{ "resourceType" : "Bundle", "id" : "290a41c4-5f57-4444-80f7-e2734b193dc3", "meta" : { "profile" : ["http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/1.2.0", "http://ema.europa.eu/fhir/definition/fhir-adapter/1.2.0.0"] }, "type" : "transaction", "entry" : [{ "fullUrl" : "http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "600000709068", "meta" : { "versionId" : "3" }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: MedicinalProductDefinition 600000709068

version: 3

Authorised Dose Form: Pharmaceutical Dose Form 100000073683: Prolonged-release tablet

identifier: http://spor.azure-api.net/pms/api/v2/6055417

domain: Human use

status: Nullified

combinedPharmaceuticalDoseForm: 100000073683

indication:

legalStatusOfSupply: Medicinal product not subject to medical prescription

additionalMonitoringIndicator: False

pediatricUseIndicator: True

classification: 100000098024, Full application (Article 8(3) of Directive No 2001/83/EC), Other

attachedDocument: DocumentReference: status = current

masterFile: DocumentReference: status = current

contact

type: Pharmacovigilance Enquiry Information

contact: Organization Dummmy Organization

contact

type: Qualified Person in the EEA for Pharmacovigilance

contact: PractitionerRole

name

productName: StopCold 5 mg/120 mg comprimidos de liberación prolongada.

part

part: StopCold

type: Invented name part

part

part: 5 MG/120 MG

type: Strength part

part

part: COMPRIMIDOS DE LIBERACIÓN PROLONGADA

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*SpainSpanish

operation

id

6519944

Types

-Reference
*This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently

confidentialityIndicator: Confidential

Characteristics

-Type
*true
" }, "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/authorisedDoseForm", "valueCoding" : { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 38 }], "system" : "http://spor.ema.europa.eu/v1/lists/200000000004", "code" : "100000073683" } }], "identifier" : [{ "system" : "http://spor.azure-api.net/pms/api/v2", "value" : "6055417" }], "domain" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 7 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000000004", "code" : "100000000012" }] }, "status" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 3 }], "system" : "http://spor.ema.europa.eu/v1/lists/200000005003", "code" : "200000005007" }] }, "combinedPharmaceuticalDoseForm" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 38 }], "system" : "http://spor.ema.europa.eu/v1/lists/200000000006", "code" : "100000073683" }] }, "_indication" : { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/language", "valueCoding" : { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Domain" }], "system" : "http://spor.ema.europa.eu/v1/lists/100000072057", "code" : "100000072147" } }] }, "legalStatusOfSupply" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Legal Status From the Supply" }], "system" : "http://spor.ema.europa.eu/v1/lists/100000072051", "code" : "100000072076" }] }, "additionalMonitoringIndicator" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Additional Monitoring Indicator" }], "system" : "http://ema.europa.eu/fhir/additionalMonitoringIndicator", "code" : "False" }] }, "pediatricUseIndicator" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Paediatric Use Indicator" }], "system" : "http://ema.europa.eu/fhir/paediatricUseIndicator", "code" : "True" }] }, "classification" : [{ "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 3 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000093533", "code" : "100000098024" }] }, { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 8 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000116045", "code" : "100000116046" }] }, { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 2 }], "system" : "http://spor.ema.europa.eu/v1/lists/200000000324", "code" : "200000003517" }] }], "attachedDocument" : [{ "reference" : "DocumentReference/13709" }], "masterFile" : [{ "reference" : "DocumentReference/mf1" }], "contact" : [{ "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 3 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000154441", "code" : "200000017719" }] }, "contact" : { "reference" : "Organization/phv5633366" } }, { "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 1 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000154441", "code" : "100000155057" }] }, "contact" : { "reference" : "PractitionerRole/qppv5633367" } }], "name" : [{ "productName" : "StopCold 5 mg/120 mg comprimidos de liberación prolongada.", "part" : [{ "part" : "StopCold", "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 9 }], "system" : "http://spor.ema.europa.eu/v1/lists/220000000000", "code" : "220000000002" }] } }, { "part" : "5 MG/120 MG", "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 9 }], "system" : "http://spor.ema.europa.eu/v1/lists/220000000000", "code" : "220000000004" }] } }, { "part" : "COMPRIMIDOS DE LIBERACIÓN PROLONGADA", "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 8 }], "system" : "http://spor.ema.europa.eu/v1/lists/220000000000", "code" : "220000000005" }] } }], "usage" : [{ "country" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 19 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000000002", "code" : "100000000529" }] }, "language" : { "coding" : [{ "system" : "urn:ietf:bcp:47", "code" : "es" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 2 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000072057", "code" : "100000072264" }] } }] }], "operation" : [{ "id" : "6519944", "type" : { "reference" : { "reference" : "ActivityDefinition/7371703" } }, "confidentialityIndicator" : { "coding" : [{ "system" : "http://spor.ema.europa.eu/v1/lists/200000004983", "code" : "200000004984" }] } }], "characteristic" : [{ "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/compliesWithDirective", "valueBoolean" : true }], "system" : "http://ema.europa.eu/fhir/gmo", "code" : "true" }] } }] }, "request" : { "method" : "PUT", "url" : "MedicinalProductDefinition/600000709068" } }, { "fullUrl" : "http://ema.europa.eu/example/api/PackagedProductDefinition/7868766", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "7868766", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 7868766

identifier: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575/1141415566651

packageFor: Bundle: type = searchset

status: Nullified

containedItemQuantity: 40(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014) (Details: Units Of Presentation code200000002152 = 'Tablet')

description:

5MG/120MG PROLONGED RELEASE TABLET

\n

MarketingStatuses

-CountryStatus
*United KingdomMarketed
" }, "identifier" : [{ "system" : "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575", "value" : "1141415566651" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/600000709068" }], "status" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 3 }], "system" : "http://spor.ema.europa.eu/v1/lists/200000005003", "code" : "200000005007" }] }, "containedItemQuantity" : [{ "value" : 40, "system" : "http://spor.ema.europa.eu/v1/lists/200000000014", "code" : "200000002152" }], "description" : "5MG/120MG PROLONGED RELEASE TABLET", "_description" : { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/language", "valueCoding" : { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/termVersion", "valueInteger" : 2 }], "system" : "http://spor.ema.europa.eu/v1/lists/100000072057", "code" : "100000072264" } }] }, "marketingStatus" : [{ "country" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Country" }], "system" : "http://spor.ema.europa.eu/v1/lists/100000000002", "code" : "100000000556", "display" : "United Kingdom" }] }, "status" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Marketing Status" }], "system" : "http://spor.ema.europa.eu/v1/lists/100000072052", "code" : "100000072083", "display" : "Marketed" }] } }] }, "request" : { "method" : "PUT", "url" : "PackagedProductDefinition/7868766" } }] }