteroni-acetas-0.496mg"> </a><a name="Norethisteroni-acetas-0.496mg-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="AdministrableProductDefinition-PhP-Estradiolum-Norethisteroni-Transdermalpatch.html">AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li><li><a href="ManufacturedItemDefinition-MI-Estradiolum-Norethisteroni-Transdermalpatch.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li></ul><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 9S44LIC7OJ}">Norethisterone acetate</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>0.496 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 Patch<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch"/>
</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="9S44LIC7OJ"/>
<display value="Norethisterone acetate"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="0.496"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Patch"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15036000"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
</Bundle>