StructureDefinition-MedicinalProductDefinition-uv-epi

Sourcehl7.fhir.uv.vulcan-eproduct-info#current:Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v5.0.0-ballot)
resourceTypeStructureDefinition
idMedicinalProductDefinition-uv-epi
canonicalhttp://hl7.org/fhir/uv/vulcan-eproduct-info/StructureDefinition/MedicinalProductDefinition-uv-epi
version1.0.0-Ballot
statusactive
nameMedicinalProductDefinitionUvEpi
titleMedicinalProductDefinition (ePI)
date2022-11-29T00:09:20+00:00
descriptionDescription of the packaged authorized medicinal product(s) associated to this ePI document.
jurisdictionsuv
fhirVersion5.0.0-ballot
kindresource
abstractfalse
sdTtypeMedicinalProductDefinition
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
Usages
Name Flags Card. Type Description & Constraints doco
. . MedicinalProductDefinition MedicinalProductDefinition
. . . identifier 1.. Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID).
. . . . system 1.. Binding: MedicinalProductDefinition identifier systems ( extensible )
. . . . value 1..
. . . type Binding: Medicinal Product Type ( preferred )
. . . domain Binding: Medicinal Product Domain ( preferred )
. . . version Business version of this product
. . . status Binding: PublicationStatus ( preferred )
. . . statusDate The date at which this status became applicable.
. . . description General description of the medicinal product referred by the ePI
. . . combinedPharmaceuticalDoseForm Binding: Combined Pharmaceutical Dose Form ( preferred )
. . . route Binding: Route Of Administration ( preferred )
. . . indication Narrative text of the authorized indication(s) for this product.
. . . legalStatusOfSupply Binding: Legal Status for the Supply ( preferred )
. . . additionalMonitoringIndicator Binding: Additional Monitoring Indicator ( preferred )
. . . pediatricUseIndicator Binding: Pediatric Use Indicator ( preferred )
. . . classification Binding: WHO ATC ( preferred )
. . . marketingStatus Marketing status of the medicinal product in contrast to marketing authorization
. . . . status Binding: Marketing Status ( preferred )
. . . packagedMedicinalProduct High level package type for this product. E.g., sample pack
Binding: High level Pack Type ( preferred )
. . . name
. . . . productName The full name of this product
Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill
. . . . type Required Pattern: At least the following
. . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000
. . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
. . . . Slices for part Slice: Unordered, Open by pattern:type
. . . . . part:ProprietaryNamePart 0..*
. . . . . . part brand name of this product
Example Example brand name: Humalog Mix50
. . . . . . type Required Pattern: At least the following
. . . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000
. . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
. . . . . part:Non-proprietaryNamePart 0..*
. . . . . . part International Non-proprietary Name (INN) of this product
Example Example INN: Insulin lispro
. . . . . . type Required Pattern: At least the following
. . . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000
. . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000003
. . . . . part:StrengthPart 0..*
. . . . . . part strength expressed as the quantity of active ingredient
Example Example quantity: 100 units/ml
. . . . . . type Required Pattern: At least the following
. . . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000
. . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000004
. . . . . part:PharmaceuticalDoseFormPart 0..*
. . . . . . part Physical manifestation of a product as intended to be delivered to the patient.
Example Example dose form: solution for injection
. . . . . . type Required Pattern: At least the following
. . . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000
. . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
. . . . usage
. . . . . country Binding: ISO Country two letter code ( preferred )
. . . . . jurisdiction Binding: ISO Country two letter code ( preferred )
. . . crossReference
. . . . type Binding: Product Cross Reference Type ( extensible )
. . . operation
. . . . type Binding: Type of operation ( preferred )
. . . . . concept 1..
. . . . organization Reference (Organization (ePI))

doco Documentation for this format

Produced 06 Apr 2023