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Class TMedicinalProductDefinition

Description
Hierarchy
Fields
Methods
Properties

Unit

bsFhir_r4b

Declaration

type TMedicinalProductDefinition = class(TDomainResource)

Description

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). If the element is present, it must have either a @value, an @id, or extensions

Hierarchy

Overview

Methods

Public constructor Create; override;

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;
Public property type_ : TCodeableConcept read Gettype_ write Settype_;
Public property domain : TCodeableConcept read Getdomain write Setdomain;
Public property version : string read Getversion write Setversion;
Public property versionElement : Tstring read GetversionElement write SetversionElement;
Public property status : TCodeableConcept read Getstatus write Setstatus;
Public property statusDate : string read GetstatusDate write SetstatusDate;
Public property statusDateElement : TdateTime_ read GetstatusDateElement write SetstatusDateElement;
Public property description : string read Getdescription write Setdescription;
Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
Public property combinedPharmaceuticalDoseForm : TCodeableConcept read GetcombinedPharmaceuticalDoseForm write SetcombinedPharmaceuticalDoseForm;
Public property route : TCodeableConceptArray read GetrouteArray;
Public property indication : string read Getindication write Setindication;
Public property indicationElement : Tmarkdown read GetindicationElement write SetindicationElement;
Public property legalStatusOfSupply : TCodeableConcept read GetlegalStatusOfSupply write SetlegalStatusOfSupply;
Public property additionalMonitoringIndicator : TCodeableConcept read GetadditionalMonitoringIndicator write SetadditionalMonitoringIndicator;
Public property specialMeasures : TCodeableConceptArray read GetspecialMeasuresArray;
Public property pediatricUseIndicator : TCodeableConcept read GetpediatricUseIndicator write SetpediatricUseIndicator;
Public property classification : TCodeableConceptArray read GetclassificationArray;
Public property marketingStatus : TMarketingStatusArray read GetmarketingStatusArray;
Public property packagedMedicinalProduct : TCodeableConceptArray read GetpackagedMedicinalProductArray;
Public property ingredient : TCodeableConceptArray read GetingredientArray;
Public property impurity : TCodeableReferenceArray read GetimpurityArray;
Public property attachedDocument : TReferenceArray read GetattachedDocumentArray;
Public property masterFile : TReferenceArray read GetmasterFileArray;
Public property contact : TMedicinalProductDefinitionContactArray read GetcontactArray;
Public property clinicalTrial : TReferenceArray read GetclinicalTrialArray;
Public property code : TCodingArray read GetcodeArray;
Public property name_ : TMedicinalProductDefinitionNameArray read Getname_Array;
Public property crossReference : TMedicinalProductDefinitionCrossReferenceArray read GetcrossReferenceArray;
Public property operation : TMedicinalProductDefinitionOperationArray read GetoperationArray;
Public property characteristic : TMedicinalProductDefinitionCharacteristicArray read GetcharacteristicArray;

Description

Methods

Public constructor Create; override;
 

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;

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.

Public property type_ : TCodeableConcept read Gettype_ write Settype_;

Regulatory type, e.g. Investigational or Authorized.

Public property domain : TCodeableConcept read Getdomain write Setdomain;

If this medicine applies to human or veterinary uses.

Public property version : string read Getversion write Setversion;

A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

Public property versionElement : Tstring read GetversionElement write SetversionElement;
 
Public property status : TCodeableConcept read Getstatus write Setstatus;

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.

Public property statusDate : string read GetstatusDate write SetstatusDate;

The date at which the given status became applicable.

Public property statusDateElement : TdateTime_ read GetstatusDateElement write SetstatusDateElement;
 
Public property description : string read Getdescription write Setdescription;

General description of this product.

Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
 
Public property combinedPharmaceuticalDoseForm : TCodeableConcept read GetcombinedPharmaceuticalDoseForm write SetcombinedPharmaceuticalDoseForm;

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).

Public property route : TCodeableConceptArray read GetrouteArray;

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.

Public property indication : string read Getindication write Setindication;

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.

Public property indicationElement : Tmarkdown read GetindicationElement write SetindicationElement;
 
Public property legalStatusOfSupply : TCodeableConcept read GetlegalStatusOfSupply write SetlegalStatusOfSupply;

The legal status of supply of the medicinal product as classified by the regulator.

Public property additionalMonitoringIndicator : TCodeableConcept read GetadditionalMonitoringIndicator write SetadditionalMonitoringIndicator;

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

Public property specialMeasures : TCodeableConceptArray read GetspecialMeasuresArray;

Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studies.

Public property pediatricUseIndicator : TCodeableConcept read GetpediatricUseIndicator write SetpediatricUseIndicator;

If authorised for use in children, or infants, neonates etc.

Public property classification : TCodeableConceptArray read GetclassificationArray;

Allows the product to be classified by various systems, commonly WHO ATC.

Public property marketingStatus : TMarketingStatusArray read GetmarketingStatusArray;

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).

Public property packagedMedicinalProduct : TCodeableConceptArray read GetpackagedMedicinalProductArray;

Package type for the product. See also the PackagedProductDefinition resource.

Public property ingredient : TCodeableConceptArray read GetingredientArray;

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.

Public property impurity : TCodeableReferenceArray read GetimpurityArray;

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.

Public property attachedDocument : TReferenceArray read GetattachedDocumentArray;

Additional information or supporting documentation about the medicinal product.

Public property masterFile : TReferenceArray read GetmasterFileArray;

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.

Public property contact : TMedicinalProductDefinitionContactArray read GetcontactArray;

A product specific contact, person (in a role), or an organization.

Public property clinicalTrial : TReferenceArray read GetclinicalTrialArray;

Clinical trials or studies that this product is involved in.

Public property code : TCodingArray read GetcodeArray;

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.

Public property name_ : TMedicinalProductDefinitionNameArray read Getname_Array;

The product's name, including full name and possibly coded parts.

Public property crossReference : TMedicinalProductDefinitionCrossReferenceArray read GetcrossReferenceArray;

Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.

Public property operation : TMedicinalProductDefinitionOperationArray read GetoperationArray;

A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

Public property characteristic : TMedicinalProductDefinitionCharacteristicArray read GetcharacteristicArray;

Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

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