CH IDMP (R5)
1.0.0-ballot - ballot
CH IDMP (R5)
1.0.0-ballot - ballot
This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
<PackagedProductDefinition xmlns="http://hl7.org/fhir">
<id value="PMP-Comprehensive-Sample-Combipack"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Comprehensive-Sample-Combipack</b></p><a name="PMP-Comprehensive-Sample-Combipack"> </a><a name="hcPMP-Comprehensive-Sample-Combipack"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-packagedproductdefinition.html">PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href="NamingSystem-PCID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Clinical Product Identifier</a>/CH-11111111-1234560010000-0002</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Comprehensive-Sample-Combipack.html">MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic</a></p><p><b>containedItemQuantity</b>: 1 Tube<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15058000 = 'Tube')</span>, 6 Vaginal Tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen</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-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000005}">D: Dispensed following expert advice</span></td></tr></table><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status 756002026002}">Marketed</span></td><td>2020-09-24 --> 2026-12-31</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number</a>/7680612345678</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: 24; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000006}">at room temperature (15 - 25°C)</span></td></tr><tr><td style="display: none">*</td><td> </td><td> </td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000004}">protect from light</span></td></tr><tr><td style="display: none">*</td><td> </td><td> </td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000011}">Store in the original container</span></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073404}">Shelf life after first opening the immediate packaging</span></td><td>No display for Duration (value: 6; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td> </td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 15007000}">Blister</span></p><p><b>quantity</b>: 3</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-MI-Comprehensive-Sample-VaginalPessary.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Pessary; unitOfPresentation = Pessary</a></td></tr></table><p><b>amount</b>: 2 countable unit(s)<span style="background: LightGoldenRodYellow"> (Details: UCUM code1 = '1')</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 15058000}">Tube</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-MI-Comprehensive-Sample-VaginalCream.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube</a></td></tr></table><p><b>amount</b>: 10 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span></p></blockquote></blockquote></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30054000}">Sachet</span></p><p><b>quantity</b>: 1</p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/pcid"/>
<value value="CH-11111111-1234560010000-0002"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Comprehensive-Sample-Combipack"/>
</packageFor>
<containedItemQuantity>
<value value="1"/>
<unit value="Tube"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15058000"/>
</containedItemQuantity>
<containedItemQuantity>
<value value="6"/>
<unit value="Vaginal Tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="15054000"/>
</containedItemQuantity>
<description
value="Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000005"/>
<display value="D: Dispensed following expert advice"/>
</coding>
</code>
</legalStatusOfSupply>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"/>
<code value="756002026002"/>
<display value="Marketed"/>
</coding>
</status>
<dateRange>
<start value="2020-09-24"/>
<end value="2026-12-31"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="https://www.gs1.org/gtin"/>
<value value="7680612345678"/>
</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="24"/>
<unit value="month"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000006"/>
<display value="at room temperature (15 - 25°C)"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000004"/>
<display value="protect from light"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000011"/>
<display value="Store in the original container"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<shelfLifeStorage>
<type>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073404"/>
<display
value="Shelf life after first opening the immediate packaging"/>
</coding>
</type>
<periodDuration>
<value value="6"/>
<unit value="month"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</periodDuration>
</shelfLifeStorage>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15007000"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="3"/>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary"/>
</reference>
</item>
<amount>
<value value="2"/>
<unit value="countable unit(s)"/>
<system value="http://unitsofmeasure.org"/>
<code value="1"/>
</amount>
</containedItem>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="15058000"/>
<display value="Tube"/>
</coding>
</type>
<quantity value="1"/>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream"/>
</reference>
</item>
<amount>
<value value="10"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</amount>
</containedItem>
</packaging>
</packaging>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30054000"/>
<display value="Sachet"/>
</coding>
</type>
<quantity value="1"/>
</packaging>
</packaging>
</PackagedProductDefinition>