-<Bundle xmlns="http://hl7.org/fhir">
 <id value="30f2e271-d2da-40d3-b5e5-018143ad01a6"/>
-<meta>
 <lastUpdated value="2022-01-18T18:49:15.7499871Z"/>
 </meta>
 <type value="searchset"/>
 <total value="7"/>
-<link>
 <relation value="self"/>
 <url value="http://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  -->
-<paediatricUseIndicator>
-<coding>
 <system value="http://ema.europa.eu/fhir/paediatricUseIndicator"/>
 <code value="Yes"/>
 </coding>
 </paediatricUseIndicator>
 <!-- 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/InventedNamePart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<countryLanguage>
 <!-- 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>
 </countryLanguage>
 </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>
 </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>
 </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>
 </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="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>
-<authorization>
 </authorization>
 </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/InventedNamePart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<countryLanguage>
 <!-- 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>
 </countryLanguage>
 </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>
-<authorization>
 </authorization>
 </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/InventedNamePart  -->
-<namePart>
 <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>
 </namePart>
 <!-- ISO name: /MedicinalProduct/MedicinalProductName/Country-Language  -->
-<countryLanguage>
 <!-- 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>
 </countryLanguage>
 </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>
-<authorization>
 </authorization>
 </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  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e49"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of SPIO Inhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential."/>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e63"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of SPIO Inhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential."/>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e77"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="Concomitant use of SPIO Inhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended. Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue."/>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e100"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include:\n- amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity);\n- platinum compounds (risk of increased nephrotoxicity and ototoxicity);\n- anticholinesterases, botulinum toxin (neuromuscular effects)."/>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e121"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include:\n- amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity);\n- platinum compounds (risk of increased nephrotoxicity and ototoxicity);\n- anticholinesterases, botulinum toxin (neuromuscular effects)."/>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/Interactions  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e134"/>
 <type value="interaction"/>
-<subject>
 </subject>
 <!-- ISO name: /MedicinalProduct/Interactions/InteractionsText  -->
 <description value="In clinical studies, patients receiving SPIO Inhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides, no evidence of drug interactions with these medicines was identified."/>
 <!-- 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>
 </ClinicalUseIssue>
 </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>
-<relatedDate>
-<datePeriod>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/DataExclusivityStartDate  -->
 <start value="2010-07-25"/>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/DataExclusivityEndDate  -->
 <end value="2022-07-25"/>
 </datePeriod>
 <!-- ISO name: (fixed value)  -->
-<type>
 <!-- ISO name: (fixed value)  -->
-<coding>
 <!-- ISO name: (fixed value)  -->
 <system value="https://ema.europa.eu/fhir/code-systems/authorisation-date-type"/>
 <!-- ISO name: (fixed value)  -->
 <code value="exclusivityDate"/>
 <display value="Exclusivity Date"/>
 </coding>
 </type>
 </relatedDate>
-<relatedDate>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/DateOfFirstAuthorisation  -->
 <dateDateTime value="2010-07-20"/>
 <!-- ISO name: (fixed value)  -->
-<type>
 <!-- ISO name: (fixed value)  -->
-<coding>
 <!-- ISO name: (fixed value)  -->
 <system value="https://ema.europa.eu/fhir/code-systems/authorisation-date-type"/>
 <!-- ISO name: (fixed value)  -->
 <code value="dateOfFirstAuthorisation"/>
 <display value="First Authorisation"/>
 </coding>
 </type>
 </relatedDate>
-<relatedDate>
 <!-- ISO name: /MedicinalProduct/MarketingAuthorisation/InternationalBirthDate  -->
 <dateDateTime value="2010-08-15"/>
 <!-- ISO name: (fixed value)  -->
-<type>
 <!-- ISO name: (fixed value)  -->
-<coding>
 <!-- ISO name: (fixed value)  -->
 <system value="https://ema.europa.eu/fhir/code-systems/authorisation-date-type"/>
 <!-- ISO name: (fixed value)  -->
 <code value="internationalBirthDate"/>
 <display value="International Birth Date"/>
 </coding>
 </type>
 </relatedDate>
 <!-- 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>
-<subject>
 </subject>
 <!-- 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  -->
-<package>
 <!-- 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  -->
-<periodQuantity>
 <value value="3"/>
 <unit value="a"/>
 <!--unknown unit -->
 </periodQuantity>
 <!-- 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  -->
-<package>
 <!-- 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  -->
-<periodQuantity>
 <value value="1"/>
 <unit value="week"/>
 <!--unknown unit -->
 </periodQuantity>
 </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>
 </package>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container  -->
-<package>
 <!-- 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  -->
-<amountQuantity>
 <value value="8"/>
 <unit value="units/blister"/>
 </amountQuantity>
 </containedItem>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component  -->
-<package>
 <!-- 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>
 </package>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Package_Component  -->
-<package>
 <!-- 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>
 </package>
 </package>
 </package>
 </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="manufacturer-name"/>
 </deviceName>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/Device/DeviceType  -->
-<type>
-<coding>
 <system value="http://ema.europa.eu/fhir/deviceType"/>
 <code value="Single-dosedrypowderinhaler"/>
 </coding>
 </type>
 <!-- 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>
-<valueCode>
-<coding>
 <code value="Class1"/>
 </coding>
 </valueCode>
 </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>
 <!-- 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  -->
-<ingredient>
-<reference>
 <reference value="Ingredient/SPIOInhaler28mg-d3e857"/>
 </reference>
 </ingredient>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<ingredient>
-<reference>
 <reference value="Ingredient/SPIOInhaler28mg-d3e984"/>
 </reference>
 </ingredient>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/Ingredient  -->
-<ingredient>
-<reference>
 <reference value="Ingredient/SPIOInhaler28mg-d3e1042"/>
 </reference>
 </ingredient>
 <!-- ISO name: /MedicinalProduct/PackagedMedicinalProduct/PackageItem_Container/PackageItem_Container/ManufacturedItem/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>
 <!-- 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  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG9999"/>
 </identifier>
 <display value="Company 1"/>
 </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  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG11111"/>
 </identifier>
 <display value="Company 2"/>
 </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>
 <!-- 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  -->
-<identifier>
 <system value="https://spor.ema.europa.eu/v1/locations"/>
 <value value="ORG22222"/>
 </identifier>
 <display value="Company EXCIPIENT 1"/>
 </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>
 <!-- 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>
 <!-- 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>
-<subject>
 </subject>
 <!-- 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>
 <!-- ISO name: /MedicinalProduct/PharmaceuticalProduct/Ingredient/IngredientRole  -->
-<role>
-<coding>
 <system value="http://ema.europa.eu/fhir/ingredientRole"/>
 <code value="ActiveMoiety"/>
 </coding>
 </role>
 </Ingredient>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication  -->
-<ClinicalUseIssue>
 <!-- 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  -->
-<population>
 <!-- ISO name: (fixed value)  -->
-<ageRange>
 <!-- ISO name: /MedicinalProduct/TherapeuticIndication/PopulationSpecifics/AgeRangeLow  -->
-<low>
 <value value="6"/>
 <unit value="a"/>
 </low>
 </ageRange>
 </population>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- 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>
 </ClinicalUseIssue>
 </contained>
-<contained>
 <!-- ISO name: /MedicinalProduct/UndesirableEffects  -->
-<ClinicalUseIssue>
 <!-- ISO name: (id is generated on the fly)  -->
 <id value="SPIOInhaler28mg-d3e1449"/>
 <type value="undesirable-effect"/>
-<subject>
 </subject>