UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/hl7-eu/unicom-ig and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="015-CopaliaHCT-EE-FullProduct"/>
<type value="transaction"/>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
<resource>
<MedicinalProductDefinition>
<id value="CopaliaHCT-EE-MPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="CopaliaHCT-EE-MPD"> </a></p><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">Resource MedicinalProductDefinition "CopaliaHCT-EE-MPD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLMedicinalProductDefinition.html">PPL Medicinal Product profile</a></p></div><p><b>identifier</b>: id: EE-100010531-3309</p><p><b>domain</b>: Human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-domain-ema-cs.html">Domain EMA</a>#100000000012)</span></p><p><b>status</b>: Provisional <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-recordStatus-ema-cs.html">Record Status EMA SPOR</a>#200000005005)</span></p><p><b>combinedPharmaceuticalDoseForm</b>: Film-coated tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073665)</span></p><p><b>legalStatusOfSupply</b>: Medicinal Product subject to medical prescription <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-legal-status-for-the-supply-ema-cs.html">Legal Status for the Supply EMA</a>#100000072084)</span></p><p><b>classification</b>: valsartan, amlodipine and hydrochlorothiazide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-WC.html">WHO ATC</a>#C09DX01)</span>, valsartan, amlodipine and hydrochlorothiazide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-ATC-Human-EMA.html">ATC Human EMA</a>#100000116213)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: COPALIA HCT 160mg / 12.5mg / 10mg õhukese polümeerikattega tabletid</p><blockquote><p><b>namePart</b></p><p><b>part</b>: COPALIA HCT</p><p><b>type</b>: Invented name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: 160mg / 12.5mg / 10mg</p><p><b>type</b>: Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: õhukese polümeerikattega tabletid</p><p><b>type</b>: Pharmaceutical dose form part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000005)</span></p></blockquote><h3>CountryLanguages</h3><table class="grid"><tr><td>-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td>*</td><td>Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></td><td>Estonian <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-language-ema-cs.html">Language EMA</a>#100000072172)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/fhir/mpId"/>
<value value="EE-100010531-3309"/>
</identifier>
<domain>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005005"/>
<display value="Provisional"/>
</coding>
</status>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072084"/>
<display
value="Medicinal Product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="C09DX01"/>
<display value="valsartan, amlodipine and hydrochlorothiazide"/>
</coding>
</classification>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000116213"/>
<display value="valsartan, amlodipine and hydrochlorothiazide"/>
</coding>
</classification>
<name>
<productName
value="COPALIA HCT 160mg / 12.5mg / 10mg õhukese polümeerikattega tabletid"/>
<namePart>
<part value="COPALIA HCT"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</namePart>
<namePart>
<part value="160mg / 12.5mg / 10mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</namePart>
<namePart>
<part value="õhukese polümeerikattega tabletid"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</namePart>
<countryLanguage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<language>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072057"/>
<code value="100000072172"/>
<display value="Estonian"/>
</coding>
</language>
</countryLanguage>
</name>
</MedicinalProductDefinition>
</resource>
<request>
<method value="PUT"/>
<url value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization/CopaliaHCT-EE-RA"/>
<resource>
<RegulatedAuthorization>
<id value="CopaliaHCT-EE-RA"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: RegulatedAuthorization</b><a name="CopaliaHCT-EE-RA"> </a></p><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">Resource RegulatedAuthorization "CopaliaHCT-EE-RA" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLRegulatedAuthorization.html">PPL Marketing Authorisation profile</a></p></div><p><b>identifier</b>: id: EU/1/09/575</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></p><p><b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000060#220000000061)</span></p><p><b>region</b>: Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></p><p><b>status</b>: Valid <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-regulatoryStatus-ema-cs.html">Regulatory Entitlement Status EMA SPOR</a>#100000072099)</span></p><p><b>statusDate</b>: 2009-11-04</p><p><b>holder</b>: <a href="#Organization_LOC-100010531-NovartisEuropharmLimited">See above (Organization/LOC-100010531-NovartisEuropharmLimited)</a></p></div>
</text>
<identifier>
<value value="EU/1/09/575"/>
</identifier>
<subject>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="100000072099"/>
<display value="Valid"/>
</coding>
</status>
<statusDate value="2009-11-04"/>
<holder>
<reference
value="Organization/LOC-100010531-NovartisEuropharmLimited"/>
</holder>
</RegulatedAuthorization>
</resource>
<request>
<method value="PUT"/>
<url value="RegulatedAuthorization/CopaliaHCT-EE-RA"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization/LOC-100010531-NovartisEuropharmLimited"/>
<resource>
<Organization>
<id value="LOC-100010531-NovartisEuropharmLimited"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="LOC-100010531-NovartisEuropharmLimited"> </a></p><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">Resource Organization "LOC-100010531-NovartisEuropharmLimited" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLOrganization.html">PPL Organization</a></p></div><p><b>identifier</b>: id: LOC-100010531, id: ORG-100007373</p><p><b>name</b>: Novartis Europharm Limited</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100010531"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/organisations"/>
<value value="ORG-100007373"/>
</identifier>
<name value="Novartis Europharm Limited"/>
</Organization>
</resource>
<request>
<method value="PUT"/>
<url value="Organization/LOC-100010531-NovartisEuropharmLimited"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition/CopaliaHCT-EE-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="CopaliaHCT-EE-APD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdministrableProductDefinition</b><a name="CopaliaHCT-EE-APD"> </a></p><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">Resource AdministrableProductDefinition "CopaliaHCT-EE-APD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLAdministrableProductDefinition.html">PPL Administrable Product profile</a></p></div><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></p><p><b>administrableDoseForm</b>: Film-coated tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-unit-of-presentation-ema-cs.html">Unit of Presentation EMA</a>#200000002152)</span></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-routes-and-methods-of-administration-ema-cs.html">Routes and Methods of Administration EMA</a>#100000073619)</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
<request>
<method value="PUT"/>
<url value="AdministrableProductDefinition/CopaliaHCT-EE-APD"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
<resource>
<ManufacturedItemDefinition>
<id value="CopaliaHCT-EE-MID"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="CopaliaHCT-EE-MID"> </a></p><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">Resource ManufacturedItemDefinition "CopaliaHCT-EE-MID" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLManufacturedItemDefinition.html">PPL Manufactured Item profile</a></p></div><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-unit-of-presentation-ema-cs.html">Unit of Presentation EMA</a>#200000002152)</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
<request>
<method value="PUT"/>
<url value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/CopaliaHCT-ingredient1-EE-I"/>
<resource>
<Ingredient>
<id value="CopaliaHCT-ingredient1-EE-I"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="CopaliaHCT-ingredient1-EE-I"> </a></p><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">Resource Ingredient "CopaliaHCT-ingredient1-EE-I" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLIngredient.html">PPL Ingredient profile</a></p></div><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></li><li><a href="#AdministrableProductDefinition_CopaliaHCT-EE-APD">See above (AdministrableProductDefinition/CopaliaHCT-EE-APD)</a></li><li><a href="#ManufacturedItemDefinition_CopaliaHCT-EE-MID">See above (ManufacturedItemDefinition/CopaliaHCT-EE-MID)</a></li></ul><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (100000072050#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Amlodipine besilate <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000090079)</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 13.87 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Amlodipine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000085259)</span></td></tr></table><p><b>strength</b>: 10 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/CopaliaHCT-EE-APD"/>
</for>
<for>
<reference value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000090079"/>
<display value="Amlodipine besilate"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="13.87"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000085259"/>
<display value="Amlodipine"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="10"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
<request>
<method value="PUT"/>
<url value="Ingredient/CopaliaHCT-ingredient1-EE-I"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/CopaliaHCT-ingredient2-EE-I"/>
<resource>
<Ingredient>
<id value="CopaliaHCT-ingredient2-EE-I"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="CopaliaHCT-ingredient2-EE-I"> </a></p><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">Resource Ingredient "CopaliaHCT-ingredient2-EE-I" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLIngredient.html">PPL Ingredient profile</a></p></div><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></li><li><a href="#AdministrableProductDefinition_CopaliaHCT-EE-APD">See above (AdministrableProductDefinition/CopaliaHCT-EE-APD)</a></li><li><a href="#ManufacturedItemDefinition_CopaliaHCT-EE-MID">See above (ManufacturedItemDefinition/CopaliaHCT-EE-MID)</a></li></ul><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (100000072050#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Valsartan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000088000)</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 160 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Valsartan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000088000)</span></td></tr></table><p><b>strength</b>: 160 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/CopaliaHCT-EE-APD"/>
</for>
<for>
<reference value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000088000"/>
<display value="Valsartan"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="160"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000088000"/>
<display value="Valsartan"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="160"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
<request>
<method value="PUT"/>
<url value="Ingredient/CopaliaHCT-ingredient2-EE-I"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/CopaliaHCT-ingredient3-EE-I"/>
<resource>
<Ingredient>
<id value="CopaliaHCT-ingredient3-EE-I"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="CopaliaHCT-ingredient3-EE-I"> </a></p><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">Resource Ingredient "CopaliaHCT-ingredient3-EE-I" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLIngredient.html">PPL Ingredient profile</a></p></div><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></li><li><a href="#AdministrableProductDefinition_CopaliaHCT-EE-APD">See above (AdministrableProductDefinition/CopaliaHCT-EE-APD)</a></li><li><a href="#ManufacturedItemDefinition_CopaliaHCT-EE-MID">See above (ManufacturedItemDefinition/CopaliaHCT-EE-MID)</a></li></ul><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (100000072050#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Hydrochlorothiazide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000091737)</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 12.5 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Hydrochlorothiazide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000091737)</span></td></tr></table><p><b>strength</b>: 12.5 mg<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/1 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/CopaliaHCT-EE-APD"/>
</for>
<for>
<reference value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000091737"/>
<display value="Hydrochlorothiazide"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="12.5"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000091737"/>
<display value="Hydrochlorothiazide"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="12.5"/>
<unit value="mg"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
<request>
<method value="PUT"/>
<url value="Ingredient/CopaliaHCT-ingredient3-EE-I"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/CopaliaHCT-package1-EE-PPD"/>
<resource>
<PackagedProductDefinition>
<id value="CopaliaHCT-package1-EE-PPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="CopaliaHCT-package1-EE-PPD"> </a></p><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">Resource PackagedProductDefinition "CopaliaHCT-package1-EE-PPD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLPackagedProductDefinition.html">PPL Packaged Product profile</a></p></div><p><b>identifier</b>: id: EE-100010531-3310-1448951</p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></p><p><b>statusDate</b>: 2009-11-04</p><p><b>containedItemQuantity</b>: 28 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p><p><b>description</b>: Package of 14</p><h3>MarketingStatuses</h3><table class="grid"><tr><td>-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td>*</td><td>Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></td><td>Not marketed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-Marketing-Status-ema-cs.html">Marketing Status EMA</a>#100000072074)</span></td></tr></table><blockquote><p><b>package</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073498)</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>package</b></p><p><b>type</b>: Blister <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073496)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: PolyVinylidene Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003225)</span>, PolyVinyl Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003222)</span></p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100010531-3310-1448951"/>
</identifier>
<packageFor>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</packageFor>
<statusDate value="2009-11-04"/>
<containedItemQuantity>
<value value="28"/>
<unit value="Tablet"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description value="Package of 14"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072074"/>
<display value="Not marketed"/>
</coding>
</status>
</marketingStatus>
<package>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<package>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003225"/>
<display value="PolyVinylidene Chloride"/>
</coding>
</material>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</reference>
</item>
<amount>
<value value="14"/>
</amount>
</containedItem>
</package>
</package>
</PackagedProductDefinition>
</resource>
<request>
<method value="PUT"/>
<url value="PackagedProductDefinition/CopaliaHCT-package1-EE-PPD"/>
</request>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/CopaliaHCT-package2-EE-PPD"/>
<resource>
<PackagedProductDefinition>
<id value="CopaliaHCT-package2-EE-PPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="CopaliaHCT-package2-EE-PPD"> </a></p><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">Resource PackagedProductDefinition "CopaliaHCT-package2-EE-PPD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLPackagedProductDefinition.html">PPL Packaged Product profile</a></p></div><p><b>identifier</b>: id: EE-100010531-3310-1448962</p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_CopaliaHCT-EE-MPD">See above (MedicinalProductDefinition/CopaliaHCT-EE-MPD)</a></p><p><b>statusDate</b>: 2009-11-04</p><p><b>containedItemQuantity</b>: 28 Tablet<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002152 = 'Tablet')</span></p><p><b>description</b>: Package of 28</p><h3>MarketingStatuses</h3><table class="grid"><tr><td>-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td>*</td><td>Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></td><td>Not marketed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-Marketing-Status-ema-cs.html">Marketing Status EMA</a>#100000072074)</span></td></tr></table><blockquote><p><b>package</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073498)</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>package</b></p><p><b>type</b>: Blister <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073496)</span></p><p><b>quantity</b>: 2</p><p><b>material</b>: PolyVinylidene Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003225)</span>, PolyVinyl Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003222)</span></p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100010531-3310-1448962"/>
</identifier>
<packageFor>
<reference value="MedicinalProductDefinition/CopaliaHCT-EE-MPD"/>
</packageFor>
<statusDate value="2009-11-04"/>
<containedItemQuantity>
<value value="28"/>
<unit value="Tablet"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description value="Package of 28"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072074"/>
<display value="Not marketed"/>
</coding>
</status>
</marketingStatus>
<package>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<package>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="2"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003225"/>
<display value="PolyVinylidene Chloride"/>
</coding>
</material>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/CopaliaHCT-EE-MID"/>
</reference>
</item>
<amount>
<value value="14"/>
</amount>
</containedItem>
</package>
</package>
</PackagedProductDefinition>
</resource>
<request>
<method value="PUT"/>
<url value="PackagedProductDefinition/CopaliaHCT-package2-EE-PPD"/>
</request>
</entry>
</Bundle>
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 4.3.0. Generated 2023-02-03
Links: Table of Contents |
QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
