-<Bundle xmlns="http://hl7.org/fhir">
 <id value="25859d1f-6710-4622-ac20-716623fe6a6d"/>
-<meta>
 <lastUpdated value="2024-04-18T11:51:07.8627701Z"/>
 </meta>
 <type value="searchset"/>
 <total value="7"/>
-<link>
 <relation value="self"/>
 <url value="https://nprogram.azurewebsites.net/html/MedicinalProductDefinition"/>
 </link>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="SpioInhaler"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2016-05-02T00:00:00Z"/>
 </meta>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/mpId"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/PaediatricUseIndicator  -->
-<pediatricUseIndicator>
-<coding>
 <system value="http://ema.europa.eu/fhir/paediatricUseIndicator"/>
 <code value="Yes"/>
 </coding>
 </pediatricUseIndicator>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/value"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="J01GB01"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2011-09-01"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="SPIO Inhaler 28mg inhalation powder, hard capsules"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="SPIO Inhaler"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<part>
 <part value="28 mg"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000004"/>
 <display value="Strength part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<part>
 <part value="inhalation powder, hard capsules"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000005"/>
 <display value="Pharmaceutical dose form part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
-<extension url="http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator">
-<valueCoding>
 <system value="http://ema.europa.eu/fhir/confidentialityindicator"/>
 <code value="Yes"/>
 </valueCoding>
 </extension>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-organization"/>
 </identifier>
 </organization>
 <!--authorization> <reference value="RegulatedAuthorization/RA-1314TZ-d3e189"/> </authorization -->
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
-<extension url="http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator">
-<valueCoding>
 <system value="http://ema.europa.eu/fhir/confidentialityindicator"/>
 <code value="Yes"/>
 </valueCoding>
 </extension>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Qualitycontroltestingofmedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-organization"/>
 </identifier>
 </organization>
 <!--authorization> <reference value="RegulatedAuthorization/RA-1314TZ-d3e283"/> </authorization -->
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
-<extension url="http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator">
-<valueCoding>
 <system value="http://ema.europa.eu/fhir/confidentialityindicator"/>
 <code value="Yes"/>
 </valueCoding>
 </extension>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Qualitycontroltestingofmedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-organization"/>
 </identifier>
 </organization>
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
-<extension url="http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator">
-<valueCoding>
 <system value="http://ema.europa.eu/fhir/confidentialityindicator"/>
 <code value="Yes"/>
 </valueCoding>
 </extension>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Processingoperationsforthemedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-organization"/>
 </identifier>
 </organization>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="Equilidem"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2017-05-02T00:00:00Z"/>
 </meta>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/MPID"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/WHOAnatomicalTherapeuticChemicalATCClassificationSystem"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2010-05-26"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="Equilidem 2.5 mg film-coated tablets"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="Equilidem"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<part>
 <part value="2.5 mg"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000004"/>
 <display value="Strength part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<part>
 <part value="film-coated tablets"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000005"/>
 <display value="Pharmaceutical dose form part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2013-03-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-organization"/>
 </identifier>
 </organization>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="Injectulin"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2017-11-12T00:00:00Z"/>
 </meta>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/MPID"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/value"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="A10AB01"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2005-11-20"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 <reference value="DocumentReference/Injectulin-d3e5"/>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="Injectulin"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="Injectulin"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-organization"/>
 </identifier>
 </organization>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="SPIOPodhaler-contained"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2016-05-02T00:00:00Z"/>
 </meta>
-<contained>
 <!-- ISO name: /MedicinalProduct/OrphanDesignationStatus  -->
-<RegulatedAuthorization>
 <!-- OrphanDesignationStatus is not specifically handled yet  -->
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e7"/>
-<subject>
 </subject>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/AuthorisationType"/>
 <!-- ISO name: /MedicinalProduct/OrphanDesignationStatus  -->
 <code value="OrphanDesignationStatus-Yes"/>
 </coding>
 </type>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e9"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Identifier  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/identifier"/>
 <value value="{identifier}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/VersionNumber  -->
-<identifier>
 <system value="http://example.com/fhir/documentVersionNumber"/>
 <value value="1"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Type  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/type"/>
 <code value="SmPC"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <date value="2010-07-20T00:00:00Z"/>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/documentLanguage  -->
-<extension url="http://ema.europa.eu/fhir/extension/documentLanguage">
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <valueCode value="EN"/>
 </extension>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Content  -->
-<attachment>
 <!-- Data is a dummy value but should be a base 64 encoding of {example text here}  -->
 <data value="e1BoeXNpY2FsQ2hhcmFjdGVyaXN0aWMuSW1hZ2V9"/>
 </attachment>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/MediaType  -->
 <!--format> <system value="http://ema.europa.eu/fhir/mediaType"/> <code value="PDF"/> </format -->
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e29"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Hypersensitivity"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Hypersensitivity to the active substance and any aminoglycoside or to any of the excipients listed in section 6.1."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e49"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="medicinalproductswithnephrotoxicpotential"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="medicinalproductswithototoxicpotential"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="drug-druginteraction"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Concurrentusenotrecommended"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e63"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="medicinalproductswithnephrotoxicpotential"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="medicinalproductswithototoxicpotential"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="drug-druginteraction"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Sequentialusenotrecommended"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e77"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="diureticcompounds"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="ethacrynicacid"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="furosemide"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="urea"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="intravenousmannitol"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="drug-druginteraction"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Increasedserumandtissueconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Concomitantusenotrecommended"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e100"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="amphotericinB"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="cefalotin"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="tacrolimus"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="polymyxins"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="platinumcompounds"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="WeakInhibitorsofP-gp"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Riskofincreasednephrotoxicity"/>
 </coding>
 </concept>
 </effect>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e121"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="platinumcompounds"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="drug-druginteraction"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="riskofincreasedototoxicity"/>
 </coding>
 </concept>
 </effect>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e134"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="dornasealfa"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="bronchodilators"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="inhaledcorticosteroids"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="macrolides"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="drug-druginteraction"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsIncidence  -->
-<incidence>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsincidence"/>
 <code value="nointeraction"/>
 </coding>
 </incidence>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1314TZ-d3e189"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="1314TZ"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-regulator"/>
 </identifier>
 </regulator>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1314TZ-d3e283"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="1314TZ"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-regulator"/>
 </identifier>
 </regulator>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1314TZ-d3e377"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="1314TZ"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1314TZ-d3e388"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="1314TZ"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="SPIOInhaler28mg-regulator"/>
 </identifier>
 </regulator>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation  -->
-<RegulatedAuthorization>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e446"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationNumber"/>
 <value value="EU/1/10/652/001"/>
 </identifier>
-<subject>
 </subject>
 <!-- ISO name: (fixed value)  -->
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
 <code value="220000000061"/>
 <display value="Marketing Authorisation"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/Country  -->
-<region>
-<coding>
 <system value="http://ema.europa.eu/fhir/country"/>
 <code value="EU"/>
 </coding>
 </region>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/authorisationstatus"/>
 <code value="active"/>
 </coding>
 </status>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatusDate  -->
 <statusDate value="2010-07-20"/>
-<validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/ValidityPeriodStart  -->
 <start value="2010-07-20"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/ValidityPeriodEnd  -->
 <end value="2098-12-31"/>
 </validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation  -->
-<holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG123"/>
 </identifier>
 <display value="King Pharma"/>
 </holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="XYZ"/>
 </identifier>
 <display value="European Medicines Agency"/>
 </regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure  -->
-<case>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/procedureIdentifier-number"/>
 <value value="EMEA/H/C/002155"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationProcedureType"/>
 <code value="EUprocedure-CentralisedProcedure"/>
 </coding>
 </type>
-<datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateStart  -->
 <start value="2009-12-23"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateEnd  -->
 <end value="2011-04-14"/>
 </datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication  -->
-<application>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/applicationIdentifier-number"/>
 <value value="EMEA/H/C/002155/0000"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationApplicationType"/>
 <code value="InitialMarketingauthorisationapplication"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationDate  -->
 <dateDateTime value="2009-12-03"/>
 </application>
 </case>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e646"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileCode  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/filecode"/>
 <value value="MFL1234"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/filetype"/>
 <code value="{filetype}"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation  -->
-<custodian>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ABCDE"/>
 </identifier>
 <display value="Pharmaco"/>
 </custodian>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: (fixed value)  -->
-<attachment>
 <!-- ISO name: (fixed value)  -->
 <url value="http://example"/>
 </attachment>
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct  -->
-<PackagedProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e706"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PCID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/pcId"/>
 <value value="{PCID}"/>
 </identifier>
-<packageFor>
 </packageFor>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageDescription  -->
 <description value="The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters. The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).\nWeekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case."/>
 <!--BatchIdentifier is not supported -->
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Carton"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="Paperboard"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/ShelfLife-Storage  -->
-<shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/ShelfLife-Storage/ShelfLifeType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder"/>
 <code value="ShelfLifeofPackagedMedicinalProduct"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/ShelfLife-Storage/ShelfLifeTimePeriod  -->
-<periodDuration>
 <value value="3"/>
 <unit value="a"/>
 <!--unknown unit -->
 </periodDuration>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/ShelfLife-Storage/SpecialPrecautionsForStorage  -->
-<specialPrecautionsForStorage>
-<coding>
 <system value="http://ema.europa.eu/fhir/specialprecautionsforstorage"/>
 <code value="TOBIPodhalercapsulesmustalwaysbestoredinthe\nblistertoprotectfrommoistureandonlyremovedimmediatelybefore\nuse."/>
 </coding>
 </specialPrecautionsForStorage>
 </shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG5678"/>
 </identifier>
 <display value="Carton Manufaturer A"/>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Devicestoragecase"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="polypropylene"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage  -->
-<shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder"/>
 <code value="Afterfirstuse"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeTimePeriod  -->
-<periodDuration>
 <value value="1"/>
 <unit value="week"/>
 <!--unknown unit -->
 </periodDuration>
 </shelfLifeStorage>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Height"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PhysicalCharacteristics/Height  -->
-<valueQuantity>
 <value value="145"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="ExternalDiameter"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PhysicalCharacteristics/ExternalDiameter  -->
-<valueQuantity>
 <value value="45"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device  -->
-<item>
-<reference>
 </reference>
 </item>
 </containedItem>
 </packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Blister"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="7"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PVC/PA/Alu/PVC"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PET/Alu"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG975"/>
 </identifier>
 <display value="Blister Manufaturer A"/>
 </manufacturer>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Height"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PhysicalCharacteristics/Height  -->
-<valueQuantity>
 <value value="195"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<item>
-<reference>
 </reference>
 </item>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedItemQuantity  -->
-<amount>
 <value value="8"/>
 <unit value="units/blister"/>
 </amount>
 </containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/ComponentType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/componenttype"/>
 <code value="FormingFoil"/>
 </coding>
 </type>
 <!-- Add implied quantity of 1 to ISO Package_Component  -->
 <!-- ISO name: (fixed value)  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/ComponentMaterial  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PVC/PA/AL/PVC"/>
 </coding>
 </material>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Colour"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/PhysicalCharacteristics/Colour  -->
-<valueCodeableConcept>
 <text value="colorless"/>
 </valueCodeableConcept>
 </property>
 </packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/ComponentType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/componenttype"/>
 <code value="Liddingfoil"/>
 </coding>
 </type>
 <!-- Add implied quantity of 1 to ISO Package_Component  -->
 <!-- ISO name: (fixed value)  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/ComponentMaterial  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PET/AL"/>
 </coding>
 </material>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Colour"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component/PhysicalCharacteristics/Colour  -->
-<valueCodeableConcept>
 <text value="White"/>
 </valueCodeableConcept>
 </property>
 </packaging>
 </packaging>
 </packaging>
 </PackagedProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-NAYRTOB464-d3e764"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="NAYRTOB464"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2011-05-05"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device  -->
-<DeviceDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e782"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceTradeName  -->
-<deviceName>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceTradeName  -->
 <name value="C-999 Inhaler"/>
 <!-- ISO name: (fixed value)  -->
 <type value="registered-name"/>
 </deviceName>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceType  -->
-<classification>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/deviceType"/>
 <code value="Single-dosedrypowderinhaler"/>
 </coding>
 </type>
 </classification>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceUsage  -->
-<safety>
-<coding>
 <system value="http://ema.europa.eu/fhir/deviceusage"/>
 <code value="7days"/>
 </coding>
 </safety>
 <!-- Device PhysicalCharacteristics not supported (because they are different from other package ones and code gets messy. Plan is to change DeviceDefinition resource.)  -->
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/OtherCharacteristics/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<property>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/OtherCharacteristics/Value  -->
-<type>
-<coding>
 <code value="valueOID"/>
 </coding>
 </type>
-<valueCodeableConcept>
-<coding>
 <code value="Class1"/>
 </coding>
 </valueCodeableConcept>
 </property>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceMaterial  -->
-<material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceMaterial/Substance  -->
-<substance>
-<coding>
 <system value="http://ema.europa.eu/fhir/deviceMaterial"/>
 <code value="polypropylene"/>
 </coding>
 </substance>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceMaterial  -->
-<material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceMaterial/Substance  -->
-<substance>
-<coding>
 <system value="http://ema.europa.eu/fhir/deviceMaterial"/>
 <code value="machinedstainlesssteel"/>
 </coding>
 </substance>
 </material>
 </DeviceDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<ManufacturedItemDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e849"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedDoseForm  -->
-<manufacturedDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufactureddoseform"/>
 <code value="Inhalationpowder,hardcapsule"/>
 </coding>
 </manufacturedDoseForm>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/UnitOfPresentation  -->
-<unitOfPresentation>
-<coding>
 <system value="http://ema.europa.eu/fhir/unitofpresentation"/>
 <code value="Capsule"/>
 </coding>
 </unitOfPresentation>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
 <!--ingredient> <reference> <reference value="Ingredient/SPIOInhaler28mg-d3e984"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/SPIOInhaler28mg-d3e1042"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/SPIOInhaler28mg-d3e1062"/> </reference> </ingredient -->
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Weight"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Weight  -->
-<valueQuantity>
 <value value="109.5"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Colour"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Colour  -->
-<valueCodeableConcept>
 <text value="White to almost white"/>
 </valueCodeableConcept>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Colour"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Colour  -->
-<valueCodeableConcept>
 <text value="Clear"/>
 </valueCodeableConcept>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Imprint"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Imprint  -->
-<valueCodeableConcept>
 <text value="NVR AVCI"/>
 </valueCodeableConcept>
 </property>
 </ManufacturedItemDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e857"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveMoiety"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG9999"/>
 </identifier>
 <display value="Company 1"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG11111"/>
 </identifier>
 <display value="Company 2"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="LOCRAMYCIN"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="28"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="capsule"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e890"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2012-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e901"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2012-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e938"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e949"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e960"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e984"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG22222"/>
 </identifier>
 <display value="Company EXCIPIENT 1"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="1,2-distearoyl-sn-glycero-3-phosphocholine"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="6.5"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="capsule"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-KDVSODJS5674-d3e1017"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="KDVSODJS5674"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2012-05-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1042"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="calciumchloride"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="0.5"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="capsule"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1062"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="sulfuricacid"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="10"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="capsule"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-BLI48676-d3e1130"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="BLI48676"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2011-05-05"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct  -->
-<AdministrableProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1181"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/PhPIDSet/PhPIDIdentifierSets  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/phpIdIdentifiersets"/>
 <value value="{PhPID}"/>
 </identifier>
 <status value="active"/>
-<formOf>
 </formOf>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/AdministrableDoseForm  -->
-<administrableDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/administrabledoseform"/>
 <code value="Inhalationpowder,hardcapsule"/>
 </coding>
 </administrableDoseForm>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
 <!--ingredient> <reference value="Ingredient/SPIOInhaler28mg-d3e1185"/> </ingredient -->
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration  -->
-<routeOfAdministration>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration/RouteOfAdministration  -->
-<code>
-<coding>
 <system value="http://ema.europa.eu/fhir/routeofadministration"/>
 <code value="InhalationUse"/>
 </coding>
 </code>
 </routeOfAdministration>
 </AdministrableProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1185"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveMoiety"/>
 </coding>
 </role>
-<substance>
-<code>
-<concept>
 <text value="unknown"/>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1229"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="InfectionPseudomonasaeruginosa"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="SPIO Inhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/DiseaseStatus  -->
-<diseaseStatus>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/diseasestatus"/>
 <code value="chronic"/>
 </coding>
 </concept>
 </diseaseStatus>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="cysticfibrosis"/>
 </coding>
 </concept>
 </comorbidity>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/intendedEffect"/>
 <code value="suppresivetherapy"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1255"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Hearingloss"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Earandlabyrinthdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1267"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Tinnitus"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Earandlabyrinthdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1279"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Haemoptysis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Vasculardisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1291"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Epistaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Vasculardisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1303"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Dyspnoea"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1316"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Dysphonia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1328"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Productivecough"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1340"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Cough"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1352"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Wheezing"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1364"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Rales"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1376"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Chestdiscomfort"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1389"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Nasalcongestion"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1401"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Bronchospasm"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1413"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Aphonia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1425"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Sputumdiscoloured"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Notknown"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1437"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Oropharnygealpain"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1449"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Vomiting"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1462"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Diarrhoea"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1474"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Throatirritation"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1486"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Nausea"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1498"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Dysgeusia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1510"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Rash"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Skinandsubcutaneoustissuedisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1522"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Musculoskeletalchestpain"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Musculoskeletal,connectivetissueandbonedisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1535"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Pyrexia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Generaldisordersandadministrationsiteconditions"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Verycommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1547"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Malaise"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="The most commonly reported adverse reactions in the main safety, active-controlled clinical study with SPIO Inhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.\nIn the placebo-controlled study with SPIO Inhaler, the adverse reactions for which reported frequency was higher with SPIO Inhaler than with placebo were pharyngolaryngeal pain, dysgeusia and dysphonia.\nThe vast majority of adverse reactions reported with SPIO Inhaler were mild or moderate, and severity did not appear to differ between cycles or between the entire study and on-treatment periods."/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Generaldisordersandadministrationsiteconditions"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Notknown"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/mpId"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/PaediatricUseIndicator  -->
-<pediatricUseIndicator>
-<coding>
 <system value="http://ema.europa.eu/fhir/paediatricUseIndicator"/>
 <code value="Yes"/>
 </coding>
 </pediatricUseIndicator>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/value"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="J01GB01"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2011-09-01"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="SPIO Inhaler 28mg inhalation powder, hard capsules"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="SPIO Inhaler"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<part>
 <part value="28 mg"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000004"/>
 <display value="Strength part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<part>
 <part value="inhalation powder, hard capsules"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000005"/>
 <display value="Pharmaceutical dose form part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG5678"/>
 </identifier>
 <display value="Spiopharm GmbH"/>
 </organization>
-<confidentialityIndicator>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/200000004983"/>
 <code value="Yes"/>
 </coding>
 </confidentialityIndicator>
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Qualitycontroltestingofmedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG7438"/>
 </identifier>
 <display value="XP Sciences"/>
 </organization>
-<confidentialityIndicator>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/200000004983"/>
 <code value="Yes"/>
 </coding>
 </confidentialityIndicator>
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Qualitycontroltestingofmedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG356457"/>
 </identifier>
 <display value="Health LTD"/>
 </organization>
-<confidentialityIndicator>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/200000004983"/>
 <code value="Yes"/>
 </coding>
 </confidentialityIndicator>
 </operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator  -->
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Processingoperationsforthemedicinalproduct"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG356457"/>
 </identifier>
 <display value="Health LTD"/>
 </organization>
-<confidentialityIndicator>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/200000004983"/>
 <code value="Yes"/>
 </coding>
 </confidentialityIndicator>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="Equilidem-contained"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2017-05-02T00:00:00Z"/>
 </meta>
-<contained>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e5"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v2/documents"/>
 <value value="{identifier}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/VersionNumber  -->
-<identifier>
 <system value="http://example.com/fhir/documentVersionNumber"/>
 <value value="2"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Type  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/type"/>
 <code value="SmPC"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <date value="2015-03-15T00:00:00Z"/>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/documentLanguage  -->
-<extension url="http://ema.europa.eu/fhir/extension/documentLanguage">
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <valueCode value="EN"/>
 </extension>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Content  -->
-<attachment>
 <!-- Data is a dummy value but should be a base 64 encoding of {example text here}  -->
 <data value="e1BoeXNpY2FsQ2hhcmFjdGVyaXN0aWMuSW1hZ2V9"/>
 </attachment>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/MediaType  -->
 <!--format> <system value="http://ema.europa.eu/fhir/mediaType"/> <code value="PDF"/> </format -->
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e25"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Hypersensitivity"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Hypersensitivity to the active substance or to any of the excipients listed in section 6.1."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e37"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Bleeding"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Active clinically significant bleeding."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e45"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see\nsection 5.2)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/Contraindication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="Hepaticdisease"/>
 </coding>
 </concept>
 </comorbidity>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e56"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Gastriculcer"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include \ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e64"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Intestinalulceration"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e72"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Neoplasmmalignant"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e80"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Braininjury"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e88"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Spinalcordinjury"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e96"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Brainoperation"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e105"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Spinaloperation"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e113"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Eyeoperation"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e121"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Hemorrhageintracranial"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e129"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Oesophagealvarices"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e137"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Arteriovenousmalformations"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e145"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Vascularaneurysms"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e154"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Spinalvasculardisorder"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e162"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Vascularmalformationcerebral"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Lesion or condition if considered a significant risk factor for major bleeding. This may include\ncurrent or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of\nbleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent\nintracranial haemorrhage, known or suspected oesophageal varices, arteriovenous\nmalformations, vascular aneurysms or major intraspinal or intracerebral vascular\nabnormalities."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e170"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH),\nlow molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives\n(fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under\nspecific circumstances of switching anticoagulant therapy (see section 4.2) or when UFH is\ngiven at doses necessary to maintain an open central venous or arterial catheter (see\nsection 4.5)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="Unfractionatedheparin(UFH)"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="Lowmolecularweightheparins"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="enoxaparin"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="dalteparin"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="Heparinderivatives"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="fondaparinux"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="Oralanticoagulants"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="warfarin"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="rivaroxaban"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics  -->
-<otherTherapy>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/TherapyRelationshipType  -->
-<relationshipType>
-<coding>
 <system value="http://ema.europa.eu/fhir/therapyrelationshiptype"/>
 <code value="Co-therapy(with)"/>
 </coding>
 </relationshipType>
 <!-- ISO name: /MedicinalProduct/Contraindication/OtherTherapySpecifics/Medication  -->
-<treatment>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/medication"/>
 <code value="dabigatran"/>
 </coding>
 </concept>
 </treatment>
 </otherTherapy>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e254"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="ketoconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="itraconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="voriconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="posaconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="ritonavir"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="StrongInhibitorofCYP3A4"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Increasedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e277"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="ketoconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="itraconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="voriconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="posaconazole"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="ritonavir"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="StrongInhibitorofP-gp"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Increasedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e301"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="diltiazem"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="verapamil"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="ModerateInhibitorsofCYP3A4"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Increasedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentisrequired"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e318"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="naproxen"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="amiodarone"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="quinidine"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="WeakInhibitorsofP-gp"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Increasedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentisrequired"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e337"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="rifampicin"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="phenytoin"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="carbamazepine"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="phenobarbital"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="St.John’sWort"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="InducersofCYP3A4"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Reducedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentforequixabanisrequiredduringconcomitanttherapywithsuchmedicinalproducts,howeverinpatientsreceivingconcomitantsystemictreatmentwithstronginducersofbothCYP3A4andP-gpequixabanshouldbeusedwithcautionforthepreventionofstrokeandsystemicembolisminpatientswithNVAFandforthepreventionofrecurrentDVTandPE.equixabanisnotrecommendedforthetreatmentofDVTandPEinpatientsreceivingconcomitantsystemictreatmentwithstronginducersofbothCYP3A4andP-gpsinceefficacymaybecompromised"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e364"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="rifampicin"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="phenytoin"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="carbamazepine"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="phenobarbital"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="St.John’sWort"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="InducersofP-gp"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Reducedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentforequixabanisrequiredduringconcomitanttherapywithsuchmedicinalproducts,howeverinpatientsreceivingconcomitantsystemictreatmentwithstronginducersofbothCYP3A4andP-gpequixabanshouldbeusedwithcautionforthepreventionofstrokeandsystemicembolisminpatientswithNVAFandforthepreventionofrecurrentDVTandPE.equixabanisnotrecommendedforthetreatmentofDVTandPEinpatientsreceivingconcomitantsystemictreatmentwithstronginducersofbothCYP3A4andP-gpsinceefficacymaybecompromised"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e387"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="atenolol"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="Other"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Reducedplasmaconcentrations"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentrequired"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e401"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="famotidine"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionsType"/>
 <code value="Other"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Noeffect"/>
 </coding>
 </concept>
 </effect>
 <!-- ISO name: /MedicinalProduct/Interactions/ManagementActions  -->
-<management>
-<coding>
 <system value="http://ema.europa.eu/fhir/managementactions"/>
 <code value="Nodoseadjustmentrequired"/>
 </coding>
 </management>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e416"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<interaction>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/Interactant  -->
-<itemCodeableConcept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactant"/>
 <code value="Activatedcharcoal"/>
 </coding>
 </itemCodeableConcept>
 </interactant>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsEffect  -->
-<effect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/interactionseffect"/>
 <code value="Reducesdrugexposure"/>
 </coding>
 </concept>
 </effect>
 </interaction>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1324TZ-d3e472"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingAuthorisationReferenceNumber"/>
 <value value="1324TZ"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-03-15"/>
 </validityPeriod>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="21430513"/>
 </identifier>
 <display value="Regulator B"/>
 </regulator>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation  -->
-<RegulatedAuthorization>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e520"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
 <value value="EU/1/11/999/001"/>
 </identifier>
-<subject>
 </subject>
 <!-- ISO name: (fixed value)  -->
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
 <code value="220000000061"/>
 <display value="Marketing Authorisation"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/Country  -->
-<region>
-<coding>
 <system value="http://ema.europa.eu/fhir/country"/>
 <code value="EU"/>
 </coding>
 </region>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/authorisationstatus"/>
 <code value="active"/>
 </coding>
 </status>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatusDate  -->
 <statusDate value="2015-01-14"/>
-<validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/ValidityPeriodStart  -->
 <start value="2015-08-16"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/ValidityPeriodEnd  -->
 <end value="2020-05-20"/>
 </validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation  -->
-<holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG5340"/>
 </identifier>
 <display value="EQUILIPHARM"/>
 </holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="XYZ"/>
 </identifier>
 <display value="European Medicines Agency"/>
 </regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure  -->
-<case>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/procedureIdentifier-number"/>
 <value value="EMEA/H/C/009999/IA/0099/G"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationProcedureType"/>
 <code value="VariationTypeIA"/>
 </coding>
 </type>
-<datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateStart  -->
 <start value="2015-08-02"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateEnd  -->
 <end value="2015-08-21"/>
 </datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication  -->
-<application>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/applicationIdentifier-number"/>
 <value value="IA38G"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationApplicationType"/>
 <code value="GroupTypeIAVariationNotification"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationDate  -->
 <dateDateTime value="2015-08-01"/>
 </application>
 </case>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation  -->
-<RegulatedAuthorization>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e548"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation/MarketingAuthorisationNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
 <value value="123-456-789"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation/Country  -->
-<region>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="NO"/>
 </coding>
 </region>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation  -->
-<RegulatedAuthorization>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e555"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation/MarketingAuthorisationNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
 <value value="123-456-123"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/JurisdictionalMarketingAuthorisation/Country  -->
-<region>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="NO"/>
 </coding>
 </region>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e690"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileCode  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/masterFileIdentifier"/>
 <value value="MFL1234"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/masterFileType"/>
 <code value="{filetype}"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation  -->
-<custodian>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ABCDE"/>
 </identifier>
 <display value="Bristol-Myers Squibb"/>
 </custodian>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: (fixed value)  -->
-<attachment>
 <!-- ISO name: (fixed value)  -->
 <url value="http://example"/>
 </attachment>
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct  -->
-<PackagedProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e760"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PCID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/pcId"/>
 <value value="{PCID}"/>
 </identifier>
-<packageFor>
 </packageFor>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageDescription  -->
 <description value="ALU-PVC/PVDC BLISTERS. CARTONS OF 10 FILM-COATED TABLETS. "/>
 <!--BatchIdentifier is not supported -->
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Carton"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PVC"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="PVDC"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="alu"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG5678"/>
 </identifier>
 <display value="Carton Manufaturer A"/>
 </manufacturer>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Height"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PhysicalCharacteristics/Height  -->
-<valueQuantity>
 <value value="50"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Width"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PhysicalCharacteristics/Width  -->
-<valueQuantity>
 <value value="136"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Depth"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PhysicalCharacteristics/Depth  -->
-<valueQuantity>
 <value value="23.5"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Blister"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="Paperboard"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage  -->
-<shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder"/>
 <code value="ShelfLifeofPackagedMedicinalProduct"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeTimePeriod  -->
-<periodDuration>
 <value value="3"/>
 <unit value="a"/>
 <!--unknown unit -->
 </periodDuration>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/SpecialPrecautionsForStorage  -->
-<specialPrecautionsForStorage>
-<coding>
 <system value="http://ema.europa.eu/fhir/specialprecautionsforstorage"/>
 <code value="Thismedicinalproductdoesnotrequireanyspecialstoragecondition."/>
 </coding>
 </specialPrecautionsForStorage>
 </shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-manufacturer"/>
 </identifier>
 </manufacturer>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Height"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PhysicalCharacteristics/Height  -->
-<valueQuantity>
 <value value="125"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Width"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PhysicalCharacteristics/Width  -->
-<valueQuantity>
 <value value="45"/>
 <unit value="mm"/>
 <!--unknown unit -->
 </valueQuantity>
 </property>
-<containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<item>
-<reference>
 </reference>
 </item>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedItemQuantity  -->
-<amount>
 <value value="10"/>
 </amount>
 </containedItem>
 </packaging>
 </packaging>
 </PackagedProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-NAYRTOB464-d3e836"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="NAYRTOB464"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2010-05-05"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<ManufacturedItemDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e859"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedDoseForm  -->
-<manufacturedDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufactureddoseform"/>
 <code value="Film-coatedtablet"/>
 </coding>
 </manufacturedDoseForm>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/UnitOfPresentation  -->
-<unitOfPresentation>
-<coding>
 <system value="http://ema.europa.eu/fhir/unitofpresentation"/>
 <code value="Tablet"/>
 </coding>
 </unitOfPresentation>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG45830"/>
 </identifier>
 <display value="Company HHHH"/>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
 <!--ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e867"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1041"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1123"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1154"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1194"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1225"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1256"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1281"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1322"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1347"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Equilidem2-5mg-d3e1372"/> </reference> </ingredient -->
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Shape"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Shape  -->
-<valueCodeableConcept>
 <text value="Oval"/>
 </valueCodeableConcept>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Colour"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Colour  -->
-<valueCodeableConcept>
 <text value="Pink"/>
 </valueCodeableConcept>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Imprint"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Imprint  -->
-<valueCodeableConcept>
 <text value="894"/>
 </valueCodeableConcept>
 </property>
-<property>
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/physicalCharacteristicType"/>
 <code value="Imprint"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/PhysicalCharacteristics/Imprint  -->
-<valueCodeableConcept>
 <text value="5"/>
 </valueCodeableConcept>
 </property>
 </ManufacturedItemDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e867"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveBase"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG9999"/>
 </identifier>
 <display value="Company equixaban 1"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG11111"/>
 </identifier>
 <display value="Company equixaban 2"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="EQUIXABAN"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2.5"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e908"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2011-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e919"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2011-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e966"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e977"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e988"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2013-01-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1041"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG22222"/>
 </identifier>
 <display value="Company EXCIPIENT 1"/>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="METHYLHYDROXYPROPYLCELLULOSE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="37.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="37.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-KDVSODJS5674-d3e1082"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="KDVSODJS5674"/>
 </identifier>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/authorisationTypeExample"/>
 <code value="220000000099"/>
 <display value="Manufacturing Authorisation"/>
 </coding>
 </type>
-<validityPeriod>
 <start value="2012-05-01"/>
 </validityPeriod>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1123"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
 <status value="active"/>
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
 <code value="FRIACEPTIN"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="8.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="8.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1154"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="CROSCARMELLOSESODIUM"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="extragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1194"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="LACTOSEMONOHYDRATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="31.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="31.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1225"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="TITANIUMDIOXIDE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="20.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="20.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1256"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="MICROCRYSTALLINECELLULOSE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="41"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1281"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="MAGNESIUMSTEARATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="0.50"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="0.75"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="extragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1322"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="LACTOSEANHYDROUS"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="50.25"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1347"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="SODIUMLAURYLSULFATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="1"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1372"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Colour"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="IRONOXIDEYELLOW(E172)"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="4.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="4.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-AASDVD35092-d3e1445"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="AASDVD35092"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-AASDVD35092-d3e1456"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="AASDVD35092"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-IHSSGH435-d3e1529"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="IHSSGH435"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct  -->
-<AdministrableProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1567"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/PhPIDSet/PhPIDIdentifierSets  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/phpididentifiersets"/>
 <value value="{PhPID}"/>
 </identifier>
 <status value="active"/>
-<formOf>
 </formOf>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/AdministrableDoseForm  -->
-<administrableDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/administrabledoseform"/>
 <code value="Film-coatedtablet"/>
 </coding>
 </administrableDoseForm>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/UnitOfPresentation  -->
-<unitOfPresentation>
-<coding>
 <system value="http://ema.europa.eu/fhir/unitofpresentation"/>
 <code value="Tablet"/>
 </coding>
 </unitOfPresentation>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
 <!--ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1590"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1764"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1843"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1874"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1914"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1945"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e1977"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e2002"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e2042"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e2067"/> </ingredient> <ingredient> <reference value="Ingredient/Equilidem2-5mg-d3e2092"/> </ingredient -->
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration  -->
-<routeOfAdministration>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration/RouteOfAdministration  -->
-<code>
-<coding>
 <system value="http://ema.europa.eu/fhir/routeofadministration"/>
 <code value="OralUse"/>
 </coding>
 </code>
 </routeOfAdministration>
 </AdministrableProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1590"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveBase"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-manufacturer"/>
 </identifier>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-manufacturer"/>
 </identifier>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="Equixaban"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2.5"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e1631"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e1642"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e1689"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e1700"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD504896-d3e1711"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD504896"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1764"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-manufacturer"/>
 </identifier>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="METHYLHYDROXYPROPYLCELLULOSE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="37.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="37.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-KDVSODJS5674-d3e1805"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="KDVSODJS5674"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1843"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="FRIACEPTIN"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="8.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="8.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1874"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="CROSCARMELLOSESODIUM"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="2"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="extragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1914"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="LACTOSEMONOHYDRATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="31.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="31.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1945"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="TITANIUMDIOXIDE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="20.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="20.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e1977"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="MICROCRYSTALLINECELLULOSE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="41"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2002"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="MAGNESIUMSTEARATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="0.50"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="0.75"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="extragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2042"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="LACTOSEANHYDROUS"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="50.25"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2067"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="SODIUMLAURYLSULFATE"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="1"/>
 <unit value="mg"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="{tablet}"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/MeasurementPoint  -->
 <measurementPoint value="intragranular"/>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2092"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Colour"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="IRONOXIDEYELLOW(E172)"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="4.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="4.00"/>
 <unit value="1"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="100"/>
 <unit value="1"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2144"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Venousthromboembolismprophylaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="Hipsurgery"/>
 </coding>
 </concept>
 </comorbidity>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="PRYLX"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2164"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Venousthromboembolismprophylaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="KneesurgeryNOS"/>
 </coding>
 </concept>
 </comorbidity>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="PRYLX"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2185"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Stroke"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="Atrialfibrillation"/>
 </coding>
 </concept>
 </comorbidity>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="PRYLX"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2256"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Deepveinthrombosis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="TREAT"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2273"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Pulmonaryembolismandthrombosis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="TREAT"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2290"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Deepveinthrombosis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/DiseaseStatus  -->
-<diseaseStatus>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/diseasestatus"/>
 <code value="Recurrent"/>
 </coding>
 </concept>
 </diseaseStatus>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="PRYLX"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2310"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Pulmonaryembolismandthrombosis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/DiseaseStatus  -->
-<diseaseStatus>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/diseasestatus"/>
 <code value="Recurrent"/>
 </coding>
 </concept>
 </diseaseStatus>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IntendedEffect  -->
-<intendedEffect>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/intendedeffect"/>
 <code value="PRYLX"/>
 </coding>
 </concept>
 </intendedEffect>
 </indication>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics  -->
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2330"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Anaemia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Bloodandlymphaticsystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2344"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Thrombocytopenia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Bloodandlymphaticsystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2357"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Hypersensitivity,allergicoedemaand\nAnaphylaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Immunesystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2370"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Hypersensitivity,allergicoedemaand\nAnaphylaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Immunesystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2385"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Pruritus"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Immunesystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2398"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Eyehaemorrhage(including\nconjunctivalhaemorrhage)"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Eyedisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2411"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Haemorrhage,haematoma"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Vasculardisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2425"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Hypotension(includingprocedural\nhypotension)"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Vasculardisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2438"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Epistaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2451"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Haemoptysis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Respiratory,thoracicandmediastinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2464"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Nausea"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2477"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Gastrointestinalhaemorrhage"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2490"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Haematochezia"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2504"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Rectalhaemorrhage,gingivalbleeding"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Gastrointestinaldisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2517"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2524"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Transaminasesincreased,aspartate\naminotransferaseincreased,gammaglutamyltransferase\nincreased,liver\nfunctiontestabnormal,bloodalkaline\nphosphataseincreased,bloodbilirubin\nincreased"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Hepatobiliarydisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2537"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Musclehaemorrhage"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Musculoskeletalandconnectivetissuedisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2550"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Haematuria"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Renalandurinarydisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2563"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Contusion"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Injury,poisoningandproceduralcomplications"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2577"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Postproceduralhaemorrhage(including\npostproceduralhaematoma,wound\nhaemorrhage,vesselpuncturesite\nhaematomaandcathetersite\nhaemorrhage),woundsecretion,\nincisionsitehaemorrhage(including\nincisionsitehaematoma),operative\nhaemorrhage"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Injury,poisoningandproceduralcomplications"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2590"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Hypersensitivity,allergicoedemaand\nAnaphylaxis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nstroke and\nsystemic\nembolism in adult\npatients with\nNVAF, with one\nor more risk\nfactors (NVAF)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Immunesystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2603"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Pruritus"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Treatment of\nDVT and PE,\nand prevention\nof recurrent\nDVT and PE\n(VTEt)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Immunesystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2616"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Brainhaemorrhage"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Treatment of\nDVT and PE,\nand prevention\nof recurrent\nDVT and PE\n(VTEt)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Nervoussystemdisorders"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Rare"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2629"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Eyedisorders"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Treatment of\nDVT and PE,\nand prevention\nof recurrent\nDVT and PE\n(VTEt)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Eyehaemorrhage(including\nconjunctivalhaemorrhage)"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Uncommon"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Equilidem2-5mg-d3e2642"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<undesirableEffect>
 <!-- ISO name: (fixed value)  -->
-<symptomConditionEffect>
-<concept>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectAsSymptom-Condition-Effect  -->
-<coding>
 <system value="http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect"/>
 <code value="Eyedisorders"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/UndesirableEffectText  -->
 <text value="Prevention of\nstroke and\nsystemic\nembolism in adult\npatients with\nNVAF, with one\nor more risk\nfactors (NVAF)"/>
 </concept>
 </symptomConditionEffect>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/Symptom-Condition-EffectClassification  -->
-<classification>
-<coding>
 <system value="http://ema.europa.eu/fhir/symptom-condition-effectclassification"/>
 <code value="Eyehaemorrhage(including\nconjunctivalhaemorrhage)"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects/FrequencyOfOccurrence  -->
-<frequencyOfOccurrence>
-<coding>
 <system value="http://ema.europa.eu/fhir/frequencyofoccurrence"/>
 <code value="Common"/>
 </coding>
 </frequencyOfOccurrence>
 </undesirableEffect>
 </ClinicalUseDefinition>
 </contained>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/MPID"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/WHOAnatomicalTherapeuticChemicalATCClassificationSystem"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2010-05-26"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="Equilidem 2.5 mg film-coated tablets"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="Equilidem"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<part>
 <part value="2.5 mg"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000004"/>
 <display value="Strength part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<part>
 <part value="film-coated tablets"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000005"/>
 <display value="Pharmaceutical dose form part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2013-03-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Equilidem2-5mg-organization"/>
 </identifier>
 </organization>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <!-- ISO name: /MedicinalProduct  -->
 <id value="Injectulin-contained"/>
 <!-- ISO name: /MedicinalProduct/Header  -->
-<meta>
 <!-- ISO name: /MedicinalProduct/Header/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <lastUpdated value="2017-11-12T00:00:00Z"/>
 </meta>
-<contained>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e5"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Identifier  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/identifier"/>
 <value value="{identifier}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/VersionNumber  -->
-<identifier>
 <system value="http://example.com/fhir/documentVersionNumber"/>
 <value value="3"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Type  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/type"/>
 <code value="SmPC"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/EffectiveDate  -->
 <!-- FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z  -->
 <date value="2016-05-17T00:00:00Z"/>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <!-- FHIR extension: http://ema.europa.eu/fhir/extension/documentLanguage  -->
-<extension url="http://ema.europa.eu/fhir/extension/documentLanguage">
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Language  -->
 <valueCode value="EN"/>
 </extension>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/Content  -->
-<attachment>
 <!-- Data is a dummy value but should be a base 64 encoding of {example text here}  -->
 <data value="e1BoeXNpY2FsQ2hhcmFjdGVyaXN0aWMuSW1hZ2V9"/>
 </attachment>
 <!-- ISO name: /MedicinalProduct/AttachedDocument/MediaType  -->
 <!--format> <system value="http://ema.europa.eu/fhir/mediaType"/> <code value="PDF"/> </format -->
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e25"/>
 <type value="contraindication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Contraindication  -->
-<contraindication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure"/>
 <code value="Hypersensitivity"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/Contraindication/ContraindicationsText  -->
 <text value="Hypersensitivity to the active substance or to any of the excipients listed in section 6.1."/>
 </concept>
 </diseaseSymptomProcedure>
 </contraindication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-1314TZ-d3e94"/>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="1314TZ"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-regulator"/>
 </identifier>
 </regulator>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation  -->
-<RegulatedAuthorization>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e142"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationNumber"/>
 <value value="EU/1/97/030/197"/>
 </identifier>
-<subject>
 </subject>
 <!-- ISO name: (fixed value)  -->
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
 <code value="220000000061"/>
 <display value="Marketing Authorisation"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/Country  -->
-<region>
-<coding>
 <system value="http://ema.europa.eu/fhir/country"/>
 <code value="EU"/>
 </coding>
 </region>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/authorisationstatus"/>
 <code value="Valid-VariedMarketingAuthorisation"/>
 </coding>
 </status>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/AuthorisationStatusDate  -->
 <statusDate value="2007-02-21"/>
-<validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/ValidityPeriodStart  -->
 <start value="2007-02-22"/>
 </validityPeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation  -->
-<holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-holder"/>
 </identifier>
 </holder>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation  -->
-<regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MedicinesRegulatoryAgency_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-regulator"/>
 </identifier>
 </regulator>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure  -->
-<case>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/procedureidentifier-number"/>
 <value value="EMEA/H/C/000901"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationProcedureType"/>
 <code value="EUauthorisationprocedures-CentralisedProcedure"/>
 </coding>
 </type>
-<datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateStart  -->
 <start value="1995-12-06"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/ProcedureDateEnd  -->
 <end value="1996-03-29"/>
 </datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication  -->
-<application>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationIdentifier-Number  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/applicationidentifier-number"/>
 <value value="IA38G"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingAuthorisationApplicationType"/>
 <code value="TypeIAVariationNotification"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/MarketingAuthorisationProcedure/MarketingAuthorisationApplication/ApplicationDate  -->
 <dateDateTime value="2016-11-29"/>
 </application>
 </case>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<DocumentReference>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e300"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileCode  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/filecode"/>
 <value value="MFL9360"/>
 </identifier>
 <!-- ISO name: (fixed value)  -->
 <status value="current"/>
 <!-- ISO name: /MedicinalProduct/MasterFile/FileType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/filetype"/>
 <code value="{filetype}"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation  -->
-<custodian>
 <!-- ISO name: /MedicinalProduct/MasterFile/MasterFileHolder_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-custodian"/>
 </identifier>
 </custodian>
 <!-- ISO name: (fixed value)  -->
-<content>
 <!-- ISO name: (fixed value)  -->
-<attachment>
 <!-- ISO name: (fixed value)  -->
 <url value="http://example"/>
 </attachment>
 </content>
 </DocumentReference>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct  -->
-<PackagedProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e363"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PCID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/pcid"/>
 <value value="{PCID}"/>
 </identifier>
-<packageFor>
 </packageFor>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageDescription  -->
 <description value="VIAL.PACK SIZE:5 X 10 ML "/>
 <!--BatchIdentifier is not supported -->
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Carton"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="Paperboard"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-manufacturer"/>
 </identifier>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container  -->
-<packaging>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageitemcontainertype"/>
 <code value="Vial"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/PackageItem_ContainerQuantity  -->
 <quantity value="1"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Material  -->
-<material>
-<coding>
 <system value="http://ema.europa.eu/fhir/packageItemContainerMaterial"/>
 <code value="type1colourlessglass"/>
 </coding>
 </material>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage  -->
-<shelfLifeStorage>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder"/>
 <code value="ShelfLifeofPackagedMedicinalProduct"/>
 </coding>
 </type>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ShelfLife-Storage/ShelfLifeTimePeriod  -->
-<periodDuration>
 <value value="2"/>
 <unit value="a"/>
 <!--unknown unit -->
 </periodDuration>
 </shelfLifeStorage>
-<containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<item>
-<reference>
 </reference>
 </item>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedItemQuantity  -->
-<amount>
 <value value="10"/>
 <unit value="ml"/>
 </amount>
 </containedItem>
 </packaging>
 </packaging>
 </PackagedProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-NAYRTOB464-d3e435"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="NAYRTOB464"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem  -->
-<ManufacturedItemDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e458"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/ManufacturedDoseForm  -->
-<manufacturedDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufactureddoseform"/>
 <code value="Solutionforinjection"/>
 </coding>
 </manufacturedDoseForm>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/UnitOfPresentation  -->
-<unitOfPresentation>
-<coding>
 <system value="http://ema.europa.eu/fhir/unitofpresentation"/>
 <code value="vial"/>
 </coding>
 </unitOfPresentation>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
 <!--ingredient> <reference> <reference value="Ingredient/Injectulin-d3e466"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Injectulin-d3e626"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Injectulin-d3e647"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Injectulin-d3e667"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Injectulin-d3e689"/> </reference> </ingredient> <ingredient> <reference> <reference value="Ingredient/Injectulin-d3e709"/> </reference> </ingredient -->
 </ManufacturedItemDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e466"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveBase"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-manufacturer"/>
 </identifier>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation  -->
-<manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Identifier  -->
-<manufacturer>
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-manufacturer"/>
 </identifier>
 </manufacturer>
 </manufacturer>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="Insulinhuman"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="100"/>
 <unit value="IU"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="ml"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="100"/>
 <unit value="IU"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="ml"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e501"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDHG469834-d3e512"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDHG469834"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD999999-d3e553"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD999999"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD999999-d3e564"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD999999"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<RegulatedAuthorization>
 <id value="RA-HDGKD999999-d3e575"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ManufacturingAuthorisationReferenceNumber  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber"/>
 <value value="HDGKD999999"/>
 </identifier>
 </RegulatedAuthorization>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e626"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="WATERFORINJECTION"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e647"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="HYDROCHLORICACID"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e667"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="METACRESOL"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e689"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="SODIUMHYDROXIDE"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e709"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="GLYCEROL"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct  -->
-<AdministrableProductDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e745"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/PhPIDSet/PhPIDIdentifierSets  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/phpididentifiersets"/>
 <value value="{PhPID}"/>
 </identifier>
 <status value="active"/>
-<formOf>
 </formOf>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/AdministrableDoseForm  -->
-<administrableDoseForm>
-<coding>
 <system value="http://ema.europa.eu/fhir/administrabledoseform"/>
 <code value="Solutionforinjection"/>
 </coding>
 </administrableDoseForm>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
 <!--ingredient> <reference value="Ingredient/Injectulin-d3e766"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e806"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e826"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e846"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e868"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e888"/> </ingredient> <ingredient> <reference value="Ingredient/Injectulin-d3e909"/> </ingredient -->
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration  -->
-<routeOfAdministration>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/RouteOfAdministration/RouteOfAdministration  -->
-<code>
-<coding>
 <system value="http://ema.europa.eu/fhir/routeofadministration"/>
 <code value="SUBCUTANEOUSUSE"/>
 </coding>
 </code>
 </routeOfAdministration>
 </AdministrableProductDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e766"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveBase"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="InsulinHuman"/>
 </coding>
 </concept>
 </code>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength  -->
-<strength>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation  -->
-<presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/numerator  -->
-<numerator>
 <value value="100"/>
 <unit value="IU"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Presentation/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="ml"/>
 <!--unknown unit -->
 </denominator>
 </presentationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration  -->
-<concentrationRatio>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/numerator  -->
-<numerator>
 <value value="100"/>
 <unit value="IU"/>
 <!--unknown unit -->
 </numerator>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Strength/Strength_Concentration/denominator  -->
-<denominator>
 <value value="1"/>
 <unit value="ml"/>
 <!--unknown unit -->
 </denominator>
 </concentrationRatio>
 </strength>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e806"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
 <status value="active"/>
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="SODIUMDIHYDROGENPHOSPHATEDIHYDRATE"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e826"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="WATERFORINJECTION"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e846"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="HYDROCHLORICACID"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e868"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="METACRESOL"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e888"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="SODIUMHYDROXIDE"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient  -->
-<Ingredient>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e909"/>
-<extension url="http://ema.europa.eu/fhir/extension/subject">
-<valueReference>
 </valueReference>
 </extension>
 <status value="active"/>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="Inactive"/>
 </coding>
 </role>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance  -->
-<substance>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/Substance/Substance  -->
-<code>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/substance"/>
 <code value="GLYCEROL"/>
 </coding>
 </concept>
 </code>
 </substance>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e951"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="Diabetesmellitus"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Diabetes mellitus where treatment with insulin is required. Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in patients with diabetes mellitus."/>
 </concept>
 </diseaseSymptomProcedure>
 </indication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e965"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="intra-andpost-operative\nstabilisation"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in patients with diabetes mellitus."/>
 </concept>
 </diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/Comorbidity  -->
-<comorbidity>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/comorbidity"/>
 <code value="Diabetesmellitus"/>
 </coding>
 </concept>
 </comorbidity>
 </indication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e982"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="hyperglycaemic\ncoma"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in patients with diabetes mellitus."/>
 </concept>
 </diseaseSymptomProcedure>
 </indication>
 </ClinicalUseDefinition>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseDefinition>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="Injectulin-d3e998"/>
 <type value="indication"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<indication>
 <!-- ISO name: (fixed value)  -->
-<diseaseSymptomProcedure>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure"/>
 <code value="ketoacidosis"/>
 </coding>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/IndicationText  -->
 <text value="Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in patients with diabetes mellitus."/>
 </concept>
 </diseaseSymptomProcedure>
 </indication>
 </ClinicalUseDefinition>
 </contained>
 <!-- ISO name: /MedicinalProduct/MPID  -->
-<identifier>
 <system value="http://ema.europa.eu/fhir/MPID"/>
 <value value="{mpid}"/>
 </identifier>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply  -->
-<legalStatusOfSupply>
-<coding>
 <system value="http://ema.europa.eu/fhir/legalstatusofsupply"/>
 <code value="Subjecttomedicalprescription"/>
 </coding>
 </legalStatusOfSupply>
 <!-- ISO name: /MedicinalProduct/ProductClassification  -->
-<classification>
 <!-- ISO name: /MedicinalProduct/ProductClassification/CodeSystem  -->
 <!-- FHIR extra mapping info: CodeSystem maps to system of Value attribute -->
-<coding>
 <system value="http://ema.europa.eu/fhir/value"/>
 <!-- ISO name: /MedicinalProduct/ProductClassification/Value  -->
 <code value="A10AB01"/>
 </coding>
 </classification>
 <!-- ISO name: /MedicinalProduct/MarketingStatus  -->
-<marketingStatus>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus  -->
-<status>
-<coding>
 <system value="http://ema.europa.eu/fhir/marketingstatus"/>
 <code value="Marketed"/>
 </coding>
 </status>
-<dateRange>
 <!-- ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart  -->
 <start value="2005-11-20"/>
 </dateRange>
 </marketingStatus>
 <!-- ISO name: /MedicinalProduct/AttachedDocument  -->
-<attachedDocument>
 <reference value="DocumentReference/Injectulin-d3e5"/>
 </attachedDocument>
 <!-- ISO name: /MedicinalProduct/MasterFile  -->
-<masterFile>
 </masterFile>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName  -->
-<name>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/FullName  -->
 <productName value="Injectulin"/>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart  -->
-<part>
 <part value="Injectulin"/>
-<type>
-<coding>
 <system value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
 <code value="220000000002"/>
 <display value="Invented name part"/>
 </coding>
 </type>
 </part>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<usage>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country  -->
-<country>
-<coding>
 <system value="http://ema.europa.eu/fhir/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction  -->
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/fhir/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language  -->
-<language>
-<coding>
 <system value="http://ema.europa.eu/fhir/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation  -->
-<operation>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType  -->
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/fhir/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate  -->
 <start value="2011-04-15"/>
 </effectiveDate>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation  -->
-<organization>
 <!-- ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="Injectulin-organization"/>
 </identifier>
 </organization>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
-<entry>
-<resource>
-<MedicinalProductDefinition>
 <id value="example"/>
-<text>
 <status value="generated"/>
-<div xmlns="http://www.w3.org/1999/xhtml">
-<p>
 <b>Generated Narrative</b>
 </p>
-<p>
 <b>Id</b>
: example
 </p>
-<p>
 <b>Identifier</b>
: {mpid}
 </p>
-<p>
 <b>Classification</b>
:
 <span title="Codes: {http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem B01AF02}">ATC: B01AF02</span>
 </p>
-<p>
 <b>Attached Document</b>
: (SmPC)
 </p>
-<p>
 <b>Master File</b>
: (Pharmacovigilence Master File)
 </p>
-<p>
 <b>Product Name</b>
: Equilidem 2.5 mg film-coated tablets
 </p>
-<blockquote>
-<p>
 <b>Name Part</b>
 </p>
-<p>
 <b>part</b>
:Equilidem
 </p>
-<p>
 <b>type</b>
:
 <span title="Codes: ">Invented</span>
 </p>
 </blockquote>
-<blockquote>
-<p>
 <b>Name Part</b>
 </p>
-<p>
 <b>part</b>
:2.5 mg
 </p>
-<p>
 <b>type</b>
:
 <span title="Codes: ">Strength</span>
 </p>
 </blockquote>
-<blockquote>
-<p>
 <b>Name Part</b>
 </p>
-<p>
 <b>part</b>
:film-coated tablets
 </p>
-<p>
 <b>type</b>
:
 <span title="Codes: ">Form</span>
 </p>
-<p>
 <b>Country & Languages</b>
 </p>
-<table class="grid">
-<tr>
 <td>-</td>
-<td>
 <b>Country</b>
 </td>
-<td>
 <b>Jurisdiction</b>
 </td>
-<td>
 <b>Language</b>
 </td>
 </tr>
-<tr>
 <td>*</td>
-<td>
 <span title="Codes: {http://ema.europa.eu/example/countryCode EU}">EU</span>
 </td>
-<td>
 <span title="Codes: {http://ema.europa.eu/example/jurisdictionCode EU}">EU</span>
 </td>
-<td>
 <span title="Codes: {http://ema.europa.eu/example/languageCode EN}">EN</span>
 </td>
 </tr>
 </table>
 </blockquote>
-<p>
 <b>Manufacturing & Business Operations</b>
 </p>
-<table class="grid">
-<tr>
 <td>-</td>
-<td>
 <b>Type</b>
 </td>
-<td>
 <b>EffectiveDate</b>
 </td>
-<td>
 <b>Authorization</b>
 </td>
 </tr>
-<tr>
 <td>*</td>
 <td>Batch Release</td>
 <td>2013-03-15 --> (ongoing)</td>
-<td>
 <span>1324TZ</span>
 </td>
 </tr>
 </table>
 </div>
 </text>
-<identifier>
 <system value="http://ema.europa.eu/example/MPID"/>
 <value value="{mpid}"/>
 </identifier>
-<classification>
-<coding>
 <system value="http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem"/>
 <code value="B01AF02"/>
 </coding>
 </classification>
-<attachedDocument>
 <reference value="DocumentReference/example"/>
 </attachedDocument>
-<masterFile>
 <reference value="DocumentReference/example"/>
 </masterFile>
-<name>
 <productName value="Equilidem 2.5 mg film-coated tablets"/>
-<part>
 <part value="Equilidem"/>
-<type>
-<coding>
 <code value="INV"/>
 </coding>
 </type>
 </part>
-<part>
 <part value="2.5 mg"/>
-<type>
-<coding>
 <code value="STR"/>
 </coding>
 </type>
 </part>
-<part>
 <part value="film-coated tablets"/>
-<type>
-<coding>
 <code value="FRM"/>
 </coding>
 </type>
 </part>
-<usage>
-<country>
-<coding>
 <system value="http://ema.europa.eu/example/countryCode"/>
 <code value="EU"/>
 </coding>
 </country>
-<jurisdiction>
-<coding>
 <system value="http://ema.europa.eu/example/jurisdictionCode"/>
 <code value="EU"/>
 </coding>
 </jurisdiction>
-<language>
-<coding>
 <system value="http://ema.europa.eu/example/languageCode"/>
 <code value="EN"/>
 </coding>
 </language>
 </usage>
 </name>
-<operation>
-<type>
-<concept>
-<coding>
 <system value="http://ema.europa.eu/example/manufacturingOperationType"/>
 <code value="Batchrelease"/>
 </coding>
 </concept>
 </type>
-<effectiveDate>
 <start value="2013-03-15"/>
 </effectiveDate>
 </operation>
 </MedicinalProductDefinition>
 </resource>
 </entry>
 </Bundle>