MedicinalProductDefinition constructor
- @Default(R5ResourceType.MedicinalProductDefinition) @JsonKey(unknownEnumValue: R5ResourceType.MedicinalProductDefinition) R5ResourceType resourceType,
- @JsonKey(includeFromJson: true, includeToJson: false) int? dbId,
- @JsonKey(name: 'id') FhirId? fhirId,
- FhirMeta? meta,
- FhirUri? implicitRules,
- @JsonKey(name: '_implicitRules') Element? implicitRulesElement,
- FhirCode? language,
- @JsonKey(name: '_language') Element? languageElement,
- Narrative? text,
- List<
Resource> ? contained, - @JsonKey(name: 'extension') List<
FhirExtension> ? extension_, - List<
FhirExtension> ? modifierExtension, - List<
Identifier> ? identifier, - CodeableConcept? type,
- CodeableConcept? domain,
- String? version,
- @JsonKey(name: '_version') Element? versionElement,
- CodeableConcept? status,
- FhirDateTime? statusDate,
- @JsonKey(name: '_statusDate') Element? statusDateElement,
- FhirMarkdown? description,
- @JsonKey(name: '_description') Element? descriptionElement,
- CodeableConcept? combinedPharmaceuticalDoseForm,
- List<
CodeableConcept> ? route, - FhirMarkdown? indication,
- @JsonKey(name: '_indication') Element? indicationElement,
- CodeableConcept? legalStatusOfSupply,
- CodeableConcept? additionalMonitoringIndicator,
- List<
CodeableConcept> ? specialMeasures, - CodeableConcept? pediatricUseIndicator,
- List<
CodeableConcept> ? classification, - List<
MarketingStatus> ? marketingStatus, - List<
CodeableConcept> ? packagedMedicinalProduct, - List<
Reference> ? comprisedOf, - List<
CodeableConcept> ? ingredient, - List<
CodeableReference> ? impurity, - List<
Reference> ? attachedDocument, - List<
Reference> ? masterFile, - List<
MedicinalProductDefinitionContact> ? contact, - List<
Reference> ? clinicalTrial, - List<
Coding> ? code, - required List<
MedicinalProductDefinitionName> name, - List<
MedicinalProductDefinitionCrossReference> ? crossReference, - List<
MedicinalProductDefinitionOperation> ? operation, - List<
MedicinalProductDefinitionCharacteristic> ? characteristic,
MedicinalProductDefinition A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).
resourceType
This is a MedicinalProductDefinition resource
id The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
meta
The metadata about the resource. This is content that is
maintained by the infrastructure. Changes to the content might not
always be associated with version changes to the resource.
implicitRules
A reference to a set of rules that were followed when the
resource was constructed, and which must be understood when processing
the content. Often, this is a reference to an implementation guide that
defines the special rules along with other profiles etc.
implicitRulesElement
("_implicitRules") Extensions for implicitRules
language
The base language in which the resource is written.
languageElement
("_language") Extensions for language
text
A human-readable narrative that contains a summary of the resource
and can be used to represent the content of the resource to a human. The
narrative need not encode all the structured data, but is required to
contain sufficient detail to make it "clinically safe" for a human to
just read the narrative. Resource definitions may define what content
should be represented in the narrative to ensure clinical safety.
contained
These resources do not have an independent existence apart
from the resource that contains them - they cannot be identified
independently, nor can they have their own independent transaction
scope. This is allowed to be a Parameters resource if and only if it is
referenced by a resource that provides context/meaning.
extension_
("extension") May be used to represent additional
information that is not part of the basic definition of the resource. To
make the use of extensions safe and managable, there is a strict set of
governance applied to the definition and use of extensions. Though any
implementer can define an extension, there is a set of requirements that
SHALL be met as part of the definition of the extension.
modifierExtension
May be used to represent additional information that
is not part of the basic definition of the resource and that modifies
the understanding of the element that contains it and/or the
understanding of the containing element's descendants. Usually modifier
elements provide negation or qualification. To make the use of
extensions safe and managable, there is a strict set of governance
applied to the definition and use of extensions. Though any implementer
is allowed to define an extension, there is a set of requirements that
SHALL be met as part of the definition of the extension. Applications
processing a resource are required to check for modifier
extensions.Modifier extensions SHALL NOT change the meaning of any
elements on Resource or DomainResource (including cannot change the
meaning of modifierExtension itself).
identifier
Business identifier for this product. Could be an MPID. When
in development or being regulated, products are typically referenced by
official identifiers, assigned by a manufacturer or regulator, and
unique to a product (which, when compared to a product instance being
prescribed, is actually a product type). See also
MedicinalProductDefinition.code.
type
Regulatory type, e.g. Investigational or Authorized.
domain
If this medicine applies to human or veterinary uses.
version
A business identifier relating to a specific version of the
product, this is commonly used to support revisions to an existing
product.
versionElement
("_version") Extensions for version
status
The status within the lifecycle of this product record. A
high-level status, this is not intended to duplicate details carried
elsewhere such as legal status, or authorization status.
statusDate
The date at which the given status became applicable.
statusDateElement
("_statusDate") Extensions for statusDate
description
General description of this product.
descriptionElement
("_description") Extensions for description
combinedPharmaceuticalDoseForm
The dose form for a single part product,
or combined form of a multiple part product. This is one concept that
describes all the components. It does not represent the form with
components physically mixed, if that might be necessary, for which see
(AdministrableProductDefinition.administrableDoseForm).
route
The path by which the product is taken into or makes contact with
the body. In some regions this is referred to as the licenced or
approved route. See also AdministrableProductDefinition resource.
MedicinalProductDefinition.route is the same concept as
AdministrableProductDefinition.routeOfAdministration.code, and they
cannot be used together.
indication
Description of indication(s) for this product, used when
structured indications are not required. In cases where structured
indications are required, they are captured using the
ClinicalUseDefinition resource. An indication is a medical situation for
which using the product is appropriate.
indicationElement
("_indication") Extensions for indication
legalStatusOfSupply
The legal status of supply of the medicinal product
as classified by the regulator.
additionalMonitoringIndicator
Whether the Medicinal Product is subject
to additional monitoring for regulatory reasons, such as heightened
reporting requirements.
specialMeasures
Whether the Medicinal Product is subject to special
measures for regulatory reasons, such as a requirement to conduct
post-authorization studies.
pediatricUseIndicator
If authorised for use in children, or infants,
neonates etc.
classification
Allows the product to be classified by various systems,
commonly WHO ATC.
marketingStatus
Marketing status of the medicinal product, in contrast
to marketing authorization. This refers to the product being actually
'on the market' as opposed to being allowed to be on the market (which
is an authorization).
packagedMedicinalProduct
Package type for the product. See also the
PackagedProductDefinition resource.
comprisedOf
Types of medicinal manufactured items and/or devices that
this product consists of, such as tablets, capsule, or syringes. Used as
a direct link when the item's packaging is not being recorded (see also
PackagedProductDefinition.package.containedItem.item).
ingredient
The ingredients of this medicinal product - when not
detailed in other resources. This is only needed if the ingredients are
not specified by incoming references from the Ingredient resource, or
indirectly via incoming AdministrableProductDefinition,
PackagedProductDefinition or ManufacturedItemDefinition references. In
cases where those levels of detail are not used, the ingredients may be
specified directly here as codes.
impurity
Any component of the drug product which is not the chemical
entity defined as the drug substance, or an excipient in the drug
product. This includes process-related impurities and contaminants,
product-related impurities including degradation products.
attachedDocument
Additional information or supporting documentation
about the medicinal product.
masterFile
A master file for the medicinal product (e.g.
Pharmacovigilance System Master File). Drug master files (DMFs) are
documents submitted to regulatory agencies to provide confidential
detailed information about facilities, processes or articles used in the
manufacturing, processing, packaging and storing of drug products.
contact
A product specific contact, person (in a role), or an
organization.
clinicalTrial
Clinical trials or studies that this product is involved
in.
code
A code that this product is known by, usually within some formal
terminology, perhaps assigned by a third party (i.e. not the
manufacturer or regulator). Products (types of medications) tend to be
known by identifiers during development and within regulatory process.
However when they are prescribed they tend to be identified by codes.
The same product may be have multiple codes, applied to it by multiple
organizations.
name
The product's name, including full name and possibly coded parts.
crossReference
Reference to another product, e.g. for linking
authorised to investigational product, or a virtual product.
operation
A manufacturing or administrative process or step associated
with (or performed on) the medicinal product.
characteristic
Allows the key product features to be recorded, such as
"sugar free", "modified release", "parallel import".
Implementation
const factory MedicinalProductDefinition({
/// [resourceType] This is a MedicinalProductDefinition resource
@Default(R5ResourceType.MedicinalProductDefinition)
@JsonKey(unknownEnumValue: R5ResourceType.MedicinalProductDefinition)
R5ResourceType resourceType,
@JsonKey(includeFromJson: true, includeToJson: false) int? dbId,
/// [id] The logical id of the resource, as used in the URL for the
/// resource. Once assigned, this value never changes.
@JsonKey(name: 'id') FhirId? fhirId,
/// [meta] The metadata about the resource. This is content that is
/// maintained by the infrastructure. Changes to the content might not
/// always be associated with version changes to the resource.
FhirMeta? meta,
/// [implicitRules] A reference to a set of rules that were followed when
/// the resource was constructed, and which must be understood when
/// processing the content. Often, this is a reference to an
/// implementation guide that defines the special rules along with other
/// profiles etc.
FhirUri? implicitRules,
/// [implicitRulesElement] ("_implicitRules") Extensions for implicitRules
@JsonKey(name: '_implicitRules') Element? implicitRulesElement,
/// [language] The base language in which the resource is written.
FhirCode? language,
/// [languageElement] ("_language") Extensions for language
@JsonKey(name: '_language') Element? languageElement,
/// [text] A human-readable narrative that contains a summary of the
/// resource and can be used to represent the content of the resource to a
/// human. The narrative need not encode all the structured data, but is
/// required to contain sufficient detail to make it "clinically safe" for
/// a human to just read the narrative. Resource definitions may define
/// what content should be represented in the narrative to ensure clinical
/// safety.
Narrative? text,
/// [contained] These resources do not have an independent existence apart
/// from the resource that contains them - they cannot be identified
/// independently, nor can they have their own independent transaction
/// scope. This is allowed to be a Parameters resource if and only if it
/// is referenced by a resource that provides context/meaning.
List<Resource>? contained,
/// [extension_] ("extension") May be used to represent additional
/// information that is not part of the basic definition of the resource.
/// To make the use of extensions safe and managable, there is a strict
/// set of governance applied to the definition and use of extensions.
/// Though any implementer can define an extension, there is a set of
/// requirements that SHALL be met as part of the definition of the
/// extension.
@JsonKey(name: 'extension') List<FhirExtension>? extension_,
/// [modifierExtension] May be used to represent additional information
/// that is not part of the basic definition of the resource and that
/// modifies the understanding of the element that contains it and/or the
/// understanding of the containing element's descendants. Usually
/// modifier elements provide negation or qualification. To make the use
/// of extensions safe and managable, there is a strict set of governance
/// applied to the definition and use of extensions. Though any
/// implementer is allowed to define an extension, there is a set of
/// requirements that SHALL be met as part of the definition of the
/// extension. Applications processing a resource are required to check
/// for modifier extensions.Modifier extensions SHALL NOT change the
/// meaning of any elements on Resource or DomainResource (including
/// cannot change the meaning of modifierExtension itself).
List<FhirExtension>? modifierExtension,
/// [identifier] Business identifier for this product. Could be an MPID.
/// When in development or being regulated, products are typically
/// referenced by official identifiers, assigned by a manufacturer or
/// regulator, and unique to a product (which, when compared to a product
/// instance being prescribed, is actually a product type). See also
/// MedicinalProductDefinition.code.
List<Identifier>? identifier,
/// [type] Regulatory type, e.g. Investigational or Authorized.
CodeableConcept? type,
/// [domain] If this medicine applies to human or veterinary uses.
CodeableConcept? domain,
/// [version] A business identifier relating to a specific version of the
/// product, this is commonly used to support revisions to an existing
/// product.
String? version,
/// [versionElement] ("_version") Extensions for version
@JsonKey(name: '_version') Element? versionElement,
/// [status] The status within the lifecycle of this product record. A
/// high-level status, this is not intended to duplicate details carried
/// elsewhere such as legal status, or authorization status.
CodeableConcept? status,
/// [statusDate] The date at which the given status became applicable.
FhirDateTime? statusDate,
/// [statusDateElement] ("_statusDate") Extensions for statusDate
@JsonKey(name: '_statusDate') Element? statusDateElement,
/// [description] General description of this product.
FhirMarkdown? description,
/// [descriptionElement] ("_description") Extensions for description
@JsonKey(name: '_description') Element? descriptionElement,
/// [combinedPharmaceuticalDoseForm] The dose form for a single part
/// product, or combined form of a multiple part product. This is one
/// concept that describes all the components. It does not represent the
/// form with components physically mixed, if that might be necessary, for
/// which see (AdministrableProductDefinition.administrableDoseForm).
CodeableConcept? combinedPharmaceuticalDoseForm,
/// [route] The path by which the product is taken into or makes contact
/// with the body. In some regions this is referred to as the licenced or
/// approved route. See also AdministrableProductDefinition resource.
/// MedicinalProductDefinition.route is the same concept as
/// AdministrableProductDefinition.routeOfAdministration.code, and they
/// cannot be used together.
List<CodeableConcept>? route,
/// [indication] Description of indication(s) for this product, used when
/// structured indications are not required. In cases where structured
/// indications are required, they are captured using the
/// ClinicalUseDefinition resource. An indication is a medical situation
/// for which using the product is appropriate.
FhirMarkdown? indication,
/// [indicationElement] ("_indication") Extensions for indication
@JsonKey(name: '_indication') Element? indicationElement,
/// [legalStatusOfSupply] The legal status of supply of the medicinal
/// product as classified by the regulator.
CodeableConcept? legalStatusOfSupply,
/// [additionalMonitoringIndicator] Whether the Medicinal Product is
/// subject to additional monitoring for regulatory reasons, such as
/// heightened reporting requirements.
CodeableConcept? additionalMonitoringIndicator,
/// [specialMeasures] Whether the Medicinal Product is subject to special
/// measures for regulatory reasons, such as a requirement to conduct
/// post-authorization studies.
List<CodeableConcept>? specialMeasures,
/// [pediatricUseIndicator] If authorised for use in children, or infants,
/// neonates etc.
CodeableConcept? pediatricUseIndicator,
/// [classification] Allows the product to be classified by various
/// systems, commonly WHO ATC.
List<CodeableConcept>? classification,
/// [marketingStatus] Marketing status of the medicinal product, in
/// contrast to marketing authorization. This refers to the product being
/// actually 'on the market' as opposed to being allowed to be on the
/// market (which is an authorization).
List<MarketingStatus>? marketingStatus,
/// [packagedMedicinalProduct] Package type for the product. See also the
/// PackagedProductDefinition resource.
List<CodeableConcept>? packagedMedicinalProduct,
/// [comprisedOf] Types of medicinal manufactured items and/or devices that
/// this product consists of, such as tablets, capsule, or syringes. Used
/// as a direct link when the item's packaging is not being recorded (see
/// also PackagedProductDefinition.package.containedItem.item).
List<Reference>? comprisedOf,
/// [ingredient] The ingredients of this medicinal product - when not
/// detailed in other resources. This is only needed if the ingredients
/// are not specified by incoming references from the Ingredient resource,
/// or indirectly via incoming AdministrableProductDefinition,
/// PackagedProductDefinition or ManufacturedItemDefinition references. In
/// cases where those levels of detail are not used, the ingredients may
/// be specified directly here as codes.
List<CodeableConcept>? ingredient,
/// [impurity] Any component of the drug product which is not the chemical
/// entity defined as the drug substance, or an excipient in the drug
/// product. This includes process-related impurities and contaminants,
/// product-related impurities including degradation products.
List<CodeableReference>? impurity,
/// [attachedDocument] Additional information or supporting documentation
/// about the medicinal product.
List<Reference>? attachedDocument,
/// [masterFile] A master file for the medicinal product (e.g.
/// Pharmacovigilance System Master File). Drug master files (DMFs) are
/// documents submitted to regulatory agencies to provide confidential
/// detailed information about facilities, processes or articles used in
/// the manufacturing, processing, packaging and storing of drug products.
List<Reference>? masterFile,
/// [contact] A product specific contact, person (in a role), or an
/// organization.
List<MedicinalProductDefinitionContact>? contact,
/// [clinicalTrial] Clinical trials or studies that this product is
/// involved in.
List<Reference>? clinicalTrial,
/// [code] A code that this product is known by, usually within some formal
/// terminology, perhaps assigned by a third party (i.e. not the
/// manufacturer or regulator). Products (types of medications) tend to be
/// known by identifiers during development and within regulatory process.
/// However when they are prescribed they tend to be identified by codes.
/// The same product may be have multiple codes, applied to it by multiple
/// organizations.
List<Coding>? code,
/// [name] The product's name, including full name and possibly coded parts.
required List<MedicinalProductDefinitionName> name,
/// [crossReference] Reference to another product, e.g. for linking
/// authorised to investigational product, or a virtual product.
List<MedicinalProductDefinitionCrossReference>? crossReference,
/// [operation] A manufacturing or administrative process or step
/// associated with (or performed on) the medicinal product.
List<MedicinalProductDefinitionOperation>? operation,
/// [characteristic] Allows the key product features to be recorded, such
/// as "sugar free", "modified release", "parallel import".
List<MedicinalProductDefinitionCharacteristic>? characteristic,
}) = _MedicinalProductDefinition;