R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial Use Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductPharmaceutical resource.

MedicinalProductPharmaceutical
Element IdMedicinalProductPharmaceutical
Definition

A pharmaceutical product described in terms of its composition and dose form.

Control1..1
TypeDomainResource
Summarytrue
MedicinalProductPharmaceutical.identifier
Element IdMedicinalProductPharmaceutical.identifier
Definition

An identifier for the pharmaceutical medicinal product.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
MedicinalProductPharmaceutical.administrableDoseForm
Element IdMedicinalProductPharmaceutical.administrableDoseForm
Definition

The administrable dose form, after necessary reconstitution.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.unitOfPresentation
Element IdMedicinalProductPharmaceutical.unitOfPresentation
Definition

Todo.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.ingredient
Element IdMedicinalProductPharmaceutical.ingredient
Definition

Ingredient.

Control0..*
TypeReference(MedicinalProductIngredient)
Summarytrue
MedicinalProductPharmaceutical.device
Element IdMedicinalProductPharmaceutical.device
Definition

Accompanying device.

Control0..*
TypeReference(MedicinalProductDeviceSpec | DeviceDefinition)
Summarytrue
MedicinalProductPharmaceutical.characteristics
Element IdMedicinalProductPharmaceutical.characteristics
Definition

Characteristics e.g. a products onset of action.

Control0..*
Summarytrue
MedicinalProductPharmaceutical.characteristics.code
Element IdMedicinalProductPharmaceutical.characteristics.code
Definition

A coded characteristic.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.characteristics.status
Element IdMedicinalProductPharmaceutical.characteristics.status
Definition

The status of characteristic e.g. assigned or pending.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration
Element IdMedicinalProductPharmaceutical.routeOfAdministration
Definition

The path by which the pharmaceutical product is taken into or makes contact with the body.

Control1..*
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.code
Element IdMedicinalProductPharmaceutical.routeOfAdministration.code
Definition

Coded expression for the route.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.firstDose
Element IdMedicinalProductPharmaceutical.routeOfAdministration.firstDose
Definition

The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement.

Control0..1
TypeQuantity
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.maxSingleDose
Element IdMedicinalProductPharmaceutical.routeOfAdministration.maxSingleDose
Definition

The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement.

Control0..1
TypeQuantity
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerDay
Element IdMedicinalProductPharmaceutical.routeOfAdministration.maxDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation.

Control0..1
TypeQuantity
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerTreatmentPeriod
Element IdMedicinalProductPharmaceutical.routeOfAdministration.maxDosePerTreatmentPeriod
Definition

The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation.

Control0..1
TypeRatio
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.maxTreatmentPeriod
Element IdMedicinalProductPharmaceutical.routeOfAdministration.maxTreatmentPeriod
Definition

The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation.

Control0..1
TypeDuration
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies
Definition

A species for which this route applies.

Control0..*
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code
Definition

Coded expression for the species.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod
Definition

A species specific time during which consumption of animal product is not appropriate.

Control0..*
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Definition

Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Definition

A value for the time.

Control1..1
TypeQuantity
Summarytrue
MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Element IdMedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Definition

Extra information about the withdrawal period.

Control0..1
Typestring
Summarytrue