-
<
MedicinalProductDefinition
xmlns="http://hl7.org/fhir">
<!--
ISO name: /MedicinalProduct
-->
<
id
value
=
"
SpioInhaler
"
/>
<!--
ISO name: /MedicinalProduct/Header
-->
-
<
meta
>
<!--
ISO name: /MedicinalProduct/Header/EffectiveDate
-->
<!--
FHIR extra mapping info: Date must be padded to include time and timezone e.g. 2018-10-06T00:00:00Z
-->
<
lastUpdated
value
=
"
2016-05-02T00:00:00Z
"
/>
</
meta
>
<!--
ISO name: /MedicinalProduct/MPID
-->
-
<
identifier
>
<
system
value
=
"
http://ema.europa.eu/fhir/mpId
"
/>
<
value
value
=
"
{mpid}
"
/>
</
identifier
>
<!--
ISO name: /MedicinalProduct/MarketingAuthorisation/LegalStatusOfSupply
-->
-
<
legalStatusOfSupply
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/legalstatusofsupply
"
/>
<
code
value
=
"
Subjecttomedicalprescription
"
/>
</
coding
>
</
legalStatusOfSupply
>
<!--
ISO name: /MedicinalProduct/PaediatricUseIndicator
-->
-
<
pediatricUseIndicator
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/paediatricUseIndicator
"
/>
<
code
value
=
"
Yes
"
/>
</
coding
>
</
pediatricUseIndicator
>
<!--
ISO name: /MedicinalProduct/ProductClassification
-->
-
<
classification
>
<!--
ISO name: /MedicinalProduct/ProductClassification/CodeSystem
-->
<!--
FHIR extra mapping info: CodeSystem maps to system of Value attribute
-->
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/value
"
/>
<!--
ISO name: /MedicinalProduct/ProductClassification/Value
-->
<
code
value
=
"
J01GB01
"
/>
</
coding
>
</
classification
>
<!--
ISO name: /MedicinalProduct/MarketingStatus
-->
-
<
marketingStatus
>
<!--
ISO name: /MedicinalProduct/MarketingStatus/Country
-->
-
<
country
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/countryCode
"
/>
<
code
value
=
"
EU
"
/>
</
coding
>
</
country
>
<!--
ISO name: /MedicinalProduct/MarketingStatus/MarketingStatus
-->
-
<
status
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/marketingstatus
"
/>
<
code
value
=
"
Marketed
"
/>
</
coding
>
</
status
>
-
<
dateRange
>
<!--
ISO name: /MedicinalProduct/MarketingStatus/MarketingDateStart
-->
<
start
value
=
"
2011-09-01
"
/>
</
dateRange
>
</
marketingStatus
>
<!--
ISO name: /MedicinalProduct/AttachedDocument
-->
-
<
attachedDocument
>
<
reference
value
=
"
DocumentReference/SPIOInhaler28mg-d3e9
"
/>
</
attachedDocument
>
<!--
ISO name: /MedicinalProduct/MasterFile
-->
-
<
masterFile
>
<
reference
value
=
"
DocumentReference/SPIOInhaler28mg-d3e646
"
/>
</
masterFile
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName
-->
-
<
name
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/FullName
-->
<
productName
value
=
"
SPIO Inhaler 28mg inhalation powder, hard capsules
"
/>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/Inventedpart
-->
-
<
part
>
<
part
value
=
"
SPIO Inhaler
"
/>
-
<
type
>
-
<
coding
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/lists/220000000000
"
/>
<
code
value
=
"
220000000002
"
/>
<
display
value
=
"
Invented name part
"
/>
</
coding
>
</
type
>
</
part
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/StrengthPart
-->
-
<
part
>
<
part
value
=
"
28 mg
"
/>
-
<
type
>
-
<
coding
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/lists/220000000000
"
/>
<
code
value
=
"
220000000004
"
/>
<
display
value
=
"
Strength part
"
/>
</
coding
>
</
type
>
</
part
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/PharmaceuticalDoseFormPart
-->
-
<
part
>
<
part
value
=
"
inhalation powder, hard capsules
"
/>
-
<
type
>
-
<
coding
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/lists/220000000000
"
/>
<
code
value
=
"
220000000005
"
/>
<
display
value
=
"
Pharmaceutical dose form part
"
/>
</
coding
>
</
type
>
</
part
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/Country-Language
-->
-
<
usage
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Country
-->
-
<
country
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/countryCode
"
/>
<
code
value
=
"
EU
"
/>
</
coding
>
</
country
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Jurisdiction
-->
-
<
jurisdiction
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/jurisdictionCode
"
/>
<
code
value
=
"
EU
"
/>
</
coding
>
</
jurisdiction
>
<!--
ISO name: /MedicinalProduct/MedicinalProductName/Country-Language/Language
-->
-
<
language
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/languageCode
"
/>
<
code
value
=
"
EN
"
/>
</
coding
>
</
language
>
</
usage
>
</
name
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation
-->
-
<
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator
-->
<!--
FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
-->
-
<
extension
url
=
"
http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
"
>
-
<
valueCoding
>
<
system
value
=
"
http://ema.europa.eu/fhir/confidentialityindicator
"
/>
<
code
value
=
"
Yes
"
/>
</
valueCoding
>
</
extension
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType
-->
-
<
type
>
-
<
concept
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/manufacturingOperationType
"
/>
<
code
value
=
"
Batchrelease
"
/>
</
coding
>
</
concept
>
</
type
>
-
<
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate
-->
<
start
value
=
"
2011-04-15
"
/>
</
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation
-->
-
<
organization
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier
-->
-
<
identifier
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/locations
"
/>
<
value
value
=
"
SPIOInhaler28mg-organization
"
/>
</
identifier
>
</
organization
>
<!--
authorization> <reference value="RegulatedAuthorization/RA-1314TZ-d3e189"/> </authorization
-->
</
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation
-->
-
<
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator
-->
<!--
FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
-->
-
<
extension
url
=
"
http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
"
>
-
<
valueCoding
>
<
system
value
=
"
http://ema.europa.eu/fhir/confidentialityindicator
"
/>
<
code
value
=
"
Yes
"
/>
</
valueCoding
>
</
extension
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType
-->
-
<
type
>
-
<
concept
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/manufacturingOperationType
"
/>
<
code
value
=
"
Qualitycontroltestingofmedicinalproduct
"
/>
</
coding
>
</
concept
>
</
type
>
-
<
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate
-->
<
start
value
=
"
2011-04-15
"
/>
</
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation
-->
-
<
organization
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier
-->
-
<
identifier
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/locations
"
/>
<
value
value
=
"
SPIOInhaler28mg-organization
"
/>
</
identifier
>
</
organization
>
<!--
authorization> <reference value="RegulatedAuthorization/RA-1314TZ-d3e283"/> </authorization
-->
</
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation
-->
-
<
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator
-->
<!--
FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
-->
-
<
extension
url
=
"
http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
"
>
-
<
valueCoding
>
<
system
value
=
"
http://ema.europa.eu/fhir/confidentialityindicator
"
/>
<
code
value
=
"
Yes
"
/>
</
valueCoding
>
</
extension
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType
-->
-
<
type
>
-
<
concept
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/manufacturingOperationType
"
/>
<
code
value
=
"
Qualitycontroltestingofmedicinalproduct
"
/>
</
coding
>
</
concept
>
</
type
>
-
<
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate
-->
<
start
value
=
"
2011-04-15
"
/>
</
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation
-->
-
<
organization
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier
-->
-
<
identifier
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/locations
"
/>
<
value
value
=
"
SPIOInhaler28mg-organization
"
/>
</
identifier
>
</
organization
>
</
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation
-->
-
<
operation
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/ConfidentialityIndicator
-->
<!--
FHIR extension: http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
-->
-
<
extension
url
=
"
http://ema.europa.eu/fhir/extension/contactConfidentialityIndicator
"
>
-
<
valueCoding
>
<
system
value
=
"
http://ema.europa.eu/fhir/confidentialityindicator
"
/>
<
code
value
=
"
Yes
"
/>
</
valueCoding
>
</
extension
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/OperationType
-->
-
<
type
>
-
<
concept
>
-
<
coding
>
<
system
value
=
"
http://ema.europa.eu/fhir/manufacturingOperationType
"
/>
<
code
value
=
"
Processingoperationsforthemedicinalproduct
"
/>
</
coding
>
</
concept
>
</
type
>
-
<
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Manufacturing-BusinessOperation/EffectiveDate
-->
<
start
value
=
"
2011-04-15
"
/>
</
effectiveDate
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation
-->
-
<
organization
>
<!--
ISO name: /MedicinalProduct/Manufacturer-Establishment_Organisation/Identifier
-->
-
<
identifier
>
<
system
value
=
"
https://spor.ema.europa.eu/v1/locations
"
/>
<
value
value
=
"
SPIOInhaler28mg-organization
"
/>
</
identifier
>
</
organization
>
</
operation
>
</
MedicinalProductDefinition
>