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    Class MedicinalProductDefinition

    MedicinalProductDefinition Class

    Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).

    FHIR Specification

    • Short: Detailed definition of a medicinal product
    • Definition: 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).
    • FHIR Version: 5.0.0

    FHIR MedicinalProductDefinition

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    constructor

    Properties

    identifier? type_? domain? version? status? statusDate? description? combinedPharmaceuticalDoseForm? route? indication? legalStatusOfSupply? additionalMonitoringIndicator? specialMeasures? pediatricUseIndicator? classification? marketingStatus? packagedMedicinalProduct? comprisedOf? ingredient? impurity? attachedDocument? masterFile? contact? clinicalTrial? code? name crossReference? operation? characteristic?

    Methods

    parse getIdentifier setIdentifier addIdentifier hasIdentifier getType setType hasType getDomain setDomain hasDomain getVersionElement setVersionElement hasVersionElement getVersion setVersion hasVersion getStatus setStatus hasStatus getStatusDateElement setStatusDateElement hasStatusDateElement getStatusDate setStatusDate hasStatusDate getDescriptionElement setDescriptionElement hasDescriptionElement getDescription setDescription hasDescription getCombinedPharmaceuticalDoseForm setCombinedPharmaceuticalDoseForm hasCombinedPharmaceuticalDoseForm getRoute setRoute addRoute hasRoute getIndicationElement setIndicationElement hasIndicationElement getIndication setIndication hasIndication getLegalStatusOfSupply setLegalStatusOfSupply hasLegalStatusOfSupply getAdditionalMonitoringIndicator setAdditionalMonitoringIndicator hasAdditionalMonitoringIndicator getSpecialMeasures setSpecialMeasures addSpecialMeasures hasSpecialMeasures getPediatricUseIndicator setPediatricUseIndicator hasPediatricUseIndicator getClassification setClassification addClassification hasClassification getMarketingStatus setMarketingStatus addMarketingStatus hasMarketingStatus getPackagedMedicinalProduct setPackagedMedicinalProduct addPackagedMedicinalProduct hasPackagedMedicinalProduct getComprisedOf setComprisedOf addComprisedOf hasComprisedOf getIngredient setIngredient addIngredient hasIngredient getImpurity setImpurity addImpurity hasImpurity getAttachedDocument setAttachedDocument addAttachedDocument hasAttachedDocument getMasterFile setMasterFile addMasterFile hasMasterFile getContact setContact addContact hasContact getClinicalTrial setClinicalTrial addClinicalTrial hasClinicalTrial getCode setCode addCode hasCode getName setName addName hasName getCrossReference setCrossReference addCrossReference hasCrossReference getOperation setOperation addOperation hasOperation getCharacteristic setCharacteristic addCharacteristic hasCharacteristic fhirType isEmpty isRequiredFieldsEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initRoute initSpecialMeasures initClassification initMarketingStatus initPackagedMedicinalProduct initComprisedOf initIngredient initImpurity initAttachedDocument initMasterFile initContact initClinicalTrial initCode initName initCrossReference initOperation initCharacteristic

    Constructors

    Properties

    identifier?: Identifier[]

    MedicinalProductDefinition.identifier Element

    FHIR Specification

    • Short: Business identifier for this product. Could be an MPID
    • Definition: 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.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true

    Private Optionaltype_

    type_?: CodeableConcept

    MedicinalProductDefinition.type Element

    FHIR Specification

    • Short: Regulatory type, e.g. Investigational or Authorized
    • Definition: Regulatory type, e.g. Investigational or Authorized.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    domain?: CodeableConcept

    MedicinalProductDefinition.domain Element

    FHIR Specification

    • Short: If this medicine applies to human or veterinary uses
    • Definition: If this medicine applies to human or veterinary uses.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    version?: StringType

    MedicinalProductDefinition.version Element

    FHIR Specification

    • Short: A business identifier relating to a specific version of the product
    • Definition: A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    status?: CodeableConcept

    MedicinalProductDefinition.status Element

    FHIR Specification

    • Short: The status within the lifecycle of this product record
    • Definition: 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.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: true
    • isModifierReason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
    • isSummary: true
    statusDate?: DateTimeType

    MedicinalProductDefinition.statusDate Element

    FHIR Specification

    • Short: The date at which the given status became applicable
    • Definition: The date at which the given status became applicable.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    description?: MarkdownType

    MedicinalProductDefinition.description Element

    FHIR Specification

    • Short: General description of this product
    • Definition: General description of this product.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    combinedPharmaceuticalDoseForm?: CodeableConcept

    MedicinalProductDefinition.combinedPharmaceuticalDoseForm Element

    FHIR Specification

    • Short: The dose form for a single part product, or combined form of a multiple part product
    • Definition: 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).
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    route?: CodeableConcept[]

    MedicinalProductDefinition.route Element

    FHIR Specification

    • Short: The path by which the product is taken into or makes contact with the body
    • Definition: 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.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    indication?: MarkdownType

    MedicinalProductDefinition.indication Element

    FHIR Specification

    • Short: Description of indication(s) for this product, used when structured indications are not required
    • Definition: 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.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    legalStatusOfSupply?: CodeableConcept

    MedicinalProductDefinition.legalStatusOfSupply Element

    FHIR Specification

    • Short: The legal status of supply of the medicinal product as classified by the regulator
    • Definition: The legal status of supply of the medicinal product as classified by the regulator.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    additionalMonitoringIndicator?: CodeableConcept

    MedicinalProductDefinition.additionalMonitoringIndicator Element

    FHIR Specification

    • Short: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
    • Definition: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    specialMeasures?: CodeableConcept[]

    MedicinalProductDefinition.specialMeasures Element

    FHIR Specification

    • Short: Whether the Medicinal Product is subject to special measures for regulatory reasons
    • Definition: Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    pediatricUseIndicator?: CodeableConcept

    MedicinalProductDefinition.pediatricUseIndicator Element

    FHIR Specification

    • Short: If authorised for use in children
    • Definition: If authorised for use in children, or infants, neonates etc.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    classification?: CodeableConcept[]

    MedicinalProductDefinition.classification Element

    FHIR Specification

    • Short: Allows the product to be classified by various systems
    • Definition: Allows the product to be classified by various systems, commonly WHO ATC.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    marketingStatus?: MarketingStatus[]

    MedicinalProductDefinition.marketingStatus Element

    FHIR Specification

    • Short: Marketing status of the medicinal product, in contrast to marketing authorization
    • Definition: 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).
    • FHIR Type: MarketingStatus
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    packagedMedicinalProduct?: CodeableConcept[]

    MedicinalProductDefinition.packagedMedicinalProduct Element

    FHIR Specification

    • Short: Package type for the product
    • Definition: Package type for the product. See also the PackagedProductDefinition resource.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    comprisedOf?: Reference[]

    MedicinalProductDefinition.comprisedOf Element

    FHIR Specification

    • Short: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
    • Definition: 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).
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    ingredient?: CodeableConcept[]

    MedicinalProductDefinition.ingredient Element

    FHIR Specification

    • Short: The ingredients of this medicinal product - when not detailed in other resources
    • Definition: 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.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    impurity?: CodeableReference[]

    MedicinalProductDefinition.impurity Element

    FHIR Specification

    • Short: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
    • Definition: 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.
    • FHIR Type: CodeableReference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    attachedDocument?: Reference[]

    MedicinalProductDefinition.attachedDocument Element

    FHIR Specification

    • Short: Additional documentation about the medicinal product
    • Definition: Additional information or supporting documentation about the medicinal product.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    masterFile?: Reference[]

    MedicinalProductDefinition.masterFile Element

    FHIR Specification

    • Short: A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
    • Definition: 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.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    contact?: MedicinalProductDefinitionContactComponent[]

    MedicinalProductDefinition.contact Element

    FHIR Specification

    • Short: A product specific contact, person (in a role), or an organization
    • Definition: A product specific contact, person (in a role), or an organization.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    clinicalTrial?: Reference[]

    MedicinalProductDefinition.clinicalTrial Element

    FHIR Specification

    • Short: Clinical trials or studies that this product is involved in
    • Definition: Clinical trials or studies that this product is involved in.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    code?: Coding[]

    MedicinalProductDefinition.code Element

    FHIR Specification

    • Short: A code that this product is known by, within some formal terminology
    • Definition: 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.
    • FHIR Type: Coding
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    name: null | MedicinalProductDefinitionNameComponent[]

    MedicinalProductDefinition.name Element

    FHIR Specification

    • Short: The product's name, including full name and possibly coded parts
    • Definition: The product's name, including full name and possibly coded parts.
    • FHIR Type: BackboneElement
    • Cardinality: 1..*
    • isModifier: false
    • isSummary: true
    crossReference?: MedicinalProductDefinitionCrossReferenceComponent[]

    MedicinalProductDefinition.crossReference Element

    FHIR Specification

    • Short: Reference to another product, e.g. for linking authorised to investigational product
    • Definition: Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    operation?: MedicinalProductDefinitionOperationComponent[]

    MedicinalProductDefinition.operation Element

    FHIR Specification

    • Short: A manufacturing or administrative process for the medicinal product
    • Definition: A manufacturing or administrative process or step associated with (or performed on) the medicinal product.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    characteristic?: MedicinalProductDefinitionCharacteristicComponent[]

    MedicinalProductDefinition.characteristic Element

    FHIR Specification

    • Short: Key product features such as "sugar free", "modified release"
    • Definition: Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true

    Methods

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise

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